(22 days)
Not Found
No
The summary describes a radiofrequency probe for creating lesions, with no mention of AI or ML in the intended use, device description, or specific sections for AI/ML details.
Yes
The device is used to create radiofrequency lesions in nervous tissue for pain management, which is a therapeutic intervention.
No
Explanation: The device creates radiofrequency lesions in nervous tissue, which is a therapeutic action, not a diagnostic one. It is used in conjunction with a generator for pain management, indicating a treatment purpose.
No
The device description explicitly states it is a "single-use device that delivers Radiofrequency (RF) energy," indicating it is a physical hardware component, 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 Radiofrequency (RF) energy." This is a form of energy delivery for treatment, not for analyzing samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological 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 Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.
Product codes (comma separated list FDA assigned to the subject device)
GXI
Device Description
The Baylis Pain Management Single-Use Probe is a sterile, single-use device that delivers Radiofrequency (RF) energy.
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
Prescription Use
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): 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
$\frac{K071745}{1. 510(k) Summary}$
Submitter Information
A. Company Name: Baylis Medical Company Inc.
B. Company Address: 2645 Matheson Blvd. East Mississauga, Ontario L4W 5S4 Canada
C. Company Phone: (905) 602-4875; ext 252
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: 22-June-2007
Device Identification
A. Device Trade Name: Baylis Pain Management Single-Use Probe
B. Device Common Name: Radiofrequency lesion 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 Single-Use Probe is a sterile, single-use device that delivers Radiofrequency (RF) energy.
Intended Use
The Baylis Pain Management Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.
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JUL 1 9 2007
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Substantial Equivalence
Baylis Medical Company Inc.
ge 2 g②
The indications for use of the Baylis Pain Management Single-Use Probe are identical to the Baylis Pain Management Probe. Both the probes in conjunction with the Radiofrequency Generator are used to create radiofrequency lesions in nervous tissue. The fundamental scientific technology of both these devices is also the same.
KO 7194
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 9 2007
Baylis Medical Company, Inc. % Meghal Khakhar, MBBS, CerRAP, RAC Regulatory Affairs Manager 2645 Matheson Boulevard East Mississauga Ontario, Canada L4W 5S4
Re: K071745
Trade/Device Name: Baylis Pain Management Single-Use Probe Regulation Number: 21 CFR 882.4725 Regulation Name: Radiofrequency lesion probe Regulatory Class: II Product Code: GXI Dated: June 22, 2007 Received: June 27, 2007
Dear Meghal Khakhar:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 Part 807); labeling (21 CFR Part 801); 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.
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) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Mark N. Melkerson
Director
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
KO 7/745
510(k) Number (if known):
Device Name: Baylis Pain Management Single-Use Probe
Indications For Use:
Baylis Pain Management Single-Use Probe will be used in conjunction with a Baylis Pain Management Connector Cable and the Baylis Pain Management Generator to create radiofrequency lesions in nervous tissue.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices
Page 1 of 1
510(k) Number L071745