The Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device is used for the symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis. It is also used as an adjunctive treatment for post-surgical and post-trauma acute pain.

Device Description

The SELECT® is a portable, dual channel TENS device with ten pre-programmed operational modes. It is powered by 3 standard AAA alkaline or rechargeable batteries. All operational modes produce the Empi Bi-Sourced® waveform. The user selects a pre-programmed mode by either pressing a Quick Select button with the picture of a body part needing treatment or by using the Program buttons to select one of ten program options. The user is able to adjust the intensity up or down. The lock mode prevents inadvertent changes to the intensity or the program option. The SELECT® is intended for use in the clinic or in the home with a prescription. A belt clip allows the patient to wear the Empi SELECT® on a belt or pants waistband. The SELECT® battery icon on the LCD will flash when the batteries need replacement. Compliance data can be retrieved by the clinician including number of sessions, average session length, and average intensity.

AI/ML Overview

This device, the Empi SELECT® TENS System, is a Transcutaneous Electrical Nerve Stimulator (TENS) intended for pain relief. The provided documentation does not include specific acceptance criteria with quantifiable metrics for device performance in the traditional sense of a diagnostic or predictive medical device. Instead, the focus is on demonstrating substantial equivalence to predicate devices through non-clinical testing.

Here's a breakdown based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria (Implicit/Explicit)	Reported Device Performance/Evidence
Safety	The device must be safe for its intended use. (Implicit criteria include electrical safety, biocompatibility of materials, and mechanical integrity).	"Non-clinical testing demonstrates that the Empi SELECT® TENS System is safe..." (This statement broadly claims safety without detailing specific tests or thresholds. It is implied that standard electrical and mechanical safety tests for TENS devices were performed and passed.)
Effectiveness	The device must be effective for its intended use (symptomatic relief/management of chronic pain, relief of pain associated with arthritis, adjunctive treatment for acute pain).	"Non-clinical testing demonstrates that the Empi SELECT® TENS System... performs as well as the predicate devices." (Effectiveness is primarily demonstrated through substantial equivalence to existing TENS devices (Empi Epix VT® TENS System, Chattanooga Group Forte CPS 400 Stim and Forte CPS 200 Stim), which are presumably already deemed effective. No new clinical effectiveness data is presented for the SELECT® itself.) The device has the "same indications for use as the predicate devices."
Performance (Technical)	The device must meet its product specifications over a range of operating and storage conditions. This would include electrical output parameters (waveform, intensity, frequency), battery life, and mechanical durability.	"Verification of the Empi SELECT® TENS System includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions." "The Empi SELECT® TENS System continues to record the number of sessions, the average session length, and the average intensity for data retrieval by a clinician." "The SELECT® battery icon on the LCD will flash when the batteries need replacement." "All operational modes produce the Empi Bi-Sourced® waveform." (Specific numerical performance metrics are not given, only the confirmation that tests were conducted and specifications were met.)
User Needs	The device must meet user needs according to marketing requirements, particularly regarding the user interface.	"Validation testing for the Empi SELECT® TENS System includes testing to show the device meets user needs according to marketing requirements." (The document highlights user interface changes from the predicate device (larger LCD, keymat style push buttons, Quick Select buttons), implying these changes addressed user needs or improved usability.)
Substantial Equivalence	The device must be demonstrably as safe and effective as legally marketed predicate devices.	The entire submission is based on demonstrating substantial equivalence to predicate TENS devices (K970203, K982828). The conclusion explicitly states, "The non-clinical testing demonstrates that the Empi SELECT® TENS System is safe, effective, and performs as well as the predicate devices." The device features "the same indications for use as the predicate devices" and "no changes to the output modes (waveforms)."

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

Test set sample size: Not applicable/Not explicitly stated. The evaluation relies on non-clinical testing (electrical and mechanical tests, and validation for user needs), not a clinical 'test set' with patient data.
Data provenance: Not applicable. The "tests" refer to engineering and functional verification/validation of the device hardware and software, not clinical data from patients.

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

Not applicable. As this is non-clinical testing and validation, there is no "ground truth" derived from expert consensus on patient data. The "ground truth" for electrical and mechanical tests would be the device's technical specifications and industry standards. For user needs validation, it would be marketing requirements and presumably user feedback/testing, but no details are provided about this.

