(39 days)
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.
| Acceptance Criteria | Reported Device Performance |
|---|---|
| CISPR 11 Class A emissions requirements (radiated and conducted) | Device demonstrated compliance with CISPR 11 (Group 1, Class A) for both radiated and conducted 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.
§ 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).