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

The Cellvizio® 100 Series System F400 is indicated for in vascular areas, including microvasculature and capillaries.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography.

Upon interstitial administration and use of ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging and visualization of the lymphatic system, including lymphatic vessels and lymph nodes.

Upon administration and use of pafolacianine consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence imaging of tissues that have taken up the drug.

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 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™ (-, -C) Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

The AQ-Flex™ 19 (-, -C) Confocal Miniprobes™ are intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscopic accessories (e.g. aspiration needles used during procedures including but not limited to EUS-FNA, EBUS-TBNA and TBNA).

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

The CranioFlex™ (-, -C) Confocal Miniprobes™ are indication within the central nervous system during cranial diagnostic and therapeutic procedures such as turnor biopsy and resection.

Device Description

Confocal Miniprobes™ are used with Cellvizio® 100 series (F800) system, which is a confocal imaging system with fiber optic probes which allows visualization of internal microstructure of tissues and blood flow including, but not limited to, the identification of cells, vessels and their orqanization or architecture, during endoscopic and laparoscopic surgical procedures, including robot-assisted procedures.

To achieve this function, the Cellvizio® 100 series system F800 with its Confocal Miniprobes™ has been designed:

. To excite fluorescent components within the human tissue with the laser light emitted by the Cellvizio® at 785nm.
To receive fluorescence signal emitted from tissue microstructures within the spectral detection . bandwidth of the Cellvizio® 800-905 nm.

ICG absorbs light in the near-infrared (NIR) region within a range of 780 nm to 805 nm with a peak absorption of 805 nm and emits fluorescence within a range of 810 nm to 850 nm with a peak emission of 820 nm (cf. ICG labeling).

Therefore, the Cellvizio® 100 series system F800 can excite ICG circulating in the vascular and lymphatic systems and image signal emitted by ICG in these two systems.

Pafolacianine absorbs light in the near-infrared (NIR) region within a range of 760 nm to 785 nm with a peak absorption of 776 nm and emits fluorescence within a range of 790 nm to 815 nm with a peak emission of 796 nm (cf. Pafolacianine Sodium labeling).

Therefore, the Cellvizio® 100 series F800 model can:

A excite ICG in the vascular system or the Ivmphatic system and image signal emitted by ICG in the vascular system or the lymphatic system after ICG has been administered to the patient according to its approved labeling.
A excite pafolacianine or tissues that have taken up pafolacianine and image signal emitted by pafolacianine or tissues that have taken up pafolacianine after pafolacianine has been administered to the patient according to its approved labeling.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Cellvizio® 100 series system, which is a confocal laser system with fiber optic probes intended for imaging the internal microstructure of tissues. This submission asserts substantial equivalence to a predicate device (VS3 Iridium System, K210265) and a reference device (Cellvizio 100 Series System with Confocal Miniprobes, K191144).

However, the provided text does not contain explicit acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy thresholds) for the device's capability to image internal microstructure, ICG, or pafolacianine. Instead, the "proof" the device meets its intended use is demonstrated through a comparison to predicate and reference devices, and through various performance testing studies, implying that the device performs comparably to or as described for these existing cleared devices.

Given this, I will infer the "acceptance criteria" based on the successful comparability shown in the performance testing and the claim of substantial equivalence. The study proves the device meets (implicitly defined) acceptance criteria by demonstrating its functional equivalence to previously cleared devices for imaging various tissues and contrast agents.

Here's an attempt to structure the information based on your request, highlighting what is present and what is missing:

Acceptance Criteria and Device Performance Study for Cellvizio® 100 series system with Confocal Miniprobes™

The Cellvizio® 100 series system with Confocal Miniprobes™ is intended to allow imaging of the internal microstructure of tissues, including the identification of cells, vessels, and their organization or architecture. For the F800 model, it also includes imaging with ICG and pafolacianine contrast agents. The acceptance criteria are implicitly defined by demonstrating comparability to the predicate and reference devices in their stated functions, and by successful outcomes in various performance tests.

