The Cellvizio® 100 Series systems (400 and/or 800) with Confocal Miniprobes™ are confocal laser systems with fiber optic probes that are intended to allow imaging of the internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture.

The GastroFlex™ (UHD, UHD-C) and ColoFlex™ (UHD, UHD-C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal systems, accessed by an endoscope or endoscopic accessories.

The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.

The CholangioFlex™ (or GastroFlex™ M) series of Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories.

The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal tracts, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.

The CystoFlex™ (F, UHD R, UHD R-C) and Uroflex™ B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

The CelioFlex™ (UHD 5, UHD 5-C) of Confocal Miniprobes™ are intended to provide visualization of body cavities. organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

Device Description

The Cellvizio® 100 Series systems with Confocal Miniprobes™ are a 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.

Materials, design and intended use of the aforementioned Cellvizio® 100 Series confocal laser imaging systems and their Confocal Miniprobes™ remain exactly the same as what were previously cleared in K111047, K122042, K123676, K133466, K150831, K151593, K160416 and K171345 respectively.

AI/ML Overview

The provided document is a 510(k) premarket notification for the "Cellvizio 100 Series System with Confocal Miniprobes™". It describes the device, its intended use, and argues for substantial equivalence to previously cleared devices.

Crucially, this document states that "As no change is being made to the devices, all testing required has been provided in previous submissions." It also notes that "Clinical demonstration based on literature review has been carried out to support this submission, as described in section 14."

This K172844 clearance is an update to the Indications for Use based on existing data and literature, rather than presenting new primary study data for the device's performance against acceptance criteria. Therefore, the information typically found in a clinical study report proving device performance against acceptance criteria for a new device or significant modification is not explicitly present in this document.

The document discusses the capabilities of the device in terms of optical resolution for imaging cells and vessels, referencing it as "proven optical resolution capabilities" and citing "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and medical societies." However, it does not provide the specifics of the studies that generated this evidence within this submission.

Therefore, many of your requested points about acceptance criteria and a study proving their achievement cannot be directly extracted from this particular 510(k) summary. This document is a re-submission leveraging prior clearances and general scientific understanding.

Based on the provided text, here's what can be gathered and what cannot:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria: Not explicitly stated as pass/fail criteria for a new study in this document. The device's "proven optical resolution capabilities" and ability to "image cells, vessels, and their organization or architecture" serve as implicit performance expectations, derived from prior clearances (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345).
Reported Device Performance: The document states that the device's "fundamental system capabilities in terms of optical resolution, field of view, etc. as compared to the size of cells and vessels are independent of anatomical location" and that "all of these Confocal Miniprobe™ capabilities are well above what is required to image cells, vessels, and their organization or architecture as described in Section 14." No specific numerical performance metrics are provided in this summary.

2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)

Not provided. The submission relies on "Real World Evidence (RWE) and independent clinical findings from well-respected clinical researchers and medical societies" and previous clearance data, rather than a new, specific test set for this particular submission.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)

Not explicitly stated in this document. The "independent clinical findings" mentioned imply expert input, but details on the number or qualifications of experts involved in prior studies or literature review are absent from this summary.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not provided.

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

Not applicable. This device is an imaging system, not an AI-assisted diagnostic tool designed to improve human reader performance in the way an AI algorithm for image interpretation would. The document does not describe an MRMC study.

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

Not applicable. This is a direct visualization device, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The implicit ground truth for the device's performance relates to its ability to image the "internal microstructure of tissues including, but not limited to, the identification of cells and vessels and their organization or architecture." This would typically be confirmed via a comparison to histology/pathology, or by expert observation using the device itself, but the specific studies and their ground truth methodology are not detailed in this summary. The mention of "Real World Evidence" and "clinical findings" suggests real-world diagnostic outcomes and expert interpretations.

8. The sample size for the training set

Not applicable. This is not an AI/machine learning device that uses a "training set."

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

Not applicable. This is not an AI/machine learning device.

In summary, the provided document (K172844) is a regulatory submission focused on clarifying and expanding the Indications for Use of a previously cleared device. It relies on the substantial equivalence principle and existing evidence (prior clearances, literature review, and "Real World Evidence") rather than presenting new, detailed study results for acceptance criteria. Therefore, specific details about sample sizes, expert qualifications, and study methodologies for proving the device's performance against defined acceptance criteria are not contained within this specific document. These details would presumably be in the support documentation for the original clearances (e.g., K111047, K122042, etc.) or the referenced scientific literature.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 15, 2017

Mauna Kea Technologies % Michael Daniel President Daniel & Daniel Consulting 340 Jones Lane Cardnerville, Nevada 89460

Re: K172844

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: September 18, 2017 Received: September 19, 2017

Dear Michael 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR

1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

David Krause -S

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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Indications for Use

510(k) Number (if known) K172844

Device Name

Cellvizio® 100 Series systems (400 and/or 800) with Confocal Miniprobes™

Indications for Use (Describe)

The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.

Type of Use (Select one or both, as applicable)
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区 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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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:

Applicant Information:

Date Prepared:	September 18, 2017
Date Revised:	November 16, 2017
Name:Address:	Mauna Kea Technologies9 Rue d'EnghienF-75010 Paris, France
Phone:Fax:	+33 1 48 24 03 45+33 1 48 24 12 18
Contact Person:Phone Number:Office:Facsimile Number:	Michael A. Daniel, Consultantmadaniel@clinregconsult.com(415) 407-0223(775) 392-2970(610) 545-0799

Device Information:

Device Trade Name:	Cellvizio® 100 Series Confocal laser imaging systems andtheir Confocal Miniprobes™
Common Name:	Endoscope and Accessories
Classification Name(s):	Confocal Optical Imaging
Product Code/Regulation:	OWN/GCJ 21 CFR876.1500
Classification:	Class II

Predicate devices:

Previously cleared versions of Cellvizio® 100 Series Confocal laser imaging systems and their Confocal Miniprobes™ (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345).

