(85 days)
The Ttech Model 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.
The Ttech 200E + TENS Device is a battery-operated device that includes controllable output channels. This TENS device creates electrical impulses whose intensity, duration, number per second and modulation can be altered with the controls and switches. There are two separate amplitude controls (channels). Every channel can be connected with the lead wire, on which two pieces of electrodes are to be connected to the end of the wire to provide stimulation for the intended part of the body.
There are three operation modes:
- . Convention Mode (c)
- Burst Mode (b)
- Modulated Mode (c) .
The operator may choose any one of them, as applicable.
The device includes the following:
- 1 TENS Unit .
- . 2 Leads
- 1 9v Battery ●
- 1 Operation Manual .
- 1 Carrying Case .
The provided document is a 510(k) summary for the Ttech Model 200E + TENS Device, submitted in 2002. It focuses on demonstrating substantial equivalence to a predicate device rather than presenting a study to prove the device meets acceptance criteria derived from clinical trials.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not explicitly defined in terms of specific performance metrics or thresholds for clinical effectiveness. | The device is stated to be "identical in all parameters, materials, processes, etc." to the predicate device (Well-TENS Model WL-2103A, K# 002874/S002). This implies that its performance is equivalent to the predicate. |
| Compliance with FDA "Guidance for TENS Devices" | Met |
| Compliance with IEC 60601-1 (medical electrical equipment - general requirements for basic safety and essential performance) | Met |
| Compliance with IEC 60601-1-2 (medical electrical equipment - electromagnetic compatibility) | Met |
Explanation: The document does not specify quantitative acceptance criteria for the device's therapeutic effect (e.g., reduction in pain scores by a certain percentage). Instead, the acceptance criteria are entirely based on demonstrating technical and functional equivalence to a legally marketed predicate device and compliance with relevant safety and performance standards.
2. Sample Size Used for the Test Set and Data Provenance
No test set for clinical performance was used or described. The submission relies on a comparison to a predicate device and adherence to engineering standards. There is no information regarding sample size or data provenance related to clinical testing.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable. No ground truth for a clinical test set was established as no clinical testing was performed for this 510(k) submission.
4. Adjudication Method for the Test Set
Not applicable. No clinical test set or adjudication method was described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No. An MRMC comparative effectiveness study was not done. The submission explicitly states "Discussion of Clinical Tests Performed: Not Applicable."
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a TENS unit, not an algorithm, and its performance is evaluated through comparison to a predicate device and engineering standards, not through standalone or human-in-the-loop algorithmic performance studies.
7. The Type of Ground Truth Used
The "ground truth" in this submission is the demonstrated "substantial equivalence" to a predicate device for safety and effectiveness, supported by compliance with relevant FDA guidance and international electrical safety standards (IEC 60601-1 and IEC 60601-1-2). There is no "clinical ground truth" in the sense of patient outcomes or pathology reports directly established for this specific device in this submission.
8. The Sample Size for the Training Set
Not applicable. No training set was used as this is not an AI/ML device requiring a training set.
9. How the Ground Truth for the Training Set was Established
Not applicable. No training set was used.
§ 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).