(172 days)
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.
CERSR™ is an electromyography system. CERSR™ is substantially equivalent 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.
This document is a 510(k) summary for the CERSR™ Electromyography System from 1999. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than presenting a detailed study of the device's performance against specific acceptance criteria.
Based on the provided text, there is no information that directly describes acceptance criteria or a study proving the device meets those criteria in a quantitative sense. The document asserts substantial equivalence based on the device's technological characteristics and its ability to perform core functions similar to existing devices.
Therefore, many of the requested details cannot be extracted from this summary.
Here's a breakdown of what can and cannot be answered:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document does not define specific acceptance criteria (e.g., sensitivity, specificity, accuracy, signal-to-noise ratio requirements) or report quantitative performance metrics for the CERSR™ system in a study format. The claim is one of "substantial equivalence" in function and technological characteristics.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. No test set or related data is discussed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Cannot be provided. No ground truth establishment activity is mentioned for a test set.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Cannot be provided. No test set or adjudication process is mentioned.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This device is an electromyography system, not an AI-assisted diagnostic tool for "human readers" in the context of MRMC studies typical for imaging or AI. No MRMC study is mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. This is an EMG system designed for monitoring and displaying bioelectric signals, inherently used by a human clinician. It does not operate as a standalone algorithm in the sense of AI or automated diagnosis.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No ground truth for performance evaluation is mentioned. The device's "ground truth" functionally lies in its ability to accurately record muscle bioelectric signals, but no formal validation study is presented here.
8. The sample size for the training set
- Cannot be provided. There's no mention of a "training set" as this predates (or doesn't involve) machine learning/AI development in this context. The device's design is based on established electromyography principles.
9. How the ground truth for the training set was established
- Cannot be provided. As there's no training set, this question is not applicable.
Summary based on the document:
The 510(k) summary for the CERSR™ Electromyography System functions as a regulatory submission arguing for "substantial equivalence" to existing, legally marketed predicate devices. It asserts that the CERSR™ shares the same indications for use and technological characteristics (monitoring and displaying bioelectric signals in standard formats) as these predicates. The approval letter from the FDA (dated August 27, 1999) confirms this determination of substantial equivalence, allowing the device to be marketed.
This type of submission typically relies on comparing the new device's design, materials, and intended use against those of already approved devices, rather than conducting a de novo performance study against pre-defined acceptance criteria for a new clinical claim.
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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))
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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))
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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
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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)
§ 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).