(99 days)
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Not Found
No
The provided text describes a network and information center for transferring and processing data from medical devices. There is no mention of AI, ML, or any related concepts like algorithms for analysis or prediction.
No
The device facilitates information transfer and processing between medical devices; it does not directly treat or diagnose a medical condition.
No
The device is described as a network and information center that transfers, stores, prints, views, and processes information from other networked devices, such as bedside monitors. It does not perform any diagnostic functions itself but rather handles data from diagnostic devices.
Unknown
The provided text describes a network and information center for medical devices. While it focuses on data transfer and processing, it doesn't explicitly state that the device itself is solely software. The description mentions "networked Datex-Engstrom devices" and "bedside monitors," implying the existence of hardware components that are part of the overall system, even if the "Network" and "Information Centre" are primarily software-driven. Without a "Device Description," it's impossible to definitively rule out hardware components being part of the submitted device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, or tissue) to provide information about a person's health.
- Device Function: The description clearly states that the Datex-Engstrom Network and Information Centre are used for transferring, displaying, storing, printing, and processing information from other networked devices, specifically bedside monitors. This information is likely physiological data collected from patients.
- No Mention of Samples: There is no mention of the device interacting with or analyzing biological samples from patients.
The device's function is focused on managing and presenting patient data collected by other medical devices, not on performing diagnostic tests on biological specimens.
N/A
Intended Use / Indications for Use
The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices.
The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS).
The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.
The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.
Product codes
74 MSX
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 (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)
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Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
FEB -6 K
Mr. Joel C. Kent Manager, Quality and Regulatory Affairs Datex-Engstorm, Inc. 2 Highwood Drive Tewksbury, MA 01876
K974101 Re: Trade Name: Datex-Engstorm Network Regulatory Class: II (two) Product Code: 74 MSX January 28,1998 Dated: January 29,1998 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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. requlatory 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.
1
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 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 (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. 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 Network
Indications For Use:
The Datex-Engstrom Network transfers information between networked Datex-Engstrom devices. It allows a networked device to display, store, print and otherwise process information received from other networked devices.
The Datex-Engstrom Information Centre maintains the network connections between the Datex-Engstrom bedside monitors and other networked devices in Datex-Engstrom Network. Furthermore, it coordinates the transfer of information between devices in the Datex-Engstrom Network as well as between the Datex-Engstrom Network and Hospital Information Systems (HIS).
The Datex-Engstrom Information Centre can be used for storing, printing, viewing or otherwise processing of information from several bedside monitors or other networked devices.
The Datex-Engstrom Network will be used for patients in the hospital and it is meant for continuous use.
(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
Danielle
(Optional Format 1-2-96)
rdiovascular. Respirato