(170 days)
The 804SIII, 804W, Libra TENS, 410 and S-TENSII are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the 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 pain signals travelling to the brain.
This document describes a 510(k) premarket notification for several Transcutaneous Electrical Nerve Stimulator (TENS) devices (804SIII, 804W, Libra TENS, 410, S-TENSII) by Body Clock Health Care Ltd. The notification primarily relies on substantial equivalence to predicate devices rather than new clinical studies for acceptance criteria.
Here's an analysis of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device: The subject devices (804SIII, 804W, Libra TENS, 410, S-TENSII) must demonstrate basic technological characteristics substantially equivalent to the predicate devices (FUJI TENS 804SIII (K893874) and FUJI TENS Myostim 410 (K853719)). | 804SIII: Identical to FUJI TENS 804SIII (K893874). |
| 804W: Slightly different from 804SIII, with one dial for pulse rate adjustment controlling both channels (vs. two independent controls) and capable of Pulse Width Adjustment. | |
| Libra TENS: Similar internal workings to 804W, with an added timer switch for 30-minute operation. | |
| 410: Single-channel unit with one adjustable Pulse Rate dial and one adjustable Output dial; equivalent to FUJI TENS Myostim 410 (K853719). | |
| S-TENS II: Single-channel unit with one adjustable Pulse Rate dial, one Output dial, and a switch for Burst, Continuous, or Modulation. | |
| All units use "shrouded patient cable connector's" as per FDA's Final Rule. | |
| Compliance with Non-Clinical Standards: All required sections of AAMI/ANSI NS-4 Standard must be met. All units must pass IEC 60601-1:1990 + a1:1993 + A2:1995 and IEC 601-1:1988 + a1:1991 + A2:1995 standards. | All required sections of the AAMI/ANSI NS-4 Standard were met. |
| All units pass the required IEC 60601-1:1990 + a1:1993 + A2:1995 standards. | |
| All units pass the IEC 601-1:1988 + a1:1991 + A2:1995 standards. | |
| Safety and Effectiveness: Devices must not pose any new questions of safety and effectiveness compared to the predicate devices. | The devices have the same intended use and similar technical characteristics as the FUJI TENS 804SIII (K893874). The information supplied illustrates that the devices do not pose any new questions of safety and effectiveness. |
| Intended Use Equivalence: The intended use of the devices must be equivalent to the predicate devices. | Intended Use: "The 804SIII, 804W, Libra TENS, 410 and S-TENSII are used for the symptomatic relief and management of chronic intractable pain and/or as an adjunctive treatment in the management of post-surgical and post-traumatic acute pain." This matches common TENS device indications. |
2. Sample Size Used for the Test Set and Data Provenance:
No clinical test set was used. The submission relies on non-clinical testing and substantial equivalence to legally marketed predicate devices.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:
Not applicable. No clinical test set or expert ground truth establishment was conducted for the purpose of this 510(k) submission.
4. Adjudication Method for the Test Set:
Not applicable. No clinical test set was used.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
No MRMC study was done, as no clinical testing was performed. The submission explicitly states "Clinical Testing: Not Applicable as there are no new or innovative aspects that have been introduced."
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:
Not applicable. These are physical TENS devices, not an algorithm, and no standalone performance study in a clinical context was conducted. The performance evaluation was based on compliance with electrical and safety standards.
7. Type of Ground Truth Used:
The "ground truth" for this submission is based on:
- Predicate Device Characteristics: The established design and performance of the legally marketed FUJI TENS devices.
- Industry Standards: Compliance with AAMI/ANSI NS-4, IEC 60601-1, and IEC 601-1 for electrical medical equipment.
8. Sample Size for the Training Set:
Not applicable. There is no mention of a "training set" in the context of machine learning or an algorithm development in this 510(k) submission for TENS devices.
9. How the Ground Truth for the Training Set Was Established:
Not applicable, as there was no training set.
§ 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).