GALILEO HIGH RESOLUTION MICRO COUPLER

K971896 · Netoptix Corp. · HET · Oct 10, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K971896
• Device Name: GALILEO HIGH RESOLUTION MICRO COUPLER
• Applicant: Netoptix Corp.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Oct 10, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2

Indications for 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.

Device Story

The Galileo Micro Coupler is a reusable optical interface device used in endoscopic procedures. It functions as a mechanical and optical bridge between an endoscope and a video camera. The device utilizes internal lenses, prisms (including beam splitters), and windows to relay the optical image captured by the endoscope to the camera sensor. It is operated by clinical staff in a surgical or clinical setting. The output is a video signal displayed on a monitor or recorded for documentation, allowing the physician to visualize internal anatomy during endoscopic procedures. The device facilitates clinical decision-making by providing real-time visualization of the surgical field.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Reusable optical coupler; utilizes lenses, prisms (including split beams), and windows for image transmission. Features mechanical interfaces for endoscope and camera attachment. No electronic or software components described.

Indications for Use

Indicated for use with endoscopy as an interface to transmit optical images from an endoscope to a video camera for viewing on a monitor or video recording.

Regulatory Classification

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.

Predicate Devices

• Precision Optics Corp. Coupler (K903458)

Submission Summary (Full Text)

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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: [phone]

## 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.

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#### 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.

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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 [phone]. Additionally, for question and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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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.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use (Per 21 CFR 801.109) | <div style="text-align: left;">✓</div> |
|---------------------------------------|----------------------------------------|
| | OR |
| Over-The-Counter Use | _________________ |

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,

and Radiological Devices

| 510(k) Number | K971896 |
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