PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE

K040565 · Physician Industries, Inc. · GXD · Jul 22, 2004 · Neurology

Device Facts

• Record ID: K040565
• Device Name: PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE
• Applicant: Physician Industries, Inc.
• Product Code: GXD · Neurology
• Decision Date: Jul 22, 2004
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Physician Industries' Radiofrequency Ablation Needle is a single use RF (radiofrequency) needle with injection capabilities. It can be used for either 1) (Fadiofrequency) in the lesioning, or 2) percutaneous nerve blocks with a local anesthetic solution. The nerve is localized by using electrical stimulation through the needle. The nerve may then be blocked either by the generating an RF lesion, or by the injecting of a local anesthetic. It is to be used only under the direction of a licensed clinician.

Device Story

Radiofrequency (RF) ablation needle; single-use; plastic hub; PTFE-coated stainless steel cannula. Used by licensed clinicians for percutaneous nerve blocks and RF lesioning. Nerve localization achieved via electrical stimulation through needle; nerve blocking performed via RF lesion generation or local anesthetic injection. Device functions as a conduit for electrical signals and fluid delivery. No complex software or automated processing involved.

Clinical Evidence

No clinical data. Bench testing only; device verified and validated to applicable standards and guidance documents under a Quality Management System.

Technological Characteristics

Single-use RF needle; plastic hub; PTFE-coated stainless steel cannula. Operates via electrical stimulation for nerve localization and RF energy for lesioning. Sterilization and manufacturing processes consistent with existing similar medical devices.

Indications for Use

Indicated for patients requiring percutaneous nerve blocks or radiofrequency lesioning. Used for nerve localization via electrical stimulation and subsequent nerve blocking via RF lesion or local anesthetic injection. For use by licensed clinicians only.

Regulatory Classification

Identification

A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.

Predicate Devices

• Radionics' Pole Needle (K021942)
• Radionics' Pole Needle (K963577)

Submission Summary (Full Text)

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510(k) PI RF Ablation Needle

Physician Industries

anufacturing M

## SUMMARY OF SAFETY AND EFFECTIVENESS

KO40565

PHYSICIAN INDUSTRIES INC. SUBMITTED BY: 2203 W. Alexander Salt Lake City UT 84119 Phone: [phone], toll free 800-241-2210.

- 01. DEVICE NAME (Trade/common, and classification): Physician Industries' Radiofrequency Ablation Needle
Classification: GXI: GXD

Regulation Nos .: 882.4775; 882.4400

## 02. PREDICATE DEVICES:

- Radionics' Pole Needle, K021942, found SE Sep 11, 2002); .
- Radionics' Pole Needle, K963577, found SE Nov. 21, 1996 .
- See also the FDA's 510(k) database of several other products under the same . classifications, also found SE, or pre-ammendment.
- DESCRIPTION: The Physician Industries Inc. needle shares major similarities with the . predicate device(s), inasmuch as the configuration, material, use, labeling and safety issues remain basically unchanged. It consists of a plastic hub, insert molded over a PTFE-coated stainless steel cannula.
- 04. INTENDED USE: The Physician Industries' radiofrequency ablation needle is a radiofrequency needle with injection capabilities. It can be used for either 1) radiofrequency (RF) lesioning, and / or 2) percutaneous nerve blocks with a local anesthetic solution. The nerve is localized by using electrical stimulation through the needle. The nerve may then be blocked by generating an RF lesion, or by the injecting of a local anesthetic. It is to be used only under the direction of a licensed clinician.
- 05. SUBSTANTIAL EQUIVALENCE (SE) RATIONALE: The Physician Industries' RF Ablation Needle shares the same basic characteristics and features and, therefore, are SE to the Radionic's Pole Needles, K021942, and K963577. In addition:
- No record of unexpected patient problems or adverse reactions were found in our o review of the FDA's MAUDE, Safety Alert ... , and MDR databases;
- The device and its packaging will be tested by and independent lab for sterility, will 0 be subjected to inspection / testing by IQC, during / after manufacture QC, and

2203 West Alexander Street • West Valley, Utah 84119 • [phone] • Fax [phone]

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510(k) PI RF Ablation Needle

monitored in the field by means of our CAPA system.

- 06. SAFETY AND EFFECIVENESS: There are no substantive differences between the device defined in this 510(k) submission and the predicate devices. It is similar to the material and manufacturing / sterilization technologies that are currently used in other similar medical devices. It was developed and documented under Physician Industries' mature Quality Management System, under the Quality System Regulation, 21 CFR Part 820, including design / change control, and is verified / validated to applicable standards / guidance documents, including vendor and our SOPs. It is designed and manufactured to be safe and effective when used as intended, under a licensed clinician's supervision.
- 07. The Physician Industries' Radiofrequency Ablation Needle, share similar indication for use, and characteristics and functional features, and thus are substantially equivalent to the currently marketed predicate devices, cited above.

- numm ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------Signed:

/s - 21 - = ] Dated:

Brian Baker, President PHYSICIAN INDUSTRIES INC. 2203 W. Alexander Salt Lake City UT 84119 Phone: [phone], toll free 800-241-2210.

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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 222004

Mr. Brian Baker President Physician Industries, Inc. 3385 West 1820 South Salt Lake City, Utah 84104

Re: K040565

Trade/Device Name: Physician Industries' Radiofrequency Ablation Needle Regulation Number: 21 CFR 882.4725, 21 CFR 882.4400 Regulation Name: Radiofrequency lesion probe; Radiofrequency lesion generator Regulatory Class: II Product Code: GXI, GXD Dated: June 9, 2004 Received: June 15, 2004

Dear Mr. Baker:

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. Brian Baker

This letter will allow you to begin marketing your device as described in your Section 510(k) I mis tetter will and w yourse of substantial equivalence of your device to a legally prematice notification. " 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 If you desire spocitio acries at [phone]. 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 other general micromational and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,
Mark A. Melkerson

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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Indications for Use

510(k) Number: K040565

Device Name: Physician Industrics' Radiofrequency Ablation Needle

Indications for Use:

"The Physician Industries' Radiofrequency Ablation Needle is a single use RF (radiofrequency) needle with injection capabilities. It can be used for either 1) (Fadiofrequency) in the lesioning, or 2) percutaneous nerve blocks with a local anesthetic solution. The nerve is localized by using electrical stimulation through the needle. The nerve may then be blocked either by the generating an RF lesion, or by the injecting of a local anesthetic. It is to be used only under the direction of a licensed clinician."

Prescription Use X (Part 21 CFR 801 Subpart D)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
Mark N Millman

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

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510(k) Number K040563