(200 days)
Not Found
No
The description focuses on the physical construction, materials, and intended use of a needle/cannula for nerve blocks and radiofrequency lesioning. There is no mention of AI or ML in the device description, intended use, or performance studies. The device relies on electrostimulation, contrast medium with radiography, and RF energy delivery, not data-driven algorithms.
Yes
The device is used for percutaneous nerve blocks with local anesthetic solution or for radiofrequency lesioning, which are therapeutic interventions.
Yes
Explanation: The device is used to localize a nerve using electrostimulation or by injecting contrast medium with radiography, which are diagnostic procedures to identify the target for further therapeutic interventions (nerve blocks or radiofrequency lesioning).
No
The device description clearly details physical components like needles, hubs, handles, cables, and a thermocouple probe, indicating it is a hardware device, not software-only.
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 to treat or diagnose a condition.
- Mechanism of Action: The device works by delivering local anesthetic or radiofrequency energy to nerve tissue. It also facilitates nerve localization through electrostimulation or contrast injection and radiography. These are all direct interventions on the patient.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (such as blood, urine, or tissue) to detect diseases, conditions, or infections. This device does not perform such tests on samples.
The device is a surgical/interventional tool used in vivo (within the living body), not in vitro (in glass/outside 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 16Ga Cannulae models 466, DHC are identical in construction, materials, energy source and intended use to predicate devices. They are single use disposable devices to be used with the Diros OWL RF Generators.
The 466 series 16Ga cannula 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 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.
The DHC series 16Ga cannula 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 handle. 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
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)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing:
- Cytotoxicity (same materials, same report as for predicate device)
- Sensitization (same materials, same report as for predicate device)
- Irritation (same materials, same report as for predicate device)
- Systemic toxicity (same materials, same report as for predicate device)
- Pyrogen Testing
Electrical safety and electromagnetic compatibility (EMC):
- Electrical safety and High Frequency testing
- EMC (Emissions and Immunity) testing is the same as for predicate device
Note: Cannulae are the same length as were tested. All cables and generators used in test are identical to those indicated
Mechanical testing:
- ISO 9626 Stainless steel needle tubing for the manufacture of medical devices
- ISO 7864 Bond force is tested between hub/handle and shaft
- ISO 6009 The nominal O.D. of needle is identified by color coding to standard
- ISO 7864 Needle Geometry
- ISO 594-1 Male 6% (Luer) conical taper
- ISO 594-2 Female 6 % (Luer) conical lock fittings
- ISO 594-1 Separation force is tested between conical fitting assembly
- Dimensional Testing
- Anchorage test cable and connector
Performance testing:
- Compatibility between probes, cannulae is verified by measurements and performance testing
- Temperature accuracy, Accuracy verified by measurements and performance testing
- Measured RF Lesion Size in Tissue Model
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 diameter of the cannulae increasing from (the largest) 18Ga to 16Ga. Testing has demonstrated identical performance between the new Diros and predicate Diros devices with a single exception of the size of the lesion created. The larger lesion is a completely expected result, because the new devices are larger in diameter and intended to create respectively larger lesions. The lesion size of the new devices should be identical to marketed by Cosman Medical (used as predicate device in this submission) for the following reasons:
- Identical diameter of active tip - 16Ga
- Identical length of active tips - 6mm or 10mm
- Identical energy type - RF energy
- Identical intended use
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.
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is an emblem featuring a stylized caduceus, which is a symbol often associated with healthcare and medicine. The caduceus is depicted with a staff entwined by two snakes and topped with wings.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 30, 2014
Diros Technology, Inc. George Darmos President 120 Gibson Drive Markham, ON L3R 2Z3 Canada
Re: K141586
Trade/Device Name: Diros OWL Sterile Single Use R.F. Insulated Cannulae, Models 466 and DHC Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency Lesion Probe Regulatory Class: Class II Product Code: GXI Dated: November 28, 2014 Received: December 1, 2014
Dear George 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
1
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 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 -SFD/△
Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K141586
Device Name
Diros OWL Single Use 16 Gauge Disposable Cannulae (466, DHC)
Indications for Use (Describe)
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.
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) |
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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: | February 10, 2015 |
DEVICE IDENTIFICATION
| Trade/Proprietary Name: | Diros OWL Sterile Single Use R.F. Insulated Cannulae |
|---|---|
| Model: | 466 and DHC |
| 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: Cosman 16Ga Cannula: K102566 K060799
PRIOR SUBMISSION
There was no prior submission for the Diros OWL Sterile Single Use Disposable 16Ga Cannulae models 466, DHC.
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DEVICE DESCRIPTION
The Diros OWL Sterile Single Use Disposable 16Ga Cannulae models 466, DHC are identical in construction, materials, energy source and intended use to predicate devices. They are single use disposable devices to be used with the Diros OWL RF Generators.
The 466 series 16Ga cannula 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 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.
