Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and summary of performance studies do not mention any AI or ML capabilities. The device appears to be a standard TENS unit with a simple microprocessor and user interface.

Therapeutic

Yes

The device description and intended use clearly state that it is a transcutaneous electrical nerve stimulator for the relief of pain associated with sore and aching muscles and chronic, intractable pain, which are therapeutic applications.

Diagnostic

No

A diagnostic device identifies a medical condition or disease. This device is used for temporary relief of pain and symptomatic relief/management, which are therapeutic rather than diagnostic purposes.

SaMD (Software as a Medical Device)

No

The device description explicitly states it consists of a microprocessor, associated components, a plastic case, buttons, and electrodes, indicating it is a hardware device with embedded software, not a software-only medical device.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

Intended Use: The intended use is for the temporary relief and management of pain associated with muscles and arthritis. This is a therapeutic use, not a diagnostic one.
Device Description: The device is a transcutaneous electrical nerve stimulator (TENS). TENS devices deliver electrical impulses to the body for pain relief. This is a physical therapy modality, not a diagnostic test performed on samples from the body.
IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health status. This device does not perform any such tests.

The device is clearly described as a therapeutic device for pain relief, which falls outside the scope of In Vitro Diagnostics.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Product codes (comma separated list FDA assigned to the subject device)

NUH, NYN

Device Description

The SmartRelief is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body.

The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case.

The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device.

Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single piece. These electrodes are manufactured in various shapes to facilitate proper placement on the body.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Not Found

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Not Found

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)

Comparison of actual output under various loads and operating parameters shows no difference in the SmartRelief and the predicate device. The only difference in the SmartRelief and the predicate device is aesthetics. The electrical design, output, function and safety characteristics are exactly the same.

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.

K113037

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.

Not Found

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

Regulation Number and Section

§ 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).

Summary

0

510(k) Summary

JUL 2 5 2013

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

1. Submitters Information:
  Eric Joseph Chattem. Inc. 1715 West 38th Street Chattanooga, TN 37409 423-822-3268 cric.joseph(@chattem.com Prepared July 25, 2013

Device Identification:

Classification Name: Transcutaneous Nerve Stimulator. Trade/Proprietary Name: SmartRelief Classification: Class II (21 CFR 882.5890) Product Code: NUH, NYN

1. Identification of Predicate Devices:
  The Chattem SmartRelief is of comparable type and substantially equivalent to the following predicate device:

PDI Works Pain-Aid. K113037

Device Description:

The SmartRelief is a transcutaneous electrical nerve stimulator for relief of muscular pain and sold without prescription. Key to its use are specially shaped electrodes that allow an untrained person to properly place them on the body.

The device consists of a microprocessor and associated components powered by a coin cell and housed in a small plastic case.

The controls for the device consist of three buttons: A power button which turns the device on and off, an intensity increase button, and an intensity decrease button. This simple user interface is further augmented by distinctive shapes to allow the user to identify the controls even if they cannot see the device.

Contact to the body is made through self-adhesive electrodes. Electrical connection from the device to the electrode is made directly through snaps on the device and the electrode; no leadwires are used. The electrodes are designed with both conductive surfaces combined into a single piece. These electrodes are manufactured in various shapes to facilitate proper placement on the body.

1

1. Intended Use:
  To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities. It is also intended for symptomatic relief and management of chronic. intractable pain and relief of pain associated with arthritis.
1. Technological Characteristics
  The table below summarizes the technological characteristics of the SmartRelief and the predicate device:

	SmartRelief (K131159)	Pain-Aid (K113037)
Intended Use	To be used for temporary relief of
pain associated with sore and aching
muscles due to strain from exercise
or normal household and work
activities.

To be used for symptomatic relief
and management of chronic,
intractable pain and relief of pain
associated with arthritis. | To be used for temporary relief of
pain associated with sore and aching
muscles due to strain from exercise
or normal household and work
activities.

2

Comparison of actual output under various loads and operating parameters shows no difference in the SmartRelief and the predicate device. The only difference in the SmartRelief and the predicate device is aesthetics. The electrical design, output, function and safety characteristics are exactly the same.

7. Conclusions:

The Chattem SmartRelief has the same intended use, design, technological characteristics, output mode, output waveform, and safety standards complied with as the cleared device Pain-Aid (K113037). Testing confirmed the equivalence in performance, including output waveform, between the SmartRelief and the predicate device. Because the SmartRelief is only different from the predicate, cleared Pain-Aid device by cosmetic details in the plastic enclosure, no differences in safety or effectiveness exist.

3

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/3/Picture/1 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol that resembles three overlapping human figures or abstract shapes, creating a sense of unity or interconnectedness.

July 25, 2013

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

Chattem, Inc C/O Eric Joseph Associate Director. Regulatory Affairs 1715 West 380 St. Chattanooga, TN 37409

Re: K131159

Trade/Device Name: SmartRelief Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator Regulatory Class: Class II Product Code: NUH, NYN Dated: April 23, 2013 Received: April 26, 2013

Dear Mr. Joseph:

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.

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Page 2 - Mr. Eric Joseph

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/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 Small Manufacturers, International and Consumer Assistance 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,

Victor Krauthamer -S

Victor Krauthamer, Ph.D. Acting 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): K131159

Device Name: SmartRelief

Indications For Use:

To be used for temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities.

To be used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.

Prescription Use (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use X (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Victor Krauthamer -S 2013.07.25 12:25:59 -04'00'

Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)

510(k) Number: K131159

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