The Aaron 910 handpiece Sheath is intended to be used as an accessory to electrosurgical handpieces. The sheath is placed over the handpiece and provides a barrier to minimize contamination. The Handpiece Sheath is non-sterile and is intended for single patient use only.

Device Description

The Aaron A910 Handpiece Sheath is a non-sterile, disposable electrosurgical handpiece cover that is designed to fit over an electrosurgical handpiece to provide a barrier between the handpiece and the patient, thus prevent contamination of the handpiece.

AI/ML Overview

The provided text is a 510(k) summary for the Aaron A910 Handpiece Sheath. This document focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study. Therefore, much of the requested information regarding specific acceptance criteria, detailed study design, sample sizes, expert involvement, and ground truth types is not applicable to this type of regulatory submission.

Here's an analysis based on the available information:

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

Acceptance Criteria (Inferred from Substantial Equivalence Claim)	Reported Device Performance (Summary of Equivalence)
Intended Use: Function as a handpiece sheath to provide a barrier.	"designed to fit over an electrosurgical handpiece to provide a barrier between the handpiece and the patient, thus prevent contamination of the handpiece."
Material Composition: Similar materials to predicates.	"same design, intended use, materials, method of preparation, and performance claims as Aaron Medical High Temperature Replacement Tip drape (K-945758)." (And other predicates)
Design: Similar design to predicates.	"same design..." (as described above)
Method of Preparation: Similar manufacturing processes.	"same... method of preparation..." (as described above)
Performance Claims: Equivalent performance to predicates.	"same... performance claims..." (as described above)
Safety: No new hazards compared to predicates.	"Hazard analysis evaluations were performed on the Aaron A910. There are no new hazards presented with the use of the Aaron A910 as compared with the predicate devices."

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

Not Applicable. This submission is based on demonstrating substantial equivalence to predicate devices, not on a clinical performance study with a test set. This means no specific sample size for a test set or data provenance from a prospective/retrospective study is reported. The "test" in this context refers to a hazard analysis, not a performance study.

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)

Not Applicable. As no clinical performance study was conducted on a test set requiring expert-established ground truth, this information is not provided. The evaluation was primarily engineering and regulatory in nature, comparing the device to existing predicate devices.

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

Not Applicable. No clinical performance study requiring adjudication of a test set was performed.

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 handpiece sheath, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study and AI-related effect size are entirely irrelevant to its submission.

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

Not Applicable. This is a medical device accessory (a sheath), not an algorithm or AI system.

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

Not Applicable. The "ground truth" in this context is the established safety and effectiveness of the legally marketed predicate devices, against which the new device is compared. There is no biological or clinical "ground truth" generated for the Aaron A910 itself in this submission.

8. The sample size for the training set

Not Applicable. This is not a machine learning or AI device, so there is no concept of a "training set" in this submission.

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

Not Applicable. As there is no training set, there is no ground truth established for it.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The "study" described in the 510(k) summary is not a clinical trial or a performance study in the traditional sense. Instead, it is a demonstration of substantial equivalence to legally marketed predicate devices. The evidence for equivalence includes:

Hazard Analysis: Evaluations were performed to confirm that the Aaron A910 presents "no new hazards" compared to the predicate devices.
Comparative Analysis: The submission asserts that the Aaron A910 Handpiece Sheath is "substantially equivalent" in:
- Design
- Intended Use
- Materials
- Method of Preparation
- Performance Claims
Predicate Device Identification: Specific predicate devices are listed and referenced (Geiger Medical Technologies Handpiece Sheath K-992149, Banta Healthcare Sanitherm Thermometer Sheath K983406, Aspen Laboratories/Conmed Handpiece Sheath K-963088, and Aaron Medical High Temperature Replacement Tip drape K-945758). The regulatory process assumes that if the new device is sufficiently similar to a device already deemed safe and effective, then the new device is also safe and effective.

In conclusion, for this type of device and regulatory submission (510(k) for substantial equivalence), a formal clinical study with detailed acceptance criteria, sample sizes, and expert adjudication as typically seen for novel diagnostic or therapeutic devices is not required or presented. The "proof" lies in the successful comparison to established, legally marketed predicate devices.

Summary

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AARON MEDICAL , A BOVIE COMPANY AARON A910 HANDPIECE SHEATH

SEP 1 82001

KO11929

510(k) SAFETY AND EFFECTIVENESS SUMMARY

Trade Name: Common Name: Classification Name:

Aaron A910 Handpiece Sheath Handpiece Sheath Electrosurgical Cutting and Coagulation Devices and Accessories (per 21CFR 878.4400)

The Aaron A910 Handpiece Sheath is substantially equivalent to the Geiger Medical Technologies Handpiece Sheath (K-992149), the Banta Healthcare Sanitherm Thermometer Sheath (K983406), and the Aspen Laboratories/Conmed Handpiece Sheath (K-963088). Additionally, the sheath is of the same design, intended use, materials, method of preparation, and performance claims as Aaron Medical High Temperature Replacement Tip drape (K-945758).

Hazard analysis evaluations were performed on the Aaron A910. There are no new hazards presented with the use of the Aaron A910 as compared with the predicate devices.

In conclusion, the Aaron A910 Handpiece Sheath is substantially equivalent to the named predicate devices in design, methods of operation, intended use, materials, and method of preparation.

Submitted By:

Richard Kozloff Vice-President ; Quality Assurance Aaron Medical 7100 30th Avenue North St. Petersburg, FL 33710

Contact Person: Richard Kozloff Date: June 19, 2001

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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 is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an emblem featuring three stylized human profiles facing to the right, resembling a bird in flight.

SEP 1 8 2001

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Mr. Richard Kozloff Vice President, Quality Assurance Aaron Medical, Inc. 7100 30th Avenue North St. Petersburg, Florida 33710

Re: K011929

Trade/Device Name: Aaron A910 Handpiece Sheath Regulation Number: 878.4400 Regulatory Class: II Product Code: GEI Dated: June 19, 2001 Received: June 20, 2001

Dear Mr. Kozloff:

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 legally marketed predicate 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 requirements, as set forth in the Quality System Regulation (QS) 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. Richard Kozloff

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) 594-4659. 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 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,

Celia M. Witten, Ph.D., M.D.

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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AARON MEDICAL INDUSTRIES AARON 910 HANDPIECE SHEATH

INDICATIONS FOR USE

510(k) Number (if known): K 011 9 29

Device Name: Aaron A910 Handpiece Sheath

Indications for Use:

(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

Koll 929 5 i J(k) Number -

(Optional Format 3-10-98)

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.