(167 days)
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.
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 The active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position.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 The Needle shaft is permanently attached to the active tip has expandable tines, which are normally withdrawn and only expanded once the device is placed in desired position.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.
The provided document is an FDA 510(k) Premarket Notification for a medical device: Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae Models DTR and DTRH.
This document describes the device, its intended use, and a comparison to predicate devices, focusing on non-clinical testing to demonstrate substantial equivalence, rather than a clinical study with human subjects validating performance against typical AI/ML acceptance criteria.
Therefore, many of the requested points regarding acceptance criteria, human reader studies, and AI/ML model training/testing are not applicable to this 510(k) submission directly, as it pertains to a physical medical device (cannulae) and its mechanical, electrical, and biocompatibility properties, demonstrated through non-clinical performance data.
However, I can extract and present the information available that most closely aligns with your request, interpreting "acceptance criteria" as the criteria for demonstrating substantial equivalence based on non-clinical testing:
Acceptance Criteria and Device Performance (Non-Clinical)
The "acceptance criteria" in this context are the standards and performance metrics that the device (Diros OWL Sterile Single Use Trident™ R.F. Insulated Cannulae) needed to meet to demonstrate substantial equivalence to its predicate devices for FDA clearance. The study proves the device meets these criteria through various non-clinical tests.
1. Table of Acceptance Criteria and Reported Device Performance
For this device, the "acceptance criteria" are compliance with established standards (ISO, IEC) and comparable performance to predicate devices in terms of material properties, electrical safety, mechanical integrity, and functional performance (e.g., lesion creation, temperature accuracy).
| Acceptance Criteria Category | Specific Test/Parameter (Acceptance Criteria) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 standards for tissue/bone/dentin contact (<24 hours). Tests include: Cytotoxicity, Sensitization, Irritation, Systemic Toxicity, and EtO residuals. (Acceptance: Passed, "no evidence of causing cell lysis or toxicity," "did not elicit a sensitization response," "non-irritant," "meets requirements for absence of pyrogens," "EtO residuals are below specified limits.") | Cytotoxicity: 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: Passed. "The article did not elicit a sensitization response under the conditions of the test assay." (Same materials, same report as for predicate device).Irritation: Passed. "The article considered a non-irritant under the conditions of the test assay." (Same materials, same report as for predicate device).Systemic Toxicity: Passed. "The article meets the requirements for the absence of pyrogens as specified under the conditions of the test assay." (Same materials, same report as for predicate device).EtO Residuals: 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). |
| Electrical Safety | Compliance with IEC 60601-1 (Medical electrical equipment - General requirements for basic safety and essential performance), IEC 60601-1-2 (EMC), and IEC 60601-2-2 (Particular requirements for high frequency surgical equipment and accessories). (Acceptance: Passed same as predicate). | Electrical Safety (IEC 60601-1): Passed (same as for predicate device).High Frequency Surgical Equip. (IEC 60601-2-2): Passed (same as for predicate device). Additional tests for HF Accessory (Leakage current, Dielectric Strength) also passed.EMC (IEC 60601-1-2): Passed (same as for predicate device). |
| Mechanical Testing | Compliance with ISO 9626 (Stainless steel needle tubing), ISO 7864 (Sterile hypodermic needles for single use - Bond force & Geometry), ISO 6009 (Color coding), ISO 594-1 & 594-2 (Luer taper fittings), Dimensional measurements, and IEC 60601-2-2 (Anchorage test for cable/connector). (Acceptance: Passed). | Stainless Tube properties: Pass (CofC).Bond force: Pass (Pull testing with axial force applied). Tested for Hub/Handle-Needle Shaft, Cap-Stylet, Hub/Handle-Tines Shaft, Hub/Handle-Tines.Needle Geometry: Pass (Triple bevel tip per drawing).Nominal O.D. identification: Pass (Visual inspection per ISO 6009 color coding).Male 6% (Luer) conical taper: Pass (Gauging).Female 6% (Luer) conical lock fittings: Pass (Liquid leakage, Air leakage, Separation force, Unscrewing torque, Resistance to overriding, Stress cracking).Dimensional measurement: Pass (Measured per drawing).Anchorage test - cable and connector: Pass (HF Accessory - Connection cable anchorage test). |
