OWL RF PROBES

K110593 · Diros Technology, Inc. · GXI · May 5, 2011 · Neurology

Device Facts

• Record ID: K110593
• Device Name: OWL RF PROBES
• Applicant: Diros Technology, Inc.
• Product Code: GXI · Neurology
• Decision Date: May 5, 2011
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 882.4725
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The OWL Sterile Single use R.F. Probe is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.

Device Story

OWL Sterile Single Use RF Probes are temperature-sensing devices used during radio-frequency (RF) heat lesion procedures for pain relief. The probes are inserted into RF cannulae to measure temperature at the lesion site during energy delivery. The device functions by providing real-time temperature feedback to the clinician, ensuring accurate monitoring during the procedure. The probes are available with either a thermistor or a thermocouple sensor. They are designed for single-use, sterile application, replacing the previously cleared reusable versions. The device is operated by clinicians in a clinical setting. By providing precise temperature data, the probe assists the physician in controlling the lesioning process, potentially improving procedural safety and efficacy for patients suffering from pain.

Clinical Evidence

Bench testing only. Comparison testing was performed to validate the temperature measurement accuracy of the thermocouple sensor against the thermistor sensor used in the predicate device. Sterilization and packaging validation were conducted to support the single-use, sterile status of the device.

Technological Characteristics

Single-use RF probes available in 25AWG and 27AWG diameters. Temperature sensing via thermistor or thermocouple. Compatible with RF cannulae of various lengths (65.8mm to 194mm). Sterile, single-use design.

Indications for Use

Indicated for patients undergoing Radio-Frequency Heat Lesion procedures for the relief of pain.

Regulatory Classification

Identification

A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.

Predicate Devices

• OWL Reusable RF Probes (K010202)

Submission Summary (Full Text)

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KIIOS93

MAY - 5 2011

## Special 510(k) SUMMARY

## Submitter Information

| Company Name:<br>Company Address: | Diros Technology Inc.<br>232 Hood Road<br>Markham, ON<br>L3R 3K8 |
|-----------------------------------|------------------------------------------------------------------|
| Company Phone: | [phone] |
| Company Fax: | [phone] |
| Contact Person: | George Darmos, President |
| Device Identification | |

| Trade/Proprietary Name: | OWL Sterile Single Use RF Probes |
|-------------------------|----------------------------------|
| Classification: | II |
| Classification Name: | Probe, Radiofrequency Lesion |
| Product Code: | GXI |
| Regulation Number: | 882.4725 |

#### Devices to which Submitted device is a modification

OWL Reusable RF Probes:

K010202

#### Device Description

The Diros OWL RF Probe/Temperature Sensor is a modification of the previously 510(k) cleared OWL Reusable RF Probes. The modification includes the change of the device from reusable to sterile and single use as well as the option to include a thermocouple in place of a thermistor for temperature measurement.

### Intended Use

The OWL Sterile Single use R.F. Probe is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.

#### Substantial Equivalence

The OWL Single Use RF Probes consist of a set of temperature measurement probes at different lengths. These probes can be inserted in RF cannulae to measure the temperature at the point of RF delivery. The probes are modifications to the set of

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reusable Diros probes approved in K010202, and any differences between the two probe sets do not affect safety or efficacy.

To demonstrate substantial equivalence, dimensional comparison, and comparison testing has been done between the cleared reusable probes and the disposable probes. Table 1 below compares the Diros single use probes to the reusable probes.

| Characteristic | Diros Disposable<br>Probes | Diros Reusable Probes<br>K010202 | Comments |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The OWL Sterile Single<br>use R.F.<br>Probe/Temperature<br>Sensor<br>is intended for use in<br>Radio-Frequency Heat<br>Lesionprocedures for<br>relief of pain. | The OWL R.F.<br>Probe/Temperature Sensor<br>is intended for use in<br>Radio-Frequency Heat<br>Lesion<br>procedures for relief of<br>pain. | Intended use is identical<br>with the exception of<br>single use characteristic<br>discussed below. |
| Diameter | 25AWG and 27 AWG | 25AWG | - |
| Lengths Available<br>(Cannulae length<br>to be used with) | 65.8mm (5cm)<br>116.5mm (10cm)<br>161mm (15cm)<br>194mm (20cm) | 65.8mm (5cm)<br>116.5mm (10cm)<br>161mm (15cm) | Length of probe is<br>determined by length of<br>cannula to ensure probe<br>measures temperature at<br>lesion site. |
| Temperature<br>measurement<br>devices available | Thermistor<br>Thermocouple | Thermistor only | Temperature accuracy of<br>thermocouple has been<br>demonstrated through<br>comparison testing with<br>predicate to be as accurate<br>as Thermistor type and is<br>provided in section 18<br>(Bench Testing) |
| Single Use | Yes | Reusable | Single use characteristic<br>does not affect safety and<br>efficacy. Sterilization and<br>packaging validation<br>confirm that single use<br>device can be used safely<br>out of package. |

## CONCLUSIONS

The differences between the OWL Reusable RF Probes and OWL Disposable RF Probes do not affected the intended use or performance characteristics, and do not raise new questions of safety and effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.

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

MAY - 5 2011

Diros Technology Inc. c/o Mr. George Darmos President 232 Hood Road Markham, Ontario L3R3K8, Canada

Re: K110593

Trade/Device Name: Diros OWL Single Use Disposable RF Probes/Temperature Sensors (D466, D467) Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: Class II Product Code: GXI Dated: April 6, 2011 Received: April 7, 2011

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

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.

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Page 2 – Mr. George Darmos

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/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/MedicalDevices/Safety/ReportaProblem/default.htm 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/MedicalDevices/Resourcesfor You/industry/default.htm.

...

Sincerely vours.

Sincerely yours,

Kesia Alexander

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 Statement

#### 510(k) Number (if known):

Device Name: Diros OWL Single Use Disposable RF Probes/Temperature Sensors (D466, D467)

#### Indications for Use:

The OWL Sterile Single Use Disposable R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.

Prescription Use _____________________________ 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 Evaluation (ODE)

J.B.

(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices

510(k) Number K110593

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