DEPARTMENT OF HEALTH & HUMAN SERVICES Public Health Service Fd and Drug Administratin 10903 New Hampshire Avenue Dcument Cntrl Center WO66-G609 Silver Spring, MD 20993-0002 Mauna Kea Technlgies c/ Michael A. Daniel Daniel & Daniel Cnsulting 340 Jnes Lane Gardenville, NV, 89460 May 20, 2016 Re: K160416 Trade/Device Name: Cellvizi 100 Series Systems with Cnfcal Miniprbes CeliFlex UHD 5-C Cnfcal Miniprbe CystFlex UHD R-C Cnfcal Miniprbe Regulatin Number: 21 CFR 876.1500 Regulatin Name: Endscpe and Accessries Regulatry Class: Class II Prduct Cde: OWN Dated: April 18, 2016 Received: April 21, 2016 Dear Mr. Daniel: We have reviewed yur Sectin 510(k) premarket ntificatin f intent t market the device referenced abve and have determined the device is substantially equivalent (fr the indicatins fr use stated in the enclsure) t legally marketed predicate devices marketed in interstate cmmerce prir t May 28, 1976, the enactment date f the Medical Device Amendments, r t devices that have been reclassified in accrdance with the prvisins f the Federal Fd, Drug, and Csmetic Act (Act) that d nt require apprval f a premarket apprval applicatin (PMA). Yu may, therefre, market the device, subject t the general cntrls prvisins f the Act. The general cntrls prvisins f the Act include requirements fr annual registratin, listing f devices, gd manufacturing practice, labeling, and prhibitins against misbranding and adulteratin. Please nte: CDRH des nt evaluate infrmatin related t cntract liability warranties. We remind yu, hwever, that device labeling must be truthful and nt misleading. If yur device is classified (see abve) int either class II (Special Cntrls) r class III (PMA), it may be subject t additinal cntrls. Existing majr regulatins affecting yur device can be fund in the Cde f Federal Regulatins, Title 21, Parts 800 t 898. In additin, FDA may publish further annuncements cncerning yur device in the Federal Register. Please be advised that FDA s issuance f a substantial equivalence determinatin des nt mean that FDA has made a determinatin that yur device cmplies with ther requirements f the Act r any Federal statutes and regulatins administered by ther Federal agencies. Yu must cmply with all the Act s requirements, including, but nt limited t: registratin and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reprting (reprting f medical
Page 2 Michael A. Daniel device-related adverse events) (21 CFR 803); gd manufacturing practice requirements as set frth in the quality systems (QS) regulatin (21 CFR Part 820); and if applicable, the electrnic prduct radiatin cntrl prvisins (Sectins 531-542 f the Act); 21 CFR 1000-1050. If yu desire specific advice fr yur device n ur labeling regulatin (21 CFR Part 801), please cntact the Divisin f Industry and Cnsumer Educatin at its tll-free number (800) 638-2041 r (301) 796-7100 r at its Internet address http://www.fda.gv/medicaldevices/resurcesfryu/industry/default.htm. Als, please nte the regulatin entitled, Misbranding by reference t premarket ntificatin (21CFR Part 807.97). Fr questins regarding the reprting f adverse events under the MDR regulatin (21 CFR Part 803), please g t http://www.fda.gv/medicaldevices/safety/reprtaprblem/default.htm fr the CDRH s Office f Surveillance and Bimetrics/Divisin f Pstmarket Surveillance. Yu may btain ther general infrmatin n yur respnsibilities under the Act frm the Divisin f Industry and Cnsumer Educatin at its tll-free number (800) 638-2041 r (301) 796-7100 r at its Internet address http://www.fda.gv/medicaldevices/resurcesfryu/industry/default.htm. Enclsure Sincerely yurs, Jennifer R. Stevensn -A Fr Binita S. Ashar, M.D., M.B.A., F.A.C.S. Directr Divisin f Surgical Devices Office f Device Evaluatin Center fr Devices and Radilgical Health
Mauna Kea Technlgies Special 510(k) Additin f 785nm t Cnfcal Miniprbe Cmpatibility 6. Indicatins fr Use Statement DEPARTMENT OF HEALTH AND HUMAN SERVICES Fd and Drug Administratin Indicatins fr Use Frm Apprved: OMB N. 0910-0120 Expiratin Date: January 31, 2017 See PRA Statement belw. 510(K) Number (if knwn) K160416 Device Name CystFlex UHD R-C and CeliFlex UHD 5-C used with Cellvizi 100 Series (800) Indicatins fr Use (Describe) Cellvizi 100 Series Systems with Cnfcal Miniprbes are cnfcal laser systems with fiber ptic prbes that are intended t allw imaging f the internal micrstructure f tissues. CeliFlex UHD 5-C Cnfcal Miniprbe is intended t be used by qualified physicians t prvide visualizatin f bdy cavities, rgans, and canals during endscpic and laparscpic surgical prcedures. CystFlex