1. Table of Acceptance Criteria (Inferred) and Reported Device Performance:

Acceptance Criteria (Inferred)	Reported Device Performance
General Imaging Capability:
- Ability to image internal microstructure of tissues.	- Confocal Miniprobes™ are used with Cellvizio® 100 series (F800) system, which allows visualization of internal microstructure of tissues. This functionality is identical to the previously cleared Cellvizio® 100 F400 series (K191144).
- Ability to identify cells, vessels, and their architecture.	- The device is intended for and performs this function. Animal study demonstrated Cellvizio® 100 series F800 model with its Confocal Miniprobes™ provides "high quality images at microscopic level, in real-time," identifying different cell types and visualizing distinct cell architectures. Clinical studies reported "clear visualization of the cellular cytoarchitecture."
- Comparable optical characteristics to reference device.	- The resolution and optical characteristics (maximum field of view, depth of observation, lateral resolution) of the Confocal Miniprobes™ on the subject device are identical to those of the reference device (K191144).
ICG Imaging Capability (F800 only):
- Ability to excite and image ICG (785nm excitation, 800-905nm detection).	- Bench testing: "In vitro imaging of ICG with different concentrations" showed the device is "capable of imaging ICG at different concentrations." The system excites ICG (785nm) and receives fluorescence (800-905nm) consistent with ICG's emission spectrum.
- Image ICG in vascular areas (microvasculature & capillaries) and lymphatic system (vessels & nodes), consistent with ICG's approved labeling.	- Clinical studies (5 reported): "All studies reported clear visualization of the cellular cytoarchitecture with the Cellvizio® 100 series F800 after intravenous injection of ICG in different tissues, such as the brain, liver, peritoneum, lymph node, diaphragm, colon, stomach, and adrenal gland." This aligns with imaging ICG in vascular and lymphatic systems depending on administration.
Pafolacianine Imaging Capability (F800 only):
- Ability to excite and image pafolacianine (785nm excitation, 800-905nm detection).	- Bench testing: "In vitro imaging of pafolacianine with different concentrations" and "In vitro imaging of human cervical carcinoma cell line with known overexpression of FRa, stained with different concentrations of pafolacianine" showed the device is "capable of imaging... pafolacianine-labeled cells." The system excites pafolacianine (785nm) and receives fluorescence (800-905nm), consistent with pafolacianine's emission spectrum.
- Image tissues that have taken up pafolacianine, consistent with its approved labeling.	- Animal study: Demonstrated the device's capability to "image cells targeted by pafolacianine sodium in tumor cell culture, and in tumor-bearing mice in vivo." It provided "high quality images at microscopic level, in real-time... to identify different cell types in different tissues and visualize distinct cell architectures based on pafolacianine sodium biodistribution in the tumor and normal organs."
Safety and Effectiveness:	- "Mauna Kea respectfully asserts that the Cellvizio® 100 series system with its Confocal Miniprobes™ described in this submission is as safe, as effective, and performs as well as the VS3-785 nm Iridium System (K210265) and is identical to the previously cleared Cellvizio® 100 Series system with Confocal Miniprobes reference device (cleared via K191144)." The technological differences (e.g., max output power, excitation/detection wavelengths for the predicate vs. subject device) are stated not to "raise different questions of safety or effectiveness."

Since this is a 510(k) submission based on substantial equivalence, the "study" proving the device meets acceptance criteria primarily relies on:

Bench Testing: Demonstrating the device's fundamental capabilities with contrast agents.
Animal Studies: Showing in vivo performance specifically for pafolacianine.
Clinical Studies (literature review): Referencing existing studies using the F800 model with ICG.
Comparison to Predicate/Reference Devices: Highlighting identical or comparable characteristics and performance parameters.

