(125 days)
Not Found
Not Found
No
The document does not contain any keywords or descriptions related to AI or ML.
No
The device is indicated for monitoring, analysis, detection, and data storage, not for treating a disease or condition.
Yes
The device is indicated for "arrhythmia analysis and detection," which are diagnostic functions.
Unknown
The provided 510(k) summary lacks a "Device Description" section, which is crucial for determining if the device is software-only. The intended use mentions "centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage," which could be implemented solely in software, but it also mentions being "connected to Datex-Engstrom monitors," implying a potential hardware component or interface. Without a device description, it's impossible to definitively classify it as software-only.
Based on the provided information, the CS/3™ Arrythmia Workstation (ARRWS) is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use describes monitoring, analysis, and storage of data from hospitalized patients connected to monitors. This involves analyzing physiological signals (likely ECG waveforms for arrhythmia detection), not analyzing samples taken from the body (like blood, urine, or tissue) in a laboratory setting.
- Device Description: While the description is "Not Found," the intended use strongly suggests a device that interacts with the patient's physiological signals directly or through connected monitors.
- Lack of IVD Characteristics: The provided information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Detecting or measuring substances in biological samples.
- Providing information for the diagnosis, monitoring, or treatment of diseases based on the analysis of biological samples.
The device appears to be a patient monitoring and data management system focused on cardiac arrhythmias, which falls under the category of patient monitoring devices rather than IVDs.
N/A
Intended Use / Indications for Use
The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.
The system is intended for use by qualified medical personnel only.
Product codes
74 DSI
Device Description
Datex-Engstrom CS/3 Arrhythmia Workstation
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
qualified medical personnel / hospitalized patients
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion around a symbol. The symbol is a stylized representation of three human profiles facing to the right, with flowing lines suggesting movement or connection.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 23 1998
Mr. Joel C. Kent Datex-Engstrom, Inc. 2 Highwood Drive Tewksbury, MA 01876
K974747 Re: CS/3™ Arrthymia Workstation Regulatory Class: III (three) Product Code: 74 DSI December 18, 1997 Dated: December 19, 1997 Received:
Dear Mr. Kent:
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 requirements, 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 - Mr. Joel C. Kent
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 requlation (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 (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,
Thomas J. Callihan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number (if known): __
Device Name: Datex-Engstrom CS/3 Arrhythmia Workstation
Indications For Use:
The CS/3™ Arrythmia Workstation (ARRWS) is indicated for centralized monitoring, arrhythmia analysis and detection, waveform data storage and patient data storage in hospitalized patients connected to Datex-Engstrom monitors.
The system is intended for use by qualified medical personnel only.
ﺼﺔ، ﻓ
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)
Division Sign-Off
Division of Cardiovascular, Respiratory, and Neurological Devices
510(k) Number_