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510(k) Data Aggregation
(90 days)
The Heat StimPlus, Model FDES115 is intended
TENS: This function is designated to be used for temporary relief of pain associated with sore and aching muscles in the shoulder, waist, back, upper extremities (arm) and lower extremities (leg)due to strain from exercise or normal household work activities.
EMS: This function is designed to be used for stimulating healthy muscles in order to improve and facilitate muscle performance.
The Heat StimPlus(Model:FDES115) is a small battery operated OTC device that provides a combination of TENS/EMS and heat for a warming sensation.
It delivers TENS/EMS only or alternating combinations of TENS/EMS and heat. TENS/EMS and heat are never applied at the same time. The device can connect to a specified external IEC 60601-1 compliant power supply for charging of the internal lithium ion battery. The device complies with AAMI/ ANSI/ES60601-1, IEC 60601-1-2 and IEC 60601-2-10.
FDES 115 feature two independent output channels and four self-adhesive electrode gel pads. They offer a wide range of functions for increasing general well- being, pain relief, maintaining physical fitness, relaxation, muscle revitalization and combating tiredness. For these purpose, the user can either choose from pre-set programs or specify their own to suit the user's individual needs.
Stimulation from FDES115 is 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:Type-C cable,an electrode cord / cable attached to electrodes pads and a Pad holder for storage.
The electrode pads allow for stimulation and have resistive elements to provide heat which is powered by the FDES115The electrodes cleared include the electrode patches/pads and electrode garments. which could be packaged together with the 510(k)-cleared devices or packaged separately as the replacement electrodes for 510(k)-cleared devices. The exact percentage of ingredients used in the electrode patch/pad may be withheld as the trade secret.
The device is battery powered and can be connected to an external power supply for charging the internal battery. The battery is lithium ion and is not user serviceable or accessible. The only external connections on the device are the power input and the electrode connector there is no connection to any other device.
The FDES115 is considered - OTC devices.
This device, "Heat StimPlus (Model FDES115)", is a Transcutaneous Electrical Nerve Stimulator (TENS) and Powered Muscle Stimulator (EMS) intended for temporary pain relief and muscle performance improvement, respectively. It does not rely on AI, machine learning, or complex algorithms that would require the typical acceptance criteria and study designs found in AI/ML medical device submissions. Therefore, the questions related to ground truth, number of experts, adjudication methods, multi-reader multi-case studies, and human-in-the-loop performance are not applicable to this device.
The provided document, an FDA 510(k) Premarket Notification summary, focuses on demonstrating substantial equivalence to a legally marketed predicate device (HIVOX OTC Electrical Stimulator EM59-2, K203574) through non-clinical performance testing.
Here's a breakdown of the requested information based on the provided document:
1. Table of acceptance criteria and the reported device performance:
Since the device is not an AI/ML device, the acceptance criteria are not in the form of diagnostic performance metrics like sensitivity, specificity, or AUC. Instead, the acceptance criteria are adherence to established medical device standards and acceptable ranges for electrical stimulation parameters. The "reported device performance" is demonstrated through compliance with these standards and comparison of its technical specifications to the predicate device.
| Acceptance Criteria Category | Specific Acceptance Criteria (Standards/Limits) | Reported Device Performance (Compliance/Value) |
|---|---|---|
| Safety - Biocompatibility | Compliance with ISO 10993-1 for tissue-contacting devices (<24 hours) with tests for Cytotoxicity, Skin Sensitization, Skin Irritation. | Compliant: Biocompatibility evaluation conducted in accordance with ISO 10993-1. Tested for Cytotoxicity, Skin Sensitization, and Skin Irritation. |
| Safety - Electrical | Compliance with IEC 60601-1: 2012 (Medical electrical equipment - General requirements for basic safety and essential performance). | Compliant: Electrical safety testing conducted, complying with IEC 60601-1: 2012. |
| Safety - EMC | Compliance with IEC 60601-1-2: 2014 (Medical electrical equipment - Collateral Standard: Electromagnetic disturbances – Requirements and tests). | Compliant: Electromagnetic compatibility (EMC) testing conducted, complying with IEC 60601-1-2: 2014. |
| Bench Testing - General | Compliance with IEC 60601-1-11: 2015 (Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment). | Compliant: Bench testing conducted, complying with IEC 60601-1-11: 2015. |
| Bench Testing - Specific | Compliance with IEC 60601-2-10 (Particular requirements for the basic safety and essential performance of nerve and muscle stimulators (Edition 2.1 2016-04)). | Compliant: Bench testing conducted, complying with IEC 60601-2-10. |
| Software | Compliance with FDA's "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices" (Moderate level of concern). | Compliant: Software verification and validation testing conducted and documentation provided as recommended by FDA guidance. Software classified as "Moderate" level of concern. |
| Usability | Compliance with FDA Guidance 1757, "Applying Human Factors and Usability Engineering to Optimize Medical Device Design." | Compliant: Usability testing conducted according to FDA Guidance 1757. |
| Output Electrical Parameters | Ranges specified for predicate device (e.g., Max Output Voltage, Current, Pulse Period, Frequency) | The proposed device, Heat StimPlus, has slightly different, but comparable, electrical output characteristics compared to the predicate device. For example: - Max Output Voltage (Vp, ±20%): @ 500Ω: 35V (Predicate: 50V), @ 2kΩ: 75V (Predicate: 90V), @ 10kΩ: 88V (Predicate: 125V). - Max Output Current (mAp, ±20%): @ 500Ω: 70mA (Predicate: 100mA), @ 2kΩ: 37.5mA (Predicate: 45mA), @ 10kΩ: 8.8mA (Predicate: 12.5mA). - Pulse Period (µs): 200 to 250 (Predicate: 50 to 450). - Frequency (Hz): 1 to 150 (Predicate: 1 to 150).The submission states that these differences do not adversely impact safety or effectiveness. |
| Max Temperature Setting | 43°C (for predicate device) | 43°C (for proposed device's max setting, specified as Level E3, with lower levels E1 up to 37°C and E2 up to 41°C). Predicate had Low and High settings up to 41°C and 43°C respectively. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Test Set Sample Size: Not applicable. For non-clinical performance testing (biocompatibility, electrical safety, EMC, bench testing), the "sample size" typically refers to the number of devices or components tested. This information is not detailed in the summary but would be part of the full test reports.
- Data Provenance: The tests are reported as having been "conducted on the Heat StimPlus (Model: FDES115)." The manufacturer is Famidoc Technology Co., Ltd. in China. The data would be prospective, as it involves testing the manufactured device.
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. As this is a physical medical device (TENS/EMS) undergoing engineering and safety testing, "ground truth" and expert reviews in the context of diagnostic interpretation are not relevant. Compliance with standards is typically assessed by engineers and testing laboratories.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for this type of device and 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:
Not applicable. This device is not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device does not have a standalone algorithm for diagnostic or clinical decision support. Its performance is intrinsic to its hardware and pre-programmed stimulation settings.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable for the reasons stated above. The "ground truth" for this device's performance is its physical and electrical adherence to engineering specifications and international safety standards.
8. The sample size for the training set:
Not applicable. This device is not an AI/ML device that requires a training set.
9. How the ground truth for the training set was established:
Not applicable. This device is not an AI/ML device that requires a training set or associated ground truth.
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