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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.

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).

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.

• 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

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The DINAMAP MPS® Select® Portable Monitor is intended to monitor a single patient's vital signs in the hospital, outpatient surgery and healthcare practitioner facilities. The patient populations include adult, pediatric and neonatal. The Portable Monitor networking capabilities are identical to the predicate device and include connection to the OBSERVER® Central Station via VHF, spread spectrum or hardwire communication; host communications for use on the auxiliary serial port or RS-232 serial port; and remote view protocol over Ethernet enabling communication with other devices such as currently-marketed DINAMAP® Monitors, remote display, data collection or hospital information system, or remote alarm. In addition, the Portable Monitor may be operated from internal NiMH batteries making the device portable. This device is intended for use by qualified healthcare personnel trained in its use.

The modified DINAMAP MPS® Select® Portable Monitor device description is identical to the currently-marketed device. The difference between the two devices lies only in the electromagnetic compatibility (EMC) emissions classification. The modified Portable Monitor meets CISPR 11 Class A emissions requirements; the original Portable Monitor met CISPR 11 Class B emissions requirements. All other EMC specifications remain unchanged.

The provided text describes a 510(k) premarket notification for a medical device, the DINAMAP MPS® Select® Portable Monitor. This submission primarily focuses on demonstrating substantial equivalence to a predicate device, with the key difference being a change in electromagnetic compatibility (EMC) emissions classification.

Therefore, the information traditionally associated with acceptance criteria performance studies for novel medical devices (like those involving clinical trials, statistical performance metrics, or ground truth establishment) is not present in this document. The "study" here is specifically related to EMC testing.

Here's a breakdown based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for this specific 510(k) submission are related to electromagnetic compatibility (EMC) emissions.

2. Sample Size Used for the Test Set and Data Provenance

• Sample Size: A "fully configured modified DINAMAP MPS® Select® Portable Monitor" was tested. This indicates a single or a small number of physical units, not a patient sample size in a clinical sense.
• Data Provenance: The testing was performed by an "ANSI-certified test facility." The country of origin of the data is not specified beyond that. The data is prospective for this specific modification.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This concept is not applicable here. EMC testing involves objective measurements against established technical standards (CISPR 11 Class A), not qualitative assessment by human experts.

4. Adjudication Method for the Test Set

Not applicable. EMC testing is based on engineering measurements, not expert adjudication.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. The submission is for an updated version of an existing vital signs monitor, with the only change being an EMC classification, not a change in clinical algorithms or human-machine interface that would warrant such a study.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was Done

Not applicable. This device is a monitor, and its "performance" in this context is its adherence to EMC standards, not an algorithm's diagnostic or predictive capability. Its function is to display vital signs, which inherently involves human interpretation.

7. The Type of Ground Truth Used

The "ground truth" for this submission is adherence to the technical standard CISPR 11 Class A for electromagnetic emissions.

8. The Sample Size for the Training Set

Not applicable. This is not a machine learning or AI-driven device requiring a training set. The device's functionality is based on established physiological monitoring principles and electrical engineering.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device modification.

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