Cellvizio® 100 Series Systems with Confocal Miniprobes™ are systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

CelioFlex™ UHD 5-C Confocal Miniprobe is intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.

CystoFlex™ UHD R-C Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

Device Description

Cellvizio® 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

Confocal Miniprobes are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.

Both CystoFlex UHD R-C and CelioFlex™ UHD 5-C have an achromatic UHD optical distal head that provide high resolution imaging for 488 to 785nm laser emission.

A "-C" suffix has been added to the commercial name of these Confocal Miniprobes compared to the predicate devices when used with a Cellvizio 100 Series (800) which has been previously cleared as Cellvizio 100 Series with F700-v2 system (K133466).

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study information:

This document is a 510(k) summary for the Cellvizio® 100 Series Systems with Confocal Miniprobes™ (CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C). The core of this submission is to demonstrate substantial equivalence to previously cleared predicate devices, specifically CystoFlex UHD R (K141358) and CelioFlex UHD 5 (K151593), and the reference device Cellvizio 100 Series F700-V2 system (K133466), which has been re-named to Cellvizio 100 Series (800) with F800-V2.

Key takeaway: The document states that "No change is being made to the fundamental technology and operating principle of the previously cleared CystoFlex™ UHD R & CelioFlex™ UHD 5 Confocal Miniprobes." The suffix "-C" was added for commercial reasons when used with the Cellvizio 100 Series (800). Therefore, the acceptance criteria and performance data primarily refer to the studies previously conducted for the predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

Given that this submission is for a device that has "no change... to the fundamental technology and operating principle" of its predicate, the acceptance criteria and reported performance mirror those established for the original predicate devices (K141358 and K151593). The document explicitly states: "All the verification and validation testing were performed on predicate devices... and have shown that subject devices... meet the design specification and user needs." and "The result from these performance evaluations demonstrated that the CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C met the acceptance criteria defined in the product specification and performed comparably to the predicate device."

Acceptance Criteria Category	Specific Criteria/Standard	Reported Device Performance
Biocompatibility	- ISO 10993-1:2009 (Evaluation and testing within a risk management process)	Met requirements; assessed for cytotoxicity, sensitization, irritation/intracutaneous reactivity, and systemic toxicity.
	- ISO 10993-5:2009 (Tests for in vitro cytotoxicity)	Met requirements.
	- ISO 10993-10:2010 (Tests for irritation and delayed-type hypersensitivity)	Met requirements.
	- ISO 10993-11:2009 (Tests for systemic toxicity)	Met requirements.
Resistance to Reprocessing Methods	- Internal specifications for number of uses	Met requirements.
	- AAMI TIR 12:2010 (Designing, testing and labeling reusable medical devices for reprocessing)	Met requirements (mechanical resistance, tensile strength, functional testing, image quality).
Efficacy of Reprocessing Methods	- AAMI TIR 12:2010	Met requirements.
	- AAMI TIR 30:2011 (Compendium of processes, materials, test methods, and acceptance criteria for cleaning reusable medical devices)	Met requirements.
Laser Safety	- IEC 60825-1:2007	Compliant.
	- 21 CFR 1040.10 and 1040.11 with Laser Notice N°50	Compliant.
Imaging Quality	- ISO 8600-1:2005 (General requirements for medical endoscopes)	Compliant.
	- ISO 8600-3:1997 & Amendment 1, 2003 (Determination of field of view and direction of view)	Compliant.
	- ISO 8600-4:1997 (Determination of maximum width of insertion portion)	Compliant.
	- Internal standards using 1951 USAF resolution test chart (MIL-STD-150A) for resolution	Met standards.
Compatibility (CystoFlex™ UHD R-C)	- With rigid cystoscopes according to specifications and IEC 60601-1-6:2010 & IEC 62366:2007	Tested and validated.
Compatibility (CelioFlex™ UHD 5-C)	- With Trocars according to specifications and IEC 60601-1-6:2010 & IEC 62366:2007	Tested and validated.
Electrical Safety (System)	- IEC 60601-1:2005 and applicable collateral standards	Compliant.

Study Information:

Since "all verification and validation testing were performed on predicate devices," the following answers refer to the studies for the predicate devices as implied by this submission. The provided document is a 510(k) summary, which generally summarizes existing data rather than providing full study protocols or detailed results. As such, specific details for some points are not explicitly stated in this summary.

