(28 days)
Not Found
No
The summary describes a physical probe used for delivering RF energy and does not mention any software, algorithms, or data processing that would indicate AI/ML.
Yes.
The device is used for pain management by creating radiofrequency lesions, which is a therapeutic intervention.
No
The device is described as creating radiofrequency lesions, which indicates a therapeutic rather than a diagnostic function.
No
The device description explicitly states it is a "sterile, single use device that delivers Radio Frequency (RF) energy while being cooled," indicating it is a physical 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 to create radiofrequency lesions in nervous tissue. This is a therapeutic procedure performed directly on the patient's body.
- Device Description: The device delivers RF energy and is cooled, which are characteristics of a device used for a therapeutic intervention, not for testing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is to directly treat tissue within the body.
N/A
Intended Use / Indications for Use
Baylis Pain Management Cooled Probe will be used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
Product codes
GXI
Device Description
The Baylis Pain Management Cooled Probe is a sterile, single use device that delivers Radio Frequency (RF) energy while being cooled.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
nervous tissue
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4725 Radiofrequency lesion probe.
(a)
Identification. A radiofrequency lesion probe is a device connected to a radiofrequency (RF) lesion generator to deliver the RF energy to the site within the nervous system where a lesion is desired.(b)
Classification. Class II (performance standards).
0
1. 510(k) Summary
Submitter Information
A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2580 Matheson Blvd. E. Mississauga, Ontario L4W 4J1 Canada
- C. Company Phone: (905) 602-4875; ext 252
- D. Company Facsimile: (905) 602-5671
- E. Contact Person: Meghal Khakhar
- F. Summary Prepared on: October 26. 2005
Device Identification
- A. Device Trade Name: Baylis Pain Management Cooled Probe
- B. Device Common Name: RF Probe
- C. Classification Name: Probe, Radiofrequency lesion. 21 CFR 882.4725
- D. Device Class: Class II
- E. Device Code: GXI
Identification of Predicate Device
Predicate device is the Baylis Pain Management Probe, which is cleared under 510(k) Premarket Notification Number K002389.
Device Description
The Baylis Pain Management Cooled Probe is a sterile, single use device that delivers Radio Frequency (RF) energy while being cooled.
Intended Use
Baylis Pain Management Cooled Probe will be used in conjunction with a Radiofrequency Generator to create radiofrequency lesions in nervous tissue.
1
Baylis Pain Management Cooled Probe
Baylis Medical Company Inc.
K053082
Substantial Equivalence
53082
Page 2 of 2
The indications for use and intended use of the Baylis Pain Management Cooled Probe are identical to the Baylis Pain Management Probe. Both the probes in conjunction with the Radio Frequency Generator are used to create radiofrequency lesions in nervous tissue. The fundamental scientific technology of both these devices is also the same.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The caduceus is rendered in black, and the text is also in black.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 3 0 2005
Meghal Khakhar, MBBS, CerRAP, RAC Regulatory Affairs Manager Baylis Medical Company, Inc. 2580 Matheson Boulevard E. Mississauga, Ontario L4W 4JI Canada
Re: K053082
Trade/Device Name: Baylis Pain Management Cooled Probe Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: October 26, 2005 Received: November 2, 2005
Dear Dr. Khakhar:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roved your beeermined 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 conniner of the ritas 20, 1977, 1977, 1977, 1977, 1997, 1999, 1999, 1999, 1999, 1999, 1999, 1999, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). and Coometer For (110) and the device, subject to the general controls provisions of the Act. The r ou may, arove, mans of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device to such additional controls. Existing major regulations affecting your device can may be babyeet to Sater as 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 r lease of acrised a determination that your device complies with other requirements of the Act that I Dr has intatutes and regulations administered by other Federal agencies. You must or any I odota bithe Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OFF in the quality systems (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
3
Page 2- Meghal Khakhar, MBBS, CerRAP, RAC
This letter will allow you to begin marketing your device as described in your Section 510(k) This lotter will anow you to begin mating of substantial equivalence of your device to a legally premarket notification: "The Pressification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please If you dosire specific darroliance at (240) 276-0115. Also, please note the regulation entitled, Connact the Office of Court to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general mornational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
ковава Виенит
for
Mark N. Melkerson Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
053082
510(k) Number (if known):
Device Name: Baylis Pain Management Cooled Probe
Indications For Use:
Baylis Pain management Cooled Probe will be used in conjunction with a Daylis Fair managomont Cooreate radiofrequency lesions in nervous tissue.
Prescription Use X_
Over-The-Counter Use AND/OR
Over the counter or
(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)
harbare Bneun
Division of General, Restorative, and Neurological Devices
Page 1 of _________________
510(k) Number K053082