Cellvizio 100 Series System with Confocal Miniprobes

K150831 · Mauna Kea Technologies · OWN · Dec 22, 2015 · Gastroenterology, Urology

Device Facts

• Record ID: K150831
• Device Name: Cellvizio 100 Series System with Confocal Miniprobes
• Applicant: Mauna Kea Technologies
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Dec 22, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endloscopic accessories. The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endloscopic accessories. The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal. The AQ-Flex 19 member of the GastroFlex M series of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles. 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 Uroflex™B and CystoFlex™F Confocal Miniprobes can be used within anatomical tracts, i.e. Urinary, including, but not limited to, urethra, bladder, and ureter, accessed through an endoscopic accessories. 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 Story

Cellvizio 100 Series System uses fiber optic confocal miniprobes to capture real-time internal tissue microstructure images. System operates via laser scanning through fiber optics; provides high-resolution optical biopsy images. Used in clinical settings by physicians during endoscopic procedures. Output displayed to clinician for immediate visualization of tissue morphology; assists in clinical decision-making regarding biopsy site selection or tissue characterization. Benefits include real-time, in-vivo assessment of tissue without immediate physical excision. This submission specifically validates compatibility with STERRAD low-temperature sterilization systems for existing probe models.

Clinical Evidence

Bench testing only. Validation included functional testing (visual assessment, insertion/removal, tensile strength, optical performance) post-sterilization, sterility assurance level (SAL) testing to 10^-6, and biocompatibility testing (cytotoxicity, sensitization, irritation) per ISO 10993-1.

Technological Characteristics

Confocal laser imaging system using fiber optic miniprobes. Materials and design identical to predicates. Connectivity via endoscope/endoscopic accessories. Sterilization: validated for low-temperature hydrogen peroxide gas plasma (STERRAD 100S, 100NX, 100NX EXPRESS, 50, 200).

Indications for Use

Indicated for imaging internal tissue microstructure in gastrointestinal, respiratory, or urinary tracts (including urethra, bladder, ureter, biliary, and pancreatic ducts) accessed via endoscope or endoscopic accessories.

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

• ColoFlex™ UHD (K111047)
• GastroFlex™ UHD (K111047)
• AlveoFlex™ (K111047)
• CholangioFlex™ (K122042)
• AQ-Flex™ 19 (K123676)
• UroFlex™ B (K132389)
• CystoFlex™ UHD R (K141358)

Submission Summary (Full Text)

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Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features the department's name encircling a stylized representation of a human figure. The figure is composed of three profiles facing right, symbolizing the department's focus on health and well-being. The text is arranged in a circular pattern around the central emblem.

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

December 22, 2015

Mauna Kea Technologies Mr. Michael A. Daniel Daniel & Daniel Consulting 340 Jones Lane Gardneville, Nevada 89460

Re: K150831

Trade/Device Name: AO-Flex™ (K123676); 2) UroFlex™ B (K132389); 3) CystoFlex™ UHD R (K141358); 4) ColoFlex™ UHD (K111047); GastroFlex™ UHD (Cholangioflex™) (K111047); 6) AlveoFlex™ (K111047); and 7) GastroFlex™ (K122042)

Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: Class II Product Code: OWN Dated: November 20, 2015 Received: November 23, 2015

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

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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 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 [phone] or [phone] 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 [phone] or [phone] or at its Internet address

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

Sincerely yours.

Binita S. Ashar -S

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

Enclosure

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# 6. Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|-------------------------------------------------------------------------|---------------------------------------------------------------|
| Indications for Use | Expiration Date: January 31, 2017<br>See PRA Statement below. |

| 510(k) Number (if known) | K150831 |
|--------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | 1) AQ-Flex™ (K123676); 2) UroFlex™ B (K132389); 3) CystoFlex™ UHD R (K141358); 4) ColoFlex™ UHD (K111047);<br>5) GastroFlex™ UHD (Cholangioflex™) (K111047); 6) AlveoFlex™ (K111047); and 7) GastroFlex™ M (K122042) |
| Indications for Use (Describe) | |
| ColoFlex™ UHD (K111047); GastroFlex™ UHD (Cholangioflex™) (K111047); AlveoFlex™ (K111047): | |

The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with
fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in
anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endloscopic
accessories.

| GastroFlex™ M (K122042): | |
|--------------------------|--|
|--------------------------|--|

The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal
microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts,
accessed by an endoscope or endloscopic accessories.

| AQ-Flex™ (K123676): | |
|---------------------|--|
|---------------------|--|

The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic
probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts,
i.e., gastrointestinal.

