(220 days)
This device is a prescription device and only for symptomatic relief of chronic intractable pain.
The device is a Transcuteneous Electrical Nerve Stimulator. This devices utilizes battery power to produce square wave pulsed energy through electrodes placed on the body. The device has multiple modes of application, which are software controlled by the patient. The outputs are limited by design, so that hazardous energy cannot be delivered to the patient.
The provided 510(k) summary for the Shenzhen Dongdixin Technology Co., Ltd. DX6605E-G and DX6609-G TENS device indicates that its acceptance criteria and the study proving it meets these criteria are based on conformance to established medical device standards and substantial equivalence to a predicate device.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Electrical Safety (EMC) | Compliance with IEC60601-1-2 2nd edition, EN55011:1998+A2:2002, EN6100-3-3:1995+A1:2001 for Electrical Immunity. | The DX6609-G (representative) complies with all these requirements. |
| Biocompatibility | Compliance with ISO10933 parts [parts not specified, but likely referring to a series like 5, 10, 100, 1000, etc. based on the numerical sequence provided] for toxicology of device accessories. | The device accessories were tested to ISO10933 parts 5, 10, 100, 1000, etc. and comply with all requirements. |
| Product Performance | Compliance with AAMI/ANSI NS-4 (specific to TENS devices). | The device complies with all requirements of this standard. |
| Safety and Effectiveness | Substantial equivalence to the predicate device: GEM-TWIN TENS, Model GM3XY/Z (GM320PT) (K042559). This implies that the new device should have the same intended use, technological characteristics, and perform as safely and effectively as the predicate without raising new questions of safety or effectiveness. | The conclusion states the DX6605E-G and DX6609-G are "safe and effective, comply with the appropriate medical device standards, and are substantially equivalent to the earlier identified predicate devices." The comparison table (not fully provided in the extract, but referenced) would detail the technical similarities to the predicate. |
| Intended Use | For symptomatic relief of chronic intractable pain (prescription device). | The device's stated intended use matches this criterion. |
| Energy Output Limitations | Designed to limit outputs so that hazardous energy cannot be delivered to the patient. | Device description explicitly states: "The outputs are limited by design, so that hazardous energy cannot be delivered to the patient." |
2. Sample size used for the test set and the data provenance
The document does not mention specific test sets or patient data (retrospective or prospective) for clinical performance validation. The performance testing described is hardware-centric and focuses on compliance with international and national standards for electrical safety, biocompatibility, and product performance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. The evaluation is based on technical standards compliance and substantial equivalence to a predicate device, not on expert-adjudicated clinical data for the device itself.
4. Adjudication method for the test set
Not applicable, as expert-adjudicated test sets are not described.
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 Transcutaneous Electrical Nerve Stimulator (TENS), not an AI-assisted diagnostic or imaging device that would involve human "readers."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. As a physical medical device, not an algorithm, the concept of "standalone" algorithm performance does not apply in this context. The device's performance is inherently its "standalone" functionality.
7. The type of ground truth used
The "ground truth" for this device's acceptance is primarily compliance with established medical device standards and demonstrated substantial equivalence to a legally marketed predicate device. The standards themselves define the "truth" of performance and safety for various aspects (electrical, biocompatibility, functional).
8. The sample size for the training set
Not applicable. This device is a TENS unit, a hardware device, and does not involve AI or machine learning models that would require a "training set."
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this device.
§ 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).