(167 days)
No
The 510(k) summary describes a physical medical device (cannulae) used for nerve blocks and radiofrequency lesioning. There is no mention of software, algorithms, or data processing that would indicate the use of AI or ML. The device relies on electrostimulation, contrast medium with radiography, and radiofrequency energy delivery, which are traditional medical techniques.
Yes
The device is used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning, which are therapeutic interventions aimed at pain relief or altering nerve function.
No
The device is primarily used for therapeutic purposes such as radiofrequency lesioning or nerve blocks, though it can assist in localizing a nerve using electrostimulation or contrast medium. These localization methods are part of the procedure rather than a standalone diagnostic function of the device.
No
The device is a physical medical device (injection needles/cannulae) used for nerve blocks and radiofrequency lesioning. The description details hardware components like needles, hubs, tines, and ports, and the performance studies focus on biocompatibility, electrical safety, mechanical testing, and performance of the physical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning. This involves a medical procedure performed directly on the patient's body.
- Device Description: The device is a needle designed for insertion into the body.
- Mechanism of Action: The device is used for delivering substances (local anesthetic, contrast medium) or energy (radiofrequency) directly to nerve tissue within the body.
- Lack of In Vitro Testing: The description does not mention any testing of samples (like blood, urine, tissue) outside of the body to diagnose a condition.
IVD devices are specifically designed to examine specimens derived from the human body in vitro (outside the body) to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH 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
GXI
Device Description
The Diros OWL Sterile Single Use Trident™ RF Cannulae DTR and DTRH models are very similar in construction, materials, energy source and intended use to predicate devices of 466 and DHC. They are single use disposable devices to be used with the Diros OWL RF Generators.
Sterile Single Use Trident™ RF Cannulae model DTR
The DTR device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.
Sterile Single Use Trident™ RF Hybrid Cannulae model DTRH
The DRTH device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Nerve
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Devices are used in clinical setting by trained professionals.
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)
All nonclinical testing performed on new devices are identical to testing performed on Diros predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the compliance to the standards and matching the performance of new devices to the predicate devices. The single difference between the new and predicate Diros devices is the shape of the lesion with tines expanded. The size of the lesion is comparable to that is created by NIMBUS device when 17Ga 10mm devices are compared.
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
- Cytotoxicity (ISO 10993-5): Passed ("Under the conditions of this study, the test article showed no evidence of causing cell lysis or toxicity." (same materials, same report as for predicate device))
- Sensitization (ISO 10993-10): Passed ("The article did not elicit a sensitization response under the conditions the of test assay." (same materials, same report as for predicate device))
- Irritation (ISO 10993-10): Passed ("The article considered a non-irritant under the conditions of the test assay." (same materials, same report as for predicate device))
- Systemic toxicity (ISO 10993-11): Passed ("The article meets the requirements for the absence of pyrogens as specified under the conditions of the test assay.")
- Ethylene oxide sterilization residuals (ISO 10993-7): Passed ("The levels of the EO residuals are below the specified limits in ISO 10993-7 for the particular contact types devices." EtO residuals testing report for predicate device)
Electrical safety testing:
- Electrical safety (IEC 60601-1): Passed (same as for predicate device)
- High frequency surgical equipment (IEC 60601-2-2): Passed (same as for predicate device)
- High frequency surgical accessories (IEC 60601-2-2): Passed (HF Accessory - Leakage current (201.8.8.3.102), HF Accessory - Dielectric Strength (201.8.8.3.103), (201.8.8.3.104))
- EMC (IEC 60601-1-2): Passed (same as for predicate device)
Mechanical testing:
- Stainless Tube dimensions, surface and mechanical properties compliance (ISO 9626): Pass (CofC)
