(259 days)
No
The device description focuses on electrical stimulation and light therapy waveforms, user interface features, and regulatory compliance, with no mention of AI or ML capabilities.
Yes
The device is described as a "neuromuscular stimulator" and its indications for use include therapeutic benefits such as "relaxation of muscle spasms", "prevention or retardation of disuse atrophy", "symptomatic relief and management of chronic, intractable pain", and "temporary relief of minor muscle and joint aches, pains and stiffness". These are all common goals of therapeutic interventions.
No
The device description and intended use indicate that the Sys*Stim 240 is a neuromuscular stimulator and light therapy device used for therapeutic purposes such as pain relief, muscle relaxation, and increasing range of motion, not for diagnosing medical conditions.
No
The device description clearly details hardware components such as a neuromuscular stimulator, applicators (laser and cluster), a display, and an optional battery pack. It is a physical medical device that utilizes software for control and functionality, but it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The listed indications are all related to therapeutic applications on the human body (muscle stimulation, pain relief, increasing blood circulation, etc.). IVDs are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Description: The description details a neuromuscular stimulator and light therapy device designed for direct application to the patient. It does not mention any components or functions related to analyzing biological samples.
- Lack of IVD-related terms: There is no mention of analyzing samples, diagnostic testing, or any other activities typically associated with IVDs.
The device is clearly intended for physical therapy and pain management through electrical stimulation and light therapy applied externally to the patient.
N/A
Intended Use / Indications for Use
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
Product codes (comma separated list FDA assigned to the subject device)
IPF, ILY, GZJ, LIH
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.
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)
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
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.
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.
K984142, K964028, K984114, K013192
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
§ 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).
0
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:
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.
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 V | |
| Lithium 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 stimulation | ||
| Auto 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 with | |||
| 21 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 have |
| Chattanooga's proprietary | |||
| VMS burst | |||
| 9. Automatic Over Current Trip | Yes | Warning only, | |
| Overcurrent | On an error such as this one, | ||
| Mettler chooses to stop all | |||
| output in the interest of | |||
| patient safety. | |||
| 10. Automatic No Load Trip | Yes | Warning only, | |
| Bad electrode | |||
| contact | Mettler chooses patient | ||
| safety, by requiring the | |||
| clinician to fix the contact | |||
| issue and then restart the | |||
| system, to assure there are | |||
| no excess outputs. | |||
| 17. Weight | 4.5 lbs. | 7 lbs. | Different design criteria, no |
| effect on function | |||
| 18. Dimensions | 8 x 8 x 13 | 8.8 x 11.375 x | |
| 12.75 | Different design criteria, no | ||
| effect 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:
-
- 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
3. 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
× 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