2. Sample size used for the test set and the data provenance:

Sample Size: Not explicitly stated in this summary for each test. Testing would involve multiple units/samples for each specific test (e.g., multiple probes for reprocessing, multiple runs for biocompatibility tests).
Data Provenance: Not explicitly stated, but typically these tests are conducted in controlled lab environments or testing facilities, often within the manufacturer's R&D or by certified third-party testing labs. The product is manufactured in France (Mauna Kea Technologies, 9 rue d'Enghien F-75010 Paris, France). It is reasonable to assume the testing was conducted in Europe or by international standards-compliant labs, but specific country of origin for the data is not given.
Retrospective or Prospective: These are predominantly prospective verification and validation tests conducted to demonstrate compliance with standards and specifications for the initial clearance of the predicate devices.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable/Not stated. The tests described are primarily engineering, electrical, optical, and biological safety tests against established international and national standards (ISO, AAMI, IEC, CFR). The "ground truth" is adherence to these quantifiable technical and safety standards, rather than expert interpretation of medical images. For functional tests, "qualified physicians" are mentioned for the intended use, but not for establishing ground truth of the technical performance tests themselves.

4. Adjudication method for the test set:

Not applicable. These are technical and safety tests, not clinical performance studies requiring adjudication of medical diagnoses. The results are typically pass/fail against predetermined acceptance criteria based on industry standards and device specifications.

5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:

No. This device is an imaging system (confocal miniprobes), not an AI-powered diagnostic or assistive tool. It provides images of the "internal microstructure of tissues." The document describes technical performance and safety, not diagnostic efficacy or AI assistance.

6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

No. This device is an imaging hardware system. It does not contain an "algorithm only" component for standalone performance evaluation in the context of AI.

7. The type of ground truth used:

Established Technical and Safety Standards: The ground truth for this device's performance is adherence to recognized international and national standards for medical devices, optics, laser safety, biocompatibility, and reprocessing (e.g., ISO, AAMI, IEC, 21 CFR).
Internal Specifications: Company-defined specifications regarding device functionality, image quality (e.g., resolution using USAF test chart), and durability (e.g., number of uses) also serve as ground truth for acceptance.

8. The sample size for the training set:

Not applicable. This device is not an AI/ML device that requires a training set.

9. How the ground truth for the training set was established:

Not applicable, as there is no training set for this type of device.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of three human profiles facing right, with flowing lines connecting them. The profiles are arranged in a way that suggests unity and connection. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the image.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

May 20, 2016

Mauna Kea Technologies c/o Michael A. Daniel Daniel & Daniel Consulting 340 Jones Lane Gardenville, NV, 89460

Re: K160416

Trade/Device Name: Cellvizio® 100 Series Systems with Confocal Miniprobes™ CelioFlex™ UHD 5-C Confocal Miniprobe CystoFlex™ UHD R-C Confocal Miniprobe Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN Dated: April 18, 2016 Received: April 21, 2016

Dear Mr. Daniel:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Isting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical

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device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Jennifer R. Stevenson -A

For Binita S. Ashar, M.D., M.B.A., F.A.C.S. Director Division of Surgical Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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6. Indications for Use Statement

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(K) Number (if known)

K160416

Device Name

CystoFlex UHD R-C and CelioFlex UHD 5-C used with Cellvizio 100 Series (800)

· Indications for Use (Describe)

Cellvizio® 100 Series Systems with Confocal Miniprobes™ are systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect

of this information collection, including suggestions for reducing this burden, to: Department of Health and Human Services

Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number. "

FORM FDA 3881 (1/14) Page 1 of 1 Psc Publishing Services (301) 443-6740 EF

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1. Premarket Notification 510(k) Summary

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

510(k) Number: 160416

Applicant Information:

Date Prepared:February 12, 2016

Name:	Mauna Kea Technologies
Address:	9 rue d'Enghien
	F-75010 Paris, France
Phone:	+33 1 48 24 03 45
Fax:	+33 1 48 24 12 18
Contact Person:	Michael A Daniel, Consultantmadaniel@clinregconsult.com
Phone Number:	(415) 407-0223
Office:	(775) 392-2970
Facsimile Number:	(610) 545-0799

Device Information:

Device Trade Name:	CelioFlex™ UHD 5-C and CystoFlex UHD R-C ConfocalMiniprobes to be used with Cellvizio® 100 Series (800)
Common Name:	Endoscope and Accessories
Classification Name(s):	Confocal Optical Imaging
Product Code/ Regulation:	OWN / GCJ 21 CFR 876.1500
Classification:	Class II

Predicate Devices:

CystoFlex UHD R has been cleared via K141358
CelioFlex UHD 5 has been cleared via K151593 ●

Reference Devices:

Cellvizio 100 Series F700-V2 system with Confocal Miniprobes has been cleared via K133466.
The name of this device model has been changed for commercial reason into Cellvizio 100 Series (800) with F800-V2 and Confocal Miniprobes. The product is unchanged. The reference to 800 instead of 700 has been made to better clarify the wavelength of emission of this system, which is 785nm. This reference device will be referred by Cellvizio 100 series (800) with F800-V2 in this current submission.

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Device Description:

Cellvizio® 100 Series systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

Confocal Miniprobes are intended to be used by qualified physicians to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures.

Both CystoFlex UHD R-C and CelioFlex™ UHD 5-C have an achromatic UHD optical distal head that provide high resolution imaging for 488 to 785nm laser emission.

