APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS

K062169 · Applied Medical Resources Corp. · HET · Aug 24, 2006 · Obstetrics/Gynecology

Device Facts

• Record ID: K062169
• Device Name: APPLIED LAPAROSCOPIC DISPOSABLE MONOPOLAR SCISSORS
• Applicant: Applied Medical Resources Corp.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Aug 24, 2006
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Applied Laparoscopic Monopolar Scissors is indicated for use in patients undergoing general, gynecologic and urologic endoscopic procedures for mobilization and transection of tissue.

Device Story

Disposable laparoscopic instrument for tissue mobilization and transection; features ratcheting handle, insulated shaft, and scissor blades. Operates via monopolar electrosurgical energy; connects to standard monopolar cables and generators. Used in general, gynecologic, and urologic endoscopic procedures. Operated by physicians in clinical settings. Provides mechanical cutting and electrosurgical cautery. Benefits include sterile, single-use design for surgical efficiency.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified via dielectric withstand testing (ANSI/AAMI HF-18: 2001), cutting functionality tests, monopolar functionality tests, and dimensional comparisons against the predicate device.

Technological Characteristics

Disposable monopolar electrosurgical instrument. Features ratcheting handle, insulated shaft (thermoplastic extruded tubing), and scissor blades (17.4mm length, 5.59mm opening). Available in 32cm and 45cm lengths. Biocompatible per ISO 10993. Sterilized via Cobalt 60 Gamma Radiation (25-40 kGy) per AAMI/ISO guidelines. Energy source: Monopolar electrosurgical.

Indications for Use

Indicated for patients undergoing general, gynecologic, and urologic endoscopic procedures requiring tissue mobilization and transection.

Regulatory Classification

Identification

A gynecologic laparoscope is a device used to permit direct viewing of the organs within the peritoneum by a telescopic system introduced through the abdominal wall. It is used to perform diagnostic and surgical procedures on the female genital organs. This generic type of device may include: Trocar and cannula, instruments used through an operating channel, scope preheater, light source and cables, and component parts.

Predicate Devices

• Applied Laparoscopic Monopolar Scissor (K040295)

Submission Summary (Full Text)

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

510(k) SUMMARY

| 510(k) NUMBER: | PENDING K062169 |
|----------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone]<br>[e-mail]<br>Fax: [phone] |
| CONTACT PERSON: | Cheryl Blake<br>Vice President Regulatory Affairs |
| DATE OF PREPARATION: | July 7, 2006 |
| NAME OF DEVICE: | Laparoscopic Disposable Monopolar Scissors |
| COMMON NAME: | Laparoscopic Scissors |
| CLASSIFICATION NAME: | Gynecologic laparoscope and accessories<br>(Regulation Number 21CFR 884.1720)<br>Product Code HET |
| TRADE NAME: | Applied Laparoscopic Disposable Monopolar<br>Scissors |
| PREDICATE DEVICE: | Applied Laparoscopic Monopolar Scissor<br>(K040295) |

The Applied Laparoscopic Monopolar Scissors is intended for use INTENDED USE: in general and gynecologic endoscopic procedures for mobilization and transection of tissue.

TECHNOLOGY CHARACTERISTICS: The Applied Laparoscopic Disposable Monopolar Scissor

## SUMMARY STATEMENT:

The Applied Laparoscopic Disposable Monopolar Scissors is designed to for a variety of general and gynecologic endoscopic procedures for mobilization and transection of tissue. The Applied Laparoscopic Disposable Monopolar Scissors consists of a ratcheting handle attached to an insulated shaft with scissor blades.

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

The handle includes male cautery connector to be utilized for monopolar cautery when attached to standard monopolar cautery cables and their generators.

The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, and 45cm. The device is to be supplied sterile in single unit pouches.

The device is in compliance with ISO 10993 for Biocompatibility. The Applied Laparoscopic Disposable Monopolar Scissors will be sterilized using a Cobalt 60 Gamma Radiation; AAMI/ISO Guideline for Radiation Sterilization will be utilized to provide a Sterility Assurance Level of 10°. The method of validation is AAMI FDS-1 TIR 27 2001 Radiation sterilization - Substantiation of 25 kGy as sterilization dose - Method VDMax. The validated does is 25 to 40 kGy.

The device is identical in materials and characteristics of the predicate device, with the exception of the insulated shaft. The predicate device utilized thermoplastic shrink tubing and the new device utilizes thermoplastic extruded tubing. The energy source, Monopolar Electrosurgical Energy, is the same energy type as used for the predicate device.

Design Analysis and comparisons, as well as bench testing, has been conducted to confirm the functional characteristics are substantially equivalent to the predicate device cited, and that the design output put mects the design input requirements.

The performance of the Applicd Laparoscopic Disposable Monopolar Scissors is compared to the performance of the Applied Medical Laparoscopic Monopolar Scissors, which is cleared to market under premarket notification, K040295. Functional Performance Testing conducted includes the performance of the following tests:

- a) Dielectric Withstand Testing per ANSI/AAMI HF-18: 2001
- b) Cutting Functionality Test
- c) Monopolar Functionality Test
- d) Dimensional Comparison

Conclusion: Based upon the technical information, intended use, and performance information provided in the pre-market notification, the Applied Laparoscopic Disposable Monopolar Scissors and the Applied Laparoscopic Monopolar Scissor (K040295) has shown to be substantially equivalent, and the design control process confirm the that design outputs mects the design input requirements.

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

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the department's name around the perimeter. Inside the circle is an abstract image of an eagle or bird-like figure with three curved lines representing its body and wings.

Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850

AUG 2 4 2006

Applied Medical Resources Corporation % Mr. Jeffrey D. Rongero Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. MELVILLE NY 11747

Re: K062169

Trade/Device Name: Applied Laparoscopic Disposable Monopolar Scissors Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: HET Dated: August 11, 2006 Received: August 14, 2006

## Dear Mr. Rongero:

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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Image /page/2/Picture/10 description: The image is a black and white circular logo. The logo has the text "1906-2006" at the top, followed by the letters "FDA" in a stylized font. Below the letters, the word "Centennial" is written in a cursive font. Three stars are at the bottom of the logo.

Protecting and Promoting Public Health

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

Page 2 -

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.

This letter will allow you to begin marketing your device as described in your Section 510(k) rms leter 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 this letter:

| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|----------------|----------------------------------|--------------|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | | 240-276-0100 |

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 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/cdrl/industry/support/index.html.

Sincerely yours,

Nancy C.Bogdon

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): KO6 2/69

Applied Laparoscopic Disposable Monopolar Scissors __ Device Name: _________________________________________________________________________________________________________________________________________________________________ Indications for Use:

Indications for Use: The Applied Laparoscopic Monopolar Scissors is indicated for use in patients undergoing general, gynecologic and urologic endoscopic procedures for mobilization and transection of tissue.

Prescription Use __ X (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

| (Division Sign-Off) | |
|---------------------------------------------------------------|---------|
| Division of Reproductive, Abdominal, and Radiological Devices | |
| 510(k) Number | 4062169 |