(92 days)
The ZOLL M Series NIBP Option is indicated for the noninvasive measurement of arterial blood pressure for resting patients in critical care and transport. The NIBP Option on M Series units is designed to measure blood pressure for adult, pediatric, and neonatal patients.
The ZOLL M Series NIBP Option non-invasively measures arterial blood pressure and pulse rate in resting adult, neonate and pediactric patients. By incorporating the SunTech Medical Instruments Advantage OEM BP™ Model 2 Module into the M Series Defibrillator/Monitor/Pacemaker devices, the option facilitates the ability to monitor and assess the physiological characteristics of the indicated patient populations.
The ZOLL M Series products (K972241) combine a defibrillator, ECG display, Noninvasive Transcutaneous Pacing, Pulse Oximetry (K982992), End Tidal CO2 (K993036), 3-, 5- and 12-Lead ECG Monitoring (K991556), Non-Invasive Blood Pressure measurement (K002029) and Invasive Blood Pressure and Temperature (K011865), data printing and recording in a single instrument.
The provided text describes ZOLL Medical Corporation's 510(k) submission for the M Series NIBP Option (K032363), a non-invasive blood pressure measurement device. The submission asserts substantial equivalence to the predicate device, Protocol Systems, Inc. Propaq CS Vital Signs Monitor (K012451), based on performance information and compliance with various standards.
Here's the breakdown of the acceptance criteria and study information based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standards Met) | Reported Device Performance (Compliance) |
|---|---|
| ANSI/AAMI SP-10-1992, Electronic or Automated Sphygmomanometers | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| EN 1060-1:1996, Non-invasive sphygmomanometers Part 1: General requirements | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| EN 1060-3:1997. Non-invasive sphygmomanometers - Part3: Supplementary requirements for electro-mechanical blood pressure measuring systems | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| EN 60601-1:1990; Amd 1 1992; Amd 2 1995; Amd 13 1995; Medical Electrical Equipment - Part 1: General Requirements for Safety | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| IEC 60601-1-2; 2001, Medical Electrical Equipment Part 1: General Requirements for Safety; Electromagnetic Compatibility | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| IEC 60601-2-4; 2001, Medical Electrical Equipment Part 2: Particular Requirements for the Safety of Cardiac Defibrillators and Cardiac Defibrillator-Monitors | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| EN 60601-2-30; 2000, Medical Electrical Equipment Part 2: Automatic Cycling Indirect Blood Pressure Monitoring Equipment | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| AAMI DF2; 1996, Cardiac Defibrillator Devices | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
| AAMI DF39; 1993, AED and Remote Control Defibrillators | Compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards |
2. Sample size used for the test set and the data provenance
The provided text does not specify the sample size for any test set or the data provenance (e.g., country of origin, retrospective or prospective) for the performance evaluation. It only states that the 510(k) includes "documentation related to the performance of the incorporated NIBP module and compliance with the applicable AAMI, CEN, and IEC automated noninvasive blood pressure, defibrillator and monitor standards." This implies that the performance was assessed against these standards, but the details of the study (e.g., number of subjects, type of data) are not included.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
The provided text does not mention experts used to establish ground truth or their qualifications. The evaluation appears to be based on compliance with established engineering and performance standards for NIBP devices, rather than a clinical ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
The provided text does not describe any adjudication method. This type of detail is typically associated with studies involving human interpretation or subjective assessments, which are not explicitly detailed here for the NIBP device performance.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
A multi-reader multi-case (MRMC) comparative effectiveness study is not mentioned in the provided text. This study type is usually relevant for AI-powered diagnostic tools where human interpretation is involved. The ZOLL M Series NIBP Option is a measurement device, and its performance evaluation is framed around compliance with technical standards.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
The provided text suggests that the performance evaluation was primarily focused on the device's technical specifications and its compliance with relevant standards (ANSI/AAMI SP-10-1992, EN 1060 series, IEC 60601 series, AAMI DF2, AAMI DF39). This implies a standalone assessment of the device's accuracy and safety against pre-defined benchmarks, without explicit mention of human operators in the loop influencing the measurement performance reported for regulatory submission. The device is used by humans, but the performance testing described focuses on its intrinsic measurement capabilities.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's performance is implicit in the standards it aims to comply with. For blood pressure measurement devices, this typically refers to a reference method (e.g., direct arterial measurement or a highly accurate auscultatory method) against which the automated device's readings are compared. The text explicitly lists various ANSI/AAMI, CEN, and IEC standards for automated noninvasive blood pressure, defibrillator, and monitor systems. These standards define the expected accuracy and performance limits, which serve as the "ground truth" or reference for the device's validation.
8. The sample size for the training set
The provided text does not mention a training set or its size. This is typical for medical devices that are not "learning" algorithms in the modern sense (e.g., AI/ML). The NIBP module is an established technology, and its performance is validated against engineering and clinical standards rather than being "trained" on data.
9. How the ground truth for the training set was established
Since no training set is mentioned, the method for establishing its ground truth is not applicable based on the provided text.
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).