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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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(135 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 and work activities.
The Maxpower relief (Model PM3032) is a small, battery operated TENS device for pain relief intended for OTC use. The device complies with AAMI ANSI ES60601-1, IEC 60601-1-2 and IEC 60601-2-10. The output modes are intended for application to the following areas: lower back, arms, legs, shoulder or foot. Software controls all controls and indicators. Software controls 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 is a 510(k) summary for the Omron Maxpower relief (PM3032), a Transcutaneous Electrical Nerve Stimulator (TENS) for pain relief. It describes the device and compares it to predicate devices to establish substantial equivalence, rather than detailing a specific study to prove acceptance criteria for a novel device. Therefore, much of the requested information regarding acceptance criteria, study design, sample sizes, expert involvement, and ground truth establishment is not directly present as it would be for a clinical trial demonstrating the efficacy or performance of a new device against predefined metrics.
However, based on the provided document, here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document establishes "substantial equivalence" as the primary acceptance criterion, specifically, that the Maxpower relief (PM3032) is substantially equivalent to predicate devices (K110068 - Omron PM3030 and K121757 - Healthmate International Pro-8AB).
| Acceptance Criteria (Substantial Equivalence) | Reported Device Performance (Maxpower relief (PM3032) vs. Predicates) |
|---|---|
| Indications for Use: 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 and work activities. | Substantially equivalent / Virtually identical to both predicate devices (PM3030: lower back, arms, or legs; Pro-8AB: shoulder, waist, back, neck, upper/lower extremities). |
| Prescriptive Status: Over-The-Counter Use (OTC) | Identical (all devices are OTC). |
| Design and Technology: Equivalent design and features, identical technology to PM3030. | Equivalent design and features when compared to predicates; identical technology to PM3030. |
| Performance and Specifications: Equivalent specifications of performance. | Equivalent specifications of performance when compared to the predicates (Tables 5.1, 5.2, and Output Specifications show detailed electrical parameter comparisons). |
| Compliance with Standards: AAMI ANSI ES6060-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-2-10. | Complies with AAMI ANSI ES60601-1, IEC 60601-1-2, IEC 60601-1-11, and IEC 60601-2-10. Predicates comply with similar, though sometimes older, versions of these standards. |
| Patient Contacting Materials (Biocompatibility): Long Life Pads must be compatible. | Long Life Pads data presented in K120516 (Irritation, delayed-type hypersensitivity, Cytotoxicity tests per ISO 10993-10 and ISO 10993-5). |
| Patient Population: Adults | Identical (adults). |
| Environment of Use: Clinics, hospital and home environments. | Identical to predicate K110068. |
| Non-Clinical Testing: Testing of all controls, indicators, battery state indicators, waveforms, and compliance with specified electrical and environmental standards (drop, vibration, temperature, humidity). | Performed and met requirements (specific results not detailed in this summary, but statement confirms testing was done). |
| Usability Testing: Performed. | Performed (results not detailed). |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not applicable in the context of this 510(k) summary, as it describes a substantial equivalence submission based on non-clinical engineering and performance comparisons, not a clinical study on a human "test set." The "test set" here refers to the device itself being tested for its electrical and physical characteristics against established engineering standards and comparison with predicate devices.
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)
This information is not applicable. Ground truth, in the context of clinical expert consensus, is not relevant here as no clinical study with human data requiring expert interpretation was performed or referenced for performance. The "ground truth" for the non-clinical tests would be the specifications derived from the predicate devices and the requirements of the standards themselves, established by engineering and regulatory experts, but not individually enumerated here.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not applicable. No clinical adjudication process was described or required for this type of submission.
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
This information is not applicable. The device is a Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
This information is not applicable. The device is a TENS unit, not an algorithm. Performance evaluation was based on its physical and electrical characteristics as a standalone medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is established by:
- Engineering specifications of the predicate devices.
- Regulatory requirements and consensus standards (e.g., IEC 60601 series, ISO 10993 series), which represent a form of expert consensus in their development.
- Previous FDA clearances (510(k) numbers K110068 and K121757) for the predicate devices, which serve as a benchmark for what is already considered safe and effective.
8. The sample size for the training set
This information is not applicable. There is no "training set" in the machine learning sense for this device. The device's design and manufacturing are based on established engineering principles and prior device models, not on a data-driven training process.
9. How the ground truth for the training set was established
This information is not applicable as there is no training set for this device.
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