(105 days)
No
The summary does not mention AI or ML capabilities, and the device description focuses on standard radiofrequency ablation technology with monitoring and control features. The "(ML)" in the device name is likely a model or version identifier, not an indication of machine learning.
Yes
The device is described as making "heat ablative lesions in central or peripheral nerve tissue for the treatment of movement disorders or for the relief of pain," and the lesions "are ablative in order to be therapeutic." This directly indicates its intent and function as a therapeutic device.
No
The device is described as making "heat ablative lesions" in nerve tissue for therapeutic purposes, such as relieving pain or treating movement disorders. It is not used to diagnose conditions.
No
The device description clearly states it is a radiofrequency generator that supplies energy and includes hardware components like channels, probes, and a display. While it mentions software testing, the core function and description are of a hardware device with integrated software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use clearly states the device is for "Lesioning nerve tissue" and "radiofrequency heat lesion procedures for the relief of pain." These are procedures performed directly on the patient's body.
- Device Description: The description details how the device uses radiofrequency energy to create heat ablative lesions in nerve tissue. This is an in-vivo (within the living body) procedure.
- Lack of In Vitro Activities: There is no mention of the device being used to examine specimens (like blood, urine, tissue samples) outside of the body to provide information about a physiological state, health, or disease.
IVDs are devices used to perform tests on samples taken from the human body to diagnose or monitor medical conditions. This device performs a therapeutic procedure directly on the patient.
N/A
Intended Use / Indications for Use
The DIROS OWL™ URF-3AP(ML) SYSTEM is intended for the following:
- 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.
Product codes
GXD
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
central or peripheral nerve tissue, thalamus within the brain, facet joint nerves in the lumbar vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
qualified medical personnel
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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.
| LEGALLY
MARKETED
PREDICATE DEVICE | MANUFACTURE
NAME | REGULATORY
CLASS AND
PRODUCT
CODE | 510(K)
REGISTRATION
NUMBER |
|-----------------------------------------|------------------------------|--------------------------------------------|----------------------------------|
| OWL URF-3AP | DIROS
TECHNOLOGY
INC | Class II/GXD | K062758 |
| PMG-115 | BAYLIS
MEDICAL
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.
2
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:
-
- 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.
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.
3
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.
4
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
5
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
-
- 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