| Performance Testing | Demonstrate similar performance to predicate devices. Specific tests include Compatibility between probes/cannulae, Temperature accuracy, and Lesion characteristics (size, shape) in a tissue model. (Acceptance: Pass, similar performance demonstrated). | Compatibility (probes/cannulae): Pass (Cannulae to probe length matching, Impedance measurement, Energy coupling).Temperature accuracy: Pass (Temperature coupling, Temperature accuracy).Lesion: Pass (Lesion size, Lesion shape measured in a Tissue Model). The size of the lesion is comparable to NIMBUS device when 17Ga 10mm devices are compared. Note: The shape of the lesion with tines expanded is a difference from predicate Diros devices, but it's comparable to the NIMBUS predicate. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size (e.g., N=X devices tested) for each non-clinical test. It states that "All nonclinical testing performed on new devices are identical to testing performed on Diros predicate devices." and results are generally described as "Passed" or "Compliance." For the biocompatibility section, it states "Additional testing per ISO 10993-7 is performed to evaluate the new device for EtO residuals," implying that new device samples were used for this specific test, while for other biocompatibility tests, the reports for the predicate device's materials were leveraged.
- Data Provenance: The data is from non-clinical laboratory testing performed on the devices themselves, not human patient data. There is no information about the country of origin of the test data. The tests are "in accordance with applicable standards," which are international (ISO, IEC). The testing is prospective in the sense that the tests were conducted specifically for this submission to verify the device's properties.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This is not a study requiring human expert ground truth for interpretation of medical images or diagnoses. The "ground truth" for these tests is defined by the objective, quantitative criteria set by international standards (e.g., a specific bond strength, a maximum leakage current, a lack of cytotoxicity). The results are objective measurements/observations from laboratory tests.
4. Adjudication Method for the Test Set
Not applicable. There is no human interpretation or adjudication involved in the test results. The tests yield objective measurements or pass/fail outcomes based on established quantitative and qualitative criteria defined by the relevant standards.
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
Not applicable. This is a physical medical device (cannulae), not an AI/ML diagnostic or assistive software. No MRMC study was performed.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device. There is no algorithm or standalone software component. The performance tests are on the physical device itself (e.g., how much lesion it creates, its electrical properties).
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The "ground truth" for this submission is based on established international standards and objective physical/chemical measurements. For example:
- Biocompatibility: In vitro (cell culture) and in vivo (animal, though for this device, existing predicate reports were largely leveraged for this category if materials were the same) tests against ISO 10993.
- Electrical Safety: Specific voltage, current, and electromagnetic compatibility thresholds defined by IEC 60601 series.
- Mechanical Testing: Physical properties and dimensional tolerances defined by ISO standards (e.g., tensile strength, dimensional accuracy, luer taper specifications).
- Performance Testing: Empirical measurements, such as lesion size and shape in a tissue model, impedance, and temperature accuracy, for which the established performance of the predicate device acts as a benchmark for "sameness."
8. The Sample Size for the Training Set
Not applicable. This involves a physical medical device, not an AI/ML model that requires a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, there is no AI/ML model or training set.
