(90 days)
No
The summary describes a standard TENS device controlled by a microprocessor and embedded software. There is no mention of AI or ML capabilities, data analysis for personalized therapy, or learning algorithms. The "virtual button" is a wireless control mechanism, not an AI feature.
Yes.
The device is intended for the temporary relief of pain associated with sore and aching muscles and for the symptomatic relief and management of chronic intractable pain, indicating a therapeutic purpose.
No
Explanation: The device is a transcutaneous electrical nerve stimulation (TENS) device intended for pain relief and management, not for diagnosing medical conditions.
No
The device description clearly states that Quell is a physical transcutaneous electrical nerve stimulator with embedded hardware components including a microprocessor, high-voltage circuit, battery, USB charging port, push button, and LED array. While it utilizes embedded software and a mobile app for control, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that Quell is a transcutaneous electrical nerve stimulation device for pain relief. This involves applying electrical stimulation to the body, not analyzing samples taken from the body (like blood, urine, or tissue).
- Device Description: The description details a device that delivers electrical pulses through electrodes placed on the skin. It does not mention any components or processes related to analyzing biological samples.
- Lack of IVD Indicators: The document does not contain any of the typical indicators of an IVD, such as:
- Analysis of biological samples.
- Detection or measurement of substances in biological samples.
- Diagnosis or monitoring of diseases based on sample analysis.
- Mentions of reagents, assays, or laboratory procedures.
Therefore, Quell falls under the category of a therapeutic device, specifically a transcutaneous electrical nerve stimulator (TENS), rather than an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Quell 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.
Quell 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
NUH
Device Description
Quell is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is sold without a prescription. - 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, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g., K140586). to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
lower extremities
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Over-The-Counter Use (21 CFR 801 Subpart C)
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Verification testing of Quell included electrical, mechanical and software tests to show that the device meets its target specifications over a range of operating and storage conditions. Validation and performance testing demonstrates that the device meets as reflected in the functional specification.
NeuroMetrix determined that bench and non-clinical testing were sufficient to demonstrate that Quell is as safe and effective as the predicate ASCEND device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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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Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
January 5, 2016
Neurometrix, Inc. Rainer Maas Director of QA/RA/Compliance 1000 Winter Street Waltham, Massachusetts 02451
Re: K152954
Trade/Device Name: Ouell Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator For Pain Relief Regulatory Class: Class II Product Code: NUH Dated: October 5, 2015 Received: October 7, 2015
Dear Mr. Maas:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); 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.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
William J. Heetderks -S
for
Carlos L. Peña. PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K152954
Device Name Quell
Indications for Use (Describe)
Quell 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.
Ouell 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.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for Ouell®
SPONSOR
NeuroMetrix, Inc. 1000 Winter Street Waltham, MA 02451 USA
| Contact Person: | Rainer Maas |
|---|---|
| Telephone: | (781) 314-2781 |
| Date Prepared: | October 5, 2015 |
DEVICE NAME
| Proprietary Name: | Quell |
|---|---|
| Common/Usual Name: | Transcutaneous Electrical Nerve Stimulator, TENS |
| Classification Name: | 882.5890 NUH |
| Transcutaneous electrical nerve stimulator for pain relief |
PREDICATE DEVICE
NeuroMetrix ASCEND (K140333)
INTENDED USE
Quell 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.
Quell 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
Quell is a single output-mode transcutaneous electrical nerve stimulator for symptomatic relief and management of chronic intractable pain that is sold without a prescription. - 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, duration, pattern, and frequency. The device is powered by an embedded rechargeable Lithium-Ion battery that is charged through a USB cable connected to an AC adapter.
The device delivers electrical stimulation to the user through a disposable electrode placed on the user's body. The device is labeled for use only with compatible NeuroMetrix electrodes (e.g., K140586). to which it connects through insulated female medical snap connectors embedded within its housing; no lead-wires are used.
4
The user interface consists of a push button and a linear 6 LED array consisting of 5 white LEDs and 1 amber LED. The push button initiates stimulation and controls the intensity. The LED array indicates stimulation status, battery charging, and error conditions.
A Quell user may initiate therapy, increase stimulation intensity and decrease stimulation intensity through a wireless control mechanism that is collectively referred to as the "virtual button." The virtual button is available through the Quell mobile app and is intended for use in the same environments as the Quell device.
| Form of Wireless Technology | Bluetooth® low energy |
|---|---|
| Type | BLE113 Bluetooth® Smart Module (Silicon Labs, Austin, TX) |
| RF Frequencies | 2.400 GHz - 2.4835 GHz ISM band |
| Maximum Output Power | 0 dBm |
| Maximum Receiver Sensitivity | -93 dBm |
| Range | 10 m (unobstructed) |
The wireless technology details are summarized below.
COMPARISON TO PREDICATE
Quell has identical indications for use as the cleared ASCEND device (K140333); 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. Both devices are only labeled for use with compatible NeuroMetrix electrodes.
The Quell and ASCEND devices have similar technological characteristics as listed below.
- One stimulation channel
- Single output mode
- User controlled intensity ●
- Fixed therapy session timer
- LED indicators (no intensity display) ●
- Powered by battery
As demonstrated by the table below, there are no significant differences in basic unit characteristics between Quell and ASCEND that would raise new questions of safety or effectiveness.
| Parameter | Quell | ASCEND K140333 |
|---|---|---|
| Device Name and Model Number | Quell | ASCEND |
| Manufacturer | NeuroMetrix | NeuroMetrix |
| Power Source(s) | Rechargeable 3.7V Lithium-Ion battery | Rechargeable 3.7V Lithium-Ion battery |
| Method of Line Current Isolation | Cannot charge while used | Cannot charge while used |
| Patient Leakage Current | ||
| Normal Condition |