The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, manipulate, coagulate and/or transect tissues in the following specialities:

Neurosurgery Plastic and Reconstructive Surgery General Surgery

Device Description

Metal and plastic construction that approximates a tweezer assembly. Includes provision for connection to the output of a standard bipolar electrosurgical generator. Also includes provision for mechanical attachment to an ultrasonic surgical aspirator. There is no energy interaction between the ultrasound unit and the electrosurgery unit.

AI/ML Overview

The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory 510(k) summary provides information on the device's adherence to voluntary standards and non-clinical tests. This document does not describe an acceptance criteria table, a study explicitly proving the device meets said acceptance criteria, or details regarding sample sizes, ground truth establishment, or human-in-the-loop studies as typically expected for imaging algorithm performance.

However, based on the provided text, we can infer the acceptance criteria are met by the successful completion of various safety and performance tests to established voluntary standards.

Here's a breakdown of the information requested, as far as it can be extracted and inferred from the provided document:

1. Table of Acceptance Criteria and Reported Device Performance

The document describes voluntary standards and non-clinical tests rather than a specific acceptance criteria table with numerical targets. The "performance" is reported as having successfully passed these tests.

Acceptance Criteria (Voluntary Standards & Non-Clinical Tests)	Reported Device Performance
Voluntary Standards:
UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Passed (device designed and tested to pass these standards)
EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety	Passed (device designed and tested to pass these standards)
EN 60601-1-2:2001 Electromagnetic Compatibility	Passed (device designed and tested to pass these standards)
EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for the safety of high frequency surgical equipment	Passed (device designed and tested to pass these standards)
FCC Part 18 EMC Requirements	Passed (device designed and tested to pass these standards)
Non-Clinical Tests (with Electrosurgical Generator):
Life Tests	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
Input Power Measurements	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
EMI Tests	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
Dielectric Tests on Mains Circuits	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
Patient Current Leakage and Patient Sink Current Measurements	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
Power Line Ground Leakage Measurements	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
Dielectric Tests on Patient Circuits	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
RF Cautery Life Tests	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
Dielectric Tests with RF Cautery Unit Attached	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
RF Cautery Unit Output Power Tests	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
Temperature testing with tips closed for prolonged period of time	Performed; testing confirmed forceps did not alter expected output characteristics of any generator tested.
In Vitro Tests:
Testing of bipolar effect on animal tissue (bench top)	Performed
Temperature testing of forceps during prolonged bench testing	Performed
Surgeon assisted trial on animal tissue (bench top) for clinician feedback	Performed

The general conclusion, based on these tests and a review of published literature, is that the device is "safe and efficacious" and "substantially equivalent" to predicate devices.

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

Sample Size for Test Set: Not specified. The document mentions "testing was done while attached to standard electrosurgical generator" and "testing of bipolar effect on animal tissue (bench top)". It does not provide numerical sample sizes for these tests.
Data Provenance: The tests are described as "internal testing" and "in vitro tests performed". "Animal tissue (bench top)" is mentioned for the in vitro tests. The country of origin is not specified but is presumably the US, given the submission to the FDA. The tests are prospective as they were conducted specifically for this submission.

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

Number of Experts: Not specified.
Qualifications of Experts: The document mentions a "Surgeon assisted trial on animal tissue (bench top) for clinician feedback." This implies input from at least one surgeon, but specific qualifications (e.g., years of experience, specialty beyond "surgeon") are not detailed.

4. Adjudication Method for the Test Set

Not applicable/specified. The document does not describe a clinical study with a test set requiring adjudication. The tests mentioned are primarily engineering and bench-top evaluations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No. The document does not describe an MRMC comparative effectiveness study where human readers' performance with and without AI assistance is evaluated. This is a medical device (forceps accessory), not an AI/software diagnostic tool.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

Not applicable. This device is a physical electrosurgical accessory, not a software algorithm, so the concept of "standalone algorithm performance" does not apply. The device's performance is inherently "with human-in-the-loop" as it is operated by a surgeon.

7. The Type of Ground Truth Used

For the non-clinical and in vitro tests, the "ground truth" would be the expected performance according to the voluntary standards (e.g., specific thresholds for leakage current, dielectric strength) and the observable effects on animal tissue in bench-top settings (e.g., successful coagulation, lack of tissue adhesion). It is based on engineering measurements and physical observation/outcomes in a controlled environment as opposed to expert consensus, pathology, or clinical outcomes data from human subjects.

8. The Sample Size for the Training Set

Not applicable. As this is not a machine learning or AI-driven device, there is no "training set."

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

Not applicable, as there is no training set.

Summary

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510(k) SUMMARY - Misonix Inc. FS-1000-RF Bipolar Forceps Exhibit E Accessory

This summary of safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21CFR 807.92.

