VERSAPOINT RESECTOSCOPIC SYSTEM

K040302 · Gynecare, A Div. of Ethicon, Inc. · HIH · Mar 9, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040302
• Device Name: VERSAPOINT RESECTOSCOPIC SYSTEM
• Applicant: Gynecare, A Div. of Ethicon, Inc.
• Product Code: HIH · Obstetrics/Gynecology
• Decision Date: Mar 9, 2004
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 884.1690
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation. - Excision of intrauterine myomas - Excision of intrauterine polyps - Lysis of intrauterine adhesions - Incision of uterine septa - Endometrial ablation

Device Story

VERSAPOINT Resectoscopic System is a surgical instrument used in gynecologic hysteroscopic electrosurgical procedures. The device facilitates tissue cutting, removal, and desiccation. The subject of this modification is the telescopic clip, a component of the resectoscopic electrodes that secures the electrode within the resectoscope. The modification involves changing the material of the telescopic clip from Polypropylene (PP) to Polybutyleneterephthalate (PBT). The device is used by clinicians in a surgical setting to treat intrauterine conditions such as myomas, polyps, adhesions, and septa, and to perform endometrial ablation.

Clinical Evidence

Bench testing and biocompatibility testing were performed to verify performance requirements. No clinical data was required or provided.

Technological Characteristics

The device is a resectoscopic electrode component. The telescopic clip material was changed from Polypropylene (PP) to Polybutyleneterephthalate (PBT). The device functions as part of a hysteroscopic electrosurgical system. No changes to sensing, energy source, or form factor were reported.

Indications for Use

Indicated for gynecologic hysteroscopic electrosurgical procedures in patients requiring treatment for intrauterine myomas, polyps, adhesions, septa, or benign conditions requiring endometrial ablation.

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

• VERSAPOINT Electrosurgery System (SCUBA)

Submission Summary (Full Text)

{0}------------------------------------------------

MAR - 9 2004

# Attachment IV - 510(k) Summary

### Statement:

Information supporting claims of substantial equivalence, as defined under the Federal Informanon supporting claims of substantial equivaness is summarized below.
Food, Drug, and Cosmetic Act, respecting safety and effectiveness with the Food, Drug, and Cosment Ass, respecting on mary is formatted in accordance with the Agency's final rule.

Modified Device Name: VERSAPOINT* Resectoscopic System

Predicate Device Name: VERSAPOINT* Electrosurgery System (SCUBA)

#### Device Description:

The telescopic clip is a component of the VRS resectoscopic electrodes, and is designed The telescopie cup is a component stal portion of the electrode within the resectoscope. The telescopic clip is currently manufactured with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).

### Indications for Use:

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, frysteroscopic crocroourgeral prd benign conditions requiring endometrial ablation.

- Excision of intrauterine myomas -
- Excision of intrauterine polyps -
- Lysis of intrauterine adhesions -
- Incision of uterine septa -
- Endometrial ablation t

### Technological Characteristics:

The modified device has the same technological characteristics as the predicate device. The only change to the device is to the material of the telescopic clip. The telescopic clip The only change to the ad with Polypropylene (PP). It is proposed to change the material to Polybutyleneterephthalate (PBT).

{1}------------------------------------------------

### Performance Data:

Biocompatibility and bench testing have been performed to verify that the product meets the performance requirements described.

### Conclusion:

Based upon the 510(k) summaries and 510(k) statements and the information provided Dascu upon the stocky outliners device is substantially equivalent to the predicate device under the Federal Food, Drug, and Cosmetic Act.

### Contact:

Patricia M. Hojnoski Sr. Project Manager Regulatory Affairs Gynecare, A Division of Ethicon, Inc. P.O. Box 151, Route 22 West Somerville, NJ 08876

### Date:

February 6, 2004

{2}------------------------------------------------

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle with three lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES" are arranged in a circular fashion around the eagle symbol.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR - 9 2004

Ms. Patricia M. Hojnoski Sr. Project Manager Regulatory Affairs Gynecare Worldwide A Division of ETHICON, Inc. U.S. Route 22 West P.O. Box 151 SOMERVILLE NJ 08876

Re: K040302 Trade/Device Name: VERSAPOINT* Resectoscope System Regulation Number: 21 CFR 884.1690 Regulation Name: Hysteroscope and accessories Regulation Number: 21 CFR 884.4160 Regulation Name: Unipolar endoscopic coagulatorcutter and accessories Regulatory Class: II Product Code: 85 HIH and HFI Dated: February 6, 2004 Received: February 10, 2004

Dear Ms. Hojnoski:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

{3}------------------------------------------------

This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:

| 8xx. 1xxx | [phone] |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | [phone] |
| 892.2xxx, 3xxx, 4xxx, 5xxx | [phone] |
| Other | [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" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.

Sincerely yours.

Nancy C. Brygdon

Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{4}------------------------------------------------

## Indications for Use

510(k) Number (if known): K040302 _VERSAPOINT* Resectoscopic System __ Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Tissue cutting, removal, and desiccation as required or encountered in gynecologic hysteroscopic electrosurgical procedures for the treatment of intrauterine myomas, polyps, adhesions, and septa, and benign conditions requiring endometrial ablation.

- Excision of intrauterine myomas -
- Excision of intrauterine polyps -
- Lysis of intrauterine adhesions -
- Incision of uterine septa
- Endometrial ablation

Prescription Use
(Part 21 CFR 801 Subpart D)

Over-The-Counter Use AND/OR (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Nancy C. Broadlon

Page 1 of 1

(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices

510(k) Number .

000003