(65 days)
Not Found
No
The device description explicitly states it is a "single-function device intended to provide clinicians with a TENS Simple Modulated Pulse (SMP) therapy" and is designed to be "easy to use without the hassle of configuration. Simply turn the device on and increase or decrease the intensity." There is no mention of AI, ML, or any adaptive or learning capabilities.
Yes
The device is described as being used 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 indicates a therapeutic purpose.
No
Explanation: The device is a Transcutaneous Electrical Nerve Stimulator (TENS) used for symptomatic relief and management of pain, not for diagnosing conditions.
No
The device description explicitly states it is a "battery powered single-function device" and mentions "electrical, mechanical, and software tests" in the non-clinical testing section, indicating it includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description and Intended Use: The Empi Active Transcutaneous Nerve Stimulator is a device that applies electrical stimulation to the skin for pain relief. It does not involve testing samples from the body.
- Lack of IVD-related information: The document does not mention any aspects related to sample collection, analysis of biological samples, or diagnostic purposes.
Therefore, the Empi Active Transcutaneous Nerve Stimulator is a therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Empi Active Transcutaneous 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 Empi Active Transcutaneous Nerve Stimulator is a battery powered single-function device intended to provide clinicians with a TENS Simple Modulated Pulse (SMP) therapy. This device is intended to be easy to use without the hassle of configuration. Simply turn the device on and increase or decrease the intensity. It is a single-function electrotherapy device with one mode of treatment that allows for Transcutaneous Electrical Nerve Stimulation (TENS).
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
Both devices are prescription devices to be used under the direction of a medical professional. Both devices are designed to be used in a clinic setting or by the patient at home.
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 Active Transcutaneous Nerve Stimulator includes electrical, mechanical, and software tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Empi Active Transcutaneous Nerve Stimulator includes testing to show the device meets user needs according to marketing requirements.
Clinical Testing: No prospective clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance in the target markets. The Empi Active Transcutaneous Nerve Stimulator does not differ from the predicate device in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence. The Empi Active Transcutaneous Nerve Stimulator does not fit the profile of devices that might require clinical data per FDA guidance document 95-4158.
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.
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
6090922 510 上:
JUN - 5 2009
Image /page/0/Picture/3 description: The image shows the word "Empi" in a stylized font. The letters are all lowercase except for the "E", which is uppercase. There is a registered trademark symbol to the right of the "i".
510(k) Summary
| 510(k) Owner's Name:
Address: | Empi, Inc.
Clear Lake Industrial Park
Clear Lake, SD 57226 |
|---------------------------------------------|-----------------------------------------------------------------------------------|
| Phone number:
Fax number: | 651-415-7344
651-415-7497 |
| Email:
Contact person:
Date prepared: | swalrod@empi.com
Sandra Walrod, Regulatory Affairs Associate
March 30, 2009 |
| Trade name:
Common name: | Empi Active Transcutaneous Nerve Stimulator
TENS |
| Classification name: | Transcutaneous Electrical Nerve Stimulator (21 CFR 882.5890) |
| Product Code: | GZJ, NYN |
| Classification: | II |
| Predicate device(s): | Empi SELECT Model 4600 Transcutaneous Nerve Stimulator
K061650 |
Device Description:
The Empi Active Transcutaneous Nerve Stimulator is a battery powered single-function device intended to provide clinicians with a TENS Simple Modulated Pulse (SMP) therapy. This device is intended to be easy to use without the hassle of configuration. Simply turn the device on and increase or decrease the intensity. It is a single-function electrotherapy device with one mode of treatment that allows for Transcutaneous Electrical Nerve Stimulation (TENS).