Here's the breakdown of the additional requested information:

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

Bench Testing (F800 with ICG/Pafolacianine):
- Sample Size: Not explicitly quantified in terms of number of samples or runs, but refers to "different concentrations" for in vitro imaging of ICG and pafolacianine, and "human cervical carcinoma cell line" for pafolacianine.
- Data Provenance: In vitro data, likely internal company data or performed by a certified lab. Country of origin not specified.
- Retrospective/Prospective: Not specified, but generally bench testing results are reported as part of a prospective submission process.
Animal Testing (F800 with Pafolacianine):
- Sample Size: "tumor-bearing mice in vivo" - specific number of mice not quantified.
- Data Provenance: Animal study data. Country of origin not specified.
- Retrospective/Prospective: Not specified, but generally animal studies for regulatory submissions are prospective.
Clinical Testing (F800 with ICG):
- Sample Size: "Five (5) studies have been reported." Sample sizes within these five studies are not detailed.
- Data Provenance: Clinical studies conducted using the Cellvizio® 100 series F800. Country of origin not specified, but likely international as it's a global company.
- Retrospective/Prospective: The text mentions "studies have been reported," implying they are existing, likely retrospective literature reviews.

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

Not explicitly stated. For bench and animal studies, "ground truth" would be established through laboratory controls, known concentrations, and histological/pathological analysis confirming tumor presence or cellular structures. For the clinical studies mentioned, the "ground truth" would be based on the clinical diagnosis and assessment from the original studies. The qualifications of the individuals interpreting the images or establishing ground truth are not provided in this summary.

4. Adjudication Method for the Test Set:

None explicitly mentioned for the reported studies. For the clinical studies (literature review), the adjudication method would depend on the methodology of those individual studies.
For the bench and animal tests, the results are presented as direct observations ("capable of imaging," "demonstrated adequate resolution and sensitivity").

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, an MRMC comparative effectiveness study was not done. This device is an imaging system providing real-time visualization of microstructure; it's not an AI-powered diagnostic algorithm designed to assist human readers in image interpretation or to provide automated diagnoses. Therefore, this type of study is not applicable.

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

Not applicable. This device is a live imaging system used by a human operator; it is not an algorithm for standalone image analysis or diagnosis. Its performance is inherent in its ability to capture and display microscopic images.

7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.):

Bench Testing: Known concentrations of ICG/pafolacianine, known cell lines (human cervical carcinoma).
Animal Testing: Likely a combination of in vivo imaging correlated with ex vivo histological/pathological analysis of targeted cells/tissues to confirm pafolacianine uptake and tumor presence.
Clinical Testing (literature review): The "clear visualization of the cellular cytoarchitecture" in these studies would imply clinical assessment and potentially correlation with biopsy/pathology, depending on the individual study designs. The document does not specify the exact ground truth methodology for these reported studies.

8. The Sample Size for the Training Set:

Not applicable. This is a medical imaging device, not an AI/ML algorithm that requires a training set. The device's functionality is based on its optical and laser engineering.

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

Not applicable. As above, there is no training set for this device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo for the U.S. Food & Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" in a square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION".

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

April 11, 2022

Re: K220477

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, GCJ, GWG Dated: February 16, 2022 Received: February 18, 2022

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 and Part 809); medical device reporting of medical device-related adverse events) (21 CFR

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for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE(@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

Neil R.P. Ogden, M.S. Assistant Director DHT4A: Division of General Surgery Devices OHT4: Office of Surgical and Infection Control Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known) K220477

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

The Cellvizio® 100 Series System F400 is indicated for in vascular areas, including microvasculature and capillaries.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography.

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 CranioFlex™ (-, -C) Confocal Miniprobes™ are indication within the central nervous system during cranial diagnostic and therapeutic procedures such as turnor biopsy and resection.

