APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS

K040295 · Applied Medical Resources Corp. · HET · Mar 12, 2004 · Obstetrics/Gynecology

Device Facts

• Record ID: K040295
• Device Name: APPLIED LAPAROSCOPIC MONOPOLAR SCISSORS
• Applicant: Applied Medical Resources Corp.
• Product Code: HET · Obstetrics/Gynecology
• Decision Date: Mar 12, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 884.1720
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Laparoscopic Monopolar Scissors is intended for use in general or gynecological surgical procedures that utilize minimally invasive surgical procedures. The primary function of the device is to provide the surgeon the ability to manipulate tissue during minimally invasive surgery.

Device Story

Device is a laparoscopic instrument for tissue mobilization and transection during minimally invasive gynecologic and general endoscopic procedures. Consists of a reusable Polyphenylsulfone/stainless steel handle and a disposable 5mm diameter insulated stainless steel shaft with scissor blades. Operates via manual actuation of blades; includes a male cautery connector for monopolar electrosurgery when attached to standard cables and generators. Used in clinical settings by surgeons. Handle features 360° rotation for user convenience. After use, shaft is disposed of; handle is cleaned and steam-sterilized for reuse. Provides surgeons with mechanical tissue manipulation and electrosurgical cutting/coagulation capabilities, facilitating minimally invasive surgical access and patient benefit through reduced trauma.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993. Sterilization validation for EO (shaft) and steam (handle) conducted to achieve a sterility assurance level of 10^6, following AAMI/ISO standards. No clinical data presented.

Technological Characteristics

Materials: Polyphenylsulfone, stainless steel. Sensing/Actuation: Manual mechanical actuation of scissor blades. Energy: Monopolar electrosurgery (external generator). Dimensions: 5mm shaft diameter; 17.4mm blade length; 5.59mm blade opening; 32cm, 38cm, 45cm working lengths. Sterilization: EO (disposable shaft), steam (reusable handle). Compliance: ISO 10993 (biocompatibility), ISO 14971 (risk management), ISO 9001/13485.

Indications for Use

Indicated for use in gynecologic and general endoscopic procedures for mobilization and transection of tissues. The device is intended for use by clinicians in minimally invasive surgical procedures. It includes a male cautery connection for use with standard monopolar cautery cables and generators.

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

• United States Surgical Auto Suture® Endoscopic Scissors (K903206)

Submission Summary (Full Text)

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MAR 1 2 2004

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## 510(k) SUMMARY

| 510(k) NUMBER: | PENDING K040295 |
|-----------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| SUBMITTED BY: | Applied Medical Resources Corporation<br>22872 Avenida Empresa<br>Rancho Santa Margarita, CA-92688<br>[phone]<br>FAX [phone] |
| CONTACT PERSON:<br>Programs | Cheryl Blake<br>Director of Regulatory Affairs and Clinical |
| DATE OF PREPARATION: | January 15, 2004 |
| NAME OF DEVICE: | Laparoscopic Monopolar Scissors |
| CLASSIFICATION NAME: | Gynecologic laparoscope and accessories<br>(Regulation Number 21CFR 884.1720 and<br>accessories). |
| TRADE NAME: | Applied Laparoscopic Monopolar Scissors |
| PREDICATE DEVICE: | United States Surgical Auto Suture® Endoscopic<br>Scissors, which is cleared to market under<br>premarket notification K903206 |

INDICATIONS FOR USE: The Applied Laparoscopic Monopolar Scissors is indicated for use in gynecologic and general endoscopic procedures for mobilization and transection of tissues. The device with a 5mm diameter insulated shaft has a male cautery connection on top of the handle and may be used for monopolar cautery when attached to standard cautery cables and their generators.

INTENDED USE: The Laparoscopic Monopolar Scissors is intended for use in general or gynecological surgical procedures that utilize minimally invasive surgical procedures. The primary function of the device is to provide the surgeon the ability to manipulate tissue during minimally invasive surgery.

## SUMMARY STATEMENT:

The Applied Laparoscopic Monopolar Scissors is designed to for a variety of general, gynecologic and urologic endoscopic procedures for mobilization and transection of

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K090295

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tissue. The Applied Laparoscopic Monopolar Scissors consists of a reusable handle and disposable insulated shaft with scissor blades. The device has a 5mm diameter disposable insulated shaft that connects to a reusable Polyenylsulfone/stainless steel handle with a male cautery connector to be utilized for monolpolar cautery when attached to standard monopolar cautery cables and their generators.

