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.

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.

AI/ML Overview

Table of Acceptance Criteria and Reported Device Performance:

The document outlines conformity to the FDA Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning.
The non-clinical tests performed are:

System and Software Requirements Verification Testing
Environmental Testing
Safety Testing
Unit & Integration Testing
ESD / EMI Testing
Stress Testing
Shipping Testing
Simulated Use Testing (Usability Testing)

The document states: "The performance data demonstrates that the device meets all the product specifications and included electrical output waveforms, energy density, safety and electromagnetic compatibility testing."

While specific numerical acceptance criteria for each test are not explicitly detailed in the provided text, the qualitative statement above indicates that the device met the required specifications derived from the guidance document.

Sample Size for Test Set and Data Provenance:

The document does not specify a distinct "test set" sample size in terms of patient data or clinical cases. The performance testing appears to be primarily non-clinical, focusing on the device's technical specifications and safety rather than performance on a biological sample set. The data provenance is not applicable in the context of clinical data, as no clinical studies are reported.

Number of Experts and Qualifications for Ground Truth:

Not applicable. The document explicitly states, "No applicable. This device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body," when discussing clinical performance data. Therefore, there was no ground truth based on expert clinical assessment for a test set.

Adjudication Method for the Test Set:

Not applicable, as no clinical test set requiring expert adjudication is mentioned.

Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No MRMC comparative effectiveness study was mentioned. The submission is for a medical device (muscle stimulator), not an AI algorithm for diagnostic or prognostic purposes, and therefore, human reader performance with or without AI assistance is not relevant to this submission.

Standalone (Algorithm Only) Performance Study:

Not applicable. This is a medical device (muscle stimulator), not an AI algorithm.

Type of Ground Truth Used:

The ground truth or performance validation relied on meeting "product specifications and included electrical output waveforms, energy density, safety and electromagnetic compatibility testing" as per the FDA Draft Guidance for Industry and FDA Staff, Class II Special Controls Guidance Document: Powered Muscle Stimulator with Limited Output for Muscle Conditioning. This represents a technical/engineering ground truth tied to regulatory standards rather than clinical outcomes or expert consensus on biological data.

Sample Size for the Training Set:

Not applicable, as this is a medical device and not an AI algorithm that would typically involve a "training set" of data.

How Ground Truth for the Training Set Was Established:

Not applicable, as there is no training set mentioned in the context of this device submission.

Summary

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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 MuscleConditioning
Classification	21 CFR 890.5850Class 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

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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

