(144 days)
The GEMORE TENS System, model GM310TP/GM320TP/GM330TP/GM340TP Transcutaneous Electrical Nerve Stimulators are indicated for:
- symptomatic relief of chronic, intractable pain .
- adjunctive treatment for post-surgical and post-traumatic acute pain
- relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand
The Gemore TENS System / Model GM310TP, GM320TP, GM330TP, and GM340TP transcutaneous electrical nerve stimulators for pain relief, are the electrically power devices used to apply an electrical current to electrode on a patient's skin to relieve pain. This series of TENS devices are indicated for:
- symptomatic relief of chronic, intractable pain
- . adjunctive treatment for post-surgical and post-traumatic acute pain
. relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand
For this definition of intended use, the Gemore TENS system is classified with the "NYN" & "GZJ" product code under 21CFR/Part 882.5890 FDA regulation classification number.
The Gemore TENS system consists mainly of two parts: the stimulus generator and electrode. The stimulus generator generates the output current specified as the input of controller. The output of controller is able to be adjusted for B/C/M/P1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cycle. For every operation mode, the operator could adjust output intensity, pulse rate and operation time. The output parts transmit the output current to the electrodes which is attached to the patient's skin so as to .transmit the generated stimulus to patient for pain relief treatment.
GM310TP/GM320TP/GM330TP/GM340TP is completely identical to that of model as mentioned in our previous submission of GEM STIM TENS, model GM310TE/ GM320TE/GM330TE/GM340TE (K032720). To change the indication for use as that of the chosen predicate devices, Gemore changed the software for these four models.
For the device included in this submission, we use the following of our 510(K) legally marketed predicate garment electrodes: - K062675, "Gemore Reuseable Self Adhesive Electrode" ; Wire Series/ Model FA5050 ( 5x5 CM or bigger size) self adhesive electrode.
GM310TP/GM320TP/GM330TP/GM340TP is a selectable dual channel, 9V battery operated TENS device with the following features: - The operation function is dual channels completely identical to the model being modified, GM310TE/GM320TE/GM330TE/GM340TE (K032720).
- The output of controller is able to be adjusted for B/C/M/P 1/P2/P3/P4/P5 eight operation modes which bear different combination for the output parameters of pulse width, pulse rate, and pulse cvcle.
- The output strength is adjustable at 0~80 mA, with maximum setting time 60 minutes counting from switching ON.
- The LCD display is provided for the indication of operation status including CH1/CH2, output program mode, pulse width, pulse rate, timer, and battery low warning
Here's an analysis of the provided text regarding the acceptance criteria and study for the GEMORE TENS System:
Summary of Device Performance and Acceptance Criteria
The submission for the GEMORE TENS System (models GM310TP/GM320TP/GM330TP/GM340TP) is a 510(k) premarket notification, which seeks to demonstrate substantial equivalence to a legally marketed predicate device (Empi - SELECT TENS System, K061650). This type of submission generally does not involve a clinical study to directly prove efficacy against acceptance criteria in the same way a de novo or PMA submission might. Instead, it focuses on demonstrating that the new device is as safe and effective as the predicate device by meeting similar technological characteristics and performance specifications.
The "acceptance criteria" here are implicitly defined by the performance characteristics of the predicate device and relevant voluntary standards. The "study" proving the device meets these criteria is a series of non-clinical tests and comparisons.
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence claim based on non-clinical testing and comparison to a predicate, the "acceptance criteria" are the performance specifications and safety standards met by the predicate device and relevant industry standards. The "reported device performance" is how the new device compares to these.
| Feature / Acceptance Criteria (Derived from Predicate/Standards) | GEMORE TENS System (Reported Performance) | Notes on Acceptance |
|---|---|---|
| Intended Use | Symptomatic relief of chronic, intractable pain; Adjunctive treatment for post-surgical and post-traumatic acute pain; Relief of pain associated with osteoarthritis of the knee and rheumatoid arthritis of the hand. | Meets: Identical to the predicate device's Indications for Use. |
| Product Code | GZJ & NYN | Meets: Identical to the predicate device. |
| Electrical Safety (IEC 60601-1) | Compliant | Meets: Declared compliance. |
| Electromagnetic Compatibility (IEC 60601-1-2) | Compliant | Meets: Declared compliance. |
| Transcutaneous Electrical Nerve Stimulators (ANSI/AAMI NS4) | Compliant | Meets: Declared compliance (predicate also complies with IEC standards). |
| Software Verification | Carried out in accordance with FDA software guidance. | Meets: Declared compliance for software. |
| Power Source | 9V battery | Different: Predicate uses 1.5Vx2 (AA Size). Deemed not to affect safety/effectiveness. |
| Method of Line Current Isolation | Type BF | Meets: Same as predicate. |
| Patient Leakage Current (Normal Condition) | Under 0.1 uA | Meets: Same as predicate. |
| Patient Leakage Current (Single Fault Condition) | Under 0.5 uA | Meets: Same as predicate. |
| Number of Output Modes | 2 | Meets: Same as predicate. |
| Channel Synchronization | Synchronous | Meets: Same as predicate. |
| Method of Channel Isolation | Output transformer | Meets: Same as predicate. |
| Output Regulation | Current | Meets: Same as predicate. |
| Software/Firmware/Microprocessor control | Yes | Meets: Same as predicate. |
| Automatic Shut Off? | Yes | Meets: Same as predicate. |
