(91 days)
The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the symptomatic relief and management of post-surgical and post-traumatic acute pain.
The TENS devices are used to transmit electrical pulses through the skin to the underlying peripheral nerves to aid in the blocking of the pain signal travelling to the brain.
The devices, "Body Clock Stimplus Pro" and "Body Clock Stimplus," are Transcutaneous Electrical Nerve Stimulators (TENS units) intended for pain relief.
Here's an analysis of the provided information regarding acceptance criteria and supporting studies:
1. Table of Acceptance Criteria and Reported Device Performance:
Based on the provided document, there are no specific, quantitative acceptance criteria defined for device performance (e.g., a certain level of pain reduction in percentage, or a specific range of electrical output). Instead, the acceptance is based on demonstrating substantial equivalence to a predicate device.
| Acceptance Criterion | Reported Device Performance (or Justification for Equivalence) |
|---|---|
| Intended Use | The Body Clock Stimplus Pro and Body Clock Stimplus are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the symptomatic relief and management of post-surgical and acute post-traumatic pain. This is stated to be the same as the predicate device (Solitens Modified - Stimplus Pro, K913522). |
| Technological Characteristics | Body Clock Stimplus Pro: Declared as identical to the predicate device (Solitens Modified - Stimplus Pro, K913522). This implies all technical specifications like intensity, power, timer settings (15s/30s), and frequency switch are the same. |
| Body Clock Stimplus: Declared as very similar and having features that are substantially equivalent to the predicate. Differences noted: timer selection (manual, 30s, 60s vs. 15s/30s on predicate/Pro) and a Rhythm Switch instead of a Frequency Switch. The document concludes that despite these minor differences, it is technically substantially equivalent. | |
| Safety Standards / Non-clinical Testing | All units are CE marked (compliant with EEC Directive 93/42/EEC Annex V). Compliance with multiple international and European standards is reported: ISO 9002, ISO 13488, EN 46002, EN 60601-1-2:1993, IEC 601-1:1988 + A1:1991 + A2:1995, EN60601-1:90 + A1:93 + A2:95 + A13:96. This indirectly serves as an acceptance criterion for electrical safety, electromagnetic compatibility, and quality management systems. |
| Clinical Performance | "Not Applicable as there are no new or innovative aspects that have been introduced." The device is considered substantially equivalent to a legally marketed predicate, implying that its clinical performance for the stated indications is expected to be the same as the predicate. |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not applicable. The submission explicitly states "Clinical Testing: Not Applicable." The basis for clearance is substantial equivalence to a predicate device, not a new clinical performance study.
- Data Provenance: Not applicable, as no new clinical testing was performed. The data provenance would refer to the existing predicate device's historical performance and regulatory clearance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not applicable. No new clinical trials were conducted to establish a ground truth for the device's performance.
4. Adjudication Method for the Test Set:
- Not applicable. No new clinical trials with a test set requiring adjudication were conducted.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No, an MRMC comparative effectiveness study was not done. The submission explicitly states "Clinical Testing: Not Applicable." TENS units are typically evaluated for efficacy in pain relief through clinical trials; however, for this 510(k), equivalence to an already approved device negated the need for new clinical trials.
6. If a Standalone (Algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a TENS unit, not an AI/algorithm-based diagnostic or assistive system. Its function is direct electrical stimulation, not processing data or providing outputs for human interpretation.
7. The Type of Ground Truth Used:
- The implicit "ground truth" for this 510(k) submission is the established safety and efficacy of the predicate device (Solitens Modified - Stimplus Pro, K913522), as determined by its prior regulatory clearance. The current submission argues that the new devices are so similar (identical or substantially equivalent) that their performance, and thus their "ground truth," would be the same.
8. The Sample Size for the Training Set:
- Not applicable. This device is a TENS unit, not typically involving a "training set" in the context of machine learning or complex diagnostic algorithms. The design and manufacturing are based on established engineering principles and safety standards, rather than data-driven model training.
9. How the Ground Truth for the Training Set was Established:
- Not applicable, as there is no "training set" in this context.
§ 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).