(20 days)
IKN
Not Found
No
The description focuses on real-time recording and display of bioelectric signals using standard signal processing techniques (waveform, RMS, frequency spectral analysis). There is no mention of AI/ML algorithms for analysis, interpretation, or diagnosis.
No
The device is indicated for monitoring and displaying bioelectric signals to aid in diagnosis and prognosis, not for treating any condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is intended "to aid in the diagnosis and prognosis of muscular disease or dysfunction."
No
The device description explicitly lists multiple hardware components, including a system cart with CPU, mouse, keyboard, monitor, printer, buffer amplifiers, power distribution box, isolation transformer, power supplies, and a static ground system. It also includes a disposable electrode array and other physical accessories.
Based on the provided information, the CERSR® Electromyography System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body (like blood, urine, tissue). The CERSR® system directly measures bioelectric signals produced by muscles on the body using surface electrodes.
- The intended use is to monitor and display bioelectric signals to aid in the diagnosis and prognosis of muscular disease or dysfunction. This is a direct physiological measurement, not an analysis of a biological specimen.
- The device description details components for signal acquisition, amplification, filtering, and display. These are characteristic of devices that measure physiological signals directly from the body.
Therefore, the CERSR® Electromyography System falls under the category of a physiological monitoring device rather than an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The CERSR® Electromyography System is intended to be used by properly trained technicians and/or physicians in clinical settings. The CERSR® Electromyography System is indicated for use to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
Product codes
IKN
Device Description
The CERSR® Electromyography System is specifically designed for a real-time recording of muscle electrophysiology. The CERSR® Electromyography System allows for a real-time recording from multiple locations by applying an array of surface electrodes over the anatomical region of interest. Each electrode is connected to its own channel with a preamplifier, amplifier, buffers and filters. The CERSR® Electromyography System produces a user display of the myoelectric signals. These recordings may be viewed in one of three standard formats, as a typical waveform, RMS display or a frequency spectral analysis plot. The system consists of the following components: 1) a system cart comprised of a CPU; 2) a mouse and keyboard; 3) monitor; 4) printer; 5) two buffer amplifiers; 6) power distribution box, which contains a filter buffer box; 7) isolation transformer; 8) two power supplies; and 9) a static ground system. The CERSR® system contains software and includes a disposable electrode array. Additional accessories provided with the system include a goniometer, a flexible transparent ruler, and two 3-pound weights.
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
properly trained technicians and/or physicians in clinical settings.
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 was completed to demonstrate substantial equivalency to the legally marketed device including:
- IEC 60601-1:1995, Medical Electrical Equipment Part 1: General . Requirements for Safety
- IEC 60601-1-2:2001. Medical Electrical Equipment, Part 1-2: . General Standard: Electromagnetic Compatibility-Requirements and Tests
- IEC 61000-3-2:2006, Electromagnetic compatibility- Part 3-2 . Limits -Limits for harmonic current emissions (Equipment Input Current ≤16 Amps Per Phase)
- IEC 61000-3-3:2005. Electromagnetic compatibility- Part 3-3 . Limits -Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems for equipment with rated current
§ 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
SpineMatrix CERSR® Electromyography System with Electrode Array JAN 2 6 201
Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared:
SpineMatrix, Inc.
4480 Lake Forest Drive Suite 412 Cincinnati. Ohio 45242
| Phone: | 513-429-4340 |
|---|---|
| Facsimile: | 513-429-4348 |
Contact Person: Tamala Wampler VP of Ouality Assurance and Regulatory Affairs
Date Prepared: 1/5/2011
Name of Device: CERSR® Electromyography System with Electrode Array
Common or Usual Name: Electromyographic System
Classification Name: 21 CFR 890.1375 Diagnostic Electromyograph, Class II
Predicate Devices
Paraspinal Diagnostic Corporation CERSR® Electromyography System
Purpose of the Special 510(k) notice.
The SpineMatrix CERSR® Electromyography System is a modification to the PDC CERSR® Electromyography System
Intended Use
The CERSR® Electromyography System is intended to be used by properly trained technicians and/or physicians in clinical settings. The CERSR® Electromyography System is indicated for use to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
Technological Characteristics
The CERSR® is an Electromyography System. The CERSR® Electromyography System is substantially equivalent to the legally marketed predicate electromyography system. Like most electromyographic systems, CERSR® allows for the monitoring and displaying of the bioelectrical signals generated by muscles.
The CERSR® Electromyography System is specifically designed for a real-time recording of muscle electrophysiology. The CERSR® Electromyography System allows for a real-time recording from multiple locations by applying an array of surface electrodes over the anatomical region of interest. Each electrode is connected to its own channel with a preamplifier, amplifier, buffers and filters. The CERSR® Electromyography System produces a user display of the myoelectric signals. These recordings may be viewed in one of three standard formats, as a typical waveform, RMS display or a frequency spectral analysis plot.
1
The SpineMatrix CERSR® Electromyography System has the same fundamental scientific technological characteristics as the PDC CERSR® Electromyography System, to which it is a modification. There have been no changes made to the fundamental scientific technology of the system, which consists of the following components: 1) a system cart comprised of a CPU: 2) a mouse and keyboard; 3) monitor; 4) printer; 5) two buffer amplifiers; 6) power distribution box. which contains a filter buffer box; 7) isolation transformer; 8) two power supplies; and 9) a static ground system. The CERSR® system contains software and includes a disposable electrode array. Additional accessories provided with the system include a goniometer, a flexible transparent ruler, and two 3-pound weights. The SpineMatrix CERSR® System components described above are the same as in the predicate device.
The principle purpose of the modifications that have been made is to upgrade the electronic components of the device and its accessories to contemporary computer equipment, printer, etc. Corresponding modifications to the software have been made to accommodate the changes in hardware. No new features or capabilities have been added to the software. None of the changes were made as a result of adverse events with the previous system. Rather, the changes that were made were implemented for purposes of improved user convenience and/or system robustness.
The following performance testing was completed to demonstrate substantial equivalency of the CERSR® Electromyography System to the legally marketed device:
- IEC 60601-1:1995, Medical Electrical Equipment Part 1: General . Requirements for Safety
- IEC 60601-1-2:2001. Medical Electrical Equipment, Part 1-2: . General Standard: Electromagnetic Compatibility-Requirements and Tests
- IEC 61000-3-2:2006, Electromagnetic compatibility- Part 3-2 . Limits -Limits for harmonic current emissions (Equipment Input Current ≤16 Amps Per Phase)
- IEC 61000-3-3:2005. Electromagnetic compatibility- Part 3-3 . Limits -Limitation of voltage changes, voltage fluctuations and flicker in public low-voltage supply systems for equipment with rated current