The AQ-Flex 19 member of the GastroFlex M series of Confocal Miniprobes can be used within
anatomical tracts, i.e., gastrointestinal, accessed by an endoscope or endoscopic accessories,
including through EUS-FNA needles.

CONTINUED ON NEXT PAGE

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> <i></i> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

CONTINUE ON A SEPARATE PAGE IF NEEDED.

FORM FDA 3881 (8/14)

Page 1 of 2

PSC Publishing Services [phone] EF

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| DEPARTMENT OF HEALTH AND HUMAN SERVICES<br>Food and Drug Administration | Form Approved: OMB No. 0910-0120 |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for Use | Expiration Date: January 31, 2017<br>See PRA Statement below. |
| 510(k) Number (if known) | K150831 |
| Device Name | 1) AQ-Flex™ (K123676); 2) UroFlex™ B (K132389); 3) CystoFlex™ UHD R (K141358); 4) ColoFlex™ UHD (K111047);<br>5) GastroFlex™ UHD (Cholangioflex™) (K111047); 6) AlveoFlex™ (K111047); and 7) GastroFlex™ M (K122042) |
| Indications for Use (Describe) | |
| CONTINUED FROM PREVIOUS PAGE | |
| UroFlex™ B (K132389): | |
| | The Cellvizio® 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that are<br>intended to allow imaging of the internal microstructure of tissues. |
| | The Uroflex™B and CystoFlex™F Confocal Miniprobes can be used within anatomical tracts, i.e. Urinary, including, but<br>not limited to, urethra, bladder, and ureter, accessed through an endoscopic accessories. |
| CystoFlex™ UHD R (K141358) | |
| | The Cellvizio® 100 Series System with Confocal Miniprobes™ is a confocal laser system with fiber optic probes that are<br>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<br>to, urethra, bladder, and ureter, accessed through an endoscope or endoscopic accessories. |
| Type of Use (Select one or both, as applicable) | |
| <input checked="" type="checkbox"/> Prescription Use (Part 21 CFR 801 Subpart D) | <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) |
| CONTINUE ON A SEPARATE PAGE IF NEEDED. | |
| This section applies only to requirements of the Paperwork Reduction Act of 1995, | |
| *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*<br>The burden time for this collection of information is estimated to average 79 hours per response, including the<br>time to review instructions, search existing data sources, gather and maintain the data needed and complete<br>and review the collection of information. Send comments regarding this burden estimate or any other aspect<br>of this information collection, including suggestions for reducing this burden, to: | |
| Department of Health and Human Services<br>Food and Drug Administration<br>Office of Chief Information Officer<br>Paperwork Reduction Act (PRA) Staff | |

Paperwork Reduction Act (PRA) Staff
[e-mail]

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

FORM FDA 3881 (8/14)

Page 1 of 1

PSC Publishing Services [phone] EF

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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: | March 28, 2015 |
| Name: | Mauna Kea Technologies |
| Address: | 9 rue d'Enghien |
| | F-75010 Paris, France |
| Phone: | [phone] |
| Fax: | [phone] |
| Contact Person: | Michael A Daniel, Consultant |
| Phone Number: | [phone] |
| Office: | [phone] |
| Facsimile Number: | [phone] |
| Device Information: | |
| Device Trade Name: | Cellvizio® 100 Series System with Confocal Miniprobes |
| Common Name: | Endoscope and Accessories |
| Classification Name(s): | Confocal Optical Imaging |
| Product Code/ Regulation: | OWN / 21 CFR 876.1500 |
| Classification: | Class II |

#### Predicate Device:

- The Cellvizio 100 Series System with Confocal Miniprobes (ColoFlexTM UHD, ● GatroFlexTM UHD and AlveoFlexTM) have been cleared in K111047.
- The CholangioFlex™ has been cleared in K122042 ●
- The compatibility with low temperature sterilization systems has been cleared for AQ-Flex™ 19 (K123676), UroFlex™ B (K132389) and CystoFlex™ UHD R (K141358)

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## Device Description:

AlveoFlex™. ColoFlex™ UHD, GastroFlex™ UHD, CholangioFlex™, AQ-Flex™. UroFlex™ B and CystoFlex™ UHD R are Confocal Miniprobes which are compatible with specific high level disinfection and low temperature sterilization methods as described in the reprocessing instructions.

Materials, design and intended use of the aforementioned Confocal Miniprobes remain exactly the same as what were previously cleared in K111047. K122042. K123676. K132389 and K141358 respectively.

