K Number

Device Name

AURA 20 BIPOLAR ELECTROSURGICAL COAGULATOR, MODEL 26-2500

Manufacturer

KIRWAN SURGICAL PRODUCTS, INC.

Date Cleared

2003-01-15

(90 days)

Product Code

GEI

Regulation Number

878.4400

Intended Use

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.

More Information

Contact

Type

Center

Panel

Date Received

Product Code

Subsequent Product Codes

Applicant Name (Manufacturer)

Device Name

Decision

Street 1

Street 2

City

State

Country Code

ZIP

Postal Code

Class Advise Committee

SSP Indicator

Third Party Reviewed

Expedited Review

Predicate Devices

28-1000, 26-1500

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description mentions "microprocessor technology" for simplification and user interface enhancements, but there is no mention of AI or ML algorithms, training data, or performance metrics typically associated with AI/ML devices.

Therapeutic

Yes.
The device is described as a "Bipolar Electrosurgical Coagulator" used on "soft body tissues" and supplies an RF signal to electrosurgical handpieces. This indicates its use in medical procedures to treat or modify body tissues, which aligns with the definition of a therapeutic device.

Diagnostic

The device is described as an electrosurgical coagulator used to supply RF signals for surgical procedures on soft body tissues, indicating a therapeutic function rather than a diagnostic one.

SaMD (Software as a Medical Device)

The device description clearly outlines a hardware device (solid state bipolar generator, footswitch, membrane keypads) that delivers RF energy. While it uses microprocessor technology, it is not solely software.

IVD (In Vitro Diagnostic)

Based on the provided text, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use clearly states it's a "general purpose solid state bipolar generator used to supply the RF signal to electrosurgical handpieces used on soft body tissues". This describes a device used on the body for surgical procedures, not a device used to test samples outside the body (in vitro).
Device Description: The description reinforces its function as an electrosurgical generator that interfaces with handpieces and delivers energy to tissue.
Lack of IVD characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or any other typical components of an in vitro diagnostic device.

Therefore, the Model 26-2500, Aura 20, Bipolar Electrosurgical Coagulator is an electrosurgical device used for surgical procedures, not an IVD.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

Product codes

GEI

Device Description

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.
The Aura 20 uses membrane keypads instead of potentiometers (knobs) as adjustable controls for tonal volume and power level settings.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

soft body tissues

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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.
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

Key Metrics

Not Found

Predicate Device(s)

28-1000, 26-1500

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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.

Summary

SUMMARY OF SAFETY AND EFFECTIVENESS

FOR THE

JAN 1 5 2003

MODEL 26-2500, AURA 20, BIPOLAR ELECTROSURGICAL COAGULATOR

K 023482

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

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

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

Page _________________________________________________________________________________________________________________________________________________________________________

510(k) Number (if known):	K023482
---------------------------	---------

Date:	10/16/02
-------	----------

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