(25 days)
TENS:
• Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain
NMES:
- Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increasing local blood circulation
- Muscle re-education
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
· Maintaining or increasing range of motion
The AMD 6605 is a 2 channel TENS/NMES stimulator device that is used to help reduce pain, with each channel being isolated from the other. The AMD 6605 is a programmable device that come equipped with 10 preset programs along with 10 user programs. The user programs are adjustable and can be changed to best help the patient at the doctor's recommendation and prescription settings. The program modes are preset programs that a clinician can conveniently choose from should they desire. This device has a special masking program to make the unwanted programs unavailable to the patients while locking the device in the needed relief setting. This way the patient does not receive the knowledge or ability to change the doctor's prescription settings without a clinician's consent. The AMD 6605 is programmed to default to program P-10 which contains the most common setting.
The device gives the clinician ability to store frequencies or to choose from a set of many frequencies that allow quick and easy selection, for prescription of stimulation regimen that can be later stored in any of the many available memory slots. However once the program is set the patients does not have the ability to alter the program from what the doctor or licensed practitioner has deemed to be the most appropriate program for their patient's needs.
The AMD 6605 has the following specifications: There is pulse mode with a bi-phase retangular pulse, the pulse frequency is 1 Hz to 3.65KHz, the pulse width is 30us, and the pulse amplitude is 140 levels(less than 70mA peak into 1000 ohms load to each channel). The power supply of AMD 6605 is 6.0V DC; this is supplied by four AAA type batteries.
Here's a breakdown of the acceptance criteria and study information for the AMD 6605 device, based on the provided document:
This submission is a 510(k) premarket notification, which means the device is seeking clearance based on its substantial equivalence to a legally marketed predicate device, rather than requiring a full de novo clinical study to prove efficacy and safety from scratch. Therefore, the "study" demonstrating it meets acceptance criteria is primarily a comparison to a predicate device and adherence to recognized standards.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the AMD 6605 are primarily derived from its substantial equivalence to the predicate device, Elpha Model II3000, and compliance with various safety and performance standards. The "reported device performance" is essentially that it matches or is comparable to the predicate device and meets the listed standards.
| Acceptance Criteria Category | Specific Criteria / Standard | AMD 6605 Reported Performance |
|---|---|---|
| Intended Use | Identical to predicate device: Symptomatic relief and management of chronic (long-term), intractable pain and an adjunctive treatment in the management of post-surgical pain and post-traumatic acute pain (TENS); Relaxation of muscle spasms, Prevention or retardation of disuse atrophy, Increasing local blood circulation, Muscle re-education, Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis, Maintaining or increasing range of motion (NMES). | Identical to predicate device. |
| Indications for Use | Identical to predicate device (TENS and NMES functions as listed above). | Identical to predicate device. |
| Target Population | 18 years of age and older. | Identical to predicate device. |
| Human Factors | Identical to predicate device. | Identical to predicate device. |
| Contraindications | Identical to predicate device: Patients with pacemakers and heart conditions should NOT use; Do NOT use stimulation over the carotids sinus nerves, the larynx or throat muscles; Do NOT use stimulation trans-cerebrally; Do NOT use on undiagnosed pain or until etiology is established. | Identical to predicate device. |
| Device Design - Type | TENS/NMES product. | TENS/NMES product. |
| Device Design - Channels | 2 channel (independently controlled). | 2 channel (independently controlled). |
| Device Design - Electrodes | 2 electrodes per channel (4 total), 2" round self-adhering reusable Amgel based electrodes, FDA approved. | 2 electrodes per channel (4 total), 2" round self-adhering reusable Amgel based electrodes, FDA approved or equivalent. |
| Device Design - Wave Form | Monophasic rectangular wave-form single phase. | Monophasic rectangular wave-form single phase. |
