AARON 1200 HIGH FREQUENCY ELECTROSURGICL GENERATOR A1200, A1200/240 by AARON MEDICAL INDUSTRIES

The Aaron 1200 High Frequency Electrosurgical Generator is intended for the removal and destruction of human tissue and the coagulation of bleeders. Modes of operation for this device include: cut, blend, coagulation, bipolar and fulguration. The Handcontrol pencil is an integral component which is used in conjunction with the Aaron 1200.
The Aaron 1200 is intended to be used for all low powered electrosury: cut, blend, coagulation, fulguration and bipolar procedures.

Device Description

The Aaron 1200 High Frequency Electrosurgical Generator is a non-serile, reusable electrosurgical generator which is designed to generate high frequencies (RF) of high voltage and low amperage current.

AI/ML Overview

This document is a 510(k) submission for an electrosurgical generator, which falls under the category of traditional medical device clearance, not an AI/ML-driven device. Therefore, many of the requested criteria, such as acceptance criteria based on AI performance metrics (sensitivity, specificity), sample sizes for test/training sets, expert ground truth establishment, MRMC studies, or standalone algorithm performance, are not applicable.

The submission focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific quantitative criteria in the way an AI/ML study would.

Here's an attempt to address the relevant points, indicating where the information is not applicable (N/A) for this type of submission:

Acceptance Criteria and Device Performance Study for Aaron 1200 High Frequency Electrosurgical Generator

The Aaron 1200 High Frequency Electrosurgical Generator's acceptance criteria and "study" are based on demonstrating substantial equivalence to legally marketed predicate devices, as per the 510(k) regulatory pathway. This involves comparing design, operation, intended use, materials, energy source, components, method of preparation, and performance claims to predicate devices, and demonstrating that no new safety or effectiveness concerns are raised.

The "acceptance criteria" can be inferred as the successful demonstration of this substantial equivalence, which includes safety testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from 510(k) process)	Reported Device Performance/Conclusion
Substantial Equivalence: Device is equivalent in design, operation, intended use, materials, energy source, components, and method of preparation to identified predicate devices.	The Aaron 1200 High Frequency Electrosurgical Generator is "substantially equivalent to the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components, method of preparation and performance claims."
Performance Equivalence: Device performance claims are equivalent to predicate devices.	"Testing which has been performed on the Aaron 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation."
Safety: No new hazards are presented compared to predicate devices.	"Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator. Test results indicated that there are no new hazards presented with the use of the Aaron 1200 High Frequency Electrosurgical Generator as compared with the predicate devices."
Compliance with General Controls: (Implicit requirement for all medical devices).	The FDA letter states that the marketing approval is "subject to the general controls provisions of the Act," including annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

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

Sample Size for Test Set: Not applicable in the context of an AI/ML study. The "testing" referred to in the summary would typically involve engineering verification and validation tests (bench testing) on a limited number of units of the device itself (e.g., electrical safety tests, power output measurements, functional tests) to confirm it meets its specifications and performs comparably to predicates. The document does not specify a "sample size" for such testing.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): Not applicable. The "data" here refers to the engineering test results and comparisons to predicate device specifications, not patient data or clinical study data in the AI/ML sense.

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

Not applicable. "Ground truth" in the AI/ML sense (e.g., expert consensus on medical images) is not relevant for this type of electrosurgical generator submission. The "truth" is established by engineering specifications, performance standards, and comparison to the known characteristics of predicate devices.

4. Adjudication method for the test set

Not applicable. Adjudication methods like 2+1 or 3+1 are for reconciling disagreements among human experts in AI/ML performance evaluation. This device relies on objective engineering tests and comparisons where "adjudication" would involve standard engineering practice or regulatory review criteria.

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 a hardware medical device (an electrosurgical generator), not an AI/ML diagnostic or assistive tool. There are no "human readers" or "AI assistance" in this context.

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

Not applicable. This device integrates into a human-controlled surgical procedure. There is no "algorithm only" performance to be evaluated independently in the AI/ML sense. The device performs its functions when operated by a human.

7. The type of ground truth used

Engineering specifications and regulatory standards for electrosurgical generators, and the known performance characteristics of the predicate devices. The "ground truth" for showing substantial equivalence would be that the device meets its own specifications, consistently delivers expected outputs (e.g., power, current characteristics), and operates safely in a manner consistent with the predicate devices, as verified by technical testing.

8. The sample size for the training set

Not applicable. This is not an AI/ML device that requires a training set.

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

Not applicable. As above, no training set for an AI/ML model is involved.

Summary

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K 980366

AARON MEDICAL INDUSTRIES, INC. Aaron 1200 High Frequency Electrosurgical Generator

510(K) NOTIFICATION Page 132 of 132

FEB 2 7 1998

510(k) SAFETY AND EFFECTIVENESS SUMMARY

Aaron 1200 High Frequency Electrosurgical Generator and Accessories TRADE NAME: Electrosurgical Generator COMMON NAME: CLASSIFICATION NAME: Electrosurgical Cutting and Coagulation Devices and Accessories (21CFR 878:4400)

The Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron 800 High Frequency Desiccator (K955681) and ValleyLab SSE4 Electrosurgical Generator (K823924) in design, operation, intended use, materials, energy source, components, method of preparation and performance claims.

Testing which has been performed on the Aaron 1200 High Frequency Electrosurgical Generator indicates that the devices are substantially equivalent in their performance and method of operation.

Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator. Test results indicated that there are no new hazards presented with the use of the Aaron 1200 High Frequency Electrosurgical Generator as compared with the predicate devices.

In conclusion, the Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices, the Aaron 800 High Frequency Desiccator and the ValleyLab SSE4 Electrosurgical Generator in methods of operation, intended use and results derived from operation.

Submitted By:

Rob Saron President Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, FL 33710-2902 (813) 384-2323

Contact Person: Date:

Rob Saron January 25, 1998

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines forming its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 27 1998

Mr. J. Robert Saron President & CEO Aaron Medical Industries, Inc. 7100 3060 Avenue North St. Petersburg, Florida 33710-2902

K980366 Re : Aaron 1200 High Frequency Electrosurgical Trade Name: Generator A1200 and A1200/240 Requlatory Class: II Product Code: GEI Dated: January 25, 1998 Received: January 29, 1998

Dear Mr. Saron:

We have reviewed your Section 510(k) notification of intent to market the devices referenced above and we have determined these devices are substantially equivalent (for the indications for use stated in the enclosures) to 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). You may, therefore, market the devices, 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 devices are classified (see above) into either class II (Special Controls) or class III (Premarket Approval), they may be subject to such additional controls. Existing major regulations affecting your devices can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A . . . . substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical General regulation (21 CFR Part 820) and that, Devices: through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. Please note: concerning your devices in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531

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Page 2 - Mr. Saron

through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

This letter will allow you to begin marketing your devices as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your devices to legally marketed predicate devices results in a classification for your devices and thus, permits your devices to proceed to the market.

If you desire specific advice for your devices on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your devices, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".

Sincerely yours,

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

Enclosures

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Page of

510(k) Number (if known):_ K955681

200 10.20 144 00004121144

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Device Name: Aaron 1200 High Frequency Electrosurgical Generator, models A1200 & A1200/24(

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The Aaron 1200 is intended to be used for all low powered electrosury: Indications For Use: cut, blend, coagulation, fulguration and bipolar procedures.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off)

Division of General Restorative Devices

510(k) Number	K980366
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Prescription Use	✓
(Per 21 CFR 801.109)

Over-The-Counter Use
(Optional Format 1-2-96)

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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.