GYRUS HYSTEROSCOPIC RESECTOSCOPE

K993749 · Gyrus Medical , Ltd. · HIH · Dec 3, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K993749
• Device Name: GYRUS HYSTEROSCOPIC RESECTOSCOPE
• Applicant: Gyrus Medical , Ltd.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Dec 3, 1999
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Gyrus Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The surgical applications include tissue cutting, removal, and dissection as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa.

Device Story

Gyrus Hysteroscopic Resectoscope; electrosurgical instrument for gynecologic procedures. Device comprises working element, rotating outer sheath, and visual obturator. Surgeon inserts device through cervical canal; visualizes uterine cavity via telescope housed in working element. High-frequency current transmitted to electrode for tissue cutting, removal, dissection, or coagulation. Features 'quick connection' for working element attachment and rotating collar for 360-degree fluid inlet rotation. Visual obturator facilitates insertion while maintaining visualization. Used in clinical/surgical settings by physicians. Output is direct visualization and electrosurgical tissue modification; assists in treating myomas, polyps, adhesions, septa, and endometrial tissue.

Clinical Evidence

Bench testing only. Preclinical and bench-top testing performed to verify performance requirements and substantiate efficacy for hysteroscopic usage.

Technological Characteristics

Materials: stainless steel, chrome-plated stainless steel, plastic, chrome-plated brass. Principle: electrosurgical resection/coagulation via high-frequency current. Form factor: hysteroscopic resectoscope with rotating outer sheath and visual obturator. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for direct viewing of cervical canal and uterine cavity for diagnostic and surgical procedures. Specific applications include excision of intrauterine myomas, polyps, lysis of adhesions, incision of uterine septa, and endometrial ablation when used with G-VAP electrode.

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

• COMEG Endoscopy Resectoscope (K971882)

Reference Devices

• Gyrus Hysteroscopic Resectoscope (K982771)

Submission Summary (Full Text)

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DEC - 3 1999

GYRUS MEDICAL DOCUMENT No. 813740

K993749 page 1

Gyrus Medical Limited
Cardiff CF33 0LT, UK
510k Premarket Notification
November, 1999

| | 510(k) Summary of Safety and Effectiveness |
|-----------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Statement | Information supporting claims of substantial equivalence, as defined under the Federal Food, Drug, and Cosmetic Act, respecting safety and effectiveness is summarized below. For the convenience of the Reviewer, this summary is formatted in accordance with the Agency's final rule "...510(k) Summaries and 510(k) Statements..." (21 CFR 807) and can be used to provide a substantial equivalence summary to anyone requesting it from the Agency. |
| | MODIFIED DEVICE NAME: Gyrus Hysteroscopic Resectoscope<br>Accessories Visual Obturator and Rotating<br>Outer Sheath |
| | PREDICATE DEVICE NAME: COMEG Endoscopy Resectoscope |
| Device<br>Description | The Gyrus Hysteroscopic Resectoscope that we intend to market employs an electrode specific resectoscope-working element. All other sheaths, etc., are standard COMEG components. A "Quick Connection" feature is used to attach the working element to the sheath. |
| | Endoscopic electrosurgical instruments and accessories are described under "Endoscope and Accessories" in 21 CFR 876.1500, and Hysteroscopes and described in 21 CFR 884.1690. |
| | The Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. |
| | The surgeon performs the examination through the cervical canal. The working elements are the devices that house and control various electrodes and lasers used to remove, cut, coagulate, and transect tissue. The surgeon controls the back and forth movement of the electrode using finger controls. The working elements also house a telescope for visualization. Current is transmitted to the electrode through a high frequency cable. |
| | Continued on next page |

