(21 days)
The VSM series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of noninvasive blood pressure, pulse rate, body temperature, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric and adult patients. The most likely locations for patients to be monitored are general medical and surgical floors, general hospital and alternate care environments. This device is available for sale only upon the order of a physician or licensed health care professional.
The VSM, Vital Signs Monitor, Model 53000 Series, (VSM 300) provides real time monitoring and display of noninvasive blood pressure (NIBP), pulse rate, body temperature and nominvasive oxygen saturation of arteriolar hemoglobin (SpO2).
- NIBP - Noninvasive Blood Pressure is intended to noninvasively measure systolic, diastolic and mean arterial pressures (MAP).
- Temperature -- Intermittent thermometer takes patient temperature in oral, axillary or rectal mode.
- SpO2 - Pulse Oximetry channel is intended to noninvasively measure oxygen saturation of arteriolar hemoglobin at a peripheral measurement site.
The subject device is a modified version of the Model 53000 Series vital signs monitor, which was cleared for marketing under 510(k) K031740. The Model 53000 Series vital signs monitor has been changed to incorporate a modified NIBP module. The modified and existing NIBP modules are similar in their basic functionality. The modified NIBP module contains an updated safety processor, which replaces a discontinued safety processor. Both safety processors belong to the same microcontroller family. The modified NIBP module also incorporates other minor software and hardware changes, including the addition of a Resistor-Capacitor network to reduce sensitivity to external vibration. The modified Vital Signs Monitor, Model 53000 Series (VSM 300) monitor communicates to the user the same basic information as the Model 53000 Series vital signs monitor, specifically: - Saturation,
- Pulse rate,
- Pleth waveform,
- Trigger waveform for audible beep, and
- Status information (e.g., sensor type, board integrity).
In addition, the user display of the above information (e.g., saturation, pulse rate, error codes) remains unchanged.
The Welch Allyn Vital Signs Monitor, Model 53000 Series (VSM 300), underwent a modification involving its noninvasive blood pressure (NIBP) module. The K063419 submission primarily focuses on demonstrating that these changes are minor and do not alter the substantial equivalence of the device to its predicate. Therefore, the "acceptance criteria" discussed here relate to internal testing and adherence to standards rather than showing a new level of clinical performance for a novel function.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not explicitly list specific acceptance criteria in terms of numerical performance thresholds for the NIBP module, nor does it provide detailed performance data against such criteria in the typical format of sensitivity, specificity, or accuracy for a diagnostic device. Instead, the "Performance Data" section references a series of internal Welch Allyn test reports that demonstrate compliance with relevant standards and internal verification.
| Feature Tested | Acceptance Standard / Test Report | Reported Performance |
|---|---|---|
| NIBP Performance (Adult) | ANSI/AAMI SP10:2002 | VSM 300 SERIES NIBP ANSI/AAMI SP10:2002 TEST REPORT (831-1245-00) indicates compliance. |
| NIBP Performance (Neonate) | ANSI/AAMI SP10:2002 | VSM 300 SERIES ANSI/AAMI SP10:2002 NEONATE TEST REPORT (831-1251-00) indicates compliance. |
| General Product Engineering | PE TEST REPORT: VSM III,NIBP/POEM II (831-1212-00) | Indicates successful engineering testing. |
| Safety Testing | Test Report: VSM III Safety Testing for POEM II (831-1213-00) | Indicates successful safety testing. |
| EMC Compliance | TEST RPT,EMC,VSM III POEM II,EN60601-1-1-2:2001 (831-0783-07) | Indicates compliance with electromagnetic compatibility standards. |
| Risk Analysis | Internal Welch Allyn Protocol's product development procedure | A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied. |
| Quality System Compliance | 21 CFR 820 and ISO 13485:2003 | Welch Allyn Protocol's Quality System conforms to 21 CFR 820 and is certified to ISO 13485:2003. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample size used for the NIBP performance testing (e.g., number of patients or measurement points). The studies referenced (e.g., ANSI/AAMI SP10:2002 test reports) are inherently designed to use defined sample sizes specified by those standards, but the specific numbers are not detailed in this summary.
The data provenance is internal to Welch Allyn, as indicated by the "Welch Allyn documents" for the test reports. It is implied these were prospective tests carried out on production-equivalent units. No information is provided regarding the country of origin of the data or if it was retrospective.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided. For NIBP validation, ground truth is typically established by invasive arterial pressure measurements or calibrated reference devices as per standards like ANSI/AAMI SP10. The summary does not detail the personnel or their qualifications involved in establishing this reference.
4. Adjudication Method for the Test Set
This information is not provided. Given the nature of NIBP validation, it's unlikely a human adjudication method (like 2+1, 3+1) would be directly applicable; rather, the "ground truth" would be objective measurements from a highly accurate reference method.
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
No MRMC study was performed. This submission is for modifications to a vital signs monitor, not an AI-assisted diagnostic device requiring human interpretation. The device provides objective vital sign measurements.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device itself is a standalone vital signs monitor. The performance studies referenced (e.g., NIBP accuracy against a standard) are inherently "algorithm only" in the sense that they assess the device's measurement capabilities independent of a human interpretation loop beyond reading the displayed values.
7. The Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
For NIBP measurements, the ground truth would typically be established through highly accurate, direct arterial pressure measurements or comparison against a validated reference monitor, as specified in the ANSI/AAMI SP10 standard. This is a form of objective, direct measurement rather than expert consensus, pathology, or outcomes data.
8. The Sample Size for the Training Set
This information is not applicable and therefore not provided. The VSM 300 is a hardware device with associated software/firmware for acquiring and processing vital signs. It is not an AI/ML device that requires a "training set" in the conventional sense for learning patterns. The "training" for such a device would be its engineering design, calibration, and validation against established medical device standards.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated above (not an AI/ML device requiring a training set).
§ 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).