(181 days)
No
The description focuses on traditional TENS technology and waveform generation, with no mention of AI or ML terms or functionalities.
Yes
The device is indicated for the "symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain," which are therapeutic applications.
No
Explanation: The device is described as a TENS (Transcutaneous Electrical Nerve Stimulation) device intended for "symptomatic relief and management of chronic, intractable pain" and "adjunctive treatment for post-surgical and post-trauma acute pain." This indicates a therapeutic, not a diagnostic, purpose. There is no mention of it being used to detect, identify, or monitor a medical condition.
No
The device description clearly states it is a "tetrad channel traditional TENS device" powered by an AC adaptor and requires lead wires and electrodes, indicating it is a hardware device with electrical components.
Based on the provided information, the Rainbow® GT-4A machine is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is described as a TENS (Transcutaneous Electrical Nerve Stimulation) device, which is a type of medical device used for pain management.
- Lack of Diagnostic Function: There is no mention of the device being used to analyze samples (like blood, urine, or tissue) or to provide information about a patient's health status or condition.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. The Rainbow® GT-4A does not fit this description.
N/A
Intended Use / Indications for Use
The Rainbow® GT-4A is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Product codes
GZJ
Device Description
The Rainbow® GT-4A is a tetrad channel traditional TENS device. It is powered by an AC adaptor. All operation modes produce the GT Bi-phasic waveform.
The GT-4A requires the use of a set of lead wires and a pair of electrodes for each channel. But no electrodes and lead wires are provided by this device. Patients must choose the products recommended by their clinician.. Selecting high quality of electrodes and lead wires is necessary for use of GT-4A and it has been observed that the quality of the electrodes may impact the ability of the GT-4A to operate efficiently, i.e. if the electrode does not adhere to the skin well the stimulative current (output) will not be delivered well.
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)
The GT-4A machine performs identically to the Epix XL 989. No clinical testing is needed.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Empi Epix XL Model 989
Reference Device(s)
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
§ 882.5890 Transcutaneous electrical nerve stimulator for pain relief.
(a)
Identification. A transcutaneous electrical nerve stimulator for pain relief is a device used to apply an electrical current to electrodes on a patient's skin to treat pain.(b)
Classification. Class II (performance standards).
0
| 510(k) Number: | |
|---|---|
| Applicant Name: | Sino-Us Information, Inc. |
| Applicant Address: | 85-13 88th Avenue |
| Woodhaven, NY 11421 | |
| Contact Person: | Yitang Sheng |
| Phone: | (718)846-6868 |
| Date Prepared: | May 5, 2003 |
| Classification Name: | Transcutaneous Electrical Nerve Stimulator |
| Common/Usual Name: | TENS Unit |
| Trade/Proprietary Name: | Rainbow GT-4A Pain Relief Machine (GT-4A) |
| Equivalent Devices: | Empi Epix XL Model 989 |
Product Description
The Rainbow® GT-4A is a tetrad channel traditional TENS device. It is powered by an AC adaptor. All operation modes produce the GT Bi-phasic waveform.
The GT-4A requires the use of a set of lead wires and a pair of electrodes for each channel. But no electrodes and lead wires are provided by this device. Patients must choose the products recommended by their clinician.. Selecting high quality of electrodes and lead wires is necessary for use of GT-4A and it has been observed that the quality of the electrodes may impact the ability of the GT-4A to operate efficiently, i.e. if the electrode does not adhere to the skin well the stimulative current (output) will not be delivered well.
Intended use
The Rainbow® GT-4A is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Comparison of Equivalent Device to the New Device
Summary of Technical Differences:
The Rainbow® GT-4A is technically identical to the Empi Epix XL Model 989, a predicate device, except that (1) an AC adaptor instead of the 9 V Alkaline Battery (or Empi rechargeable bettery), (2) only 2 and 100 Hz rates output rather than 2, 10, 20, 40, 60, 80, 100 and 150 Hz output, (3) 4 independent channels rather than 2 channels and (4) No Low Battery Indicator.
The adopted AC adaptor meets UL2601 Standards and the whole GT-4A device meets it too. i.e. it is of safety electrically. In addition, some predicate devices, e.g. Arista SD Plus TENS (K970429), are powered by an AC Adaptor too.
So this difference does not raise new questions of safety and effectiveness, and the GT-4A is as safe and as effective as the legally marketed device.
The differences in (2), (3) and (4) are not really differences in technological characteristics since underlying technology is the same as equivalent device.
Those differences do not require testing to establish equivalence.
1
Summary of Performance-Nonclinical
The GT-4A machine performs identically to the Epix XL 989. No clinical testing is needed.
Product Verification and Validation
The functional testing was performed and the results analyzed against product specifications demonstrates that the product meets requirements and is acceptable for its intended use.
Conclusions
This 510(k) premarket notification has demonstrated Substantial Equivalence as defined and understood in the FD&C Act and various guidance documents issued by CDRH.
Comparison of Product Specifications
See the following chart for details on the similarities and differences of the predicate device and GT-4A.
(See next pages)
2
Image /page/2/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with three curved lines representing its wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV 1 3 2003
Yitang Sheng, President Sino-U.S. Information, Inc. 85-13 88th Avenue Woodhaven, New York 11421
Re: K031546
Trade/Device Name: Rainbow GT-4A Pain Relief Machine Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: GZJ Dated: October 15, 2003 Received: October 20, 2003
Dear Mr. Sheng:
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.
3
Page 2 - Yitang Sheng
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 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 vours,
Sincerely yours,
Mark N Millerson
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
4
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K031546
Device Name: Rainbow® GT-4A
Indications For Use:
The Rainbow® GT-4A machine is indicated for the symptomatic relief and management of chronic, intractable pain and adjunctive treatment for post-surgical and post-trauma acute pain.
Concurrence of CDRH, Office of Device Eveluation (ODE)
Mark A. Milker
(Division Sign-Off)
1 Restorative
(Division Sign-Orl), Restorative Divisiourological Devices
.510(k) Number -
(OptionalFormat 3-10-98)