GALILEO DISPOSABLE HYSTEROSCOPES

K974297 · Netoptix Corp. · HIH · Feb 13, 1998 · Obstetrics/Gynecology

Device Facts

• Record ID: K974297
• Device Name: GALILEO DISPOSABLE HYSTEROSCOPES
• Applicant: Netoptix Corp.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Feb 13, 1998
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2

Intended Use

The Galileo Hysteroscopes are endoscopes intended for direct visualization of the cervical canal and uterine cavity for diagnostic procedures during gynecological procedures. The Hysteroscope diagnostic include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain.

Device Story

Fiberoptic endoscope for direct visualization of cervical canal and uterine cavity; used in gynecological diagnostic procedures. Device transmits light from external high-intensity source through optical fibers to distal tip; image captured via objective lens and fiberoptic bundle for viewing through proximal eyepiece or video monitor. Operated by clinicians in clinical settings. Disposable configuration; compatible with specific Galileo coupler. Benefits include visualization of anatomical structures to assist in diagnosing conditions like abnormal bleeding or infertility.

Clinical Evidence

Bench testing only. Evaluated optical performance (field of view, angle of view, resolution, illumination uniformity) before and after mechanical deflection testing using an Instron Tensile Tester. Results showed no change in optical performance criteria for either polyimide or stainless steel sheathed samples, confirming structural integrity.

Technological Characteristics

Fiberoptic endoscope; 2.8 mm OD x 270 mm length. Materials include polyimide and stainless steel. External high-intensity light source required. Image transmission via objective lens and fiberoptic bundle. Disposable configuration. No software or electronic processing components.

Indications for Use

Indicated for direct visualization of the cervical canal and uterine cavity in patients undergoing diagnostic gynecological procedures, including evaluation of abnormal uterine bleeding, infertility, pregnancy wastage, abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea, and pelvic pain.

Regulatory Classification

Identification

A hysteroscope is a device used to permit direct viewing of the cervical canal and the uterine cavity by a telescopic system introduced into the uterus through the cervix. It is used to perform diagnostic and surgical procedures other than sterilization. This generic type of device may include obturators and sheaths, instruments used through an operating channel, scope preheaters, light sources and cables, and component parts.

Predicate Devices

• Galileo Hysteroscopes (K962116)
• U.S. Surgical Surgiview Endoscopes (K925968)
• Richard Wolf Hysteroscopes and Laparoscopes (K880314)
• Richard Wolf Hysteroscopes and Laparoscopes (K770378)

Submission Summary (Full Text)

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K974297

P1073

# 510(k) Summary Galileo Corporation Galileo Disposable Hysteroscopes

### Sponsor/Applicant Name and Address 1.

Galileo Corporation Galileo Park · P.O. Box 550 Sturbridge, MA 01566 Telephone [phone]

## Contact Person

Enrique Bernal G. Director of Corporate Product Development

# Date of Summary Preparation

November 7, 1997

#### Device Name 2.

Proprietary Name: Common/Usual Name: Classification Name:

Galileo Disposable Hysteroscopes Hysteroscopes Hysteroscopes and accessories

### Identification of Predicate or Legally Marketed Device(s) 3.

The Galileo Hysteroscopes are substantially equivalent to several legally marketed endoscopes including the Galileo Hysteroscopes (K962116), U.S. Surgical Surgiview Endoscopes, (K925968) and the Richard Wolf Hysteroscopes and Laparoscopes (K880314 and K770378).

#### 4. Device Description

The Galileo Disposable Hysteroscopes are a line of disposable endoscopes based on existing endoscope technology. The Galileo Disposable Hysteroscopes will be available in 2.8 mm OD X 270 mm length size.

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K 974297
P2073

The Galileo Disposable Hysteroscopes are fiber optic design endoscopes that are offered in disposable configurations only. Fiberoptic design endoscopes function by light being transmitted from a standard external high intensity light source through optical fibers to the distal tip of the endoscope. The image of the target is then transmitted from the distal end via an objective lens and a fiberoptic imaging bundle to a proximal eyepiece. The image can be viewed directly or it may be transmitted through a video camera to a video monitor.

