The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. This device is intended to be used whenever monopolar electrosurgical coagulation and fluid aspiration are indicated.

Device Description

The suction coagulator is a hand held electrosurgical device used for coagulation and aspiration during electrosurgical procedures. The device is available in two different configurations: hand controlled and foot controlled models. Both models are supplied with holsters.

AI/ML Overview

The provided 510(k) submission (K072559) for the Megadyne Suction Coagulator does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.

This submission is a 510(k) Premarket Notification, which primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than providing detailed clinical efficacy or performance studies with specific acceptance criteria as you might find for novel or higher-risk devices.

Here's a breakdown based on the provided text, indicating what information is not present:

1. Table of Acceptance Criteria and Reported Device Performance

Not present in the document. The submission discusses conformance to voluntary standards but does not list specific acceptance criteria or quantitative performance results from a device-specific study compared against those criteria.

2. Sample Size for Test Set and Data Provenance

Not present in the document. There is no mention of a test set, its sample size, or any data provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth and Their Qualifications

Not present in the document. No information about experts, ground truth establishment, or their qualifications is provided as there is no specific performance study detailed.

4. Adjudication Method for the Test Set

Not present in the document. Since no test set or expert evaluation is described, no adjudication method is mentioned.

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

Not present in the document. No MRMC study or any comparison of human readers with/without AI assistance is mentioned. This device is a surgical instrument, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance Study

Not present in the document. This device is a physical electrosurgical instrument; there is no "algorithm only" performance to evaluate.

7. Type of Ground Truth Used

Not present in the document. No ground truth establishment is described.

8. Sample Size for the Training Set

Not present in the document. As an electrosurgical device, it would not have a "training set" in the context of an algorithm or diagnostic model.

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

Not present in the document. No ground truth for training is relevant or mentioned.

Summary of what is present and relevant to safety/performance, though not matching the requested structure:

Conformance to Standards: "Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices." This indicates safety and basic performance testing was done against recognized industry standards, which is a common way to demonstrate safety and effectiveness for predicate-based devices.
Substantial Equivalence: The primary "proof" in this 510(k) is the demonstration of substantial equivalence to predicate devices (MegaDyne Suction Coagulator K946327 and Valleylab's Lectrovac K791752) based on shared technological characteristics and intended use. The FDA's letter explicitly states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent...".

In essence, for this type of device and submission, the "acceptance criteria" are generally met by demonstrating compliance with established voluntary consensus standards and showing that the device is technologically similar and has the same intended use as a legally marketed predicate. Specific numerical performance metrics against detailed acceptance criteria from a dedicated clinical study are typically not required or provided in a 510(k) for such a device.

Summary

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KO72559

510(k) Summary Section 5

September 6, 2007

A. Submitter's Name / Address

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

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OCT 5, 2007

B. Contact Person

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

Ihsan Samara Alternate: Quality Manager 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): Suction Coagulator

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K072559

D. Device Name

Common Name:

Device, electrosurgical, cutting & coagulatio accessories

Trade Name:

Classification (if known):

21 CFR 878.4400, Electrosurgical cutting and coagulation device and accessories

E. Predicate Devices

The predicate devices include the MegaDyne Suction Coagulator which was cleared for marketing via 510(k) # K946327 by FDA's Office of Device Evaluation on June-7, 1995; and Valleylab's Lectrovac which was cleared for marketing via 510(k) #K 791752 on October 4, 1979.

Suction Coagulator

F. Applicant Device Description

G. Applicant Device Intended Use

The intended use of this device is to conduct monopolar electrosugical energy from an electrosugical generator (ESU) to target tissue during ENT and general surgical procedures. It is also a suction apparatus and is intended to be used to remove surgical smoke and fluids from the site. The device is intended for single use; it is not intended to be cleaned or reused.

H. Technological Characteristics

The proposed device shares the same technological characteristics found in the predicate devices. It is a handheld electrosurgical device used for coagulation and aspiration during electrosurgical procedures.

I. Safety information

Questions of safety and effectiveness are the same for this device as they are for the predicate devices and other suction coagulators on the market. There are no new technologies incorporated into the device.

Megadyne has conducted extensive testing to ensure conformance to the voluntary standard ISO 60601-2-2:2006, Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment, and ANSI / AAMI HF 18-2001, Electrosurgical Devices.

Megadyne Medical Products. Inc. 510(k): Suction Coagulator

Page 12 of 41

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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized symbol featuring three abstract human profiles facing to the right, with flowing lines representing hair or clothing.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Megadyne Medical Products, Inc. % Ms. Ronda K. Magneson Director, Regulatory Affairs and Quality Assurance 11506 South State Street Draper, Utah 84020

OCT 5 2007

Re: K072559

Trade/Device Name: Suction Coagulator Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 06, 2007 Received: September 11, 2007

Dear Ms. Magneson:

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. Iisting 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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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 (240) 276-0115. 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 (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely vours.

Mark A. Milliken

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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Section 4 Indications for Use Statement

KO 42559 510(k) Number (if known): Device Name: Suction Coagulator

Indications for use:

Prescription Use (Per 21 CFR 801.109)

Over-The-Counter Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Mark A. Milliken

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

10(k) Number

Megadyne Medical Products, Inc. 510(k): Suction Coagulator

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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.