(71 days)
No
The summary describes a confocal laser imaging system and its components, focusing on real-time visualization and hardware. There is no mention of AI, ML, or any related concepts like image processing algorithms that would typically indicate the presence of such technology.
No.
The device's intended use is for imaging the internal microstructure of tissues for visual inspection, which is diagnostic, not therapeutic.
Yes
The "Intended Use / Indications for Use" section states that the device is "intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract... accessed by the endoscope." This imaging of tissue microstructure is for the purpose of aiding in forming a diagnosis.
No
The device description explicitly states it is composed of several elements including a Laser Scanning Unit, a flat panel display, and Miniaturized Fiber Optic Probes, in addition to proprietary software. This indicates it is a system with significant hardware components, not a software-only device.
Based on the provided information, the Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states that the device is for "confocal laser imaging of the internal microstructure of tissues in the anatomical tract... accessed by the endoscope." This describes an in vivo imaging procedure, meaning it is performed within the living body.
- Device Description: The description further emphasizes "in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure."
- IVD Definition: In Vitro Diagnostics (IVDs) are devices intended for use in the examination of specimens derived from the human body (such as blood, urine, tissue samples) outside of the body to provide information for diagnostic purposes.
The Cellvizio system is used to visualize tissues directly within the body during an endoscopic procedure, which is the opposite of an in vitro process.
N/A
Intended Use / Indications for Use
The Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.
Product codes
GCJ
Device Description
The Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) is a confocal microscope with a fiber optic probe which allows in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure. The F-600 system has been designed to allow real-time observations of tissues. The device is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers and is thus composed of several elements: a Laser Scanning Unit, proprietary software running on a remote computer, a flat panel display and Miniaturized Fiber Optic Probes. The F-600 system can be used with any legally marketed endoscope with a working channel of 2.8 mm or greater.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
confocal laser imaging
Anatomical Site
gastrointestinal or respiratory (pulmonary) tract
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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Ko61664
Mauna Kea Technologies Special 510(k): F-600 System
Premarket Notification Special 510(k) Summary 10.0
In accordance with the Safe Medical Devices Act of 1990 and 21 CFR 807.92, a Premarket Notification 510(k) Summary for the F-600 system Premarket Notification is provided below
10.1 Submitter Information
Company Name and Address:
Mauna Kea Technologies 9, rue d'Enghien 75010 Paris France
Contact Name:
Fouad Tarabah, PharmD. Director of Quality and Regulatory Affairs Mauna Kea Technologies Telephone: +33 1 70 08 09 61 Fax: +33 1 48 24 12 18 e-mail: fouad@maunakeatech.com
Date Prepared: May 2006
10.2 Name of Device
Proprietary Name: Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex)
Classification Name: Endoscope and/or Accessories
10.3 Predicate Device(s) Information
Pentax Confocal Laser System, K042740
Pentax EC-3870CILK Confocal Video Colonoscope, K042741
superDimension Bronchus, K042438
10.4 Device Description
The Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) is a confocal microscope with a fiber optic probe which allows in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure. The F-600 system has been designed to allow real-
1
61666
Mauna Kea Technologies Special 510(k): F-600 System
time observations of tissues. The device is based on a common laser scanning technology adapted for imaging through a bundle of optical fibers and is thus composed of several elements: a Laser Scanning Unit, proprietary software running on a remote computer, a flat panel display and Miniaturized Fiber Optic Probes. The F-600 system can be used with any legally marketed endoscope with a working channel of 2.8 mm or greater.
10.5 Intended Use
The Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) is a confocal faser system that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or respiratory, accessed by the endoscope.
10.6 Comparison to Predicate Device(s)
The comparison to the predicate devices was based on a review of the F-400 system information included in the company's 510(k) Premarket Notification K051585 and information concerning the predicate devices that was available in the public domain. The F-400 system is the Mauna Kea Technologie's legally marketed device (K051585) which serves as the unmodified device for the Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) special 510(k) submission.
2
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2006
Mauna Kea Technologies % Fouad Tarabah Director of Quality and Regulatory Affairs 9, Rue D'Enghien Paris, France 75010
Re: K061666
Trade/Device Name: Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: June 20, 2006 Received: June 25, 2006
Dear Fouad Tarabah:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product
3
Page 2 -- Fouad Tarabah
radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely vours.
Vabare Preelup
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Mauna Kea Technologies Special 510(k): F-600 System
ODE Indications Statement
Special 510(k) Number (if known): K061666
Device Name: Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex)
Indications for Use:
The Cellvizio® (-GI, -LUNG) with Confocal Miniprobe™ (Coloflex, Gastroflex, Alveoflex) is a confocal laser imaging system with fiber optic probes that is intended to allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.
Prescription Use: ____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-the-Counter Use:
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tarbar Buchen for wwn
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K061666
F-600 System Special 510(k) July 17, 2006
Confidential Page 10 of 63