(269 days)
No
The document describes a device that integrates surface EMG with functional capacity sensors (range of motion, grip, pinch). It focuses on objective measurement and interpretation of muscle function based on these sensor inputs. There is no mention of AI, ML, or any algorithms that learn from data or perform complex pattern recognition beyond basic signal processing and comparison. The validation tests described are for sensor accuracy and repeatability, not for the performance of any AI/ML model.
No
The device is described as providing non-invasive muscle testing and monitoring, which suggests a diagnostic or assessment purpose rather than a therapeutic one. Its uses include pinpointing muscle activity, establishing baselines, evaluating chronic vs. acute muscle function, and ascertaining ischemic activity, all of which are related to diagnosis or monitoring.
Yes
The device is described as providing "non-invasive muscle testing" and the ability to "pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns." It also aims to "establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress" and "pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities, and refer pain sources." These functions are consistent with diagnosing physiological conditions.
No
The device description explicitly states that the PMRU-S "combines surface EMG with functional capacity sensors range of motion, grip and pinch strength sensors." This indicates the device includes hardware components (sensors) in addition to any potential software.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body. They are used to detect diseases, conditions, or infections.
- Device function: The description clearly states the device performs "Surface Electromyography with range of motion functional capacity assessment grip and pinch strength." It measures muscle activity, range of motion, and force applied during various physical tasks.
- No mention of biological samples: There is no indication that this device analyzes any biological samples taken from the patient. It interacts with the patient externally to measure physiological responses and physical capabilities.
Therefore, the device described falls under the category of a medical device used for physiological monitoring and assessment, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
Indications For Use: Surface Electromyography with range of motion functional capacity assessment grip and pinch strength. The Intended Use Section is identical to the original device PMRU (K022719) To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities, and refer pain sources. To evaluate a baseline muscle activity for preemployment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.
Product codes
IKN
Device Description
The Physical Monitoring Registration Unit-S, (PMRU-S) like the legally cleared PMRU combines surface EMG with functional capacity sensors range of motion, grip and pinch strength sensors. This integration allows for a reproducible, objective interpretation of muscle function and effort via the range of motion, fce, pinch and grip. All muscle groups of the body from cervical (to mid back, low back and extremities can be monitored with the device). Bilateral muscle testing is done to compare antagonist muscle groups. The devices monitors bilateral muscle activity with the force produced by the patient while he or she pulls on the strain gauge, with the range of motion. is to provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To measure surface emg along the spine, extremities or cervical region. To measure the EMG with functional tasks, to measure the EMG with range of motion, to measure the EMG with pinch and or grip. This this is identical to the already cleared PMRU. The PMRU-S uses all the same technological characteristics, it uses the same strain gage, grip, pinch and EMG sensors. The only difference from a technological characteristic is the data is transmitted via Bluetooth.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
All muscle groups of the body from cervical (to mid back, low back and extremities.
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)
Validation tests were performed to validate the accuracy and repeatability of the EMG, Range of Motion, FCE, Pinch and Grip Sensors. It was shown through validation using weights for FCE, Pinch, and Grip, inclinometer testing for Range of Motion, and Signal Generator for EMG Sensors. It was shown through this validation testing that all sensors captured data accurately and repeatability.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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).
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PMRU-S 510(k) Application
Section F 510(k) Summary
Submitted by: MaryRose Cusimano-Reaston, Ph.D. and Phil Reaston
7225 S. 85th E. Ave. Suite 300
Tulsa, OK 74133
Telephone: 702-234-1014
Date Prepared: December 7, 2012
SEP 1 3 2013
Contact: MaryRose Cusimano-Reaston, Ph.D. mreaston@emergedx.com 702-234-1014
Trade Name: Physical Monitoring Registration Unit -S (PMRU-S)
Common Name: EMG
Classification Name: Diagnostic Electromyography (890.1375)
Product code: IK N
Class II
Legally Marketed Predicate Device to which we are claiming equivalence. Physical Monitoring Registration Unit (PMRU) K022719, Class II
Description of Device:
The Physical Monitoring Registration Unit-S, (PMRU-S) like the legally cleared PMRU combines surface EMG with functional capacity sensors range of motion, grip and pinch strength sensors. This integration allows for a reproducible, objective interpretation of muscle function and effort via the range of motion, fce, pinch and grip. All muscle groups of the body from cervical (to mid back, low back and extremities can be monitored with the device). Bilateral muscle testing is done to compare antagonist muscle groups. The devices monitors bilateral muscle activity with the force produced by the patient while he or she pulls on the strain gauge, with the range of motion. is to provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To measure surface emg along the spine, extremities or cervical region. To measure the EMG with functional tasks, to measure the EMG with range of motion, to measure the EMG with pinch and or grip. This this is identical to the already cleared PMRU.
