Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The description focuses on standard electrical muscle stimulation technology with pre-optimized parameters and does not mention any adaptive or learning capabilities.

Therapeutic

No.
The device is intended to stimulate healthy muscles for improvement or facilitation of muscle performance, muscle training, and development of firmer muscles, which are not considered therapeutic uses. The "Summary of Performance Studies" explicitly states, "No clinical performance data was applicable as the device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body."

Diagnostic

No
The device is described as a muscle stimulator intended to improve or facilitate muscle performance and muscle training, not to diagnose any condition. The "Summary of Performance Studies" explicitly states, "No clinical performance data was applicable as the device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body."

SaMD (Software as a Medical Device)

No

The device description explicitly details hardware components such as electrical stimulation delivery through channels, output signal characteristics, battery power, gel pad electrodes, and optional accessories (Ab Belt, BackPad). This indicates it is a physical medical device with embedded software, not a software-only device.

IVD (In Vitro Diagnostic)

No, 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 Contour Technology Muscle Stimulator is an external device that applies electrical stimulation to muscles through electrodes placed on the skin. It does not analyze any samples taken from the body.
Intended Use: The intended use is to stimulate healthy muscles for performance improvement, muscle training, strengthening, and toning. This is a physical intervention, not a diagnostic test.
Device Description: The description details the electrical stimulation process and how it affects muscle contraction, not the analysis of biological samples.
Performance Studies: The performance studies mentioned are related to the device's electrical output, safety, and usability, not the accuracy of a diagnostic test.

Therefore, based on the provided information, the Contour Technology Muscle Stimulator is a physical therapy or fitness device, not an In Vitro Diagnostic.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training.

The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.

The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.

Product codes (comma separated list FDA assigned to the subject device)

NGX

Device Description

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training for improvement of muscle tone, for the strengthening of the following muscles: upper back, lower/mid back, lower back, biceps, triceps, forearm-flexor, forearm-extensor, deltoids, abdominal, gluteus, hamstrings, quadriceps, and calves for the development of firmer muscles.

The electrical stimulation is delivered to the muscles through two channels. The output signal is monophasic, rectangular and based on a regulated voltage technology. The parameters (pulse rate, pulse duration, stimulation time, rest time) are optimized for each program. The power is supplied by 4 AAA batteries.

Pulses, transmitted by the Contour Technology Muscle Stimulator are sent to Gel Pad electrodes placed over the muscle region. The signal reaches out to the motor neuron that innervates the muscle fiber resulting in contraction of the muscle. The energy is delivered through 2-3 pairs of gel pads. Optional accessories are available to allow for hands free operation of the device when placed on the abdomen or back.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

upper back, lower/mid back, lower back, biceps, triceps, forearm-flexor, forearm-extensor, deltoids, abdominal, gluteus, hamstrings, quadriceps, and calves

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)

Non-clinical tests were performed for the Contour Technology Muscle Stimulator. The tests included: System and Software Requirements Verification Testing, Environmental Testing, Safety Testing, Unit & Integration Testing, ESD / EMI Testing, Stress Testing, Shipping Testing, and Simulated Use Testing (Usability Testing). The performance data demonstrates that the device meets all the product specifications and included electrical output waveforms, energy density, safety and electromagnetic compatibility testing.

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.

K011880, K031611, K030708

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

Regulation Number and Section

§ 890.5850 Powered muscle stimulator.

(a)
Identification. A powered muscle stimulator is an electrically powered device intended for medical purposes that repeatedly contracts muscles by passing electrical currents through electrodes contacting the affected body area.(b)
Classification. Class II (performance standards).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for Libramedical. The logo consists of a stylized letter "O" on the left and the word "LIBRAMEDICAL" on the right. The letter "O" is made up of three concentric circles, with the inner and outer circles being thicker than the middle circle.

5. 510(K) SUMMARY

5.1 Administrative Information

MAY 2 3 2012

5.1.1 Name and address

510(k) Owner/Sponsor:

Mike Esson Contour Technology 10 South 5th Street, Suite 990 Minneapolis, Minnesota 54402 Phone: 612-230-3802 Fax: 612 -230-3810

Primary Contact Person

Sara Petrie Regulatory Consultant at Libra Medical Inc. 8401 73td Ave North, Suite 63 Minneapolis, MN 55428 Phone: 612-396-9849 Fax: 763-477-6357 Email: spetrie@libramed.com

Date Prepared: 5/15/2012

5.1.2 Device Name

Trade Name	Contour Technology Muscle Stimulator
Common Name	Muscle Stimulator
Classification Name	Powered Muscle Stimulator with Limited Output for Muscle
Conditioning
Classification	21 CFR 890.5850
Class II
Product Code	NGX
Model	MX9

5.1.3 Applicant's Name

Contour Technology 10 South 5th Street, Suite 1000 Minneapolis, Minnesota 54402 Telephone: 612-230-3801 Fax: 612-230-3810

1

5.1.4 Substantial Equivalence

Contour Technology Muscle Stimulator covered by this substantially equivalent to other legally marketed devices namely the following:

K011880, Compex Sport, Compex S.A. �
. K031611, P4-Fitness, ValMed Corporation
� K030708, Slendertone Flex 515, Bio-Medical Research Ltd.

