(350 days)
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Not Found
No
The summary does not mention AI, ML, or any related concepts like image processing or training/test sets, which are typically associated with AI/ML medical devices. The device description is for a simple RF cannula.
Yes
The device is intended for "relief of pain" through a medical procedure, which is a therapeutic purpose.
No
The description states the device is "intended for use in radio-frequency (RF) Heat lesion procedures for relief of pain," which is a treatment, not a diagnostic purpose.
No
The 510(k) summary describes a "BMC RF Cannula," which is a physical medical device used in radio-frequency procedures. There is no mention of software as the primary or sole component.
Based on the provided information, the BMC RF Cannula is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "radio-frequency (RF) Heat lesion procedures for relief of pain." This describes a therapeutic procedure performed directly on a patient's body, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Device Description: The description is simply "BMC RF Cannula," which aligns with a surgical or procedural tool.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Mentioning reagents, assays, or laboratory procedures
Therefore, the BMC RF Cannula is a medical device used in a therapeutic procedure, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BMC RF Cannula is intended for use in radio-frequency (RF) Heat lesion procedures for relief of pain.
Product codes
GXI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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 Department of Health & Human Services USA. The logo is a circular seal with the words "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 7 1998
Mr. Kris Shah · Vice President Product Development Baylis Medical Company, Inc. 5160 Explorer Drive, Unit 5 Mississauga, Ontario Canada L4W 4T7
Re: K972846/S2 Trade Name: BMC RF Cannula Regulatory Class: II Product Code: GXI Dated: June 9, 1998 Received: June 15, 1998
Dear Mr. Shah:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 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.
1
Page 2 - Mr. Kris Shah
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Salie M. Wittwer, PhD, MD
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Page
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name: BMC RF Cannula
Indications For Use:
The BMC RF Cannula is intended for use in radio-frequency
(RF) Heat lesion procedures for relief of pain.
(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 Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K972046
Prescription Use
(Per 21 CFR 801.109)
ામ
Over-Tne-Counter Use يي
(Optional Formal 1-2-96)