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

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

AI/ML Overview

The provided text is a 510(k) Summary for the Infinity Electrotherapy System. This document focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, the requested information about acceptance criteria, device performance tables, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone studies, and ground truth establishment cannot be extracted from the provided text. The document does not describe any specific studies conducted to establish performance metrics for the Infinity Electrotherapy System against defined acceptance criteria.

The 510(k) submission process for this type of device (a Class II or unclassified device) generally relies on demonstrating that the new device is "substantially equivalent" to a legally marketed predicate device. This is often done by comparing design, materials, intended use, and performance characteristics to the predicate, rather than conducting new clinical trials with acceptance criteria.

Information that can be extracted related to the device and its regulatory status:

Device Name: Infinity Electrotherapy System
Intended Use/Indications for Use:
- Symptomatic relief of acute pain.
- Symptomatic relief and management of chronic intractable pain.
- Symptomatic relief for post-surgical and post-trauma acute pain.
Predicate Devices:
- Empi 300 PV (K021100)
- Ryan Telemedicine (K030254)
Basis for Substantial Equivalence: The Infinity is described as an extension of the 300 PV and similar in design and functions, offering multiple treatment programs. Differences noted are that Infinity is a two-channel system (300 PV is four-channel) and Infinity is not indicated for NMES, FES, or TENS.
Regulatory Decision: A substantial equivalence determination was made by the FDA on December 17, 2004, allowing the device to be marketed.

Summary

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K042057

DEC 17 2004

510(k) Summary for Infinity Electrotherapy System

1. SPONSOR
  Empi 599 Cardigan Road St. Paul, Minnesota 55126-4099

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 CurrentStimulator

3. PREDICATE DEVICES

Empi 300 PV	K021100
Ryan Telemedicine	K030254

4. INTENDED USE

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

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5. DEVICE DESCRIPTION

. 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

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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.

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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

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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

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).