UHD R-C Cnfcal Miniprbe can be used within anatmical tracts, i.e., urinary, including, but nt limited t urethra, bladder, and ureter, accessed thrugh an endscpe r endscpic accessries. Type f Use (Select ne r bth, as applicable) Prescriptin Use (Part 21 CFR 801 Subpart D) Over-The-Cunter Use (21 CFR 801 Subpart C) CONTINUE ON A SEPARATE PAGE IF NEEDED. This sectin applies nly t requirements f the Paperwrk Reductin Act f 1995. *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time fr this cllectin f infrmatin is estimated t average 79 hurs per respnse, including the time t review instructins, search existing data surces, gather and maintain the data needed and cmplete and review the cllectin f infrmatin. Send cmments regarding this burden estimate r any ther aspect f this infrmatin cllectin, including suggestins fr reducing this burden, t: Department f Health and Human Services Fd and Drug Administratin Office f Chief Infrmatin Officer Paperwrk Reductin Act (PRA) Staff PRAStaff@fda.hhs.gv An agency may nt cnduct r spnsr, and a persn is nt required t respnd t, a cllectin f infrmatin unless it displays a currently valid OMB number. FORM FDA 3881 (1/14) Page 1 f 1 PSC Publishing Services (301) 443-6740 EF Daniel &Daniel Cnsulting, LLC / MKT Cnfidential Page 22 f 98
Mauna Kea Technlgies Special 510(k) Additin f 785nm t Cnfcal Miniprbe Cmpatibility 1. Premarket Ntificatin 510(k) Summary This summary f 510(k) safety and effectiveness infrmatin is submitted in accrdance with the requirements f SMDA 1990 and 21 CFR 807.92. 510(k) Number: 160416 Applicant Infrmatin: Date Prepared: February 12, 2016 Name: Mauna Kea Technlgies Address: 9 rue d'enghien F-75010 Paris, France Phne: +33 1 48 24 03 45 Fax: +33 1 48 24 12 18 Cntact Persn: Michael A Daniel, Cnsultant madaniel@clinregcnsult.cm Phne Number: (415) 407-0223 Office: (775) 392-2970 Facsimile Number: (610) 545-0799 Device Infrmatin: Device Trade Name: CeliFlex UHD 5-C and CystFlex UHD R-C Cnfcal Miniprbes t be used with Cellvizi 100 Series (800) Cmmn Name: Endscpe and Accessries Classificatin Name(s): Cnfcal Optical Imaging Prduct Cde/ Regulatin: OWN / GCJ 21 CFR 876.1500 Classificatin: Class II Predicate Devices: CystFlex UHD R has been cleared via K141358 CeliFlex UHD 5 has been cleared via K151593 Reference Devices: Cellvizi 100 Series F700-V2 system with Cnfcal Miniprbes has been cleared via K133466. The name f this device mdel has been changed fr cmmercial reasn int Cellvizi 100 Series (800) with F800-V2 and Cnfcal Miniprbes. The prduct is unchanged. The reference t 800 instead f 700 has been made t better clarify the wavelength f emissin f this system, which is 785nm. This reference device will be referred by Cellvizi 100 series (800) with F800-V2 in this current submissin. Daniel &Daniel Cnsulting, LLC / MKT Cnfidential Page 1 f 4
Mauna Kea Technlgies Special 510(k) Additin f 785nm t Cnfcal Miniprbe Cmpatibility Device Descriptin: Cellvizi 100 Series systems with Cnfcal Miniprbes are cnfcal laser systems with fiber ptic prbes that are intended t allw imaging f the internal micrstructure f tissues. Cnfcal Miniprbes are intended t be used by qualified physicians t prvide visualizatin f bdy cavities, rgans, and canals during endscpic and laparscpic surgical prcedures. Bth CystFlex UHD R-C and CeliFlex UHD 5-C have an achrmatic UHD ptical distal head that prvide high reslutin imaging fr 488 t 785nm laser emissin. A -C suffix has been added t the cmmercial name f these Cnfcal Miniprbes cmpared t the predicate devices when used with a Cellvizi 100 Series (800) which has been previusly cleared as Cellvizi 100 Series with F700-v2 system (K133466). Indicatins fr Use: Cellvizi 100 Series Systems with Cnfcal Miniprbes are cnfcal laser systems with fiber ptic prbes that are intended t allw imaging f the internal micrstructure f tissues. CeliFlex UHD 5-C Cnfcal Miniprbe is intended t be used by qualified physicians t prvide visualizatin f bdy cavities, rgans, and canals during endscpic and laparscpic surgical prcedures. CystFlex UHD R-C Cnfcal Miniprbe can be used within anatmical tracts, i.e., urinary, including, but nt limited t urethra, bladder, and ureter, accessed thrugh an endscpe r endscpic accessries. Cmparisn t Previus Devices: N change is being made t the fundamental technlgy and perating principle f the previusly cleared CystFlex UHD R & CeliFlex UHD 5 Cnfcal Miniprbes (K141358 & K151593). Cmmercial name f these Cnfcal Miniprbes has been changed when they are used with a Cellvizi 100 Series (800). Intended use and indicatins fr use f the CystFlex UHD R-C and CeliFlex UHD 5 are the same as the predicate devices (K141358 & K151593). Testing Cmpleted: All the verificatin and validatin testing were perfrmed n predicate devices (CystFlex UHD R and CeliFlex UHD 5 cnfcal Miniprbes) and reference device and have shwn that subject devices (CystFlex UHD R-C and CeliFlex UHD 5-C) meet the design specificatin and user needs. The fllwing tests were perfrmed: Bicmpatibility (Cyttxicity, Sensitizatin, Irritatin r Intracutaneus reactivity & Systemic txicity) accrding t: Daniel &Daniel Cnsulting, LLC / MKT Cnfidential Page 2 f 4
