(64 days)
Not Found
No
The summary describes a modification to a previously cleared device, focusing on changes from reusable to single-use and the type of temperature sensor. There is no mention of AI or ML in the intended use, device description, or performance studies.
Yes
The device is intended for "relief of pain" through "Radio-Frequency Heat Lesion procedures," which is a treatment for a medical condition.
No
The device is described as a probe/sensor for Radio-Frequency Heat Lesion procedures for relief of pain. This indicates it is used for therapeutic purposes (pain relief through lesioning), not for diagnosing a condition.
No
The device description explicitly states it is a "Sterile Single Use Disposable R.F. Probe/Temperature Sensor," which are physical hardware components used in a medical procedure.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for use in Radio-Frequency Heat Lesion procedures for relief of pain." This describes a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient to diagnose a condition.
- Device Description: The device is a "R.F. Probe/Temperature Sensor" used in a medical procedure. This is consistent with a device used for treatment, not diagnosis.
- Lack of IVD Characteristics: The description does not mention analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device's function is to deliver radio-frequency heat for pain relief, which is a therapeutic action.
N/A
Intended Use / Indications for Use
The OWL Sterile Single use R.F. Probe is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.
The OWL Sterile Single Use Disposable R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.
Product codes (comma separated list FDA assigned to the subject device)
GXI
Device Description
The Diros OWL RF Probe/Temperature Sensor is a modification of the previously 510(k) cleared OWL Reusable RF Probes. The modification includes the change of the device from reusable to sterile and single use as well as the option to include a thermocouple in place of a thermistor for temperature measurement.
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)
Comparison testing has been done between the cleared reusable probes and the disposable probes.
Key results:
- Intended use is identical with the exception of single use characteristic.
- Diameter: 25AWG and 27 AWG for disposable probes vs 25AWG for reusable probes.
- Lengths Available: 65.8mm (5cm), 116.5mm (10cm), 161mm (15cm), 194mm (20cm) for disposable probes vs 65.8mm (5cm), 116.5mm (10cm), 161mm (15cm) for reusable probes. Length of probe is determined by length of cannula to ensure probe measures temperature at lesion site.
- Temperature measurement devices: Thermistor and Thermocouple for disposable probes vs Thermistor only for reusable probes. Temperature accuracy of thermocouple has been demonstrated through comparison testing with predicate to be as accurate as Thermistor type.
- Single Use: Yes for disposable vs Reusable for reusable. Single use characteristic does not affect safety and efficacy. Sterilization and packaging validation confirm that single use device can be used safely out of package.
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
KIIOS93
MAY - 5 2011
Special 510(k) SUMMARY
Submitter Information
| Company Name:
Company Address: | Diros Technology Inc.
232 Hood Road
Markham, ON
L3R 3K8 |
|-----------------------------------|------------------------------------------------------------------|
| Company Phone: | (905) 415-3440 |
| Company Fax: | (905) 415-0667 |
| Contact Person: | George Darmos, President |
| Device Identification | |
| Trade/Proprietary Name: | OWL Sterile Single Use RF Probes |
|---|---|
| Classification: | II |
| Classification Name: | Probe, Radiofrequency Lesion |
| Product Code: | GXI |
| Regulation Number: | 882.4725 |
Devices to which Submitted device is a modification
OWL Reusable RF Probes:
Device Description
The Diros OWL RF Probe/Temperature Sensor is a modification of the previously 510(k) cleared OWL Reusable RF Probes. The modification includes the change of the device from reusable to sterile and single use as well as the option to include a thermocouple in place of a thermistor for temperature measurement.
Intended Use
The OWL Sterile Single use R.F. Probe is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.
Substantial Equivalence
The OWL Single Use RF Probes consist of a set of temperature measurement probes at different lengths. These probes can be inserted in RF cannulae to measure the temperature at the point of RF delivery. The probes are modifications to the set of
1
reusable Diros probes approved in K010202, and any differences between the two probe sets do not affect safety or efficacy.
To demonstrate substantial equivalence, dimensional comparison, and comparison testing has been done between the cleared reusable probes and the disposable probes. Table 1 below compares the Diros single use probes to the reusable probes.
| Characteristic | Diros Disposable
Probes | Diros Reusable Probes
K010202 | Comments |
|-----------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The OWL Sterile Single
use R.F.
Probe/Temperature
Sensor
is intended for use in
Radio-Frequency Heat
Lesionprocedures for
relief of pain. | The OWL R.F.
Probe/Temperature Sensor
is intended for use in
Radio-Frequency Heat
Lesion
procedures for relief of
pain. | Intended use is identical
with the exception of
single use characteristic
discussed below. |
| Diameter | 25AWG and 27 AWG | 25AWG | - |
| Lengths Available
(Cannulae length
to be used with) | 65.8mm (5cm)
116.5mm (10cm)
161mm (15cm)
194mm (20cm) | 65.8mm (5cm)
116.5mm (10cm)
161mm (15cm) | Length of probe is
determined by length of
cannula to ensure probe
measures temperature at
lesion site. |
| Temperature
measurement
devices available | Thermistor
Thermocouple | Thermistor only | Temperature accuracy of
thermocouple has been
demonstrated through
comparison testing with
predicate to be as accurate
as Thermistor type and is
provided in section 18
(Bench Testing) |
| Single Use | Yes | Reusable | Single use characteristic
does not affect safety and
efficacy. Sterilization and
packaging validation
confirm that single use
device can be used safely
out of package. |
CONCLUSIONS
The differences between the OWL Reusable RF Probes and OWL Disposable RF Probes do not affected the intended use or performance characteristics, and do not raise new questions of safety and effectiveness.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
MAY - 5 2011
Diros Technology Inc. c/o Mr. George Darmos President 232 Hood Road Markham, Ontario L3R3K8, Canada
Re: K110593
Trade/Device Name: Diros OWL Single Use Disposable RF Probes/Temperature Sensors (D466, D467) Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: Class II Product Code: GXI Dated: April 6, 2011 Received: April 7, 2011
Dear Mr. Darmos:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug. and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration. Iisting 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.
3
Page 2 – Mr. George Darmos
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 Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/industry/default.htm.
...
Sincerely vours.
Sincerely yours,
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Statement
510(k) Number (if known):
Device Name: Diros OWL Single Use Disposable RF Probes/Temperature Sensors (D466, D467)
Indications for Use:
The OWL Sterile Single Use Disposable R.F. Probe/Temperature Sensor is intended for use in Radio-Frequency Heat Lesion procedures for relief of pain.
Prescription Use _____________________________ AND/OR Over-The-Counter Use _ (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
J.B.
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number K110593
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