(157 days)
Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
The Rhythm Touch Q 2-Way is a dual channeled powered nerve stimulator. It electronically stimulates nerves. It comprises two main components, namely, an electronic stimulatory module which generates the required stimulation signals, and skin electrodes with lead wires.
The product is supplied with two sets of electrodes, a belt to fix and hold the unit and the electrodes, an instruction manual, and a set of batteries. Power is derived from two AAA cells located in a compartment protected by a removable battery cover.
The electrodes provided with this model have 510(k) clearance. They are rectangular, 1.5"x1.75" in size. The lead wires also have 510(k) clearance.
The provided text is a 510(k) Summary for the Rhythm Touch Q 2-Way, a transcutaneous electrical nerve stimulator (TENS) for pain relief.
The acceptance criteria and study information typically found in a detailed clinical performance study report are not present in the provided document. The 510(k) summary focuses on demonstrating substantial equivalence to a predicate device rather than presenting a de novo performance study with specific acceptance criteria, sample sizes, expert ground truth, or MRMC studies.
Here's a breakdown based on the information provided and what is missing:
1. Table of Acceptance Criteria and Reported Device Performance
- Acceptance Criteria: Not explicitly stated in the document. For a TENS device, acceptance criteria would typically relate to safety (e.g., electrical safety standards, biocompatibility of materials) and effectiveness (e.g., measurable reduction in pain scores in a clinical trial).
- Reported Device Performance: The document states, "The Rhythm Touch Q 2-Way and the predicate device have similar technological characteristics. The Rhythm Touch Q 2-Way does not pose any new or different safety hazards, and the devices are substantially equivalent." This implies that its performance is considered equivalent to the predicate device (BIOSTIM KIT, K050174), which is legally marketed for similar indications. No specific performance metrics are reported for the Rhythm Touch Q 2-Way device itself.
2. Sample size used for the test set and the data provenance
- Not applicable/Not provided. This document is a 510(k) summary for substantial equivalence. It does not describe a clinical performance study with a "test set" in the context of AI/machine learning or detailed clinical trials. The basis for clearance is similarity to a predicate, not new clinical performance data from a specific test set.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable/Not provided. Ground truth determination by experts is relevant for studies evaluating diagnostic or prognostic devices, especially those using image analysis or complex data interpretation. This TENS device does not fall into that category, and no such study is described.
4. Adjudication method for the test set
- Not applicable/Not provided. As no test set and expert review are described, no adjudication method is relevant.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- No. This product is a transcutaneous electrical nerve stimulator, not an AI-powered diagnostic or interpretive device. Therefore, MRMC studies involving AI assistance for human readers are not relevant and were not performed or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable/Not provided. This is a hardware medical device (TENS unit), not an algorithm or software. Its mechanism of action is electrical stimulation, independent of human interpretation or AI algorithms.
7. The type of ground truth used
- Not applicable/Not provided. The concept of "ground truth" as typically applied in AI/diagnostic studies (e.g., pathology, outcomes data) is not relevant for demonstrating substantial equivalence of a TENS device. The "ground" for comparison is the predicate device's established safety and effectiveness.
8. The sample size for the training set
- Not applicable/Not provided. This is a hardware device cleared through substantial equivalence, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
- Not applicable/Not provided. As there is no training set for an AI model, there is no ground truth to establish for it.
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MAY 2 4 2007
510(k) Summary
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| Date prepared: | 14 December 2006 / revised 2 April 2007 |
|---|---|
| Applicant: | Shockim Enterprise Ltd.2500 Wilshire Boulevard, Suite 1115Los Angeles, CA 90057 |
| Contact person: | Nicolaas C. Besseling, ConsultantBesTech Consulting Services28711 Jaeger DriveLaguna Niguel, CA 92677949.466.7472bestechconsulting@cox.net |
| Trade name: | Rhythm Touch Q 2-Way |
| Common name: | Stimulator, nerve, transcutaneous,for pain relief |
| Classification name: | Transcutaneous electrical nervestimulator for pain relief |
| Predicate device: | BIOSTIM KIT, K050174 |
| Class: 2Product GZJ,codes: NUH | |
| Device description: | The Rhythm Touch Q 2-Way is a dual channeled powerednerve stimulator. It electronically stimulates nerves. It com-prises two main components, namely, an electronic stimula-tory module which generates the required stimulation sig-nals, and skin electrodes with lead wires.The product is supplied with two sets of electrodes, a belt tofix and hold the unit and the electrodes, an instruction man-ual, and a set of batteries. Power is derived from two AAAcells located in a compartment protected by a removablebattery cover.The electrodes provided with this model have 510(k) clear-ance. They are rectangular, 1.5"x1.75" in size. The leadwires also have 510(k) clearance. |
| Intended use: | Temporary relief of pain associated with sore and achingmuscles in the lower back due to strain from exercise ornormal household and work activities. |
| Summary of the technologicalcharacteristics of our devicecompared to the predicatedevice: | The Rhythm Touch Q 2-Way and the predicate device havesimilar technological characteristics. The Rhythm Touch Q2-Way does not pose any new or different safety hazards,and the devices are substantially equivalent. |
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Public Health Service
Image /page/1/Picture/2 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular and contains the department's name around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight. The symbol is composed of three stylized lines that form the wings and body of the bird.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 4 2007
Shockim Enterprise Ltd. % BesTech Consulting Services Mr. Nicolaas C. Besseling Consultant 2500 Wilshire Boulevard, Suite 1115 Los Angeles, California 90057
RE: K063743
Trade/Device Name: Rhythm Touch Q 2-Way Regulation Number: 21 CFR 888.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: NUH Dated: April 3, 2007 Received: April 9, 2007
Dear Mr. Besseling:
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 for abo stated in the 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 r toat FDA has made a determination that your device complies with other requirements of the Act that I Dr I had Intatutes and regulations administered by other Federal agencies. You must or uny vith 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
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Page 2 - Mr. Michael Kvitnitsky
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 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 (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,
Mark A. Milliman
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:
Rhythm Touch Q 2-Way
Device name:
Indications for use:
Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities.
Over-The-Counter use and/or Prescription use ﮯ (Part 21 CFR 801 Subpart D) (Part 21 CFR 801 Subpart D)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Mark A. Millhuser
(Division Sign-Off) (Division Sugaronal, Restorative, and Neurological Devices
510(k) Number
510(k) Number
§ 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).