The PMRU-S
- has the same intended use as the predicate;
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- technological characteristics the predicate; has the same as . has the same intended use as the predicate;
- The PMRU-S uses all the same technological characteristics, it uses the same strain . gage, grip, pinch and EMG sensors. The only difference from a technological characteristic is the data is transmitted via Bluetooth.
Indications For Use:
Surface Electromyography with range of motion functional capacity assessment grip and pinch strength.
Intended Use
The Intended Use Section is identical to the original device PMRU (K022719) To provide non-invasive muscle testing integrating with range of motion, functional capacity of lifting, pulling, pushing, pinching and gripping. To pinpoint muscle activity during movement objectively isolating abnormal movements with abnormal muscle patterns. To establish relative functioning of muscle in any specific anomaly that may occur due to muscle damage, muscle fatigue, hypertonicity or stress. To pinpoint referred pain pattern associated with cervical, thoracic, lumbosacral upper and lower extremities, and refer pain sources. To evaluate a baseline muscle activity for preemployment screening, sport medicine. To look at chronic vs. acute muscle function and range of motion to ascertain good effort with FCE, range of motion, and gripping, and pinch. To ascertain the ischemic activity of muscles. To ascertain chronic damage to muscles. To monitor the frequency range for cardiac muscle.
| PMRU | PMRU-S | |
|---|---|---|
| EMG leads | 6" clip to snap | 6"clip to snap |
| Strain | ||
| gage | ||
| pinch/fce | Force measuring platform | Force measuring platform |
| grip | Jamar dynamometer | Jamar dynamoter |
| Sample rate | 1000 HZ | 1024 HZ |
| CMRR | >90db (at 10 hz) | >90db (at 10hz) |
| Filters | Current limiting | Current Limiting |
| EMG | The instrumentation | |
| amplifiers stage detects | ||
| the voltage difference | The instrumentation amplifiers stage | |
| detects the voltage difference between the | ||
| two (2) points of electrodes on the |
System Comparisons
2
| | between the two (2) patients skin with ground on each EMG
points of electrodes on
the patients skin with 1
universal ground | patients skin with ground on each EMG
sensor |
|----------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DAQ | The DAC module
converts analog voltage
to a digital value, which
is then passed through an
optical isolation device
and is then available for
processing by the lap top
computer. The DAQ is
housed in the main circuit
board and box for all
sensors | The DAC module converts analog voltage
to a digital value. This DAQ module is
housed in each individual sensor. Since
the patient is not connected to a power
source no optical isolation is needed. |
| Power Source | 110V AC power from
any conventional outlet. | Battery Operated |
| Data
transmission | USB or PCMCI cable | Bluetooth |
The PMRU-S is substantially equivalent to the PMRU cleared in K022719 based on the following similarities:
A laptop computer to acquire data
Surface electrodes with range of motion. functional grip and pinch sensors
Data acquisition converting analog to digital signals.
There has been a change to the original device. This is a change for the data transfer to a wireless (Bluetooth) platform. None of these modifications including the Bluetooth data transfer, which is the subject of this submission lead to a change in the indications or intended use of the original device nor do they alter the fundamental scientific technology or introduce a fundamentally new scientific technology. Furthermore, none of these modifications poses an new issues with safety or efficacy. The design change which is the is to transfer the data to host computer without a cable and to further increase the device's safety through use of a battery operated wireless sensors and Bluetooth wireless technology to eliminate any possible connection between the patient and line voltage.
Both PMRU and PMRU-s conform to 60601. In addition, validation tests were performed to validate the accuracy and repeatability of the EMG, Range of Motion, FCE, Pinch and Grip Sensors. It was show through validation using weights for FCE, Pinch, and Grip, inclinometer testing for Range of Motion, and Signal Generator for EMG Sensors. It was
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shown through this validation testing that all sensors captured data accurately and repeatability.
4
Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles an abstract human figure or a caduceus, which is a symbol often associated with healthcare.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 13, 2013
OKTX, LLC c/o Ms. MaryRose Cusimano-Reaston 7225 S 85th E. Ave. Suite 300 Tulsa, OK 74137
Re: K123902
Trade/Device Name: Physical Monitoring Registration Unit-S (PMRU-S) Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN Dated: August 9, 2013 Received: August 12, 2013
Dear Ms. MaryRose Cusimano-Reaston:
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 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 (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.
5
Page 2 - Ms. MaryRose Cusimano-Reaston
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 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,
Joyce M. Whang -S
for Victor Krauthamer, Ph.D. Acting Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number (if known): K123902
Device Name: PMRU-S (Physical Monitoring Registration Unit-S)
Indications For Use:
Surface Electromyography with range of motion.functional capacity assessment.grip and pinch strength.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
e M. Whang -
Division Sign Off) Division of Neurological and Physical Medicine Devices (DNPMD)
K123902 510(k) Number
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