(269 days)
Not Found
No
The description focuses on the physical characteristics and intended use of the cannulae for nerve blocks and radiofrequency lesioning, with no mention of AI or ML capabilities.
Yes
The device is used for a nerve block by injecting local anesthetic solution or making a radiofrequency lesion, both of which are therapeutic interventions.
No
The device is an injection needle (cannula) used for delivering local anesthetic or performing radiofrequency lesioning. While it aids in localizing a nerve (which could be considered a diagnostic step), its primary function is therapeutic (injection, lesioning), not to diagnose a condition or disease itself. The localization is a preparatory step for therapy.
No
The device description clearly describes physical cannulae (needles) with varying gauges and lengths, designed for injection and radiofrequency lesioning, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. This involves direct intervention on the patient's body for therapeutic or diagnostic purposes related to nerve function and pain management.
- Device Description: The description details the physical characteristics of injection needles/cannulae designed for delivering substances or energy into the body.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) outside of the body to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are specifically designed to perform tests on samples taken from the body to provide diagnostic information. This device is used for direct intervention and treatment/diagnosis within the body.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GXI
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
K062946, K080771, K010202, K994344, K060799, K041021, K972846
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
JUN - 3 2011
510(k) SUMMARY SUBMITTER INFORMATION
. •
| Company Name:
Company Address: | Diros Technology Inc.
232 Hood Road
Markham, ON
L3R 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
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.
1
INTENDED USE
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.
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.
2
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
3
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
4
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:
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.
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