(88 days)
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Not Found
No
The 510(k) summary describes a pain management generator used for creating lesions, and there is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is indicated for use "to create lesions during neurological lesion procedures," which implies a direct medical intervention for treatment purposes.
No
The device is indicated for use to create lesions during neurological lesion procedures, which is a therapeutic rather than a diagnostic function.
No
The device is described as a "Pain Management Generator" and mentions "lesion/temperature probes," which are hardware components. The description does not indicate it is solely software.
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 lesions during neurological lesion procedures." This describes a therapeutic procedure performed directly on a patient, not a test performed on a sample taken from a patient.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's condition
- Using reagents or assays
The device is a therapeutic device used in a medical procedure.
N/A
Intended Use / Indications for Use
Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.
Product codes
GEI, GXD
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
Prescription Use (Per 21 CFR 801.109)
Description of the training set, sample size, data source, and annotation protocol
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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)
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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).
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§ 882.4400 Radiofrequency lesion generator.
(a)
Identification. A radiofrequency lesion generator is a device used to produce lesions in the nervous system or other tissue by the direct application of radiofrequency currents to selected sites.(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 circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half. Inside the circle is a stylized image of an eagle with three lines representing its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kris Shah Vice President, Product Development Baylis Medical Company, Inc. 5160 Explorer Drive, Unit 33 Mississauga, Ontario, Canada L4W 4T7
Re: K020354
Trade/Device Name: Bayliss Pain Management Generator Model PMG - 115 (For Domestic Use) Model PMG - 230 (For International Use)
Regulation Number: 878.4400, 882.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Radiofrequency lesion generator
MAY 0 3 2002
Regulatory Class: II Product Code: GEI, GXD Dated: January 28, 2002 Received: February 4, 2002
Dear Mr. Shah:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreated of the enactment date of the Medical Device American Device American D commerce prior to they 2011-03-11 accordance with the provisions of the Federal Food, DNI, a devices that mave ocen require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The I va may, dierelore, mains of the Act include requirements for annual registration, listing of general other is provision 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 rr your device 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 r louse of actived that I termination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I vith 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.
1
Page 2 – Mr. Kris Shah
This letter will allow you to begin marketing your device as described in your Section 510(k) rms lower will and hy a the FDA finding of substantial equivalence of your device to a legally prestitution of a lovice 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
for Celia M. Witten, Ph.D., M.D.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) NUMBER (IF KNOWN):
K020354 ______________________________________________________________________________________________________________________________________________________________________
DEVICE NAME:
Baylis Pain Management Generator PMG - 115 (For Domestic Use) Model: PMG - 230 (For International Use)
INDICATIONS FOR USE:
Baylis Pain Management Generator; Model PMG-115 (For Domestic Use) and Model PMG-230 (For International Use) is indicated for use to create lesions during neurological lesion procedures. The Baylis PMG is to be used with separately approved lesion/temperature probes such as Baylis Pain Management Probes and Oratec Spinecath™.
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| Prescription Use | |
| (Per 21 CFR 801.109) | OR |
| Over-The-Counter-Use _______ |
| Miriam C. Provost |
|---|
| (Division Sign-Off) |
| Division of General, Restorative |
| and Neurological Devices |
| 510(k) Number | K020354 |
|---|---|
| --------------- | --------- |