(69 days)
28-1000, 26-2500, RF111, 80-1170
28-1000, 26-2500, RF111, 80-1170
No
The summary describes a standard electrosurgical generator and irrigation pump with no mention of AI or ML capabilities. The performance studies focus on electrical safety and software validation, not AI/ML performance metrics.
Yes
The device is described as an "Electrosurgical Coagulator" used for procedures on "soft body tissue," indicating its role in surgically treating or modifying tissue.
No
Explanation: This device is an electrosurgical coagulator used to supply RF signals for treatment purposes (coagulation of soft body tissue), not for diagnosing medical conditions.
No
The device description explicitly states it is a "solid state bipolar generator" and mentions "electrosurgical hand-pieces" and a "peristaltic irrigation pump," which are all hardware components. The performance studies also reference standards for medical electrical equipment and electrosurgical devices, further indicating a hardware-based device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is a "General purpose solid state bipolar generator to supply RF signal to electrosurgical hand-pieces used on soft body tissue". This describes a device used on the body for surgical procedures, not a device used to examine specimens outside the body to diagnose conditions.
- Device Description: The description reinforces the intended use, describing it as a "bipolar electrosurgical coagulator" used "on soft body tissues".
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue samples, etc.), reagents, or diagnostic purposes.
Therefore, this device falls under the category of a surgical device used for electrosurgery, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
General purpose solid state bipolar generator to supply RF signal to electrosurgical hand-pieces used on soft body tissue where a wide range of tissue types, patient conditions and load impedances are encountered. Where applicable (i.e., Auraplus, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
Product codes
GEI
Device Description
The model 28-2000, Aura, 70 Watt Bipolar Electrosurgical Coagulator and the model 28-2600, Auraplus, 70 Watt Irrigating Bipolar Electrosurgical Coagulator model 20 2.000, haraphid state bipolar generators used to supply the RF signal to electrosurgical hand-pieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Where applicable (i.e., Auraplus) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
Technological safety and effectiveness is established by the fact that the Aura 70, like its predicates, offers well-proven, basic electrosurgical unit technology. Its fike to productivation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard 4mm female banana jacks. The Aura 70 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 70 does not require the placement of an external jumper in order to select between the two different voltage levels.
- Activation of the Aura 70 is via footswitch only, eliminating the optional s hand switch activation of its 28-1000 predicate, which is viewed as a littleused option and expendable in order to simplify construction, and limit size.
- While similarly relying on solid-state electronics, the Aura 70 has been greatly simplified over some of its predicates by the use of microprocessor technology and modular medical-grade power supply.
- The Aura 70 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
Not Found
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance safety has been tested in accordance with, and found to comply with, the requirements of the applicable sections of the following standards and quidelines:
- 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
- ANSI/AAMI/ISO 14971:2000, Medical devices Application of risk management to medical devices.
- General Principles of Software Validation; Final Guidance for Industry and FDA Staff (issued January 11, 2002).
- Guidance for FDA Reviewers and Industry. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 29, 1998).
Safety and hazard analysis has determined that the hazard conditions for the Aura 70 range in the low-to-moderate level and for this reason are acceptable.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
28-1000, 26-2500, RF111, 80-1170
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows a logo for KIRVAN SURGICAL PRODUCTS. The logo includes a medical symbol to the left of the company name. The image also includes the date OCT 20 2005 and the text "Page 1 of 2".
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
{as required by 21 CFR, section 807.92( c )}
FOR
MODELS 28-2000 & 28-2600, AURA, 70 WATT SERIES BIPOLAR ELECTROSURGICAL COAGULATORS
Common name: Electrical Surgical unit (ESU) / Electrosurgical Generator.
Classification name: Electrosurgical Cutting and Coagulation Device and Accessories (§878.4400)
Product code: GEI
The model 28-2000, Aura, 70 Watt Bipolar Electrosurgical Coagulator and the model 28-2600, Auraplus, 70 Watt Irrigating Bipolar Electrosurgical Coagulator model 20 2.000, haraphid state bipolar generators used to supply the RF signal to electrosurgical hand-pieces used on soft body tissues where a wide range of tissue types, patient conditions, and load impedances are encountered. Where applicable (i.e., Auraplus) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
Technological safety and effectiveness is established by the fact that the Aura 70, like its predicates, offers well-proven, basic electrosurgical unit technology. Its fike to productivation and solid state circuitry delivers low voltage RF/bipolar energy, interfacing with electrosurgical accessories via its standard 4mm female banana jacks. The Aura 70 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 70 does not require the placement of an external jumper in order to select between the two different voltage levels.
Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, MA 02050 Phone: (781) 834-9500 Fax: (781) 834-0022 Contact: Kevin P. Prario,Regulatory Affairs Manager Date prepared: 8/5/2005
1
052203
Page 2 of 2
- Activation of the Aura 70 is via footswitch only, eliminating the optional s hand switch activation of its 28-1000 predicate, which is viewed as a littleused option and expendable in order to simplify construction, and limit size.
- While similarly relying on solid-state electronics, the Aura 70 has been 트 greatly simplified over some of its predicates by the use of microprocessor technology and modular medical-grade power supply.
- The Aura 70 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 and quidelines:
- ANSI/AAMI/IEC 60601-1-2 (2001), Medical Electrical Equipment Part 1; 를 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
- ANSI/AAMI/ISO 14971:2000, Medical devices Application of risk . management to medical devices.
- General Principles of Software Validation; Final Guidance for Industry and 트 FDA Staff (issued January 11, 2002).
- Guidance for FDA Reviewers and Industry. Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices (issued May 29, 1998).
Safety and hazard analysis has determined that the hazard conditions for the Aura 70 range in the low-to-moderate level and for this reason are acceptable.
Therefore, the Aura 70 is substantially equivalent in intended use, technological safety and effectiveness, and performance to the following predicates;
- 28-1000, Kirwan 50 Watt Bipolar Generator, l
- 26-2500, Aura, 20 Watt Bipolar Electrosurgical Coagulator, 내
- RF111, Pegasys Electrosurgical Generator, and 에
- 80-1170, Malis™ Bipolar Electrosurgical System CMC-III. 트
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with three heads, representing health, human services, and well-being. The eagle is surrounded by the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 0 2005
Kevin P. Prario Regulatory Affairs Manager Kirwan Surgical Products, Inc. 180 Enterprise Drive Marshfield, Massachusetts 02050
Re: K052203
Trade/Device Name: Models 28-2000 and 28-2600, Aura 70 Watt Bipolar Electrosurgical Coagulators Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 12, 2005 Received: August 16, 2005
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 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.
3
Page 2- Kevin P. Prario
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter with and in yourse FDA finding of substantial equivalence of your device to a legally premative noticated on "Tresults 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 if you deale office of Compliance at (240) 276-0115. Also, please note the regulation entitled, Conider the Ories of Comparket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational 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 vours.
Barbara Buemo
to
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): _KOS2203
Device Name:
Models 28-2000 and 28-2600, Aura 70 Watt Bipolar Electrosurgical Coagulators
Indications for Use:
General purpose solid state bipolar generator to supply RF signal to General purpose oona otals used on soft body tissue where a wide electrosurgiour hardent conditions and load impedances are runge of thouse type applicable (i.e., Aurap/us, 28-2600) a peristaltic irrigation pump controls flow rate individually or simultaneously while coagulating.
X Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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)
Cailane theund foruken
(Divis . Restorative. Division of Gener and Neurological Devices
Page 1 of 1
510(k) Number J052203