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K Number
K113010
Device Name
FDES100(TENS AND EMS STIMULATOR, FDES102(ED402) TENS STIMULATOR
Manufacturer
FAMIDOC TECHNOLOGY CO., LTD
Date Cleared
2012-12-21

(437 days)

Product Code
IPF,GZJ
Regulation Number
890.5850
Type
Traditional
Panel
PM
Reference & Predicate Devices
K093138
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

FDES101(ED401) TENS and EMS Stimulator
For TENS mode

  1. Symptomatic relief of chronic intractable pain
  2. Post traumatic pain
  3. post surgical pain
    For EMS mode
  4. Relaxation of muscle spasm.
  5. Increase of local blood flow circulation
  6. Prevention or retardation of disuse atrophy
  7. Muscle re-education
  8. Maintaining or increasing range of motion
  9. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
    FDES102(ED402) TENS Stimulator
  10. Symptomatic relief of chronic intractable pain
  11. Post traumatic pain
  12. Post surgical pain
    FDES103(ED403) EMS Stimulator
  13. Relaxation of muscle spasm.
  14. Increase of blood flow circulation
  15. Prevention or retardation of disuse atrophy
  16. Muscle re-education
  17. Maintaining or increasing range of motion.
  18. Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
Device Description

The FDES101(ED401) Series Stimulator, which includes models FDES101(ED401), FDES102(ED402) and FDES103(ED403), 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 three models FDES101(ED401), FDES102(ED402) and FDES103(ED403) have the same housing in a molded portable plastic case with a viewable LCD display, an accessible keypad, and accessible battery storage compartment. The case shape is rectangular. The LCD is located on the upper half of the rectangular face of the device, above the keypad. The LCD is used to display system information to the user.
The device is equipped with a keypad composed of push buttons which are located below the LCD. The function for each button is defined by a symbol on the LCD corresponding to the button immediately below it. The process to set the parameter and attach lead wires to the five models is also the same. Yet, they have different liquid crystal display and parameters for patients to create their own settings.
The FDES101(ED401) TENS and EMS Stimulator is the combination unit with the TENS. EMS functions, the function can be selected by press buttons. The range of settings is identical to those of FDES102(ED402) and FDES103(ED403). The difference on the five units can be identified by the LCD display.

AI/ML Overview

The provided document is a 510(k) Summary for FAMIDOC TECHNOLOGY CO., LTD.'s FDES101 (ED401) Series Electro-Stimulator. It focuses on demonstrating substantial equivalence to a predicate device rather than providing the results of a de novo study with specific acceptance criteria and performance metrics typically associated with AI/ML device evaluations. Therefore, many of the requested elements are not applicable or cannot be extracted from this type of regulatory submission.

However, I can extract the information relevant to non-clinical testing for substantial equivalence and general device specifications.

1. A table of acceptance criteria and the reported device performance

For a 510(k) submission, the "acceptance criteria" for performance are typically substantial equivalence to a predicate device and compliance with relevant safety and performance standards. The "reported device performance" is demonstrated through these comparisons and adherence to standards.

