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 Description

The subject device, "Cellvizio® 100 Series F700-v2 system with Confocal Miniprobes" operates in the same way as the predicate devices in order to provide confocal images of the internal microstructure of tissues in anatomical tracts. The only difference between the devices is the laser used for imaging at 785nm, along with the filters that have been adapted to this wavelength. The Cellvizio® 100 Series F700-v2 system is equipped with a laser emitting at 785nm whereas predicate devices are equipped witha laser emitting at 488nm or 660nm.

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Cellvizio® 100 Series System with Confocal Miniprobes™, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria Category	Specific Criteria/Test	Reported Device Performance
Laser Safety	Conformance with IEC 60825-1:2007	The laser conforms with requirements of IEC 60825-1:2007.
	Conformance with 21 CFR Part 1040	Requirements of 21 CFR Part 1040 are met.
Optical Performance	Spectral Sensitivity evaluation	Spectral sensitivity meets all requirements.
Electrical Safety	Conformance with IEC 60601-1-1.2000	The product conforms to all electrical safety requirements.
	Conformance with IEC 60601-1-2:2001	The product conforms to all electrical safety requirements.
	Conformance with IEC 60601-1-4	The product conforms to all electrical safety requirements.
	Conformance with IEC 60601-2-18	The product conforms to all electrical safety requirements.
Software	Software validation	Product software has been satisfactorily validated.
Image Quality	Provide similar image performance as predicate device	Mauna Kea Technologies Confocal Miniprobes have been verified to be compatible with the Cellvizio® 100 Series F700-v2 system, and to provide similar image performance as the predicate device.

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

The document does not specify sample sizes for test sets in terms of patient data or image data. The performance data primarily relies on engineering and regulatory compliance testing.

The provenance of this data (e.g., country of origin, retrospective/prospective) is not explicitly stated beyond stating "Performance Data on which Substantial Equivalence is Based". Given the nature of the tests (laser safety, electrical safety, spectral sensitivity, software validation), these are typically conducted in a laboratory setting by the manufacturer or accredited testing facilities.

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

This information is not provided in the document. The study described focuses on technical and regulatory compliance rather than clinical accuracy adjudicated by experts.

4. Adjudication Method for the Test Set:

An adjudication method (e.g., 2+1, 3+1) is not applicable or described in this document as the evaluation is based on technical specifications and functional equivalence, not on clinical performance requiring expert consensus on a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done:

No, an MRMC comparative effectiveness study was not done or reported. The submission focuses on demonstrating substantial equivalence to a predicate device based on technical characteristics and safety/performance testing, not on comparative clinical effectiveness with or without AI assistance. The document is for a device that provides images, and the "AI" aspect (if any) is not discussed in terms of improving human reading.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

This device is an imaging system (endoscope and accessories) that produces images for human interpretation. There is no mention of an "algorithm only" or standalone performance study as there isn't an explicit algorithm being independently evaluated separate from the human-in-the-loop use. The primary focus is the performance of the hardware (laser, filters, electrical components, software) to produce images.

7. The Type of Ground Truth Used:

The ground truth used for these tests is based on established engineering standards and regulatory requirements. For example:

Laser Safety: Ground truth is defined by the limits and specifications in IEC 60825-1:2007 and 21 CFR Part 1040.
Electrical Safety: Ground truth is defined by the requirements in IEC 60601-1 series.
Spectral Sensitivity: Ground truth would be the expected or specified spectral response of the system.
Software Validation: Ground truth is the software design specifications and expected functionality.
Image Quality: The ground truth for "similar image performance" is qualitative comparison against the predicate device's known image output.

It is not based on expert consensus, pathology, or outcomes data in the clinical sense.

8. The Sample Size for the Training Set:

The document does not mention a training set. This type of submission (510(k) for a hardware modification) does not typically involve machine learning or AI models that require training sets in the computational sense. The "software validation" mentioned refers to traditional software engineering validation, not AI model training.

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

As there is no training set mentioned, this question is not applicable to the provided document.

Summary

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Section 7. Premarket Notification "510(k) Summary" JUL 2 5 2014

JUL 2 5 2014

This summary of 510(k) safety and effectiveness information is submitted in accordance with the requirements of 21 CFR 807.92©.