- Bond force is tested between hub/handle, shaft, stylet and tines (ISO 7864): Pass (Pull testing with an axial force is applied in a direction of the separation of the parts; Hub/Handle - Needle Shaft, Cap- Stylet, Hub/Handle -Tines Shaft, Hub/Handle -Tines)
- Needle Geometry (ISO 7864): Pass (Triple bevel tip per drawing)
- The nominal O.D. of needle is identified by color coding to standard (ISO 6009): Pass (Visual inspection)
- Male 6% (Luer) conical taper (ISO 594-1): Pass (Gauging (5.1))
- Female 6 % (Luer) conical lock fittings (ISO 594-2): Pass (Liquid leakage - (5.2), Air leakage - (5.3), Separation force - (5.4), Unscrewing torque - (5.5), Resistance to overriding - (5.7), Stress cracking - (5.8))
- Dimensional measurement (Drawings): Pass (Measured per drawing)
- Anchorage test - cable and connector (IEC 60601-2-2): Pass (HF Accessory - Connection cable anchorage test (201.8.10.4.2))
Performance testing:
- Compatibility between probes, cannulae (Verified by dimensional measurements and performance testing): Pass (Cannulae to probe length matching, Impedance measurement, Energy coupling)
- Temperature accuracy, (Accuracy verified by measurements and performance testing): Pass (Temperature coupling, Temperature accuracy)
- Lesion (Measured RF Lesion Size in Tissue Model): Pass (Lesion size, Lesion shape)
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
§ 882.4725 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
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract symbol that resembles three human profiles facing right, with flowing lines beneath them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 30, 2015
Diros Technology, Inc. George Darmos President 120 Gibson Drive Markham, ON L3R 2Z3 Canada
Re: K150371
Trade/Device Name: Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: July 21, 2015 Received: July 22, 2015
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 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
1
Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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.
Carlos L. Pena न्त्र //
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K150371
Device Name
Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH
Indications for Use (Describe)
Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
510(k) SUMMARY
SUBMITTER INFORMATION
| Company Name:
Company Address: | Diros Technology Inc.
120 Gibson Drive
Markham, ON
L3R 2Z3
Canada |
|-----------------------------------|-------------------------------------------------------------------------------|
| Company Phone: | (905) 415-3440 |
| Company Fax: | (905) 415-0667 |
| Contact Person: | George Darmos, President |
| Date Prepared: | July 28, 2015 |
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models
DTR and DTRH |
|-------------------------|--------------------------------------------------------------------------------------|
| Classification: | II |
| Generic Device Name: | Cannulae |
| Classification Name: | Probe, Radiofrequency Lesion |
| Product Code: | GXI |
| Regulation Number: | 21 CFR 882.4725 |
PREDICATE DEVICES
| Diros RF Cannula: | K102566, K141586 |
|---|---|
| Biomerics. LLC NIMBUS Cannula: | K121773 |
4
DEVICE DESCRIPTION
The Diros OWL Sterile Single Use Trident™ RF Cannulae DTR and DTRH models are very similar in construction, materials, energy source and intended use to predicate devices of 466 and DHC. They are single use disposable devices to be used with the Diros OWL RF Generators.
Sterile Single Use Trident™ RF Cannulae model DTR
The DTR device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. Needle shaft is permanently attached to the hub that is used as a handle and the fluid injection port. The active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The device also has a detachable stylet with cap. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.
5
Sterile Single Use Trident™ RF Hybrid Cannulae model DTRH
The DRTH device consists of a sharp insulated needle with a partially uninsulated part of the shaft near the tip. The Needle shaft is permanently attached to the active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position. The handle also is permanently attached to the thermocouple probe, cable (with connector) and injection port. The Thermocouple probe is used to deliver the RF energy from the generator and measure the needle tip temperature. The injection port is used for fluid injection. The device is supplied with a protection tube that protects the needle from damage. The protection tube is detached from the device prior to use.
Image /page/5/Figure/2 description: The image shows two diagrams of a Trident Hybrid Cannula. The top diagram shows the cannula with a stylet and protection tube, and the active tip is withdrawn. The bottom diagram shows the cannula with an insulated needle shaft, and the active tip is expanded. The image also labels the cable, connector, and injection port.
