The electrodes are accessories to the Ellman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.

Device Description

Ellman has been manufacturing and distributing electrodes for many years. The Ellman electrodes are used with an electrosurgical generator (such as Ellman Surgi Max K061174, Ellman Surgitron K052241). The electrical power operating at radio frequency (RF) is transferred to tissue at the surgical site. The time-varying voltage produced by the RF electrical power source yields a predetermined electrosurgical effect, such as tissue cutting or coagulation. The Ellman family of electrodes are available in various shapes and sizes depending on the need of the surgeon. The Ace-Tip electrodes are composed of the new noble alloy. Several of the classical Ellman electrodes are now available in the new noble alloy including: Loop Electrode 3mm and 5mm, Micro Incision Needle Electrode, Ball Electrode 2mm, Tapered Ball Electrode 3mm, Fine Wire Electrode, VariTip Electrode.

AI/ML Overview

The provided 510(k) document (K071343) for Ellman Ace-Tip Electrodes describes a device intended for electrosurgical cutting and coagulation. However, it does not include detailed acceptance criteria or a specific study proving the device meets performance criteria in the way typically expected for complex AI/ML medical devices.

Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Ellman Electrodes Preamendment) based on technological characteristics and material properties. The provided text details the device, its intended use, and a general statement about its performance, but lacks the specific, quantifiable performance metrics, study designs, and statistical analyses requested in your prompt.

Here's a breakdown of why the requested information cannot be fully extracted and what is available:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Not explicitly stated as quantifiable metrics. The document focuses on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance thresholds.	"The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device."
Implicitly: Biocompatibility	Passed (as stated)
Implicitly: Electrical safety/integrity	Passed dielectric testing (as stated)
Implicitly: Functionality for tissue cutting and coagulation	"performs similarly to the predicate device"

Reasoning for "Not explicitly stated": The document claims "The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics." This type of 510(k) relies on the similarity to a device already on the market, rather than a de novo demonstration of performance against predefined criteria.

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

Sample size: Not applicable or not provided. There is no mention of a clinical or in vitro performance test set with a defined sample size for evaluating the device's cutting or coagulation performance against a specific ground truth.
Data provenance: Not applicable or not provided.

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

Not applicable or not provided. There is no mention of a test set requiring expert-established ground truth.

4. Adjudication method for the test set

Not applicable or not provided. As there's no described test set, no adjudication method is mentioned.

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

No. This device is an electrosurgical electrode, not an AI/ML diagnostic or assistive device for human readers. Therefore, an MRMC study comparing human reader performance with and without AI assistance is irrelevant and not mentioned.

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

Not applicable. This is a physical electrosurgical electrode, not an algorithm.

7. The type of ground truth used

The concept of "ground truth" as it applies to AI/ML or diagnostic devices is not relevant here. The "proof" of performance for these electrodes is based on their physical and electrical specifications, biocompatibility, and functionality being similar to existing (predicate) electrodes. The ground truth for such a device would likely be its ability to safely and effectively cut and coagulate tissue, which is implicitly accepted by its substantial equivalence to a pre-amendment device.

8. The sample size for the training set

Not applicable. This is a physical medical device, not an AI/ML model that requires a training set.

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

Not applicable.

Summary of the Study (as described in the 510(k)):

The "study" or justification for equivalence presented in this 510(k) is a comparison to a predicate device (Ellman Electrodes Preamendment). The core argument is based on:

Technological Characteristics: The Ace-Tip electrodes are described as using a "new noble alloy" and are available in various shapes and sizes, similar to existing Ellman electrodes.
Performance Data: The document states, "The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device." This implies that material safety (biocompatibility) and electrical integrity/functionality have been verified to be acceptable and comparable to the predicate.
Conclusion: The changes in the new electrodes are considered "minor," and the devices are concluded to be "as safe and effective as the predicate device."

In essence, this 510(k) relies on the principle of substantial equivalence, where detailed de novo performance studies with specific statistical metrics are not required or provided, because the device is deemed sufficiently similar to a device already on the market.

Summary

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510 (k) S

K071343

28 11

Date Prepared [21 CFR 807.92(a)(1)] [Revised] August 28, 2007

Submitter's Information [21 CFR 807.92(a)(1)]

This 510(k) is being submitted by Joseph Azary on behalf of Ellman International Inc.

Contact Information / Regulatory Consultant: Joseph Azary Azary Technologies LLC 543 Long Hill Avenue Shelton, CT 06484 Tel: (203) 944-9320 Fax: (203) 944-9317 Email: info@azarytech.com

Manufacturer / Sponsor: Ellman International Inc. 3333 Royal Avenue Oceanside, NY 11572.

Establishment Registration for Ellman International Inc. is 2428235

Trade Name [21 CFR 807.92(a)(2)] Device trade name is Ace-Tip Electrodes

Device Common, Usual, or Classification Names

Electrodes, Electrosurgical Unit Accessories, Electrosurgical Cutting and Coagulation and Accessories

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K 0 7 1 3 4 3

Page 2 of 3

Classification Panel

Classification of this device would fall under the responsibility of the Division of General, Restorative, and Neurological Devices.

Class

Classification: Class 2 Product Code: GEI, 21 CFR 878.4400

Predicate Device |21 CFR 807.92(a)(3)]

The predicate devices are listed as follows:

Ellman Electrodes Preamendment .

Description of the Device [21 CFR 807.92(a)(4)]

The Ellman family of electrodes are available in various shapes and sizes depending on the need of the surgeon.

The Ace-Tip electrodes are composed of the new noble alloy. Several of the classical Ellman electrodes are now available in the new noble alloy including:

Loop Electrode 3mm and 5mm 0
Micro Incision Needle Electrode 0
Ball Electrode 2mm 0
O Tapered Ball Electrode 3mm
o Fine Wire Electrode
VariTip Electrode o

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Page 3 of (3)

Intended Use [21 CFR 807.92(a)(5)]

The electrodes are accessories to the Ellman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.

Technological Characteristics [21 CFR 807.92(a)(6)]

The device is substantially equivalent to the predicate device based on a comparison on physical and performance characteristics.

Performance Data [21 CFR 807.92(b)(1)]

The subject device is composed of biocompatible materials, has passed dielectric testing, and performs similarly to the predicate device.

Conclusion [21 CFR 807.92(b)(3)]

We believe the changes are minor and conclude that the subject devices are as safe and effective as the predicate device.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" arranged in a circular pattern around the symbol. The logo is black and white.

Public Health Service

FEB 2 8 2008

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ellman International, Inc. % Azary Technologies, LLC Mr. Joseph M. Azary 543 Long Hill Avenue Shelton, Connecticut 06484

Re: K071343

Trade/Device Name: Ellman Ace Tip Electrodes Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: January 25, 2008 Received: February 6, 2008

Dear Mr. Azary:

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 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. Joseph M. Azary

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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance. please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.

Mark N Millerson

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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K071343

Indications for Use

5 10(k) Number (if known):

Device Name: Ellman Ace Tip Electrodes

The electrodes are accessories to the Eliman electrosurgical generators for cutting of tissue and coagulation by use of high frequency electrical current.

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

Over-The-Counter Use (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page 1 of 1

Mark A. Milken

(Division Sig . Il) Division of General. Restorative, and Neurolog al Devices

510(k) Number K071343

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.