(255 days)
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No
The summary describes a standard physiological monitor with basic parameter monitoring and display changes, with no mention of AI/ML terms or capabilities.
No
The device is described as a "physiological monitor" used to monitor parameters like ECG, Heart Rate, Pulse Oximetry, and Non-Invasive Blood Pressure, which are diagnostic functions, not therapeutic.
No
This device is a physiological monitor that measures parameters like ECG, Heart Rate, Pulse Oximetry, and Non-Invasive Blood Pressure. While these measurements can inform diagnoses, the device itself is for monitoring and not for making a diagnosis or processing images for diagnostic purposes.
No
The device description explicitly mentions hardware components like a Liquid Crystal Display and LED's, indicating it is a physical medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The description clearly states that the Model 405P is a physiological monitor that measures parameters like ECG, Heart Rate, Pulse Oximetry, and Non-Invasive Blood Pressure. These are measurements taken directly from the patient's body, not from samples in vitro (in glass or outside the body).
- Intended Use: The intended use is for monitoring patients in various clinical settings, which aligns with the function of a physiological monitor, not an IVD.
Therefore, the Model 405P is a physiological monitor, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Models 405T and 405P are both intended for use in Emergency Room, Surgery, Recovery Room, Intensive Care and surgical applications.
Product codes (comma separated list FDA assigned to the subject device)
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Device Description
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
adult or neonate
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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§ 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).
0
Image /page/0/Picture/0 description: The image shows a date, "AUG 16 1996". The month is August, the day is the 16th, and the year is 1996. The text is in a bold, sans-serif font and is black in color. The background is white.
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