| Device Design - Pulse Width | 300 uS. | 30-300 uS (AMD 6605 offers a range including the predicate's 300uS). |
| Device Design - Max Output Current | 100mA. | 70mA (acknowledged as less intense but equivalent for indications). |
| Device Design - Polarity | Red = plus, Black = minus. | Red = plus, Black = minus. |
| Device Design - Power Source | Battery powered. | Battery powered. |
| Device Design - Batteries | 9V 1ea. Alkaline or Rechargeable. | AAA 4ea. Alkaline or Rechargeable. |
| Device Design - Dimensions | 114 x 60 x 31 mm. | 141(L) x 60(W) X 18(H) mm. |
| Device Design - Weight | 158 grams (with batteries). | 115 grams (with batteries). |
| Performance - Locking Feature | Keyboard lock (safety feature). | Keyboard lock (safety feature). |
| Performance - Alarm | Electrode alarm. | Electrode alarm. |
| Performance - Level Adjustment | Intensity adjustment (by 1 mA). | Intensity adjustment (by 0.5 mA). |
| Performance - Treatment Timer | Treatment Timer with auto shut off. | Treatment Timer with auto shut off. |
| Performance - Auto Treat & Repeat | Automatic setting & repeat of treatment. | Automatic setting & repeat of treatment. |
| Biocompatibility | ISO 10993-1:1997, ISO 10993-12:2007, ISO 10993-10:2002. | Met these standards (information NOT available in table, but stated met in non-clinical data section). |
| General Safety | IEC 60601-1:1988+A1:1991+A2:1995. | Met this standard. |
| Electromagnetic Compatibility | IEC 60601-1-2:2001/A1:2004. | Met this standard. |
| Safety Requirements (Software) | IEC 60601-1-4:2000. | Met this standard. |
| Declaration of Conformity | IEC 60601-1-6:2004. | Met this standard. |
| Risk Analysis | Acceptable and mitigated potential hazards. | Demonstrated acceptable and mitigated potential hazards. |
2. Sample Size Used for the Test Set and Data Provenance
This document describes a 510(k) submission for a non-AI/ML medical device. It does not rely on a "test set" of patient data in the way an AI/ML device would. Instead, its "test set" for demonstrating substantial equivalence is the predicate device itself (Elpha II 3000) and laboratory testing to confirm adherence to electrical safety and biocompatibility standards.
- Sample Size for Test Set: Not applicable in the context of clinical data for an AI/ML model. The evaluation is based on comparison with a predicate device and adherence to engineering and safety standards.
- Data Provenance: Not applicable. The "data" here refers to the device specifications and performance characteristics, and compliance with international standards for medical devices. The country of origin of the device manufacturer is Shenzhen, P.R. China, but this doesn't directly relate to data provenance for an AI/ML context. The study is a pre-market notification process, not a clinical trial studying patient outcomes.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
Not applicable. For this type of device (TENS/NMES stimulator), "ground truth" as it relates to expert consensus on medical images or diagnoses is not a component of the substantial equivalence pathway. The "truth" is established by matching the predicate device's functional specifications and meeting recognized safety and performance standards.
4. Adjudication Method for the Test Set
Not applicable. There is no "adjudication method" described in the context of expert review of data as there would be for an AI/ML system.
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 not an AI/ML device, and no MRMC study was performed or is relevant to its 510(k) clearance. The device is a direct-to-patient (prescription-based) electrotherapy stimulator.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is not an algorithm-based device. Its performance is inherent in its physical and electrical design and functionality as an electrotherapy stimulator.
7. The Type of Ground Truth Used
The "ground truth" for this substantial equivalence determination is:
- Predicate Device Specifications and Performance: The established specifications, indications, contraindications, and performance characteristics of the legally marketed Elpha II 3000.
- Recognized Consensus Standards: International standards for medical device safety, EMC, and biocompatibility (e.g., IEC 60601 series, ISO 10993 series).
- Risk Analysis: Demonstrating that potential hazards are identified and mitigated to an acceptable level.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/ML device and does not involve a "training set" in the computational learning sense.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, there is no ground truth established for it.
§ 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).