(106 days)
Not Found
No
The 510(k) summary describes a radiofrequency generator for creating lesions and coagulating/decompressing disc material. It mentions a modification for multi-RF mode but does not include any language related to AI, ML, image processing, or data-driven algorithms.
Yes
The device is indicated for use in creating lesions during neurological procedures and for the coagulation and decompression of disc material to treat symptomatic patients, which are therapeutic interventions.
No
The device is described as a "Pain Management Generator" used to "create lesions" and for "coagulation and decompression," indicating a therapeutic function rather than a diagnostic one.
No
The device description explicitly states it is a "generator" and mentions a "Multi-RF cable" and "radiofrequency probes," indicating it is a hardware device that generates and delivers radiofrequency energy.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for creating lesions and coagulating/decompressing disc material within the body during surgical procedures. This is an in vivo (within a living organism) application.
- Device Description: The description reinforces its use in conjunction with probes inserted into the body for radiofrequency procedures.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are specifically designed to perform tests on samples taken from the body, not to directly treat or modify tissues within the body.
N/A
Intended Use / Indications for Use
Baylis Pain Management Generator - TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG-TD is to be used with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.
Product codes (comma separated list FDA assigned to the subject device)
GXD, GEI
Device Description
The Baylis Pain Management Generator - TD is a modification of the previously 510(k) cleared Baylis Pain Management Generator -TD (510(k): K031950). The modification includes the addition of a multi-radiofrequency (Multi-RF) mode to create multiple lesions during neurological lesion procedures. The generator is used with its accessory, the Multi-RF cable that connects 1 to 4 radiofrequency probes to facilitate multiple monopolar RF lesions at a given time.
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)
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
§ 878.4400 Electrosurgical cutting and coagulation device and accessories.
(a)
Identification. An electrosurgical cutting and coagulation device and accessories is a device intended to remove tissue and control bleeding by use of high-frequency electrical current.(b)
Classification. Class II.
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Baylis Pain Management Generator - TD
of 2
Baylis Medical Company Inc.
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
DEC I 9 2007. -
C. Company Phone: (905) 602-4875; ext 252
D. Company Facsimile: (905) 602-5671
E. Contact Person: Meghal Khakhar
F. Summary Prepared on: 31-August-2007
Device Identification
A. Device Trade Name: Baylis Pain Management Generator - TD
B. Device Common Name: Radiofrequency lesion generator
C. Classification Name: Generator; Lesion; Radiofrequency, 21 CFR 882.4400; Electrosurgical cutting and coagulation device and accessories, 21 CFR 878.4400
- D. Device Class: Class II
E. Device Code: GXD, GEI
Identification of Predicate Device
Predicate device is the Baylis Pain Management Generator - TD, which is cleared under 510(k) Premarket Notification Number K031950.
Device Description
The Baylis Pain Management Generator - TD is a modification of the previously 510(k) cleared Baylis Pain Management Generator -TD (510(k): K031950). The modification includes the addition of a multi-radiofrequency (Multi-RF) mode to create multiple lesions during neurological lesion procedures. The generator is used with its accessory, the Multi-RF cable that connects 1 to 4 radiofrequency probes to facilitate multiple monopolar RF lesions at a given time.
1
Baylis Pain Management Generator - TD
Intended Use
Baylis Pain Management Generator - TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs. The Baylis PMG-TD is to be used with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.
Substantial Equivalence
The indications for use of the proposed design of the Baylis Pain Management Generator - TD are identical to the Baylis Pain Management Generator - TD (510(k) #: K031950). The fundamental scientific technology of both these devices is also the same.
2
Image /page/2/Picture/1 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is a stylized design of three human profiles, stacked on top of each other, with flowing lines extending from the top profile.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 9 2007
Baylis Medical Company, Inc. % Meghal Khakhar Regulatory Affairs Manager 2645 Matheson Boulevard East Mississauga, Ontario L4W 5S4 Canada
Re: K072478
Trade/Device Name: Baylis Pain Management Generator - TD Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GEI, GXD Dated: November 26, 2007 Received: November 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, 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 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
3
Page 2 - Meghal Khakhar
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at (240) 276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at (240) 276-3464. 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 vours.
Mark N Millman
- Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name: Baylis Pain Management Generator - TD
Indications for Use:
Baylis Pain Management Generator - TD; Model PMG-115-TD (For Domestic Use) and Model PMG-230-TD (For International Use) is indicated for use to create lesions during neurological lesion procedures, and for the coagulation and decompression of disc material to treat symptomatic patients with contained discs. The Baylis PMG-TD is to be used with separately approved probes such as Baylis TransDiscal Probe, Oratec Spinecath™ and Baylis Pain Management Probes.
Prescription Use X (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 Division C and New
S(unk) Number