(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.
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JUL 3 0 2002
EXHIBIT #1
510(K) SUMMARY
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR §807.92.
The assigned 5l0(k) number is:_KO21436
1. Submitter's Identification:
Theratech. Inc. 1109 Myatt Blvd Madison, TN 37115
Date Summary Prepared:
Contact: Ms. Tammy McGarr
2. Name of the Device:
Ttech Model 200E + TENS Device
3. Predicate Device Information:
K# 002874/S002, Well-TENS, Model WL-2103A, Well-Life Healthcare Inc.
4. Device Description:
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:
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- 1 TENS Unit .
- . 2 Leads
- 1 9v Battery ●
- 1 Operation Manual .
- 1 Carrying Case .
5. Intended Use:
The Ttech 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.
Please refer to our "Indications for Use" statement which is attached as Exhibit B.
દ. Comparison to Predicate Devices:
The Ttech Model 200E+ is identical in all parameters, materials, processes, etc. to the Well-TENS Model WL-2103A device (K# 002874).
7. Discussion of Non-Clinical Tests Performed for Determination of Substantial Equivalence are as follows:
All required sections of the FDA "Guidance for TENS Devices" were met. All required IEC 60601-1 and IEC 60601-1-2 testing was met.
8. Discussion of Clinical Tests Performed:
Not Applicable
9. Conclusions:
The Ttech Model 200E + TENS Device is identical to the predicate device with no new safety or effectiveness issues raised.
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Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health & Human Services. The seal features the department's name encircling a symbol. The symbol is a stylized representation of a human figure with three faces in profile, suggesting a focus on people and well-being. The overall design is simple and conveys a sense of government authority and public service.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 3 0 2002
Theratech. Inc. MDI Consultants, Inc. c/o Susan D. Goldstein-Falk 55 Northern Boulevard, Suite 200 Great Neck. New York 11021
Re: K021436
Trade Name: Ttech Model 200 E + TENS Device Regulation Number: 882.5890 Regulation Name: Transcutaneous electrical muscle stimulator Regulatory Class: II Product Code: GZJ Dated: May 2, 2002 Received: May 9, 2002
Dear Ms. Goldstein-Falk:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Susan D. Goldstein-Falk
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Sincerely yours,
Mark N Millenson
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Exhibit B
Page _ 1 __ of _ 1 __
510(k) Number (if known): _ K 021436
Device Name: Ttech Model 200E + TENS Device
Indications For Use:
- 1
The Ttech Model 200E + TENS Device is intended for symptomatic relief of chronic intractable pain.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative and Neurological Devices
| 510(k) Number | K021436 |
|---|---|
| --------------- | --------- |
| Prescription Use (Per 21 CFR 801.109) | OR | Over-The-Counter Use (Optional Format 1-2-96) | |
|---|---|---|---|
| --------------------------------------- | -- | ---- | ----------------------------------------------- |
§ 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).