Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes

K183640 · Mauna Kea Technologies · OWN · Feb 22, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K183640
• Device Name: Cellvizio 100 Series Confocal laser Imaging systems and their Confocal Miniprobes
• Applicant: Mauna Kea Technologies
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Feb 22, 2019
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

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

Device Story

Cellvizio 100 Series is a confocal laser imaging system using fiber optic probes (Confocal Miniprobes) to visualize internal tissue microstructure in real-time. The AQ-Flex 19 probe is inserted through endoscopic accessories (e.g., EUS-FNA, EBUS-TBNA, TBNA needles) to access gastrointestinal and respiratory tracts. The system captures optical signals via the probe, which are processed to produce high-resolution images of cells and tissue architecture. Used in clinical settings by physicians, the output provides immediate visual feedback to assist in identifying tissue characteristics, potentially guiding biopsy site selection or clinical decision-making. The subject device is a 3-meter version of the previously cleared 4-meter probe, maintaining identical design, materials, and function.

Clinical Evidence

Bench testing only. Testing included biocompatibility (cytotoxicity, sensitization, irritation, systemic toxicity), mechanical resistance, tensile strength, reprocessing efficacy, laser safety, and imaging quality. Compatibility with EBUS-TBNA and TBNA accessories was validated through mechanical testing (n=25) to ensure no sharp edges/spikes on the distal tip and verification of mechanical resistance during insertion/extraction/bending (n=25). Protrusion testing (n=5) confirmed secure positioning.

Technological Characteristics

Confocal laser imaging system; fiber optic probe (AQ-Flex 19); 3-meter length. Materials meet biocompatibility standards. Connectivity via fiber optic interface to console. Sterilization/reprocessing per validated methods. Software-based image processing for real-time visualization. Complies with ISO 8600-1 for endoscope/accessory mechanical safety.

Indications for Use

Indicated for imaging of internal microstructure of tissues, including cells and vessels, within gastrointestinal and respiratory tracts accessed via endoscopes or endoscopic accessories (e.g., aspiration needles for EUS-FNA, EBUS-TBNA, and TBNA procedures).

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Cellvizio® 100 Series Confocal laser imaging systems and the AQ-Flex™ 19 Confocal Miniprobe™ (K123676, K150831, and K172844)

Reference Devices

• AlveoFlexTM Confocal MiniprobeTM (K111047, K150831, and K172844)

Submission Summary (Full Text)

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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.

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

February 22, 2019

Re: K183640

Trade/Device Name: Cellvizio 100 Series Confocal Laser Imaging systems and their Confocal Miniprobes Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: Class II Product Code: OWN, GCJ Dated: December 21, 2018 Received: December 26, 2018

Dear Michael Daniel:

We have reviewed vour 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

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

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 ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

| For | Neil R<br>Ogden -S | Digitally signed by<br>Neil R Ogden -S<br>Date: 2019.02.22<br>09:27:22 -05'00' |
|-----|--------------------------------------------|--------------------------------------------------------------------------------|
| | 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) K183640

Device Name

Cellvizio® 100 Series with Confocal Miniprobe™ AQ-Flex™ 19

Indications for Use (Describe)

Cellvizio® 100 Series System 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 AQ-Flex™ 19 Confocal Miniprobe™ is 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 EUS-FNA, EBUS-TBNA and TBNA needles).

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

| <span></span> | Prescription Use (Part 21 CFR 801 Subpart D) | <span></span> | Over-The-Counter Use (21 CFR 801 Subpart C) |
|---------------|----------------------------------------------|---------------|---------------------------------------------|
|---------------|----------------------------------------------|---------------|---------------------------------------------|

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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: K183640

#### Applicant Information:

Date Prepared: December 21, 2018

Manufacturer Contact:

| Aline Criton | |
|--------------|------------------------|
| Name: | Mauna Kea Technologies |
| Address: | 9 rue d'Enghien |
| | F-75010 Paris, France |
| Phone: | [phone] |
| Fax: | [phone] |

Submission Contact:

Michael A Daniel, Consultant

[e-mail] Phone Number: [phone] [phone] Office: Facsimile Number: [phone]

#### Device Information:

| Device Trade Name: | Cellvizio® 100 Series Confocal laser imaging systems and the<br>Confocal Miniprobe™ AQ-Flex™ 19 |
|-------------------------|-------------------------------------------------------------------------------------------------|
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/ Reg.: | OWN / GCJ 21 CFR 876.1500 |
| Classification: | Class II |

#### Predicate Devices:

- Previously cleared versions of Cellvizio® 100 Series Confocal laser imaging systems . and the AQ-Flex™ 19 Confocal Miniprobe™ (K123676, K150831, and K172844).
#### Reference Devices:

- Previously cleared versions of Cellvizio® 100 Series Confocal laser imaging systems . and the AlveoFlexTM Confocal MiniprobeTM (K111047, K150831, and K172844).

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## Device Description:

AQ-Flex™ 19 Confocal Miniprobes™ is used with Cellvizio® 100 Series system to provide imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories. It is designed to be used during transbronchial needle aspiration (TBNA), endoscopic ultrasound transbronchial needle aspiration (EBUS-TBNA) and endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) procedures.

There are no changes in design, materials, or function between the subject AQ-Flex™ 19 device and the cleared AQ-Flex™ 19 Confocal Miniprobe™ (K123676, K150831, and K172844), except for the length of the AQ-Flex 19 which has been reduced from 4 to 3 meters (AQ-Flex™ 19 Confocal Miniprobe™ has previously been cleared with a length of 4 meters).

