(157 days)
No
The description focuses on pre-defined programs and user-controlled adjustments, with no mention of adaptive learning or data-driven decision making characteristic of AI/ML.
Yes
The device is described as "transcutaneous electrical nerve stimulation for the purposes of relief of chronic intractable pain" and is used "for the relief of chronic intractable pain by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions," which falls under the definition of a therapeutic device.
No
The device is described as a transcutaneous electrical nerve stimulator for pain relief, not for diagnosing medical conditions. Its function is to provide therapy, not to identify or characterize diseases.
No
The device description explicitly states it is a "compact, battery powered transcutaneous electrical nerve stimulator," indicating it is a hardware device that delivers electrical pulses.
Based on the provided information, the Smart-TENS is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use is for "transcutaneous electrical nerve stimulation for the purposes of relief of chronic intractable pain." This is a therapeutic application, not a diagnostic one.
- Device Description: The device delivers electrical pulses to the body for pain relief. It does not analyze samples (like blood, urine, or tissue) to provide diagnostic information.
- Lack of IVD Characteristics: The description does not mention any features or functions related to analyzing biological samples, detecting biomarkers, or providing diagnostic results.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Smart-TENS does not fit this definition.
N/A
Intended Use / Indications for Use
The Smart-TENS is used for transcutaneous electrical nerve stimulation for the purposes of relief of chronic intractable pain.
Product codes
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Device Description
The Smart-TENS is a compact, battery powered transcutaneous electrical nerve stimulator. It is used for the relief of chronic intractable pain by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the programs in the Smart-TENS cannot be set by the user. Two channels are available on the Smart-TENS. Each channel operates independently and if desired they may be used simultaneously. The clinician may set the prescribed program from a list of defined programs. The patient may then use this program or another available program called MultiTens which provides a pattern of sequences which allows variation and modulation on the stimulation pulse. The patient may also initiate burst mode on certain programs, cause one of the pattern of sequences in MultiTens Mode to repeat continuously, advance to the next sequence or pause the treatment session, increase or decrease the amplitude intensity of the stimulation or lock the intensity controls. Use of the device is recorded internally, allowing the clinician to determine compliance with the prescribed treatment regimen.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
Non-clinical tests: Comparisons of stimulation outputs for the Smart-TENS and the predicate Bio Tens Model: ST-601 show similar results that are suitable for TENS. To minimize potential electrical and mechanical hazards, Bio-Medical Research adheres to recognised and established industry practice and all devices are subject to final performance testing. The Smart-TENS is designed to conform to EN60601-1 (IEC 601-1) and conforms to EN 60601-1-2 (IEC 601-1-2).
Clinical tests: No clinical testing was performed.
Test conclusions: Testing of the stimulation output parameters of the Smart-TENS indicate that the device is safe, that it provides appropriate stimulation output for effective relief of chronic pain and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.
Key Metrics
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Predicate Device(s)
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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).
0
1613710 510(k) Notification for Smart-TENS: Appendix IX SEP 1 2 1996
510(k) Summary of Safety and Effectiveness
This summary is submitted in compliance with the FDA interim rule 21 CFR 807.92.
Bio-Medical Research Ltd., (1) Submitted by: (a) BMR House, 16 Merchants Road, Galway. Republic of Ireland Telephone: + 353 91 566911 + 353 91 566907 Fax:: Isaac Finnegan Contact Person: Design Engineer - Regulatory Affairs Position/ Title: Date of preparation: 4 April, 1996 (2) Trade name of device: Smart-TENS, Model 456 TENS Common name: Transcutaneous Electrical Nerve Stimulator Classification name: for pain relief; $882.5890 Identification of predicate (3) Bio Tens Model: ST-601 or legally marketed device: (Skylark Device Co. Ltd., 510(k) # K912178)
1
510(k) Notification for Smart-TENS: Appendix IX
Description of device: (4)
The Smart-TENS is a compact, battery powered transcutaneous electrical nerve stimulator. It is used for the relief of chronic intractable pain by providing transcutaneous electrical pulses to areas of the body that require therapy for the indicated medical conditions. The parameters of the programs in the Smart-TENS cannot be set by the user. Two channels are available on the Smart-TENS. Each channel operates independently and if desired they may be used simultaneously. The clinician may set the prescribed program from a list of defined programs. The patient may then use this program or another available program called MultiTens which provides a pattern of sequences which allows variation and modulation on the stimulation pulse. The patient may also initiate burst mode on certain programs, cause one of the pattern of sequences in MultiTens Mode to repeat continuously, advance to the next sequence or pause the treatment session, increase or decrease the amplitude intensity of the stimulation or lock the intensity controls. Use of the device is recorded internally, allowing the clinician to determine compliance with the prescribed treatment regimen.
- (ട) Intended uses:
The Smart-TENS is used for transcutaneous electrical nerve stimulation for the purposes of relief of chronic intractable pain.
These uses are similar to the predicate marketed device identified in section (3) of this summary.
- ((8) Technological comparison
The Smart-TENS is similar the Bio Tens Model: ST-601 in that both are portable, compact battery powered TENS devices. Output for either device is suitable for the relief of chronic pain using standard skin surface electrodes. Both devices are similar in basic operational design and use the impedance of the output transformer to achieve a near net zero charge into the skin. The Smart-TENS is effectively a more user controllable device which indicates patient compliance.
2
510(k) Notification for Smart-TENS: Appendix IX
(b) (1) Non-clinical tests:
Comparisons of stimulation outputs for the Smart-TENS and the predicate Bio Tens Model: ST-601 show similar results that are suitable for TENS. To minimize potential electrical and mechanical hazards, Bio-Medical Research adheres to recognised and established industry practice and all devices are subject to final performance testing. The Smart-TENS is designed to conform to EN60601-1 (IEC 601-1) and conforms to EN 60601-1-2 (IEC 601-1-2).
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(2) Clinical tests:
No clinical testing was performed. -
(3) Test conclusions:
Testing of the stimulation output parameters of the Smart-TENS indicate that the device is safe, that it provides appropriate stimulation output for effective relief of chronic pain and that it performs as well as or better than the legally marketed predicate device identified in section (3) of this Summary.