AED MONOPOLAR LAP ACCESSORIES

K081503 · National Advanced Endoscopy Devices, Inc. · GEI · Sep 25, 2008 · General, Plastic Surgery

Device Facts

• Record ID: K081503
• Device Name: AED MONOPOLAR LAP ACCESSORIES
• Applicant: National Advanced Endoscopy Devices, Inc.
• Product Code: GEI · General, Plastic Surgery
• Decision Date: Sep 25, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

Device Story

AED Monopolar Lap Accessories consist of insulated monopolar handles, insulated shafts, and Class I inserts (forceps, scissors, biopsy cups, needle holders) with electrodes. Devices are reusable and provided non-sterile; require cleaning and sterilization before use. Used in general laparoscopic surgical procedures by surgeons to perform electrosurgical cutting and coagulation. Device functions as an accessory to electrosurgical units to deliver high-frequency energy to tissue.

Clinical Evidence

Bench testing only. Compliance with IEC 60601-2-2 (safety of high-frequency surgical equipment) and ISO 14937 (sterilization validation) demonstrated.

Technological Characteristics

Reusable laparoscopic accessories including insulated handles, shafts, and various inserts (forceps, scissors, biopsy cups, needle holders). Energy source: external electrosurgical generator. Sterilization: validated per ISO 14937. Compliance: IEC 60601-2-2.

Indications for Use

Indicated for patients undergoing general laparoscopic surgical procedures requiring electrosurgical cutting and/or coagulation. Prescription use only.

Regulatory Classification

Identification

An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.

Predicate Devices

• Dan Monopolar Lap Accessories, Dannoritzer Medizintechnik GmbH (K052759)
• Gyrus Open Forceps, Gyrus Medical, Inc. (K024286)

Submission Summary (Full Text)

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SEP 2 5 2008

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## АТТАСНМЕНТ В

# 510(k) Summary of Safety and Effectiveness

| Date: | May 22, 2008 |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | National Advanced Endoscopy Devices, Inc.<br>22134 Sherman Way<br>Canoga Park, CA 91303 |
| Telephone: | 818.227.2720 |
| Fax: | 818.227.2724 |
| Contact Person: | Gayle M. Butler<br>Compliance Manager |
| Product:<br>Trade Name: | AED Monopolar Lap Accessories |
| Classification: | Class II |
| Common Name: | Laparoscopic Accessories for General & Plastic Surgery |
| Classification Name: | Laparoscope, General & Plastic Surgery<br>(GCJ, 21 CFR 876.1500)<br>Electrosurgical Cutting & Coagulation & Accessories<br>(GEI, 21 CFR 878.4400) |
| Predicate Devices: | Dan Monopolar Lap Accessories, Dannoritzer<br>Medizintechnik GmbH, K052759<br>Gyrus Open Forceps, Gyrus Medical, Inc., K024286 |
| Device Description: | AED Monopolar Lap Accessories consist of<br>Standard insulated monopolar handlesInsulated ShaftsClass I inserts (forceps, scissors, biopsy cups, needle holders)Electrodes<br>The device is reusable and provided non-sterile. It<br>must be cleaned and sterilized before use. |
| Intended Use: | AED Monopolar Lap Accessories are reusable<br>devices (forceps and electrodes) intended to be used in<br>general laparoscopic surgical procedures requiring the<br>use of electrosurgical cutting and/or coagulation. |
| Comparison to Predicate Device: | Design analysis and comparison confirm that basic<br>functional characteristics are substantially equivalent to<br>the predicate devices cited and raise no new issues of<br>safety and effectiveness. |

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K051503 p. Zotz

Performance Standards: AED Monopolar Lap Accessories IEC 60601 -2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (Fourth Edition, 2006). ISO 14937:2000 Sterilization of health care products – General Requirements for Characterization of a Sterilizing Agent and the Development, Validation, and Routine Control of a Sterilization Process for Medical Devices. Conclusion: Based on the technical information provided, intended use and performance information provided in this premarket notification, AED Monopolar Lap Accessories have been shown to be substantially equivalent to the current legally marketed predicate devices.

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Public Health Service

Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, clutching a caduceus in its talons. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.

SEP 2 5 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

National Advanced Endoscopy Devices, Inc. % Ms. Gayle M. Butler Compliance Manager 22134 Sherman Way Canoga Park, California 91303

Re: K081503

Trade/Device Name: AED Monopolar Lap Accessories Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 26, 2008 Received: August 29, 2008

Dear Ms. Butler:

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.

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Page 2 - Ms. Gayle M. Butler

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 10gally 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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at [phone]. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at [phone]. 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 a its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours.

Mark M Milburn

- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure

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#### ATTACHMENT A

### INDICATIONS FOR USE

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## 510(k) Number (if known): K081503

Device Name: AED Monopolar Lap Accessories

Indications for Use:

AED Monopolar Lap Accessories are reusable devices (forceps and electrodes) intended to be used in general laparoscopic surgical procedures requiring the use of electrosurgical cutting and/or coagulation.

Prescription Use X (Per 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (Per 21 CFR 807 Subpart C)

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

Concurrence of CDHR, Office of Device Evaluation (ODE)

N.L.

(Division Sign-Off) Division of General, Restorative, and Neurological Devices

**510(k) Number** Ic frI 503