AARON ELECTROSURGICAL HANDCONTROL PENCIL, MODEL ESP5 by AARON MEDICAL INDUSTRIES

The Aaron Electrosurgical Handcontrol Pencil is intended to be used in general electrosurgical applications for cutting and coagulating during surgical procedures. It is provided sterile and is intended for limited reuse.

Device Description

The Aaron Electrosurgical Handcontrol Pencil is a sterile, limited reuse electrosurgical handcontrol pencil. It utilizes an insert-molded body that encapsulates a printed circuit board used to sense either CUT or COAG button activation thus activating an electrosurgical generator. It is an accessory to an electrosurgical generator.

AI/ML Overview

The provided text is a 510(k) summary for the Aaron Electrosurgical Handcontrol Pencil. This type of regulatory submission focuses on demonstrating substantial equivalence to a predicate device rather than fulfilling specific acceptance criteria through a detailed clinical or performance study with defined metrics. Therefore, many of the requested elements (like detailed acceptance criteria and a structured study proving device performance against those criteria, or information on AI/ML studies) are not present in this document.

However, I can extract information related to the demonstration of substantial equivalence and what could be inferred as "performance" in this context.

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

Since this is a 510(k) for a basic electrosurgical pencil, the "acceptance criteria" are implicitly met by demonstrating substantial equivalence to predicate devices. The "reported device performance" is that it functions identically or equivalently to these predicates.

Acceptance Criteria (Implied by Substantial Equivalence)	Reported Device Performance
Design: Identical or equivalent to predicate devices.	Identical to Medtrex Encore Electrosurgical Handcontrol Pencil (K970039). Substantially equivalent to Valleylab Model E2502B (K914400) and Aaron Medical Industries, Inc Model A801 (K955681) in design.
Operation: Identical or equivalent to predicate devices.	Substantially equivalent to predicates in operation. It utilizes an insert-molded body encapsulating a PCB to sense CUT/COAG button activation for generator activation.
Intended Use: Identical or equivalent to predicate devices.	Intended for general electrosurgical applications (cutting and coagulating during surgical procedures), identical to predicate devices.
Materials: Identical or equivalent to predicate devices.	Substantially equivalent to predicates in materials.
Components: Identical or equivalent to predicate devices.	Substantially equivalent to predicates in components.
Performance Claims: Identical or equivalent to predicate devices.	Testing indicates substantial equivalence in performance claims.
Safety: No new hazards presented compared to predicate devices.	Hazard analysis evaluations indicated no new hazards compared to predicate devices.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide details on specific sample sizes for a test set in the traditional sense of a clinical or performance study. The "testing" mentioned likely refers to engineering verification and validation testing to ensure the device performs as expected and meets safety standards, rather than a statistical sample involving human subjects or a large dataset.

Sample Size: Not specified.
Data Provenance: Not specified, but generally, such testing would be conducted internally by the manufacturer (Aaron Medical Industries, Inc.) in the USA.
Retrospective/Prospective: Not applicable in the context of comparative equivalence for this type of device.

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)

This information is not applicable to a 510(k) submission for an electrosurgical handcontrol pencil, as the "ground truth" is established by the functional performance and safety compliance of the device itself and its comparison to legally marketed predicate devices, not through expert consensus on medical images or outcomes.

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

Not applicable. The evaluation of this device is based on technical specifications, functional testing, and comparison to predicate devices, not on expert adjudication of a test set.

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 device is an electrosurgical handcontrol pencil, not an AI/ML-driven diagnostic or image analysis device that would involve human readers or cases in an MRMC study.

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

Not applicable. This device does not involve an algorithm or AI.

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

The "ground truth" in this context is the established safety and effectiveness of the predicate devices. The device's performance is measured against its ability to function safely and effectively in a manner substantially equivalent to these predicates. This relies on:

Engineering specifications and testing (functional, electrical safety, biocompatibility, sterilization validation).
Demonstration that its design, materials, and operation are comparable to legally marketed devices.
Hazard analysis to ensure no new hazards are introduced.

8. The sample size for the training set

Not applicable. This device does not involve AI or machine learning, so there is no training set.

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

Not applicable. There is no training set for this device.

Summary

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AARON MEDICAL INDUSTRIES, INC. Aaron Electrosurgical Handcontrol Pencil 510(K) NOTIFICATION

K983761

510(k) SAFETY AND EFFECTIVENESS SUMMARY

TRADE NAME: Aaron Electrosurgical Handcontrol Pencil COMMON NAME: Electrosurgical Handcontrol Pencil CLASSIFICATION NAME: Electrosurgical cutting and Coagulation Devices and Accessories (21 CFR 878:4400)

The Aaron Electrosurgical Handcontrol Pencil is IDENTICAL to the Medtrex Encore Electrosurgical Handcontrol Pencil, cleared under K970039 dated February 26, 1997. It is substantially equivalent to the Valleylab Model E2502B cleared under 510(k) K914400, and the Aaron Medical Industries, Inc Model A801 monopolar handpiece cleared under 510(k) K955681in design, operation, intended use, materials, components and performance claims.

Testing which has been performed on the Aaron Electrosurgical Handcontrol Pencil indicates that the devices are substantially equivalent in their performance and method of operation.

Hazard analysis evaluations where performed on the Aaron Electrosurgical Handcontrol Pencil. Test results indicated that there are no new hazards presented with the use of the Aaron Electrosurgical Handcontrol Pencil as compared with the predicate devices.

In conclusion, the Aaron Electrosurgical Handcontrol Pencil is substantially equivalent to the predicate devices, the Medtrex Encore Model 35001-001, the Aaron Medical Industries, Inc Model A801 monopolar handpiece and the Valleylab Model #2502B.

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

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Image /page/1/Picture/2 description: The image is a logo for the U.S. Department of Health & Human Services. The logo is circular in shape, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the top half of the circle. In the center of the circle is a stylized image of a human figure, with three faces in profile, one behind the other. The figure is black and white.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

DEC 30 1998

Mr. J. Robert Saron President and Chief Executive Officer Aaron Medical Industries, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710-2902

K983761 Re: Trade Name: Aaron Electrosurgical Handcontrol Pencil Regulatory Class: II Product Code: GEI Dated: October 23, 1998 Received: October 26, 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 (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) 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,

Murle M. Millerson

Celia 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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510(k) Number (if known):

Aaron Electrosurgical Handcontrol Pencil 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)

Prescription Use
(Per 21 CFR 801.109)

Over-The-Counter Use __

Mark N melkein

(Optional Format 1-2-96)

for (Division Sign-Off)
CMW Division of General Restorative Devices

510(k) Number __

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.