The Disposable Hysteroscopes are offered with a coupler that includes a light source which is provided by Galileo Electro-Optics Corporation. The Galileo coupler is compatible only with the Galileo Disposable Hysteroscopes and the other cleared commercially available Galileo endoscopes.

#### ડ. Intended Use

The Galileo Disposable Hysteroscopes are endoscopes intended for direct visualization of cervical canal and uterine cavity for diagnostic procedures during gynecological procedures. The Galileo Disposable Hysteroscopes are designed to be introduced through natural body cavities or through introducers, catheters, sheaths or other devices with thru-lumens having inside diameters larger than the outside diameter of the endoscope.

#### 6: Comparison of Technological Characteristics

The Galileo Disposable Hysteroscopes and the substantially equivalent devices are identical in intended use in that they are all endoscopes intended to be passed through a lumen of an introducer or into natural body cavities for visualization of body cavities, tissues, organs or canals.

The Galileo Disposable Hysteroscopes and the substantially equivalent devices are similar in designs in that they all offer various configurations including rod/lens or fiberoptic design, optional working channels, several OD's and lengths, and use external light sources, and similar stainless steel materials.

The Galileo Disposable Hysteroscopes and the substantially equivalent devices are similar in technological characteristics in that they offer a channel for either viewing body cavities, tissues, organs or canals and an optional channel for passing instruments into the desired anatomical sites.

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K974297 130 }

Testing was performed to:

- determine the capability of the units to transmit image after deflection of . the sheath portion of the device through a specific set of distances, and
- demonstrate that the polyimide sheath is equivalent to the stainless steel . sheath in the framework of the rigid scope.

Samples of each type of hysteroscope containing the lens, image fiber, and illumination fiber were used for this testing. A baseline optical test was performed prior to the deflection test. The deflection test was performed by holding the shaft of one sample in one of the jaws of an Instron Tensile Tester and applying weight at the other end of the shaft until a desired deflection was obtained or until the tube is damaged at the plane it is held at in the fixture. All samples were tested ensuring the distance from the point of hold to the point of application of weight is constant. The hysteroscope assemblies were then retested for the desired image conduction properties.

The acceptance criteria for this testing were all optical tests performed before and after the deflection test of the sample must pass the optical acceptance criteria.

The field of view, angle of view, resolution on axis and uniformity of illumination were evaluated for acceptance criteria. The results of this testing showed that both the stainless steel and the polyimide sheathed sample scopes showed no change in any tested optical performance criteria. These results demonstrate that both samples maintained structural integrity of the optics assembly when subjected to the test protocol.

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Image /page/3/Picture/0 description: The image shows a black and white logo of the Department of Health. The logo features a stylized bird-like symbol with three curved lines representing the wings or body. The text "DEPARTMENT OF HE" is vertically oriented and curved along the left side of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 3 1998

Galileo Corporation c/o Ms. Mary McNamara-Cullinane, RAC Staff Consultant Medical Device Consultants, Inc. 49 Plain Street North Attleboro, MA 02760

Re: K974297 Galileo Disposable Hysteroscopes Dated: November 14, 1997 Received: November 17, 1997 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH

Dear Ms. McNamara-Cullinane:

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 rechassified 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 OS 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 questions on the promotion 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,

H.M.Liau Yi

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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510(k) Number (if known): _

Device Name: Galileo Disposable Hysteroscopes

Indications For Use:

The Galileo Hysteroscopes are endoscopes intended for direct visualization of the cervical canal and uterine cavity for diagnostic procedures during gynecological procedures. The Hysteroscope diagnostic include abnormal uterine bleeding, infertility and pregnancy wastage, evaluation of abnormal hysterosalpingogram, intrauterine foreign body, amenorrhea and pelvic pain.

I

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert R. Ratliff

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 197429 510(k) Number

Prescription Use
(Per 21 CFR 801.109) ✓

OR

Over-The-Counter Use _

(Optional Format 1-2-96)