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 Description

AED Monopolar Lap Accessories consist of Standard insulated monopolar handles Insulated Shafts Class I inserts (forceps, scissors, biopsy cups, needle holders) Electrodes The device is reusable and provided non-sterile. It must be cleaned and sterilized before use.

AI/ML Overview

The provided text describes AED Monopolar Lap Accessories, focusing on their substantial equivalence to predicate devices rather than reporting on a study with specific acceptance criteria and performance metrics in the way one might expect for a novel AI/software medical device.

Therefore, for many of your requested points, the information is not directly available in the provided text. The device is a physical surgical accessory, and the "study" referred to is a comparison to predicate devices and adherence to performance standards, not a clinical trial or performance evaluation with human readers or AI.

Here's the information based on the provided text, with notes where information is not applicable or not present:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Standard/Predicate)	Reported Device Performance
Safety	Substantially equivalent to predicate devices (Dan Monopolar Lap Accessories, Gyrus Open Forceps) in basic functional characteristics, raising no new safety issues.	Confirmed substantial equivalence in basic functional characteristics.
Effectiveness	Substantially equivalent to predicate devices in basic functional characteristics, raising no new effectiveness issues.	Confirmed substantial equivalence in basic functional characteristics.
Electrical Safety	IEC 60601-2-2: Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment (Fourth Edition, 2006).	Implicitly met as part of substantial equivalence and performance standards. No specific performance values are given.
Sterilization	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.	Implicitly met as part of substantial equivalence and performance standards. No specific performance values are given.

2. Sample Size Used for the Test Set and Data Provenance

This information is not applicable or not provided as this is not an AI/software device that uses a "test set" in the traditional sense of data or images. The evaluation is based on design analysis and comparison to predicate physical devices, and adherence to established performance standards.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable as there is no "test set" of data requiring expert ground truth establishment for this physical device. The evaluation relies on engineering and regulatory assessment.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" or diagnostic assessment requiring adjudication.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. An MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic devices that analyze medical images or data interpreted by human readers, often with AI assistance. The AED Monopolar Lap Accessories are physical surgical tools.

6. Standalone (Algorithm only without human-in-the-loop performance) Study

No. A standalone performance study of an algorithm was not done. This device is a physical surgical instrument, not an algorithm.

7. Type of Ground Truth Used

The "ground truth" for this device's evaluation is based on established engineering standards (IEC 60601-2-2, ISO 14937:2000) and the demonstrated safety and effectiveness of legally marketed predicate devices (Dan Monopolar Lap Accessories, Gyrus Open Forceps). The evaluation confirms that the new device's design and functional characteristics are substantially equivalent, meaning it performs similarly to what is already accepted as safe and effective.

8. Sample Size for the Training Set

This information is not applicable as this is not an AI/software device that uses a "training set."

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as there is no "training set" for this physical device.

Summary

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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.22134 Sherman WayCanoga Park, CA 91303
Telephone:	818.227.2720
Fax:	818.227.2724
Contact Person:	Gayle M. ButlerCompliance Manager
Product:Trade Name:	AED Monopolar Lap Accessories
Classification:	Class II
Common Name:	Laparoscopic Accessories for General & Plastic Surgery
Classification Name:	Laparoscope, General & Plastic Surgery(GCJ, 21 CFR 876.1500)Electrosurgical Cutting & Coagulation & Accessories(GEI, 21 CFR 878.4400)
Predicate Devices:	Dan Monopolar Lap Accessories, DannoritzerMedizintechnik GmbH, K052759Gyrus Open Forceps, Gyrus Medical, Inc., K024286
Device Description:	AED Monopolar Lap Accessories consist ofStandard insulated monopolar handlesInsulated ShaftsClass I inserts (forceps, scissors, biopsy cups, needle holders)ElectrodesThe device is reusable and provided non-sterile. Itmust be cleaned and sterilized before use.
Intended Use:	AED Monopolar Lap Accessories are reusabledevices (forceps and electrodes) intended to be used ingeneral laparoscopic surgical procedures requiring theuse of electrosurgical cutting and/or coagulation.
Comparison to Predicate Device:	Design analysis and comparison confirm that basicfunctional characteristics are substantially equivalent tothe predicate devices cited and raise no new issues ofsafety 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 (240) 276-0115. 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 (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 (800) 638-2041 or (240) 276-3150 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

Page _1_of _1

510(k) Number (if known): K081503

Device Name: AED Monopolar Lap Accessories

Indications for Use:

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

Regulation Number and Section

§ 878.4400 Electrosurgical cutting and coagulation device and accessories.

(a)
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.(b)
Classification. Class II.