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.

AI/ML Overview

The provided 510(k) summary for the Diros OWL Sterile Single Use RF Probes describes a device that is a modification of a previously cleared reusable RF probe. The acceptance criteria and the study proving the device meets these criteria are primarily focused on demonstrating substantial equivalence to the predicate device, K010202.

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for the new device are established through direct comparison to the predicate device (OWL Reusable RF Probes, K010202) and verifying that the modifications (single-use nature and inclusion of thermocouple option) do not adversely affect its safety or efficacy. The "reported device performance" is essentially the demonstrated equivalence.

Characteristic	Acceptance Criteria (Predicate Device Performance)	Reported Device Performance (Diros Disposable Probes)	Conclusion (Device Meets Criteria)
Intended Use	The OWL R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.	The OWL Sterile Single use R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.	Meets: Intended use is identical with the exception of the "single use" characteristic, which is addressed by the safety and performance evaluation.
Diameter	25AWG	25AWG and 27 AWG	Meets: The new device offers 25AWG (matching predicate) and an additional 27AWG, which is an expansion, not a deviation that would negatively impact performance. The document implies this difference is acceptable and does not raise new questions of safety/efficacy.
Lengths Available (Cannulae length to be used with)	65.8mm (5cm), 116.5mm (10cm), 161mm (15cm)	65.8mm (5cm), 116.5mm (10cm), 161mm (15cm), 194mm (20cm)	Meets: The new device offers all lengths of the predicate and an additional 194mm (20cm). This expansion is acceptable, as probe length is "determined by length of cannula to ensure probe measures temperature at lesion site."
Temperature Measurement Devices Available	Thermistor only	Thermistor, Thermocouple	Meets: The new device includes the thermistor (matching predicate) and adds a thermocouple. The document states that "Temperature accuracy of thermocouple has been demonstrated through comparison testing with predicate to be as accurate as Thermistor type."
Single Use	Reusable	Yes (Single Use)	Meets: This is the primary modification. "Single use characteristic does not affect safety and efficacy. Sterilization and packaging validation confirm that single use device can be used safely out of package."

2. Sample Size Used for the Test Set and the Data Provenance

The provided document describes comparison testing between the cleared reusable probes and the disposable probes.

Sample Size: The exact sample size for this testing is not specified in the summary. It mentions "comparison testing has been done" but doesn't quantify how many probes were tested or how many test cycles were performed.
Data Provenance: The data provenance is prospective bench testing conducted by the manufacturer, Diros Technology Inc. The country of origin is implied to be Canada, where the company is located.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

Number of Experts: This type of study (demonstrating substantial equivalence through bench testing) does not typically involve external human experts establishing ground truth in the same way clinical studies do. The "ground truth" for the performance characteristics (e.g., temperature accuracy, dimensions) would be established by validated measurement equipment and established engineering standards/specifications that define the acceptable performance range.
Qualifications of Experts: Not applicable in the context of expert consensus for ground truth as this was a technical comparison study. The "experts" would be the engineers and quality control personnel at Diros Technology Inc. responsible for performing and verifying the comparison testing, whose qualifications are not detailed.

4. Adjudication Method for the Test Set

Adjudication Method: Not applicable. This was a technical comparison study, not a clinical study involving subjective assessments that require adjudication. The performance metrics are objective and measurable (e.g., temperature readings, dimensions).

5. 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

MRMC Study: No, an MRMC comparative effectiveness study was not done. This device is a radiofrequency probe for heat lesion procedures. It is a medical instrument, not an AI-powered diagnostic or assistive tool for human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone Performance Study: Not applicable. This device is a physical medical probe, not an algorithm or software requiring a standalone performance evaluation in that sense. Its "standalone" performance is assessed by its physical and electrical characteristics as described in the comparison table (e.g., temperature accuracy, dimensions, mechanical integrity). The comparison testing served this purpose.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

The "ground truth" for this substantial equivalence submission is based on:

Predicate Device Specifications: The established and cleared specifications and performance of the Diros OWL Reusable RF Probes (K010202) serve as the primary ground truth or benchmark.
Bench Test Measurements: Measurements taken during comparison testing for dimensions, temperature accuracy, and other physical characteristics of both the new and predicate devices, verified against engineering standards and internal specifications.
Validated Sterilization and Packaging: For the single-use characteristic, the ground truth is established through validated sterilization and packaging protocols, ensuring the device meets sterility assurance levels and maintains integrity.

8. The Sample Size for the Training Set

Sample Size for Training Set: Not applicable. This device is a hardware product, not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

9. How the Ground Truth for the Training Set was Established

Ground Truth for Training Set: Not applicable. As there is no training set for an AI/ML model, the concept of establishing ground truth for it is irrelevant to this device.

Summary

{0}------------------------------------------------

KIIOS93

MAY - 5 2011

Special 510(k) SUMMARY

Submitter Information

Company Name:Company Address:	Diros Technology Inc.232 Hood RoadMarkham, ONL3R 3K8
Company Phone:	(905) 415-3440
Company Fax:	(905) 415-0667
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

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

{1}------------------------------------------------

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 DisposableProbes	Diros Reusable ProbesK010202	Comments
Intended Use	The OWL Sterile Singleuse R.F.Probe/TemperatureSensoris intended for use inRadio-Frequency HeatLesionprocedures forrelief of pain.	The OWL R.F.Probe/Temperature Sensoris intended for use inRadio-Frequency HeatLesionprocedures for relief ofpain.	Intended use is identicalwith the exception ofsingle use characteristicdiscussed below.
Diameter	25AWG and 27 AWG	25AWG	-
Lengths Available(Cannulae lengthto be used with)	65.8mm (5cm)116.5mm (10cm)161mm (15cm)194mm (20cm)	65.8mm (5cm)116.5mm (10cm)161mm (15cm)	Length of probe isdetermined by length ofcannula to ensure probemeasures temperature atlesion site.
Temperaturemeasurementdevices available	ThermistorThermocouple	Thermistor only	Temperature accuracy ofthermocouple has beendemonstrated throughcomparison testing withpredicate to be as accurateas Thermistor type and isprovided in section 18(Bench Testing)
Single Use	Yes	Reusable	Single use characteristicdoes not affect safety andefficacy. Sterilization andpackaging validationconfirm that single usedevice can be used safelyout 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.

{2}------------------------------------------------

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.

{3}------------------------------------------------

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 (800) 638-2041 or (301) 796-7100 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

{4}------------------------------------------------

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

20 .

Regulation Number and Section

§ 882.4725 Radiofrequency lesion probe.

(a)
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.(b)
Classification. Class II (performance standards).