Device Description:

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Intended Use:

The 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 including, but not limited to, the identification of cells and their organization or architecture.

The individual Confocal Miniprobes™ have been previously cleared as summarized in the following table:

Application	Mode of Operation
	400	800
GastrointestinalEndoscopy,	GastroFlex™ UHD (K111047, K150831)ColoFlex™ UHD (K111047, K150831)GastroFlex™ UHD-C (K133466)ColoFlex™UHD-C (K133466)	GastroFlex™ UHD-C (K133466)ColoFlex™UHD-C (K133466)
GastrointestinalEndoscopy, includingbiliary and pancreaticducts	CholangioFlex™ (or GastroFlex™ M)(K122042, K150831)
GastrointestinalEndoscopy, NeedleEndoscopy, includingbiliary and pancreaticducts	AQ-Flex™ 19 (K123676, K150831)
Lung Endoscopy	AlveoFlex™ (K111047, K150831)AlveoFlex™-C (K133466)	AlveoFlex™-C (K133466)
Urinary Endoscopy	CystoFlex™ UHD R (K150831)CystoFlex™ F (K150831)UroFlex™ B (K150831)CystoFlex™ UHD R-C (K160416)	CystoFlex™ UHD R-C (K160416)
Laparoscopy, Manualand robot-assistedlaparoscopic surgery	CelioFlex™ UHD 5 (manual laparoscopy:K151593, robot-assisted laparoscopy:K171345)CelioFlex™ UHD 5-C (manual laparoscopy:K160416, robot-assisted laparoscopy: K171345)	CelioFlex™ UHD 5-C (manual laparoscopy:K160416, robot-assisted laparoscopy: K171345)

Table 1 Table summarizing cleared Confocal Miniprobe™ with models Cellvizio® 100 Series systems with K numbers.

The fundamental system capabilities in terms of optical resolution, field of view, etc. as compared to the size of cells and vessels are independent of anatomical location and for this reason, we are requesting the additional intended use wording be associated with the laser imaging system itself separate from the individual Confocal Miniprobes™. There are relatively small differences in Confocal Miniprobe™ image resolution as described below in Section 14, however all of these Confocal Miniprobe™ capabilities are well above what is required to image cells, vessels, and their organization or architecture as described in Section 14.

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Indications for Use:

The AlveoFlex™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., respiratory systems, accessed by an endoscope or endoscopic accessories.

The CystoFlexTM (F, UHD-R, UHD-C) and UroflexTM B of Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories.

The CelioFlex™ (UHD 5, UHD 5-C) of Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

Comparison to previous Devices:

The Cellvizio® 100 Series systems and its Confocal Miniprobes™ remain exactly the same devices in terms of design, performance and general intended use (allow imaging of the internal microstructure) as the previously cleared devices.

Testing Completed:

As no change is being made to the devices, all testing required has been provided in previous submissions (K111047, K122042, K123676, K133466, K150831, K151593, K160416, K171345).

Clinical demonstration based on literature review has been carried out to support this submission, as described in section 14.

Summary:

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

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cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

There are two models of the Cellvizio® 100 Series systems cleared by the F400 (K111047) and the F800 [K160416, formerly cleared as F700-v2 system (K133466)]. All cleared Cellvizio® 100 Series Confocal Miniprobes™ are compatible with the Cellvizio® 100 Series system (400) - F400 (K111047) but not all are compatible with the Cellvizio® 100 Series system (800) - F800 (K133466, K160416) as shown in the following table (Table 2).

Cellvizio 100 SeriesConfocal Miniprobe™	ClearanceK number	Cellvizio® 100 Seriessystem (400) - F400(K111047)	Cellvizio® 100 Series system(800) - F800 (K133466,K160416)
AlveoFlex™	K111047 K150831	Compatible	Not Compatible
AlveoFlex-C™	K133466	Compatible	Compatible
ColoFlex™ UHD	K111047 K150831	Compatible	Not Compatible
ColoFlex™ UHD-C	K133466	Compatible	Compatible
GastroFlex™ UHD	K111047 K150831	Compatible	Not Compatible
GastroFlex™ UHD-C	K133466	Compatible	Compatible
CystoFlex™ F	K150831	Compatible	Not Compatible
CystoFlex™ UHD R	K150831	Compatible	Not Compatible
CystoFlex™ UHD R-C	K160416	Compatible	Compatible
CelioFlex™ UHD 5	K151593,K171345	Compatible	Not Compatible
CelioFlex™ UHD 5-C	K160416,K171345	Compatible	Compatible
CholangioFlex™ (orGastroFlex™ M)	K150831,K123676	Compatible	Not Compatible
AQ-Flex™ 19	K150831,K122042	Compatible	Not Compatible
UroFlex™ B	K150831	Compatible	Not Compatible

Table 2 Compatibility of Cleared Confocal Miniprobe™ with models Cellvizio® 100 Series systems. F400 and F800.

Please note: A "-C" suffix has been added to the commercial name of Confocal Miniprobes™ to distinguish probes compatible with both Cellvizio® 100 Series systems F400 and F800 from probes compatible only with the Cellvizio® 100 Series system F400.

The objective of this submission is to clarify the previously cleared Indications for Use consistent with the proven optical resolution capabilities of the system, corresponding anatomical sizes of cells and vessels, Real World Evidence (RWE) and independent clinical findings from wellrespected clinical researchers and medical societies.

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.