AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500 by KIRWAN SURGICAL PRODUCTS, INC.

The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered.

Device Description

The Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator, is a general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Its footswitch activation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard female banana jacks. The Aura 20 differs technologically from its predicates with only minor operational features designed to enhance user interface. The following are some of those features.

While operating on both 115 and 230 VAC mains supply as its predicates, the Aura 20 does not require the placement of an external jumper in order to select between the two different voltage levels.
Activation of the Aura 20 is via footswitch only, eliminating the optional hand switch activation of its predicates, which is viewed as a little-used option and expendable in order to simplify construction, and limit size.
While similarly relying on solid-state electronics, the Aura 20 has been greatly simplified over its predicates by the use of microprocessor technology and modular medical-grade power supply.
The Aura 20 uses membrane keypads instead of potentiometers (knobs) as adjustable controls for tonal volume and power level settings.

AI/ML Overview

The provided text is a 510(k) summary for the Aura 20 Bipolar Electrosurgical Coagulator. It focuses on establishing substantial equivalence to predicate devices based on intended use, technological characteristics, and compliance with safety standards.

Crucially, the document does NOT contain information about acceptance criteria, device performance, or specific studies that would typically be described in the context of clinical or performance validation studies for AI/ML devices.

The document states that "Technological safety and effectiveness is established by the fact that the Aura 20, like its predicates, offers well-proven, basic electrosurgical unit technology." and "Performance safety has been tested in accordance with, and found to comply with, the requirements of the applicable sections of the following standards". It then lists relevant electrical safety standards (e.g., IEC 60601-1-2, IEC 60601-2-2, ANSI/AAMI HF 18).

Therefore, based solely on the provided text, I cannot complete the requested table or answer most of the questions about acceptance criteria and studies as they relate to performance or clinical outcomes. The device is not an AI/ML device, and the information is from 2003, predating the widespread use of clinical validation studies for AI.

Here's what I can extract and infer:

1. A table of acceptance criteria and the reported device performance

Acceptance Criteria	Reported Device Performance
Compliance with ANSI/AAMI/IEC 60601-1-2 (2001) - Medical Electrical Equipment Part 1; General Requirements for the Safety.	"found to comply with, the requirements of the applicable sections of the following standards"
Compliance with IEC 60601-2-2 (1998) - Medical Electrical Equipment Part 2; particular Requirements for the safety of High Frequency Surgical Equipment.	"found to comply with, the requirements of the applicable sections of the following standards"
Compliance with ANSI/AAMI HF 18 (2001) - American National Standard for Electrosurgical Devices.	"found to comply with, the requirements of the applicable sections of the following standards"
Substantial equivalence to predicate devices (26-1500, Kirwan 20 Watt Bipolar Micro Coagulator, and 28-1000, Kirwan 50 Watt Bipolar Generator) in intended use, technological safety/effectiveness, and performance.	The FDA granted 510(k) clearance, indicating agreement with the substantial equivalence claim.

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 / Not provided. The document describes compliance with electrical safety standards and substantial equivalence, not a clinical performance study with a test set of data.

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 / Not provided. This information is for clinical ground truth, which is not discussed.

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

Not applicable / Not provided.

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

No. This is not an AI device, and no MRMC study is mentioned.

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

No. This is not an AI device.

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

Not applicable. The "ground truth" for this device would be defined by its electrical and functional performance conforming to established engineering standards, rather than clinical outcomes or expert consensus on diagnostic tasks.

8. The sample size for the training set

Not applicable / Not provided. This is not an AI/ML device.

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

Not applicable / Not provided. This is not an AI/ML device.

Summary

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SUMMARY OF SAFETY AND EFFECTIVENESS

FOR THE

JAN 1 5 2003

MODEL 26-2500, AURA 20, BIPOLAR ELECTROSURGICAL COAGULATOR

K 023482

Technological safety and effectiveness is established by the fact that the Aura 20, like its predicates, offers well-proven, basic electrosurgical unit technology. Its footswitch activation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard female banana jacks. The Aura 20 differs technologically from its predicates with only minor operational features designed to enhance user interface. The following are some of those features.

While operating on both 115 and 230 VAC mains supply as its predicates, the Aura 20 ■ does not require the placement of an external jumper in order to select between the two different voltage levels.
Activation of the Aura 20 is via footswitch only, eliminating the optional hand switch ■ activation of its predicates, which is viewed as a little-used option and expendable in order to simplify construction, and limit size.
. While similarly relying on solid-state electronics, the Aura 20 has been greatly simplified over its predicates by the use of microprocessor technology and modular medical-grade nower supply.
프 The Aura 20 uses membrane keypads instead of potentiometers (knobs) as adjustable controls for tonal volume and power level settings.

Performance safety has been tested in accordance with, and found to comply with, the requirements of the applicable sections of the following standards;

ANSI/AAMI/IEC 60601-1-2 (2001), Medical Electrical Equipment Part 1; General ■ Requirements for the Safety.
트 IEC 60601-2-2 (1998), Medical Electrical Equipment Part 2; particular Requirements for the safety of High Frequency Surgical Equipment.
ANSI/AAMI HF 18 (2001), American National Standard for Electrosurgical Devices l

Therefore, the Aura 20 is substantially equivalent in intended use, technological safety and effectiveness, and performance to both the;

26-1500, Kirwan 20 Watt Bipolar Micro Coagulator, and
28-1000, Kirwan 50 Watt Bipolar Generator. ■

Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, MA 02050

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol. The overall design is simple and professional, reflecting the organization's role in public health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JAN 1 5 2003

Kirwan Surgical Products, Inc. Kevin P. Prario Regulatory Affairs Manager 180 Enterprise Drive P.O. Box 427 Marshfield, Massachusetts 02050

Re: K023482

Trade/Device Name: Aura 20 Bipolar Electrosurgical Coagulator, Model 26-2500 Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: Class II Product Code: GEI Dated: October 16, 2002 Received: October 17, 2002

Dear Mr. Prario:

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

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Page 2 - Mr. Kevin P. Prario

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.

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). Other general information on your responsibilities under the Act may be obtained 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,

Mark n Millerme

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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Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):	K023482
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Date:	10/16/02
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Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator Device Name:

Indications For use:

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

Concurrence of CDRH, Office of Evaluation (ODE)

l Mach N Millerson

Division S (Division of General, Restorative and Neurological Devices

510(k) Number K023482

(Optional Format 3-10-98)

Prescription Use

Per 21 CFR 801.109

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.