(118 days)
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Not Found
No
The summary does not mention AI, ML, or related terms, nor does it describe features or performance metrics typically associated with AI/ML-powered medical devices.
No
The device is described as a "Recording System" for clinical electrophysiology procedures, which suggests it is used for data acquisition and monitoring, not directly for treating a medical condition.
Yes
The device is described as an "Electrophysiology Recording System" intended for "clinical electrophysiology procedures," which are inherently diagnostic in nature as they involve measuring electrical activity to identify medical conditions.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine if the EP-WorkMate® Computerized Electrophysiology Recording System is software-only or includes hardware components.
Based on the provided information, it is highly unlikely that the EP-WorkMate® Computerized Electrophysiology Recording System is an IVD (In Vitro Diagnostic) device.
Here's why:
- Intended Use: The intended use is "during clinical electrophysiology procedures." Electrophysiology procedures typically involve recording electrical activity within the body (in vivo), specifically related to the heart's electrical system. IVD devices, by definition, are used to examine specimens from the human body (in vitro), such as blood, urine, or tissue samples.
- Lack of IVD Indicators: The provided information does not mention any of the typical characteristics of an IVD device, such as:
- Analyzing biological specimens.
- Providing diagnostic information based on the analysis of specimens.
- Mentioning specific analytes or biomarkers.
- Focus on Recording System: The name "Computerized Electrophysiology Recording System" strongly suggests a device that records electrical signals directly from the patient's body, not from a sample.
Conclusion:
The EP-WorkMate® Computerized Electrophysiology Recording System appears to be a device used for in vivo recording of electrical activity during medical procedures, not for in vitro diagnostic testing of biological specimens. Therefore, it is not an IVD device.
N/A
Intended Use / Indications for Use
The EP-WorkMate® Computerized Electrophysiology Recording System is intended for use during clinical electrophysiology procedures.
Product codes
DQK
Device Description
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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
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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
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Key Metrics
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Predicate Device(s)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1425 Programmable diagnostic computer.
(a)
Identification. A programmable diagnostic computer is a device that can be programmed to compute various physiologic or blood flow parameters based on the output from one or more electrodes, transducers, or measuring devices; this device includes any associated commercially supplied programs.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with human profiles incorporated into its design.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 3 2000
Mr. Joseph C. Griffin, III EP MedSystems, Inc. 100 Stierli Court Suite 107 Mt. Arlington, NJ 07856
K994011 Re: EP WorkMate Computerized Electrophysiology Recording System Requlatory Class: II (two) Product Code: DQK Dated: February 19,2000 Received: February 22,2000
Dear Mr. Griffin:
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 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). 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 requirements, as set forth in the Quality System Requlation (QS) for Medical Devices: General requlation (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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. Joseph C. Griffin
for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at Also, please note the regulation entitled, (301) 594-4639. "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Morgan Mayhew
James E. Dillard III Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use Statement
510(k) Number: K994011
Device Name: EP-WorkMate®
Indications for Use: The EP-WorkMate® Computerized Electrophysiology Recording System
is intended for use during clinical electrophysiology procedures.
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
OR
Prescription Use (Per 21 CFR 801. 109) Over-The-Counter Use
Megan Mayhew
for Jim Dillard