(8 days)
Not Found
No
The description focuses on standard physiological monitoring, data display, and alarm generation based on preset limits and arrhythmia detection performed by the bedside monitors/telemetry units, not the central station itself. There is no mention of AI, ML, or related concepts.
No
The device is described as a "Nurse Central Station" for "cardiac and vital signs monitoring." It displays and records physiological data and generates alarms, but it does not provide any treatment or therapy to a patient.
No
Explanation: The device is described as a central station for monitoring and displaying physiological data and generating alarms. While it helps detect anomalies, the "Arrhythmia detection and alarm determination are functions of the individual bedside or telemetry channel," indicating that the diagnostic function resides in other connected devices, not the CNS-9700 itself. It doesn't perform diagnostic analysis or interpretation on its own.
No
The device description explicitly states it displays and records physiological data from "individual bedside monitors and /or telemetry receiver/transmitters," which are hardware components. The performance studies also mention electromagnetic, environmental, and safety testing, which are typically associated with hardware devices.
Based on the provided information, the CNS-9700 Series Nurse Central Station is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The intended use is for "cardiac and vital signs monitoring for multiple patients." This involves monitoring physiological data directly from the patient (via bedside monitors or telemetry), not analyzing samples taken from the patient (like blood, urine, etc.).
- Device Description: The description reinforces that it displays and records physiological data from bedside monitors and telemetry units. It doesn't mention any analysis of biological samples.
- Lack of IVD-related terms: The document does not contain any terms typically associated with IVD devices, such as "in vitro," "sample," "assay," "reagent," "analyte," etc.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. The CNS-9700 Series Nurse Central Station is a patient monitoring system, which is a different category of medical device.
N/A
Intended Use / Indications for Use
The CNS-9700 Series Nurse Central Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry receiver/transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit. This product will be available for use by medical personnel on all patient populations within a medical facility.
Product codes
MHX
Device Description
Common names for the device include Central Nurse Station, Central Monitoring Station and Telemetry Monitoring Station. The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients, up to 16, within a medical facility. The device will display and record physiological data from individual bedside monitors and telemetry receiver/transmitters and generate an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the individual bedside or telemetry channel.
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
all patient populations
Intended User / Care Setting
medical professionals / medical facility
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)
The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the related functions of acquiring, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.
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.
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.
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.
0
SECTION 2 - 510(K) SUMMARY
Name and Address of Applicant
OCT 2 4 2002
Nihon Kohden America, Inc. Attn: Regulatory Affairs 90 Icon St. Foothill Ranch, Ca 92610 Phone: (949) 580-1555 Fax: (949) 580-1550
The device has been classified as Class III by the Cardiovascular Device Classification Panel under 21 CFR Part 870.1025 "Monitor, Physiological, Patient (with arrhythmia detection or alarms)" per MHX.
The predicate-marketed device is Nihon Kohden CNS-9300 series per 510(K) # K001433, cleared in November 2000.
Common names for the device include Central Nurse Station, Central Monitoring Station and Telemetry Monitoring Station.
The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients, up to 16, within a medical facility. The device will display and record physiological data from individual bedside monitors and telemetry receiver/transmitters and generate an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the individual bedside or telemetry channel.
To date, no special controls or performance standards are known or established for this device.
The device is not sterile.
The device is not contacting patients. Therefore, no good laboratory practice studies were required per 21 CFR 58.
The device was subject to electromagnetic, environmental, safety and performance testing procedures. These tests verified the operation of the device. Software validation tested the operation of the related functions of acquiring, displaying and recording of all functions of the device. The results confirmed that the device performed within specifications.
Nihon Kohden believes that the CNS-9700 series Central Nurse Stations are substantially equivalent to the Nihon Kohden CNS-9300 series Central Stations.
1
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Nihon Kohden America, Inc. c/o Mr. Serrah Namini Regulatory Affairs 90 Icon Street Foothill Ranch, CA 92610
Re: K023475
Trade Name: CNS-9700 Series Central Nurse Station Regulation Number: 21 CFR 870.1025 Regulation Name: Patient Monitoring System Regulatory Class: Class III (three) Product Code: MHX Dated: October 15, 2002 Received: October 16, 2002
Dear Ms. Namini:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Serrah Namini
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. 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" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer 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,
Kallitin
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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NIHON KOHDEN AMERICA, INC.
510(k) NOTIFICATION CNS-9700 Series Central Nurse Station
G. Indications for Use Statement
023475 510(k) Number (if known):
Device Name: CNS-9700 series Central Nurse Station
Indications for Use:
The CNS-9700 Series Nurse Central Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from individual bedside monitors and /or telemetry receiver/transmitters and mimics an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the bedside monitor or telemetry unit.
This product will be available for use by medical personnel on all patient populations within a medical facility.
Prescription Use
(Per 21 CFR 801.109)
Division of Cardiovascular & Respiratory Devices
510(k) Number K023475