DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400

• K Number: K992638
• Device Name: DINAMAP PRO SERIES MONITOR, MODELS 100, 200, 300, 400
• Manufacturer: CRITIKON COMPANY,LLC
• Date Cleared: 2000-02-24 ( 202 days)
• Product Code: MWI
• Regulation Number: 870.2300
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K955113 , K971569 , K970182

Intended Use

The DINAMAP® Pro Series 100, 200, 300, 400 Monitor is intended to monitor a single adult, pediatric or neonatal patient's vital signs at the bedside or during intra-hospital or ground transport. Vital signs parameters include non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate and/or oxygen saturation (pulse oximetry). The portable device is designed for use in numerous clinical settings in various hospital departments such as emergency, radiology, recovery, medical/surgical, labor and delivery, endoscopy, cardiac step-down. It can also be used in satellite areas, physicians' offices, or alternate care settings.

Device Description

The DINAMAP Pro Monitor, Series 100, 200, 300, 400 is a prescription device intended for use only by health care professionals. Four configurations of the monitor - all with an integrated printer - will offer the following vital signs parameters: . DINAMAP Pro Series 100: Non-Invasive Blood Pressure and Pulse Rate - DINAMAP Pro Series 200: Non-Invasive Blood Pressure and Monitor/Predictive Oral/Rectal . Temperature - . DINAMAP Pro Series 300: Non-Invasive Blood Pressure and Nellcor® Pulse Oximetry and Pulse Rate - . DINAMAP Pro Series 400: Non-Invasive Blood Pressure and Pulse Rate; Monitor/Predictive Oral/Rectal Temperature; and Nellcor® Oxygen Saturation and Pulse Rate (Pulse Oximetry) This portable device includes an integrated printer and is capable of operation from an external AC mains power source or an internal lead-acid rechargeable battery. The device uses the same technology and materials as the predicate devices, the DINAMAP MPS™ Select™ Multiparameter System (K955113 cleared 8/15/96); the DINAMAP MPS™ Select™ Portable Monitor (K971569 cleared 9/19/97); and the DINAMAP® Compact Monitor (K970182 cleared 8/18/97).

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the DINAMAP® Pro Monitor, Series 100, 200, 300, 400, based on the provided text:

Acceptance Criteria and Device Performance for DINAMAP® Pro Monitor

1. Table of Acceptance Criteria and Reported Device Performance

This device combines multiple physiological monitoring functionalities. The acceptance criteria and performance are detailed for each major component: Non-Invasive Blood Pressure (NIBP), Oxygen Saturation (SpO2), and Temperature.

Feature Area	Acceptance Criteria	Reported Device Performance
NIBP	Compliance with ANSI/AAMI SP10-1992 and SP10A-1996 for:

• Labeling (4.1)
• Stability (4.2.4, excluding 4.2.1, 4.2.2, 4.2.3 and including 4.2.4.1 Voltage Range; 4.2.4.2 Life)
• Safety (4.3, including 4.3.1.1 Maximum Cuff Pressure; 4.3.1.2 Cuff Deflation; 4.3.2 Electrical Safety; 4.3.3 Conductive Components)
• Performance (4.4, including 4.4.1 Pressure Indicator Accuracy; 4.4.3 Battery-Powered Devices)
• Environmental performance as per November 1993 Draft Reviewer Guidance. | The new device met the requirements of ANSI/AAMI SP10 and SP10A for the specified sections. It passed all bench tests related to stability, safety, and performance. Clinical accuracy for the NIBP algorithm was established in adult, pediatric, and neonatal populations during prior studies for predicate devices (DINAMAP MPS Select NIBP Module) which use the same NIBP algorithm, software, processor family, operating system, and accessories. |
  | Oxygen Saturation (SpO2) | Met Nellcor sensor specifications for accuracy against arterial blood oxygen saturation co-oximeter measurements across a range of oxygen saturation (100% down to 70%). This includes performance in low perfusion/low signal conditions. | Co-Oximeter Correlation Study: Pooled results for all three subjects indicated that the three new devices met sensor specifications.
  Non-Invasive Controlled Hypoxia Study: The oxygen saturation parameter of the new devices met oxygen saturation with all Nellcor sensors.
  Bench Testing: The new devices met the acceptance criteria for Saturation Comparison Verification, Low Perfusion/Low Signal Saturation, and Pulse Rate Comparison studies. |
  | Temperature | Monitor Mode/Probe Accuracy: Liquid-bath testing according to ASTM E 1112 - 86 (Reapproved 1991), Table 1 maximum error ranges, relative to a mercury-in-glass thermometer.
  Predictive Mode Accuracy: Liquid-bath testing to establish equivalence with Alaris Medical Systems IVAC® 2080 Measurement (using a Critikon-developed procedure), relative to an IVAC 2080 Measurement System, within ASTM E 1112 - 86 (Reapproved 1991) Table 1 maximum error ranges.
  Clinical Accuracy: Mean difference

Regulation Number and Section

§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).

(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).