Relaxation of muscle spasms
Prevention or retardation of disuse atrophy
Increase local blood circulation
Muscle re-education
Maintaining or increasing range of motion
Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis

Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms

Symptomatic relief and management of chronic, intractable pain
Post-traumatic acute pain
Post-surgical acute pain

Indications for DC (Direct Current) Mode

Relaxation of muscle spasm

The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:

Temporary increase in local blood circulation
Temporary relief of minor muscle and joint aches, pains and stiffness
Relaxation of muscles
Temporary relief of muscle spasms
Temporary relief of minor pain and stiffness associated with arthritis

Device Description

The new Sys*Stim® 240 neuromuscular stimulator features nine discrete waveforms designed to facilitate clinical versatility. Waveforms may be combined with on-off programs for neuromuscular education as well as frequency and amplitude modulation programs for optimal pain management.

New touch-sensitive technology has been used to make starting a treatment easy. The high-resolution color display allows clinicians to monitor all treatment parameters continuously. The patented M Wheel™ provides easy navigation through all of the menus.

Clinicians can add full-featured light therapy capabilities to the SysStim 240 by purchasing either the cluster or laser applicator package. The laser applicator has an 80 mW, 785 nm, laser diode and the cluster emits 500 mW at 600 and 950 nm. Applicator holders are provided with each applicator and can be attached to the sides of the SysStim 240.

Treatment protocols complete with electrode placement quidance allow clinicians to quickly program treatment parameters for their patients. There is even space to save special treatment protocols for each waveform and for light therapy.

The Sys*Stim 240 has an optional battery pack so that clinicians can take either electrical stimulation or light therapy to their patients. A carrying case is also available which holds the units and all the accessories necessary for therapy on the road.

AI/ML Overview

The Mettler Sys*Stim 240 is a neuromuscular stimulator and low-level light therapy device. The provided text describes its features, intended uses, and lists performance testing certifications but does not contain information about a study proving specific performance acceptance criteria for diagnostic or clinical efficacy aspects that would typically require a test set, ground truth, or expert evaluation.

Instead, the acceptance criteria and supporting "study" are focused on compliance with established electrical safety, electromagnetic compatibility (EMC), and laser safety standards, as well as showing substantial equivalence to a predicate device based on technical specifications and functional capabilities.

Here's a breakdown of the information requested, based on the provided text:

1. A table of acceptance criteria and the reported device performance

The acceptance criteria are primarily compliance with various electrical safety and performance standards. The "reported device performance" is the certification of compliance.

Acceptance Criteria (Standard Compliance)	Reported Device Performance (Certification)
ITS certification for ETL and C-ETL Listing	Certified
Compliance with EMC, EN 60601-1-2: 2001 and FCC's 47 CFR, FCC Sub Part 18	Certified
Compliance to IEC 60601-2-22: 2007	Certified
Compliance to IEC 60825-1: 2007	Certified
Compliance to IEC 62471: 2006	Certified
Compliance to EN60601-2-10, (IEC 601-2-10) 2001	Certified
ISO 14971 : 2000 (Risk Management)	Yes (Claimed for comparison with predicate)
UL 60601-1 (Medical Electrical Equipment)	Yes (Claimed for comparison with predicate)
CSA C22.2 NO 601.1-M90 (Medical Electrical Equipment)	Yes (Claimed for comparison with predicate)
IEC/EN 60601-1 (Medical Electrical Equipment)	Yes (Claimed for comparison with predicate)
IEC/EN 60601-1-2 (EMC)	Yes (Claimed for comparison with predicate)
IEC/EN 60601-2-10 (Nerve and muscle stimulators)	Yes (Claimed for comparison with predicate)
MDD 93/42/EEC, Annex II (Medical Device Directive)	Yes (Claimed for comparison with predicate)
Compliance with 21 CFR 898 (Performance Standards for Diagnostic X-Ray Systems)	Yes (Claimed for comparison with predicate)
Patient Leakage Current (Normal Condition) < 100 μA	78 μA
Patient Leakage Current (Single Fault Condition) < 500 μA	78 μA
Automatic Over Current Trip functionality	Yes (Stops output)
Automatic No Load Trip functionality	Yes (Requires fix and restart for safety)

2. Sample size used for the test set and the data provenance

Not applicable. The "test" in this context refers to engineering and compliance testing of the physical device and its electrical outputs against standards, not a clinical study on a patient population. There is no test set of patient data described.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth for clinical assessment is not relevant to the compliance testing described. Certifications are typically issued by accredited testing bodies (e.g., ITS, ETL).