Mauna Kea Technlgies Special 510(k) Additin f 785nm t Cnfcal Miniprbe Cmpatibility ISO 10993-1:2009 Bilgical evaluatin f medical devices - Part 1: Evaluatin and testing within a risk management prcess, ISO 10993-5:2009 Bilgical evaluatin f medical devices - Part 5: Tests fr in vitr cyttxicity, ISO 10993-10:2010 "Bilgical evaluatin f medical devices - Part 10: Tests fr irritatin and delayed-type hypersensitivity", ISO 10993-11:2009 Bilgical evaluatin f medical devices - Part 11: Tests fr systemic txicity Resistance t reprcessing methds: mechanical resistance, tensile strength assessment, functinal testing, image quality etc. accrding t Our internal specificatins regarding the number f uses fr each Cnfcal Miniprbes mdel and AAMI TIR 12:2010 "Designing, testing and labeling reusable medical devices fr reprcessing in health care facilities: A guide fr medical device manufacturers" Efficacy f reprcessing methds has been tested accrding t AAMI TIR 12:2010 "Designing, testing and labeling reusable medical devices fr reprcessing in health care facilities: A guide fr medical device manufacturers" and AAMI TIR 30:2011 A cmpendium f prcesses, materials, test methds, and acceptance criteria fr cleaning reusable medical devices Laser safety has been tested cmpliant with IEC 60825-1:2007 and 21 CFR 1040.10 and 21 CFR 1040.11 with Laser Ntice N 50. Imaging quality tested in cmpliance with the fllwing standards: ISO 8600-1:2005 Optics and phtnics -- Medical endscpes and endtherapy devices -- Part 1: General requirements, ISO 8600-3:1997 Optics and ptical instruments Medical endscpes and endcpic accessries Part 3: Determinatin f field f view and directin f view f endscpes with ptics and ISO 8600-3, Amendement 1, 2003, ISO 8600-4:1997 Optics and ptical instruments Medical endscpes and endcpic accessries Part 4: Determinatin f maximum width f insertin prtin. The reslutin is measured accrding t ur internal standards using 1951 USAF reslutin test chart as a reslutin test pattern cnfrming t MIL-STD-150A standard. Cmpatibility f the CystFlex UHD R Cnfcal Miniprbe with rigid cystscpes cmmnly used t image the urinary tract during endscpic prcedures has been tested and validated accrding t specificatins fr the Cnfcal Miniprbe, and in cmpliance with IEC 60601-1-6:2010 and IEC 62366:2007. Cmpatibility f the CeliFlex UHD 5 R Cnfcal Miniprbe with Trcar cmmnly used during laparscpic prcedures, tested accrding t specificatins fr the Cnfcal Miniprbe, and in cmpliance with IEC 60601-1-6:2010 and IEC 62366:2007 Daniel &Daniel Cnsulting, LLC / MKT Cnfidential Page 3 f 4
Mauna Kea Technlgies Special 510(k) Additin f 785nm t Cnfcal Miniprbe Cmpatibility CystFlex UHD R-C and CeliFlex UHD 5-C when used with Cellvizi 100 Series (800) have been tested cmpliant t IEC 60601-1:2005 and all applicable cllateral standards. The result frm these perfrmance evaluatins demnstrated that the CystFlex UHD R-C and CeliFlex UHD 5-C met the acceptance criteria defined in the prduct specificatin and perfrmed cmparably t the predicate device. Summary: Based upn the intended use, indicatins fr use, prduct technical infrmatin, perfrmance, reprcessing parameters, and bicmpatibility prvided in the submissins f the previusly cleared devices CystFlex UHD R and CeliFlex UHD 5, the subject devices CystFlex UHD R-C and CeliFlex UHD 5-C Cnfcal Miniprbes, when used as part f the Cellvizi 100 Series (800), have been shwn t be substantially equivalent t CystFlex UHD R and CeliFlex UHD 5 predicate devices. The subject devices are identical in technlgical characteristics t the Cnfcal Miniprbe predicate devices when used with the reference device Cellvizi 100 Series (800). Verificatin and validatin testing prvided in previus cleared 510(k) submissins demnstrate that the subject devices can safely and effectively be used t visualize and image the internal micrstructure f tissues during endscpic and laparscpic surgical prcedures. Daniel &Daniel Cnsulting, LLC / MKT Cnfidential Page 4 f 4