(141 days)
Not Found
No
The device description and intended use clearly define the device as an optical coupler for image transmission, with no mention of image processing, AI, or ML.
No.
The device is described as an interface for transmitting optical images from an endoscope to a video camera for viewing or recording, and does not mention any therapeutic function.
No
Explanation: The device is described as an "interface" and "optical coupler" that allows the transmission of an optical image from an endoscope to a video camera for viewing or recording. It does not perform any analysis, interpretation, or diagnosis based on the images.
No
The device description explicitly states it is a "line of reusable optical couplers," which are hardware components used for image transfer.
Based on the provided information, the Galileo Micro Coupler is not an IVD (In Vitro Diagnostic).
Here's why:
- 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.
- Galileo Micro Coupler's function: The device's intended use and description clearly state that it is an optical interface used to transmit images from an endoscope to a video camera. It is used for viewing or recording images from within the body during an endoscopic procedure. It does not perform any tests on biological samples.
Therefore, the Galileo Micro Coupler falls under the category of a medical device used for imaging and visualization during a medical procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Galileo Micro Coupler is indicated for use with endoscopy. It is an interface which allows the transmission of optical image from the endoscope to a video camera for video recording or viewing on a monitor.
Product codes
85 HET, 85 HIH
Device Description
The Galileo Micro Couplers are a line of reusable optical couplers used in the transfer of image from an endoscope to a video camera for either image recording or viewing on a monitor. The Galileo Micro Couplers are available in several configurations which will allow coupling to different Endoscopes and camera.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
optical image from the endoscope
Anatomical Site
Not Found
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)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 884.1720 Gynecologic laparoscope and accessories.
(a)
Identification. A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.(b)
Classification. (1) Class II (performance standards).(2) Class I for gynecologic laparoscope accessories that are not part of a specialized instrument or device delivery system, do not have adapters, connector channels, or do not have portals for electrosurgical, lasers, or other power sources. Such gynecologic laparosope accessory instruments include: the lens cleaning brush, biopsy brush, clip applier (without clips), applicator, cannula (without trocar or valves), ligature carrier/needle holder, clamp/hemostat/grasper, curette, instrument guide, ligature passing and knotting instrument, suture needle (without suture), retractor, mechanical (noninflatable), snare, stylet, forceps, dissector, mechanical (noninflatable), scissors, and suction/irrigation probe. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807 of this chapter, subject to the limitations in § 884.9.
0
OCT 10 1997 112
K971896
APPENDIX E
510(k) Summary Galileo Corporation Galileo Micro Coupler
Sponsor/Applicant Name and Address I.
Galileo Corporation Galileo Park P.O. Box 550 Sturbridge, MA 01566 Telephone: (508) 347-9191
Contact Person
Kin M. Wong, Director of Quality Assurance
Date of Summary Preparation
October 6, 1997
2. Device Name
Proprietary Name: Common/Usual Name: Classification Name:
Galileo Micro Coupler Endocoupler Coupler
Identification of Predicate or Legally Marketed Device(s) 3.
The Galileo Micro Coupler is substantially equivalent to Precision Optics Corp. Coupler (K903458).
Device Description 4.
The Galileo Micro Couplers are a line of reusable optical couplers used in the transfer of image from an endoscope to a video camera for either image recording or viewing on a monitor. The Galileo Micro Couplers are available in several configurations which will allow coupling to different Endoscopes and camera.
1
న్. Intended Use
The Galileo Micro Couplers act as an interface to transmit the optical image from the endoscope to the camera for either direct viewing on a monitor or video image recording.
Comparison of Technological Characteristics 6.
The Galileo Micro Couplers and the substantially equivalent devices are identical in intended use in that they are all use lenses, prisms (including split beams) and windows to transmit the image from the endoscope to the camera.
The Galileo Micro Couplers and the substantially equivalent devices are identical in the various thechanical interfaces with the endoscope and the camera.
2
Image /page/2/Picture/0 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized abstract design resembling an eagle or bird in flight, composed of three curved lines that suggest the head and wings. Encircling the design is the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
10 1997 OCT
Mr. Kin Wong Director, Quality Assurance Galileo Electro-Optics Corporation Galileo Park P.O. Box 550 Sturbridge, Massachusetts 01566
Re: K971896
Galileo Micro Coupler Dated: August 26, 1997 Received: September 2, 1997 Regulatory class: II 21 CFR §884.1720/Product code: 85 HET 21 CFR §884.1690/Product code: 85 HIH
Dear Mr. Wong:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, 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 III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4613. Additionally, for question and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
W.Liau Yu
Lillian Yin, Ph.D.
Lillian Yin, Ph.D. Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
ID:
Page 2 of 2
510(k) Number (if known):
Device Name: __ Galileo Micro Coupler ________________________________________________________________________________________________________________________________________
Indications For Use:
The Galileo Micro Coupler is indicated for use with endoscopy. It is an interface which allows the transmission of optical image from the endoscope to a video camera for video recording or viewing on a monitor.
(IPLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use (Per 21 CFR 801.109) | ✓ |
|---|---|
| OR | |
| Over-The-Counter Use | _________________ |
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
| 510(k) Number | K971896 |
|---|---|
| --------------- | --------- |