OWL UNIVERSAL RF SYSTEM URF-3AP (ML)

K093185 · Diros Technology, Inc. · GXD · Jan 22, 2010 · Neurology

Device Facts

• Record ID: K093185
• Device Name: OWL UNIVERSAL RF SYSTEM URF-3AP (ML)
• Applicant: Diros Technology, Inc.
• Product Code: GXD · Neurology
• Decision Date: Jan 22, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.4400
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The DIROS OWL™ URF-3AP(ML) 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. The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery.

Device Story

Diros OWL URF-3AP(ML) is a radiofrequency (RF) lesion generator used by qualified medical personnel to create heat ablative lesions in nerve tissue. Input: RF energy (up to 50W at 481kHz) delivered via probes; system monitors probe temperature, power, duration, and impedance. Operation: Controlled heating of tissue surrounding electrode tip; thermosensor feedback regulates temperature; impedance monitoring ensures safety. Output: RF energy for ablation; low-frequency stimulus pulses (monopolar mode) for nerve localization. The MLA-4 adaptor enables up to four simultaneous lesions (excluding brain surgery). Clinical use: Treatment of movement disorders (e.g., Parkinson's tremor) or pain relief (e.g., facet joint nerves). Healthcare providers use real-time display data to guide lesion creation, directly impacting surgical precision and patient outcomes through targeted nerve destruction.

Clinical Evidence

Bench testing only. Performance validated through risk analysis (ISO 14971) and electrical/mechanical safety testing per IEC 60601-1, UL 60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC 60601-1-2, FCC 15 Subpart B, and IEC 60601-2-2. Software performance testing conducted to verify functional requirements.

Technological Characteristics

RF generator (481kHz, 50W max); monopolar/bipolar capability; thermosensor-based temperature control; impedance monitoring; MLA-4 multi-lesion adaptor. Standards: IEC 60601-1, UL 60601-1, CAN/CSA C22.2 No. 601.1-M90, IEC 60601-1-2, FCC 15 Subpart B, IEC 60601-2-2. Connectivity: Standalone system with probe inputs.

Indications for Use

Indicated for patients requiring functional neurosurgical procedures (thalamotomies, pallidotomies, tractomies, myelotomies) or radiofrequency heat lesioning for pain relief. MLA-4 adaptor contraindicated for brain surgery.

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-3AP (K062758)
• PMG-115 (K072478)

Submission Summary (Full Text)

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Koa93185

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#### DIROS TECHNOLOGY INC. 510(K) SUBMITTAL OWL™ RF LESION GENERATOR MODEL URF-3AP WITH MULTI-LESION ADAPTOR (MLA-4)

## 510(k) Summary

#### Submitter:

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

JAN 2 2 2010

#### Contact:

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

Date: September 28, 2009

Trade Name: Diros OWL™ URF-3AP(ML)

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

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### DIROS TECHNOLOGY INC. 510(K) SUBMITTAL OWL™ RF LESION GENERATOR MODEL URF-3AP WITH MULTI-LESION ADAPTOR (MLA-4)

## Predicate Devices:

We are making the claim that the DIROS OWL URF-3AP(ML) which is the URF-3AP with the multiple lesion adaptor accessory MLA-4 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-3AP | DIROS<br>TECHNOLOGY<br>INC | Class II/GXD | K062758 |
| PMG-115 | BAYLIS<br>MEDICAL<br>COMPANY | Class II/GXD | K072478 |

The rationale of declaring the DIROS OWLIM URF-3AP(ML) 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. The PMG-115 includes an accessory that provides up to four simultaneous lesions.
- Same/similar components for treatment and measurement. >
- > Similar size, power source, and performance

## Description:

The Diros OWL™ radiofrequency generator URF-3AP(ML) 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 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.

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Image /page/2/Picture/1 description: The image shows a logo or emblem with the letters 'DTI' prominently displayed. The 'D' is a large, blocky letter on the left, and the 'I' is a vertical line on the right. In the center, between the 'D' and the 'I', there is a symbol that resembles a stylized caduceus, which is often associated with medicine or commerce. The overall design appears to be somewhat textured or patterned, giving it a slightly rough or vintage look.

#### DIROS TECHNOLOGY INC. 510(K) SUBMITTAL OWL™ RF LESION GENERATOR MODEL URF-3AP WITH MULTI-LESION ADAPTOR (MLA-4)

The URF-3AP(ML) supplies up to 50 Watts of Radio Frequency energy at 481kHz under power or temperature control while continuously monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance. This 50W RF source can be directed to one of four channels, one at a time, to create simultaneously up to four lesions.

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 OWL™ URF-3AP(ML) SYSTEM 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

The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery.

## 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 TMURF-3AP(ML) 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(ML) has been subjected to performance testing to applicable safety, electrical, mechanical, EMC standards. The DIROS OWL URF-3AP(ML) 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, IEC 60601-1-2 and FCC 15 Subpart B. The URF-3AP(ML) has also been evaluated and satisfies the requirements to IEC 60601-2-2 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-3 AP(ML) 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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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized depiction of an eagle with outstretched wings, symbolizing protection and care. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Diros Technology, Inc. c/o Mr. George Darmos President 232 Hood Rd. Markham, Ontario Canada L3R 3K8

JAN 2 2 2010

Re: K093185

Trade/Device Name: DIROS OWL™ URF-3AP(ML) Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency Lesion Generator Regulatory Class: II Product Code: GXD Dated: December 2, 2009 Received: December 7, 2009

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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CcntersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance,

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,

Kesia Alexander for

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known): K093185

Device Name; DIROS OWL™ URF-3AP(ML)

#### Indications for Use:

The DIROS OWL™ URF-3AP(ML) LESION GENERATOR is intended for the following:

- Lesioning nerve tissue for funetional netwosurgical procedures such as thalamotorinies, .............................................................................................................................................................................. pallidotomies, tractomies, and myelotomics; or
- 2. radiofrequency heat lesion procedures for the relief of pain

The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery.

Prescription Use X AND/OR Over-The-Counter Use (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Exaluation (ODE

*(Division Sign-Off)*

Division of Ophthalmic, Neurological an Nose and Throat Devices

510(k) Number K093185