(143 days)
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No
The description mentions a microprocessor and embedded software controlling basic electrical stimulation parameters, but there is no mention of AI, ML, or any adaptive or learning capabilities. The performance study focuses on usability, not algorithmic performance.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that "ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles" and "for the symptomatic relief and management of chronic intractable pain". These are therapeutic applications.
No
The device description clearly states its purpose as a "transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain," not for diagnosis.
No
The device description explicitly states that ASCEND is a "single output-mode transcutaneous electrical nerve stimulator" that utilizes a "microprocessor running embedded software to control a high-voltage circuit" and is "powered by an embedded rechargeable Lithium-Ion battery." It also mentions connecting to "disposable electrodes." These are all hardware components, indicating it is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that ASCEND is a "transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles" and for "symptomatic relief and management of chronic intractable pain." This describes a therapeutic device that applies electrical stimulation to the body.
- Device Description: The description details how the device generates and delivers electrical pulses through electrodes placed on the skin. This is consistent with a TENS device, not an IVD.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) from the human body to provide information for diagnosis, monitoring, or screening.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device operates in vivo (on the body) to provide pain relief through electrical stimulation.
N/A
Intended Use / Indications for Use
ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.
ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.
The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.
Product codes (comma separated list FDA assigned to the subject device)
NUH
Device Description
ASCEND is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is available over the counter. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, The device is powered by an embedded rechargeable Lithium-Ion duration, pattern, and frequency. battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the user through disposable electrodes placed on the user's The device is labeled for use only with compatible NeuroMetrix electrodes (e.g. SENSUS body. Electrode, K121816), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. Compatible NeuroMetrix electrodes are comprised of four individual hydrogel pads arranged in a linear array. The hydrogel pads are electrically connected in pairs such that the two outer hydrogel pads constitute one electrode and the two inner hydrogel pads constitute a second electrode. The user interface consists of a push button and a two-color LED. The push button initiates and controls stimulation intensity. The LED indicates stimulation status, battery charging, and error conditions.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
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Anatomical Site
Lower extremities (for temporary pain relief)
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Usability Study:
- Study type: Prospective usability study.
- Sample size: 29 participants were enrolled, and all completed the study.
- Key results: The objective was to validate that previously untrained users can operate ASCEND in a safe and effective manner based on their reading and following of the directions for use contained in the device labeling without the supervision or assistance of a medical professional. Specifically, the usability study examined labeling consisting of an instructional video and quick start instructions. These materials cover five basic device tasks: checking battery, placing device and configuring, starting a therapy session, modifying stimulation intensity, and stopping a therapy session. The acceptance criterion was that at least 80% of participants successfully completed all five tasks. The percentage of participants completing all five tasks successfully was 86.2% (95% CI, 68.3 - 96.1), i.e., 25 of 29 participants. The upper bound of the 95% confidence interval (96.1%) exceeded 80%, and therefore the null hypothesis that the true pass rate was >= 80% could not be rejected. No significant usability issues were identified. The study supported the safe and effective use of ASCEND, as labeled, in the intended population for over-the-counter use.
Non-Clinical Testing:
- Study type: Verification testing, validation, performance testing.
- Key results: Verification testing included electrical, mechanical and software tests to show that the device meets its target specifications over a range of operating and storage conditions. Validation, performance, and usability testing demonstrated that the device meets user needs as reflected in the functional specification. ASCEND conforms to IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62304:2006, and 21 CFR 898.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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510(k) Summary for ASCEND™M
JUL 0 3 2014 KI40333
SPONSOR
NeuroMetrix, Inc. 62 Fourth Avenue : Waltham. MA 02451 USA
| Contact Person: | Rainer Maas |
|---|---|
| Telephone: | (781) 314-2781 |
| Date Prepared: | February 7, 2014 |
DEVICE NAME
Proprietary Name: ASCEND Common/Usual Name: Transcutaneous Electrical Nerve Stimulator, TENS 882.5890 Classification Name: NUH Transcutaneous electrical nerve stimulator for pain relief
PREDICATE DEVICE
NeuroMetrix SENSUS (K130919) PDI Works Pain-Aid (K113037)
INTENDED USE
ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for temporary relief of pain associated with sore and aching muscles in the lower extremities due to strain from exercise or normal household and work activities.
