Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH
Device Facts
| Record ID | K150371 |
|---|---|
| Device Name | Diros OWL Sterile Single Use TridentTM R.F. Insulated Cannulae,Models DTR and DTRH |
| Applicant | Diros Technology, Inc. |
| Product Code | GXI · Neurology |
| Decision Date | Jul 30, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.4725 |
| Device Class | Class 2 |
| Attributes | Therapeutic |
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.
Device Story
Single-use, sterile, insulated cannulae (DTR and DTRH models) for percutaneous nerve blocks and RF lesioning; used with Diros OWL RF generators. DTR requires separate RF probe; DTRH features integrated thermocouple probe. Input: RF energy from generator; needle tip placement near target nerve. Operation: Nerve localization via electrostimulation or contrast injection/radiography; RF energy delivered to tip to disable pain-conducting nerve fibers. DTRH includes integrated cable/connector for temperature monitoring. Used in clinical settings by trained professionals. Output: Thermal lesion in target tissue. Benefits: Targeted pain relief via nerve ablation. DTRH simplifies procedure by eliminating need for separate probe.
Clinical Evidence
Bench testing only. No clinical data. Testing included biocompatibility (ISO 10993-5, -7, -10, -11), electrical safety (IEC 60601-1, -1-2, -2-2), mechanical integrity (ISO 7864, ISO 594-1/2, ISO 9626), and performance verification (impedance, temperature accuracy, lesion size/shape in tissue models).
Technological Characteristics
Materials: 304 Stainless Steel shaft, Polyester insulation, Nitinol tines, Polycarbonate/ABS handles. Energy: RF (temperature-controlled). Connectivity: Wired connection to Diros OWL RF generator. Sterilization: EtO. Standards: ISO 10993, IEC 60601-1, IEC 60601-2-2, ISO 7864, ISO 594. Form factor: Single-use needle with expandable tip.
Indications for Use
Indicated for percutaneous nerve blocks with local anesthetic or radiofrequency lesioning for pain management in patients requiring nerve localization via electrostimulation or radiography.
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
Submission Summary (Full Text)
{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) |
|------------------------------------------------------------------------------------|
| <span style="font-size:14px">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:14px">☐</span> 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:<br>Company Address: | Diros Technology Inc.<br>120 Gibson Drive<br>Markham, ON<br>L3R 2Z3<br>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<br>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<br>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/<br>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<br>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<br>Shaft | Stainless Steel 304 | same |
| Material<br>Shaft Insulation | Polyester | same |
| Biocompatibility | Devices are classified and in compliance with the same ISO 10993<br>standards. | same |
| Compatibility with<br>other devices | Devices are performing identically in conjunction with the same<br>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<br>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<br>pouch | same |
| Sterilization | Both devices are EtO sterilized | same |
| Material<br>Tines | "Trident" device- Nitinol<br>"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 < 24hours and tested for compliance to applicable ISO<br>10993 standards. New device is similar in classification and the materials used in construction as a predicate device<br>therefore the same – reports are used for Cytotoxicity, Sensitization, Irritation, Systemic toxicity as for a predicate device<br>Additional testing per ISO 10993-7 is performed to evaluate the new device for EtO residuals. | | |
| Test | Test method Summary | Results |
| Cytotoxicity | ISO 10993-5<br>Biological evaluation of medical devices –Part 5:<br>Tests for in vitro cytotoxicity | Passed<br>"Under the conditions of this<br>study, the test article showed<br>no evidence of causing cell lysis<br>or toxicity."<br>(same materials, same report as<br>for predicate device) |
| Sensitization | ISO 10993-10<br>Biological evaluation of medical devices –Part 10:<br>Tests for irritation and skin sensitization | Passed<br>"The article did not elicit a<br>sensitization response under the<br>conditions the of test assay."<br>(same materials, same report as<br>for predicate device) |
| Irritation | ISO 10993-10<br>Biological evaluation of medical devices –Part 10:<br>Tests for irritation and skin sensitization | Passed<br>"The article considered a non-<br>irritant under the conditions of<br>the test assay."<br>(same materials, same report as<br>for predicate device) |
| Systemic toxicity | ISO 10993-11<br>Biological evaluation of medical devices –Part 11:<br>Tests for systemic toxicity | Passed<br>"The article meets the<br>requirements for the absence of<br>pyrogens as specified under the<br>conditions of the test assay." |
Biological evaluation of medical devices -Part 7:
Ethylene oxide sterilization residuals
ISO 10993-7
EtO residuals
(same materials, same report as
"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)
Passed
{9}------------------------------------------------
#### Electrical safety testing
The new device is similar in size, materials, construction and used with the same equipment as a predicate device, therefore the same- IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-2 test reports are applicable as for a predicate device. Additional testing also performed as a part of IEC 60601-2-2 for high frequency surgical accessories.
