MODULAR LAPAROSCOPY ACCESSORIES, HANDLE; SISSORS (STRAIGHT AND CURVED); GRASPER (AGGRESSIVE, ALLIS, ATAUMATIC; DISSECTOR by AARON MEDICAL INDUSTRIES

Laparoscopic electrodes and handles are surgical instruments with interchangeable tip inserts designed to be introduced through a 5.5mm diameter (or larger) cannula, during laparoscopic surgical procedures. The devices can be used with electrosurgical generators. The interchange ability of the tip inserts allows for three main benefits:

. A removable insert allows for easier cleaning and disinfection of the instrument components.
Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.
The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.

AI/ML Overview

The provided 510(k) summary for the Laparoscopic Electrodes and Handle does not contain the detailed information typically found in a study proving a device meets specific acceptance criteria based on performance metrics. Instead, this document focuses on demonstrating substantial equivalence to predicate devices.

Here's an analysis of why the requested information cannot be fully provided from the given text:

Type of Device: This is a surgical instrument (electrosurgical cutting and coagulation device and accessories). For such devices, "acceptance criteria" are usually related to safety and functional performance (e.g., sterilization effectiveness, electrical safety, material compatibility, mechanical integrity, cutting/coagulation performance). The document confirms compliance with a safety standard but doesn't detail performance criteria.
Substantial Equivalence (SE) Pathway: The entire document is a 510(k) submission, which is a premarket notification where the manufacturer demonstrates that their new device is "substantially equivalent" to a legally marketed predicate device. This pathway often relies on comparison to predicate device specifications and established standards, rather than extensive de novo clinical performance studies with specific acceptance criteria as might be seen for novel analytical or diagnostic devices.

Therefore, many of the requested fields are not applicable in the context of this 510(k) summary, as it does not describe a performance study in the way a diagnostic or AI-driven device's regulatory submission would.

However, I can extract what is available and explain why other information is absent:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred from regulatory context)	Reported Device Performance (as stated in the document)
Safety and Effectiveness	"There are no significant differences in technology, performance, or intended use between the Aaron Laparoscopic Electrodes and Handle and the given predicate devices."
Technological Equivalence	"These devices use technology substantially equivalent to the Aesculap USA Modular Monopolar Electrodes (K970541) and the ACMI Circon Surgical Instrument for Minimally Invasive Surgery (K914883)."
Intended Use Equivalence	"Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures" (Identical to intended use of predicate devices, as implied by SE).
Sterilization Compatibility	"Laparoscopic electrodes are reusable and are resterilized using steam sterilization."
Electrical Safety Standards Compliance	"Aaron Laparoscopic Electrodes and Handle conform to the requirements of safety standard ANSI/AAMI HF-18 Electrosurgical Devices."
New Safety/Effectiveness Questions	"There are no new questions raised regarding safety or effectiveness."
Cleaning/Disinfection	"A removable insert allows for easier cleaning and disinfection of the instrument components."

Explanation:
The document primarily establishes substantial equivalence by stating that the device has no significant differences in technology, performance, or intended use from predicate devices (K970541 and K914883). It explicitly states compliance with a relevant safety standard (ANSI/AAMI HF-18). It does not provide quantitative performance metrics (e.g., specific cutting speeds, coagulation temperatures, or power outputs) against predefined numerical acceptance criteria for this specific device. Instead, the implicit acceptance criterion is "performance equivalent to legally marketed predicate devices."

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

Test set sample size: Not applicable/Not provided. This 510(k) summary does not describe a clinical performance study with a distinct "test set" in the context of diagnostic accuracy or AI performance. The evaluation is based on comparison to predicate devices and compliance with standards.
Data provenance: Not applicable. No specific data provenance (e.g., country of origin, retrospective/prospective) is provided as there isn't a performance study dataset.

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

Not applicable/Not provided. This information is relevant for studies that require expert consensus for ground truth (e.g., image-based AI diagnostics). This document describes a surgical instrument, not a diagnostic or AI device that would require such ground truth establishment for performance evaluation.

