The AtriCure dissector™ is intended to dissect soft tissue during general, ENT, thoracic, urological and gynecological surgical procedures. The Dissector's battery-powered light source is used to navigate soft tissue for identification of anatomic structures.

Device Description

The AtriCure dissector™ is a hand held, single use, surgical articulated dissector with integral light source.

AI/ML Overview

The provided text is a 510(k) summary for the AtriCure dissector™, a surgical device. It does not describe a study that proves the device meets specific acceptance criteria in the way an AI/software device submission would. Instead, it focuses on demonstrating substantial equivalence to a predicate device through product testing and material suitability.

Therefore, many of the requested elements for an AI/software device study, such as sample size, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth types, are not applicable or not provided in this document.

However, I can extract the information that is present and indicate where the requested information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Predicate Device Equivalence	The AtriCure dissector™ is substantially equivalent to the Stryker Knifelight Lighted Knife (K961122).
Indications for Use Equivalence	The indications for use are substantially equivalent to the predicate device.
Basic Overall Function Equivalence	The basic overall function is substantially equivalent to the predicate device.
Material Equivalence	The materials used are substantially equivalent to the predicate device.
Biocompatibility	Testing was conducted in accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.
Conformance to Product Specification	Appropriate product testing was conducted to evaluate conformance to product specification.
Substantial Equivalence to Predicate Devices	Appropriate product testing was conducted to evaluate substantial equivalence to predicate devices.

2. Sample size used for the test set and the data provenance

Not applicable. This is not an AI/software device being evaluated with a test set of data. The "testing" refers to product testing for device function and biocompatibility.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for an AI test set is not relevant for this type of medical device submission.

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

Not applicable.

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. This is not an AI-assisted device for diagnostic interpretation.

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

Not applicable. This is a physical surgical tool.

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

Not applicable. Ground truth as typically understood for AI evaluation is not relevant here. The "ground truth" for this device would be its ability to perform its intended mechanical and lighting functions safely and effectively, which is assessed through engineering and biocompatibility testing against predefined specifications and predicate device equivalence.

8. The sample size for the training set

Not applicable. This is not an AI/software device that undergoes a training process.

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

Not applicable.

Summary

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K041681

510(k) Summary

General Information JUL 0 1 2004 Classification Class I/Ii Trade Name AtriCure dissector™ Manufacturer AtriCure, Inc. 6033 Schumacher Park Drive West Chester, OH 45069 Contact Elsa Abruzzo Vice President, Regulatory and Clinical Affairs

Intended Use

Predicate Devices

The predicate device for the AtriCure dissector™ is the Stryker Knifelight Lighted Knife (K961122). The Stryker Knifelight Lighted Knife is classified as a Dissector, Surgical, General and Plastic Surgery, per 21CFR878.4800 and a Lamp, Surgical, per 21CFR 878.4580.

Device Description

The AtriCure dissector™ is a hand held, single use, surgical articulated dissector with integral light source.

Materials

All materials used in the manufacture of the AtriCure dissector™ are suitable for this use and have been used in numerous previously cleared products. Testing was conducted in Accordance with ISO 10993-1 to ensure appropriate biocompatibility of all materials.

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K041681 page 2/2

Testing

Appropriate product testing was conducted to evaluate conformance to product specification and substantial equivalence to predicate devices.

Summary of Substantial Equivalence

The AtriCure dissector™ is equivalent to the predicate products. The indications for use, basic overall function, and materials used are substantially equivalent.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract caduceus or a representation of human figures.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

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

JUL 01 2004

Re: K041681

Trade/Device Name: AtriCure Dissector™ Regulation Number: 21 CFR 878.4580 Regulation Name: Surgical lamp Regulatory Class: II Product Code: FTD Dated: June 17, 2004 Received: June 21, 2004

Dear Mr. Job:

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 - Mr. Mark Job

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 (301) 594-4659. 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/dsma/dsmamain.html

Sincerely yours,

Miriam C. Provost

Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known):

Device Name: AtriCure dissector™

Indications For Use:

___ Prescription Use _________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The-Counter Use

(Part 21 CFR 801 Subpart D)

(21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Miriam C. Provost

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

Page 1 of 1

510(k) Number K041681

000150

Regulation Number and Section

§ 878.4580 Surgical lamp.

(a)
Identification. A surgical lamp (including a fixture) is a device intended to be used to provide visible illumination of the surgical field or the patient.(b)
Classification. Class II (special controls). The device, when it is an operating room lamp, a surgical instrument light, a surgical floor standing light, an endoscopic surgical light, a surgical light connector, a ceiling mounted surgical light, a surgical light carrier, surgical light accessories, a surgical lamp, a remote illuminator, or an incandescent surgical lamp, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 878.9.