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.

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.

AI/ML Overview

The provided summary describes the SmartRelief device, a transcutaneous electrical nerve stimulator, and its substantial equivalence to a predicate device (PDI Works Pain-Aid, K113037). The acceptance criteria and the study proving the device meets them are based on this substantial equivalence.

Here's the breakdown of the information requested:

1. Table of Acceptance Criteria and Reported Device Performance

The core acceptance criterion for the SmartRelief device is its substantial equivalence to the predicate device, the PDI Works Pain-Aid (K113037). This equivalence is based on identical technological characteristics, intended use, and safety/effectiveness profiles.

Acceptance Criteria (based on Predicate Device Equivalence)	Reported Device Performance (SmartRelief)
Intended Use: Temporary relief of pain associated with sore and aching muscles due to strain from exercise or normal household and work activities; symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis.	Identical: The SmartRelief has the exact same intended use as the predicate device, as explicitly stated in the 510(k) summary and the "Indications for Use" section.
Technological Characteristics: Power Source, Number of Outputs, Number of Output Modes, Treatment Timer, Output Waveform, Shape, Housing Materials, Weight, Dimensions, Max Pulse Freq., Pulse Width, Technology/Control System, Patient Connection, Safety.	Identical: The table in Section 6 explicitly details that all these technological characteristics (e.g., 3V lithium battery, 1 output, 30-minute fixed timer, asymmetrical biphasic waveform, 100 Hz max pulse frequency, 30-220 µsec pulse width, microprocessor control, self-adhesive electrodes, limited power/simple user interface) are the same as the predicate device. The text further states: "Comparison of actual output under various loads and operating parameters shows no difference in the SmartRelief and the predicate device." And "The electrical design, output, function and safety characteristics are exactly the same."
Safety and Effectiveness: Compliance with voluntary standards (EN60601-1, EN60601-1-2), no differences in safety or effectiveness.	Identical: The SmartRelief also complies with EN60601-1 and EN60601-1-2. The conclusion explicitly states: "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." Testing confirmed equivalence in performance, including output waveform.

2. Sample size used for the test set and the data provenance

Sample size: Not explicitly mentioned as a clinical test set for performance comparison in the traditional sense. The comparison is primarily based on technical specifications and output measurements rather than patient outcomes. If output measurements are considered as a "test set" for technical characteristics, the sample size would refer to the number of devices tested and the conditions under which the output was measured. This detail is not provided.
Data provenance: Not applicable in the context of a clinical study. The data is based on the technical specifications and output testing of the SmartRelief device in comparison to the predicate device. It's an engineering and design comparison rather than a human clinical trial.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Number of experts and qualifications: Not applicable. The "ground truth" for this substantial equivalence submission is the technical specifications and verified performance of the predicate device (K113037), which has already been cleared by the FDA. The comparison is against established device parameters, not adjudicated expert interpretations of clinical data.

4. Adjudication method for the test set

Adjudication method: Not applicable. There was no clinical test set requiring expert adjudication. The comparison is based on objective technical measurements and design specifications.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

MRMC study: No, an MRMC comparative effectiveness study was not done. This device is a transcutaneous electrical nerve stimulator, not an imaging or diagnostic AI device that would typically involve human readers.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Standalone performance study: Not applicable. This device is a physical electromedical device, not an algorithm, and it is designed for direct patient use. Its "performance" is its ability to generate electrical pulses according to specifications, which was confirmed to be equivalent to the predicate device.

7. The type of ground truth used

Type of ground truth: The ground truth used for the comparison is the engineering specifications, technical performance, and previously established safety and effectiveness of the predicate device (PDI Works Pain-Aid, K113037). The SmartRelief device is considered equivalent because its physical and electrical characteristics match those of the legally marketed predicate.

8. The sample size for the training set

Sample size for training set: Not applicable. This device is not an AI/machine learning algorithm, so there is no concept of a "training set" in the context of this 510(k) submission.

9. How the ground truth for the training set was established

Ground truth for training set establishment: Not applicable, as there is no training set for this device.

Summary

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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 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.

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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 ofpain associated with sore and achingmuscles due to strain from exerciseor normal household and workactivities.To be used for symptomatic reliefand management of chronic,intractable pain and relief of painassociated with arthritis.	To be used for temporary relief ofpain associated with sore and achingmuscles due to strain from exerciseor normal household and workactivities.To be used for symptomatic reliefand management of chronic,intractable pain and relief of painassociated with arthritis.
Power Source	3V lithium battery	3V lithium battery
Number ofOutputs	1	1
Number ofOutput Modes	1	1
Treatment Timer	30 minutes, fixed	30 minutes, fixed
OutputWaveform	Asymmetrical Biphasic	Asymmetrical Biphasic
Shape	Rectangular	Rectangular
HousingMaterials andConstruction	Molded Plastic	Molded Plastic
Weight	20 grams	20 grams
Dimensions(mm) [W x H xD]	64x38x13	64x38x13
Max Pulse Freq.(Hz)	100 Hz	100 Hz
Pulse Width(µsec)	30 - 220µsec	30 - 220µsec
Technology /Control System	Microprocessor Control,Battery Powered	Microprocessor Control,Battery Powered
PatientConnection	Self-adhesive Electrodes	Self-adhesive Electrodes
Safety	Limited Power, Simple UserInterface	Limited Power, Simple UserInterface
Compliance withVoluntaryStandards	Yes	Yes
	EN60601-1	EN60601-1
	EN60601-1-2	EN60601-1-2

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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.

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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

Page 1 of 1

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).