(326 days)
FDES106 (ED406) Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in order to improve and facilitate muscle performance.
FDES106A (ED406A) Multi-function Mini TENS &EMS Device
For program N1, B and H of TENS mode
To be used for temporary relief of pain associated with sore and aching muscles in the lower back, abdomen, thigh, and arm due to strain from exercise or normal household work activities.
For program E1 and E2 of EMS mode
Used to stimulate healthy muscles in the lower back, abdomen, thigh, and arm in order to improve and facilitate muscle performance.
FDES105 (ED405) Pain Relief Plaster
To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household work activities.
FDES107 (ED407) Abdominal Fitness Belt
Used to stimulate healthy muscles in order to improve and facilitate muscle performance for abdominal.
The FDES106(ED406) Series Stimulator, which includes models FDES106(ED406), FDES106A(ED406A), FDES105(ED405) and FDES107(ED407), are Transcutaneous Electrical Nerve Stimulator and muscle stimulator for pain relief and/or Electrical Muscle Stimulator. The stimulator sends gentle electrical current to underlying nerves and muscle group via electrodes applied on the skin. The parameters of units are controlled by the press buttons. Its intensity level is adjustable according to the needs of patients.
The device unit of FDES106(ED406) and FDES106A(ED406A) are same, only the applied part are different: the applied part of FDES106(ED406) is electrode pad; the applied part of FDES106A(ED406A) is electrode belt. They are portable device, battery powered (3.0V DC) multi-function device offering both Transcutaneous Electrical Nerve Stimulator(TENS) and Powered Muscle Stimulator (EMS) qualities in one device.
The FDES106 (ED406) includes FDE$105 (ED405). FDES106 (ED406) has TENS and EMS two treatment mode 5 programs (N, B, H, E1, E2), FDES105 (ED405) only has TENS mode 5 treatment programs (N1, N2, B, H, F).Their appearance, structure, circuit, software operation is exactly the same, only different output treatment procedure.
FDES107 (ED407) has 10 EMS treatment process, whose intended use, waveform characteristics and is basically the same as FDES106 (ED406) EMS model, The difference is from only operation mode and structure appearance.
Independent channel (by electrode pad or electrode belt) that effectively transfers your desired choice of pre-programmed electrical pulses directly through electrode pad or electrode belt) to suggested area of the body where the electrode are placed, causing minimal muscle contractions. The FDES106 (ED406 ) and FDES106A (ED406A ) have 3 TENS programs and 2 EMS programs; FDES105 (ED405) have 5 TENS programs; FDES107 (ED107) have 10 EMS programs.
The provided document is a 510(k) premarket notification for the Famidoc FDES106 Series Electro-Stimulator devices (including models FDES106, FDES106A, FDES105, and FDES107). It aims to demonstrate substantial equivalence to legally marketed predicate devices.
Critical Note: This document explicitly states: "The FDES106(ED406) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there are no acceptance criteria based on clinical performance metrics (like sensitivity, specificity, accuracy), nor is there any study related to device performance in a clinical context reported within this document. The "acceptance criteria" and "device performance" in this context refer to adherence to established electrical, mechanical, and biocompatibility safety standards.
Below is an analysis based on the information provided regarding the non-clinical tests and comparisons.
Acceptance Criteria and Study to Demonstrate Device Meets Criteria
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission for an electro-stimulator, the acceptance criteria are generally based on compliance with recognized safety and performance standards for such devices, and substantial equivalence to predicate devices. The "reported device performance" refers to the device's adherence to these standards and its characteristics as compared to the predicates.
