Lesioning nerve tissue for functional neurosurgical procedures such as thalamotomies, pallidotomies, tractomies, and myelotomies; or
radiofrequency heat lesion procedures for the relief of pain
The MLA-4 Multi-Lesion adaptor is not intended for use in brain surgery.

Device 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.
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.

AI/ML Overview

The provided text from the 510(k) submission for the DIROS OWL™ RF LESION GENERATOR MODEL URF-3AP WITH MULTI-LESION ADAPTOR (MLA-4) does not contain the specific information required to complete a table of acceptance criteria and reported device performance related to diagnostic accuracy, sensitivity, or specificity, nor does it detail a study that proves the device meets such criteria in the way a diagnostic AI device submission would.

Instead, this document focuses on demonstrating substantial equivalence to predicate devices for a radiofrequency lesion generator, which is a therapeutic device. The performance testing outlined here is primarily centered on safety, electrical, mechanical, and EMC standards, and ensuring the device performs its intended function (generating RF energy, monitoring temperature, impedance, etc.) safely and effectively, rather than on diagnostic accuracy metrics.

Therefore, many of the requested fields cannot be populated based on the provided text.

Here's an attempt to answer what is possible, and clearly indicate what information is not available within the provided text:

Acceptance Criteria and Device Performance

Acceptance Criteria Category	Specific Criteria (if available)	Reported Device Performance
Functional Performance	Device generates up to 50W of RF energy at 481kHz under power or temperature control.	Verified to deliver RF energy at specified parameters and control modes. Continues monitoring and displaying actual power delivered, measured probe temperature, time of power duration, and measured impedance.
	Direct RF source to one of four channels, one at a time, to create simultaneously up to four lesions.	Device can direct RF energy to multiple channels for lesion creation. (Implied by the "Multi-Lesion Adaptor" functionality).
	Deliver low-frequency stimulus pulses (monopolar probes).	Verified to deliver low-frequency stimulus pulses in either voltage or current controlled modes when used with monopolar probes.
Safety	Compliance with IEC 60601-1, UL 60601-1, CAN/CSA C22.2No.601.1-M90, IEC 60601-1-2, FCC 15 Subpart B, IEC 60601-2-2.	Passed all mechanical and electrical safety according to CSA International. Specifically: IEC 60601-1, UL 60601-1 and CAN/CSA C22.2No.601.1-M90 certified, IEC 60601-1-2 and FCC 15 Subpart B satisfied, and IEC 60601-2-2 requirements satisfied.
Risk Analysis	Identification of potential hazards and documentation of mitigations.	A risk analysis based on EN 1441/ISO14971 was developed and applied.
Software Performance	Software functions as intended for controlling and monitoring the device.	Specific performance testing of the software was performed to show that the performance was met.
Substantial Equivalence	Similar indications for use, key design technical characteristics, components, size, power source, and performance to predicate devices (OWL URF-3AP, PMG-115).	Device demonstrated substantial equivalence to predicate devices based on the rationale provided.

Study Details (Based on available information)

Sample size used for the test set and the data provenance:
- Not Applicable / Not Provided. The document describes performance testing for a therapeutic device (RF Lesion Generator) focused on safety and functional performance, not diagnostic accuracy. Therefore, there isn't a "test set" in the sense of a dataset of patient images or clinical cases for evaluation of diagnostic performance. The testing involved electrical, mechanical, and software verification as per medical device standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable / Not Provided. As this is not a diagnostic device undergoing a diagnostic performance study, there's no concept of "ground truth" derived from expert consensus on medical images or patient outcomes in the context of this 510(k) submission.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable / Not Provided. There was no "test set" requiring adjudication in the context of diagnostic performance evaluation.
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 / Not Performed. This device is an RF lesion generator, not an AI-powered diagnostic tool. Therefore, an MRMC study related to human reader improvement with AI assistance is not relevant and was not conducted.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable / Not Performed. This is not an algorithm-based diagnostic device. Performance testing focused on the device's hardware and software functionality in isolation (standalone electrical, mechanical, software testing).
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable / Not Provided in the context of diagnostic "ground truth." The "ground truth" for this device's performance would be derived from instrumental measurements (e.g., power output, temperature readings, impedance values) against known calibrated standards, and successful completion of predefined engineering and safety tests according to international and national standards.
The sample size for the training set:
- Not Applicable / Not Provided. This is not an AI/ML device that requires training data.
How the ground truth for the training set was established:
- Not Applicable / Not Provided. This is not an AI/ML device.

Summary

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Koa93185

Image /page/0/Picture/1 description: The image shows a logo with the letters "DTI" in a stylized font. The "D" is large and textured, the "T" is represented by a caduceus symbol, and the "I" is a simple vertical line with a textured pattern. Above the caduceus, there are some smaller letters that are difficult to read due to the image quality.

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: 905-415-3440 Fax: 905-415-0667 gpdarmos@dirostech.com

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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Image /page/1/Picture/1 description: The image shows a logo with the letters "DTI" stacked vertically. The "D" and "I" are large and stylized, with the "D" on top and the "I" on the bottom. Between the "D" and "I" is a smaller symbol that appears to be a caduceus, a symbol often associated with medicine. The logo has a textured or patterned fill, giving it a slightly three-dimensional appearance.

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.

LEGALLYMARKETEDPREDICATE DEVICE	MANUFACTURENAME	REGULATORYCLASS ANDPRODUCTCODE	510(K)REGISTRATIONNUMBER
OWL URF-3AP	DIROSTECHNOLOGYINC	Class II/GXD	K062758
PMG-115	BAYLISMEDICALCOMPANY	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:

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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
1. 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 (800) 638-2041 or (240) 276-3150 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
1. 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

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).