AARON ESU FOOT-CONTROL ADAPTER #A1205A by AARON MEDICAL INDUSTRIES

The Aaron ESU Foot-Controll Adapter will allow a single pin foot controlled pencil or suction / coagulator to be used with the Aaron 1200 Electrosurgical Generator for cutting or coagulating procedures.

Device Description

The Aaron ESU Foot Control Adapter is a non-sterile, reusable device. It utilizes an insert-molded body that allows a foot-controlled pencil or suction/coagulation tube. The foot control adapter plug allows activation of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998. It is an accessory to the Aaron 1200 electrosurgical generator.

AI/ML Overview

This document describes the pre-market notification (510(k)) for the Aaron ESU Foot Control Adapter #A1205A. The submission demonstrates substantial equivalence to a predicate device, as confirmed by the FDA.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criterion	Reported Device Performance	Comments
Safety: Device presents no new hazards.	Hazard analysis evaluations performed; test results indicated no new hazards with the use of the adapter.	This is crucial for medical devices. The assessment confirmed the adapter doesn't compromise the safety profile established for the existing Aaron 1200 Electrosurgical Generator.
Performance: Device does not change the operation of the Aaron 1200 electrosurgical generator or the foot-controlled devices.	"Testing which has been performed on the Aaron ESU Foot Control Adapter indicates that the use of the Adapter does not change the operation of either the Aaron 1200 or the foot controlled devices."	The primary function of the adapter is to enable compatibility without altering the core functionality of connected devices. The testing explicitly states this.
Intended Use: Device allows a single pin foot-controlled pencil or suction/coagulator to be used with the Aaron 1200 Electrosurgical Generator for cutting or coagulating procedures.	"The adapter will allow the use of a disposable foot-controlled pencil or suction irrigator with a single pin connector with the Aaron 1200 electrosurgical generator." "The Aaron ESU Foot-Control Adapter will allow a single pin foot controlled pencil or suction / coagulator to be used with the Aaron 1200 Electrosurgical Generator for cutting or coagulating procedures."	This acceptance criterion directly addresses the device's stated purpose and functionality. The product description and indications for use confirm this.
Substantial Equivalence: The device remains substantially equivalent in performance and method of operation to the predicate device (Aaron 1200 electrosurgical generator, K980366) and other legally marketed devices when used with the adapter.	"Consequently, the devices remain substantially equivalent in their performance and method of operation."	This is the overarching regulatory principle for 510(k) clearances. The conducted testing supports this claim by demonstrating no change in operation or new hazards.
Design/Materials: The adapter does not change the design, materials, or components of the Aaron 1200 electrosurgical generator.	"The Aaron ESU Foot Control Adapter while allowing the use of single pin foot controlled pencils, does not change the design, operation, intended use, materials, components and performance claims of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998."	This ensures that the adapter acts solely as an interface and does not necessitate re-evaluation of the core generator itself.

Study Information:

This submission is a 510(k) Pre-market Notification for an accessory (adapter plug). The regulatory pathway for such devices primarily focuses on demonstrating substantial equivalence to a predicate device, rather than requiring extensive clinical trials or complex performance studies typical for novel, high-risk devices or AI/CAD systems.

Therefore, many of the typical data points requested (like sample size for test/training sets, number of experts, adjudication methods, MRMC studies, standalone performance for AI) are not applicable to this type of device and submission.

Here's what can be inferred or explicitly stated from the provided text:

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 specified in the provided text. The testing described is functional and safety testing on the device itself, rather than testing on a dataset of patient images or clinical cases. The "test set" would refer to the actual adapter prototypes and the electrosurgical units it's designed to connect to. There is no indication of patient data or clinical data being used for this specific assessment.
- The testing would have been conducted by the manufacturer, Aaron Medical Industries, Inc., likely within the USA, as they are a US-based company and applying to the US FDA.
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 specified. Ground truth establishment by experts is relevant for diagnostic or AI-driven devices where human assessment is the reference standard. For an electrosurgical adapter, the "ground truth" would be established through engineering specifications, electrical safety standards, and functional verification. The "experts" would be engineering and quality control professionals.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not specified. Adjudication is relevant for resolving discrepancies in expert interpretations, typically in diagnostic imaging studies. This is not pertinent to the functional and safety testing of an adapter.
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. MRMC studies are specific to diagnostic imaging devices, particularly those involving AI/CAD systems, to assess the impact on human reader performance. This device is an electrosurgical accessory.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Not applicable. This question pertains to AI/CAD system performance, which is not relevant for an electrosurgical adapter.
The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- For this device, the "ground truth" for the testing would be based on engineering specifications, electrical safety standards (e.g., IEC standards for electromedical equipment), and functional performance criteria. The tests would verify that the adapter maintains electrical integrity, does not introduce signal interference, and allows proper activation and function of the connected devices as designed.
The sample size for the training set:
- Not applicable. There is no "training set" in the context of this device. Training sets are used for machine learning algorithms.
How the ground truth for the training set was established:
- Not applicable. As there is no training set, this question is not relevant.

In summary, the "study" proving the device meets the acceptance criteria is the series of safety evaluations and functional performance tests conducted by the manufacturer. These tests demonstrated that the Aaron ESU Foot Control Adapter #A1205A maintains the safety and operational characteristics of the connected devices (Aaron 1200 electrosurgical generator and foot-controlled pencils/suction coagulators) and introduces no new hazards. This evidence was sufficient to establish substantial equivalence for regulatory clearance.

Summary

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2/10/99

K 984236

AARON MEDICAL INDUSTRIES, INC. Aaron ESU Foot Control Adapter #A1205A

510(K) NOTIFICATION

510(k) SAFETY AND EFFECTIVENESS SUMMARY

TRADE NAME: Aaron ESU Foot Control Adapter #A1205A COMMON NAME: Adapter Plug CLASSIFICATION NAME: Electrosurgical cutting and Coagulation Devices and Accessories (21 CFR 878:4400)

The Aaron ESU Foot Control Adapter is intended to be used with the Aaron 1200 electrosurgical generator. The adapter will allow the use of a disposable foot-controlled pencil or suction irrigator with a single pin connector with the Aaron 1200 electrosurgical generator. It is non-sterile and is reusable.

The Aaron ESU Foot Control Adapter while allowing the use of single pin foot controlled pencils, does not change the design, operation, intended use, materials, components and performance claims of the Aaron 1200 electrosurgical generator cleared under K980366 dated January 29, 1998.

Testing which has been performed on the Aaron ESU Foot Control Adapter indicates that the use of the Adapter does not change the operation of either the Aaron 1200 or the foot controlled devices. Consequently, the devices remain substantially equivalent in their performance and method of operation.

Hazard analysis evaluations were performed on the Aaron ESU Foot Control Adapter. Test results indicated that there are no new hazards presented with the use of the Aaron ESU Foot Control Adapter.

In conclusion, the Aaron ESU Foot Control Adapter is an accessory to the Aaron 1200 and will allow the doctor to choose between the reusable pencil included with the Aaron 1200 or a single use disposable foot controlled pencil or suction coagulator.

Submitted By: J. Robert Saron President & CEO Official Correspondent

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 1 0 1999

Mr. J. Robert Saron President and Chief Executive Officer, Official Correspondent Aaron Medical Industries 7100 30ª Avenue North St. Petersburg, Florida 33710

K984236 Re: Trade Name: Aaron ESU Foot-Control Adapter #A1205A Regulatory Class: II Product Code: GEI Dated: November 23, 1998 Received: November 25, 1998

Dear Mr. Saron:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) 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 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.

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Page 2 - Mr. J. Robert Saron

This letter will allow you to begin marketing your device as described in your 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 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 device, 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,

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

Enclosure

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K984236 510(k) Number (if known):

Aaron ESU Foot-Control Adapter Device Name:

Indications For Use:

(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 K984236
510(k) Number

Prescription Use
(Per 21 CFR 801.109)

510(k) Number

Over-The-Counter Use

(Optional Format 1-2-96)

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.