Low temperature sterilization methods will be added to the reprocessing instructions. Compatibility and efficacy of these methods with Confocal Miniprobes have been validated. The extent of validation testing relevant to this submission is provided below

- 1. Validation of an additional low temperature sterilization system (STERRAD 100NX EXPRESS) on AQ-Flex™ 19 (K123673), UroFlex™ B (K132389) and CystoFlex™ UHD R (K141358).
- 2. Validation of compatibility with low temperature sterilization systems (STERRAD 100S, and 100NX (EXPRESS)) with CholangioFlex™ (K122042), GastroFlex™ UHD, ColoFlex™ UHD and AlveoFlex™ (K111047).

Verification and validation testing confirm that GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™ and CholangioFlex™ Confocal Miniprobes™ can be reprocessed safely using STERRAD® sterilization systems 100S and 100NX (EXPRESS) according to reprocessing instructions.

## Indications for Use:

## ColoFlex™ UHD (K111047); GastroFlex™ UHD (K111047); AlveoFlex™ (K111047):

The Cellvizio 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal or respiratory, accessed by an endoscope or endoscopic accessories.

## GastroFlex™ M (CholangioFlex™) (K122042):

The GastroFlex M series of Confocal Miniprobes are intended to allow imaging of the internal microstructure of tissues in the upper gastrointestinal tract including biliary and pancreatic ducts, accessed by an endoscope or endoscopic accessories.

#### AO-Flex™ 19 (K123676):

The Cellvizic 100 Series System with Confocal Miniprobes is a confocal laser system with fiber optic probes that is intended to allow imaging of the internal microstructure of tissues in anatomical tracts, i.e., gastrointestinal.

The AQ-Flex 19 member of the GastroFlex M series of Confocal Miniprobes can be used within anatomical tracts, i.e., gastrointestinal, accessed by an endoscope or endoscopic accessories, including through EUS-FNA needles.

## UroFlex™ B (K132389):

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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 UroflexTMB and CystoFlex™F Confocal Miniprobes 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.

## CystoFlex™ UHD R (K141358)

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.

## Comparison to Predicate Device:

No change is being made to the predicate devices in term of design, materials nor intended use. Subject devices are identical to previously cleared devices (AlveoFlex™, ColoFlex™ UHD, GastroFlex™ UHD (K111047)), CholangioFlex™ (K122042), UroFlex™ B (K132389), AQ-Flex™ 19 (K123676), CystoFlex™ UHD R (K141358). Further, all Confocal Miniprobes exhibit a similar external geometry. The differences between models are in the internal optical components that allow for different performance characteristics but do not substantially change the outer geometry. Further details regarding probe differences are described in tables 3, 4 and 5 of this submission and in the previously cleared K141358. K132389, K123676, K122042 and K111047 submissions and their corresponding Request for Additional Information submissions.

The only change in this submission is the addition of low temperature sterilization systems to the reprocessing instructions of the previously cleared Confocal Miniprobes (AlveoFlexIM, ColoFlex™ UHD, GastroFlex™ UHD, CholangioFlex™, UroFlex™ B, AQ-Flex™ 19, CystoFlex™ UHD R). This change does not alter the fundamental technology and purpose of the previously cleared Confocal Miniprobes™.

The extension of the previously cleared AQ-Flex™ 19, UroFlex™ B and CystoFlex™ UHD R compatibility with sterilization to CholangioFlex™, ColoFlex™ UHD, GastroFlex™ UHD and AlveoFlex™ is demonstrated based on similarities in terms of design and materials between these products.

## Performance Evaluation:

The following performance testing was completed:

- . Functional testing post sterilization validation included visual assessment of component condition, insertion and removal tests, tensile strength and optical performance assessment. These tests also confirmed material compatibility.
- Sterilization validation was performed on the products to confirm sterility assurance ● levels (SAL) of 10-6

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- . Biocompatibility per relevant portions of ISO 10993-1
- o Cytotoxicity
- o Sensitization
- o Irritation

#### Summary:

Based upon the intended use, indications for use, product technical information, performance testing provided in this special 510(k) submission

- AQ-Flex™ 19, UroFlex™ B and CystoFlex™ UHD R can safely and efficiently be ● reprocessed using STERRAD® 50, 200, 100S, 100NX EXPRESS and 100NX Duo cycles according to reprocessing instructions. Chemical resistance as well as a sterility assurance level (SAL) of 10° has been demonstrated.
- GastroFlex™ UHD, ColoFlex™ UHD, AlveoFlex™ and CholangioFlex™ Confocal . Miniprobes can be reprocessed using STERRAD® sterilization systems 100S, 100NX EXPRESS according to reprocessing instructions as an alternative to previously cleared high-level disinfection methods. The compatibility with these sterilization methods has been demonstrated.