(168 days)
ETG 255 Combo Stimulator,
For TENS mode
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
For EMS mode
- Relaxation of muscle spasm.
- Increase of local blood flow circulation
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
- Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
TEN 260 Stimulator
Symptomatic relief of chronic intractable pain, relief of acute post-surgical and posttraumatic pain.
ETG 255 Combo Stimulator, TEN 260 Combo Stimulator are non-invasive devices. The devices contain the following main parts: TENS stimulation unit, Support Belt, electrode, and snap cable. The electrode is permanently sewn up in the support belt. Each belt is flexible, and is available in range of sizes to ensure good patient contact. A male snap connector is placed within the electrode and is connected via the female snap connector to a short lead wire. The lead wire has a female pin connection at the distal end which accepts the lead wire connection from the stimulator. The device can be worn on the low back part of user so as to place the electrode on the treatment location of low back.
The provided text describes a 510(k) summary for the "Care back pain relief stimulator" (models TENS 7000 and LT3074). This submission is to demonstrate substantial equivalence to a predicate device, not to prove clinical efficacy through acceptance criteria and a study.
Therefore, many of the requested sections (acceptance criteria table, sample sizes, expert qualifications, adjudication methods, MRMC study details, standalone performance, and ground truth information) are not applicable or cannot be extracted directly from this type of premarket notification for a Class II medical device claiming substantial equivalence.
Here's what can be extracted and inferred:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state "acceptance criteria" in the context of a clinical study or performance goals. Instead, the approach is to demonstrate substantial equivalence to a predicate device based on similar intended use and technological characteristics. The performance is reported in terms of various electrical output parameters.
| Parameter | Acceptance Criteria (Predicate Device) | Reported Device Performance (TENS 7000) | Reported Device Performance (LT3074) |
|---|---|---|---|
| Indications for use | Temporary relief of pain associated with sore and aching muscles in the lower back due to strain from exercise or normal household and work activities. | Temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities. | Temporary relief of pain associated with sore and aching muscles in the lower back due to strain form exercise or normal household and working activities. |
| Power Source | 9V Battery | 9V Battery | 4.5V Battery |
| Max Output Voltage (V) @500Ω | 40.0V | 40.0V | 45.0V |
| Max Output Voltage (V) @2kΩ | 120.0V | 100.0V | 50.0V |
| Max Output Voltage (V) @10kΩ | 150.0V | 110.0V | 60.0V |
| Max Output Current (mA) @500Ω | 80.0 mA | 80.0mA | 90.0mA |
| Max Output Current (mA) @2kΩ | 60.0 mA | 50.0mA | 25.0mA |
| Max Output Current (mA) @10kΩ | 15.0 mA | 11.0mA | 6.0mA |
| Pulse Width Range (us) | 150-260 us | 50-300us | 50-250us |
| Frequency (Hz) | 2-120Hz | 2-150Hz | 2-110Hz |
| Timer Range (minutes) | 15min, 30min, 60min and continuous | 5 - 60 minutes or Continuous | 30 minutes |
| Maximum Average Current @500Ω | 2.5mA | 3.6mA | 2.5mA |
| RMS current | 20.0 mA.r.m.s | 17.0 mA.r.m.s | 14.2 mA.r.m.s |
| Maximum Current Density @500Ω | $0.56mArms/cm^2$ | $0.56mArms/cm^2$ | $0.14mArms/cm^2$ |
| Maximum Power Density @500Ω | $3.3mWrms/cm^2$ | $4.8mWrms/cm^2$ | $1.0mWrms/cm^2$ |
| Compliance with Voluntary Standards? | IEC60601-1, IEC60601-1-2, IEC60601-2-10 | IEC60601-1, IEC60601-1-2, IEC60601-2-10 | IEC60601-1, IEC60601-1-2, IEC60601-2-10 |
| Compliance with 21 CFR 898? | Yes | Yes | Yes |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document states: "Care back pain relief stimulator did not conduct, nor rely upon, clinical tests to determine substantial equivalence." Therefore, there is no test set or related data provenance for a clinical study.
- The comparison is based on technical specifications and non-clinical bench testing.
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 no clinical test set was used to establish substantial equivalence.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable as no clinical test set was used to establish substantial equivalence.
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 a TENS stimulator, not an AI-powered diagnostic or assistive tool for human readers. No MRMC study was performed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a TENS stimulator, not an algorithm. The performance evaluation was based on its electrical output characteristics and compliance with standards.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the context of clinical ground truth. The "ground truth" for demonstrating substantial equivalence relied on comparing the technical specifications and safety standards compliance of the proposed device against those of the legally marketed predicate device.
8. The sample size for the training set
- Not applicable as no machine learning algorithm was involved, and no clinical training set was used.
9. How the ground truth for the training set was established
- Not applicable as no machine learning algorithm was involved, and no clinical training set was used.
Summary of the Study (Demonstration of Substantial Equivalence):
The "study" presented is a 510(k) premarket notification to the FDA, where Shenzhen Dongdixin Technology Co., Ltd. sought to demonstrate that their "Care back pain relief stimulator" (Models TENS 7000 and LT3074) is substantially equivalent to a legally marketed predicate device, the "Low Back Pain Relief System" (K060222) by Gemore Technology Co.,Ltd.
The basis for demonstrating substantial equivalence was:
- Identical Intended Use: Both devices are intended for the temporary relief of pain associated with sore and aching muscles in the lower back.
- Similar Technological Characteristics: A side-by-side comparison of electrical output parameters (voltage, current, pulse width, frequency, timer, etc.), power source, physical dimensions, and materials was provided (as detailed in the table above). While there are some differences in specific values (e.g., pulse width range, frequency), the manufacturer asserts these differences do not affect the fundamental scientific technology or safety and effectiveness.
- Non-Clinical Bench Testing & Standards Compliance: The manufacturer submitted test reports certifying compliance with voluntary standards, including IEC60601, IEC60601-1-2, IEC60601-2-10, ISO 10993 (biocompatibility, implying the electrode materials are safe for skin contact, though not explicitly an "acceptance criterion" in the table), and ISO14971 (risk management). Software verification was also carried out according to FDA guidance.
Conclusion: The manufacturer concluded that the proposed device maintains the same safety and effectiveness as the predicate device, despite minor engineering differences, therefore establishing substantial equivalence. The FDA concurred with this assessment in their letter.
§ 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).