(145 days)
The Press-Mate BX-10 and BX-10An are indicated for use on adult, pediatric, and neonatal patients by a trained and qualified healthcare professional in the hospital, outpatient surgery practitioner facilities, or in an environment where patient care is provided by qualified healthcare personnel who will determine when use of this device is indicated, based upon their professional assessment of the patient's medical condition.
The Press-Mate BX-10 patient monitor is intended to monitor a single patient's noninvasive blood pressure and pulse rate.
The Press-Mate BX-10An patient monitor is intended to monitor a single patient's noninvasive blood pressure as well as blood oxygen saturation and pulse rate via Nellcor's oximetry technology.
The Press-Mate BX-10 Series Monitor is a fully portable multiparameter monitoring device which provides the capability for nonitoring of adult, pediatric and neonatal patients in numerous hospital, nursing home and clinical settings. It is a prescription device intended for use only by health care professionals. The oscillometric method, upper arm measurement is employed. The Press-Mate BX-10 is configurable with Nellcor® oxygen saturation (Pulse Oximetry) utilizing the finger for the placement of the sensor. The monitor uses a single tube reusable cuff or may be optionally used with a disposable single tube cuff.
The Press-Mate BX-10 has an optional replaceable and rechargeable battery as well as an optional thermal printer to print displayed data, waveforms and trend information. A liquid crystal display (LCD) and (LED) provides high visibility and clarity in most light conditions. The available parameters displayed will depend on the mode selected by the user.
Visual and audible alarms are provided to alert the user to monitor operational conditions or should patient values exceed default or operator-set high/low limits.
Model BX-10: Non-Invasive Blood Pressure and Pulse Rate
Model BX-10-An: Non-Invasive Blood Pressure and Pulse Rate; and Nellcor® Pulse Oximetry.
This portable device includes an optional integrated printer and is capable of operation from an external AC power source or an internal rechargeable battery. The device uses the same technology and materials as the predicate devices, the Press -- Mate 8800 (K890876 cleared 6/22/89),Press -Mate Advantage (K 973637 cleared 9/25/98) and the Press-Mate Prodigy (K022537 cleared 9/13/02)
The following accessories are available for use with the device:
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- Power cord
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- Printer Paper
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- Operations Manual
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- Disposable cuffs
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- Reusable cuffs
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- Cuff extension hose
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- Finger Probe
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- Extension Cable
Here's a breakdown of the acceptance criteria and the study information for the Press-Mate BX-10 Vital Signs Monitor, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Standard) | Reported Device Performance |
|---|---|
| Non-Invasive Blood Pressure (NIBP) | |
| ANSI/AAMI SP10-1992 Accuracy | The device successfully met AAMI SP-10 1992 Standards for accuracy. |
| Environmental Performance | Met requirements specified in the November 1993 Draft Reviewer Guidance for Pre-market Notification Submissions of the Anesthesiology and Respiratory Devices Branch. |
| Bench Testing (IEC & EN equivalent to ANSI/AAMI SP10) | |
| Stability: 4.2.4.1 Voltage Range | Passed |
| Stability: 4.2.4.2 Life | Passed |
| Safety Requirements: 4.3.1.1 Maximum Cuff Pressure | Passed |
| Safety Requirements: 4.3.2 Cuff Deflation | Passed |
| Safety Requirements: 4.3.2 Electrical Safety | Passed |
| Safety Requirements: 4.3.3 Conductive Components | Passed |
| Performance Requirements: 4.4.1 Pressure Indicator Accuracy | Passed |
| Performance Requirements: 4.4.3 Battery-Powered Devices | Passed |
Note: The document explicitly states that the device "successfully met AAMI SP-10 1992 Standards for accuracy." However, it does not provide specific numerical results (e.g., mean difference and standard deviation) from the clinical study that would directly quantify the accuracy achieved against the AAMI SP10 criteria. It relies on the previous clearance of the predicate devices which used the same NIBP algorithm.
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size for Test Set:
- Clinical Study for NIBP Accuracy (on the new monitor): 85 adult and pediatric subjects were tested.
- Clinical Study for NIBP Accuracy (from predicate Press-Mate 8800): A total of 85 adults, 85 pediatrics, and 15 neonates. (The NIBP algorithm is stated to be the same in the new monitor as in the 8800, 2100, and Advantage.)
- Data Provenance: Retrospective for the primary clinical accuracy study referenced (Press-Mate 8800), as the "accuracy of the NIBP algorithm was established in the adult, pediatric, and neonatal populations with the ANSI/AAMI SP10 clinical study for the Press – Mate 8800 and the Press – Mate Advantage monitors." A new, additional accuracy study was performed on the new monitor, also according to AAMI SP-10, with 85 adult and pediatric subjects.
- Country of Origin: The predicate device study was conducted at Baylor College of Medicine (USA). The Press-Mate Prodigy evaluation against arterial line was performed at the University of Tennessee Medical Center (USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not specify the number of experts or their qualifications for establishing ground truth for the NIBP clinical accuracy studies. It only mentions that the studies were conducted under IRB approval with informed consent. For NIBP studies, ground truth is typically established by trained technicians using a reference method (e.g., auscultation with a mercury sphygmomanometer) as per AAMI standards.
4. Adjudication Method for the Test Set
The document does not explicitly state the adjudication method. For NIBP validation against AAMI SP10, it's common practice to have multiple observers perform auscultation, and their readings might be averaged or discrepancies resolved by a third party, but this is not detailed here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device is a vital signs monitor, not an AI diagnostic tool requiring human reader interpretation enhancement.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
Yes, a standalone performance study for the NIBP algorithm was performed, as evidenced by the "Clinical Study for Accuracy - Overall System Efficacy" which evaluated the device's NIBP algorithm directly against a reference standard in patients according to ANSI/AAMI SP10. The device itself automatically calculates blood pressure, so the focus is on this algorithmic performance.
7. Type of Ground Truth Used
- For NIBP Accuracy (predicate device studies and new device study): The implicit ground truth for NIBP accuracy, as per ANSI/AAMI SP10, is typically based on simultaneous auscultation measurements by trained observers using a reference sphygmomanometer.
- For Press-Mate Prodigy (PM-2100) mean blood pressure evaluation: Arterial line was used as the reference standard. This is a more direct and invasive measure of blood pressure.
8. Sample Size for the Training Set
The document does not provide information about a separate "training set" or its sample size. This is typical for medical devices relying on established algorithms (like oscillometric NIBP) that have been developed and refined over time. The "training" in such devices usually refers to the initial algorithm development and refinement, which might have involved a different set of data not detailed here, or iterative development based on general physiological principles. The focus of these submissions is typically on the validation of the final algorithm.
9. How the Ground Truth for the Training Set Was Established
Since no specific training set is mentioned as part of this submission, the method for establishing its ground truth is not described.
§ 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).