4. Adjudication method for the test set

Not applicable. This concept is for clinical studies, not product safety and performance standard compliance testing.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is an electrical stimulator and light therapy device, not an AI-powered diagnostic tool. No MRMC study was conducted or mentioned.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. There is no algorithm for diagnostic performance described. The "standalone performance" would be the device's adherence to its electrical output specifications and safety standards, which are evaluated through engineering tests.

7. The type of ground truth used

For the engineering and safety compliance tests, the "ground truth" would be the defined parameters and limits specified by the electrical, EMC, and laser safety standards (e.g., IEC 60601-1, IEC 60825-1, FCC regulations).

8. The sample size for the training set

Not applicable. This is not a machine learning or AI device.

9. How the ground truth for the training set was established

Not applicable.

Summary

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K113017
PAGE 1 OF 5

JUN 2 6 2012

510(k) SUMMARY

Mettler Sys*Stim 240, ME 240

Submitter's Name: Mettler Electronics Corp. Address: 1333 South Claudina Street Anaheim, CA 92805

Telephone: 714-533-2221 x331 Fax: 714-635-7539

Christina Cavuela Contact: QS/RA Manager

September 29, 2011 Date Prepared: Revised copy : March 27, 2012 Revised copy: May 23, 2012 Revised copy: June 25, 2012

Proposed Device Name:

a. TRADE NAME: Sys*Stim 240

b. CLASSIFICATION NAME: Powered Muscle Stimulator (890.5850), Transcutaneous Electrical Nerve Stimulator for pain relief (882.5890) and Infrared Lamp (890.5500) c. COMMON NAME: Combination Neuromuscular Stimulator

and Low Level Light Therapy device

Predicate Devices:

a. TRADE NAME: Chattanooga Group's Vectra Genisys 2channel electrotherapy system
b. 510(k) Number: (K031077)
c. TRADE NAME: Mettler Electronic Corp.'s Laser Sys*Stim 540, infrared lamp, therapeutic heating device
d. 510(k) Number: (K043586)

{1}------------------------------------------------

Description of Proposed Device:

{2}------------------------------------------------

Proposed Device Intended Use Statement:

Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms

· Relaxation of muscle spasms
· Prevention or retardation of disuse atrophy
· Increase local blood circulation
· Muscle re-education
· Maintaining or increasing range of motion
· Immediate post surgical stimulation of calf muscles to prevent venous
thrombosis

Additional Indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic, and TENS waveforms

· Symptomatic relief and management of chronic, intractable pain
· Post-traumatic acute pain
· Post-surgical acute pain

Indications for DC (Direct Current) Mode

· Relaxation of muscle spasm

The laser and cluster applicators of the Sys Stim 240 emit infrared energy for:

Temporary increase in local blood circulation .
Temporary relief of minor muscle and joint aches, pains and stiffness .
Relaxation of muscles .
Temporary relief of Muscle spasms .
Temporary relief of minor pain and stiffness associated with arthritis

Biocompatibility Certification: Electrodes to be provided with this device are the same as those previously submitted since 1997 with Mettler Electronics Corp. devices: Sonicator Plus 992/994 (K984142); SysStim 226 (K964028); SysStim 294 (K984114); and Sonicator Plus 930 (K013192).

Performance Testing: The Sys*Stim 240 has been certified for:

ITS certification for ETL and C-ETL Listing .
Compliance with EMC, EN 60601-1-2: 2001 and FCC's 47 CFR, . FCC Sub Part 18
Compliance to IEC 60601-2-22: 2007 ●
Compliance to IEC 60825-1: 2007 .
Compliance to IEC 62471: 2006 ●
Compliance to EN60601-2-10, (IEC 601-2-10) 2001

