(214 days)
The Pennypad 904 and Pennypad 909 are indicated for 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 Pennypad 907 is indicated for Arm & Leg Pain Relief is intended for temporary relief of pain associated with sore and aching muscles in the upper and lower extremities (arm and/or leg) due to strain from exercise or normal household and work activities.
The HIVOX Electric Stimulator OTC TENS, Pennypad 904, Pennypad 907, and Pennypad 909 can generate small pulses of electrical current. Delivered these pulses pass through the skin and activated underlying nerves.
HIVOX BIOTEK INC. submitted a 510(k) premarket notification (K112392) for their HIVOX Electric Stimulator OTC TENS devices (Pennypad 904, 907, and 909) on July 13, 2011. The submission aimed to demonstrate that these devices are substantially equivalent to previously cleared predicate devices (K060846 and K040512). The FDA cleared the device on March 19, 2012.
1. A table of acceptance criteria and the reported device performance
The acceptance criteria for this device are implicitly that the performance of the HIVOX Electric Stimulator OTC TENS devices (Pennypad 904, 907, and 909) must be substantially equivalent to the predicate devices in terms of electrical safety, electromagnetic compatibility, and specific output parameters. The reported performance is a comparison table against two predicate devices. The "reported device performance" is the measured electrical output characteristics of the HIVOX devices.
| Parameter | HIVOX PP909 Performance (Subject Device) | Predicate Device K040512 (2402/2403) Performance | Predicate Device K060846 (T1040) Performance | Acceptance Criteria (Implicit) |
|---|---|---|---|---|
| Waveform | Symmetrical Biphasic | Biphasic | Substantially equivalent (Biphasic and Symmetrical Biphasic are considered equivalent in this context) | |
| Shape | Rectangular | Rectangular | Substantially equivalent (Rectangular) | |
| Maximum Output Voltage (Vpp) @500Ω | 40.0Vpp | 57.6Vpp | 40.7V | Within acceptable range compared to predicate devices |
| Maximum Output Voltage (Vpp) @2KΩ | 84.0Vpp | 89.6Vpp | 105.1V | Within acceptable range compared to predicate devices |
| Maximum Output Voltage (Vpp) @10KΩ | 92.0Vpp | 96.0Vpp | 154.1V | Within acceptable range compared to predicate devices |
| Maximum Output Current (mApp) @500Ω | 80.0mApp | 115.2mApp | 81.4mA | Within acceptable range compared to predicate devices |
| Maximum Output Current (mApp) @2KΩ | 42.0mApp | 44.8mApp | 47.8mA | Within acceptable range compared to predicate devices |
| Maximum Output Current (mApp) @10KΩ | 9.2mApp | 9.6mApp | 15.4mA | Within acceptable range compared to predicate devices |
| Pulse Duration (µSec) | 200µSec (fixed) | 250 µSec | 4.1~500mS | Within acceptable range compared to predicate devices (fixed vs variable but similar order of magnitude) |
| Frequency (Hz) | 35 | 2, 5, and 40 | 245Hz | Within acceptable range compared to predicate devices |
| Net Charge (µC) per pulse @500Ω | 0.3200 | 0.2304 | 4.07 | Within acceptable range compared to predicate devices |
| Maximum Charge (µC) @500Ω | 16.0 | 23.04 | 16.9 | Within acceptable range compared to predicate devices |
| Maximum Current Density (mA/cm², r.m.s.) @500Ω | 1.964 | 2.828 | 2.71 | Within acceptable range compared to predicate devices |
| Maximum Average Power Density (W/cm²) @500Ω | 0.078 | 0.163 | 5.35mW/cm² | Within acceptable range compared to predicate devices |
| Burst Mode (PP909 only): | Not Available | Not Available | Acceptable as an additional feature, not present in all predicates, but within safety limits. | |
| a. Pulse per burst | 1 | NA | NA | |
| b. Burst per second | 4 | NA | NA | |
| c. Burst duration (sec) | 2 | NA | NA | |
| d. Duty Cycle | 8 | NA | NA | |
| ON Time (sec) | 120 | NA | NA | Within acceptable limits for TENS devices |
| Off Time (sec) | 0 | NA | NA | Within acceptable limits for TENS devices |
| HIVOX PP907 Performance (Subject Device) | ||||
| Maximum Output Voltage (Vpp) @500Ω | 68.8V | 40.7V rms | Within acceptable range compared to predicate devices | |
| Maximum Output Voltage (Vpp) @2KΩ | 88.0V | 105.1 V rms | Within acceptable range compared to predicate devices | |
| Maximum Output Voltage (Vpp) @10KΩ | 95.2V | 154.1V rms | Within acceptable range compared to predicate devices | |
| Maximum Output Current (mApp) @500Ω | 137.6mA | 81.4mA rms | Within acceptable range compared to predicate devices | |
| Maximum Output Current (mApp) @2KΩ | 44.0mA | 47.8mA rms | Within acceptable range compared to predicate devices | |
| Maximum Output Current (mApp) @10KΩ | 9.52mA | 15.4mArms | Within acceptable range compared to predicate devices | |
| Pulse Duration (µSec) | 200µSec (fixed) | 4.1~500mS | Within acceptable range compared to predicate devices | |
| Frequency (Hz) | 2 and 40 | 245Hz | Within acceptable range compared to predicate devices | |
| Net Charge (µC) per pulse @500Ω | 1.1008 | 4.07 | Within acceptable range compared to predicate devices | |
| Maximum Charge (µC) @500Ω | 27.52 | 16.9 | Within acceptable range compared to predicate devices | |
| Maximum Current Density (mA/cm², r.m.s.) @500Ω | 3.378 | 2.71 | Within acceptable range compared to predicate devices | |
| Maximum Average Power Density (W/cm²) @500Ω | 0.232 | 5.35mW/cm² | Within acceptable range compared to predicate devices |
Study to prove device meets acceptance criteria:
The study proving the device meets the acceptance criteria is a non-clinical performance testing and substantial equivalence comparison against legally marketed predicate devices.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample size for the test set: Not applicable in the context of this 510(k) submission. The testing conducted was electrical safety and performance testing on the device itself, rather than a clinical study with a patient test set.
- Data provenance: The testing was performed in accordance with international standards, implying compliance with established methodologies for medical device electrical safety and electromagnetic compatibility. The submitter, HIVOX BIOTEK INC., is based in New Taipei City, Taiwan, R.O.C., which is the country of origin of the device and likely where the non-clinical testing was conducted. The data is prospective, in that it was generated for the purpose of this submission.
- Retrospective or prospective: Prospective (tests were specifically conducted for the purpose of this 510(k) submission).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Number of experts: Not applicable. This was a non-clinical device performance and safety testing submission, not a study requiring expert readers to establish ground truth for a test set of medical cases.
- Qualifications of those experts: Not applicable.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication method: Not applicable. There was no clinical test set requiring adjudication.
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
- MRMC study: No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This device is a TENS unit, not an AI-assisted diagnostic or therapeutic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone study: Not applicable. This is a physical medical device (TENS unit), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Type of ground truth: The "ground truth" in this context refers to established international consensus standards for electrical safety (IEC/EN 60601-1, IEC/EN 60601-1-2, IEC/EN 60601-2-10) and the electrical output specifications of the predicate devices. The HIVOX devices' measured electrical parameters were compared against these standards and the predicate device specifications to demonstrate substantial equivalence.
8. The sample size for the training set
- Sample size for the training set: Not applicable. There is no AI component or machine learning involved that would require a training set.
9. How the ground truth for the training set was established
- How ground truth for 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).