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510(k) Data Aggregation
(239 days)
Symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain.
Prescription Use
The Electronic Pulse Massager, which includes Models PL009, PL009A, and PL029, is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. TENS can help to relieve the pain caused by trauma or continual strain, and is suitable to be used on the user's back, neck, shoulders, legs, arms, and feet. The proposed Electronic Pulse Massager, which is compact, portable, and microprocessor-controlled, delivers a gentle electrical pulse to the underlying nerve through the wires and electrode pads placed on the skin of users. According to the need of users, the pulse intensity can be adjustable on the front control panel of the massager. Both Models PL009 and PL009A have five automatic stimulation programs and three manual programs, while Massager PL029 contains five automatic stimulation programs and eight selectable programs. The only difference between Models PL009 and PL009A is the former has a "REPEAT" program function and the latter does not. All these programs as well as the pulse intensity and time remaining can be displayed on the liquid crystal display screen of both massagers.
The provided K113544 510(k) Summary for the Electronic Pulse Massager, Models PL009, PL009A, and PL029, does not describe the use of a study with acceptance criteria and reported device performance in the typical sense of a clinical trial or algorithm performance evaluation.
This submission is for a Transcutaneous Electrical Nerve Stimulator (TENS) device, which is a medical device and not an AI/ML algorithm. Therefore, the questions related to AI/ML specific aspects like training sets, test sets, ground truth establishment by experts, adjudication methods, and MRMC studies are not applicable.
Instead, the submission demonstrates substantial equivalence to a predicate device (TENS 3000 Stimulator, K102014) through a comparison of technological characteristics and compliance with a set of voluntary non-clinical design standards.
Here's an breakdown based on the information provided and addressing the nature of the device:
1. A table of acceptance criteria and the reported device performance
For this type of device (TENS), "acceptance criteria" and "reported device performance" are primarily demonstrated through compliance with recognized standards and comparison to a predicate device. The submission does not provide explicit numerical "performance" metrics/acceptance criteria like sensitivity/specificity for disease detection, but rather shows that its properties and functionalities meet expected standards for safety and effectiveness for a TENS device.
| Acceptance Criteria (Demonstrated through Standard Compliance & Predicate Comparison) | Reported Device Performance (as demonstrated by compliance and comparison) |
|---|---|
| Safety: | |
| Electromagnetic compatibility (Emissions) | Complies with EN55014-1 |
| Electromagnetic compatibility (Immunity) | Complies with EN55014-2 |
| Household electrical appliances safety (General requirements) | Complies with EN60335-1 |
| Safety for massage appliances (Particular requirements) | Complies with EN60335-2 |
| Measurement methods for electromagnetic fields (Human exposure) | Complies with EN62233 |
| Medical electrical equipment safety (General requirements) | Complies with IEC 60601-1 |
| Medical electrical equipment safety (Collateral Standard) | Complies with IEC 60601-1-2 |
| Medical electrical equipment safety (Nerve and muscle stimulators) | Complies with IEC 60601-2-10 |
| Compliance with 21 CFR 898 (presumably related to performance standards for diagnostic X-ray systems, though its relevance here for a TENS is unclear without further context, but claimed compliance) | Complies with 21 CFR 898 (Yes) |
| Effectiveness/Functionality: | |
| Intended Use | Symptomatic relief of acute post traumatic pain, acute post surgical pain, and chronic intractable pain (Same as predicate) |
| Power Source | 6V Battery (PL009/PL009A), 3V Battery (PL029) - Different from predicate (9V), but functional |
| Output Channels | 2 (Same as predicate) |
| Channel Isolation | By Enclosure (Same as predicate) |
| Software/Firmware/Microprocessor Control | Yes (Same as predicate) |
| Automatic Overload/Over Current/No-Load Trip | No (Same as predicate) |
| Automatic Shut Off | No (Same as predicate) |
| Patient Override Control | No (Same as predicate) |
| Indicator Display | Yes (Same as predicate) |
| Timer Range | 15 min, continue (Same as predicate) |
| Waveform | Biphasic or Monophasic Rectangular Pulse (Same as predicate) |
| Frequency | 2-60 Hz - Different from predicate (2-150 Hz), but within range for TENS |
| Weight | 150g (PL009/PL009A), 125g (PL029) - Different from predicate (115g), but acceptable design difference |
| Dimensions (HxWxT) | 200x55x33mm (PL009/PL009A), 203x63x13mm (PL029) - Different from predicate (95x65x23.5mm), but acceptable design difference |
| Housing Materials & Construction | Enclosure: ABS Plastic (Same as predicate) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is cleared through substantial equivalence based on non-clinical testing and comparison to a predicate, not clinical data or performance on a test set of patient data.
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)
Not applicable. Ground truth for a test set is not established for this type of device clearance.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
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
Not applicable. This is not an AI-assisted device, and no MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable. For this device, "ground truth" is conceptually represented by the established safety and performance standards for TENS devices and the characteristics of the legally marketed predicate device.
8. The sample size for the training set
Not applicable. This is not an AI/ML device, so there is no training set.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this device.
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