{3}------------------------------------------------

Comparison Table for Sys Sti 510K Submission

Section 2

1.	510 K #	K	K031077
2.	Device Name	Sys*Stim 240	Vectra Genisys
3.	Manufacturer	Mettler Electronics	Encore Medical(Chattanooga Group)
4.	Power Source	AC line or optional battery pack 10.8 VLithium Ion	AC line or optional battery pack
	Line Current Isolation	Yes	Yes
	Patient Leakage Current (μΑ)
	Normal condition (ac)	78 (Less than 100 μΑ)	Less than 100 μΑ
	Single fault condition (ac)	78 (Less than 500 μΑ)	Less than 500 μΑ
5.	Number Of Output Modes	9 (one less output )	10
6.	Channel(s)	2 Channel	2 Channel
	Synchronous	1 & 2	1 & 2
	Reciprocal	1 & 2	1 & 2
	Other	Yes	Yes
7.	Constant Current	Optional	Optional
	Constant Voltage	Optional	Optional
8.	Software / Firmware /Microprocessor Control	Yes	Yes
9.	Automatic Overload Trip	Yes	Yes
	Automatic Over Current Trip	Yes	Warning only, Overcurrent
	10. Automatic No Load Trip	Yes	Warning only, Bad electrode contact
	11. Automatic Shut Off	Yes	Yes
	12. Patient Override	Yes	Yes
	Control Method	Patient interrupt switch	Patient interrupt switch
	13. Indicator Display
	On / Off Status	Yes	Yes
	Low Battery Indicator	Yes	Yes
	Voltage / Current Level	Yes	Yes
	14. Timer Display: (Stimulator)	0 - 60 minutes for stimulationAuto based on dosage for light therapy	0 - 60 minutes
	15. Standards
	ISO 14971 : 2000	Yes	Yes
	UL 60601-1	Yes	Yes
	CSA C22.2 NO 601.1-M90	Yes	Yes
	IEC/EN 60601-1	Yes	Yes
	IEC/EN 60601-1-2	Yes	Yes
	IEC/EN 60601-2-10	Yes	Yes
	MDD 93/42/EEC, Annex II	Yes	Yes
	16. Compliance with21 CFR 898	Yes	Yes
	17. Weight (lbs.)	4.5 lb / 5.50 lb with Battery (Lighter wt)	7
	18. Dimensions (in.) H x W x L	8 in (H) x 8 in (W) x 13 in (L)	8.8 x 11.375 x 12.75
	19. Housing Materials &Construction	ABS Plastic	ABS Plastic

{4}------------------------------------------------

Explanation of Differences on the Comparison Table for the Sys*Stim® 240

Item	Mettler	Chattanooga	Explanation
5. Number of output modes	9	10	Mettler does not haveChattanooga's proprietaryVMS burst
9. Automatic Over Current Trip	Yes	Warning only,Overcurrent	On an error such as this one,Mettler chooses to stop alloutput in the interest ofpatient safety.
10. Automatic No Load Trip	Yes	Warning only,Bad electrodecontact	Mettler chooses patientsafety, by requiring theclinician to fix the contactissue and then restart thesystem, to assure there areno excess outputs.
17. Weight	4.5 lbs.	7 lbs.	Different design criteria, noeffect on function
18. Dimensions	8 x 8 x 13	8.8 x 11.375 x12.75	Different design criteria, noeffect on function

{5}------------------------------------------------

DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/5/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

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

JUN 2 6 2012

Mettler Electronics Corporation % Ms. Christina Cayuela OS/RA Manager 1333 South Claudina Street Anaheim, California 92805

Re: K113017

Trade/Device Name: SYS*stim 240 Regulation Number: 21 CFR 890.5850 Regulation Name: Powered muscle stimulator Regulatory Class: II Product Code: IPF, ILY, GZJ, LIH Dated: May 26, 2012 Received: June 04, 2012

Dear Ms. Cayuela:

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.

{6}------------------------------------------------

Page 2 - Ms. Christina Cayuela

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 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.

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 yours,

Eunice Keith

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

Enclosure

{7}------------------------------------------------

Indications for Use

510(k) Number (if known): K113017

Sys*Stim® 240, Model ME240 Device Name:

1. Indications for Medium Frequency (Russian), Biphasic, High Volt Pulsed Current (HVPC), Interferential (4P) and Premodulated (2P) waveforms
- · Relaxation of muscle spasms
- · Prevention or retardation of disuse atrophy
- · Increase local blood circulation
- · Muscle re-education
- · Maintaining or increasing range of motion
- · Immediate post-surgical stimulation of calf muscles to prevent venous thrombosis
1. Additional indications for Microcurrent, Interferential (4P), Premodulated (2P), Biphasic and TENS waveforms
- · Symptomatic relief and management of chronic, intractable pain
- · Post-traumatic acute pain
- · Post-surgical acute pain

3. Indications for DC (Direct Current) Mode

Relaxation of muscle spasm
1. The laser and cluster applicators of the Sys*Stim 240 emit infrared energy for:
- · Temporary increase in local blood circulation
- · Temporary relief of minor muscle and joint aches, pains and stiffness
- · Relaxation of muscles
- · Temporary relief of muscle spasms
- Temporary relief of minor pain and stiffness associated with arthritis

× Prescription Use

AND/OR

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

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

Evaluation (ODE) Concurrent of CDRH Office of Device

KAYLA L. LYNCH
(Division Sign-Off)

Division of Surgical, Orthopedic, and Restorative Devices

5 . 0(k) Number

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).