A locking accessory already available in the package of the predicate device is used as an aid to secure placement inside the needle used during EUS-FNA procedures and can also be used during TBNA, and EBUS-TBNA procedures.

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

### Indications for Use:

The AQ-Flex™ 19 Confocal Miniprobe™ is intended to allow imaging of anatomical tracts, i.e., gastrointestinal and respiratory tracts, accessed by an endoscope, or endoscopic accessories (e.g. aspiration needles used during procedures including EUS-FNA, EBUS-TBNA and TBNA needles).

#### Comparison to Predicate Device:

The Cellvizio® 100 Series systems and the AQ-Flex™ 19 Confocal Miniprobe™ remain exactly the same devices in terms of design (except for the AQ-Flex™ 19 Confocal Miniprobe™ reduced from 4 to 3 meters), performance and general intended use (allow imaging of the internal microstructure) as the previously cleared devices (K123676, K150831, and K172844). The indication for use is being expanded to include selected needle-based endoscopic procedures for TBNA and EBUS-TBNA procedures.

Verification and validation testing has shown that the AQ-Flex™ 19 Confocal Miniprobes™ are compatible with endoscopes or endoscopic accessories designed and commonly used in these procedures (such as endoscopic needles).

# Testing Completed:

The table below summarizes the verification and validation testing performed on predicate device (AQ-Flex™ 19 Confocal Miniprobe™) and the reference device (AlveoFlex™ Confocal Miniprobe ™) that have been provided in previous submissions K111047, K123676, K150831, and K172844 respectively.

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| <b>Test performed</b> | <b>Acceptance Criteria</b> | <b>Test Results</b> |
|--------------------------------------------------------------------------------------------------------------------------------------|----------------------------|---------------------|
| Biocompatibility (Cytotoxicity, Sensitization, Irritation<br>or Intracutaneous reactivity & Systemic toxicity) | All requirements met | Pass |
| Resistance to reprocessing methods: mechanical<br>resistance, tensile strength assessment, functional<br>testing, image quality etc. | All requirements met | Pass |
| Efficacy of reprocessing methods | All requirements met | Pass |
| Laser safety | All requirements met | Pass |
| Imaging quality | All requirements met | Pass |
| Compatibility of the AQ-Flex™ 19 Confocal<br>Miniprobe™ with endoscopic accessories used during<br>EUS-FNA procedures. | All requirements met | Pass |

The potential risks associated with the use of AQ-Flex™ 19 Confocal Miniprobes™ during EBUS-TBNA and TBNA procedures have been assessed. Additional testing with endoscopic accessories used during EBUS-TBNA and TBNA was performed to validate that the AQ-Flex 19 ™ Confocal Miniprobes™ can be used during EBUS-TBNA and TBNA procedures without change of safety, performance and increase of residual risks. The same test protocols as the ones used when previously testing the AQ-Flex™ 19 Confocal Miniprobes™ for EUS-FNA in the gastro-intestinal tract have been used to assess the risks with EBUS-TBNA and TBNA accessories.

The results from these tests, summarized in the table below, demonstrate that the use of AQ-Flex ™ 19 Confocal Miniprobes™ during EBUS-TBNA and TBNA procedures does not change performance or safety and effectiveness, and do not change the global residual risk.

| Test performed | Acceptance Criteria | Result |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------|
| Compatibility of the AQ-FlexTM 19 Confocal<br>MiniprobeTM with endoscopic accessories used<br>during (EBUS)-TBNA procedures:<br>Mechanical tests to verify no creation of sharp<br>edges on distal head. | Verification of smooth<br>distal surface and absence<br>of spikes and edges on<br>distal tip according to ISO<br>8600-1 standard | Pass<br>(25/25) |
| Compatibility of the AQ-FlexTM 19 Confocal<br>MiniprobeTM with endoscopic accessories used<br>during (EBUS)-TBNA procedures: Confocal<br>Miniprobe TM strength test by<br>insertion/extraction and bending in (EBUS)-<br>TBNA needles. | Verification of mechanical<br>resistance of the probe after<br>extraction of AQ-FlexTM 19<br>from needle in EUS-TBNA<br>and TBNA retroflex<br>position | Pass<br>(25/25) |
| Protrusion test of the of the AQ-FlexTM 19<br>Confocal MiniprobeTM length when used with | Securing position of AQ-<br>FlexTM 19 distal tip with | Pass (5/5) |

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## Summary:

The AQ-Flex™ 19 Confocal Miniprobe™, when used as part of the Cellvizio® 100 Series, has been shown to be substantially equivalent to the cleared predicate device and can be used as intended to image the internal microstructure of tissues in a variety of anatomical locations. The previously cleared Confocal Miniprobe™ has been verified to be compatible with endoscopes and endoscopic accessories designed to be used in these applications.

Based upon the Intended Use, Indications for Use, product technical information, performances, safety and effectiveness, and biocompatibility provided in this submission and in the submissions of the previously cleared AQ-Flex™ 19 Confocal Miniprobe™ (K123676, K150831) used during EBUS-TBNA and TBNA procedures, the subject device is substantially equivalent to the predicate device. The subject device can safely and effectively be used to visualize and image the internal microstructure of tissues during endoscopic and during EBUS-TBNA and TBNA procedures.