(220 days)
Not Found
Not Found
No
The provided text describes a radiofrequency generator for tissue coagulation and does not mention any AI or ML components or functionalities.
Yes
The device is intended for "coagulation of soft tissues" and lists several medical applications like "Facette Denervation" and "Trigeminus Neuralgia," which are therapeutic interventions.
No
Explanation: The device is described as a radiofrequency (RF) generator intended for the coagulation of soft tissues in various surgical applications. Its purpose is therapeutic (to treat by coagulation), not to diagnose a condition.
No
The device description explicitly states it is a "RF Generator" and is used "in combination with the Stryker RF Electrodes and Cannulae," indicating it is a hardware device that generates radiofrequency energy and uses physical electrodes and cannulae for treatment.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Stryker Interventional Pain RF Generator is used for the coagulation of soft tissues within the body during surgical procedures. It directly interacts with the patient's tissues.
The intended use and device description clearly indicate that this is a device used for surgical intervention on the patient, not for testing samples from the patient.
N/A
Intended Use / Indications for Use
The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coagulation of soft tissues in orthopedic, arthroscopic, spinal, and neurosurgical applications. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral Neuralgia, and Rhizotomy.
Product codes
GXD
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
soft tissues (in orthopedic, arthroscopic, spinal, and neurosurgical applications)
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
§ 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/0 description: The image shows the logo for Valley Forge Scientific. The logo consists of a stylized "V" shape at the top, followed by the words "VALLEY FORGE" in a bold, sans-serif font. Below that, the word "SCIENTIFIC" is written in a smaller, sans-serif font. The logo has a textured, slightly distressed appearance.
K032601 1/1
APR = 1 2004
Device Name:
| Trade Name: | Stryker Interventional Pain RF Generator |
|---|---|
| Common Name: | Electrosurgical generator |
| Classification Name: | Generator, Lesion, RF : 21 CFR 882.4400, GXD |
Device Sponsor:
Manufacturer:
Valley Forge Scientific 136 Green Tree Rd. P.O. Box 1179 Oaks, PA 2521567
Requiatory Class: Class II
Summary of Safety and Effectiveness:
The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, is intended for coaqulation of soft tissues in orthroscopic, spinal, and neurosurgical applications. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, and Rhizotomy.
The Stryker Interventional Pain RF Generator is equivalent in intended use, safety, and effectiveness to existing devices being marketed by Oratec, Radionics, Baylis, NeuroTherm, and Arthrocare.
The Stryker interventional Pain RF Generator does not raise any new safety and efficacy concerns when compared to similar devices already legally marketed. Therefore, the Stryker Interventional Pain RF Generator is substantially equivalent to these existing devices.
By: Jerry Malls President, CE
Dated: 3.31.04
Simply the finest energy source available for surgerym
1
Image /page/1/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 words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread, rendered in a simple, abstract design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR = 1 2004
Mr. Jerry Malis President Valley Forge Scientific Corp. 136 Green Tree Road. Suite 100 Oaks, Pennsylvania 19456
Re: K032601
Trade/Device Name: Stryker Interventional Pain RF Generator Regulation Number: 21 CFR 882.4400 Regulation Name: Radiofrequency lesion generator Regulatory Class: II Product Code: GXD Dated: January 30, 2004 Received: February 3, 2004
Dear Mr. Malis:
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.
2
Page 2 - Mr. Jerry Malis
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
3
Image /page/3/Picture/0 description: The image shows the logo for Valley Forge Scientific. The logo consists of a stylized "V" shape with a circle in the middle, above the words "VALLEY FORGE" in a blocky font. Below that, the word "SCIENTIFIC" is written in a smaller, similar font.
Indications for Use
| 510(k) Number: | K032601 |
|---|---|
| Device Name: | Stryker Interventional Pain RF Generator |
| Indications For Use: | The Stryker Interventional Pain RF Generator, in combination with the Stryker RF Electrodes and Cannulae, |
arthroscopic, spinal, and neurosurgical applications. Examples include, but are not limited to, Facette Denervation, Percutaneous Chordotomy/Dorsal Root Entry Zone (DREZ) Lesion, Trigeminus Neuralgia, Peripheral
is intended for coagulation of soft tissues in orthopedic,
| Prescription Use | X |
|---|---|
| ------------------ | ----------------------------------------- |
AND/OR
Neuralgia, and Rhizotomy.
Over-The- Counter Use
(Per 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thurman C. Provost
District Clerk
(Division Sign-Off) Division of General, Restorative. and Neurological Devices
510(k) Number K632601
Simply the finest energy source available for surgery
Page 1 nf 136 Green Tree Road Suite 100 P.O. Sox 1179 Oaks, PA 19456 PHONE 610-666-7500 FAX 610-666 7565