The disposable shaft consists of a stainless steel outer shaft housing an actuation rod, which connects to the scissor blades and handle actuation rod. The disposable shaft is to be supplied sterile in single unit pouches. The scissor blade length is 17.4mm and the blade opening is 5.59mm and will be available in working lengths of 32cm, 38cm, and 45cm.

The reusable handle is comprised of Polyphenylsulfone male and female handles with various stainless connectors and contacts. The reusable handle will be supplied non-sterile. The handle includes a 360° rotation knob for user convenience.

The reusable handle is steam sterilized by the user and then connected to the sterile disposable shaft. Following use the shaft and handle are disassembled. The shaft is disposed of and the handle is cleaned and re-sterilized.

The device is in compliance with ISO 10993 for Biocompatibility. The Applied Laparoscopic Monopolar Scissors Shaft is sterilized using 100% Ethylene Oxide (EO). Applied's 100% EO sterilization cycle provides a sterility assurance level of 106. Sterilization validation for Applied Medical's EO cycle uses three halfcycle validation runs, which incorporate biological indicators and temperature monitors distributed throughout the load to verify gas penetration and profile temperature distribution. Spore strip biological indicators (BIs) of Bacillius atrophaus var. niger (formerly known as Bacillus subtilis) with a population of 106 are used to monitor routine finished product sterilization loads. Sterilant residue levels will be in compliance with ANSVAAMI/ISO 10993-7:1995 for limited exposure devices which is 20 mg ethylene oxide and 12 mg ethylene chlorohydrin.

The Laparoscopic Monopolar Scissors Handle is provided non-sterile. Sterilization instructions are provided in the Product Information Data Sheet. The Applied steam sterilization and cleaning validation methods are based on the AAMI TIR No. 12 - 1994, Designing, Testing and Labeling Reusable Devices for Reprocessing in Health Care Facilities: A Guide for Device manufactures, and proves a sterility assurance level of 106. Sterilization validation of the steam sterilizations is based on three sterilization cycles at one-half the exposure time. The use of Bacillus sterothermophilus spore strips or inoculum is the utilized indicator.

The Laparoscopic Monopolar Scissors is substantially equivalent to the United States Surgical Auto Suture® Endoscopic Scissors, which is cleared to market

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KO40295
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under premarket notification K903206, in intended use, design, and use methodology and is manufactured from similar materials.

Applied Medical is the manufacturer of the device and has followed design control regulations per 21 CFR § 820.30. The design controls have been in place since 1997 and have been audited by FDA on several occasions. The design of the Laparoscopic Monopolar Scissors was within the Applied Medical Design Control System.

A Design Risk Assessment Profile was conducted in accordance to Applied Medical internal Stand Operating Procedures, EN 1441 standards, ISO 9001/ISO 13485, AAMI/ISO TIR 14971, and 21 CFR § 820.30, validation and verification activities addressed the profile. Based on the risk analysis, validation and verification activities were formally controlled and addressed by Applied Medical, the activities included the methods, tests used, and acceptance criteria applied.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an eagle or bird-like figure with three wing-like extensions.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 1 2 2004

Applied Medical Resources Co. % Ms. Elizabeth Drew Underwriters Laboratories, Inc. Santa Clara Division 1655 Scott Boulevard SANTA CLARA CA 95050-4169 Re: K040295 Trade/Device Name: AMRC's Laparoscopic Monopolar Scissors Regulation Number: 21 CFR 884.1720 Regulation Name: Gynecologic laparoscope and accessories Regulatory Class: II Product Code: 85 HET Dated: February 23, 2004 Received: February 26, 2004

Dear Ms. Drew:

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 fisting (2) 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,

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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. Brogdon

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

Enclosure

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## INDICATIONS FOR USE

Applied Medical Resources is providing this separate cover page for the Applied Applied Medical Resources is prs "Indications for Use" as required.

K04 0295 Not assigned 510(k) Number:

Applied Laparoscopic Monopolar Scissors Device Name:

The Applied Laparoscopic Monopolar Scissors is indicated for use Indications for Use: in gynecologic and general endoscopic procedures for mobilization and transection of in gynecologic and general chaoscopic processed shaft has a male cautery connection on tissues. The device with a min diamotor instituted cautery when attached to standard cautery cables and their generators.

Title: Director RA/Clinical Programs_ Date: 1/15/04 Signature:

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use (Per 21 CFR 801.109)

Over-The -Counter Use OR

Nancy Brogdon

(Division Sign-OHX)
Division of Reproductive, Abdominal,
and Radiological Devices
510(k) Number. K040295

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