Type of Use (Select one or both, as applicable)

X Prescription Use (Part 21 CFR 801 Subpart D)

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

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Premarket Notification 510(k) Summary 1

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: K220477

Applicant Information:

Date Prepared: March 28, 2022

Name:	Mauna Kea Technologies
Contact Person:	Aline Criton, Ph.D.
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
e-mail:	madaniel@clinregconsult.com
Phone Number:	(415) 407-0223

Subject Device Information:

Device Trade Name:	Cellvizio® 100 series system with Confocal Miniprobes™
Common Name:	Confocal Optical Imaging
Classification Name(s):	Endoscope and Accessories
Product Code/ Regulation:	OWN / GCJ / GWG 21 CFR 876.1500, 21 CFR 882.1480

Classification:

Class II

Predicate Device:

VS3 Iridium System, Visionsense Ltd., K210265.

Reference Device:

Cellvizio 100 Series System with Confocal Miniprobes, Mauna Kea Technologies, K191144.

Indications for Use:

The Cellvizio® 100 Series System F400 is indicated for imaging blood flow in vascular areas, including microvasculature and capillaries.

Upon intravenous administration and use of an ICG consistent with its approved labeling, the Cellvizio® 100 Series System F800 is used to perform fluorescence angiography.

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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™ (-. -C) Confocal Miniprobes™ are intended to allow imaging of the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscopic accessories.

The CystoFlex™ (F, F-C, and UHD, UHD-C) and UroFlex™ B (-, -C) 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) Confocal Miniprobes™ are intended to provide visualization of body cavities, organs, and canals during endoscopic and laparoscopic surgical procedures, including robotassisted procedures.

The CranioFlex™ (-, -C) Confocal Miniprobes™ are indicated to provide visualization within the central nervous system during cranial diagnostic and therapeutic procedures such as tumor biopsy and resection.

Subject Device Description:

To achieve this function, the Cellvizio® 100 series system F800 with its Confocal Miniprobes™ has been designed:

. To excite fluorescent components within the human tissue with the laser light emitted by the Cellvizio® at 785nm.
To receive fluorescence signal emitted from tissue microstructures within the spectral detection . bandwidth of the Cellvizio® 800-905 nm.

Therefore, the Cellvizio® 100 series system F800 can excite ICG circulating in the vascular and lymphatic systems and image signal emitted by ICG in these two systems.

Therefore, the Cellvizio® 100 series F800 model can:

A excite ICG in the vascular system or the Ivmphatic system and image signal emitted by ICG in the vascular system or the lymphatic system after ICG has been administered to the patient according to its approved labeling.
A excite pafolacianine or tissues that have taken up pafolacianine and image signal emitted by pafolacianine or tissues that have taken up pafolacianine after pafolacianine has been administered to the patient according to its approved labeling.

Comparison to Predicate and Reference Devices:

The table below details the Indications for Use between the subject device, the predicate device and the reference device.

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Device&PredicateDevice(s):	K220477	K210265	K191144
General Device Characteristics
Device Name	Cellvizio® 100 SeriesSystem with ConfocalMiniprobes	VS3 Iridium system	Cellvizio® 100 SeriesSystem with ConfocalMiniprobes
Operatingmechanism	The tissue is illuminated bythe laser light transmitted bythe fibers of the ConfocalMiniprobe™ through itsdistal objective lens. Theoptical signal from thetissue is collected back bythe same objective andfibers. The fibers areconnected to the LaserScanning Unit (LSU) thatintegrates the illuminationsource and the opticaldetector. Once digitized, thesignal is transmitted to theConfocal Processor™ thatprocesses the image to bedisplayed on a monitor.	IR laser/LED is integrated inVS3- 785 nm IridiumSystem endoscope /microscope, and it is usedto provide illumination of theanatomy underexamination. The light istransmitted from the IRlaser/LED to the distal tipvia two glass fiber lightbundles. The raw datacaptured at the distal tipSilicon Image Sensor in theCamera is converted to avideo signal by the printedcircuit board (PCB). Itallows the image to bedisplayed on a monitor.	The tissue is illuminated bythe laser light transmitted bythe fibers of the ConfocalMiniprobe™ through itsdistal objective lens. Theoptical signal from thetissue is collected back bythe same objective andfibers. The fibers areconnected to the LaserScanning Unit (LSU) thatintegrates the illuminationsource and the opticaldetector. Once digitized, thesignal is transmitted to theConfocal Processor™ thatprocesses the image to bedisplayed on a monitor.
Light Source	Laser	Laser	Laser
Maximumoutputpower	40 mW	500 mW	15 mW
Excitationwavelength	785 nm	785 nm	488 nm
Detectionbandwidth	800 - 905 nm	800 - 850 nm	500 - 650 nm
Opticalcomponents	Rigid section includingobjective lens, flexibleoptical fibers to transmitvisible light to and from thetissue.	Rigid section includingobjective lens, flexibleoptical fibers to transmitNIR light to and from thetissue.	Rigid section includingobjective lens, flexibleoptical fibers to transmitvisible light to and from thetissue.
Angle of view	0 degrees	0 and 30 degrees	0 degrees
Field of view	Circular, diameters of 240,325, and 600 μm	70 - 95 degrees to providevisualization at amacroscopic level	Circular, diameters of 240,325, and 600 μm
Depthofobservation	0 – 65 μm	0 μm	0 – 65 μm
Lateral resolution	1 - 3.5 μm	50 – 250 μm	1 – 3.5 μm
VisualizationofReal-Time Images	9 - 12 FPS	45 FPS	9 - 12 FPS
Useofcontrastagent	ICG, pafolacianine	ICG, pafolacianine	Sodium Fluorescein