The Contour Technology Muscle Stimulator and the predicate devices have the same intended use and similar indications, technological characteristics and principles of operation that includes the delivery of small amount of electrical stimulation to skeletal muscles for conditioning of the muscles. There are design and engineering differences between the Contour Technology Muscle Stimulator and the predicate devices. However, these differences do not raise new questions of safety or efficacy. Specifically, the only technological difference between the Contour Technology Muscle Stimulator and its predicates is the shape of the stimulator, user interface and specific duration and pulse energy of each of the pre-set programs. These differences do not present any new issues of safety or effectiveness as the Contour Technology Muscle Stimulator is substantially similar to the three cited predicates. Further, performance testing conducted by the company demonstrates that the device meets the FDA Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning.

Thus, the Contour Technology Muscle Stimulator is substantially equivalent to the predicate devices.

5.1.5 Device Description

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training for improvement of muscle tone, for the strengthening of the following muscles: upper back, lower/mid back, lower back, biceps, triceps, forearm-flexor, forearm-extensor, deltoids, abdominal, gluteus, hamstrings, quadriceps, and calves for the development of firmer muscles.

The electrical stimulation is delivered to the muscles through two channels. The output signal is monophasic, rectangular and based on a regulated voltage technology. The parameters (pulse rate, pulse duration, stimulation time, rest time) are optimized for each program. The power is supplied by 4 AAA batteries.

Pulses, transmitted by the Contour Technology Muscle Stimulator are sent to Gel Pad electrodes placed over the muscle region. The signal reaches out to the motor neuron that innervates the muscle fiber resulting in contraction of the muscle. The energy is delivered through 2-3 pairs of gel pads. Optional accessories are available to allow for hands free operation of the device when placed on the abdomen or back.

5.1.6 Indications for Use/Intended Use

The Contour Technology Muscle Stimulator is intended to stimulate healthy muscles in order to improve or facilitate muscle performance. The Contour Technology Muscle Stimulator may therefore be considered a technique or method for muscle training.

2

The Contour Technology Muscle Stimulator Ab Belt accessory is intended for use on abdominal muscles only for strengthening and toning of abdominal muscles.

The Contour Technology Muscle Stimulator BackPad accessory is intended for use on the lower back muscles only.

5.1.7 Contraindications

Do not use this device if you have a cardiac pacemaker, implanted defibrillator, or other implanted metallic or electronic device. Such use could cause electric shock, burns, electrical interference, or death.

5.1.8 Summary of Technological Characteristics compared to predicate devices

Technological characteristics compared to predicate devices can be found in Table 1.

| ltem | Contour Technology
Muscle Stimulator | Predicate:
Compex Sport | Predicate:
ValMed P4-Fitness | Predicate:
Slendertone Flex 515 |
|-------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | K111476 | K011880 | K031611 | K030708 |
| Indications for
Use | The Contour Technology
Muscle Stimulator is
intended to stimulate
healthy muscles in order
to improve or facilitate
muscle performance. The
Contour Technology
Muscle Stimulator may
therefore be considered a
technique or method for
muscle training.
The Contour Technology
Muscle Stimulator Ab
Belt accessory is intended
for use on abdominal
muscles only for
strengthening and toning
of abdominal muscles.
The Contour Technology
Muscle Stimulator
BackPad accessory is
intended for use on the
lower back muscles only. | "Compex®
Sport" is
intended to
stimulate healthy
muscles in order
to improve or
facilitate muscle
performance.
"Compex®
Sport" is not
intended to be
used in
conjunction with
therapy or
treatment of
medical diseases
or medical
conditions of any
kind. None of the
"Compex®
Sport" training
programs is
designed for
injured or ailing
muscles and its
use on such
muscles is
contraindicated.
The "Compex®
Sport" electrical
impulses allow
triggering action
potentials on | The P4-Fitness is
intended for
stimulation of healthy
muscles in order to
enhance and facilitate
improved muscle
performance. The P-4
Fitness is therefore
properly considered as
a technique or method
for muscle training.
The P4-Fitness is NOT
intended for use in any
therapy or for
treatment of any
medical conditions or
diseases. The P4-
Fitness training
programs are not
designed or intended
for injured or
otherwise impaired
muscles and use of the
P4-Fitness on such
muscles is
contraindicated. | The improvement of
abdominal muscle tone,
for the strengthening of
abdominal muscles and
for the development of a
firmer abdomen. |
| Item | Contour Technology
Muscle Stimulator | Predicate:
Compex Sport | Predicate:
ValMed P4-Fitness | Predicate:
Slendertone Flex 515 |
| | | motoneurones of
motor nerves
(excitations). The
excitations of
motoneurones are
transmitted to the
muscle fibers via
the motor
endplate hwere
they generate
mechanical
muscle fiber
responses that
correspond to
muscle work.
Depending on the
parameters of the
electrical
impulses (pulse
frequency,
duration of
contraction,
duration of rest,
total session
duration),
different types of
muscle work can
be imposed on the
stimulated
muscles.