The Diros OWL cannulae are injection needles which may be used either for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. A nerve is localized either by using electrostimulation through the needle or by injecting contrast medium through the needle and using radiography concomitantly. The nerve may then be blocked by injecting local anesthetic solution or a radiofrequency lesion may be made.

Device Description

The Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST, DHC are single use disposable cannulae designed for use with the Diros OWL RF Lesion Generator, model URF-3AP. The models DRC, DXE, DHC and DST provide flexible injection ports and are used to administer for the delivery of local anaesthesia. The DXE and DHC models along with the standard RF cannulae product line additionally provide the capability for delivery of RF therapy. The DHC model includes an embedded thermocouple for thermally controlled lesion generation. The Diros OWL Sterile Single Use Disposable Cannulae are available in multiple sizes. The cannulae gauge ranges from 18 to 24 and the length from 30mm to 200mm. All cannulae in this submission are for single use only and are supplied sterile.

AI/ML Overview

This submission for 510(k) K102566 describes the Diros OWL Cannulae, which are injection needles intended for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The provided document does not specify quantitative acceptance criteria or a direct performance study to demonstrate that the device meets such criteria. The submission for the Diros OWL Cannulae relies on demonstrating substantial equivalence to predicate devices. This means that the device is considered safe and effective because its intended use, technological characteristics, material properties, and dimensions are the same as or very similar to devices already legally marketed.

Therefore, a direct table of acceptance criteria and reported device performance, in the typical sense for a new clinical efficacy study, cannot be generated from this document. The "performance" demonstrated is its similarity to existing, approved devices.
- Acceptance Criteria (Implicit): The device's characteristics (intended use, technological characteristics, material properties, dimensions) are sufficiently similar to legally marketed predicate devices to raise no new questions of safety and effectiveness.
- Reported Device Performance: The document states, "The Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST and DHC have the same intended use, technological characteristics, material properties, and dimensions as the identified legally marketed predicate devices."
Sample Size Used for the Test Set and the Data Provenance:

No test set in the sense of a clinical trial or performance study on humans or biological models is described for this 510(k) submission. The submission relies on comparative analysis with predicate devices. Therefore, there is no sample size for a test set or data provenance to report in this context.
Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:

Not applicable. Since no test set or clinical study is described, there's no ground truth established by experts in this context. The determination of substantial equivalence is made by the FDA based on the provided technical and comparative information.
Adjudication Method for the Test Set:

Not applicable. No test set requiring expert adjudication is described.
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. This device is a physical cannula, not an imaging or diagnostic AI-powered device. Therefore, an MRMC study or AI-related effectiveness study is not relevant.
If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This device is a physical medical instrument, not a software algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

Not applicable in the traditional sense of a clinical study. The "ground truth" for this 510(k) is the established safety and effectiveness of the predicate devices through their long-term market history and prior FDA clearances. The applicant asserts that their device shares these fundamental characteristics.
The sample size for the training set:

Not applicable. There is no training set mentioned or implied as this is not an AI/ML device or a device requiring a statistical model to be trained.
How the ground truth for the training set was established:

Not applicable. There is no training set for which ground truth would be established.

Summary

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K102566

JUN - 3 2011

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:	Diros OWL Cannulae.
Classification:	II
Generic Device Name:	Cannulae
Classification Name:	Probe, Radiofrequency Lesion
Product Code:	GXI
Regulation Number:	21 CFR 882.4725

Devices to Which Substantial Equivalence is Claimed:

Top Neuropole Needles (ST, X, RC, XE and TL):	K062946
Top Neuropole Needles:	K080771
Diros OWL Cannulae:	K010202
Neurotherm Radio Frequency Cannulae:	K994344
Cosman Cannulae:	K060799
Epimed RF Cannula:	K041021
Baylis BMC RF Cannula	K972846

DEVICE DESCRIPTION

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INTENDED USE

SUBSTANTIAL EQUIVALENCE

The Diros OWL Sterile Single Use Disposable Cannulae models 466, 467, DXE, DRC, DST and DHC have the same intended use, technological characteristics, material properties, and dimensions as the identified legally marketed predicate devices.

CONCLUSIONS

The intended use and performance characteristics of the Diros OWL Cannulae is the same as the predicates and raise no new questions of safety and effectiveness.

The Diros OWL Cannulae are substantially equivalent to the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized image of an eagle in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circle around the eagle.

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

Diros Technologies % Mr. George Darmos President 232 Hood Road Markham, Ontario Canada, L3R 3K8

Re: K102566

JUN - 3 2011

Trade/Device Name: Diros OWL Cannulae Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: May 10, 2011 Received: May 12, 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, listing 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.

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

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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/ReportalProblem/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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Debra Falls

Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, 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): K102566

Device Name: Diros OWL Single Use Disposable Cannula (466, 467, DXE, DRC, DST, DHC)

Indications for Use:

Prescription 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)

signature

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

510(k) Number K102566

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).