4. Adjudication method for the test set

Not applicable. There is no clinical test set requiring adjudication.

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

No. This device is a TENS unit, not an AI-powered diagnostic or interpretive device. Therefore, a MRMC study involving human readers and AI assistance is not relevant or applicable.

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

Yes, in a sense. The "non-clinical testing" and "validation testing" described are standalone evaluations of the device's inherent safety and performance characteristics (electrical, mechanical, meeting specifications, user needs). There is no "algorithm" in the context of an AI device, but the device's own functional performance was tested independently.

7. The type of ground truth used

For electrical and mechanical tests: Device specifications, engineering standards, and regulatory requirements (e.g., for safety).
For validation testing (user needs): Marketing requirements and potentially user feedback/usability studies (though details are not provided).
For substantial equivalence: The established safety and effectiveness profiles of the predicate devices.

8. The sample size for the training set

Not applicable. This device does not involve a "training set" in the context of machine learning or AI models. The device's design and programming are based on established engineering principles and the intended physiological effects of TENS.

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

Not applicable, as there is no training set. The "ground truth" for the device's functionality is its design specifications and compliance with relevant standards for TENS devices.

Summary

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K061650

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510(k) Summary

510(k) Owner:	Empi
Address:	599 Cardigan Rd.St. Paul, MN 55126
Phone number:	651.389.0771
Fax number:	651.638.0477

JAN 2 2 2007

Contact person:	Carl Beaurline, VP of Global Regulatory Affairs
Date prepared:	June 7, 2006
Trade name:	SELECT® TENS System
Common name:	TENS
Classification name:	Transcutaneous Electrical Nerve Stimulator(21 CFR 882.5890, Product Code GZJ)
Classification:	II
Predicate devices:	Empi Epix VT® TENS System (K970203),Chattanooga Group Forte CPS 400 Stim and Forte CPS 200 Stim(K982828)

Device Description:

Intended Use:

Comparison to predicate:

The Empi SELECT® TENS System has the same indications for use as the predicate devices but the technological characteristics are different. There are no changes to the

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K061650

output modes (waveforms) for the SELECT® compared to the Epix VT®. The major difference between the Epix VT® and SELECT® are user interface characteristics. The Epix VT® has a small LCD display and membrane switches for controlling and displaying adjustable settings. The SELECT® has a keymat style push button system and a larger LCD screen controlling and displaying the adjustable settings. Also, the pain scale used on the Epix VT® is removed from the SELECT® and replaced by an On/Off button and five Quick Select buttons with pictures of body parts linking to preset recommended programs already existing on the device. The Quick Select buttons are similar to the Clinical Protocols on the Chattanooga Group Forte CPS 400 Stim and Forte CPS 200 Stim. The SELECT® continues to record the number of sessions, the average session length, and the average intensity for data retrieval by a clinician.

Non-clinical Testing:

Verification of the Empi SELECT® TENS System includes electrical and mechanical tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Empi SELECT® TENS System includes testing to show the device meets user needs according to marketing requirements.

Clinical Testing:

The Empi SELECT® TENS System does not require clinical testing in order to determine substantial equivalence to the predicate devices.

Conclusion:

The non-clinical testing demonstrates that the Empi SELECT® TENS System is safe, effective, and performs as well as the predicate devices.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle, represented by three curved lines that suggest the bird's head, neck, and wing.

FEB 2 2 2007

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Empi % Mr. Carl Beaurline Vice President, Regulatory Affairs 599 Cardigan Road St. Paul, Minnesota 55126

Re: K061650

Trade Name: Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous electrical nerve stimulator for pain relief Regulatory Class: II Product Code: GZJ, NYN Dated: January 22, 2007 Received: January 22, 2007

Dear Mr. Beaurline:

This letter corrects our substantially equivalent letter of January 22, 2007. 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.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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); 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.

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Page 2 - Mr. Carl Beaurline

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

For Pdhmm

Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use

510(k) Number (if known): K061650

Device Name: Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device

Indications for Use:

Prescription Use	X (Part 21 CFR 801 Subpart D)
AND/OR	Over-the-Counter Use ______ (21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
	(Division S--Off)
	Division of General, Restorative, and Neurological Devices
510(k) Number	L061650

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).