(223 days)
Not Found
No
The description details a device with pre-programmed modes and user-adjustable intensity, with no mention of adaptive learning, data analysis for personalized treatment, or any terms related to AI/ML.
Yes
The device details explicitly state its intended use for "symptomatic relief and management of chronic, intractable pain and relief of pain associated with arthritis," and as an "adjunctive treatment for post-surgical and post-trauma acute pain," which are therapeutic applications.
No
This device is a TENS unit, which is used for pain relief by stimulating nerves. It does not diagnose medical conditions.
No
The device description clearly outlines a physical hardware device (portable, dual channel TENS device, powered by batteries, with buttons, LCD, and belt clip) that delivers electrical stimulation. While it has software components for controlling modes and intensity, it is not solely software.
Based on the provided information, the Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device is not an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is for the symptomatic relief and management of pain. This is a therapeutic application, not a diagnostic one.
- Device Description: The device is a TENS (Transcutaneous Electrical Nerve Stimulator) device that delivers electrical stimulation to the body. This is a physical therapy modality, not a method for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status based on laboratory tests.
- Using reagents or other laboratory consumables.
In summary, the Empi® SELECT is a therapeutic device used to manage pain through electrical stimulation, which falls outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
GZJ, NYN
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.
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
clinic or in the home with a prescription
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)
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.
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.
Empi Epix VT® TENS System (K970203), Chattanooga Group Forte CPS 400 Stim and Forte CPS 200 Stim (K982828)
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
§ 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).
0
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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:
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.
Intended Use:
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.
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
1
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.
2
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.
3
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
4
Indications for Use
510(k) Number (if known): K061650
Device Name: Empi® SELECT Transcutaneous Electrical Nerve Stimulator Device
Indications for Use:
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.
| 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 |