5.1.6 Indications for Use/Intended Use

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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 TechnologyMuscle Stimulator	Predicate:Compex Sport	Predicate:ValMed P4-Fitness	Predicate:Slendertone Flex 515
510(k) Number	K111476	K011880	K031611	K030708
Indications forUse	The Contour TechnologyMuscle Stimulator isintended to stimulatehealthy muscles in orderto improve or facilitatemuscle performance. TheContour TechnologyMuscle Stimulator maytherefore be considered atechnique or method formuscle training.The Contour TechnologyMuscle Stimulator AbBelt accessory is intendedfor use on abdominalmuscles only forstrengthening and toningof abdominal muscles.The Contour TechnologyMuscle StimulatorBackPad accessory isintended for use on thelower back muscles only.	"Compex®Sport" isintended tostimulate healthymuscles in orderto improve orfacilitate muscleperformance."Compex®Sport" is notintended to beused inconjunction withtherapy ortreatment ofmedical diseasesor medicalconditions of anykind. None of the"Compex®Sport" trainingprograms isdesigned forinjured or ailingmuscles and itsuse on suchmuscles iscontraindicated.The "Compex®Sport" electricalimpulses allowtriggering actionpotentials on	The P4-Fitness isintended forstimulation of healthymuscles in order toenhance and facilitateimproved muscleperformance. The P-4Fitness is thereforeproperly considered asa technique or methodfor muscle training.The P4-Fitness is NOTintended for use in anytherapy or fortreatment of anymedical conditions ordiseases. The P4-Fitness trainingprograms are notdesigned or intendedfor injured orotherwise impairedmuscles and use of theP4-Fitness on suchmuscles iscontraindicated.	The improvement ofabdominal muscle tone,for the strengthening ofabdominal muscles andfor the development of afirmer abdomen.
Item	Contour TechnologyMuscle Stimulator	Predicate:Compex Sport	Predicate:ValMed P4-Fitness	Predicate:Slendertone Flex 515
		motoneurones ofmotor nerves(excitations). Theexcitations ofmotoneurones aretransmitted to themuscle fibers viathe motorendplate hwerethey generatemechanicalmuscle fiberresponses thatcorrespond tomuscle work.Depending on theparameters of theelectricalimpulses (pulsefrequency,duration ofcontraction,duration of rest,total sessionduration),different types ofmuscle work canbe imposed on thestimulatedmuscles.The various typesof muscles workthat "Compex®Sport" canimpose on thestimulatedmuscles are ableto improve orfacilitate muscleperformance."Compex®Sport" maytherefore beconsidered atechnique ofmuscle training.
PoweredMuscleStimulator	YES	YES	YES	YES
Batteryoperated	Four (4) 1.5V only (AAA)alkaline	One (1) NIMHRechargeablebattery (7.2V=1200mA/h)	One-9V lithium,alkaline or NiMhbattery	Three (3) AAA 1.5V DCbatteries
Regulated	YES	YES	YES	YES
Item	Contour TechnologyMuscle Stimulator	Predicate:Compex Sport	Predicate:ValMed P4-Fitness	Predicate:Slendertone Flex 515
Current /Voltage
Plastic HousingMaterials	YES	YES	YES	YES
MaximumCurrent Density	0.55 mA (rms) / cm²(Smallest size electrode40.5cm²)	4mAmp/cm²	1 mA (rms)/ cm²If electrode impedanceis <100 Ωsmallest size electrodesø 3.2 cm=10cm²	Information NotAvailable
Independentchannels withpossibility toregulate thecurrentindividually	YES	YES	YES	YES
Pulse Duration(Width)	340 μs	200 and 400 μs	200μs or 240μsfor upper extremities320 μs or 340μs forlegs	Positive: 200-300 μsInterphase: 100 μsNegative: 200-300 μs
Frequency	1 to 120 Hz	1 to 120 Hz	1 to 120 Hz	45-77 Hz
Reusable Gelpads	YES	YES	YES	YES

Table 1: Technological Characteristics comparison

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The technological characteristics, features, specifications, materials, and indications for use of the Contour Technology Muscle Stimulator are substantially equivalent to the predicate devices.

Therefore, there are no new safety and efficacy issues raised with the Contour Technology Muscle Stimulation Device.

5.1.9 Brief Description of non-clinical tests

Non-clinical tests were performed for the Contour Technology Muscle Stimulator and a summary is provided in Table 2.

Test
System and Software Requirements Verification Testing
Environmental Testing
Safety Testing
Unit & Integration Testing
ESD / EMI Testing
Stress Testing
Shipping Testing
Simulated Use Testing (Usabililty Testing)

	Table 2: Summary of Non-Clinical Tests
--	----------------------------------------	--	--	--

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The performance data demonstrates that the device meets all the product specifications and included electrical output waveforms, energy density, safety and electromagnetic compatibility testing.

5.1.10 Brief Description of clinical performance data

No applicable. This device does not diagnose, cure, mitigate, treat or prevent disease or affect the function of the human body.

5.1.11 Conclusion

The Contour Technology Muscle Stimulator is substantially equivalent to the predicate devices. Test results demonstrate that the device is safe and effective for its intended use and the results support determination of substantial equivalence.

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Image /page/6/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird-like figure with three curved lines forming its body and wings. The logo is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around the emblem.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

MAY 2,3 2012

Contour Technology % Libra Medical, Inc. Ms. Sara Petrie 8401 73rd Avenue North, Suite 63 Minneapolis, Minnesota 55428

Re: K111476

Trade/Device Name: Contour Technology Muscle Stimulator Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: Class II Product Code: NGX Dated: May 01, 2012 Received: May 02, 2012

Dear Ms. Petrie:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you: however, that device labeling must be truthful and not misleading.

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

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Page 2 - Ms. Sara Petrie

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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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/MedicalDevices/Safety/ReportaProblem/default.htm 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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Mark N. Melkerson | -Director Division of Surgical, Orthopedic and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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4. INDICATIONS FOR USE STATEMENT

Indications for Use

510(k) Number (if known): K111476

Device Name: Contour Technology Muscle Stimulator

Indications for Use:

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.

Prescription Use (Part 21 CFR 801 Subpart D)

AND/OR

Over-The-Counter Use (21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Signature

(Division Sign-Off Division of Surgical, Orthopedic, and Restorative Devices

Page 1 of 1

510(k) Number K111476

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).