(101 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 and alarm determination are functions of the telemetry receivers/transmitters or individual beside monitor.
The Prefense EDNS-9000 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from telemetry receivers/transmitters and alarms when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the telemetry unit.
This product will be available for use by medical personnel on all patient populations with a medical facility.
The Prefense EDNS-9000 Series Central Nurse Station is intended for use by medial 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 and alarm determination are functions 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).
The new device receives a small subset (non-invasive telemetry parameters) all of the same information as the predicate device, i.e., receives physiological signal from telemetry transmitters/receivers from ORG 9700 Multiple Patient Receiver signal simultaneously, receives and displays physiological information. generates audible and/or visual alarm indictors when an alarm violation is detected by the telemetry units, stores waveforms for review and printing as full disclosure, stores tabular and graphical trending data for review and printing, provides network communications using commercially available LAN/WAN products, provides remote data access through NetProse access software and records and prints physiological patient data.
I am sorry, but based on the provided text, there is no information about specific acceptance criteria or a study proving the device meets them, as requested in your prompt.
The document discusses the regulatory submission for the NIHON KOHDEN NKUS LAB PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION, focusing on its substantial equivalence to a predicate device. It briefly mentions "design validation confirmed the operation of the software and hardware of the device is in accordance to the design specifications" and that the device "was subjected to electromagnetic, environmental, safety and performance testing procedures." However, it does not provide details on:
- A table of acceptance criteria and reported device performance.
- Sample sizes, data provenance, number of experts, or adjudication methods for any test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done.
- Whether a standalone performance study was done.
- The type of ground truth used for any evaluations.
- Sample size for training sets or how ground truth was established for them.
The device's description clarifies that "Arrhythmia detection and alarm determination are functions 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)." This indicates that the core arrhythmia detection logic resides in separate, previously cleared devices, and the Central Nurse Station primarily displays and records data from these units.
Therefore, I cannot fulfill your request for details on acceptance criteria and study proving their achievement from the provided text.
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NIHON KOHDEN NKUS LAB 510(k) NOTIFICATION PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
SECTION 2 - 510(K) SUMMARY
- Name and Address of Applicant .
MAR 2 8 2008
| Nihon Kohden America, Inc. | Telephone: (949) 580-1555 Ext. 3325 |
|---|---|
| 90 Icon Street | Fax: (949) 580-1550 |
| Foothill Ranch, Ca 92610 | Attn: Jack Coggan, Director of Regulatory Affairs |
Date: November 21, 2007
- . 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-marketed device is the CNS-9700 Series Central Nurse station and accessories per 510(k) K023475, commercial distribution dated October 16, 2002.
- . A description of the device is intended for use by medial 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 and alarm determination are functions 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).
- . A summary of the technological characteristics of the device compared to the predicate device: The new device receives a small subset (non-invasive telemetry parameters) all of the same information as the predicate device, i.e., receives physiological signal from telemetry transmitters/receivers from ORG 9700 Multiple Patient Receiver signal simultaneously, receives and displays physiological information. generates audible and/or visual alarm indictors when an alarm violation is detected by the telemetry units, stores waveforms for review and printing as full disclosure, stores tabular and graphical trending data for review and printing, provides network communications using commercially available LAN/WAN products, provides remote data access through NetProse access software and records and prints physiological patient data.
To date, no special controls or performance standards are known or established for this device.
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Image /page/1/Picture/1 description: The image shows the number "2/3" written in the top right corner. Below that, the text "K073550" is written in a handwritten style. The text is black against a white background.
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 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 is substantially equivalent to the predicate device, CNS-9700 Series Central Nurse Station.
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NIHON KOHDEN NKUS LAB 510(k) NOTIFICATION PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
SECTION 3 - PROPOSED LABELING
A. 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 and alarm determination are functions of the telemetry receivers/transmitters or individual beside monitor.
Device/Package Labels B.
The proposed product labels for the devices are presented in Attachment # 2
C. Proposed Packaging
Packaging for the device is depicted in Attachment # 2
D. Instruction for Use
The proposed instructions for use are provided with each packaged device and are presented in Attachment #11.
E. Advertisement/Promotional Literature
To date no advertisement or promotional literature for the Prefense EDNS-9000 Series Central Nurse Station has been created for distribution in the United States.
F. Contraindications, Precautions & Warnings
Warnings and cautions are listed in the Operator's Manual as shown in Attachment # 3
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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three tail feathers, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" are arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 8 2008
Nihon Kohden America, Inc. c/o Mr. Jack Coggan Regulatory Affairs Director 90 Icon Street Foothill Ranch, CA 92610
Re: K073550
Trade/Device Name: Nihon Kohden Prefense EDNS-9000 Series Central Nurse Station Regulation Number: 21 CFR 870.1025 Regulation Name: Arrhythmia Detector and Alarm (including ST-segment Measurement and Alarm) Regulatory Class: Class II (two) Product Code: MHX Dated: February 29, 2008 Received: February 29, 2008
Dear Mr. Coggan:
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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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 (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. 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Angela C. Smirnova fone
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 NKUS LAB 510(k) NOTIFICATION PREFENSE EDNS-9000 SERIES CENTRAL NURSE STATION
G. Indications for Use Statement
510(k) Number (if known): ______________ K073550
Device Name: Prefense EDNS-9000 Series Central Nurse Station
Indications for Use:
The Prefense EDNS-9000 Series Central Nurse Station is intended for cardiac and vital signs monitoring for multiple patients. The device will display and record physiological data from telemetry receivers/transmitters and alarms when a measured parameter falls outside a preset limit or when an arrhythmia is detected by the telemetry unit.
This product will be available for use by medical personnel on all patient populations with a medical facility.
Prescription use: X (21 CFR Part 801 Subpart D)
AND/OR
Over - the - Counter Use ( 21 CFR Part 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ouzen C. Smith Joe B. Zimmerman
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K073550
Page 1 of 1___
Page 8 of 11
§ 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.