(255 days)
The Models 405T and 405P are both intended for use in Emergency Room, Surgery, Recovery Room, Intensive Care and surgical applications.
The Model 405P physiological monitor is the same in function and operation as the F.D.A. approved Ivy Biomedical Systems Model 405T physiological monitor, with the following exceptions:
- The replacement of the flat panel electrolumiesent display with a Liquid Crystal Display and LED's . for numerics
- The deletion of the option to monitor Temperature. .
- The deletion of the option to monitor invasive blood pressure. .
The 405P monitors the following parameters: ECG, Heart Rate, Pulse Oximetry and Non-Invasive Blood Pressure.
This document is a 510(k) Summary for the Ivy Biomedical Systems Model 405P physiological monitor, prepared on October 12, 1995. It states that the 405P model is substantially equivalent to the previously FDA-approved Model 405T, with a few exceptions.
Based on the provided text, there is no information available regarding acceptance criteria, device performance studies, sample sizes, expert qualifications, adjudication methods, multi-reader multi-case studies, standalone performance details, or ground truth establishment.
The document discusses the substantial equivalence of the 405P to the 405T model, highlighting the following differences:
- Replacement of the electroluminescent display with a Liquid Crystal Display (LCD) and LEDs for numerics.
- Deletion of the option to monitor Temperature.
- Deletion of the option to monitor invasive blood pressure.
The summary asserts that these changes "have no adverse effect on the safety or effectiveness of the device when used as labeled."
The 405P monitors ECG, Heart Rate, Pulse Oximetry, and Non-Invasive Blood Pressure, targeting use in Emergency Rooms, Surgery, Recovery Rooms, Intensive Care, and surgical applications for both adult and neonate patients.
Therefore, I cannot fulfill the request to provide a table of acceptance criteria and device performance or details about the study, as this information is not present in the provided text.
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Image /page/0/Picture/1 description: The image shows a handwritten sequence of characters, which appears to be a combination of letters and numbers. The sequence reads 'K95546'. The characters are written in a bold, cursive style, and they are positioned above three horizontal lines. The image is in black and white.
BIOMEDICAL SYSTEMS,
510(K) SUMMARY
Ivy Biomedical Systems, Inc. 11 Business Park Drive Branford, CT 06405 (203) 481-4183 Contact: Dick Listro
Prepared: 10/12/95
Classification Name: Patient Monitor Common Name: Patient Monitor Model 405P Proprietary Name:
This Summary of 510(K) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807-92.
Substantial Equivalence
The Model 405P physiological monitor is the same in function and operation as the F.D.A. approved Ivy Biomedical Systems Model 405T physiological monitor, with the following exceptions:
- The replacement of the flat panel electrolumiesent display with a Liquid Crystal Display and LED's . for numerics
- The deletion of the option to monitor Temperature. .
- The deletion of the option to monitor invasive blood pressure. .
These exceptions have no adverse effect on the safety or effectiveness of the device when used as labeled.
The Models 405T and 405P patient monitors are both adult or neonate monitors
The 405P monitors the following parameters: ECG, Heart Rate, Pulse Oximetry and Non-Invasive Blood Pressure.
The Models 405T and 405P are both intended for use in Emergency Room, Surgery, Recovery Room, Intensive Care and surgical applications.
Richard Atwater
Signature
11/21/95
Date
510ksum.doc Section 2
§ 870.2340 Electrocardiograph.
(a)
Identification. An electrocardiograph is a device used to process the electrical signal transmitted through two or more electrocardiograph electrodes and to produce a visual display of the electrical signal produced by the heart.(b)
Classification. Class II (performance standards).