(109 days)
Not Found
No
The description focuses on standard physiological monitoring, data display, recording, and alarm generation based on pre-set limits or arrhythmia detection performed by separate bedside monitors or telemetry units. There is no mention of AI, ML, or any learning algorithms.
No
The device is described as a monitor that displays and records physiological data and generates alarms; it does not provide any treatment or therapy.
No
The device is intended for monitoring and recording physiological data, and generating alarms. It does not perform diagnostic functions but rather displays information from other diagnostic devices. The arrhythmia detection and alarm determination are functionalities of the telemetry receivers/transmitters or individual bedside monitors, not the central nurse station itself.
No
The device description and performance studies explicitly mention both software and hardware components, indicating it is not a software-only medical device.
Based on the provided information, the CNS-6200 Series Central Nurse Station is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The description of the CNS-6200 clearly states its purpose is to display and record physiological data from patients via bedside monitors and telemetry. It monitors vital signs and cardiac activity directly from the patient, not from a sample taken from the patient.
- The intended use and device description focus on monitoring and alarming based on real-time physiological measurements. There is no mention of analyzing biological samples.
Therefore, the CNS-6200 Series Central Nurse Station falls under the category of a patient monitoring device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The CNS-6200 Series Central Nurse 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 received 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.
Product codes
MHX
Device Description
The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor.
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 personnel on all patient populations within a medical facility.
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)
Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.
The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device. Design validation confirmedthe operation of the software and hardware of the device is in accordance to the design specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
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.
0
510(K) SUMMARY
- . Name and Address of Applicant
Nihon Kohden America, Inc. 90 Icon Street Foothill Ranch, Ca 92610
. . . . . .
Telephone: (949) 580-1555 Ext. 3325 Fax: (949) 580-1550 Attn: Steve Geerdes, Director of Regulatory Affairs
・ = ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ ・ - - -
DEC - 7 2010
102376
Date: August 12, 2010
- Name/Trade Name of the Device: CNS-6200 Series Central Nurse Station (i.e. CNS-6201) and . Accessories
- . The common or usual Name: Monitor, physiological, patient (with arrhythmia detection or alarms) and Telemetry Monitoring Station.
- . The Classification: The device has been classified as Class II by the Cardiovascular Device Classification Panel under 21 CFR Part 870.1025 "Monitor, Physiological, Patient (with arrhythmia detection or alarms)" per MHX
- The legally marketed equivalence: The predicate device is the Nihon Kohden CNS-9701 and . Accessories per 510(k) K023475 cleared on October 16, 2002,
- A description of the device: The device is intended for use by medical professionals to provide . cardiac and vital signs monitoring for multiple patients within a medical facility. The CNS-6200 Series Central Nurse Station will display and record physiological data from up to forty telemetry receiver/transmitters and generates an alarm when a measured parameter falls outside a pre-set limit or when life threatening arrhythmia is detected. Arrhythmia detection and alarm determination are functions of the telemetry receivers/transmitters or individual bedside monitor.
. Intended Use
The CNS-6200 Series Central Nurse 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 received 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.
- A summary of the technological characteristics of the device compared to the predicate . device:
- The technical characteristics of the CNS-9701A predicate and the new CNS-6200 Series o are the same with the exception that the new device has new hardware such as CPU and LCD monitor
1
CNS-6200 Series Central Nurse Station complies with IEC 60601-1 subclause 56.3 (C) implemented by 21 CFR Part 868 Performance Standard for Electrode Lead Wires and Patient Cables.
To date, no other 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.
Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications.
The device was subjected to electromagnetic, environmental, safety and performance testing procedures. These test verified the proper operation of the device. Design validation confirmedthe operation of the software and hardware of the device is in accordance to the design specifications.
Therefore based on the above, Nihon Kohden believes that the CNS-6200 Series Central Nurse Station is substantially equivalent to the predicate device, Nihon Kohden CNS-9701A Central Nurse Station.
102376
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a stylized eagle with three curved lines representing its wings, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged in a circular fashion around the eagle.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Nihon Kohden Corporation c/o Mr. Steve Geerdes Director. OA/RA 90 Icon Street Foothill Ranch, CA 92610
DEC - 7 2010
Re: K102376
Trade/Device Name: Nihon Koden CNS-6200 Series Central Nurse Station, Model Number CNS-6201 Regulatory Number: 21 CFR 870.1025 Regulation Name: Patient Physiological Monitor (with arrhythmia detection and alarms) Regulatory Class: II (two) Product Code: MHX Dated: November 8, 2010 Received: November 9, 2010
Dear Mr. Geerdes:
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 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. Steve Geerdes
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); medical device reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Dinah R-Vahmer
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use Form
510(k) Number (if known): __ K | 0 2 3 7 6
Device Name: ___ CNS-6200 Series Central Nurse Station____
DEC - 7 2010
Indications for Use:
The CNS-6200 Series Central Nurse 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 received 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 (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Anne R. V. Hines
Division Sign-Off) (Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K102376
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