Image /page/4/Figure/3 description: The image shows three different views of a medical device. The top view shows the device with a stylet and protection tube. The middle view shows the hub, insulated needle shaft, and active tip. The bottom view shows the cap, stylet, and protection tube.
The DHC series 16Ga cannula 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 handle. 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/4/Figure/5 description: This image shows a device with a protection tube. The device has several labeled parts, including a cable, connector, injection port, handle, insulated needle shaft, and active tip. There is also a protection tube shown below the device.
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MATERIALS
| Component | Material | Body Contact (Y/N) |
|---|---|---|
| Shaft | 304 Stainless Steel | Y |
| Insulation | Polyester | Y |
| Hub | Polycarbonate | Indirect through injected fluid |
| Adhesive | UV Adhesive | N |
| Protection tube | LDPE | N |
Materials used in 466 series devices
Materials used in DHC series devices
| Component | Material | Body Contact (Y/N) |
|---|---|---|
| Shaft | 304 Stainless Steel | Y |
| Insulation | Polyester | Y |
| Handle | Polycarbonate | Indirect through injected fluid |
| Adhesive | UV Adhesive | N |
| Cable | Silicone | N |
| Connector | Nylon | N |
| Thermocouple | Copper/Constantan | N |
| Injection Port | Tubing: Vinyl | Indirect through injected fluid |
| Cap: PEBD | ||
| Female Luer: PVC | ||
| 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 466 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 tip of 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 DHC series cannulae consist of a sharp insulated needle with partially uninsulated part of the shaft near the tip. The tip of the DHC 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 DHC series devices have the built in probes. The injection port of the device is used to administer the injections when it is required.
6
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.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICES
The 16G cannulae 466 and DHC series that are included in this submission are identical to predicate devices in the following aspects listed in the table below:
The technological principle for the subject and the predicate devices is identical. Both devices are using the conductive metal shaft to deliver the RF energy to target tissue. Both devices are creating the lesion only in the tissue surrounding the bare tip (uninsulated part) of the device. The size of the lesion is ruled by the size of the bare tip, temperature and the duration of the procedure.
Technological elements that are the same between the subject and the predicate devices;
- Indications for use
- Where used
- " Energy used
- · Design features
- Performance
- Standards applicable
- Materials used
- · Biocompatibility
- Compatibility with other devices
- · Sterility
- Electrical safety
- Mechanical safety
Technological elements that are different between the subject and the predicate devices;
- The 16Ga cannulae included in this submission are larger gauge cannula that extends the range of cannula cleared in K102566 (18Ga-22Ga). In addition, equivalent 16Ga cannula are currently marketed by Cosman Medical and cleared under K060799.
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SUMMARY OF NONCLINICAL TESTING (PERFORMANCE DATA)
The following performance data were provided in support of the substantial equivalence determination.
Biocompatibility testing
- Cytotoxicity (same materials, same report as for predicate device) o
- Sensitization (same materials, same report as for predicate device) O
- Irritation (same materials, same report as for predicate device) O
- Systemic toxicity (same materials, same report as for predicate device) o
- Pyrogen Testing O
Electrical safety and electromagnetic compatibility (EMC)
- Electrical safety and High Frequency testing;
■ EMC (Emissions and Immunity) testing is the same as for predicate device Note: Cannulae are the same length as were tested. All cables and qenerators used in test are identical to those indicated
Mechanical testing
- · Mechanical testing is provided in the testing;
- o ISO 9626 Stainless steel needle tubing for the manufacture of medical devices
- o ISO 7864 Bond force is tested between hub/handle and shaft
- ISO 6009 The nominal O.D. of needle is identified by color coding to standard O
- ISO 7864 Needle Geometry O
- ISO 594-1 Male 6% (Luer) conical taper O
- ISO 594-2 Female 6 % (Luer) conical lock fittings O
- ISO 594-1 Separation force is tested between conical fitting assembly O
- Dimensional Testing O
- Anchorage test cable and connector O
Performance testing
· Performance testing;
- o Compatibility between probes, cannulae is verified by measurements and performance testing
- Temperature accuracy, Accuracy verified by measurements and performance O testing
- Measured RF Lesion Size in Tissue Model o
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 diameter of the cannulae increasing from (the largest) 18Ga to 16Ga. Testing has demonstrated identical performance between the new Diros and predicate Diros devices with a single exception
8
of the size of the lesion created. The larger lesion is a completely expected result, because the new devices are larger in diameter and intended to create respectively larger lesions. The lesion size of the new devices should be identical to marketed by Cosman Medical (used as predicate device in this submission) for the following reasons:
Identical diameter of active tip - 16Ga Identical length of active tips - 6mm or 10mm Identical energy type - RF energy Identical intended use
CONCLUSIONS
The predicate devices were cleared based on the results of non-clinical data. Subject and predicate device performance data were compared to support the safety of the subject devices and demonstrate that the Diros OWL 16Ga Model 466 and DHC Cannulae should perform as intended in the specified use conditions.