17

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K993749

GYRUS MEDICAL DOCUMENT No. 813740

Gyrus Medical Limited
Cardiff CF3 0LT, UK
510k Premarket Notification
November, 1999

| Device Description (Cont'd) | These devices are composed of stainless steel, stainless steel chrome plated, plastic and brass chrome plated parts. The Gyrus Hysteroscopic Resectoscope as cleared in K982771, is identical to the COMEG Resectoscope cleared via K971882, with the working element modified to fit the Gyrus Medical Ltd. electrode. Endoscopic electrosurgical instruments and accessories are described in endoscope and accessories, 21 CFR 876.1500, and endoscope ESU units and accessories are described in 21 CFR 876.4300. Hysteroscopes are described in 21 CFR 884.1690. The Rotating Outer Sheath connection for the working element is of a "snap-on" construction, identical to the cleared device. The principal difference is in the rotating collar which allows 360 degree rotation of the fluid inlet. The Visual Obturator provides the same functionality as the standard obturator facilitating insertion to the uterus. In addition, the Visual Obturator allows use of the hysteroscope (telescope) during insertion, allowing visualization. |
|-------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Gyrus Hysteroscopic Resectoscope is intended to enable the viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. The surgical applications include tissue cutting, removal, and dissection as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa. |
| Indications Statement | The Gyrus Hysteroscopic Resectoscope is used to permit the direct Viewing of the cervical canal and the uterine cavity for the purpose of performing diagnostic and surgical procedures. |
| Technological Characteristics | The modified device has the same technological characteristics as the predicate devices. The form, fit and function is similar. |
| Performance Data | Preclinical as well as bench top testing has been performed to verify that The product meets the performance requirements described. This substantiates the efficacy of the resectoscope for the hysteroscopic usage. |

Continued on next page

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K993749 page 3/3

GYRUS MEDICAL DOCUMENT No. 813740

Gyrus Medical Limited
Cardiff CF33 0LT, UK
510k Premarket Notification
November, 1999

| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR 807)<br>and the information provided herein, we conclude that the new device is<br>substantially equivalent to the predicate devices under the Federal Food,<br>Drug, and Cosmetic Act. |
|------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact | David Kay<br>Director<br>Regulatory Affairs and Quality Assurance<br>Gyrus Medical Ltd.<br>Fortran Road<br>St. Mellons<br>Cardiff, CF3 OLT<br>United Kingdom |
| Date | November 4, 1999 |

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

- 3 1999

Mr. David Kay Director, Regulatory Affairs & Quality Assurance Gyrus Medical Limited Fortran Road St Mellons Cardiff CF3 OLT nk

Re: K993749

Hysteroscopic Rotating Sheath and Visual Obturator Dated: November 4, 1999 Receive: November 5, 1999 Regulatory Class: II 21 CFR §884.1698/Procode: 85HIH

Dear Mr. Kay:

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 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major requlations 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 requirements, 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 regult 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 the Electronic Product Radiation Control provisions, or other Federal laws or requlations,

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 vitto diagnostic devices), piease 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/dsma/dsmamain.html".

Sincerely yours,

CAPT Daniel G. Schultz, M.D. Acting 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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## GYRUS MEDICAL DOCUMENT No. 813740

Gyrus Medical Limited
Cardiff CF33 0LT, UK
510k Premarket Notification
November, 1999

## INDICATIONS FOR USE

| 510(k) Number (if known): | K993749 |
|---------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Gyrus Hysteroscopic Resectoscope |
| Indications for Use: | Used to permit direct viewing of the cervical canal and the uterine<br>Cavity for the purpose of performing diagnostic and surgical<br>procedures. As used with the Gynecare Versapoint System, the<br>indications for use include:<br>Excision on intrauterine myomas<br>Excision of intrauterine polyps<br>Lysis of intrauterine adhesions<br>Incision of uterine septa<br><br>When used for resection of endometrial tissue with the G-VAP<br>Electrode, the device is indicated for Endometrial Ablation. |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use | OR | Over-The-Counter Use |
|------------------|----|----------------------|
|------------------|----|----------------------|

(Optional Format 1-2-96)

(Division Sign-Off)

Division of Reproductive, Abdominal, ENT,
and Radiological Devices

510(k) Number: K993749