(140 days)
No
The document describes a standard electrotherapy device with various pre-set and adjustable parameters, but there is no mention of AI or ML capabilities in the device description, intended use, or any other section.
Yes.
The device's intended use is for symptomatic relief of pain, which aligns with therapeutic purposes.
No
Explanation: The device is described as an electrotherapy device used for symptomatic relief and management of pain. It is a treatment device, not a diagnostic one.
No
The device description clearly outlines hardware components such as channels, intensity controls, and outputs for electrical stimulation, indicating it is a physical electrotherapy device, not software-only.
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 Function: The description clearly states that the Infinity is an electrotherapy device that uses electrical stimulation for pain relief. It applies current to the body externally.
- Lack of Biological Sample Analysis: There is no mention of the device analyzing any biological samples from the patient.
The device's function and intended use fall under the category of physical therapy or pain management devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions:
- Symptomatic relief of acute pain .
- . Symptomatic relief and management of chronic intractable pain
- . Symptomatic treatment for post-surgical and post-trauma acute pain
Product codes
LIH
Device Description
The Infinity is a multifunction electrotherapy device with various treatment modes that allows for interferential current stimulation (IFS) and premodulated interferential current stimulation. It has the ability to provide two channels of conventional interferential and premodulated interferential stimulation. The Infinity offers the following features:
- . Channels 1 and 2, which are multi-purpose outputs (IF and PM IF)
- . Each channel has a dedicated intensity control
- . Maximum stimulation of 50 mA/500 V from each channel
- . Timed therapy sessions
- . Continuous stimulation
- . Adjustable pulse rates
- Balanced asymmetrical and symmetrical biphasic waveforms
- . Seven programs: three for conventional interferential, three for premodulated interferential and one for custom stimulation
- . Lock option for clinician to control treatment regimens and stimulus intensity
- . Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
DEC 17 2004
510(k) Summary for Infinity Electrotherapy System
-
- SPONSOR
Empi 599 Cardigan Road St. Paul, Minnesota 55126-4099
- SPONSOR
Contact Person: Kathleen Schmitt (651) 415-9000 Telephone:
Date Prepared: December 13, 2004
2. DEVICE NAME
| Proprietary Name: | Infinity Electrotherapy System |
|---|---|
| Common/Usual Name: | Electrical Muscle and Nerve Stimulator |
| Classification Names: | Powered Muscle Stimulator, Interferential Current |
| Stimulator |
3. PREDICATE DEVICES
| Empi 300 PV | K021100 |
|---|---|
| Ryan Telemedicine | K030254 |
4. INTENDED USE
The Infinity is a multi-function electrotherapy device with various treatment modes that allow for conventional interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions:
- Symptomatic relief of acute pain .
- . Symptomatic relief and management of chronic intractable pain
- . Symptomatic treatment for post-surgical and post-trauma acute pain
December 13, 2004
510(k) Summary · Page E-1
1
5. DEVICE DESCRIPTION
The Infinity is a multifunction electrotherapy device with various treatment modes that allows for interferential current stimulation (IFS) and premodulated interferential current stimulation. It has the ability to provide two channels of conventional interferential and premodulated interferential stimulation. The Infinity offers the following features:
- . Channels 1 and 2, which are multi-purpose outputs (IF and PM IF)
- . Each channel has a dedicated intensity control
- . Maximum stimulation of 50 mA/500 V from each channel
- . Timed therapy sessions
- . Continuous stimulation
- . Adjustable pulse rates
- Balanced asymmetrical and symmetrical biphasic waveforms
- . Seven programs: three for conventional interferential, three for premodulated interferential and one for custom stimulation
- . Lock option for clinician to control treatment regimens and stimulus intensity
- . Pause function for patient to pause stimulation. During pause, the timer will not count down if timing has been set up. Upon restart, the device assumes the previous treatment stimulation parameters but a stimulus intensity of zero
BASIS FOR SUBSTANTIAL EQUIVALENCE 6.
The Infinity is an extension of the 300 PV and is similar in design and functions. Both offer multiple treatment programs, and the user can either choose one or more of these options or customize the treatment regimen within the available parameter ranges. The Infinity is a two-channel system that includes conventional and premodulated interferential stimulation whereas the 300 PV is a four-channel system. Additionally, it is not indicated for NMES, for FES or TENS since it does not include the accessories for FES, nor does it include the waveforms for FES and TENS. The conclusion of this technical comparison is that the Empi Infinity is substantially equivalent to the predicate devices for the indications specified.
December 13, 2004
510(k) Summary · Page E-2
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 seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a series of flowing lines, possibly representing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 2004
Empi, Inc. C/o Ms. Mary McNamara-Cullinane, RAC Medical Device Consultants, Inc. Staff Consultant 49 Plain Street North Attleboro, Massachusetts 02760
Re: K042057
Trade/Device Name: Infinity Electrotherapy System Device Name: Interferential current therapy Regulatory Class: Unclassified Product Code: LIH Dated: December 8, 2004 Received: December 9, 2004
Dear Ms. McNamara-Cullinane:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreative to regard) the enactment date of the Medical Device Amendments, or to conniner of the May 20, 1977, ... . ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... ... .. de vices that have been form do not require approval of a premarket approval application (PMA). and Costiette Ace (110.) that as nevice, subject to the general controls provisions of the Act. The I ou may, therefore, mains of the Act include requirements for annual registration, listing of general controls provision 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 thay be fabyer to deen 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 r toals of a not a 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 of uny I oderal battler and streequirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set OI It Fart 007), assems (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 - Ms. Mary McNamara-Cullinane, RAC
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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark H. Melkerson
Celia M. Witten, Ph.D., M.D. 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):
Device Name: Infinity Electrotherapy System
Indications for Use:
The Infinity is a multi-function electrotherapy device with various treatment modes that The Internety is a thank interferential and premodulated interferential current stimulation (IFS) and is indicated for the following conditions:
- Symptomatic relief of acute pain .
- Symptomatic relief and management of chronic intractable pain .
- Symptomatic relief for post-surgical and post-traumatic 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)
Mark A. Milburn
E 36 Super Division of General. Restorative. and Neurological Devices
510(k) Number K042057