Indications for Use:

Cellvizio® 100 Series Systems with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues.

CystoFlexTM UHD R-C Confocal Miniprobe can be used within anatomical tracts, i.e., urinary, including, but not limited to urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

Comparison to Previous Devices:

No change is being made to the fundamental technology and operating principle of the previously cleared CystoFlex™ UHD R & CelioFlex™ UHD 5 Confocal Miniprobes (K141358 & K151593). Commercial name of these Confocal Miniprobes has been changed when they are used with a Cellvizio 100 Series (800).

Intended use and indications for use of the CystoFlex™ UHD R-C and CelioFlex™ UHD 5 are the same as the predicate devices (K141358 & K151593).

Testing Completed:

All the verification and validation testing were performed on predicate devices (CystoFlex™ UHD R and CelioFlex™ UHD 5 confocal Miniprobes) and reference device and have shown that subject devices (CystoFlex™M UHD R-C and CelioFlexTM UHD 5-C) meet the design specification and user needs. The following tests were performed:

Biocompatibility (Cytotoxicity, Sensitization, Irritation or Intracutaneous reactivity & . Systemic toxicity) according to:

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ISO 10993-1:2009 "Biological evaluation of medical devices Part 1: Evaluation and testing O within a risk management process".
ISO 10993-5:2009 "Biological evaluation of medical devices Part 5: Tests for in vitro O cytotoxicity",
ISO 10993-10:2010 "Biological evaluation of medical devices Part 10: Tests for irritation O and delayed-type hypersensitivity",
ISO 10993-11:2009 "Biological evaluation of medical devices Part 11: Tests for systemic o toxicity"
Resistance to reprocessing methods: mechanical resistance, tensile strength assessment, functional testing, image quality etc. according to
- Our internal specifications regarding the number of uses for each Confocal Miniprobes model o and
- O AAMI TIR 12:2010 "Designing, testing and labeling reusable medical devices for reprocessing in health care facilities: A guide for medical device manufacturers"
Efficacy of reprocessing methods has been tested according to ●
- AAMI TIR 12:2010 "Designing, testing and labeling reusable medical devices for O reprocessing in health care facilities: A guide for medical device manufacturers" and
- AAMI TIR 30:2011 "A compendium of processes, materials, test methods, and acceptance O criteria for cleaning reusable medical devices"
Laser safety has been tested compliant with ●
- IEC 60825-1:2007 and o
- 21 CFR 1040.10 and O
- 21 CFR 1040.11 with Laser Notice Nº50. O
Imaging quality tested in compliance with the following standards:
- ISO 8600-1:2005 "Optics and photonics -- Medical endoscopes and endotherapy devices -o Part 1: General requirements",
- ISO 8600-3:1997 "Optics and optical instruments Medical endoscopes and endocopic O accessories – Part 3: Determination of field of view and direction of view of endoscopes with optics" and ISO 8600-3, Amendement 1, 2003,
- ISO 8600-4:1997 "Optics and optical instruments Medical endoscopes and endocopic O accessories - Part 4: Determination of maximum width of insertion portion".
- The resolution is measured according to our internal standards using 1951 USAF resolution o test chart as a resolution test pattern conforming to MIL-STD-150A standard.
Compatibility of the CystoFlex™ UHD R Confocal Miniprobe with rigid cystoscopes ● commonly used to image the urinary tract during endoscopic procedures has been tested and validated according to specifications for the Confocal Miniprobe, and in compliance with IEC 60601-1-6:2010 and IEC 62366:2007.
. Compatibility of the CelioFlex UHD 5 R Confocal Miniprobe with Trocar commonly used during laparoscopic procedures, tested according to specifications for the Confocal Miniprobe, and in compliance with IEC 60601-1-6:2010 and IEC 62366:2007

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CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C when used with Cellvizio 100 Series (800) have been tested compliant to IEC 60601-1:2005 and all applicable collateral standards.

The result from these performance evaluations demonstrated that the CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C met the acceptance criteria defined in the product specification and performed comparably to the predicate device.

Summary:

Based upon the intended use, indications for use, product technical information, performance, reprocessing parameters, and biocompatibility provided in the submissions of the previously cleared devices CystoFlex™ UHD R and CelioFlex™ UHD 5, the subject devices CystoFlex™ UHD R-C and CelioFlex™ UHD 5-C Confocal Miniprobes, when used as part of the Cellvizio® 100 Series (800), have been shown to be substantially equivalent to CystoFlex™ UHD R and CelioFlex™ UHD 5 predicate devices. The subject devices are identical in technological characteristics to the Confocal Miniprobe predicate devices when used with the reference device Cellvizio 100 Series (800). Verification and validation testing provided in previous cleared 510(k) submissions demonstrate that the subject devices can safely and effectively be used to visualize and image the internal microstructure of tissues during endoscopic and laparoscopic surgical procedures.

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.