MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH

K972426 · Imagyn Medical, Inc. · HIH · Sep 23, 1997 · Obstetrics/Gynecology

Device Facts

• Record ID: K972426
• Device Name: MICROSPAN GOLD HYSTEROSCOPE AND MICROSPAN HYSTEROSCOPE SHEATH
• Applicant: Imagyn Medical, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Sep 23, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The MicrSpan Hysteroscope Sheath is indicated for use in providing access to the uterine cavity for the Imagyn Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.

Device Story

The MicroSpan Gold Hysteroscope is a rigid, fiberoptic endoscope used for visualizing the cervical canal and uterine cavity. It consists of a stainless steel shaft, illumination fibers, and an imaging fiber bundle with a rotatable eyepiece. The device connects to an external light source and can be coupled to a camera for video monitoring. The accompanying MicroSpan Hysteroscope Sheath provides access to the uterine cavity, featuring irrigation/insufflation and aspiration ports, and an instrument channel to maintain uterine distention during procedures. The system is used by physicians in clinical settings to perform diagnostic and operative hysteroscopy. The output is a direct visual image, which assists the clinician in identifying pathology or performing surgical interventions, potentially reducing the need for more invasive procedures.

Clinical Evidence

Bench testing only. Evaluation included optical and mechanical characteristics, simulated reuse effects, electrical safety, thermal characteristics, and biocompatibility testing.

Technological Characteristics

Rigid fiberoptic hysteroscope; stainless steel shaft; illumination and imaging fiber bundles; rotatable eyepiece; compatible with external xenon light sources and video camera couplers. Sheath includes irrigation/insufflation/aspiration ports and instrument channel. Single-use, sterile. No software or electronic processing components.

Indications for Use

Indicated for patients requiring diagnostic or surgical visualization of the cervical canal and uterine cavity. Used by clinicians to facilitate access for hysteroscopic instruments.

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

• Imagyn MicroSpan Hysteroscope
• Imagyn MicroLap-Gold Laparoscope
• Optimed Technologies Rigid Fiber Optic Hysteroscope

Submission Summary (Full Text)

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K972426
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Imágyn

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SEP 2 3 1997

## 510(k) Summary

| Submitter: | Imagyn Medical, Inc.<br>27651 La Paz Road<br>Laguna Niguel, CA 92677-3917<br>[phone]<br>Contact: Debra A. Rinderer |
|----------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary Preparation: | June 25, 1997 |
| Device: | MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath |
| Predicate Devices: | Imagyn MicroSpan Hysteroscope<br>Imagyn MicroLap-Gold Laparoscope<br>Optimed Technologies Rigid Fiber Optic Hysteroscope |
| Device Description: | The MicroSpan-Gold Hysteroscope is a small diameter, rigid, fiberoptic<br>hysteroscope without through lumens. The device consists of an outer<br>stainless steel shaft, inner illumination fibers, and an imaging fiber bundle.<br>At one end of the imaging bundle is the distal lens and at the other is the<br>rotatable eyepiece. An endoscopic light source is connected to the light post<br>of the hysteroscope through compatible light cables. If desired, the eyepiece<br>can be connected through a focusing optical coupler to a camera head which<br>carries the image by cable to the camera.<br>The MicroSpan Hysteroscope Sheath is offered with irrigation/insufflation and aspiration ports and an instrument channel. The device is provided<br>sterile for single use, and is made from both metal and plastic components. |
| Intended Use of Device: | The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical<br>canal and the uterine cavity for the purpose of performing diagnostic and<br>surgical procedures.<br>The MicrSpan Hysteroscope Sheath is indicated for use in providing access<br>to the uterine cavity for the Imagyn Hysteroscope or other hysteroscopic<br>instruments during diagnostic and operative hysteroscopic procedures. |
| Technological Comparisons: | Light from a high intensity light source (e.g. xenon) is transmitted through<br>illumination fibers to the distal end of the hysteroscope in order to illuminate<br>the target object. The distal lens system focuses the image of the object onto<br>image fibers, which then transmits the image to the proximal lens system.<br>The proximal lens system magnifies and focuses the image onto an eyepiece<br>at the proximal end of the hysteroscope for viewing and/or directly to<br>standard video cameras, monitors and recording equipment. The MicroSpan<br>Gold Hysteroscope and the predicate devices all have equivalent<br>technological characteristics. |

Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, CA 92677 Tel: [phone] Fax: [phone]

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510(k) Summary MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath Page 2 of 2

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K 972426

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| Technological Comparisons<br>(continued) | The MicroSpan Hysteroscope Sheath is identical in all respects except<br>maximum outer diameter to the previously cleared MicroSpan Hysteroscope<br>Sheath. The device is designed to achieve hysteroscope and/or hysteroscopic<br>instrument insertion without loss of uterine distention. |
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| Performance Summary | Non-clinical tests were performed to demonstrate that the device performed<br>according to its description. Testing included evaluation of optical and<br>mechanical characteristics of the device and the effect of simulated reuses on<br>these characteristics. The device was also evaluated for its electrical safety,<br>thermal characteristics, and biocompatibility. |

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SEP 2 3 1997

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Debra A. Rinderer Regulatory Affairs Specialist Imagyn Medical, Inc. 27651 La Paz Road Laguna Niguel, California 92677 Re: K972426

MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath Dated: June 26, 1997 Received: June 27, 1997 Regulatory class: II 21 CFR §884.1690/Product code: 85 HIH

Dear Ms. Rinderer:

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 Device Amendments, or to 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 (OS) 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 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.

William Yu

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

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## INDICATIONS FOR USE

510(k) Number (if known): k972426

Device Name: MicroSpan Gold Hysteroscope and MicroSpan Hysteroscope Sheath

## Indications for Use:

The MicroSpan Gold Hysteroscope is used to permit viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures.

The MicroSpan Hysteroscope Sheath is used to provide access to the uterine cavity for the MicroSpan Gold Hysteroscope or other hysteroscopic instruments during diagnostic and operative hysteroscopic procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Robert D. Natting/

(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 510(k) Number_16972426

Prescription Use

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Over-The-Counter Use