GYRUS HYSTEROSCOPIC RESECTOSCOPE

K982771 · Gyrus Medical , Ltd. · HIH · Jan 21, 1999 · Obstetrics/Gynecology

Device Facts

• Record ID: K982771
• Device Name: GYRUS HYSTEROSCOPIC RESECTOSCOPE
• Applicant: Gyrus Medical , Ltd.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Jan 21, 1999
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Indications for 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 is an electrosurgical instrument for gynecologic procedures; enables visualization of cervical canal and uterine cavity. Device consists of electrode-specific working element, telescope, and standard sheaths; utilizes 'Quick Connection' for assembly. Surgeon operates device manually via finger controls to manipulate electrodes for cutting, coagulating, and transecting tissue; high-frequency electrical current delivered via cable. Used in clinical settings by physicians to treat intrauterine myomas, polyps, adhesions, and septa. Provides direct visualization and surgical access; facilitates tissue removal and dissection; improves patient outcomes by enabling minimally invasive intrauterine surgery.

Clinical Evidence

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

Technological Characteristics

Materials: stainless steel, chrome-plated stainless steel, plastic, brass. Principle: electrosurgical resection/coagulation via high-frequency current. Form factor: hysteroscopic resectoscope with telescope and electrode-specific working element. Connectivity: none. Sterilization: not specified.

Indications for Use

Indicated for patients requiring diagnostic or surgical hysteroscopy, including excision of intrauterine myomas, excision of intrauterine polyps, lysis of intrauterine adhesions, and incision of uterine septa.

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
• Karl Storz Hysteroscopic Resectoscope Models 27040/27050

Submission Summary (Full Text)

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SECTION 7

| 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 |
| | PREDICATE DEVICE NAME: COMEG Endoscopy Resectoscope and Karl Storz Hysteroscopic Resectoscope Models 27040/27050. |
| Device 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 are 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. |
| | These devices are composed of stainless steel, stainless steel chrome plated, plastic and brass chrome plated parts. |
| | |

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## 510(k) Summary of Safety and Effectiveness, Continued

| Intended Use | The Gyrus Hysteroscopic Resectoscope is intended to enable the viewing of<br>the cervical canal and the uterine cavity for the purpose of performing<br>diagnostic and surgical procedures. The surgical applications include tissue<br>cutting, removal, and dissection as required or encountered in gynecologic<br>hysteroscopic electrosurgical procedures for the treatment of intrauterine<br>myomas, polyps, adhesions, and septa. | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Indications<br>Statement | The Gyrus Hysteroscopic Resectoscope is used to permit the direct viewing of<br>the cervical canal and the uterine cavity for the purpose of performing<br>diagnostic and surgical procedures. | |
| Technological<br>characteristics | The modified device has the same technological characteristics as the predicate<br>devices. The form, fit and function is similar. | |
| Performance<br>Data | Pre-clinical as well as bench top testing has been performed to verify that the<br>product meets the performance requirements described. This substantiates the<br>efficacy of the resectoscope for the hysteroscopic usage. | |
| Conclusion | Based upon the 510(k) summaries and 510(k) statements (21 CFR 807) and<br>the information provided herein, we conclude that the new device is<br>substantially equivalent to the predicate devices under the Federal Food, Drug,<br>Cosmetic Act. | |
| Contact | David Kay<br>Director of Regulatory Affairs and Quality Assurance<br>Gyrus Medical Ltd.<br>Fortran Road<br>St. Mellons<br>Cardiff, CF3 0LT<br>United Kingdom | |
| Date | August 4, 1998 | |

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Rockville MD 20850

Food and Drug Administration 9200 Corporate Boulevard

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JAN 2 1 1999

David Kay Director, Regulatory Affairs & Quality Assurance Gyrus Medical Fortran Road St. Mellons Cardiff CF3 OLT UNITED KINGDOM

Re: K982771

Gyrus Axipoler™ Hysteroscopic Resectoscope Dated: November 23, 1998 Received: November 25, 1998 Regulatory Class: II 21 CFR 884.1690/Procode: 85 HIH

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 (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major requlations affecting your device can be found in the Code of Federal Requlations, 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 verily 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 the Electronic Product 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 requlation (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/dsma/dsmamain.html".

Sincerely yours,

Capt. Daniel G. Schultz, M.D.

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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## INDICATIONS FOR USE

| 510(k) Number (if known): | K982771 |
|---------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name: | Gyrus Hysteroscopic Resectoscope |
| Indications for Use: | Used to permit direct viewing and access to the cervical canal and<br>the uterine cavity for the purpose of performing diagnostic and<br>surgical procedures. As used with the Gynecare Versapoint<br>System, the indications for use include:<br>Excision of intrauterine myomas<br>Excision of intrauterine polyps<br>Lysis of intrauterine adhesions<br>Incision of uterine septa |

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Concurrence of CDRH, Office of Device Evaluation (ODE)

signature

Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devi CD I S10(k) Number

Prescription Use

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Over-The-Counter Use _

(Optional Format 1-2-96)

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Gyrus Hysteroscopic Resectoscope Gyrus Medical, Ltd.