Intended Use:
The Empi Active Transcutaneous Nerve Stimulator is indicated for use as a Transcutaneous Electrical Nerve Stimulation (TENS) device. This is the same indication as for the Empi SELECT device. The Empi Active Transcutaneous Nerve Stimulator incorporates a TENS
Empi
i
1
Simple Modulated Pulse mode for relief and management of chronic and intractable pain. The Empi SELECT incorporates the very same TENS Simple Modulated Pulse stimulation treatment mode for relief and management of chronic and intractable pain. Both devices are prescription devices to be used under the direction of a medical professional. Both devices are designed to be used in a clinic setting or by the patient at home. Therefore, the intended use of the Empi Active Transcutaneous Nerve Stimulator are the same as those for the Empi SELECT.
Comparison to predicate:
This submission is intended to demonstrate that the Empi Active Transcutaneous Nerve Stimulator has the same intended use as the predicate device and that there are no changes to the fundamental scientific technology and the basic considerations described in the guidance.
The Empi Active Transcutaneous Nerve Stimulator is indicated for use as a Transcutaneous Electrical Nerve Stimulation (TENS) device. This is the same indication as for the Empi SELECT device. The Empi Active Transcutaneous Nerve Stimulator incorporates a TENS Simple Modulated Pulse mode for relief and management of chronic and intractable pain. The Empi SELECT incorporates the very same TENS Simple Modulated Pulse stimulation treatment mode for relief and management of chronic and intractable pain. Therefore, the indications for use of the Empi Active Transcutaneous Nerve Stimulator are the same as those for the Empi SELECT. Both devices are prescription devices to be used under the direction of a medical professional. Both devices are designed to be used in a clinic setting or by the patient at home. Therefore, the intended use of the Empi Active Transcutaneous Nerve Stimulator are the same as those for the Empi SELECT.
Non-clinical Testing:
Verification of the Empi Active Transcutaneous Nerve Stimulator includes electrical, mechanical, and software tests to show that the device meets its product specifications over a range of operating and storage conditions. Validation testing for the Empi Active Transcutaneous Nerve Stimulator includes testing to show the device meets user needs according to marketing requirements.
The Empi Active device conforms to the following voluntary standards:
- UL 60601-01 Medical electrical equipment Part 1: General requirements for safety . 2003
- CAN/CSA C22.2 No.601.1-M90 with Amendment A2. 2005 �
- IEC60601-1-2 Medical Electrical Equipment Part 1-2: General Requirements for Safety � - Collateral standard: Electromagnetic Compatibility - Requirements and Tests (Edition 2:2001 with Amendment 1:2004)
Clinical Testing:
1
No prospective clinical studies are required to demonstrate safety and efficacy of the device in support of an application for premarket clearance in the target markets. The Empi Active
2
Transcutaneous Nerve Stimulator does not differ from the predicate device in technological characteristics or intended use, where the device has a significant influence on clinical endpoints, and where prospective clinical studies would be necessary to determine safety and efficacy equivalence. The Empi Active Transcutaneous Nerve Stimulator does not fit the profile of devices that might require clinical data per FDA guidance document 95-4158.
Conclusion:
The Empi Active Transcutaneous Nerve Stimulator is substantially equivalent the predicate device.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle. The eagle is black, and the text is also black. The logo is simple and recognizable.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Empi, Inc. c/o Virginia L. Conger Director of Quality and Regulatory 205 Hwy 22 East Clear Lake, SD 57226-0709
JUN - 5 2009
Re: K090922
Trade/Device Name: Empi Active Transcutaneous Nerve Stimulator Regulation Number: 21 CFR 882.5890 Regulation Name: Transcutaneous Electrical Nerve Stimulator for Pain Relief Regulatory Class: Class II Product Code: GZJ Dated: May 11, 2009 Received: May 15, 2009
Dear Ms. Conger:
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 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 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.
4
Page 2 - Ms. Virginia L. Conger
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/cdrh/mdr/ 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Kevin Alexander Jr.
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Empi
Empi SELECT Special 510(k) Submission
Indications for Use
K090922 510(k) Number (if known):
Device Name: Empi Active Transcutaneous Nerve Stimulator
Indications for Use:
The Empi Active Transcutaneous 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 Sign-Off) Division of Ophthalmic and Ear, Jose and Throat Devices
510(k) Number K090522