(172 days)
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No
The description focuses on the hardware and signal processing capabilities of a standard EMG system, with no mention of AI or ML algorithms for analysis or interpretation.
No
The device aids in diagnosis and prognosis and monitors bioelectric signals, but it does not directly treat or provide therapy for muscular disease or dysfunction.
Yes
The "Intended Use / Indications for Use" states that the system is used "to aid in the diagnosis and prognosis of muscular disease or dysfunction," which clearly indicates a diagnostic purpose.
No
The device description explicitly mentions hardware components like "surface electrodes," "channel with preamplifier, amplifier, buffers and filters," indicating it is a hardware-based system with associated software for display and analysis.
Based on the provided information, the CERSR™ Electromyography System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The CERSR™ system directly measures bioelectric signals from muscles on the surface of the body using electrodes. It does not analyze samples like blood, urine, or tissue in a laboratory setting.
- The intended use describes monitoring and displaying signals from the body. The description focuses on the real-time recording and display of muscle electrophysiology, which is a direct measurement from the patient.
The CERSR™ system falls under the category of in vivo diagnostic devices, as it is used to diagnose conditions by directly interacting with and measuring signals from a living organism (the patient).
N/A
Intended Use / Indications for Use
The CERSR™ Electromyography System is used to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
Product codes (comma separated list FDA assigned to the subject device)
IKN
Device Description
CERSR™ is an electromyography system. CERSR™ is substantially equivalent2 to legally marketed predicate electromyographic systems. Like most electromyographic systems. CERSR™ allows for the monitoring and displaying of the bioelectrical signals generated by muscles.
CERSR™ is specifically designed for a real-time recording of muscle electrophysiology. Most electromyographic systems have at most five channels for monitoring and displaying the activity of several muscle groups simultaneously. The CERSR™ reduces the problems associated with too few channels and 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 preamplifier, amplifier, buffers and filters. The CERSR™ produces a user display of the myoelectric signals. These recordings may viewed in one of three standard formats, as a typical waveform, RMS display or as a frequency spectral analysis plot.
In conclusion, relevant to the issue of substantial equivalence, the CERSR™ system has the same technological characteristics as legally marketed predicate devices. That is, the technological characteristics of the CERSR™ and the predicate devices are those necessary to accurately record, and monitor bioelectric signals of the target muscles and display these signals in standard formats including normal waveforms, RMS values and FFT spectrally analyzed plots.
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
muscles
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)
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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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§ 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
990766
510(k) SUMMARY CERSR™ Electromyography System March 8, 1999
This summary is provided in accordance with the Safe Medical Devices Act of 1990 (SMDA). The information provided in the 510(k), premarket notification was in accordance with 21 CFR 807.87.
1. Applicant, Official Correspondent and Owner of 510(k)
Paraspinal Diagnostic Corporation 1275 Kinnear Road, Suite 135 Columbus, Ohio 43212
Attn:: Richard L. Hitchcock, Vice President of Operations Telephone: (614) 487-3652 Fax (614) 487-3642
2. Name of Device
Trade/Proprietary Name: CERSR™ Electromyography System
Common/Usual Name: Electromyographic System
Classification Name: 21 CFR 890.1375 "Diagnostic Electromyograph", Class II.
3. Legally Market Predicate Devices
The CERSR is substantially equivalent to legally marketed predicate devices including:
- Synergy Multimedia EMG/EP, Teca Corporation; ●
- Advantage 3000 series, Advantage Medical Division of CME Telemetrix; .
- Sierra Console, Cadwell Laboratories;
- Compass PortaBook II, Nicolet Biomedical. ●
1 Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to refer to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. (Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355))
1
4. Indications for Use
The CERSR™ Electromyography System is used to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
5. Device Description and Substantial Equivalence
CERSR™ is an electromyography system. CERSR™ is substantially equivalent2 to legally marketed predicate electromyographic systems. Like most electromyographic systems. CERSR™ allows for the monitoring and displaying of the bioelectrical signals generated by muscles.
CERSR™ is specifically designed for a real-time recording of muscle electrophysiology. Most electromyographic systems have at most five channels for monitoring and displaying the activity of several muscle groups simultaneously. The CERSR™ reduces the problems associated with too few channels and 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 preamplifier, amplifier, buffers and filters. The CERSR™ produces a user display of the myoelectric signals. These recordings may viewed in one of three standard formats, as a typical waveform, RMS display or as a frequency spectral analysis plot.
In conclusion, relevant to the issue of substantial equivalence, the CERSR™ system has the same technological characteristics as legally marketed predicate devices. That is, the technological characteristics of the CERSR™ and the predicate devices are those necessary to accurately record, and monitor bioelectric signals of the target muscles and display these signals in standard formats including normal waveforms, RMS values and FFT spectrally analyzed plots.
2 Any statement made in conjunction with this submission regarding a determination of substantial equivalence to any other product is intended only to refer to whether the product can be lawfully marketed without pre-market approval or reclassification and is not intended to be interpreted as an admission or any other type of evidence in patent infringement litigation. (Establishment Registration and Premarket Notification Procedures, Final Regulation, Preamble, August 23, 1977, FR 42520 (Docket No. 76N-0355))
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are rendered in black and have a flowing, wave-like appearance. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the image.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 27 1999
Paraspinal Diagnostic Corporation c/o Joel S. Faden, Ph.D. Regulatory Consultant 11605 Hitching Post Lane Rockville. Maryland 20852
Re: K990766
Trade Name: CERSR™ Electromyography System Regulatory Class: II Product Code: IKN Dated: June 14, 1999 Received: June 15, 1999
Dear Dr. Faden:
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 provisions of the Federal Food, Drug, and Cosmetic Act (Act). 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.
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 - Joel S. Faden, Ph.D.
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 legally 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) 594-4595. 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,
Mark N. McKenna
Celia M. Witten, Ph.D., M.D. Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Premarket Notification Paraspinal Diagnostic Corporation CERSR
Indications For Use
Device Name: CERSR™ Electromyography System
Indications For Use:
The CERSR™ Electromyography System is used to monitor and display the bioelectric signals produced by muscles to aid in the diagnosis and prognosis of muscular disease or dysfunction.
Mark M Milliman
Image /page/4/Picture/7 description: The image shows a simple line drawing of a fly on the left side. To the right of the fly, there is some text, but it is not clear enough to read.
Division Sign-Off) Division of General Restorative Devices 510(k) Number
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use: (Per 21 CFR 801.109)
ﺮ ﺍﻟﻤﺮﺍﺟﻊ
OR
Over-The-Counter:
(Optional Format 1-2-96)