1. Submitter's Identification

Submitter's Name:	MISONIX INCORPORATED
Address:	1938 New Highway, Farmingdale, NY 11735
Telephone Number:	516-694-9555
Contact Person:	Ronald R. Manna
Date Prepared:	August 22, 2005

2. Name of Device

一

Proprietary Name:	Misonix Inc. FS-1000-RF Bipolar ForcepsAccessory
Common/Usual Name:	Electrosurgical cutting and coagulationdevice and accessories
Product Code:	GEI
Classification:	Class II

3. Predicate Device Information

Predicate Devices	Boston Surgical Products Inc. Disposable BipolarCoagulating Forceps K942710Olsen Electrosurgical Inc. Teflon Coated Electrodesfor Electrosurgical Handles K913108Guenter Bissinger Medizintechnik GmbH ClarisNon Stick Bipolar Forceps K051429
Device Description	Metal and plastic construction that approximates atweezer assembly. Includes provision forconnection to the output of a standard bipolarelectrosurgical generator. Also includes provisionfor mechanical attachment to an ultrasonic surgical

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aspirator. There is no energy interaction between the ultrasound unit and the electrosurgery unit.

Intended Use:

The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, mampulate, coagulate and/or transect tissues in the following specialities:

Neurosurgery Plastic and Reconstructive Surgery General Surgery

6. Comparison to Predicate Device

FS-1000-RF Bipolar Forceps Accessory is similar in design, material and operating parameters to the Boston Surgical Products Inc. Disposable Bipolar Coaculpting Forceps, the Olsen Electrosurgical Inc. Teflon Coated Electrodes for Electrasurgical Handles and the Guenter Bissinger Medizintechnik GmbH Claris Non Stick Birgolar Forceps.

All devices utilize two electrodes made of metal material, usually stainless steel or titanium. A coating of titanium oxide is used on the Misonix FS-1000-RF focce or accessory to minimize tissue adhesion. Predicates use other coatings such as Teflon to accomplish the same effect.

The prongs of the forceps are held together at the proximal end by plastic assemblies which both provide a spring action to either hold the forceps open or closed without. operator intervention. Nylon coatings insulate the prongs so that the operator is not touching the RF energized metal, providing a measure of safety.

7 Safety and Performance Data

The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory have been designed and tested to pass the following Voluntary Standards:

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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UL 2601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1 Medical Electrical Equipment, Part 1: General Requirements for Safety EN 60601-1-2:2001 Electromagnetic Compatibility EN 60601-2-2 Medical Electrical Equipment, Part 2: Particular Requirements for the

safety of high frequency surgical equipment

FCC Part 18 EMC Requirements

This device does not contain software. 7. Software Validation
1. Sterilization Validations Validation statements are contained in Exhibit J.
Non-Clinical Tests Performed for Determination of Substantial Equivalence の are as follows:

Note: Forceps are passive devices. Testing was done while attached to standard electrosurgical generator. Testing confirmed that forceps did not alter expected output characteristics of any generator tested.

Life Tests Input Power Measurements EMI Tests Dielectric Tests on Mains Circuits Patient Current Leakage and Patient Sink Current Measurements Power Line Ground Leakage Measurements Dielectric Tests on Patient Circuits RF Cautery Life Tests Dielectric Tests with RF Cautery Unit Attached RF Cautery Unit Ouput Power Tests Temperature testing with tips closed for prolonged period of time

In Vitro Tests Performed 9.

Testing of bipolar effect on animal tissue (bench top) Temperature testing of forceps during prolonged bench testing Surgeon assisted trial on animal tissue (bench top) for clinician feedback

10. Conclusions

Based upon a review of the published literature and its internal testing. Misonix Inc. can state that the use of the FS-1000-RF Bipolar Forceps Accessory for grasping, manipulating, coagulation and transecting tissue is safe and efficacious. We can also state that the FS-1000-RF Bipolar Forceps Accessory is substantially equivalent in this regard to the Boston Surgical Products Inc. Disposable Bipolar Coagulating Forceps, the Olsen Electrosurgical

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科

Inc. Teflon Coated Electrodes for Electrosurgical Handles and the Guenter Bissinger Medizintechnik GmbH Claris Non Stick Bipolar Forceps.

Based upon the engineering and in vitro testing experiences outlined herein, the device poses no new issues of safety or efficacy for coagulating and transecting tissue.

and the controlled on the commend and commend of the comments of the comments of the comments of the comments of

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Image /page/4/Picture/1 description: The image shows the seal of the Department of Health and Human Services (HHS). The seal features a stylized caduceus, a symbol often associated with medicine and healthcare, with three parallel lines forming the staff and a snake winding around it. The seal is encircled by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.

NOV 2 1 2005

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ronald R. Manna Vice President Regulatory Affairs Misonix, Inc. 1938 New Highway Farmingdale, New York 11735

Re: K052702

Trade/Device Name: Misonix Inc. FS-1000-RF Bipolar Forceps Accessory Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: September 23, 2005 Received: September 28, 2005

Dear Mr. Manna:

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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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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Barbara Buckins

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

Enclosure

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510(k) Number (if known): _KQ52 702

Device Name: Misonix Inc. FS-1000-RF Bipolar Forceps Accessory

Indications for Use:

The Misonix Inc. FS-1000-RF Bipolar Forceps Accessory is indicated for use in bipolar procedures to grasp, manipulate, coagulate and/or transect tissues in the following specialities:

Neurosurgery Plastic and Reconstructive Surgery General Surgery

Prescription Use ズ (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Louare buchns

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

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510(k) Number K052702

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.