E Surgical Coated Electrodes are intended as an alternative to uncoated stainless steel electrodes or "non-stick" coated electrodes for use in conventional monopolar electrosurgical accessories. The Coated Electrodes are intended for use in situations where monopolar electrosurgical cutting and coagulation are normally used.

Device Description

The E Surgical coated electrodes are designed as a standard stainless steel active electrode with a nonstick coating to prevent tissue and char build-up on the electrode. Three models: ball, needle, and blade are included.

AI/ML Overview

The provided text describes a 510(k) summary for E Surgical Coated Electrodes. It outlines the device's indications for use, predicate devices, and a summary of its technological characteristics. However, the document primarily focuses on regulatory approval and substantial equivalence to predicate devices rather than a detailed study proving performance against specific acceptance criteria in the way a clinical study or robust scientific experiment would.

Therefore, much of the requested information regarding acceptance criteria, study details, ground truth, and expert involvement is not explicitly stated in the provided 510(k) summary. The summary highlights safety and performance data in a general sense, aligning with regulatory requirements rather than providing a detailed study protocol and results.

Here's a breakdown of the available information based on your request:

1. Table of acceptance criteria and the reported device performance

The document lists "Safety and Performance Data" but these are presented as characteristics the device meets rather than clearly defined acceptance criteria with numerical performance targets and reported results against those targets.

Acceptance Criterion (Inferred/Stated)	Reported Device Performance
Meets safety and performance requirements under ANSI/AAMI HF 18 Electrosurgical Devices.	Stated as "Meets safety and performance requirements under ANSI/AAMI HF 18 Electrosurgical Devices." (No specific numerical results or details are provided).
Non-stick coating integrity after bending.	"Finished product non-stick coating was bent to 90 degrees ten times without visible cracking of the coating."
Cutting or coagulation initiation performance.	"Cutting or coagulation is initiated immediately at both lower and higher power settings."
Easy to clean properties after use on tissue.	"Easy to clean properties after use on tissue."
Biocompatibility of materials.	"Materials used in the construction of the electrodes meet ISO 10993 Biocompatibility requirements."

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

Sample size for test set: Not specified. The document does not describe a formal "test set" in the context of a clinical or comparative study. The listed performance data (e.g., coating bend test) likely refers to in-house testing, but the sample sizes for these tests are not provided.
Data provenance: Not specified. Given the nature of a 510(k) summary focusing on substantial equivalence and general safety/performance, the data provenance for the internal tests is not detailed (e.g., country of origin, retrospective/prospective).

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

Not applicable. The document does not describe a test set requiring expert-established ground truth in a clinical or diagnostic context. The performance claims are based on engineering and material characteristic tests rather than diagnostic accuracy.

4. Adjudication method for the test set

Not applicable. No clinical or diagnostic test set requiring adjudication 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 an electrosurgical electrode, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study related to human readers and AI assistance would not be relevant.

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

Not applicable. This device is an electrosurgical electrode and does not involve algorithms or AI for standalone performance evaluation in that context.

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

Not applicable in the conventional sense of diagnostic performance. The "ground truth" for the reported performance criteria would be:

ANSI/AAMI HF 18: Compliance with the standard.
Coating integrity: Visual inspection against cracking.
Cutting/coagulation initiation: Likely observed by engineers or trained personnel during testing.
Easy to clean properties: Subjective assessment or a defined cleaning protocol with a pass/fail criterion.
Biocompatibility: Documentation/certification of meeting ISO 10993.

8. The sample size for the training set

Not applicable. There is no mention of a training set as this is not an AI/machine learning device.

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

Not applicable, for the same reason as above.

In summary: The provided 510(k) document is a regulatory submission for substantial equivalence. It confirms the device meets general safety and performance requirements and is comparable to predicate devices but does not contain the detailed study protocols, sample sizes, expert involvement, or statistical analyses typically found in clinical studies or papers proving specific performance against quantitative acceptance criteria for diagnostic devices.

Summary

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510(k) Summary

$\qquad k\omega 6187\delta$

E Surgical, LLC 1990 N. California Blvd., Suite 1040 Walnut Creek, CA 94596 925-280-8388 Phone 925-280-1788 Fax Contact: Hans Richter

I. Trade Name: E Surgical Coated Electrode: Electrode, Coated Ball Electrode, Coated Blade Electrode, Coated Needle

OCT 2 4 2006

II. Common Name: Active Electrode

III. Classification: 21 CFR 878.4400, Class II, Electrosurgical Cutting and Coagulation Accessory

IV. Product Code: GEI

V. Indications for Use

VI. Predicate Devices

a. Valleylab Edge™ Coated Electrodes, K962044 b. New Deantronics, Ltd. Disposable Hand Switching Pencil, K982742

VII. Device Description

VIII. Summary of Technological Characteristics

The active electrodes are substantially equivalent to the New Deantronic electrodes in the disposable hand switching pencil, K982742, and the Valleylab Edge™ Coated Electrodes, K962044. The electrodes are a modification to the single-use electrodes of various tip configurations. A proprietary coating provides a non-stick surface for easier cleaning of eschar during use.

The electrodes are intended for use during monopolar electrosurgery. The electrodes fit in currently marketed electrosurgical pencils offered by New Deantronics and other manufacturers.

IX. Safety and Performance Data

a. Meets safety and performance requirements under ANSI/AAMI HF 18 Electrosurgical Devices.

b. Finished product non-stick coating was bent to 90 degrees ten times without visible cracking of the coating.

c. Cutting or coagulation is initiated immediately at both lower and higher power settings.

d. Easy to clean properties after use on tissue.
e. Materials used in the construction of the electrodes meet ISO 10993 Biocompatibility requirements.

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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized caduceus, a symbol often associated with medicine and healthcare, with three abstract shapes resembling birds in flight. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

OCT 2 4 2006

E. Surgical, LLC % L.W. Ward and Associates, Inc. Mr. Lewis Ward 4655 Kirkwood Court Boulder, Colorado 80301

Re: K061878

Trade/Device Name: E Surgical, Electrodes, Coated Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: October 4, 2006 Received: October 10, 2006

Dear Mr. Ward:

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. Lewis Ward

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,

F. Pdplhn

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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Ko61878

INDICATIONS FOR USE

510(k) Number (if known):

Device Name: E Surgical, Electrodes, Coated

Indications for Use:

Prescription Use X (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)

(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
510(k) Number	4061878

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.