CERSR ELECTROMYOGRAPHY SYSTEM
Device Facts
| Record ID | K110048 |
|---|---|
| Device Name | CERSR ELECTROMYOGRAPHY SYSTEM |
| Applicant | Spinematrix, Inc. |
| Product Code | IKN · Physical Medicine |
| Decision Date | Jan 26, 2011 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 890.1375 |
| Device Class | Class 2 |
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.
Device Story
CERSR® Electromyography System records muscle electrophysiology in real-time; utilizes array of surface electrodes applied to anatomical regions of interest. Each electrode connects to dedicated channel with preamplifier, amplifier, buffers, and filters. System processes signals to produce visual output for clinicians; displays include typical waveform, RMS, or frequency spectral analysis plots. Used in clinical settings by trained technicians or physicians. Modifications involve hardware upgrades to contemporary computer equipment and corresponding software updates for system robustness and user convenience. Output assists clinicians in diagnosing and monitoring muscular disease or dysfunction.
Clinical Evidence
Bench testing only. No clinical data presented. Testing included IEC 60601-1 (safety), IEC 60601-1-2 (EMC), IEC 61000-3-2/3 (emissions/fluctuations), ISO 10993-1/5/10 (biocompatibility), IEC 60601-1-4 (programmable systems), and ASTM D4169/D7386 (packaging/shipping).
Technological Characteristics
Electromyography system; surface electrode array; multi-channel signal acquisition via preamplifiers, amplifiers, buffers, and filters. Components: CPU, monitor, printer, buffer amplifiers, power distribution/filter box, isolation transformer, power supplies, static ground system. Standards: IEC 60601-1, IEC 60601-1-2, IEC 61000-3-2/3, ISO 10993-1/5/10, IEC 60601-1-4, ASTM D4169, ASTM D7386. Software-controlled signal processing.
Indications for Use
Indicated for monitoring and displaying muscle bioelectric signals to aid in diagnosis and prognosis of muscular disease or dysfunction in patients requiring electromyographic assessment.
Regulatory Classification
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.
Predicate Devices
- Paraspinal Diagnostic Corporation CERSR® Electromyography System
Submission Summary (Full Text)
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K110048
### 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.
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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 <16 amps per phase and not subject to conditional connection
- ISO 10993-10:2002. Biological Evaluation of Medical Devices -. Part 10: Tests for Irritation and Delayed Type Hypersensitivity
- ISO 10993-10:2009, Biological Evaluation of Medical Devices -� Part 10: Tests for Irritation and Delayed Type Hypersensitivity
- ISO 10993-5:2009 Biological Evaluation of Medical Devices -� Part 5: Tests for Cytotoxicity, In Vitro Methods
- ISO 10993-1: 2009 Biological Evaluation of Medical Devices -� Part 1: Evaluation and Testing
- IEC 60601-1-4:2000 Medical electrical equipment Part 1-4: . General Requirements for safety - Collateral Standard: Programmable electrical medical systems.
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- ASTM D4169 09, Standard Practice for Performance Testing of Shipping Containers and Systems (Cycle 12 Level III)
- ASTM D7386 08. Standard Practice for Performance Testing of . Packages for Single Parcel Delivery
The CERSR® Electromyography System nonclinical performance testing demonstrated that this device performs as safely and effectively as the legally marketed device. No new issues were raised in the electrical safety/electromagnetic compatibility testing, biocompatibility testing, software verification and validation testing, or packaging/shipping testing of the modified device.
# Substantial Equivalence
The SpineMatrix CERSR® Electromyography System has the exact same intended use and indications for use as the PDC CERSR® Electromyography System. The minor differences in the hardware and software do not raise any new questions of safety or effectiveness. Thus, the CERSR® Electromyography System is substantially equivalent to its predicate device.
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Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an image of an eagle with its wings spread, symbolizing the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Spinematrix, Inc. c/o Hogan Lovells US LLP Ms. Janice M. Hogan 1835 Market Street, 29th Floor Philadelphia, PA 19103
JAN 2 6 251
Re: K110048
Trade/Device Name: CERSR® Electromyography System Regulation Number: 21 CFR 890.1375 Regulation Name: Diagnostic Electromyograph Regulatory Class: Class II Product Code: IKN Dated: January 6, 2011 Received: January 6, 2011
Dear Ms. Hogan:
1. 1. 1. 1. 1.
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.
and the comments of the
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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.
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Ruch. Ken, mo for
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K11048
#### Indications for Use Statement
Device Name: CERSR® Electromyography System
Indications for Use:
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.
Prescription Use X (Per 21 C.F.R. 801.109)
AND/OR
Over-The-Counter Use (Per 21 C.F.R. 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
KRISTEN BOWSHER
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number_K 1 100 48