| Display Indicators | On/Off Status, Low Battery | Meets: Same as predicate. (Note: Predicate says "Same" for Voltage/Current Level, but new device says "No"). Substantial equivalence maintained. |
| Timer Range (Minutes) | 15, 30, and 60 | Different: Predicate has 1~60. Deemed not to affect safety/effectiveness. |
| Weight | 140 g | Similar: Predicate is 138.9 g. |
| Dimensions (W x H x D) | 108x61.5x25 mm | Similar: Predicate is 109.5x60x34.9 mm. |
| Housing Materials | ABS | Meets: Same as predicate. |
| Waveform | Monophasic | Meets: Same as predicate. |
| Shape | Rectangular | Meets: Same as predicate. |
| Maximum Output Voltage (V) (+/- 20%) | 40V @500Ω, 96V @2kΩ, 110V @10kΩ | Different: Predicate is lower. Deemed not to affect safety/effectiveness, possibly offering more robust output at higher impedances. |
| Maximum Output Current (mA) (+/- 20%) | 80mA @500Ω, 48mA @2kΩ, 11mA @10kΩ | Different: Predicate is lower. Deemed not to affect safety/effectiveness. |
| Duration of primary phase (usec) | 260 (usec) Max | Different: Predicate is 400 (usec) Max. Deemed not to affect safety/effectiveness, but shows a difference. |
| Pulse Duration (usec) | 260 Max | Different: Predicate is 400 Max. |
| Frequency (Hz) / Rate (pps) | 160 Max | Different: Predicate is 150 Max. |
| Symmetrical phases (for multiphasic waveforms) | No (monophasic) | Meets: Same as predicate (both are monophasic). |
| Max Phase Charge (uQ) | 20.8 uQ (for all modes) | Meets / Similar: Same as predicate (20.8uQ). |
| Max Current Density (mA/cm²) | Ranges from 0.083 to 0.133 | Similar: Predicate value is 0.1248. Differences are within acceptable limits for substantial equivalence. |
| Max Avg Current (mA) | Ranges from 2.08 to 3.328 | Similar: Predicate value is 3.12 (in most cases), 13.12 (P1). Differences are within acceptable limits for substantial equivalence. |
| Max Power Density (w/cm²) | Ranges from 0.0033 to 0.0053 | Similar: Predicate value is 0.0037. Differences are within acceptable limits for substantial equivalence. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: Not applicable in the context of this 510(k) submission. This is a technical comparison and non-clinical performance verification, not a clinical trial with a "test set" of patients. The "test set" for performance characteristics would refer to the TENS devices themselves being tested in a lab environment.
- Data Provenance: The data comes from the manufacturer's (Gemore Technology Co., Ltd., Taiwan) internal testing and comparison against the specifications of the predicate device (Empi - SELECT TENS System). It is entirely non-clinical.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
- Number of Experts: Not applicable. Ground truth for a device's technical specifications and compliance with standards is established through engineering and electrical testing, not typically by clinical experts in the sense of reviewing patient data.
- Qualifications of Experts: N/A.
4. Adjudication Method for the Test Set
- Adjudication Method: Not applicable. There is no ambiguous patient data requiring expert adjudication in a 510(k) submission focused on technical equivalence.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No, an MRMC comparative effectiveness study was not done. This type of study is specifically for evaluating the diagnostic performance of a device (often imaging AI) by multiple human readers across multiple cases, and comparing performance with and without AI assistance. The GEMORE TENS System is a pain relief device, and this specific submission is for technical equivalence, not clinical efficacy through such a study design.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
- Standalone Performance: While the TENS device itself operates "standalone" in delivering electrical stimulation, the concept of "standalone performance" and "human-in-the-loop" typically applies to AI diagnostic algorithms. For a TENS device, the "performance" is its ability to deliver specified electrical outputs accurately. This was verified through engineering tests. There's no AI algorithm here that performs a diagnostic task independently or with human input.
7. The Type of Ground Truth Used
- Type of Ground Truth: The "ground truth" here is the technical specifications and performance characteristics of the predicate device, as well as the relevant voluntary standards (ANSI/AAMI NS4-1985, IEC 60601-1, and IEC 60601-1-2) for electrical safety and electromagnetic compatibility. The new device's performance was measured against these established engineering benchmarks.
8. The Sample Size for the Training Set
- Sample Size for Training Set: Not applicable. This device does not use machine learning or AI that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
- Ground Truth for Training Set: Not applicable. As there is no training set, there is no ground truth establishment for it.
Conclusion of the Submission:
The study presented here is a pre-market submission (510(k)) demonstrating substantial equivalence between the new GEMORE TENS System and a previously cleared predicate device. This is achieved through:
- Detailed technical comparison of features, intended use, operating modes, and physical characteristics.
- Performance comparison of electrical output parameters (voltage, current, pulse duration, frequency, phase charge, current density, average current, power density).
- Declaration of compliance with recognized voluntary standards (ANSI/AAMI NS4-1985, IEC 60601-1, and IEC 60601-1-2).
- Software verification according to FDA guidance.
The manufacturer asserts that despite some minor differences (e.g., power source, maximum output parameters, timer range), these differences do not affect the intended use or alter the fundamental scientific technology of the device, thus maintaining the same safety and effectiveness as the cleared predicate. The FDA agreed with this assessment, granting 510(k) clearance.
§ 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).