CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)

• K Number: K133466
• Device Name: CELLVIZIO 100 SERIES SYSTEM WITH CONFOCAL MINIPROBES (TM)
• Manufacturer: MAUNA KEA TECHNOLOGIES
• Date Cleared: 2014-07-25 ( 255 days)
• Product Code: OWN
• Regulation Number: 876.1500

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 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.

Predicate Devices

K111047, K061666

Reference Devices

K111047

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary focuses on hardware changes (laser wavelength) and standard safety/performance testing, with no mention of AI/ML, image processing beyond basic acquisition, or data sets for training/testing algorithms.

Therapeutic

No.
The device is intended for imaging and diagnostic purposes, not for treating conditions.

Diagnostic

Yes

The device is intended to allow "imaging of the internal microstructure of tissues" to provide "confocal images of the internal microstructure of tissues in anatomical tracts," which is a form of diagnostic imaging.

SaMD (Software as a Medical Device)

No

The device description explicitly states it is a "confocal laser system with fiber optic probes" and mentions hardware components like lasers and filters, indicating it is a hardware device with associated software.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use describes imaging of the internal microstructure of tissues in vivo (within the body) in anatomical tracts. IVDs are used to examine specimens in vitro (outside the body), such as blood, urine, or tissue samples.
• Device Description: The device is a confocal laser system with fiber optic probes used with an endoscope, which is a tool for examining the inside of the body. This further supports its in vivo application.
• Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.

The device is clearly intended for direct imaging of tissues within a living patient, which falls under the category of medical imaging devices, not IVDs.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

OWN

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.

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

confocal laser system with fiber optic probes

Anatomical Site

gastrointestinal or respiratory

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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)
• 2. 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
• 5. 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;
• 2. Requirements of 21 CFR Part 1040 are met;
• 3. Spectral sensitivity meets all requirements;
• The product conforms to all electrical safety requirements, and 4)
• Product software has been satisfactorily validated.

Key Metrics

Not Found

Predicate Device(s)

K111047, K061666

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

0

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 Technologies
9 rue d'Enghien
F-75010 Paris, France
Phone:
Fax:	[phone]
[phone]
Contact Person:	Michael A Daniel, Consultant

Phone Number: [phone] Office: [phone] Facsimile Number: [phone]

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 Confocal
MiniprobesTM
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)]:

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.

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.

1

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.

TM

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)
• 2. 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
• 5. 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;
• 2. Requirements of 21 CFR Part 1040 are met;
• 3. 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

3

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 [phone] or [phone] 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 [phone] or [phone] 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)

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.

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'

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