| Test | Test method Summary | Results |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| Electrical safety | IEC 60601-1<br>Medical electrical equipment<br>Part 1: General requirements for basic safety and<br>essential performance | Passed<br>(same as for predicate device) |
| High frequency surgical<br>equipment | IEC 60601-2-2<br>Medical electrical equipment<br>Part 2-2: Particular requirements for basic safety<br>and essential performance of high frequency<br>surgical equipment and high frequency surgical<br>accessories | Passed<br>(same as for predicate device) |
| High frequency surgical<br>accessories | IEC 60601-2-2<br>Medical electrical equipment<br>Part 2-2: Particular requirements for basic safety<br>and essential performance of high frequency<br>surgical equipment and high frequency surgical<br>accessories | Passed<br>HF Accessory - Leakage current<br>(201.8.8.3.102)<br>HF Accessory - Dielectric Strength<br>(201.8.8.3.103)<br>(201.8.8.3.104) |
| EMC | IEC 60601-1-2<br>Medical electrical equipment<br>Part 1-2: General requirements for safety -<br>Collateral standard: Electromagnetic compatibility | Passed<br>(same as for predicate device) |
#### Mechanical testing
The new device and a predicate device are similar in size, materials, construction and used with the same equipment, therefore the same tests were executed and passed successfully,
| Test | Test method Summary | Results |
|-------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Stainless Tube dimensions,<br>surface and mechanical<br>properties compliance | ISO 9626<br>Stainless steel needle tubing for the manufacture<br>of medical devices | Pass<br>CofC |
| Bond force is tested between<br>hub/handle, shaft, stylet and<br>tines | ISO 7864<br>Sterile hypodermic needles for single use | Pass<br>Pull testing with an axial force is<br>applied in a direction of the<br>separation of the parts;<br>Hub/Handle - Needle Shaft<br>Cap- Stylet<br>Hub/Handle -Tines Shaft<br>Hub/Handle -Tines |
| Needle Geometry | ISO 7864<br>Sterile hypodermic needles for single use | Pass<br>Triple bevel tip per drawing |
| The nominal O.D. of needle is<br>identified by color coding to<br>standard | ISO 6009<br>Hypodermic needles for single use –<br>Colour coding for identification | Pass<br>Visual inspection |
| Male 6% (Luer) conical taper | ISO 594-1<br>Conical fittings with a 6 % (Luer) taper for<br>syringes, needles and certain other medical<br>equipment -- Part 1: General requirements | Pass<br>Gauging<br>(5.1) |
| Female 6 % (Luer) conical lock<br>fittings | ISO 594-2<br>Conical fittings with 6 % (Luer) taper for syringes,<br>needles and certain other medical equipment --<br>Part 2: Lock fittings | Pass<br>Liquid leakage - (5.2)<br>Air leakage - (5.3)<br>Separation force - (5.4)<br>Unscrewing torque - (5.5)<br>Resistance to overriding - (5.7)<br>Stress cracking - (5.8) |
| Dimensional measurement | Drawings | Pass<br>Measured per drawing |
| Anchorage test - cable and<br>connector | IEC 60601-2-2<br>Medical electrical equipment<br>Part 2-2: Particular requirements for basic safety<br>and essential performance of high frequency<br>surgical equipment and high frequency surgical<br>accessories | Pass<br>HF Accessory - Connection cable<br>anchorage test<br>(201.8.10.4.2) |
{10}------------------------------------------------
| Performance testing<br>The new and the predicate device will be used in the same setting and for the same reason. Testing executed on a new<br>device and the predicate device, demonstrated similar performance under the same conditions. | | |
|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------|---------------------------------------------------------------------------------------|
| Test | Test method Summary | Results |
| Compatibility between probes,<br>cannulae | Verified by dimensional measurements and<br>performance testing | Pass<br>Cannulae to probe length matching<br>Impedance measurement<br>Energy coupling |
| Temperature accuracy, | Accuracy verified by measurements and<br>performance testing | Pass<br>Temperature coupling<br>Temperature accuracy |
| Lesion | Measured RF Lesion Size in Tissue Model | Pass<br>Lesion size<br>Lesion shape |
## CONCLUSIONS
The predicate devices were cleared based on the results of non-clinical data. Subject device has a similar safety profile when compared to the predicate devices and demonstrate that the Diros OWL Sterile Single Use Trident™ RF Cannulae DTR and DTRH series should perform as intended in the specified use conditions
