OWL URF-3AP

K062758 · Diros Technology, Inc. · GXD · Sep 27, 2006 · Neurology

Device Facts

• Record ID: K062758
• Device Name: OWL URF-3AP
• Applicant: Diros Technology, Inc.
• Product Code: GXD · Neurology
• Decision Date: Sep 27, 2006
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OWL Radiofrequency System, Model URF-3AP, intended use is for: 1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or 2. radiofrequency heat lesion procedures for the relief of pain

Device Story

The OWL URF-3AP is a radiofrequency (RF) lesion generator used by qualified medical personnel in clinical settings to create heat-ablative lesions in central or peripheral nerve tissue. The device delivers up to 50 Watts of RF energy at 481kHz in either bipolar or monopolar modes. It utilizes a probe with an integrated thermosensor to provide controlled heating of tissue surrounding the electrode tip. The system continuously monitors and displays power delivery, probe temperature, duration, and impedance to ensure safety. In monopolar mode, it also delivers low-frequency stimulus pulses. Healthcare providers use the real-time data to guide the ablation process, which therapeutically destroys specific nerve tissue to treat movement disorders (e.g., Parkinson's tremor) or block pain transmission (e.g., facet joint nerves).

Clinical Evidence

No clinical data. Performance was validated through bench testing, including electrical and mechanical safety evaluations per IEC 60601-1, UL 60601-1, CAN/CSA C22.2 No. 601.1-M90, and IEC 601-2-2. Risk analysis was conducted per ISO 14971.

Technological Characteristics

RF lesion generator; 481kHz output; 50W max power; monopolar/bipolar modes. Features thermosensor-based temperature control and impedance monitoring. Standards: IEC 60601-1, UL 60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC 601-2-2.

Indications for Use

Indicated for patients requiring functional neurosurgical procedures (thalamotomies, pallidotomies, tractomies, myelotomies) or radiofrequency heat lesioning for pain relief.

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

• OWL URF-2AP (K021869)
• PMG-115 (K020354)

Submission Summary (Full Text)

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### DIROS TECHNOLOGY INC. 510(K) SUBMITTAL OWL™ RF LESION GENERATOR MODEL OWL URF-3AP

K0i2758

510(k) Summary

Submitter:

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DIROS TECHNOLOGY INC 232 Hood Road Markham, ON L3R3K8, Canada

#### Contact:

Mr. George Darmos Telephone: [phone] Fax: [phone] [e-mail]

Date: July 27, 2006

Trade Name: OWL URF-3AP

Common Name: OWL Radiofrequency System

Classification Name: Generator, Lesion, Radiofrequency

Regulatory Class: II

Product Code: GXD

Regulation Number: 882.4400

REGISTRATION NO: 8043398

OWNER/OPERATOR NO: 9001301

SEP 27 2006

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K 062758

## DIROS TECHNOLOGY INC. 510(K) SUBMITTAL OWL™ RF LESION GENERATOR MODEL OWL URF-3AP

Predicate Devices:

Page 2 of 3

We are making the claim that the DIROS OWL URF-3AP is substantially equivalent to the predicated devices listed in the chart below.

| LEGALLY<br>MARKETED<br>PREDICATE DEVICE | MANUFACTURE<br>NAME | REGULATORY<br>CLASS AND<br>PRODUCT<br>CODE | 510(K)<br>REGISTRATION<br>NUMBER |
|-----------------------------------------|------------------------------|--------------------------------------------|----------------------------------|
| OWL URF-2AP | DIROS<br>TECHNOLOGY<br>INC | Class II/GXD | K021869 |
| PMG-115 | BAYLIS<br>MEDICAL<br>COMPANY | Class II/GXD | K020354 |

The rationale of declaring the DIROS OWL URF-3AP is substantially equivalent to the above 2 predicate devices is based on the following:

- Same Indications for use: All systems provide treatments by making heat ablative > lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. All systems are using the same fundamental scientific technology.
- > Similar key design technical characteristics- Pain relief is achieved by the controlled heating of the area surrounding the electrode tip. A thermosensor in the probe is used to control tissue temperature. Impedance values are displayed to guard against unsafe conditions.
- Same/similar components for treatment and measurement. >
- > Similar size, power source, and performance

#### Description:

The OWL radiofrequency generator URF-3AP is used by qualified medical personnel to make heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain. The lesions are ablative in order to be therapeutic; i.e. the destruction of a small portion of the thalamus within the brain interferes with the motor pathway causing the tremor of Parkinson's disease, thereby relieving the tremor, or the

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GY INC. 510(K) SUBMITTAL RF LESION GENERATOR MODEL OWL URF-3AP

destruction of the facet joint nerves in the lumbar vertebrae to block pain transmission by these nerves and thereby relieve certain types of low back pain.

The URF-3AP supplies up to 50 Watts of Radio Frequency energy at 481kHz in bipolar or monopolar modes under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance.

When used with monopolar probes, the system also delivers low-frequency stimulus pulses in either voltage or current controlled modes.

# Indications for Use:

The DIROS® URF-3AP LESION GENERATOR is intended for the following:

- 1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
- 2. radiofrequency heat lesion procedures for the relief of pain

# Summary of Performance Testing:

A risk analysis identifying potential hazards and documenting mitigations of the hazards has been developed and applied as part of the DIROS OWL URF-3AP product development cycle. The risk analysis is based on EN 1441/ISO14971 - Risk Analysis for Medical Devices.

Testing was performed to validate the functional performance of the DIROS system. In particular, specific performance testing of the software was performed to show that the performance was met.

The DIROS OWL URF-3AP has been subjected to performance testing to applicable safety, electrical, mechanical, EMC standards. The DIROS OWL URF-3AP system has been evaluated and has passed all mechanical and electrical safety according to CSA International. Standards that were investigated are: IEC 60601-1, UL 60601-1 and CAN/CSA C22.2No.601.1-M90 certified. The URF-3AP has also been evaluated and satisfies the requirements to IEC 601-2-2 Medical electrical equipment, Part 2: Particular requirements for the safety of high frequency surgical equipment.

# Conclusion:

As stated above, DIROS TECHNOLOGY INC.'s conclusion is that the DIROS OWL URF-3AP is safe and effective and complies with the appropriate medical standards and is substantially equivalent to the above identified predicate devices.

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#### DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

Image /page/3/Picture/2 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The seal is simple and iconic, representing the department's role in protecting the health of all Americans.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Diros Technology, Inc., % Mr. George Darmos President 232 Hood Road Markham, Ontario Canada L3R 3K8

SEP 2 7 2006

Re: K062758

Trade/Device Name: OWL Radiofrequency System, Model URF-3AP Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD, GXI Dated: August 3, 2006 Received: September 15, 2006

Dear Mr. Darmos:

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. George Darmos

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 [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 Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

Fur Panta

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

K062758 510(k) Number (if known):

OWL Radiofrequency System, Model URF-3AP Device Name:

Indications For Use:

The OWL Radiofrequency System, Model URF-3AP, intended use is for:

- 1. Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
- 2. radiofrequency heat lesion procedures for the relief of pain

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 Devige Evaluation (ODE)

Veshm

(Division Sign-On) Division of General, Restorative, and Neurological Devices

510(k) Number