(184 days)
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No
The description focuses on basic EMG technology and sensitivity testing, with no mention of AI, ML, or complex data processing beyond monitoring muscle activity.
Yes
The device is intended for muscle re-education and relaxation training, which are therapeutic uses.
Yes
Explanation: The device is an EMG (Electromyography) device that monitors muscle activity. While its intended uses are relaxation training and muscle re-education, EMG itself is a diagnostic technique used to evaluate the electrical activity produced by skeletal muscles. The device's ability to "effectively monitor muscle activity" implies it provides information that can be used for diagnosis or assessment of muscle function/dysfunction.
No
The device description explicitly mentions hardware components such as electrodes, a battery, and a power supply, and describes sensitivity testing of the device itself, indicating it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Description: The MuscleSense™ II is an EMG device that measures electrical activity in muscles. It uses electrodes placed on the skin to monitor muscle activity.
- Intended Use: The intended uses are "Relaxation Training" and "Muscle Re-education." These are therapeutic and monitoring applications, not diagnostic testing of bodily specimens.
- No Specimen Analysis: The description explicitly states there is "no electrical current being delivered to the patient" and the device monitors muscle activity via electrodes on the skin. There is no mention of collecting or analyzing any bodily fluids or tissues.
Therefore, the MuscleSense™ II falls under the category of a medical device used for monitoring and therapy, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
-
- Relaxation Training
-
- Muscle Re-education
Product codes (comma separated list FDA assigned to the subject device)
84HCC
Device Description
The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation training. The device is supplied with pre-gelled conductive electrodes. The device is battery powered or by a UL544 approved wall mounted power supply.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The MuscleSense™ II threshold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
510(k) Summary
Smith & Nephew, Inc. DonJoy Division 2777 Loker Ave. West Carlsbad, CA 92008
JUL 1 0 1997
Contact Person: Dan W. Miller
Phone: (760) 438-9091
Date Prepared: April 11, 1997
INTRODUCTION
The MuscleSense™ II is an EMG (Electromyography) device intended for medical use for muscle re-education and relaxation We consider the Smith & Nephew MuscleSense™ II training. portable EMG to be substantially equivalent to the Autogenics Systems' AT Dual Channel EMG and the Promethius Group Pathway™ MR :5 EMG System. The MuscleSense II, AT , and Pathway MR-25 are all indicated for relaxation training and muscle reeducation. All three devices are used in conjucnction electrodes. The MuscleSense™ II tnresold sensitivity testing confirmed the device to fall within an acceptable sensitivity range to effectively monitor muscle activity. There is no electrical current being delivered to the patient. The device is supplied with pre-gelled conductive electrodes which have been cleared for marketing by the Food and Drug Administration under K851522/A. The device is battery powered or by a UL544 approved wall mounted power supply.
Smith & Nephew, Inc. DonJoy Division
Dan A. Milich
Dan W. Miller Director, Regulatory Affairs & Quality Assurance
1
SPECIFICATIONS
Input Impedance: 1010 Ohms 0.5 µV rms Sensitivity: 45-300 Hz Bandwidth: 1159B CMRR : 60 Hz, 24dB Notch Filter: 0.28 µV Input Noise: Bias Current: 5 nA 0-50uV rms ×1 Range: 0-500pV rms x10 0-2500μV rms x50 PEAK, COUNT, RATIO Modes : Power Source 7 Vdc wall mount supply external: (UL544 approved) 6 Vir rechargeable battery pack: Ni Jad battery pack (optional) 8 hours battery life: Dimensions 6" width: ર " length: 3.25" height: 25 oz weight: -20°C to +50°C Storage Temperature: (-4°F to +122°F) 0°C to +50°C Operating Temperature: (+32°F to +122°F)
Note: Electrical specifications are typical.
and the comments of the country of
100 - 100 - 100 - 100
and the comments of the comments of
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Image /page/2/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in a bold, serif font. The text is centered horizontally in the image. The text is black against a white background.
Image /page/2/Picture/1 description: The image shows the seal of the U.S. Department of Health and Human Services. The seal features an abstract eagle design with three curved lines representing the eagle's body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle. The seal is black and white.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Dan W. Miller Director, Regulatory Affairs & Quality Assurance Smith & Nephew DonJoy, Inc. --------------------------------------------------------------------------------------------------------------------------------------------------... 2777 Loker Avenue West Carlsbad, California 92208-6601
JUL 1 0 1997
Re: K970051 MuscleSense II Dual Channel Electromyography Device Trade Name: Requlatory Class: II Product Code: 84HCC Dated: April 11, 1997
Received: April 15, 1997
Dear Mr. Miller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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 You provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Mr. Dan W. Miller
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
MuscleSense II Dual Channel Electromyography Device Device Name:_
Indications For Use:
- l) Relaxation Training
-
- Muscle Re-education
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Thomas J. Call
Division Sign Off)
Division of Cardiovascular, Respiratory,
ad Neurological Devices
10(k) Number K970051
X
on Use
Over The Counter Ice
Prescription Use (Per 21 CFR 801.109)
(Optional Format 1-2-96)