4. Adjudication method for the test set

Not applicable/Not provided. As there is no test set in the context of a diagnostic or AI performance study, no adjudication method is described.

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 a surgical instrument, not an AI-assisted diagnostic or imaging system. Therefore, an MRMC study comparing human readers with AI assistance is not relevant or described.

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

Not applicable. This device is an electrosurgical instrument; it does not involve algorithms or AI for standalone performance evaluation in this context.

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

Not applicable/Not provided in the traditional sense. For a medical device like this, "ground truth" for proving safety and effectiveness typically involves engineering verification and validation (e.g., material testing, electrical safety tests, sterilization validation, biocompatibility studies) and comparison to the known safe and effective performance of predicate devices. These are not explicitly detailed as "ground truth" types in this summary.

8. The sample size for the training set

Not applicable/Not provided. This device does not use machine learning or AI that would require a "training set."

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

Not applicable/Not provided. As there is no training set for an AI model, this information is not relevant.

In summary, the provided 510(k) summary demonstrates that the Laparoscopic Electrodes and Handle meet regulatory requirements by establishing substantial equivalence to legally marketed predicate devices and conforming to a relevant safety standard (ANSI/AAMI HF-18). It does not present a detailed performance study with explicit acceptance criteria and corresponding results in the manner one would expect for a more complex diagnostic or AI-driven medical device.

Summary

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Page 1 of 2

510(k) SUMMARY (per CFR21 807.92(c))

062337

5 2006

DEVICE DESCRIPTION:

Predicate Devices:

Aesculap USA: Modular Monopolar Electrodes K970541

ACMI Circon: Surgical Instrument for Minimally Invasive Surgery K914883

INTENDED USE:

Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures

DEVICE COMPONENTS AND OPERATION:

. A removable insert allows for easier cleaning and disinfection of the instrument components.
Versatility of the instrument is greatly increased as one handle can accept many tip configurations,
Semi-disposability allows for multiple uses of one tip insert with cost effective replacement when worn or damaged.

The device consists of two components: an insulated, reusable handle and a series of reusable tips. Radiofrequency energy is passed to the tip through the handle and shaft by using a powered lead from an electrosurgical generator to a connector port on the handle. The insulated handle is the device that will be used by the physician or nurse to attach the tip and control the action of the tip via the grip. A rotary knob allows the tip to be positioned (rotated) while in the cannula.

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Image /page/1/Picture/0 description: The image shows the text "K062337" at the top, with a line underneath it. Below that is a blacked out section, followed by the text "510(k) SUMMARY (per CFR21 807.92(c))". The text appears to be part of a document or form, possibly related to a regulatory submission.

Page 2 q(2)

These devices use technology substantially equivalent to the Aesculap USA Modular Monopolar Electrodes (K970541) and the ACMI Circon Surgical Instrument for Minimally Invasive Surgery (K914883). Each consists of handles and a series of electrodes that are used to cut and coagulate tissue through the utilization of high frequency radiofrequency energy.

Laparoscopic electrodes are reusable and are resterilized using steam sterilization.

Aaron Laparoscopic Electrodes and Handle conform to the requirements of safety standard ANSI/AAMI HF-18 Electrosurgical Devices.

There are no significant differences in technology, performance, or intended use between the Aaron Laparoscopic Electrodes and Handle and the given predicate devices. There are no new questions raised regarding safety or effectiveness.

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Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The background is white.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT - 5 2006

Aaron Medical % Mr. Richard A. Kozloff Vice President, Quality Assurance Regulatory Affairs 7100 30th Avenue North St. Petersburg, Florida 33710-2902

Re: K062337

Trade/Device Name: Laparoscopic Electrodes and Handle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: August 9, 2006 Received: August 10, 2006

Dear Mr. Kozloff:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (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 complics 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 A. 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), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or ---(240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Karbay Buchner
for

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K062337

Laparoscopic Electrodes and Handle Device Name:

Indications for Use:

Laparoscopic Electrodes and Handle are used to grasp, hold, coagulate, and cut tissue during laparoscopic surgical procedures

Prescription Use _ > (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Barbara Buchm

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

510(k) Number K062337

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.