(143 days)
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.
The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers/transmitters. Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters.
The device is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility. The Prefense EDNS-9000 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 is a function of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005). Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005).
The provided text is a 510(k) summary for the Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station. The submission is for a software change to an existing predicate device, primarily allowing the central nurse station itself to perform alarm determination, which was previously handled exclusively by the telemetry receivers/transmitters.
Based on the provided text, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state acceptance criteria in terms of specific performance metrics (e.g., sensitivity, specificity, accuracy for arrhythmia detection, or alarm-related performance). Instead, it relies on substantial equivalence to a predicate device and general validation of software and hardware operation.
The "device performance" reported is largely that the device operates according to design specifications and that the non-clinical tests (electromagnetic, environmental, safety, and performance) verified proper operation.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Operation of software and hardware in accordance to design specifications. | Design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications. |
| Proper operation verified by non-clinical tests. | The device was subjected to electromagnetic, environmental, safety, and performance testing, which verified the proper operation of the device. |
| Substantial equivalence to predicate device. | Nihon Kohden asserts that the device is substantially equivalent to the predicate devices (Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station and ORG 9700A Multiple Patient Receiver) based on technical characteristics and testing. |
2. Sample size used for the test set and the data provenance
The document does not specify a sample size for a "test set" in the context of clinical performance evaluation (e.g., patient data for arrhythmia detection). The studies mentioned are primarily non-clinical: electromagnetic, environmental, safety, and general performance testing, as well as design validation. Therefore, there is no mention of data provenance (e.g., country of origin, retrospective/prospective).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided. Since the submission focuses on a software change to an existing device and relies on non-clinical testing and substantial equivalence, there is no indication of expert-established ground truth for a clinical test set.
4. Adjudication method for the test set
This information is not provided. No clinical test set with human-adjudicated ground truth is described.
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
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is a central nurse station for physiological monitoring and alarm generation, not an AI-assisted diagnostic tool that would typically involve human readers interpreting output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The document states that "Arrhythmia detection is a function of the telemetry receivers/transmitters" and "Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters." This implies that the device (or its components) performs alarm determination algorithmically and automatically. However, the exact performance metrics of this standalone algorithmic detection (e.g., sensitivity, specificity, positive predictive value for arrhythmia detection) are not provided in this summary. The summary focuses on the functionality of the alarm determination rather than its specific performance characteristics.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Given the nature of the device (physiological monitor and alarm system) and the type of information provided, the ground truth for "performance testing" and "design validation" would likely involve:
- Engineering specifications and test protocols: Verification that the device functions as designed against pre-defined engineering requirements (e.g., alarm triggers correctly at set limits, data display is accurate).
- Simulated physiological signals: For testing arrhythmia detection and alarm generation, simulated ECG signals with known arrhythmias would likely be used.
However, the document does not explicitly detail the type of ground truth used beyond "design specifications" and verification of "proper operation." There is no mention of ground truth established through expert consensus on clinical data, pathology, or outcomes data.
8. The sample size for the training set
This information is not provided. The document describes a software change to an existing device, not the development of a new algorithm that would typically involve a separate training set.
9. How the ground truth for the training set was established
This information is not provided, as there is no mention of a training set.
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510(K) SUMMARY
DEC 1 7 2010
. 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
Date: July 20, 2010 Updated November 12, 2010
- . Name/Trade Name of the Device: Prefense EDNS-9000 Series Central Nurse Station
- . 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 and 21 CFR 870.2910 "Radiofrequency physiological Signal Transmitter and Receiver per DRG.
- The legally marketed equivalence: The predicate devices are the Nihon Kohden Prefense . EDNS-9000 Series Central Nurse Station and Accessories per 510(k) K073550 cleared on March 28, 2008 and the Nihon Kohden ORG-9700A Multiple Patient Receiver per 510(k) K071058 cleared on June 29, 2007
- 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 Prefense EDNS-9000 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 is a function of the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005). Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers (Model ORG-9700 Multiple Patient Receiver, per 510k K071058 Commercial distribution certification dated June 29, 2007) transmitter (Model ZS-940PA, per 510(k) K043517 Commercial Distribution certification dated February 3, 2005).
Intended Use .
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.
The Prefense EDNS-9000 Series Central Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is detected. Arrhythmia detection is a function of the telemetry receivers/transmitters. Alarm determination can be configured to be rentormed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters.
Page 1 of 2
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- . A summary of the technological characteristics of the device compared to the predicate device: The new device consists of a software change to the predicate device (EDNS-9000) that allows alarm determination to be performed by the EDNS 9000 or the ORG 9700A
- o The technical characteristics of the EDNS-9000 predicate and the new EDNS-9000 are identical with the exception that the new device can perform alarm detection. The alarm detection feature of the predicate ORG-9700A is available in the new device EDNS-9000
To date, no special controls or performance standards are known or established for this device.
The device is not sterile.
The device does not contact patient. Therefore, no good laboratory practice studies were required per 21 CFR 58. There is minimal contact of the device (CPU and Display) with the user so the ISO 10993 standard was reviewed and based on the flow chart in Annex B, the material used on the CPU and display hardware are commercially available and the MSDS data from the manufacture confirms that the standards requirement for ISO 10993 for this device have been met.
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 the following non-clinical tests; electromagnetic, environmental, safety and performance testing. These test verified the proper operation of the device. Design validation confirmed the 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 Prefense EDNS-9000 Series Central Nurse Station with Software Update is substantially equivalent to the predicate device, Nihon Kohden Prefense EDNS-9000 Series Central Nurse and the ORG 9700A Multiple patient Receiver.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
DEC 1 7 2010
Nihon Kohden Corp. c/o Mr. Steve Geerdes Director QA/RA 90 Icon Street, Foothill Ranch, CA 92610
Re: K102106
Trade/Device Name: Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station Regulation Number: 21 CFR 870.2910 Regulation Name: Physiological Signal Transmitters and Receivers Regulatory Class: Class II (two) Product Code: DRG Dated: November 19, 2010 Received: November 23, 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.
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
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Page 2 - Mr. Steve Geerdes
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 (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/CDRH0ffices/ucm115809.html 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,
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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Indications for Use Form
510(k) Number (if known): K102106_
Device Name: Prefense EDNS-9000 Series Central Nurse Station
Indications for Use:
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medical professionals to provide cardiac and vital signs monitoring for multiple patients within a medical facility.
The Prefense EDNS-9000 Series Céntral Nurse Station will display and record physiological data from up to forty telemetry receivers/transmitters and generates an alarm when a measured parameter falls outside a preset limit or when an arrhythmia is
detected. Arrhythmia detection is a function of the telemetry receivers/transmitters. Alarm determination can be configured to be performed by either the Prefense EDNS-9000 Series Central Nurse Station or by the telemetry receivers/transmitters.
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)
W.M.S.
Division Sign-Off Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) K021026
Page 1 of
§ 870.2910 Radiofrequency physiological signal transmitter and receiver.
(a)
Identification. A radiofrequency physiological signal transmitter and receiver is a device used to condition a physiological signal so that it can be transmitted via radiofrequency from one location to another, e.g., a central monitoring station. The received signal is reconditioned by the device into its original format so that it can be displayed.(b)
Classification. Class II (performance standards).