CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES

K111047 · Mauna Kea Technologies, Inc. · OWN · Aug 8, 2011 · Gastroenterology, Urology

Device Facts

• Record ID: K111047
• Device Name: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES
• Applicant: Mauna Kea Technologies, Inc.
• Product Code: OWN · Gastroenterology, Urology
• Decision Date: Aug 8, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 876.1500
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

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 endoscopic accessories.

Device Story

Cellvizio 100 Series is a confocal laser imaging system; utilizes fiber optic probes (Confocal Miniprobes) to capture internal tissue microstructure images. System components include Laser Scanning Unit (LSU), Confocal Processor with software, and peripherals (foot-switch, keyboard, trackball, screen). Operated by clinicians in clinical settings during endoscopic procedures. Laser scanning technology transmits light through optical fiber bundles; reflected light is processed to generate real-time images. Output displayed on screen for physician review; assists in visualizing tissue microstructure. Benefits include enhanced visualization of internal anatomy during endoscopic access. System integrated into a mobile cart.

Clinical Evidence

Bench testing only. Comparison of images obtained using representative tissue samples with both the upgraded system and predicate devices demonstrated that software and hardware updates do not affect image quality or imaging performance.

Technological Characteristics

Confocal laser scanning system; fiber optic probe-based imaging. Components: Laser Scanning Unit, Confocal Processor, fiber optic Miniprobes. Integrated cart-based form factor. Software-controlled image processing. ISO 9001 and ISO 13485 compliant design process.

Indications for Use

Indicated for patients requiring imaging of internal tissue microstructure within gastrointestinal or respiratory tracts 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

• Cellvizio® F-400 System (K051585)
• Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) (K061666)

Submission Summary (Full Text)

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K11047 page ① of ③

Mauna Kea Technologies

AUG - 8 2011

Special 510(k)

# Section 7: Premarket Notification 510(k) Summary

## A. Submitter Information

i. Company name and address

Mauna Kea Technologies 9 rue d'Enghien 75010 Paris France

Image /page/0/Picture/8 description: The image shows a logo or symbol consisting of a circular arrangement of dots. There is a larger dot in the center, surrounded by smaller dots in a hexagonal pattern. To the right of the symbol is the letter "M".

Mauna Kea Technologies

## ii. Contact name

Chris Tihansky (Official Correspondent) President North America Mauna Kea Technologies 660 Newtown-Yardley Rd., Suite 107 Newtown, PA 18940, USA Tel : + 1 215 279 8415 Cell : + 1 484 988 0079 Fax : + 1 215 279 8463 email: [e-mail]

iii. Date prepared

July 22th, 2011

#### B. Name of the device

#### i. Proprietary name

Cellvizio® 100 Series (Cellvizio® 100 Series System with Confocal Miniprobes™)

#### ii. Model number

Cellvizio® 100 Series System with F400-v2 Confocal Miniprobes™:

- ColoFlex™ (Z and UHD types), .
- . GastroFlex™ (Z and UHD types), and
- AlveoFlex™

#### iii. Common names

Cellvizio®, Cellvizio® 100 Series, Confocal Miniprobes™, GastroFlex™, and AlveoFlex™

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K111J47 Page (2) of R

Mauna Kea Technologies

Special 510(k)

# iv. Classification name

Endoscope and/or Accessories (21 CFR 876.1500)

#### v. Classification

Class II

vi. Product Code

GCJ

## C. Predicate device(s) information

| Device Name | Manufacturer | Premarket Notification<br>510(k) No. | Clearance<br>Date |
|---------------------------------------------------------------------------------------|---------------------------|--------------------------------------|---------------------|
| Cellvizio® F-400 System | Mauna Kea<br>Technologies | K051585 | September 6<br>2005 |
| Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™<br>(Coloflex, Gastroflex, Alveoflex) | Mauna Kea<br>Technologies | K061666 | August 24<br>2006 |

## D. Device description

Cellvizio® 100 Series is a confocal laser imaging system with a variety of fiber optic probes (Confocal Miniprobes™) that is intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e. gastrointestinal or respiratory, accessed through an endoscope.

Cellvizio® 100 Series is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers which is the raw component of the Confocal Miniprobes™.

Cellvizio® 100 Series is composed of several components, including:

- . Main opto-electronical components:
- Laser Scanning Unit (LSU) .
- . Confocal Miniprobes™
- . Confocal Processor with Cellvizio® Software
- . Peripherals:
- . Foot-switch
- . Keyboard
- . Trackball
- . Screen
- . Video converter
- . lsolation transformer
- . User documentation: Cellvizio® 100 Series System User Guide, Confocal Miniprobes™ User Guide and Reprocessing Instructions
- . Accessories (such as Cletop-S Confocal Miniprobes™ connector cleaning system, Confocal Miniprobes™ clip, storage box, caps, späre fuses)

All components are integrated into a cart.

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Special 510(k)

7 Page 3 of

Mauna Kea Technologie

## E. Intended use

Cellvizio® 100 Series is intended to allow confocal laser imaging of the internal microstructure of tissues in anatomical tracts, i.e. gastrointestinal or respiratory, accessed through an endoscope.

The intended use of the device has not changed since the K051585 and K061666 clearances.

## F. Indications for 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 endoscopic accessories.

## G. Comparison to predicate device(s) & Performance data

The comparison to the predicate devices was based on a review of the Company's 510(k) Premarket Notifications K051585 and K061666, that refer to previously cleared versions of the Cellvizio® device.

This submission is being made for device modifications that do not alter the scientific premise. technological characteristics or intended use of the device.

The changes made to the device that are reflected in this Special 510(k) have been made and evaluated in accordance with the Company's Quality Management System and Design Control process, which is certified as ISO 9001 and ISO 13485 compliant, and it has been determined that the upgrades made to the system do not introduce any new concerns related to the safety or effectiveness compared to the predicate devices and the data presented herein demonstrate that the device continues to operate as intended.

Bench testing has been conducted to confirm that the device satisfies the performance requirements for its intended use. Results of bench testing show that the upgrades made to the system do not introduce any new concerns related to the safety or effectiveness compared to the predicate devices. Additionally, comparison of images obtained in bench testing, using representative tissue samples with both the upgraded system and the predicate devices demonstrates that both software and hardware updates do not affect image quality and imaging performance.

#### H. Conclusions

The testing demonstrates that Cellvizio® 100 Series is equivalent to predicate devices and can be used as 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.

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#### DEPARTMENT OF "HEALTH" & "HUMAN" SERVICES"

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features the department's seal, which includes an emblem with three stylized human figures. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular pattern around the emblem. The overall design is simple and recognizable, representing the department's role in public health and human services.

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

Mauna Kea Technologies, Inc. % TUV Rheinland of North America, Inc. Mr. Michael S. Ogunleye 12 Commerce Road Newton. Connecticut 06470

AUG - 8 2011

Re: K111047

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: July 22, 2011 Received: July 27, 2011

Dear Mr. Ogunleye:

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

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Page 2 – Mr. Michael S. Ogunleye

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 practive requirements as set forth in the quality systems (OS) 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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

fin
N. Melkerson

Mark N. Melkerson Director Division of Surgical, Orthopedic And Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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## Section 6: Indications for Use Statement

510(k) Number: K111047

Device Name:

Cellvizio® 100 Series System with Confocal Miniprobes™

Indications for 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 endoscopic accessories.

Prescription X_____________________________________________________________________________________________________________________________________________________________________________

Use AND/OR Over-The-Counter

(Part 21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nil R.P. Dyle for mxm
(Division Sign Off)

Use

ision of Surgical, Orthopedic,

510(k) Number K111047
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