(156 days)
For Over-The-Counter Use:
TENS:
ManaFlexx 2 (MF002-OTC) is used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, arm, and leg, due to strain from exercise or normal household and work activities. ManaFlexx 2 (MF002-OTC) is also intended for symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.
PMS/NMES:
ManaFlexx2 (MF002-OTC) is used to stimulate healthy muscles in order to improve and facilitate muscle performance. To be used for the improvement of muscle tone and firmness, and for strengthening muscles in the arms, abdomen, legs, and buttocks. Not intended for use in any therapy or for the treatment of any medical conditions or diseases. ManaFlexx2 (MF002-OTC) is also intended to temporarily increase local blood circulation in the healthy muscles of lower extremities.
For Prescription Use:
TENS:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Symptomatic relief and management of chronic, intractable pain
- Adjunctive treatment for post-surgical and post-trauma acute pain
- Relief of pain associated with arthritis
PMS/NMES:
ManaFlexx2 (MF002-RX) is intended for the following use:
- Temporary relaxation of muscle spasm
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion
- Increase of local blood flow in the treatment area
- Prevention of post-surgical venous thrombosis through immediate stimulation of calf muscles
The ManaFlexx 2 delivers electric pulse generated to the user's body areas through the electrodes. The device has two program modes of different pulse frequencies, covering TENS and PMS/NMES. The main unit is egg shape, includes operating elements, such as the ON/OFF button, intensity increase button and intensity decrease button, and there are two snap connectors on the rear of the device which are for connecting with electrode. The device could be easily operated through its buttons to manually realize its functions, such as turning on/off and increasing/decreasing intensity, and there is a LED screen to display the selected mode, intensity level and charging status.
The electrode is a long strip shape with a size of 21cm x 5.3cm, its conductive part is black color, and there is white non-conductive area with a width of 1 cm in the middle, which divides the electrode into two parts: positive and negative. There are 2 snap connectors on the electrode used for connection with main unit.
The device has two models have the same appearance, the identical hardware and software, only the model names are different and model MF002-Rx is for prescription use and MF002-OTC is for OTC use.
The provided text is a 510(k) Summary for the ManaFlexx 2 device, a TENS/PMS/NMES unit. It details the device's comparison to predicate devices and summarizes non-clinical performance testing. However, it explicitly states: "Clinical testing was not performed on the device."
This means there is no study described that proves the device meets acceptance criteria based on human-in-the-loop performance, expert consensus, or clinical outcomes. The acceptance criteria and "study that proves the device meets the acceptance criteria" in this document refer exclusively to non-clinical performance testing against recognized standards.
Below is a breakdown of the requested information based only on the provided text, focusing on the non-clinical performance testing mentioned. Many points cannot be answered as they relate to clinical studies that were "not performed."
Device: ManaFlexx 2 (model: MF002-RX, MF002-OTC)
1. A table of acceptance criteria and the reported device performance
| Test Title | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| General requirements for basic safety and essential performance (against ANSI AAMI ES60601-1:2005/(R)2012 & A1:2012, C1:2009/(R)2012 & A2:2010/(R)2012 (Cons. Text) [Incl. AMD2:2021]) | The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. | Pass |
| Electromagnetic disturbances (against IEC 60601-1-2 Edition 4.1 2020-09) | No degradation of performance was found during test. | Pass |
| Requirements for medical electrical equipment and systems used in the home healthcare environment (against IEC 60601-1-11 Edition 2.1 2020-07) | The device operates normally, and can provide basic safety and essential performance. | Pass |
| Requirements for the basic safety and essential performance of nerve and muscle stimulators (against IEC 60101-2-10 Edition 2.1 2016-04) | The test is carried out under the test method specified in the standard, and the test result is within the test acceptance range of the standard. | Pass |
| Dispersion and Shelf Life Test | The impedance change before the new and aging electrode, used electrode should not exceed ± 20% of the initial average impedance. | Pass |
| Waveform & Output Test | According to "IEC 60601-2-10, Particular requirements for the safety of nerve and muscle stimulators", the limitation of output parameters with 500Ω resistance load should meet the following requirement: | |
| ● The output current limit r.m.s. with 500Ω resistance load is 80mA | ||
| ● For pulse durations of less than 0.1s, the pulse energy with 500Ω resistance load shall not exceed 300mJ per pulse. | ||
| ● The output voltage shall not exceed a peak value of 500V, when measured under open-circuit condition. | ||
| Otherwise, the following two Acceptance Criteria for the device according to FDA Guidance: | ||
| ● Maximum Power Density ≤ 0.25 (W/cm²) | Pass | |
| Biocompatibility testing (against predicate SM Electrodes cleared in K183154) | The conductive hydrogel electrode of ManaFlexx 2 is identical to the SM Electrodes as it was cleared in K183154, 2019, in formulation, processing, and sterilization, and no other chemicals have been added. | Deemed identical |
| Usability Testing (against IEC 62366-1 and IEC 60601-1-6) | The device complies with IEC 62366-1 and IEC 60601-1-6. | Complies |
| Software verification and validation testing (against FDA Guidance "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices") | Software for this device was considered as a "moderate" level concern, since a malfunction of, or a latent design flaw in, the Software Device leads to an erroneous diagnosis or a delay in delivery of appropriate medical care that would likely lead to Minor Injury. (Implied acceptance is that the V&V was successful for this concern level). | Conducted and documented |
| Cybersecurity | No external interfaces, thus no need for cybersecurity evaluation per FDA guidance "Content of Premarket Submissions for Management of Cybersecurity in Medical Devices." | Not applicable |
| Shelf-life testing | Maintain performance in 2 years (acceptable criteria similar to K171722). | Maintain performance |
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 performance testing (bench tests), the sample size is stated as "The test sample is the final, finished product." No specific number is given, but typically this means a small number of units (e.g., 3-5) are tested to demonstrate compliance.
- Data Provenance: The tests are non-clinical, lab-based performance tests against international standards. The 510(k) application is from ManaMed, Inc. (USA) with an application correspondent in Guangzhou, Guangdong, China. The testing likely occurred in a lab affiliated with the manufacturer or a third-party testing facility, potentially in China (where the correspondent is located). The data is generated prospectively as part of the regulatory submission process.
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 as typically understood in AI/clinical studies (e.g., expert consensus on medical images or patient outcomes) was not established because "Clinical testing was not performed on the device." The "ground truth" for these tests is defined by the technical specifications and performance limits set by the referenced international standards (e.g., IEC, ANSI AAMI).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This concept applies to human consensus or expert review processes, which were not part of the described non-clinical testing.
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
- No. "Clinical testing was not performed on the device."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This device is a physical TENS/PMS/NMES unit, not an AI algorithm. The performance tests are for the electrical and mechanical functions of the device itself.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
- The "ground truth" for the non-clinical tests is the adherence to the published performance specifications and limits defined by the referenced international consensus standards (e.g., IEC 60601 series, ANSI AAMI ES60601-1). This is a technical standard compliance model, not a clinical "ground truth."
8. The sample size for the training set
- Not applicable. The device is a physical stimulator, not an AI/ML model that requires a training set of data.
9. How the ground truth for the training set was established
- Not applicable, as there is no training set for an AI/ML model for this device.
§ 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).