General-purpose electrosurgical generator designed to produce radio frequency (RF) current for cutting and coagulation to be delivered to target tissue through an accessory electrode during open and laparoscopic surgical procedures.

Device Description

The Megadyne MEGA Power Electrosurgical Generator is a microprocessor controlled, isolated output, high frequency generator designed for use in cutting and coagulating of tissue. The Generator has the ability to perform both monopolar cutting and coagulation and bipolar coagulation of tissue in a wide range of surgical applications.

AI/ML Overview

The provided text is a 510(k) summary for an electrosurgical generator, which is a medical device used for cutting and coagulating tissue. As such, the concept of "acceptance criteria" and "device performance" in this context refers to engineering and electrical safety standards rather than clinical performance metrics typically associated with AI/ML-based diagnostic devices (e.g., sensitivity, specificity).

Therefore, the requested information regarding "acceptance criteria" and "study that proves the device meets the acceptance criteria" will be interpreted in the context of electrical safety and performance standards for electrosurgical generators. Other numbered points related to AI/ML device testing (sample size for test set, data provenance, expert ground truth, adjudication, MRMC studies, standalone performance, ground truth type for training, training set sample size, ground truth for training) are not applicable to this type of device and submission.

Acceptance Criteria and Study Proving Device Meets Acceptance Criteria

The acceptance criteria for the Megadyne MEGA Power Electrosurgical Generator are primarily based on conformance to established electrical safety and performance standards for electrosurgical devices. The study proving the device meets these criteria is the testing conducted to demonstrate this conformance.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Standard Conformance)	Reported Device Performance (Claimed Conformance)
AAMI HF 18:2001 (Electrosurgical Devices Safe Current Limits)	Conforms to applicable sections of AAMI HF 18:2001
IEC 60601-1:2003 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance)	Conforms to applicable sections of IEC 60601-1:2003
IEC 60601-2-2:1998 (Medical electrical equipment - Part 2-2: Particular requirements for the safety of high frequency surgical equipment)	Conforms to applicable sections of IEC 60601-2-2:1998
IEC 60601-1-2:2001 (Medical electrical equipment - Part 1-2: General requirements for safety - Collateral standard: Electromagnetic compatibility - Requirements and tests)	Conforms to applicable sections of IEC 60601-1-2:2001

Note: The submission states that the "operating principle of the proposed device is identical to the predicate device" and that "questions of safety and effectiveness are the same for this device as they are for the other electrosurgical generators on the market." These statements, combined with conformance to recognized consensus standards, serve as the basis for demonstrating substantial equivalence for this device type. Detailed performance specifications (e.g., power output accuracy, leakage current measurements) would typically be found in the full 510(k) submission, not just the summary.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not Applicable. For this type of electrosurgical generator, a "test set" in the context of clinical data or image analysis for AI/ML is not relevant. The testing involved electrical and functional performance verification against engineering standards directly on the device itself. Data provenance (country of origin, retrospective/prospective) is not applicable to engineering compliance testing.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not Applicable. Ground truth in this context refers to established harmonized standards for electrical safety and performance, not expert consensus on clinical findings. The "experts" would be the engineers and technicians who conducted the specified tests, ensuring the device's adherence to the technical requirements of the standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not Applicable. Adjudication methods are used to resolve discrepancies in expert interpretations, particularly in clinical data studies. For engineering compliance testing, a pass/fail criterion based on objective measurements against a standard is typically used, not an adjudication process.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not Applicable. MRMC studies are associated with diagnostic imaging devices and AI assistance for human readers. This device is an electrosurgical generator, not an AI-enabled diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

Not Applicable. This question relates to the performance of an AI algorithm in isolation. The device concerned is an electrosurgical generator, which does not incorporate AI algorithms in this manner.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

The "ground truth" for this device's acceptance is defined by the objective, measurable criteria specified within the referenced consensus standards (AAMI HF 18:2001, IEC 60601-1:2003, IEC 60601-2-2:1998, and IEC 60601-1-2:2001). This includes parameters like leakage current, power output accuracy, safety mechanisms, electromagnetic compatibility, etc. The device must perform within the limits and specifications set by these engineering standards.

8. The sample size for the training set

Not Applicable. This question relates to AI/ML model training. This device does not use a training set for an AI/ML model.