ASCEND is intended for use as a transcutaneous electrical nerve stimulation device for the symptomatic relief and management of chronic intractable pain.
The device may be used during sleep. The device is labeled for use only with compatible NeuroMetrix electrodes.
DEVICE DESCRIPTION
ASCEND is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is available over the counter. The device utilizes a microprocessor running embedded software to control a high-voltage circuit that generates currentregulated stimulating pulses with specific technical characteristics including pulse shape, amplitude, The device is powered by an embedded rechargeable Lithium-Ion duration, pattern, and frequency. battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the user through disposable electrodes placed on the user's The device is labeled for use only with compatible NeuroMetrix electrodes (e.g. SENSUS body. Electrode, K121816), to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used. Compatible NeuroMetrix electrodes are comprised of four
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individual hydrogel pads arranged in a linear array. The hydrogel pads are electrically connected in pairs such that the two outer hydrogel pads constitute one electrode and the two inner hydrogel pads constitute a second electrode. The user interface consists of a push button and a two-color LED. The push button initiates and controls stimulation intensity. The LED indicates stimulation status, battery charging, and error conditions.
COMPARISON TO PREDICATES
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ASCEND has similar indications for use and identical technological characteristics as the cleared SENSUS device (K130919). The only substantive difference is that ASCEND is labeled for over-thecounter use while SENSUS is labeled for prescription use. The over-the-counter labeling is based on the substantial equivalence of ASCEND to PDI Works Pain-Aid (K 113037), a transcutaneous electrical nerve stimulator labeled for over-the-counter use and sold without a prescription. In further support of overthe-counter labeling, this submission includes results from a prospective usability study that demonstrates the safe, and effective use of ASCEND, as labeled, in the intended population.
Comparison of Indications for Use
As stated above, ASCEND has the similar indications for use as the cleared SENSUS device i.e., both are intended for use as a transcutaneous electric nerve stimulation device for the symptomatic relief and management of chronic intractable pain, and may be used during sleep. The table below compares ASCEND, SENSUS and Pain-Aid indications for use. All three devices are indicated for the symptomatic relief and management of chronic intractable pain.
| Comparison of Indications for Use. | ||
|---|---|---|
| NeuroMetrix ASCEND | NeuroMetrix SENSUS (K130919) | PDI Works Pain-Aid (K113037) |
| ASCEND is intended for use as a | ||
| transcutaneous electrical nerve | ||
| stimulation device for temporary | ||
| relief of pain associated with sore | ||
| and aching muscles in the lower | ||
| extremities due to strain from | ||
| exercise or normal household and | ||
| work activities. | The NeuroMetrix SENSUS is | |
| intended for use as a transcutaneous | ||
| electric nerve stimulation device for | ||
| the symptomatic relief and | ||
| management of chronic intractable | ||
| pain. | To be used for temporary relief of | |
| pain associated with sore and aching | ||
| muscles in the upper and lower | ||
| back, and upper and lower | ||
| extremities due to strain from | ||
| exercise or normal household and | ||
| work activities. | ||
| ASCEND is intended for use as a | ||
| transcutaneous electrical nerve | ||
| stimulation device for the | ||
| symptomatic relief and management | ||
| of chronic intractable pain. | The device may be used during | |
| sleep. The device is labeled for use | ||
| only with the NeuroMetrix SENSUS | ||
| Electrode | To be used for the symptomatic | |
| relief and management of chronic, | ||
| intractable pain and relief of pain | ||
| associated with arthritis. | ||
| The device may be used during | ||
| sleep. The device is labeled for use | ||
| only with compatible NeuroMetrix | ||
| electrodes. |
f Indications for Use
Comparison of Technological Characteristics
ASCEND and SENSUS have identical technological characteristics. ASCEND and Pain-Aid have the same basic technological characteristics as listed below.
