The Porex Electrosurgery Needle is an electrosurgery electrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.

Device Description

The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode for use with monopolar electrosurgical accessories (cautery handpieces). It is constructed of a tungsten tip held by a gold plated stainless shaft/sleeve. The electrode shaft has two layers of insulation.

AI/ML Overview

The provided text is a 510(k) summary for the Porex Electrosurgery Needle. It does not contain any information about acceptance criteria or a study proving device performance against those criteria. The document focuses on regulatory approval based on demonstrating substantial equivalence to predicate devices, rather than presenting performance data from a specific study against predefined acceptance criteria.

Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them from the provided text.

Specifically, the document contains:

Device Identification: Name, submitter, contact, common name, classification details.
Predicate Device Identification: List of devices to which the Porex Electrosurgery Needle is considered substantially equivalent.
Description: Physical construction details of the needle.
Intended Use: How the device is designed to be used (cutting, dissecting, cauterizing soft tissue).
FDA Correspondence: Letter from the FDA confirming the 510(k) clearance and substantial equivalence determination.
Indications for Use: Formal statement of the device's intended applications.

There is no mention of:

A table of acceptance criteria or reported device performance.
Sample sizes for test sets or data provenance.
Number or qualifications of experts for ground truth.
Adjudication methods.
MRMC comparative effectiveness studies.
Standalone algorithm performance.
Type of ground truth used (expert consensus, pathology, outcomes data, etc.).
Sample size for training sets.
How ground truth for training sets was established.

Summary

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MAR 2 8 2006

03/23/06

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SUMMARY 510(k) NUMBER: K052297

POREX SURGICAL ELECTROSURGICAL NEEDLE

SUBMITTER

Porex Surgical, Inc. 15 Dart Road Newnan, GA 30265-1017 Tel: (678) 479-1610, Fax: (678)423-1435

CONTACT CONTACT CONTACT

Eric V. Hohenstein Vice President, Special Developmental Projects Tel: (678) 479-1610 / (323) 876-3767 Fax: (678) 423-1435 / (323) 876-5592 /

PROPRIETARY NAME: Porex Electrosurgery Needle

COMMON NAME: Microdissection Needle, Electrosurgical Needle

DEVICE CLASSIFICATION
DEVICE NAME	CLASS NO.	CLASS	REG NO.
Device, Electrosurgical, cutting &	JOS	2	878.4400

ત્ coagulation & accessories

IDENTIFICATION OF EQUIVALENT DEVICE___________________________________________________________________________________________________________________________________________

Porex Surgical, Inc. Electrosurgery Needles are substantially equivalent to the following predicate devices in their intended use, material, design, and surgical procedure:

Colorado MicroDissection Needle (K000348)

Megadyne Electrode, Electrosurgery (K903302)

Valleylab Coated Electrodes (K962044)

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05297

DESCRIPTION

INTENDED USE

The Porex Surgical, Inc. Electrosurgery Needle is an electrosurgical electrode used for cutting, dissecting and cauterizing soft tissue by use of high-frequency electrical current.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its wings. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA." The text is arranged around the perimeter of the circle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

MAR 2 8 2006

Porex Surgical Inc. c/o Mr. Eric V. Hohenstein V.P., Special Developmental Projects 15 Dart Road Newnan, Georgia 30265-1017

Re: K052297

Trade/Device Name: Porex Electrosurgery Needle Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI, JOS Dated: March 6, 2006 Received: March 8, 2006

Dear Mr. Hohenstein:

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 I·DA'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

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Page 2 -- Mr. Eric V. Hohenstein

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. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

Hubert Lehman

r / 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

052297

510(k) Number (if known):

Device Name: Porex Electrosurgery Needle

Indications For Use:

The Porex Electrosurgery Needle is an electrosurgery clectrode for use in monopolar electrosurgical handpieces. It is a single-use device intended for cutting, dissecting, and cauterizing of soft tissue.

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 IS NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)
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Julin Lemer
Division Sign-Off

Division of General, Restorative, and Neurological Devices

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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.