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510(k) Data Aggregation
(157 days)
This device is intended for the relief of pain associated with sore or aching, muscles of the lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. When used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis, use the Shoulder mode of stimulation. Environments of Use: Clinics, hospital and home environments Patient Population: Adult
The Omron Healthcare Maxpower Relief Model PM3032B is a small, battery operated TENS device for pain relief intended for OTC use. It complies with ES60601-1, IEC60601-1-2, IEC60601-2-10 and IEC 60601-1-11. The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. The Omron Healthcare Maxpower Relief Model PM3032B is software controlled which includes all functions, indicators and waveform characteristics. 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 nor connection to any other device.
The provided text describes the 510(k) summary for the Omron Healthcare Maxpower Relief Model PM3032B. This is a Transcutaneous Electrical Nerve Stimulator (TENS) device intended for pain relief. The submission aims to demonstrate substantial equivalence to predicate devices, K141978 (Omron MaxPower Relief) and K172079 (Omron Avail), to expand its indications for use.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable form for device performance. Instead, it demonstrates substantial equivalence by comparing various features of the new device to two predicate devices. The "performance" is generally described as "identical" or "equivalent" to the predicates, and compliance with recognized standards.
| Feature/Criterion | New Device (Omron Healthcare Maxpower Relief Model PM3032B) Performance | Comment (Relative to Predicates) |
|---|---|---|
| Indications for Use | Relief of pain associated with sore or aching muscles of lower back, arms, legs, shoulder, or foot due to strain from exercise or normal household work activities. Added: Symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis (using Shoulder mode). | Identical to primary predicate (K141978) for initial indications. Similar to secondary predicate (K172079) for expanded indications. |
| Environments of Use | Clinics, hospital, and home environments | Identical |
| Patient Population | Adult | Identical |
| Regulation Number | 21 CFR §882.5890 | Identical |
| Product Codes | Primary: NUH (stimulator, nerve, transcutaneous, over-the-counter) Secondary: NYN (stimulator, electrical, transcutaneous, for arthritis) | Shares NUH with primary predicate, shares NUH and NYN with secondary predicate. |
| Prescriptive | No, OTC | Identical |
| Contraindications | Identical to predicates (cardiac pacemaker, implanted defibrillator, other implanted metallic/electronic device) | Identical |
| Single Use (Pads) | Pads are for single patient use | Identical to primary predicate. |
| Sterility | External contacting device, nonsterile | Identical |
| Power Source | Two AAA alkaline batteries | Identical to primary predicate. |
| Line Current Isolation | N.A. (internal power source) | Identical |
| Patient Leakage Current - Normal Condition | 1 µA | Identical to primary predicate (vs. <10µA for secondary). |
| Patient Leakage Current - Single Fault Condition | 8.9 max µA | Identical to primary predicate (vs. <50µA for secondary). |
| Average DC current through electrodes (no pulse) | 0 µA | Identical |
| Number of Output Modes | 9 TENS modes | Identical to primary predicate (vs. 9 TENS + 1 Microcurrent for secondary). |
| Number of Output Channels | 1 Ch (Synchronous or Alternating) | Identical |
| Method of Channel Isolation | None | Identical |
| Regulated Current/Voltage | Regulated Current | Identical |
| Software/Firmware/Microprocessor Control | Microprocessor | Identical |
| Automatic Overload Trip | No | Identical |
| Automatic No-Load Trip | Yes | Identical |
| Automatic Shut Off | Yes | Identical |
| User Override Control | Yes, Power On/Off button | Identical to primary predicate. |
| Indication Display | ON/Off status, Low Battery, Voltage/Current Level | Identical to primary predicate (secondary predicate had App display). |
| Timer Range (minutes) | 15 minutes | Identical to primary predicate (vs. 5-60 and 30-180 for secondary). |
| Compliance with Voluntary Standards | ES60601-1, IEC60601-1-2, IEC60601-2-10, IEC60601-1-11 | Identical |
| Compliance with 21 CFR 898 | Yes | Identical to primary predicate (secondary N/A). |
| Weight | Approx. 100g (incl. batteries) | Identical to primary predicate. |
| Dimensions (W x H x D) | 52 x 112 x 25mm | Identical to primary predicate. |
| Operating Conditions | 10 to 40 °C, 30 to 80 %RH, 700 to 1060 hPa (non-condensing) | Similar to primary predicate, same as secondary. |
| Charging Conditions | N/A (Battery-operated) | Identical to primary predicate. |
| Transporting Conditions | -20 to 60 °C, 10 to 95% RH, 700 to 1060 hPa (non-condensing) | Identical to primary predicate. |
| Electrode Style | Long Life Pad, Reusable | Identical to primary predicate. |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "No clinical testing was performed" (Page 11). Therefore, there is no test set sample size or data provenance to report. The evaluation relies heavily on bench testing and comparison to predicate devices, which had already established their safety and effectiveness.
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)
Since no clinical testing was performed, there was no ground truth requiring expert establishment.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable as no clinical testing or test set was used for this device.
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 device is a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief, not an AI-assisted diagnostic or imaging device involving human readers.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This device is not an algorithm, but a physical TENS unit. Its performance relies on its electrical stimulation capabilities, not an algorithm's output.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
No specific ground truth (expert consensus, pathology, outcomes data) was generated for this application as no new clinical studies were conducted. The "ground truth" for demonstrating substantial equivalence is based on the previously established safety and effectiveness of the predicate devices and the physical/electrical conformity of the new device to those predicates and relevant electrical safety standards.
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI models that require a training set.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
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