(79 days)
Not Found
Not Found
No
The summary describes a system for disc material coagulation and decompression, and there are no mentions of AI, ML, image processing, or data sets typically associated with AI/ML development or validation.
Yes
The device is used to treat symptomatic patients with contained herniated discs, indicating a therapeutic purpose.
No
The device is indicated for "coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs," which describes a therapeutic/treatment function, not a diagnostic one.
No
The device description refers to a "system" and a "generator," which are typically hardware components, not solely software. The intended use also describes a physical action ("coagulation and decompression of disc material"), further suggesting a hardware-based device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs." This describes a therapeutic procedure performed directly on the patient's body.
- Device Description: The device is described as a "Transdiscal System" used in combination with a "Pain Management Generator-TD." This further indicates a device used for a medical procedure, not for testing samples outside the body.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing diagnostic information based on sample analysis
- Use in a laboratory setting
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to directly treat a condition within the body.
N/A
Intended Use / Indications for Use
The Transdiscal system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs
Product codes
GEI
Device Description
Transdiscal System
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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.
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling an abstract human figure or a bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP. 1 1 2003
Mr. Kris Shah Vice President, Product Development Baylis Medical Company, Inc. 5160 Explorer Drive, Unit 33 Mississauga, Ontario Canada L4W 4T7
Re: K031951
Trade/Device Name: Transdiscal System Regulation Number: 21 CFR 878.4400 Regulation Name: Electrosurgical cutting and coagulation device and accessories Regulatory Class: II Product Code: GEI Dated: June 20, 2003 Received: June 24, 2003
Dear Mr. Shah:
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 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) 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 (301) 594-4659. 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Muriam C. Provost
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
2
510(k) NUMBER (IF KNOWN):
1031951
DEVICE NAME:
Transdiscal System
INDICATIONS FOR USE:
The Transdiscal system, in combination with the Baylis Pain Management Generator-TD (PMG-TD), is indicated for the coagulation and decompression of disc material to treat symptomatic patients with contained herniated discs
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21 CFR 801.109) | X |
|---|---|
| ------------------------------------------ | -------------- |
OR
| Over-The-Counter-Use | |
|---|---|
| ---------------------- | -- |
Miriam C. Provost
(Division Sign-Off) (Division Sign Coral, Restorative and Neurological Devices
510(k) Number K031951