Table: Comparison the subject device and previously cleared predicate and reference devices

Materials, design, and intended use of the aforementioned Cellvizio® 100 series F800 system Confocal laser imaging systems and its Confocal Miniprobes™ remain exactly the same as previously cleared in K191144. The F800 system is similar to the VS3 Iridium System (cleared via K210265) including the use of the system with the approved infrared contrast agents, ICG or pafolacianine sodium injection (or Pafolacianine).

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The subject device, the Cellvizio® 100 series F800 with Confocal Miniprobes™ operates in an identical way as the reference device, the Cellvizio® 100 F400 series with Confocal Miniprobes™ (cleared via K191144) in order to provide confocal images of the internal microstructure of tissues including, but not limited to, the identification of cells, vessels and their organization or architecture.

No change is being made in terms of design, fundamental technology, and operating principle of the previously cleared CholangioFlex™, AQ-Flex™ 19, CystoFlex™ F, and UroFlex™ B Confocal Miniprobes™ (cleared via K172844 and K183640). The commercial name of these Confocal Miniprobes™ has been changed when they are used with a Cellvizio 100 Series F800 model. Indications for use of the CholangioFlex™ -C, AQ-Flex™ 19 -C, CystoFlex™ F-C, and UroFlex™ B-C Confocal Miniprobes™ are the same as the reference device (K191144).

The subject device, the Cellvizio® 100 (F800) series with its Confocal Miniprobes™ and the reference device, the Cellvizio® 100 (F400) series with its Confocal Miniprobes™ (cleared via K191144) are similar as they have the identical indications for use, material, design, fundamental technology, and operating principle.

Performance Testing - Bench Completed:

Bench testing has been performed to validate the capability of the Cellvizio® 100 series F800 model with Confocal Miniprobes™ to image ICG and pafolacianine. These tests consisted of the following:

In vitro imaging of ICG with different concentrations,
In vitro imaging of pafolacianine with different concentrations,
In vitro imaging of human cervical carcinoma cell line with known overexpression of FRa, stained with different concentrations of pafolacianine.
These tests showed that the Cellvizio 100 series F800 model with Confocal Miniprobes™ is capable of imaging ICG at different concentrations and pafolacianine-labeled cells.

Performance Testing - Animal Completed:

The objective of this animal study was to assess the capability of the Cellvizio® 100 series F800 model with its Confocal Miniprobes™, also called Confocal Laser Endomicroscopy (CLE), to image cells targeted by pafolacianine sodium in tumor cell culture, and in tumor-bearing mice in vivo.

