PHYSICIAN INDUSTRIES RADIOFREQUENCY ABLATION NEEDLE by PHYSICIAN INDUSTRIES, INC.

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 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.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the Physician Industries' Radiofrequency Ablation Needle. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving safety and effectiveness through extensive, de novo clinical trials with detailed performance metrics and acceptance criteria. As such, the document does not contain the typical information for acceptance criteria and a study proving a device meets them in the way modern AI/software device submissions would.

However, I can extract the relevant information from the document that speaks to how the device's safety and effectiveness were supported for its 510(k) clearance.

Here's a breakdown based on the information available:

1. Table of Acceptance Criteria and Reported Device Performance

This document does not present a table of specific, quantifiable acceptance criteria or device performance metrics in the way a clinical trial for a novel device would. Instead, the "performance" is demonstrated by showing "substantial equivalence" to predicate devices. The implicit acceptance criteria are that the device performs as safely and effectively as the predicate devices.

Acceptance Criteria Category (Implicit)	Reported Device Performance
Configuration and Material Similarity	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."
Intended Use Equivalence	"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." Intended uses are identical: 1) radiofrequency (RF) lesioning, and / or 2) percutaneous nerve blocks with a local anesthetic solution.
Safety Record	"No record of unexpected patient problems or adverse reactions were found in our review of the FDA's MAUDE, Safety Alert..., and MDR databases" for the predicate devices.
Manufacturing and Quality Control	The device and its packaging will be tested by an independent lab for sterility, subjected to inspection/testing by IQC during/after manufacture QC, and monitored in the field by means of their CAPA system. Developed and documented under Physician Industries' mature Quality Management System, including design/change control, and verified/validated to applicable standards.
Overall Substantial Equivalence	"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."

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

Test Set: No specific test set of patients or medical cases is described in the document. The "test" for substantial equivalence relies on comparison with the predicate devices and their established safety and performance records.
Data Provenance: The document refers to "review of the FDA's MAUDE, Safety Alert..., and MDR databases" for adverse event data related to predicate devices. This would be retrospective data from the United States.

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

Not applicable. The ground truth for this 510(k) submission is not established by expert consensus on a test set of data. Instead, the "ground truth" for the device's acceptable performance is implicitly the established safety and effectiveness of the existing predicate devices on the market, as cleared by the FDA.

4. Adjudication method for the test set

Not applicable, as no human-adjudicated test set 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 is a medical device (a physical RF ablation needle), not an AI/software device. Therefore, no MRMC study, human reader improvement, or AI assistance is relevant.

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

Not applicable, as this is a physical medical device.

7. The type of ground truth used

The "ground truth" in the context of this 510(k) submission is the documented safety and effectiveness of the predicate devices (Radionics' Pole Needle, K021942 and K963577) as legally marketed and reviewed by the FDA. This is based on regulatory history and prior clearances rather than an independent gold standard for a new device.

8. The sample size for the training set

Not applicable. This is a physical medical device. There is no "training set" in the machine learning sense. The design and manufacturing processes are informed by general engineering principles and quality systems compliant with 21 CFR Part 820.

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

Not applicable. There is no training set as understood in AI/ML contexts. The device design and manufacturing are based on established engineering practices, material science, and regulatory requirements for medical devices, aiming to replicate the established performance and safety profile of equivalent predicate devices.

Summary

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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: 801-886-9505, toll free 800-241-2210.

1. 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.
1. 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.
1. 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 • (801) 886-9505 • Fax (801) 886-9081

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510(k) PI RF Ablation Needle

monitored in the field by means of our CAPA system.

1. 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.
1. 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: 801-886-9505, 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 (301) 594-4659. 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 (800) 638-2041 or (301) 443-6597 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

Regulation Number and Section

§ 882.4400 Radiofrequency lesion generator.

(a)
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.(b)
Classification. Class II (performance standards).