6
MATERIALS
| Component | Material | Body Contact (Y/N) |
|---|---|---|
| Shaft | 304 Stainless Steel | Y |
| Insulation | Polyester | Y |
| Tines | Nitinol | Y |
| Hub | Polycarbonate | Indirect through injected fluid |
| Handle/Actuator | ABS | N |
| Protection tube | LDPE | N |
Materials used in Trident™ RF Cannulae (DTR) devices
Materials used in Trident™ RF Hybrid Cannulae (DTRH) devices
| Component | Material | Body Contact (Y/N) |
|---|---|---|
| Shaft | 304 Stainless Steel | Y |
| Insulation | Polyester | Y |
| Tines | Nitinol | Y |
| Handle | Polycarbonate | Indirect through injected fluid |
| Injection Port | LDPE/EVA/PVC | |
| Multilayer Tubing (DEHP free) | Indirect through injected fluid | |
| Handle/Actuator | ABS | N |
| Protection tube | LDPE | N |
ENERGY TYPE
The devices are using RF energy supplied by Diros OWL RF generators. The Diros OWL RF Generator applies temperature-controlled, radio frequency (RF) energy into targeted nerve tissue near the active tip of device. This energy disables the nerve tissue's ability to conduct electrical signals. Pain relief is achieved by creating lesions on pain-conducting nerve fibers or tissue.
TECHNOLOGICAL FEATURES
The DTR series cannulae consist of a sharp insulated needle with partially uninsulated part of the shaft near the tip. The needle also has a removable stylet with cap. The cannula is placed near the target nerve and the stylet is then removed from the device. Then a separate RF probe is introduced into the cannulae to perform the procedure, which may include the stimulation and RF lesion. The same cannula is used (with stylet and probe withdrawn) to administer the injections when it is required.
The DTRH series cannulae consist of a sharp insulated needle with partially uninsulated part of the shaft near the tip. The tip of the DTRH cannula is placed near the target nerve to perform the procedure, which may include the stimulation and RF lesion.
There is no separate RF probe required to perform the procedure, because the DTRH series devices have the built in probes. The injection port of the device is used to administer the injections when it is required.
7
INDICATIONS FOR USE
The Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH 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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The Diros OWL Sterile Single Use Trident™ RF Cannulae DTR and DTRH series that are included in this submission are identical to predicate devices 466 and DHC in the following aspects listed in the table below:
| Characteristic | Comments | Comparison |
|---|---|---|
| Intended Use/ | ||
| Indications for use | Devices are indicated for RF heat lesion procedures. | same |
| Where used | Devices are used in clinical setting by trained professionals. | same |
| Energy used | Devices are using the RF energy | same |
| Design features | Insulated needle with partially uninsulated part of the shaft near the tip. | same |
| Performance | Devices are performing identically in the same settings. Devices are using | |
| the conductive metal shaft to deliver the RF energy to target tissue. | same | |
| Standards applicable | Devices are subjected and in compliance with the same standards. | same |
| Material | ||
| Shaft | Stainless Steel 304 | same |
| Material | ||
| Shaft Insulation | Polyester | same |
| Biocompatibility | Devices are classified and in compliance with the same ISO 10993 | |
| standards. | same | |
| Compatibility with | ||
| other devices | Devices are performing identically in conjunction with the same | |
| equipment. | same | |
| Electrical safety | Devices are in compliance with the same IEC 60101-X-X standards. | same |
| Mechanical safety | Devices are similar in design and construction. Devices were subjected | |
| and passed to the same mechanical testing. | same | |
| Sterility | Devices supplied "STERILE" | same |
| Packaging | Device individually packaged and sealed in a single use Tyvek/Poly | |
| pouch | same | |
| Sterilization | Both devices are EtO sterilized | same |
| Material | ||
| Tines | "Trident" device- Nitinol | |
| "Nimbus" device- unknown | different |
Technological elements those are different between the subject and the predicate devices;
The DTR and DTRH included in this submission have an expandable tip, equivalent to NIMBUS that is currently marketed by Biomerics. LLC and cleared under K121773.
8
SUMMARY OF NONCLINICAL TESTING (PERFORMANCE DATA)
All nonclinical testing performed on new devices are identical to testing performed on Diros predicate devices. Tests setup and execution are performed in accordance with applicable standards. Results of the testing are demonstrating the compliance to the standards and matching the performance of new devices to the predicate devices. The single difference between the new and predicate Diros devices is the shape of the lesion with tines expanded. The size of the lesion is comparable to that is created by NIMBUS device when 17Ga 10mm devices are compared.
The following performance data were provided in support of the substantial equivalence determination.
| Biocompatibility testing | ||
|---|---|---|
| Patient contact materials are classified as tissue/bone/dentin |