{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 DriveMarkham, ONL3R 2Z3Canada |
|---|---|
| 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 ModelsDTR 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/PVCMultilayer 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 usingthe 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 |
| MaterialShaft | Stainless Steel 304 | same |
| MaterialShaft Insulation | Polyester | same |
| Biocompatibility | Devices are classified and in compliance with the same ISO 10993standards. | same |
| Compatibility withother devices | Devices are performing identically in conjunction with the sameequipment. | 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 subjectedand passed to the same mechanical testing. | same |
| Sterility | Devices supplied "STERILE" | same |
| Packaging | Device individually packaged and sealed in a single use Tyvek/Polypouch | same |
| Sterilization | Both devices are EtO sterilized | same |
| MaterialTines | "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 < 24hours and tested for compliance to applicable ISO10993 standards. New device is similar in classification and the materials used in construction as a predicate devicetherefore the same – reports are used for Cytotoxicity, Sensitization, Irritation, Systemic toxicity as for a predicate deviceAdditional testing per ISO 10993-7 is performed to evaluate the new device for EtO residuals. | ||
| Test | Test method Summary | Results |
| Cytotoxicity | ISO 10993-5Biological evaluation of medical devices –Part 5:Tests for in vitro cytotoxicity | Passed"Under the conditions of thisstudy, the test article showedno evidence of causing cell lysisor toxicity."(same materials, same report asfor predicate device) |
| Sensitization | ISO 10993-10Biological evaluation of medical devices –Part 10:Tests for irritation and skin sensitization | Passed"The article did not elicit asensitization response under theconditions the of test assay."(same materials, same report asfor predicate device) |
| Irritation | ISO 10993-10Biological evaluation of medical devices –Part 10:Tests for irritation and skin sensitization | Passed"The article considered a non-irritant under the conditions ofthe test assay."(same materials, same report asfor predicate device) |
| Systemic toxicity | ISO 10993-11Biological evaluation of medical devices –Part 11:Tests for systemic toxicity | Passed"The article meets therequirements for the absence ofpyrogens as specified under theconditions 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 60601-1Medical electrical equipmentPart 1: General requirements for basic safety andessential performance | Passed(same as for predicate device) |
| High frequency surgicalequipment | IEC 60601-2-2Medical electrical equipmentPart 2-2: Particular requirements for basic safetyand essential performance of high frequencysurgical equipment and high frequency surgicalaccessories | Passed(same as for predicate device) |
| High frequency surgicalaccessories | IEC 60601-2-2Medical electrical equipmentPart 2-2: Particular requirements for basic safetyand essential performance of high frequencysurgical equipment and high frequency surgicalaccessories | PassedHF Accessory - Leakage current(201.8.8.3.102)HF Accessory - Dielectric Strength(201.8.8.3.103)(201.8.8.3.104) |
| EMC | IEC 60601-1-2Medical electrical equipmentPart 1-2: General requirements for safety -Collateral standard: Electromagnetic compatibility | Passed(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,surface and mechanicalproperties compliance | ISO 9626Stainless steel needle tubing for the manufactureof medical devices | PassCofC |
| Bond force is tested betweenhub/handle, shaft, stylet andtines | ISO 7864Sterile hypodermic needles for single use | PassPull testing with an axial force isapplied in a direction of theseparation of the parts;Hub/Handle - Needle ShaftCap- StyletHub/Handle -Tines ShaftHub/Handle -Tines |
| Needle Geometry | ISO 7864Sterile hypodermic needles for single use | PassTriple bevel tip per drawing |
| The nominal O.D. of needle isidentified by color coding tostandard | ISO 6009Hypodermic needles for single use –Colour coding for identification | PassVisual inspection |
| Male 6% (Luer) conical taper | ISO 594-1Conical fittings with a 6 % (Luer) taper forsyringes, needles and certain other medicalequipment -- Part 1: General requirements | PassGauging(5.1) |
| Female 6 % (Luer) conical lockfittings | ISO 594-2Conical fittings with 6 % (Luer) taper for syringes,needles and certain other medical equipment --Part 2: Lock fittings | PassLiquid 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 | PassMeasured per drawing |
| Anchorage test - cable andconnector | IEC 60601-2-2Medical electrical equipmentPart 2-2: Particular requirements for basic safetyand essential performance of high frequencysurgical equipment and high frequency surgicalaccessories | PassHF Accessory - Connection cableanchorage test(201.8.10.4.2) |
{10}------------------------------------------------
| Performance testingThe new and the predicate device will be used in the same setting and for the same reason. Testing executed on a newdevice and the predicate device, demonstrated similar performance under the same conditions. | ||
|---|---|---|
| Test | Test method Summary | Results |
| Compatibility between probes,cannulae | Verified by dimensional measurements andperformance testing | PassCannulae to probe length matchingImpedance measurementEnergy coupling |
| Temperature accuracy, | Accuracy verified by measurements andperformance testing | PassTemperature couplingTemperature accuracy |
| Lesion | Measured RF Lesion Size in Tissue Model | PassLesion sizeLesion 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
§ 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).