(83 days)
Not Found
No
The summary describes a confocal laser imaging system for real-time tissue observation. It mentions proprietary software for controlling the system and displaying images, but there is no mention of AI, ML, or any image processing or analysis capabilities that would suggest the use of these technologies. The performance studies focus on safety and effectiveness compared to predicate devices, not on the performance of any analytical algorithms.
No.
The device is described as a confocal laser imaging system intended for microscopic visual inspection of tissues, which is diagnostic, not therapeutic.
Yes
The device is intended to allow "confocal laser imaging of the internal microstructure of tissues" for "in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure," which falls under diagnostic purposes.
No
The device description explicitly states that the system is composed of several elements including a Laser Scanning Unit, a medical grade flat panel display, and Miniaturized Fiber Optic Probes, in addition to proprietary software. This indicates it is a hardware system with accompanying software, not a software-only device.
Based on the provided information, the Mauna Kea Technologies F-400 System is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "allow confocal laser imaging of the internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope." This describes a system used for direct visualization and imaging of tissues in vivo (within a living organism).
- Device Description: The description reinforces this by stating it allows "in vivo visual inspection of tissues with a microscopic resolution during an endoscopic procedure" and "real-time observations of tissues."
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are performed outside the body (in vitro).
The F-400 system is clearly designed for in vivo imaging and observation, not for testing samples in vitro.
N/A
Intended Use / Indications for Use
The Mauna Kea Technologies F-400 System 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 F-400 system 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-400 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 medical grade flat panel display and Miniaturized Fiber Optic Probes. The F-400 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
internal microstructure of tissues in the anatomical tract, i.e., gastrointestinal or pulmonary, accessed by the endoscope.
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
Accepted scientific methods were followed to conduct non-clinical testing, i.e., design verification and validation and testing to recognized standards. The purpose of this testing served to evaluate whether safety or effectiveness had been adversely affected by technological differences between the F-400 system and the predicate devices. Testing to FDA recognized standards was performed in the areas of electrical safety, electromagnetic compatibility, laser safety, endoscopic equipment, bioburden, soft-controlled medical devices, risk analysis, biocompatibility and packaging. In conclusion, the data from the non-clinical testing, i.e., design verification and validation and testing to FDA recognized standards demonstrated that the F-400 system is as safe and effective as all of the above mentioned predicate devices.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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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Image /page/0/Picture/0 description: The image shows the text "SEP - 6 2005" at the top, followed by the text "K051585". Below this is a black circle with the letters "MKT" inside. To the right of the circle is the text "Mauna Kea Technologies". The image appears to be a stamp or logo with a date and company name.
E.0 Premarket Notification 510(k) Summary
E.1 Submitter Information
Company Name and Address:
Mauna Kea Technologies 9, rue d'Enghien 75010 Paris FRANCE
Contact Name:
Alexandre Loiseau, Ph.D. (Official Correspondent) President Mauna Kea Technologies Telephone: +33 1 48 24 06 21 Fax: +33 1 48 24 12 18
Date Prepared: June 9, 2005 ; revised August 16, 2005
E.2 Name of Device
Proprietary Name: F-400 System
Classification Name: Endoscope and/or Accessories
E.3 Predicate Device(s) Information
Pentax Confocal Laser System, K042740
Pentax EC-3870CILK Confocal Video Colonoscope, K042741
superDimension Bronchus, K042438
Mauna Kea Technologies SAS Société par actions simplifiée au capital de 163.157,34 Euros -431 268 028, RCS Paris. Siège social : 9, rue d'Enghien - 75010 Paris - France Tél : 01 48 24 03 45 - Fax : 01 48 24 12 18
F-400 System 510(k) Summary - Appendix E June 9, 2005 - Revised August 16, 2005
Confidential Page E-2 of E-4
1
Image /page/1/Picture/0 description: The image shows the letters "MKT" in white text inside of a black circle. To the right of the circle, the letter "M" is visible. The image is simple and contains a logo or abbreviation.
Kajis Sis
Mauna Kea Technologies
Device Description E.4
The F-400 system 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-400 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 medical grade flat panel display and Miniaturized Fiber Optic Probes. The F-400 system can be used with any legally marketed endoscope with a working channel of 2.8 mm or greater.
E.5 Intended Use
The Mauna Kea technologies F-400 system is a confocal laser imaging 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.
E.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 and information concerning the predicate devices that was available in the public domain. A product brochure for the Pentax Confocal Laser System, K042740, and Pentax EC-3870CILK Confocal Video Colonoscope, K042741 was reviewed and information for the superDimension / Bronchus was obtained from the superDimension web site, www.superdimension.com. Copies of reviewed information are included in the F-400 System 510(k) Premarket Notification. The comparison reviewed general technological considerations as well as specific performance parameters for all predicate devices where information was available. Neither animal nor clinical data were assessed.
Accepted scientific methods were followed to conduct non-clinical testing, i.e., design verification and validation and testing to recognized standards. The purpose of this testing served to evaluate whether safety or effectiveness had been adversely affected by technological differences between the F-400 system and the predicate devices.
Mauna Kea Technologies SAS Société par actions simplifiée au capital de 163.157,34 Euros -431 268 028, RCS Paris. Siège social : 9, rue d'Enghien - 75010 Paris - France Tél : 01 48 24 03 45 - Fax : 01 48 24 12 18
F-400 System 510(k) Summary - Appendix E June 9, 2005 - Revised August 16, 2005
Confidential Page E-3 of E-4
2
cs'jj's
Image /page/2/Picture/1 description: The image contains the logo for Mauna Kea Technologies. The logo consists of a black circle with the letters "MKT" in white, followed by the words "Mauna Kea Technologies" in black. The text is in a sans-serif font and is aligned horizontally.
Testing to FDA recognized standards was performed in the areas of electrical safety, electromagnetic compatibility, laser safety, endoscopic equipment, bioburden, soft-controlled medical devices, risk analysis, biocompatibility and packaging.
In conclusion, the data from the non-clinical testing, i.e., design verification and validation and testing to FDA recognized standards demonstrated that the F-400 system is as safe and effective as all of the above mentioned predicate devices.
Mauna Kea Technologies SAS Société par actions simplifiée au capital de 163.157,34 Euros 431 268 028, RCS Paris. Siège social : 9, rue d'Enghien - 75010 Paris - France Tél : 01 48 24 03 45 - Fax : 01 48 24 12 18
F-400 System 510(k) Summary - Appendix E June 9, 2005 - Revised August 16, 2005
Confidential Page E-4 of E-4
3
Image /page/3/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three lines representing its wings and body. The eagle is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES, USA" in a circular arrangement. The seal is black and white and appears to be a simple, official emblem.
SEP -6 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Alexandre Loiseau, Ph.D. President Mauna Kea Technologies 9, rue d'Enghien 75010 Paris France
Re: K051585
Trade/Device Name: F-400 System Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: GCJ Dated: August 16, 2005 Received: August 17, 2005
Dear Dr. Loiseau:
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 radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
4
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Saubare Buchholz
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure .
5
Indications Statement
510(k) Number (if known): K# 051585
Device Name: F-400 System
Indications for Use:
The Mauna Kea Technologies F-400 System 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: __ X (Part 21 CFR 801 Subpart D) AND/OR
Over-the-Counter Use: (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)
Saubere Boucher for MXM
(Division Sign-C Division of General, Restorative, and Neurological Devices
510(k) Number K051525