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510(k) Data Aggregation
(216 days)
Counter OTC TENS Device, Model CSD-737Z
To be used for temporary relief of pain associated with sore and aching muscles in the upper and lower back due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 4.
To be used for temporary relief of pain associated with sore and aching muscles in the upper extremities (arm) due to strain from exercise or normal household work activities choose Manual modes A, B, C, D, F, E or Auto 1 or Auto 3..
To be used for temporary relief of pain associated with sore and aching muscles in the lower extremities (leg) due to strain from exercise or normal household work activities choose Manual modes A, B, E or Auto 1 or Auto 4.
To be used for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, choose Manual modes A and C or Auto 1, Auto 2, Auto 3, or Auto 4.
To be used to stimulate healthy muscles in order to improve and facilitate muscle performance choose Manual Mode A or Mode B.
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The provided text is a letter from the FDA regarding a 510(k) premarket notification for a Transcutaneous Electrical Nerve Stimulator (TENS) device. It confirms the substantial equivalence of the device to legally marketed predicate devices and includes the "Indications for Use" for the device.
However, the document does not contain any information about acceptance criteria, device performance studies, sample sizes, ground truth establishment, expert qualifications, adjudication methods, or comparative effectiveness studies. These types of details are typically found in the accompanying technical documentation or clinical study reports submitted as part of the 510(k) application, which are not present here.
Therefore, I cannot provide the requested information from this document. The prompt asks to "describe the acceptance criteria and the study that proves the device meets the acceptance criteria" based on the input, but this input does not contain that specific information.
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(212 days)
COUNTER OTC TENS DEVICE
This TENS Device is to be used for temporary relief of pain associated with sore or aching muscles of lower back, arms, or legs due to strain from exercise or normal household and work activities.
The Counter Pain Therapy Device, Model P.T.S.-IV features two channels and seven (7) preset programs. The output of both channels can be adjusted individually for intensity in sixteen (16) steps and the treatment time is selectable from 20, 30 or 40 minutes. All features are well indicated by large icons on a backlit LCD screen for easy reading. The device is powered by three (3) rechargeable Lithium Batteries which are permanently built into the main unit and can be recharged with the charging unit supplied for the device. The Pain Therapy Device consists of the handheld main unit (controller), two pairs of self-adhesive electrodes, a plug-in charging unit (adaptor 120VAC to 5VDC) and two pairs of electrode cables.
The Counter Pain Therapy Device, Model P.T.S.-IV is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for the temporary relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
The device's acceptance criteria and performance were established through non-clinical testing for substantial equivalence to a predicate device, the OMRON Electro Therapy Pain Relief, Model PM3030 (K110068).
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria Standard | Reported Device Performance |
|---|---|---|
| Electrical Safety | IEC 60601-1:1988 + A1:1991 + A2:1995 "Medical electrical Equipment - Part 1: General requirements for basic safety and essential performance". | The device has been tested to and meets the requirements of IEC 60601-1. Performance testing established that, with respect to electrical safety in its intended operational environment, the device conforms to all applicable requirements of IEC 60601-1. |
| Particular Safety for Nerve & Muscle | IEC 60601-2-10: 1987 (first Edition + amendment 1 (2001) for use in conjunction with IEC 60601-1 (1988), Amendments 1 (1991) and 2 (1995) "Medical electrical equipment - Part 2: "Particular Requirements for safety of nerve and muscle stimulators". | The device has been tested to and meets the requirements of IEC 60601-2-10. |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2: 2001 + A1: 2004 & IEC60601-2-10: 1987 + A1: 2001 Clause 36 Medical Electrical Equipment, Part1-2: "General requirements for Basic Safety and Essential Performance" Collateral Standard: Electromagnetic Compatibility. (Also cited as IEC 60601-1-2 in other sections) | The device has been tested to and meets the requirements of IEC 60601-1-2. Performance testing established that, with respect to EMC in its intended operational environment, the device conforms to all applicable requirements of IEC 60601-1-2. |
| Biocompatibility | Not explicitly stated as a separate standard, but addressed. | The electrodes (the only body contacting parts) have been tested for biocompatibility as part of their separate FDA 510(k) clearance. |
| Software Performance | Not explicitly stated as a separate standard, but addressed internally. | Based upon test results, it was concluded that the software performs within specifications and is safe for the stated intended use. A permanent hazard analysis is implemented in the software development process, and the test protocol sufficiently verifies the software's main functional operation due to its clear architecture. |
| Cleaning Effectiveness | Not explicitly stated as a separate standard, but addressed internally. | The cleaning instructions in the Instruction Manual have been tested and validated to be sufficient. All testing concluded that the device can be cleaned by the methods described in the Instruction Manual. |
| Substantial Equivalence (Overall) | Performance and safety compared to predicate device (OMRON Electro Therapy Pain Relief, Model PM3030 - K110068). | Bench testing and safety report documentation demonstrated that the submitted device could maintain the same safety and effectiveness as the predicate device. Differences (7 program modes vs 3, 2 channels vs 1) do not affect intended use, raise new questions of safety or effectiveness, or alter the fundamental scientific technology. Therefore, the device is substantially equivalent to the predicate. |
2. Sample Size Used for the Test Set and Data Provenance
No specific "test set" in the context of clinical data (e.g., patient data) was used. The substantial equivalence determination was based on non-clinical testing, primarily engineering and performance verification against recognized consensus standards.
- Sample size: Not applicable in terms of patient data. Testing involved engineering samples of the device.
- Data Provenance: The testing was conducted by or for Counter Scientific Development (GZ) Ltd. in China, to demonstrate compliance with international standards for medical electrical equipment.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
Not applicable. Ground truth, in this context, pertains to clinical outcomes or expert consensus on medical conditions, which were not part of this non-clinical submission. The "truth" in this submission was adherence to engineering and safety standards, evaluated through standard test methodologies, not expert medical assessment of patient data.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC comparative effectiveness study was conducted. The submission explicitly states: "Counter did not conduct, nor rely upon, clinical tests to determine substantial equivalence of the Pain Therapy Device Model P.T.S.-IV. vs. the predicate."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Not applicable, as this is a physical medical device (TENS unit), not an algorithm or AI system for diagnostic or treatment decisions. The "software" mentioned refers to embedded firmware controlling the device's functions, not a standalone diagnostic algorithm.
7. Type of Ground Truth Used
The "ground truth" for this submission was compliance with recognized consensus standards for electrical safety, electromagnetic compatibility, and specific requirements for nerve and muscle stimulators (IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2). Additionally, design requirements and specifications from the manufacturer formed the basis for verifying software performance and cleaning efficacy.
8. Sample Size for the Training Set
Not applicable, as there was no artificial intelligence or machine learning component requiring a training set. This was a non-clinical device submission based on engineering and safety testing.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there was no training set in the context of machine learning.
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