(28 days)
Not Found
Not Found
No
The provided text does not contain any mention of AI, ML, or related concepts. The device description and performance study sections are also missing, which would be the most likely places to find such information.
Yes
The device is indicated for medical purposes such as pain relief, muscle spasm relaxation, prevention of disuse atrophy, increasing blood flow, muscle re-education, preventing venous thrombosis, and maintaining or increasing range of motion, which are all therapeutic applications.
No
The provided text describes the indications for use of the device, which are all related to therapeutic applications (pain relief, muscle relaxation, muscle re-education, etc.). None of the listed indications involve diagnosing a condition or disease.
Unknown
The provided text only includes the intended use/indications for use. Without a device description, it is impossible to determine if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVDs are used to examine specimens from the human body. The intended uses listed for this device (pain relief, muscle relaxation, blood flow increase, etc.) are all related to applying electrical stimulation directly to the body for therapeutic purposes.
- The description does not mention any analysis of biological samples. There is no mention of blood, urine, tissue, or any other specimen being collected or analyzed by this device.
- The device description is "Not Found," but the intended uses clearly point to a device that interacts with the body externally, not internally with biological samples.
Therefore, this device appears to be a therapeutic electrical stimulator, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The indications for use are:
-
- Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (TNS Mode);
-
- Relaxation of muscle spasm (Interferential Mode);
-
- Prevention or retardation of disuse atrophy (Interferential Mode);
-
- Increasing local blood flow (Interferential Mode);
-
- Muscle re-education (Interferential Mode);
-
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis (Interferential Mode); and
-
- Maintaining or increasing range of motion (Interferential Mode).
Product codes
IPF, GZJ, LIH
Device Description
Metron Vectorsurge 5 Model VS-470
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)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services. The seal features the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" in a circular pattern around the top half of the seal. In the center of the seal is a stylized image of an eagle.
OCT 1 6 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. David Toman Technical Director Metron Medical Australia Pty. Ltd. 57 Aster Avenue P.O. Box 2164 Carrum Downs Victoria, Australia 3201
Re: K030648
Trade/Device Name: Vectorsurge 5 Model VS 470 Regulation Numbers: 21 CFR 890.5850, 21 CFR 882.5890 Regulation Names: Powered muscle stimulator, Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: Class II
Product Codes: IPF, GZJ, LIH Dated: February 25, 2003 Received: February 28, 2003
Dear Mr. Toman:
This letter corrects our substantially equivalent letter of March 28, 2003.
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 (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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In
1
Page 2 -- Mr. David Toman
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.
This letter will allow you to continue 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 (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
barbarefmeim
Mark N. Melkerson 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):
K 030648
DEVICE NAME:
Metron Vectorsurge 5 Model VS-470
INDICATIONS FOR USE:
The indications for use are:
-
- . Relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain (TNS Mode);
- Relaxation of muscle spasm (Interferential Mode); 2.
- ന് Prevention or retardation of disuse atrophy (Interferential Mode);
-
- Increasing local blood flow (Interferential Mode);
-
- Muscle re-education (Interferential Mode);
- Immediate post-surgical stimulation of calf muscles to prevent ে venous thrombosis (Interferential Mode); and
-
- Maintaining or increasing range of motion (Interferential Mode).
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use | X |
|---|---|
| (Per 21 CFR 801.109) |
OR
| Over-The-Counter-Use | _________________ |
|---|---|
| (Optional Format 1-2-96) |
Barbara Michto
(Division Sign-Off)
Division of General, Restorative,
and Neurological Devices
| 510(k) Number | K030648 |
|---|---|
| --------------- | ------------------------------------------------------- |