510(k) Number: K133466

Applicant Information [807.92(a)(1)]:

Date Prepared:	July 23, 2014
Name:Address:	Mauna Kea Technologies9 rue d'EnghienF-75010 Paris, France
Phone:Fax:	+33 1 48 24 03 45+33 1 48 24 12 18
Contact Person:	Michael A Daniel, Consultant

Phone Number: (415) 407-0223 Office: (775) 392-2970 Facsimile Number: (775) 392-2972

Device Information [807.92(a)(2)]:

Device Trade Name:	Cellvizio® 100 Series System with Confocal MiniprobesTM
Device Model:	Cellvizio® 100 Series F700-v2 system with ConfocalMiniprobesTM
Common Name:	Endoscope and Accessories
Classification Name(s):	Confocal Optical Imaging
Product Code/ Regulation:	OWN / 21 CFR 876.1500
Classification:	Class II

Predicate Device(s) [807.92(a)(3)]:

Cellvizio® 100 Series System with Confocal Miniprobes™ (K111047) .
Cellvizio® (-GI, -Lung) with Confocal Miniprobe™ (K061666) .

Device Description: [807.92(a)(4)]:

This alternative laser, working at 785nm, allows confocal imaging of tissues with similar quality as the 488nm laser previously-cleared with the Cellvizio® 100 Series system in K111047.

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510(k) Summary Continued:

Intended Use / Indications for Use [807.92(a)(5)]:

The Cellvizio® 100 Series F700-v2 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 endoscopic accessories.

Summary of the Technological Characteristics compared to the Predicate Device [807.92(a)(6)]:

The updated Cellvizio® 100 Series F700-v2 system, using a laser emitting at 785nm, has the following similarities to the Cellvizio® 100 Series F400-v2 system which previously received 510(k) concurrence:

same Indications for use;
same operating principle;
incorporates the same basic design;
incorporates the same materials and is packaged using the same materials and processes.

The only difference between the subject and the predicate devices is the laser used for confocal imaging, along with the filters adapted to its wavelength. The other elements of the Confocal Imaging system are unchanged.

Mauna Kea Technologies Confocal Miniprobes , designed and commonly used in imaging the internal microstructure of tissues in anatomical tracts, have been verified to be compatible with the Cellvizio® 100 Series F700-v2 system, and to provide similar image performance as the predicate device.

Performance Data on which Substantial Equivalence is Based [807.92(b)(1) and (2)]:

Laser safety testing in conformance with IEC 60825-1 2007 Laser Safety 1)
1. 21 CFR Part 1040 Performance standards for light emitting products
Spectral Sensitivity evaluation 3)
Electrical Safety testing in conformance with applicable portions of IEC 60601-1-1.2000 4) and IEC 60601-1-2:2001 and IEC 60601-1-4 and IEC 60601-2-18
1. Software validation

Conclusions Drawn from Performance Data [807.92(b)(3)]

Conclusions from the performance data collected (listed above) are:

1. The laser conforms with requirements of IEC 60825-1:2007;
1. Requirements of 21 CFR Part 1040 are met;
1. Spectral sensitivity meets all requirements;
The product conforms to all electrical safety requirements, and 4)
Product software has been satisfactorily validated.

In summary, the Cellvizio® 100 Series F700-v2 system with Confocal Miniprobes™ described in this submission is substantially equivalent to the predicate devices.

Additional Information [807.92(d)]

None.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

July 25, 2014

Mauna Kea Technologies % Mr. Michael A. Daniel Regulatory Consultant to Mauna Kea Technologies 8 Snowberry Court Orinda, California 94563

Re: K133466

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: June 25, 2014 Received: June 26, 2014

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 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

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Page 2 - Mr. Michael A. Daniel

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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/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 (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

David Northse -S

for

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

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known) K133466

Device Name

Cellvizio 100 Series System with Confocal Miniprobes

Indications for Use (Describe)

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

2 Prescription Use (Part 21 CFR 801 Subpart D)

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

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

Concurrence of Center for Devices and Radiological Health (CDRH) (Signature)

Neil R Ogden -S 2014.07.25 09:05:14 -04'00'

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.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"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."

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.