| Acceptance Criterion (Standard or Characteristic) | Reported Device Performance (Compliance / Comparison) |
|---|---|
| Safety Standards Compliance | |
| IEC 60601-1 (General safety) | Compliant |
| IEC 60601-1-2 (EMC) | Compliant |
| IEC 60601-1-11 (Home healthcare environment) | Compliant |
| IEC 60601-1-4 (Programmable electrical medical systems) | Compliant |
| IEC 60601-2-10 (Nerve and muscle stimulators safety) | Compliant |
| Biocompatibility Standards Compliance | |
| ISO 10993-5 (Cytotoxicity) | Compliant for electrode pad/belt and ABS enclosure materials |
| ISO 10993-10 (Irritation and skin sensitization) | Compliant for electrode pad/belt and ABS enclosure materials |
| Software Verification | Carried out according to FDA software guidance. |
| Electrical Output Specifications | Compared to predicate devices (T1040™ and Slenderton FLEX Abdominal Training System type 515), the new devices demonstrate similar waveform (Biphasic square), Max Output Voltage, Max Output Current, Pulse Width, Maximum Current Density, Maximum Average Current, Maximum Power Density, Maximum Average Power Density, and Duration of primary phase. Details are provided in tables in the submission (e.g., Pages 9-11). The differences are presented as not affecting intended use or equivalence. |
| Mechanical Features & Design | Compared to predicate devices, devices are internally powered equipment, have Type BF applied part protection, are Class II devices, and have similar features regarding output channels, treatment programs, materials of construction, automatic safety features (e.g., over current trip, no load trip, shut off time), and physical dimensions/weight. The differences are detailed in tables (e.g., Pages 5-8). |
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 Description: The "test set" in this context refers to the Famidoc FDES106 Series devices themselves, which underwent non-clinical (bench) testing.
- Sample Size: The document does not specify a quantitative sample size for the bench testing (e.g., "N units were tested"). It describes the tests generally applied to the device series. It is implied that representative units of each model (FDES106, FDES106A, FDES105, FDES107) were tested to demonstrate compliance.
- Data Provenance:
- Country of Origin: The test results are presumably from China, where the manufacturer (Famidoc Technology Co., Ltd.) is located.
- Retrospective or Prospective: The testing described is prospective, in the sense that the devices were tested against established standards to support the premarket notification.
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)
- Ground Truth Establishment: For non-clinical device safety and performance testing, "ground truth" is established by recognized international and national standards (e.g., IEC 60601 series, ISO 10993 series, FDA software guidance). These standards represent a consensus among experts (engineers, medical professionals, regulatory bodies) over years of development and revision.
- Number of Experts: Not applicable in the sense of individual expert review for each test outcome. Compliance is assessed against the defined requirements of the standards.
- Qualifications of Experts: The experts involved are those who developed and maintain the relevant IEC and ISO standards, and FDA guidance documents. Their qualifications would typically include extensive experience in electrical engineering, biomedical engineering, materials science, toxicology, and regulatory affairs pertaining to medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Adjudication Method: Not applicable. The "adjudication" for non-clinical testing refers to the objective measurement of device parameters against the defined limits or requirements of the standard. There is no human subjective adjudication of the test results themselves, beyond internal quality control and regulatory review for compliance.
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
- MRMC Study: No. This is not an imaging or diagnostic device that relies on human readers interpreting results, nor does it incorporate AI. The device is an electro-stimulator for pain relief and muscle conditioning.
- Effect Size of AI: Not applicable, as there is no AI component or MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This is a physical medical device (electro-stimulator), not a software-only algorithm. The "software verification" mentioned confirms the software functions as designed and complies with FDA guidance, but it's not a standalone performance study in the sense of an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Type of Ground Truth: The ground truth for this submission is compliance with international safety and performance standards (IEC, ISO) and FDA software guidance. This reflects an expert consensus on what constitutes a safe and acceptably performing electro-stimulator. The claims of "substantial equivalence" are based on comparing the device's characteristics to those of legally marketed predicate devices, which themselves have met these regulatory standards.
8. The sample size for the training set
- Training Set Sample Size: Not applicable. This is not a machine learning model, so there is no "training set."
9. How the ground truth for the training set was established
- Training Set Ground Truth Establishment: Not applicable, as there is no training set.
§ 890.5850 Powered muscle stimulator.
(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).