(14 days)
LT3000 Combo Stimulator
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
- Increase of blood flow in the treatment area
- Relaxation of muscle spasm
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
- Prevention or retardation of disuse atrophy
- Muscle re-education
- Maintaining or increasing range of motion.
LT3001 TENS Stimulator
- Symptomatic relief of chronic intractable pain, acute post traumatic pain or acute post surgical pain
LT3002 EMS Stimulator
- Relaxation of muscle spasm.
- Increase of blood flow in the treatment area
- Immediate post-surgical stimulation of muscles to prevent venous thrombosis
- Muscle re-education
- Prevention or retardation of disuse atrophy
- Maintaining or increasing range of motion.
The LT3000 Series Stimulator, which includes models LT3000, LT3001 and LT3002, 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 through the cable and electrode placed on the skin. The parameters of units are controlled by the rotate buttons. Its intensity level is adjustable according to the needs of patients.
The three models LT3000, LT3001 and LT3002 have the same housing in a molded portable plastic case, an accessible buttons、 switch, and accessible battery storage compartment. The case shape is rectangular. The process to set the parameter and attach lead wires to the three models is also the same except the Housing printing artwork, Mode No & destination.
The LT3000 Combo Stimulator is the combination unit with both TENS and EMS functions, the function can be selected by switch. The range of settings is identical to those of LT3001 and LT3002. The difference on the three units can be identified by printing artwork, Mode No.
The acceptance criteria and study information for the LT3000 Series Electro-Stimulator are outlined below based on the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
For the LT3000 Series Electro-Stimulator (K100117), the acceptance criteria for substantial equivalence were primarily based on technological characteristics and safety standards adherence. Since this is a 510(k) submission for a medical device that did not involve clinical trials for its substantial equivalence determination, the "reported device performance" is not in terms of clinical outcomes but rather conformance to established safety and performance benchmarks relative to a predicate device.
The presented information focuses on demonstrating that the new device meets the same safety and performance profiles as its predicate device through non-clinical testing and comparison of technical specifications.
| Acceptance Criteria (Technological Characteristics & Safety) | Reported Device Performance (LT3000 Series) |
|---|---|
| Intended Use | Same as predicate device (Symptomatic pain relief, muscle relaxation, blood flow increase, etc.) |
| Fundamental Technology | Same as predicate device (Transcutaneous Electrical Nerve Stimulation & Electrical Muscle Stimulation) |
| Power Source | 9V Battery |
| Method of Line current isolation | Battery Supply N/A |
| Patient Leakage Current (Normal) | 1.1uA (Lower than predicate's 1.5uA) |
| Patient Leakage Current (Single fault) | 1.3uA (Lower than predicate's 1.7uA) |
| Number of Output Modes | 6 (Close to predicate's 7) |
| Number of Output Channels | 2 Synchronous and Alternating |
| Method of channel isolation | By enclosure (Different from predicate's "By transformer" but deemed safe) |
| Regulated Current or Regulated Voltage? | Voltage control |
| Software/Firmware/Microprocessor Control? | Yes |
| Automatic Overload Trip? | No |
| Automatic Over Current Trip? | No |
| Automatic No Load Trip? | No |
| Automatic Shut off? | No |
| Patient Override Control? | No |
| Indicator Display (On/Off Status, Voltage/Current Level, Low Battery) | Yes for all |
| Timer Range (minutes) | 30min, 60min, continue (Similar to predicate's 5~90minutes or continue) |
| Waveform | Biphasic Rectangular |
| Pulse Width Range | 50-300us |
| Frequency | 2-120Hz (Similar to predicate's 2-150Hz) |
| Compliance with Voluntary Standards (IEC60601-1, IEC60601-1-2) | Yes |
| Compliance with IEC 60601-2-10 | Yes (for nerve and muscle stimulators) |
| Compliance with 21 CFR 898? | Yes |
| Biocompatibility of Electrodes | Electrodes from K070612 manufacturer. |
| Biocompatibility of Device Shell Material | ABS material passed testing in Jiangsu TUV Product Service Ltd. Shanghai Branch (Identification No: 080960). |
2. Sample Size Used for the Test Set and Data Provenance
The submission explicitly states: "The LT3000 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".
Therefore, there are no "test set" or "training set" in the context of patient data or clinical trials. The "test set" here refers to the actual devices being tested in a laboratory setting. There is no specific sample size mentioned for the number of devices tested, but it's implied that the non-clinical tests were conducted on representative samples of the LT3000 Series Electro-Stimulators.
The data provenance is from non-clinical bench testing conducted by the manufacturer (Shenzhen Dongdixin Technology Co., Ltd.) and relevant testing laboratories (e.g., Jiangsu TUV Product Service Ltd. Shanghai Branch for biocompatibility). This is considered retrospective in the sense that it's a report on tests already performed. The country of origin of the manufacturer is China.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
Not applicable. As no clinical studies were performed, there was no test set requiring expert ground truth establishment in a clinical context. The "ground truth" for non-clinical tests is based on adherence to engineering and safety standards, and performance specifications.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set requiring adjudication was used.
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 an electro-stimulator, not an imaging or diagnostic device that would typically involve human readers or AI assistance in interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm or AI system.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the non-clinical tests was adherence to:
- Voluntary design standards: IEC 60601-1, IEC 60601-1-2, and IEC 60601-2-10 for medical electrical equipment safety.
- Manufacturer's specified design requirements.
- Biocompatibility test results for materials used.
Essentially, the ground truth was conformance to established engineering, safety, and material standards for medical devices of this type.
8. The Sample Size for the Training Set
Not applicable. No training set was used as this was not a machine learning or AI device, nor did it involve clinical data for performance validation.
9. How the Ground Truth for the Training Set Was Established
Not applicable. No training set was used.
§ 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).