(183 days)
Not Found
No
The device description details standard electronic components for signal amplification and processing (amplifiers, rectifiers, integrators) and explicitly states the functions provided are amplification, bandwidth limiting, and signal integration. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance studies focus on comparing the device's signal processing characteristics to a predicate device using standard test signals.
No.
The device is described as an EMG amplifier used for diagnosis and treatment evaluation by recording electrical activity, not for providing therapy.
Yes
The indications for use explicitly state that the device is intended "as an aid in the diagnosis" (Indication 2).
No
The device description explicitly details hardware components such as amplifiers, rectifiers, and integrators, indicating it is a hardware device with associated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The M-Scan is an EMG amplifier that records electrical activity directly from muscles within the body (in vivo). It does not analyze specimens taken from the body.
- Intended Use: The intended uses clearly describe recording and monitoring muscle activity in situ for aid in diagnosis and treatment evaluation.
Therefore, the M-Scan falls under the category of a medical device used for physiological measurement, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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- To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
-
- To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
-
- To determine the degree of relaxation (intra-patient) of 2 muscles at rest
-
- To measure relative (intra-patient) levels of activity of 2 muscles during a function act
Product codes (comma separated list FDA assigned to the subject device)
KZM
Device Description
The M-Scan is a 2-channel, portable, battery operated electromyographic amplifier which includes: a) two (2) identical high-gain differential input amplifiers, b) two (2) buffer amplifiers, c) two (2) full wave rectifiers, and d) two (2) integrators. The overall amplification of the M-Scan is calibrated to 2500. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The M-Scan does not include isolated power converter since it is battery operated, portable, and does not interface with any external equipment (it is never connected to the a-c line). Only three (3) functions are provided by the M-Scan: 1) amplification, 2) bandwidth limiting, and 3) integration of the signal for the integrated display.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
muscles of the stomatognathic system, especially temporalis or masseter
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)
Utilizing a calibrated function generator and oscilloscope we have applied test signals to both instruments. In Appendix E we have supplied comparable graphic plots of the waveforms and the frequency response characteristics of both instruments. In the M-Scan it is clear that we have retained comparable levels of amplification and band-pass filtering as used in the BioEMG III predicate device. EMG testing was performed on the M-Scan. Software validation testing was performed on the software for the M-Scan. This submission does not contain clinical data.
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.
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
§ 890.1375 Diagnostic electromyograph.
(a)
Identification. A diagnostic electromyograph is a device intended for medical purposes, such as to monitor and display the bioelectric signals produced by muscles, to stimulate peripheral nerves, and to monitor and display the electrical activity produced by nerves, for the diagnosis and prognosis of neuromuscular disease.(b)
Classification. Class II (performance standards).
0
510(k) Summary
BioResearch Associates, Inc. 9275 North 49th Street Suite 150 Brown Deer, WI 53223 Phone: (414) 357-7525 Fax: (414) 357-7545 Official Correspondent: John Radke 24 July 2013
Trade Name: M-Scan
Common Name: 2-channel, portable, battery operated electromyography
Regulation Number: 21 CFR 890.1375
Regulation Name: Diagnostic Electromyography
Regulatory Class: Class II
Product Code: KZM
Equivalent Device: BioEMG III (K082927)
Previous submissions: None
Product Description:
The M-Scan is a 2-channel, portable, battery operated electromyographic amplifier which includes: a) two (2) identical high-gain differential input amplifiers, b) two (2) buffer amplifiers, c) two (2) full wave rectifiers, and d) two (2) integrators. The overall amplification of the M-Scan is calibrated to 2500. The bandwidth filtering is set (fixed) from 30 Hz to 1000 Hz (± 3dB). The common mode rejection ratio is ≥ 130 dB at the power line frequency (50/60 Hz). The M-Scan does not include isolated power converter since it is battery operated, portable, and does not interface with any external equipment (it is never connected to the a-c line). Only three (3) functions are provided by the M-Scan: 1) amplification, 2) bandwidth limiting, and 3) integration of the signal for the integrated display.
Intended Use of electromyography: (same as for the BioEMG III - K082927)
-
- To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
- in To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
-
- To determine the degree of relaxation (intra-patient) of 2 muscles at rest
- To measure relative (intra-patient) levels of activity of 2 muscles during a functional act 4.
JUL 2 5 2013
1
Technological Characteristics:
The technological advantages of the M-Scan (compared to the predicate device) include:
- The M-Scan is a portable, self contained, battery operated unit with no requirement for any 1. external connections.
- The M-Scan is dedicated to simple tests comparing two muscles at rest or in function. 2.
- Due to its simplicity and low-power electronic components, the M-Scan will use less energy than 3. the predicate device.
- The functional characteristics of the M-Scan amplifiers are essentially identical to those of the 4. BioEMG III (K082927); literally the same I.C. components are used. See Appendix G.
-
- New features of the M-Scan include: a) miniaturized, self contained operation, b) built-in rectification and averaging filter hardware, and c) built-in digital display
Non-Clinical Test Data:
Utilizing a calibrated function generator and oscilloscope we have applied test signals to both instruments. In Appendix E we have supplied comparable graphic plots of the waveforms and the frequency response characteristics of both instruments. In the M-Scan it is clear that we have retained comparable levels of amplification and band-pass filtering as used in the BioEMG III predicate device. EMG testing was performed on the M-Scan. Software validation testing was performed on the software for the M-Scan. This submission does not contain clinical data.
Conclusion:
Based on the information provided concerning the M-Scan is substantially equivalent to the declared predicate of the BioEMG III (K082927).
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular pattern around the symbol. The logo is black and white and appears to be a scanned image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 25, 2013
BioResearch Associates, Incorporated C/O Mr. John Radke President 9275 North 49th Street, Suite 150 BROWN DEER WI 53223
Re: K130158
Trade/Device Name: M-Scan Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyography Regulatory Class: II Product Code: KZM Dated: June 25, 2013 Received: June 28, 2013
Dear Mr. Radke:
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. Ilsting 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.
3
Page 2 - Mr. Radke
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 (reporting of medical devicerelated 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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kwame Ulmer, M.S. Acting Division Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known): K | 30 15 8
M-Scan Device Name:
Indications for Use:
Indications for use; 2 channel, hand held, mobile EMG amplifier
-
- To record electrical activity of 2 muscles of the stomatognathic system, especially temporalis or masseter
-
- To clinically monitor 2 different muscles as an aid in the diagnosis and treatment evaluation by recording the electrical activity of muscles of the stomatognathic system
-
- To determine the degree of relaxation (intra-patient) of 2 muscles at rest
-
- To measure relative (intra-patient) levels of activity of 2 muscles during a function act
(PLEASE TO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use_ Yes (Pat 21 CFR 801 subpart D) AND/OR
1
Over-the-counter Use (Part 21 CFR 801 subpart D) Andrew I. Steen -S Andrew I. Steen -5
(Division Sign-Off) (Olvision of Anesthesiology, General Hospital Infection Control, Dental Devices
KISOIS
610{k) Number: