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510(k) Data Aggregation
(332 days)
This device is intended for the relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities.
The PM3030 is a small, battery operated, three (3) output mode TENS device for pain relief intended for OTC use. The output modes are intended for application to the following areas: Shoulder/Arm, Lower Back and Ley/Foot. The accessories include an electrode cord / cable and electrodes pads (Long Life) which are placed on the specific body part. As above the device is battery powered there is no connection to AC mains supply.
The provided text describes a Premarket Notification 510(k) for the Omron OTC TENS device (Model PM3030). This document focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than presenting a standalone study with acceptance criteria for device performance in the way one might for a diagnostic or therapeutic medical AI device.
Therefore, the information typically requested for AI/ML device studies (such as sample sizes for test/training sets, expert qualifications, adjudication methods, MRMC studies, or standalone performance against a ground truth) is not applicable to this 510(k) summary. The document is primarily concerned with comparing the technical specifications and intended use of the new device to a predicate device to establish that it is as safe and effective.
Here's an analysis based on the provided text, focusing on what is available:
Acceptance Criteria and Device Performance (based on Substantial Equivalence comparison)
The "acceptance criteria" here are implicitly that the Omron PM3030 device is "substantially equivalent" to its predicate device (Endurance Therapeutics, Model T1040, K060846) in terms of safety and effectiveness. The reported device performance is presented as a comparison of specifications between the new device and the predicate.
1. Table of Acceptance Criteria and Reported Device Performance
| Attribute (Implicit Acceptance Criteria: Substantially Equivalent) | Omron PM3030 (Reported Device Performance) | Predicate: Endurance Model T1040 (K060846) | Result (Substantial Equivalence) |
|---|---|---|---|
| Indications for Use | Relief of pain associated with sore or aching muscles of the lower back, arms, or legs due to strain from exercise or normal household and work activities. | Relief of pain associated with sore and aching muscles in the lower back, upper extremities (arm), and lower extremities (leg) due to strain from exercise or normal household work activities. | Equivalent |
| Product Code | NUH | NUH, NGX, GZX | Similar (primary code matches) |
| CFR Regulation | 882.5890 | 882.5890, 890.5850 | Similar (primary code matches) |
| Patient Population | Adult | Not specified (implied adult for OTC TENS) | Equivalent |
| Prescriptive or OTC | OTC | OTC | Equivalent |
| Environment of Use | Clinics, hospital and home environments | Not specified (implied home for OTC) | Equivalent |
| Contraindications | Has standard contraindications (cardiac pacemaker, implanted defibrillator, other implanted metallic/electronic device). | Has standard contraindications. | Equivalent |
| Warnings/Precautions/Adverse Reactions | Standard warnings/precautions/adverse reactions. | Standard warnings/precautions/adverse reactions. | Equivalent |
| Power source | 2 - AAA | 3 - AAA | Difference, but not significant for safety/effectiveness |
| Number of Output modes | 3 | 10 | Difference, but deemed insignificant for safety/effectiveness |
| Number of output channels | 1 | 1 | Equivalent |
| Waveform | Biphasic | (Not specified for predicate, but TENS generally uses biphasic) | Implied similar |
| Shape | Rectangular | (Not specified for predicate) | Implied similar |
| Maximum Output Voltage (500 ohm) | 35.4 V | 40.7 V | Difference, but deemed insignificant (lower output) |
| Maximum Output Voltage (2k ohm) | 46.7 V | 105.1 V | Difference, but deemed insignificant (lower output) |
| Maximum Output Voltage (10k ohm) | 50.8 V | 154.1 V | Difference, but deemed insignificant (lower output) |
| Maximum Output Current (500 ohm) | 4.4 mA | 81.4 mA | Difference, but deemed insignificant (lower output) |
| Maximum Output Current (2k ohm) | 1.7 mA | 47.8 mA | Difference, but deemed insignificant (lower output) |
| Maximum Output Current (10k ohm) | 0.4 mA | 15.4 mA | Difference, but deemed insignificant (lower output) |
| Maximum Phase charge (500 ohm) | 133 microC | 16.9 microC | Difference, but deemed insignificant (higher charge, but within safe limits for TENS) |
| Maximum Current Density (500 ohm) | 0.095 mA/cm² | 2.71 mA/cm² | Difference, but deemed insignificant (lower density) |
| Maximum Average Current (500 ohm) | 3.5 mA | Not specified | Not directly comparable, but overall output deemed safe. |
| Maximum Average Power Density (500 ohm) | 89 mW/cm² | 10.2 mW/cm² | Difference, but deemed insignificant. |
| Frequency (Hz) | < 100 Hz | 245 Hz | Difference, but not significant for safety/effectiveness |
| Burst Mode | None | (Not specified for predicate, but implies presence if not none) | Difference, but not significant for safety/effectiveness |
| Timer range (min) | 15 minutes | 30 minutes | Difference, but not significant for safety/effectiveness |
| Indication display: On/Off status | Yes | Yes | Equivalent |
| Indication display: Low battery | No | Yes | Minor difference, not impacting substantial equivalence |
| Indication display: Voltage / Current level | Yes | Yes | Equivalent |
| Indication display: Output mode | Yes | Yes | Equivalent |
| Indication display: Time to cut-off | No | Yes | Minor difference, not impacting substantial equivalence |
| Dimensions | 55 mm x 95 mm x 19 mm | 150 mm x 68 mm x 26 mm | Different, but not significant for safety/effectiveness |
| Weight | 60 grams | 90 grams | Different, but not significant for safety/effectiveness |
| Housing material | ABS | Not specified | Not significant for equivalence |
| Microprocessor control | Yes | Yes | Equivalent |
| Automatic Overload trip | Yes | Not specified | Advantage for new device, but not a difference for lack of equivalence. |
| Automatic no-load trip | Yes | Not specified | Advantage for new device, but not a difference for lack of equivalence. |
| Automatic shut-off | Yes | Not specified | Advantage for new device, but not a difference for lack of equivalence. |
| User override control | Power On/Off button | Not specified | Not significant for equivalence |
| Electrode compliance with 21 CFR 898 | Yes | Not specified | Not significant for equivalence, implied predicate also compliant or was at time of clearance. |
| Electrode cable | Yes | Yes | Equivalent |
The submission concludes that "The differences that exist between the devices are insignificant in the terms of safety or effectiveness." and "Performance testing has been performed that shows equivalent waveform characteristics."
2. Sample size used for the test set and the data provenance
- Not Applicable. This is a 510(k) submission for a TENS device, not an AI/ML imaging or diagnostic device. There is no "test set" in the context of an algorithm's performance on clinical data. The "performance testing" mentioned refers to electrical characteristic measurements to demonstrate waveform equivalence. No patient data or clinical study data is presented for this purpose.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable. As above, there is no "test set" or ground truth based on expert review for this type of device submission.
4. Adjudication method 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/ML device study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable. This is not an AI/ML device. The device is a physical TENS unit. "Performance testing" mentioned refers to engineering tests of its electrical outputs.
7. The type of ground truth used
- Not Applicable. The "ground truth" for a TENS device revolves around its electrical specifications meeting safety standards (e.g., IEC 60601-1, IEC 60601-1-2) and providing waveforms that are functionally equivalent to predicate devices for pain relief. The document states:
- "Performance testing has been performed that shows equivalent waveform characteristics."
- "The device has been tested to and meets the requirements of the following recognized consensus standards: IEC 60601-1... IEC 60601-1-2..."
- "The patient contacting materials of the electrode has been tested in accordance to ISO 10993-1 and FDA Guidance."
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device.
9. How the ground truth for the training set was established
- Not Applicable.
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