(226 days)
Temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, neck, upper extremities (arm), lower extremities (leg), abdomen and bottom due to strain from exercise or normal household work activities.
The Progenix Select Stim (Model: PRO1205-OTC1) device is a portable, battery powered (9 V battery) two channel device designed to provide Transcutaneous Electrical Nerve Stimulation (TENS) for the purpose of the symptomatic relief of pain.
The device consists of the TENS stimulator, two lead wires and set of four Skin Electrodes. It provides 10 preset TENS treatment programmes. The programs include four modes of operation: Conventional TENS(Continuous), Burst Mode, Modulation mode and HAN TENS. The device LCD screen shows the information of program, intensity level of each channel and operating time.
The electrode pads are cleared by FDA (510(k) number K160138). They are used as an accessory to the TENS device unit, to transmit electrical current to patient skin. The electrodes consist of biocompatible self-adhesive conductive application use. These electrodes are sized 50x50mm and are sold under the model number PRO5050.
The provided FDA 510(k) clearance letter for the Progenix Select Stim (K242460) is for a Transcutaneous Electrical Nerve Stimulator (TENS) device. Based on the document, this device is cleared as substantially equivalent to a predicate device (HIVOX OTC Electrical Stimulator, K190347).
It is crucial to understand that a 510(k) clearance, especially for devices like TENS units, primarily relies on demonstrating substantial equivalence to a previously cleared predicate device, rather than requiring extensive de novo clinical trials or complex AI performance studies. The provided document explicitly states under "9. Clinical Performance Data" that it is "Not applicable." This means the clearance was granted based on non-clinical (bench) testing demonstrating that the device performs similarly to the predicate and meets relevant safety standards.
Therefore, the request to describe "acceptance criteria and the study that proves the device meets the acceptance criteria" in the context of AI performance metrics (like sensitivity, specificity, MRMC studies, ground truth establishment by experts, etc.) is not directly applicable to this specific device and clearance. The device is a TENS unit, not an AI/ML-driven diagnostic or interpretative system.
However, I can extract and structure the information related to the device's performance relative to its substantial equivalence claim and the non-clinical testing performed, which serves as its "proof of meeting acceptance criteria" in this context.
Here's a breakdown based on the provided document, addressing the closest relevant points:
Acceptance Criteria and Study that Proves the Device Meets the Acceptance Criteria (for a TENS Device)
For the Progenix Select Stim (K242460), the "acceptance criteria" are primarily defined by its substantial equivalence to the predicate device and compliance with applicable voluntary safety standards. The "study that proves the device meets the acceptance criteria" refers to the non-clinical (bench) testing performed to demonstrate this equivalence and safety.
1. Table of Acceptance Criteria and Reported Device Performance
Given that this is not an AI/ML device, the "performance" is about meeting electrical and mechanical specifications, and adherence to safety standards, rather than diagnostic accuracy metrics. The table below summarizes key comparative parameters that demonstrate substantial equivalence, which serve as "acceptance criteria" for the device's design and function.
| Parameter Description | Acceptance Criteria (Predicate Device K190347/K171803) | Reported Device Performance (Progenix Select Stim K242460) | Met Criteria? (SE Justification) |
|---|---|---|---|
| Regulation Number | 21 CFR 882.5890 | 21 CFR 882.5890 | Met (SE) - Same regulatory classification. |
| Classification | Class II | Class II | Met (SE) - Same device class. |
| General Classification | OTC | OTC | Met (SE) - Both are Over-The-Counter devices. |
| Intended Use | Temporary pain relief (TENS) | Temporary pain relief (TENS) | Met (SE) - The intended use for TENS is identical. The predicate also has EMS function, which the new device does not, but this is acceptable for substantial equivalence for the TENS function. |
| Power Source(s) | 4.5V (3xAAA) | 9V (1xPP3 alkaline) | Met (SE Note 1) - Difference in voltage and battery type. Justified as not affecting safety/efficacy, as both deliver low-voltage electrical impulses and the device passed IEC 60601-1 tests. |
| Patient Leakage Current (Normal) | 6.0 μA | 3 μA | Met (SE) - Proposed device has lower leakage, indicating better safety performance. |
| Patient Leakage Current (Single Fault) | 5.6 μA | 1 μA | Met (SE) - Proposed device has lower leakage, indicating better safety performance. |
| Output Waveform/Shape | Biphasic, Rectangular | Biphasic, Rectangular | Met (SE) - Identical. |
| Number of Output Channels | 2 | 2 | Met (SE) - Identical. |
| Regulated Output | Regulated Current | Regulated Current | Met (SE) - Identical. |
| Maximum Output Voltage | @500Ω 100V, @2kΩ 180V, @10kΩ 250V | @500Ω 40V, @2kΩ 100V, @10kΩ 145V | Met (SE Note 1) - Lower maximum output voltages. Justified as safer without compromising effectiveness, and device compliant with IEC 60601-1 and 60601-2-10. |
| Maximum Output Current | @500Ω 200mA, @2kΩ 90mA, @10kΩ 25mA | @500Ω 80mA, @2kΩ 50mA, @10kΩ 19mA | Met (SE Note 1) - Lower maximum output currents. Justified as safer without compromising effectiveness, and device compliant with IEC 60601-1 and 60601-2-10. |
| Pulse Width (μs) | 50-450 | 50-200 | Met (SE Note 2) - Narrower range. Justified as still within effective range for stimulating sensory/motor nerves and potentially minimizing discomfort. |
| Frequency (Hz) | 1-150 | 2-100 | Met (SE Note 3) - Narrower range. Justified as still within safe and effective range for therapeutic stimulation, covering low- and medium-frequency applications. |
| Maximum Phase Charge (μC @ 500 Ω) | 45 | 16 | Met (SE Note 4) - Lower. Justified as not exceeding safety limits ( |
§ 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).