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

The CystoFlex™ UHD R 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

The CystoFlex UHD R Confocal Miniprobe, when used as part of the Cellvizio 100 Series system and the Cellvizio system, is intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e., urinary, including, but not limited to, urethra and bladder, accessed through an endoscope or endoscopic accessories.

The CystoFlex UHD R Confocal Miniprobe is similar in design to the UroFlex B Confocal Miniprobe, except for its distal optical head, which is a UHD-type distal head. The CystoFlex UHD R Confocal Miniprobe can be inserted into endoscope lumens with inner diameter equal to or higher than 2.8mm, allowing them to work in currently used rigid cystoscopes.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cellvizio 100 Series System with Confocal Miniprobes, specifically focusing on the CystoFlex UHD R Confocal Miniprobe. The submission aims to demonstrate substantial equivalence to a previously cleared predicate device, the UroFlex B Confocal Miniprobe.

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

1. Table of Acceptance Criteria and Reported Device Performance:

The document primarily focuses on demonstrating substantial equivalence to a predicate device rather than defining new, specific performance acceptance criteria for a novel AI device. The "performance" assessment is based on the device's technical specifications and physical design modifications.

Acceptance Criteria (Implied for Substantial Equivalence to Predicate)	Reported Device Performance
Fundamental Technology and Operating Principle: No change from predicate device.	"No change is being made to the fundamental technology and operating principle of the previously cleared UroFlex™ B Confocal Miniprobe..." (Page 4)
Indications for Use: Unchanged from predicate device.	"The indications for use is unchanged and remains to image the urinary tract during endoscopic procedures." (Page 4)
Biocompatibility: No changes.	"...biocompatibility testing provides evidence that there are no changes to the biocompatibility of the device." (Page 4)
Design Specifications & User Needs (for modifications): Modifications meet design specifications and user needs.	"Verification and validation testing provides proof that the modifications meet the design specifications and user needs..." (Page 4)
Compatibility with Cystoscopes: Compatible with cystoscopes designed for urinary tract applications (specifically rigid cystoscopes with working channel ≥ 2.8 mm).	"The CystoFlex™ UHD R is designed to fit into rigid cystoscopes with working channel ≥ 2.8 mm." (Page 4) "This Confocal Miniprobe has been verified to be compatible with cystoscopes that are designed to be used in these applications." (Page 5)

2. Sample Size Used for the Test Set and Data Provenance:

The document does not explicitly mention "test sets," "sample sizes," or "data provenance" in the context of clinical studies for performance metrics. The testing described is primarily engineering and design verification/validation directly related to the physical changes and compatibility of the device.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:

This information is not provided in the document. As the submission is for a physical medical device (confocal miniprobe) and focuses on substantial equivalence based on design and technical specifications, rather than AI algorithm performance requiring expert-adjudicated ground truth, this type of information is not relevant to the content provided.

4. Adjudication Method for the Test Set:

This information is not provided and is not relevant given the nature of the submission (hardware modification seeking substantial equivalence).

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance:

This information is not applicable/not provided. The device is a confocal miniprobe for imaging, not an AI-assisted diagnostic or decision-support system for human readers. Therefore, an MRMC study related to AI assistance is not relevant to this submission.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This information is not applicable/not provided. The device is a physical diagnostic tool for imaging, not a standalone algorithm.

7. The Type of Ground Truth Used:

The "ground truth" in this context is primarily related to the engineering specifications and functional performance of the physical device and its compatibility. For example, fitting into a cystoscope with a certain internal diameter, or ensuring biocompatibility. It's not about clinical diagnostic accuracy against a definitive pathological diagnosis for patient cases as would be seen with an AI diagnostic tool.

8. The Sample Size for the Training Set:

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable/not provided. The device is not an AI algorithm that requires a training set.

Summary of what the document focuses on:

The provided document is a 510(k) summary for a physical medical device (confocal miniprobe). The core argument for FDA clearance is substantial equivalence to a previously cleared predicate device. This equivalence is established by:

Demonstrating that the fundamental technology and operating principles are unchanged.
Confirming that the indications for use are identical.
Detailing minor design modifications (distal optical head) and providing verification and validation testing to show these modifications meet design specifications and user needs.
Ensuring biocompatibility remains unchanged.
Verifying compatibility with existing medical equipment (cystoscopes) for the stated use.

Therefore, the study information requested (e.g., sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone AI performance) is typically relevant for AI/software as a medical device (SaMD) submissions, not for this type of hardware-focused 510(k) submission based on substantial equivalence to an existing device with minor design changes.

Summary

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

September 25, 2014

Mauna Kea Technologies % Mr. Michael A. Daniel Daniel and Daniel Consulting 340 Jones Lane Gardnerville, Nevada 89460

Re: K141358

Trade/Device Name: Cellvizio 100 Series System with Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN Dated: August 27, 2014 Received: August 29, 2014

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, listing 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,

David Krause -S

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

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Indications for Use

510(k) Number (if known) K141358

Device Name

Cellvizio 100 Series System with Confocal Miniprobes

Indications for Use (Describe)

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

The CystoFlex UHD R 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.

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)

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

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Section 7. 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:	K141358
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Applicant Information:

Date Prepared:	May 6, 2014
Name:	Mauna Kea Technologies
Address:	9 rue d'EnghienF-75010 Paris, France
Phone:	+33 1 48 24 03 45
Fax:	+33 1 48 24 12 18

Contact Person: Michael A Daniel, Consultant

Phone Number:	(415) 407-0223
Office:	(775) 392-2970
Facsimile Number:	(775) 392-2972

Device Information:

Device Trade Name:	Cellvizio® 100 Series System with ConfocalMiniprobes™
Common Name:	Endoscope and Accessories
Classification Name(s):	Confocal Optical Imaging
Product Code/ Regulation:	OWN / 21 CFR 876.1500

Predicate Device:

Classification:

Regarding the Cellvizio Confocal Imaging System, the Cellvizio 100 . Series System has been cleared in K111047.
Class II
. Regarding the compatibility of the access during urological procedures in rigid cystoscopes and the visualization and examination of the urinary tract, the CystoFlex UHD R Confocal Miniprobe is substantially equivalent to the previously cleared UroFlex B Confocal Miniprobe (K132389).

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Device Description:

Indications for Use:

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

Comparison to Predicate Device:

No change is being made to the fundamental technology and operating principle of the previously cleared UroFlex™ B Confocal Miniprobe used in this submission as a predicate device (K132389). The CystoFlex UHD R is identical to this predicate device, only differing by the design of its distal optical head ("UHD-type" for the CystoFlex™ UHD R instead of "Z-type" for the UroFlex™ B). The indications for use is unchanged and remains to image the urinary tract during endoscopic procedures.

Due to this UHD-type distal optical head, the CystoFlex™ UHD R is designed to fit into rigid cystoscopes with working channel ≥ 2.8 mm.

Verification and validation testing provides proof that the modifications meet the design specifications and user needs, and biocompatibility testing provides evidence that there are no changes to the biocompatibility of the device.

Summary:

Based upon the intended use, indications for use, product technical information, performance testing and biocompatibility information provided in this premarket notification, the CystoFlex™ UHD R Confocal Miniprobe, when used as part of the Cellvizio 100 Series and the Cellvizio Systems, has been shown to be substantially equivalent to the UroFlex™ B Confocal Miniprobe, and can be used as intended to image the internal microstructure

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Mauna Kea Technologies

of tissues in the urinary tract during endoscopic procedures. This Confocal Miniprobe has been verified to be compatible with cystoscopes that are designed to be used in these applications.

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.