This animal study demonstrated that Cellvizio® 100 series F800 model with its Confocal Miniprobes™ can provide high quality images at microscopic level, in real-time, pafolacianine sodium targeted cells and tissues. Endomicroscopic images demonstrated adequate resolution and sensitivity to identify different cell types in different tissues and visualize distinct cell architectures based on pafolacianine sodium biodistribution in the tumor and normal organs.

Performance Testing - Clinical:

Five (5) studies have been reported on the use of the Cellvizio® 100 series F800 confocal laser endomicroscopy for tissue characterization using ICG as a contrast agent.

All studies reported clear visualization of the cellular cytoarchitecture with the Cellvizio® 100 series F800 after intravenous injection of ICG in different tissues, such as the brain, liver, peritoneum, lymph node, diaphragm, colon, stomach, and adrenal gland.

Summary:

The subject device, the Cellvizio® 100 series F800 model with Confocal Miniprobes™ and the predicate device Medtronic VS3-785 nm Iridium System (K210265) have the same intended use and the same operating procedure and are made of the same, main components (optical fibers and optical lenses) that allow imaging of tissues, the vascular system or the lymphatic system.

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The subject device, the Cellvizio® 100 series F800 model with Confocal Miniprobes™ and the predicate device Medtronic VS3-785 nm Iridium System (K210265) are comparable when used in conjunction with ICG or pafolacianine as:

A The concentration, rate of administration, or route of administration for the use of ICG or pafolacianine are the same for both devices and as those described in the approved labeling of the contrast agents.
A Body systems imaged with the Cellvizio® 100 series F800 model and the predicate device in conjunction with pafolacianine (tissues that have taken up pafolacianine) and ICG (vascular system or lymphatic system) are the same as those described in the approved labeling of the contrast agent, pafolacianine and ICG.
A The patient population for which the subject device will be used is the same as the predicate, the VS3 Iridium System. Indeed, the predicate system is used to perform intraoperative fluorescence imaging of tissues that have taken up the drug. The subject device is used to perform fluorescence imaging of tissues that have taken up the drug during endoscopic, laparoscopic surgical, and surgical procedures.
A The imaging modality performed by both the predicate and the subject devices is comparable. Both devices achieve fluorescence imaging by:
- を exciting fluorescent components within the human tissue that have taken up pafolacianine with the laser light emitted at 785nm
- ゃ receiving fluorescence signal emitted from tissues that have taken up pafolacianine within the spectral detection bandwidth (800-850 nm for the VS3 Iridium System and 800-905 nm for the Cellvizio®).

In both cases. ICG and Pafolacianine are administered to the patient according to their approved labeling, excitation light is shown onto the tissue and emitted fluorescent light is used to observe the blood flow in vascular areas or visualize the lymphatic system for ICG (depending on the route of administration or ICG), or perform fluorescence imaging of tissues that have taken up the Pafolacianine. While the systems have specific technological differences, they each have the functions for viewing and recording fluorescent images. The technological differences do not raise different questions of safety or effectiveness.

Both devices use ICG and Pafolacianine as contrast agents to perform fluorescent imaging without changes to the formulation, mode of action, approved dose or route of administration.

ICG and Pafolacianine are used in an identical manner for both devices.

Additionally, the Confocal Miniprobes™ of the subject device have technical characteristics (maximum field of view, depth of observation, lateral resolution) as Confocal Miniprobes™ of the reference device.

The subject device, the Cellvizio® 100 (F800) series system with Confocal Miniprobes™ and the reference device, Cellvizio® 100 (F400) series system with Confocal Miniprobes™ (cleared via K191144), have the same indications for use. The resolution and optical characteristics of the Confocal Miniprobes™ on both the reference and subject devices are identical.

Therefore, Mauna Kea respectfully asserts that the Cellvizio® 100 series system with its Confocal Miniprobes™ described in this submission is as safe, as effective, and performs as well as the VS3-785 nm Iridium System (K210265) and is identical to the previously cleared Cellvizio® 100 Series system with Confocal Miniprobes reference device (cleared via K191144).

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.