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- One stimulation channel
- Single output mode
- Patient controlled intensity .
- Fixed therapy session timer .
- LED indicator (no intensity display) .
- . Powered by battery
Both ASCEND and Pain-Aid have output specifications that are within the range of other FDA cleared transcutaneous electrical nerve stimulators. In the case of ASCEND, the basic unit characteristics and output specifications are identical to those of the SENSUS device, which FDA recently cleared through its 510(k) review process (K130919); i.e., it is the same device. The basic unit characteristics and output specifications of ASCEND, SENSUS and Pain-Aid are summarized in the tables below.
There are no technical differences between ASCEND and SENSUS. The primary technical differences between ASCEND and Pain-Aid are the (i) pulse waveform shape and duration, (ii) maximum output current, (iii) pulse pattern, and (iv) trip conditions.
- (i) Pulse waveform shape and duration: ASCEND generates a symmetrical biphasic rectangular output current pulse. Pain-Aid generates an asymmetrical biphasic pulse with the initial phase rectangular. The ASCEND pulse duration is fixed at 100 usec per phase while the initial phase of the Pain-Aid pulse duration is modulated between 30 and 220 usec. Because the physiological effectiveness of nerve stimulation is dependent on total charge delivered, the shape of the pulse waveform does not impact device's effectiveness. In other words, either pulse waveform shape is effective. Therefore this difference does not raise new types of questions of safety or effectiveness.
- (ii) Maximum output current: ASCEND has a higher maximum output current; 100 mA as compared to Because the charge delivered per pulse is set by the patient to a strong but 63 mA in Pain-Aid. comfortable sensation, the charge delivered is, therapeutically effective with either device. Furthermore, ASCEND has the same maximum output current as the predicate SENSUS device. Therefore, this difference does not raise new types of questions of safety or effectiveness.
- (iii)Pulse pattern: ASCEND stimulates with a fixed duration pulse at a randomly varying frequency between 60 and 100 HZ with mean 80 Hz. Pain-Aid stimulates with pulses that cycle through a range of durations and frequencies between 2 and 100 Hz. This difference between ASCEND and Pain-Aid does not raise new types of safety or effectiveness guestions because (i) neither device gives the 1 . patient control over frequency, (ii) both devices are using standard TENS stimulation frequencies, (iii) random frequency stimulation is within the standard practice for TENS devices and is used in the predicate SENSUS device, and (iv) the clinical effectiveness of transcutaneous electrical nerve stimulation for chronic intractable pain is not dependent on the use of modulated pulse trains such as those generated by Pain-Aid, and can be equally achieved through random frequency stimulation as delivered by ASCEND.
- (iv) Trip conditions: ASCEND has trip conditions not found in Pain-Aid. These include detection of over-load, no-load, insufficient charge, high impedance, and short circuit conditions. Detection of any of these immediately halts stimulation. ASCEND also includes an electrode peeling trip condition that addresses the potential hazard of electrode peeling during sleep. These trip conditions enhance the safety of ASCEND compared to Pain-Aid and therefore this difference does not raise · new types of questions of safety or effectiveness.
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| Basic Unit Characteristics. | ||
|---|---|---|
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| Parameter | NeuroMetrix
ASCEND | NeuroMetrix
SENSUS | PDI Works
Pain-Aid |
|----------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------|-------------------------------------------------|
| 510(k) Number | (to be assigned) | K130919 | K113037 |
| Device Name and Model Number | ASCEND | SENSUS | Pain-Aid |
| Manufacturer | NeuroMetrix | NeuroMetrix | PDI Works |
| Power Source(s) | 3.7V Lithium-Ion
battery (rechargeable) | 3.7V Lithium-Ion
battery (rechargeable) | 3V Lithium battery (non-rechargeable) |
| Method of Line Current Isolation | Physically isolated; device cannot connect to electrodes and battery recharger concurrently | Physically isolated; device cannot connect to electrodes and battery recharger concurrently | Non-rechargeable, no connection to line current |
| Patient Leakage Current | | | |
| Normal Condition | Battery powered ( Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
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