AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR, MODEL A1200 AARON 1200 HIGH FREQUENCY ELECTROSURGICAL GENERATOR MOD by AARON MEDICAL INDUSTRIES

The Aaron 1200 is intended to be used for large loop excision of the transformation zone, loop electrosurgical excision procedures and other similar low powered procedures in the area of obstetrics and gynecology. LLETZ is indicated for those patients who have had an abnormal pap smear report with cytologic evidence of CIN, colposcopic examination of the cervix with unsatisfactory findings and who, in the physician's opinion are suitable candidates for the procedure. Indications for the LLETZ procedure include::

a cytological and colposcopic suspicion of CIN
a transformation zone which is fully visible and fully confined to the cervix .
a suspicion (cytological or colposcopic) of glandular abnormalities .
a recurrent and troublesome cervical infection with persistent atypicality .
a disparity between the cytological and colposcopic diagnosis .
. a suspicion supported by evidence (cytological or colposcopic) of microinvasive disease

Device Description

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

AI/ML Overview

The provided text describes a 510(k) submission for the Aaron 1200 High Frequency Electrosurgical Generator. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than conducting a de novo study with acceptance criteria and performance metrics against a defined ground truth in the way a diagnostic AI device would.

Therefore, many of the requested categories are not applicable or cannot be extracted directly from this document. The submission relies on comparisons to existing, legally marketed devices.

Here's the information that can be extracted or deduced, and an explanation of why other requested categories are not applicable:

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

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (if applicable)	Reported Device Performance / Evaluation Method
Substantial Equivalence	Equivalence in design, operation, intended use, materials, energy source, components, method of preparation, and performance claims to predicate devices.	Demonstrated as substantially equivalent to: - Aaron 1200 High Frequency Electrosurgical Generator (K980366) - Aaron 800 High Frequency Desiccator (K955681) - ValleyLab SSE4 Electrosurgical Generator (K823924) Test results indicated substantial equivalence in performance and method of operation.
Safety	No new hazards presented compared to predicate devices.	Hazard analysis evaluations performed. Test results indicated no new hazards with the use of the Aaron 1200 compared to predicate devices.
Intended Use	Alignment with intended use of predicate devices.	Intended for removal and destruction of human tissue and coagulation of bleeders, including LLETZ and similar low-powered OB/GYN procedures. This aligns with or expands upon the uses of the predicate devices.
Modes of Operation	Inclusion of standard electrosurgical modes.	Device includes: Cut, Blend, Coagulation, Bipolar, and Fulguration modes.
Features	Inclusion of an integral handcontrol pencil.	Handcontrol pencil is an integral component used in conjunction with the device.

Explanation: In a 510(k) submission for electrosurgical generators, the "acceptance criteria" are not typically framed as specific performance metrics (e.g., sensitivity, specificity) against a clinical outcome, but rather as demonstrating that the new device is as safe and effective as a legally marketed predicate device. The "performance" is therefore the demonstration of this equivalence through various tests and analyses, as summarized above.

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

Not applicable for this type of device. Electrosurgical generators are hardware devices; their "performance" is evaluated through engineering tests, safety assessments, and direct comparison of specifications and features to predicate devices. There is no "test set" of patient data in the way a diagnostic algorithm would have. Data provenance for clinical efficacy or diagnostic accuracy is not relevant here.

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

Not applicable. There is no "ground truth" derived from expert consensus for a test set in the context of an electrosurgical generator's substantial equivalence review. Performance is assessed through engineering and safety standards.

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

Not applicable. No clinical test set requiring adjudication.

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 an electrosurgical generator, not an AI-assisted diagnostic tool.

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

Not applicable. This is a medical device, not an algorithm. Its operation involves human-in-the-loop directly.

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

Not applicable. The "ground truth" for this device's approval is its conformance to engineering standards and its demonstrated substantial equivalence to predicate devices in terms of safety, performance characteristics (e.g., power output, modes), and intended use.

8. The sample size for the training set:

Not applicable. Electrosurgical generators do not have "training sets" in the context of machine learning.

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

Not applicable. No training set exists for this device.

Summary of the Study (as described in the document):

The "study" refers to the testing and analysis performed to demonstrate substantial equivalence to previously cleared devices. This included:

Comparison of specifications: The Aaron 1200 was compared to the Aaron 1200 High Frequency Electrosurgical Generator (K980366), the Aaron 800 High Frequency Desiccator (K955681), and the ValleyLab SSE4 Electrosurgical Generator (K823924) across various parameters: design, operation, intended use, materials, energy source, components, method of preparation, and performance claims.
Performance testing: "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." Specific test details are not provided in this summary but would have been part of the full 510(k) submission.
Hazard analysis: "Hazard analysis evaluations were performed on the Aaron 1200 High Frequency Electrosurgical Generator." The results showed no new hazards compared to the predicate devices.

The conclusion was that the Aaron 1200 High Frequency Electrosurgical Generator is substantially equivalent to the predicate devices.

Summary

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

510(K) NOTIFICATION Page 132 of 132

510/k) SAFETY AND EFFECTIVENESS SUMMARY

Aaron 1200 High Frequency Electrosurgical Generator and Accessories TRADE NAME: Electrosurgical Generator COMMON NAME: CLASSIFICATION NAME: Gynecologic electrocautery and accessories (21CFR 884.4120)

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 High Frequency Electrosurgical Generator is substantially equivalent to the Aaron 1200 High Frequency Electrosurgical Generator (K980366), the Aaron 800 High Frequency Desicator (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 1200 High Frequency Electrosurgical Generator, 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:

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

Contact Person: Date:

J. Robert Saron April 29, 1998

J. Menon

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. J. Robert Saron President & CEO AARON MEDICAL INDUSTRIES, INC. 7100 30th Avenue North St. Petersburg, FL 33710-2902

Re: K981570 Aaron 1200 HF Electrosurgical Generator Dated: August 11, 1998 Received: August 12, 1998 Regulatory Class: II 21 CFR 878.4400/Procode: 79 GEI 21 CFR 884.4120/Procode: 85 HGI

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 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 requirements, 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 regult 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.

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) 594-4613. 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/cdrb/dsmaldsmam.html".

Sincerely yours

Lillian Yin, Ph.D.

Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Page of of

510(k) Number (if known):

Device Name: Aaron 1200 High Frequency Electrosurgical Generator, Models A1200 & A1200/240

Indications For Use:

a cytological and colposcopic suspicion of CIN
a transformation zone which is fully visible and fully confined to the cervix .
a suspicion (cytological or colposcopic) of glandular abnormalities .
a recurrent and troublesome cervical infection with persistent atypicality .
a disparity between the cytological and colposcopic diagnosis .
. a suspicion supported by evidence (cytological or colposcopic) of microinvasive disease

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use V (Per 21 CFR 801 109)

Over-The-Counter Use

(Optional Format 1-2-96)

David C. Grayson

(Division Sign-Off) Division of Reproductive. Abdominal, and Radiological D 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.