Acceptance Criteria (Demonstration of Substantial Equivalence and Safety)Reported Device Performance (as compared to predicate and standards)
Functional Equivalence to Predicate DeviceThe FDES101(ED401) Series Electro-Stimulator is stated to be "basically the same" as the predicate device (MT9000 Series Electro-Stimulator, K093138) in "design, function, materials, operational principles and intended use."
Patient Leakage Current (Normal Condition)Acceptance: Meet requirements of IEC 60601-1.
Reported Performance: 3.0 uA (New Device) vs. 0.61 uA (Predicate). Judged as "SE, meet the requirements of IEC 60601-1."
Patient Leakage Current (Single Fault Condition)Acceptance: Meet requirements of IEC 60601-1.
Reported Performance: 5.8 uA (New Device) vs. 0.68 uA (Predicate). Judged as "SE, meet the requirements of IEC 60601-1."
Type of protection against electric shockReported Performance: Internally powered equipment (New Device) vs. Internally powered equipment (Predicate). Judged as "SE" (Substantially Equivalent).
Degree of protection against electric shockReported Performance: Type BF applied part (New Device) vs. Type BF applied part (Predicate). Judged as "SE".
Device ClassReported Performance: Class II (New Device) vs. Class II (Predicate). Judged as "SE".
Number of Output ChannelsReported Performance: 2 (New Device) vs. 2 (Predicate). Judged as "SE".
Synchronous or Alternating OutputReported Performance: Synchronous and Alternating (New Device) vs. Synchronous and Alternating (Predicate). Judged as "SE".
Method of Channel IsolationReported Performance: By electrical circuit and software (New Device) vs. By electrical circuit and software (Predicate). Judged as "SE".
Constant Current? Constant Voltage?Reported Performance: Yes/No (New Device) vs. Yes/No (Predicate). Judged as "SE".
Software/Firmware/Microprocessor Control?Reported Performance: Yes (New Device) vs. Yes (Predicate). Judged as "SE".
Automatic Overload/Over Current Trip?Reported Performance: Yes/Yes (New Device) vs. Yes/Yes (Predicate). Judged as "SE".
Automatic No Load Trip?Reported Performance: Yes (New Device) vs. Yes (Predicate). Judged as "SE".
Automatic Shut off?Reported Performance: Yes (New Device) vs. Yes (Predicate). Judged as "SE".
Patient Override Control?Reported Performance: No (New Device) vs. No (Predicate). Judged as "SE".
Indication Function (On/Off, Voltage/Current Level, Low Battery)Reported Performance: Yes for all (New Device) vs. Yes for all (Predicate). Judged as "SE".
Electrical Safety Standards ComplianceAcceptance: Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safety standards.
Reported Performance: "Compliant with requirements of IEC 60601-1, IEC 60601-2-10, IEC 60601-1-2 safety standards." Judged as "SE".
Mechanical Safety Standards ComplianceAcceptance: Compliant with requirements of IEC 60601-1, IEC 60601-2-10 safety standards.
Reported Performance: "Compliant with requirements of IEC 60601-1, IEC 60601-2-10 safety standards." Judged as "SE".
Biocompatibility Standards ComplianceAcceptance: Compliant with requirements of ISO 10993-5 and ISO 10993-10 standards. Biocompatibility testing report provided (Report No: RZ106309 for ABS shell) and electrodes from a cleared supplier (K070612). Reported Performance: "Compliant with requirements of ISO 10993-5 and ISO 10993-10 standards." Judged as "SE".
Energy Delivery LimitsAcceptance: Limited according to requirements of collateral IEC 60601-2-10 safety standards.
Reported Performance: "The delivered energy is limited according to requirements of collateral IEC 60601-2-10 safety standards." Judged as "SE".

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This document describes a 510(k) submission for an electro-stimulator, which is a hardware device. It demonstrates substantial equivalence through comparisons to a predicate device and adherence to international safety and performance standards.

  • No "test set" in the context of AI/ML performance evaluation (e.g., retrospective vs. prospective data, country of origin) is mentioned or applicable here.
  • The comparison is based on the technical specifications and safety testing of the device itself and its components, against those of a predicate device and industry standards.

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. This is a hardware device submission, not specifically an AI/ML diagnostic or prognostic device that requires expert-established ground truth for a test set.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as there is no "test set" or human expert review process described for performance evaluation in the context of an AI/ML 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 is a hardware device submission, not an AI/ML device intended to assist human readers. The document explicitly states: "The FDES101(ED401) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence."

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. The device is a physical electro-stimulator, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable. For this type of device, "ground truth" relates to compliance with engineering and safety standards, and functional equivalence to an already legally marketed device, rather than diagnostic accuracy against a clinical reference standard. The "proof" is through non-clinical bench testing and comparative analysis of specifications against predicate devices.

8. The sample size for the training set

Not applicable. This is a hardware device, not an AI/ML algorithm requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is a hardware device, and the concept of a training set and its ground truth is not relevant to this submission.

Summary of the Study that Proves the Device Meets Acceptance Criteria:

The study proving the device meets its "acceptance criteria" (which in this 510(k) context is primarily substantial equivalence to a predicate device and compliance with recognized safety standards) is a non-clinical bench testing and comparative analysis study.

  • The document explicitly states: "The FDES101(ED401) Series Electro-Stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence. Nonclinical testing was performed in order to validate the design according with the company's specified design requirements, and to assure conformance with the following voluntary design standards:"

    • IEC 60601-1 "Medical electrical equipment Part 1: General requirements for safety".
    • IEC 60601-1-2 "Medical electrical equipment Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility- Requirements and tests, Interpretation Sheet."
    • IEC 60601-1-4 "Medical electrical equipment Part 1-4: General requirements for safety - Collateral standard: Programmable electrical medical systems"
    • IEC 60601-2-10 "Medical electrical equipment Part 2: Particular requirements for the safety of nerve and muscle stimulators"

  • Evidence of Compliance: The submission includes bench testing results, safety reports, and a Risk Analysis Report to demonstrate that any engineering differences from the predicate device "do not affect the intended use or alter the fundamental scientific technology of the device," thus maintaining "the same safety and effectiveness as that of predicate device." Specific comparisons like power source, patient leakage current, electrical/mechanical safety classifications, and material properties are presented.

  • Data Provenance: The comparative data is derived from the technical specifications and test results of the new device manufactured by Famidoc Technology Co., Ltd. (China) and the predicate device (MT9000 Series Electro-Stimulator, K093138, manufactured by Shenzhen Dongdixin Technology Co., Ltd.). This is a retrospective comparison based on existing device specifications and non-clinical test data.

§ 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).