Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.

Device Description

Aaron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes are used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.

AI/ML Overview

The provided text describes a 510(k) premarket notification for Aaron Reusable Electrosurgical Electrodes. The submission focuses on demonstrating substantial equivalence to predicate devices and validating cleaning and resterilization processes for reuse.

Based on the provided information, the device is an electrosurgical electrode, not an AI or imaging device, and therefore the standard AI/Imaging study characteristics are not applicable. The provided text addresses traditional medical device performance and safety.

Here's an interpretation of the "acceptance criteria" and "study" based on the context of a 510(k) submission for this type of device:

Acceptance Criteria and Device Performance (Interpreted from 510(k) Summary)

The primary acceptance criteria for this 510(k) submission revolve around demonstrating substantial equivalence to predicate devices and validating the reusability claims through cleaning and sterilization processes.

Acceptance Criteria Category	Specific Criteria (Interpreted)	Reported Device Performance (as stated in the document)
Substantial Equivalence - Method of Operation	Device operates in the same fundamental way as predicate devices.	"substantially equivalent to Aaron Reusable Electrosurgical Electrodes (K931338 and K942986) in operation"
Substantial Equivalence - Intended Use	Device's intended medical application is the same as predicate devices.	"substantially equivalent to ... in ... intended use"
Substantial Equivalence - Energy Source	Device uses the same type of energy source as predicate devices.	"substantially equivalent to ... in ... energy source"
Substantial Equivalence - Method of Preparation (Initial State)	Device's initial manufacturing/packaging state is similar (specifically, not sold sterile here, which is a key difference being addressed).	"Performance claims for the reusable electrodes differ from the predicate device in that they are not sold sterile."
Reusability - Cleaning Efficacy	Device can be effectively cleaned to remove biological material as per established standards.	"Cleaning and resterilization processes are validated in accordance with Good Hospital Practice: Steam Sterilization and Sterility Assurance (ANSI/AAMI ST46: 1993) and Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers (AAMI TIR 12: 1994)."
Reusability - Sterilization Efficacy	Device can be effectively sterilized by steam under pressure as per established standards.	"Cleaning and resterilization processes are validated in accordance with Good Hospital Practice: Steam Sterilization and Sterility Assurance (ANSI/AAMI ST46: 1993)..."
Durability - Loop Configuration	Loop electrodes maintain safety and performance after repeated cleaning and sterilization cycles.	"Aaron Reusable Electrosurgical Electrodes in the loop configuration may be cleaned and sterilized up to 5 times."
Durability - Blade, Needle, Ball Configurations	Blade, needle, and ball electrodes maintain safety and performance after repeated cleaning and sterilization cycles.	"Aaron Reusable Electrosurgical Electrodes in the blade, needle, and ball configurations may be cleaned and sterilized up to 25 times."
Overall Safety and Performance	Testing indicates equivalent safety and performance compared to predicate devices.	"Testing performed on Aaron Reusable Electrosurgical Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance."

Study Information (Based on a Traditional Medical Device 510(k))

Sample size used for the test set and the data provenance:
- The document does not specify sample sizes for the "testing performed" to demonstrate substantial equivalence or for the cleaning/sterilization validation. This level of detail is typically found in the full 510(k) submission, not the summary.
- Data Provenance: Not explicitly stated (e.g., country of origin, retrospective/prospective). This would be internal testing performed by the manufacturer to support their claims.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable in the context of this device and submission. "Ground truth" with expert consensus is typically relevant for diagnostic devices (e.g., imaging devices) where expert interpretation is compared. For this electrosurgical electrode, "ground truth" would be established by objective measurements (e.g., material degradation tests, sterility tests, electrical performance tests) against established engineering and medical device standards.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- None. Adjudication methods are relevant for subjective assessments (like image interpretation) where multiple readers disagree. This submission focuses on objective performance characteristics validated against standards.
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:
- No. This is an electrosurgical device, not an AI or diagnostic imaging device. MRMC studies are not applicable.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- No. This is an electrosurgical device, not an algorithm or AI system.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the reusability claims: The "ground truth" would be objective testing results comparing the device's performance (e.g., electrical impedance, material integrity, sterility assurance levels) against established engineering standards (e.g., ANSI/AAMI ST46:1993, AAMI TIR 12:1994) after specified numbers of sterilization cycles.
- For substantial equivalence: Comparison against the predicate device's known performance specifications and general safety/effectiveness requirements for electrosurgical electrodes.
The sample size for the training set:
- Not applicable. This device does not use machine learning or AI, so there is no "training set."
How the ground truth for the training set was established:
- Not applicable. No training set exists.

Summary

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AARON MEDICAL INDUSTRIES, A BOVIE COMPANY AARON REUSABLE ELECTROSURGICAL ELECTRODES

KO14201

FEB 2 5 2002

510(k) SAFETY AND EFFECTIVENESS SUMMARY

Trade Name: Common Name: Classification Name: Aaron Reusable Electrosurgical Electrode Electrosurgical Electrode Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)

Electrosurgical is substantially equivalent to Aaron Reusable The Aaron Electrosurgical Electrodes (K931338 and K942986) in operation, intended use, energy source, and method of preparation. Performance claims for the reusable electrodes differ from the predicate device in that they are not sold sterile and that they may be cleaned and resterilized by steam under pressure. Aaron Reusable Electrosurgical Electrodes in the loop configuration may be cleaned and sterilized up to 5 times. Aaron Reusable Electrosurgical Electrodes in the blade, needle, and ball configurations may be cleaned and sterilized up to 25 times. Cleaning and resterilization processes are validated in accordance with Good Hospital Practice: Steam Sterilization and Sterility Assurance (ANSI/AAMI ST46: 1993) and Designing, Testing, and Labeling Reusable Medical Devices for Reprocessing in Healthcare Facilities: A Guide for Device Manufacturers (AAMI TIR 12: 1994). The validated cleaning and sterilization processes are provided in device labeling and instructions.

Testing performed on Aaron Reusable Electrosurgical Electrodes indicate that the devices are substantially equivalent in method of operation, safety, and performance.

In conclusion, Aaron Reusable Electrosurgical Electrodes substantially equivalent to predicate devices (Aaron Electrosurgical Electrodes) in methods of operation, intended use, and results derived from operation.

Submitted By:	Richard KozloffVice-President ; Quality AssuranceAaron Medical Industries7100 30th Avenue NorthSt. Petersburg, FL 33710
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Contact Person: Richard Kozloff Date: December 17, 2001

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Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its wing and tail. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

FEB 2 5 2002

Mr. Richard Kozloff Vice President, Quality Assurance and Regulatory Affairs Aaron Industries 7100 30th Avenue North St. Petersburg, Florida 33710

Re: K014201

Trade/Device Name: Aaron Reusable Electrosurgical Electrodes Regulation Number: 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: December 20, 2001 Received: December 21, 2001

Dear Mr. Kozloff:

We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your been wind the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use surfor 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, de neces that have been require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The r ou may, aterest, mains of the Act include requirements for annual registration, listing of general controls proficituring 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.

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Page 2 - Mr. Richard Kozloff

This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html

Sincerely yours,

Mark A Miller

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

Enclosure

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510 (K) NOTIFICATION

AARON MEDICAL INDUSTRIES AARON REUSABLE ELECTROSURGICAL ELECTRODE

INDICATIONS FOR USE

510(k) Number (if known): KO14201

Device Name: Aaron Reusable Electrosurgical Electrodes

Indications for Use:

A aron Reusable Electrosurgical Electrodes are non-sterile, reusable electrosurgical electrodes, used in conjunction with an electrosurgical handpiece and generator to deliver RF energy used to cut and excise tissue or to coagulate blood vessels during surgery.

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

(Division Sign-Off) Division of General, Restorative and Neurological Devices Koly201

(Optional Format 3-10-98)

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.