(8 days)
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.
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.
The provided text is a 510(k) summary for the Nihon Kohden CNS-9700 Series Central Nurse Station. It describes the device, its intended use, classification, and substantial equivalence to a predicate device. However, the document does not contain information regarding objective acceptance criteria or detailed study results directly proving the device meets specific performance criteria through clinical or technical studies.
The text mentions general testing for operation and software validation, but no specific performance metrics like sensitivity, specificity, accuracy, or any thresholds for these metrics that would constitute "acceptance criteria." It also does not describe any specific studies with sample sizes, expert involvement, or ground truth establishment.
Therefore, I cannot populate the requested table or answer most of the detailed questions based on the provided input.
Here's a breakdown of what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. The document states: "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." This is a high-level statement and does not include specific, measurable acceptance criteria or reported performance results (e.g., "accuracy > 95%").
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Cannot be provided. No information on sample sizes for any test sets or data provenance is present.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Cannot be provided. No information regarding expert involvement in establishing ground truth is present.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Cannot be provided. No information on adjudication methods is present.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- Cannot be provided. This device is a central monitoring station, not an AI-assisted diagnostic tool for human readers. No MRMC study is mentioned or implied. The device's function is to display and record physiological data and generate alarms based on preset limits or arrhythmia detection by individual bedside monitors/telemetry.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Cannot be provided. While the device itself operates "standalone" in its function, the document does not describe specific "standalone performance studies" with quantifiable metrics typically associated with algorithms (e.g., sensitivity, specificity of arrhythmia detection). It only states "Software validation tested the operation of the related functions... The results confirmed that the device performed within specifications." The arrhythmia detection logic is stated to be a function of the bedside or telemetry channel, not necessarily the central station's primary algorithmic function for evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Cannot be provided. No information about the type of ground truth is mentioned.
8. The sample size for the training set
- Cannot be provided. No information on training sets is present. This device is not described as utilizing a machine learning algorithm that requires a "training set" in the typical sense.
9. How the ground truth for the training set was established
- Cannot be provided. (See point 8).
Summary of what the document DOES state regarding testing and performance:
- Testing types: Electromagnetic, environmental, safety, and performance testing procedures. Software validation.
- Purpose of testing: Verified the operation of the device. Confirmed that the device performed within specifications.
- Key finding: The device is substantially equivalent to the Nihon Kohden CNS-9300 series.
This regulatory document focuses on substantial equivalence to a predicate device and general compliance with safety and operational requirements, rather than providing detailed performance data from a specific study against objective acceptance criteria for advanced functionalities like a diagnostic algorithm.
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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.
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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
§ 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.