9. How the ground truth for the training set was established

Not Applicable. This question relates to AI/ML model training. This device does not use a training set for an AI/ML model.

Summary

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MAR 2 4 2005

050579

Section XV 510(k) Summary

February 9, 2005

A. Submitter's Name / Address

Ronda K. Magneson Manager, Regulatory Affairs and Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax

Page 1 of 2

B. Contact Person

Primary: Ronda K. Magneson Manager of Regulatory Affairs / Quality Assurance Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax

Alternate: Ihsan Samara Compliance Engineer Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax

C. Megadyne's Manufacturing Facility

Megadyne Medical Products, Inc. 11506 South State Street Draper, UT 84020 (801) 576-9669 (801) 576-9698 fax

Megadyne Medical Products, Inc. 510(k): Mega Power Electrosurgical Generator

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Page 2 of (2)

D. Device Name

Common Name:

Trade Name: Classification (if known):

Device, electrosurgical, cutting & coagulation & accessories MEGA Power 21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

E. Predicate Device

Valleylab Force FXc (K944602).

F. Applicant Device Description

G. Applicant Device Intended Use

H. Technological Characteristics

The operating principle of the proposed device is identical to the predicate device.

The proposed device conforms to the applicable sections of AAMI HF 18:2001, IEC 60601-1:2003 IEC 60601-2-2:1998 and IEC 60601-1-2:2001.

I. Safety information

Questions of safety and effectiveness are the same for this device as they are for the other electrosurgical generators on the market.

The proposed device conforms to the applicable sections of AAMI HF 18:2001, IEC 60601-1:2003 IEC 60601-2-2:1998 and IEC 60601-1-2:2001.

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Image /page/2/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the edge. In the center of the seal is a stylized image of a caduceus, which is a symbol of medicine. The caduceus is made up of a staff with two snakes coiled around it, and a pair of wings at the top.

MAR 2 4 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Megadyne Medical Products, Inc. c/o Mr. Mark Job Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K050579

Trade/Device Name: MEGA Power™ Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: March 3, 2005 Reccived: March 7, 2005

Dear Mr. Job:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becaon 310(t) pe device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the cholosale) to regars the Medical Device Amendments, or 10 commerce prior to May 20, 1978, the enaonance with the provisions of the Federal Food. Drug. de rices that have been require approval of a premarket approval application (PMA). alle Cosmetic rearly that do not require and controls provisions of the Act. The I ou may, merciole, manel the act include requirements for annual registration. Iisting of general controll pro receive, 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 If your device is classined (soc aborto) als. Existing major regulations affecting your device can Ifray be subject to suell additions, 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 r lease be advised that i Dri- 3 issuance over device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must or any I edetar statutes and regisments, including, but not limited to: registration and listing (21 Comply with an the Hot 87043FR Part 801); good manufacturing practice requirements as set OF IT att 6077, laboring (21 OFF egulation (21 CFR Part 820); and if applicable, the electronic form in the quality bybions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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Page 2 -- Mr. Mark Job

This letter will allow you to begin marketing your device as described in your Section 5 10(k) This letter will allow you to begin marketing your avice of your device of your device to a legally
premarket notification. The FDA finding of substantial equir device than premarket notification. The FDA inding of substantal equive and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Parl 801), please
r the results of the man 2012 11:54 at has and as a regulation entitled If you desire specific advice for your device at (240) 276-0115. Also, please note the regulation entitled. contact the Office of Complanes at (210) 2017 - 12 (21CFR Part 807.97). You may obtain " Misbranding by reference to premance noutitean.org other general information on your responsions and its toll-free number (800) 638-2041 or and Manufacturers, International and Consumer Assistance arovedrh/industry/support/index.html.

Sincerely yours,

Elaine, M.D. Ph.D.

Miriam C. Provost, Ph.D Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Section IV Indications for Use Statement

510(k) Number (if known):

Device Name:

MEGA Power™

Indications for use:

K050579

Prescription Use V (Per 21 CFR 801.109)

Over-The-Counter Use ___________

Concurrence of CDRH, Office of Device Evaluation (ODE)

Big
ion of G Restorative
rological Sciences

Kosos79

Megadyne Medical Products, Inc. Megadyne Medical Products, Integrosurgical Generator Page 8 of 74

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.