(26 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 noninvasive 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 modified to allow it to interface with the Masimo pulse oximeter as an alternative to the Nellcor MP506A pulse oximeter. The Masimo and Nellcor MP506A pulse oximeters are very similar in basic functionality and in their connection to the Model 53000 Series main board. The main board software has been modified to interpret the Masimo pulse oximeter protocol.
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 VSM, Vital Signs Monitor, Model 53000 Series (VSM 300) is a modified version of a previously cleared device (K031740). The modification involves incorporating an optional Masimo pulse oximeter as an alternative to the Nellcor MP506A pulse oximeter. This submission is a Special 510(k) Premarket Notification Modification, which implies that the changes are minor and do not significantly alter the device's fundamental safety or effectiveness.
Here's an analysis of the requested information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly state "acceptance criteria" in a quantitative, measurable sense for the modified device. Instead, it relies on the concept of substantial equivalence to the predicate device (VSM Model 53000 Series cleared under K031740) and successful completion of internal testing.
Since the modification is the incorporation of a different pulse oximeter, the "performance" is implicitly tied to the continued functionality of all vital signs monitoring parameters and the safe integration of the Masimo oximeter.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Technological Equivalence to Predicate Device | The modified Model 53000 Series (VSM 300) vital signs monitor has the same technological characteristics as originally cleared with the predicate device (K031740). This includes: |
- Same basic design
- Same energy source
- Same operating principle
- Same basic materials
- Same packaging materials and processes. |
| Functional Equivalence of Masimo Pulse Oximeter | The Masimo and Nellcor MP506A pulse oximeters are described as "very similar in basic functionality and in their connection to the Model 53000 Series main board." The main board software was modified to interpret the Masimo protocol. The user display of information (saturation, pulse rate, error codes) remains unchanged. |
| Verification of Device Functionality after Modification | The subject device has been tested in accordance with Welch Allyn documents 831-1031-02, "PE Test Report, VSM 300 Update" and 831-1050-00, "Test Report, VSM 3 Masimo" using production equivalent units prior to market release. |
| Risk Management | A risk analysis identifying potential hazards and documenting mitigation of the hazards has been developed and applied as part of Welch Allyn Protocol's product development procedure. |
| Quality System Adherence | Welch Allyn Protocol's Quality System conforms to 21 CFR 820 and is certified to ISO 9001 and ISO 13485. |
| Maintenance of Intended Use | The intended use of the Vital Signs Monitor, Model 53000 Series, as described in its labeling, has not changed as a result of this modification. The device is intended for monitoring NIBP, pulse rate, body temperature, and SpO2 in neonatal, pediatric, and adult patients in various healthcare settings. |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document mentions that testing was done "using production equivalent units." It does not specify the number of units or the number of patients/measurements included in these tests.
- Data Provenance: The documents "831-1031-02, 'PE Test Report, VSM 300 Update'" and "831-1050-00, 'Test Report, VSM 3 Masimo'" are internal Welch Allyn documents. Therefore, the data provenance is internal company testing. The document does not provide information on whether this testing involved human subjects, and if so, their country of origin or whether it was retrospective or prospective. Given the nature of a Special 510(k) for a component change, it is more likely to be bench testing and possibly limited human factors/usability testing rather than large-scale clinical trials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- The document does not provide information regarding the use of external experts to establish "ground truth" for a test set. The validation appears to be based on internal testing against existing (presumably validated) monitoring capabilities and industry standards for vital signs monitoring.
4. Adjudication Method for the Test Set
- The document does not describe any adjudication method. This type of information is typically not required for a Special 510(k) where the primary claim is substantial equivalence through minor modification.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size of How Much Human Readers Improve with AI vs Without AI Assistance
- No, an MRMC comparative effectiveness study was not done. This device is a vital signs monitor, not an AI-assisted diagnostic tool that would involve "human readers" interpreting images or data alongside AI. The concept of "AI assistance" and "effect size" for human readers is not applicable to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
- The device is a vital signs monitor with integrated components, not an "algorithm only" device. The performance data relates to the integrated system's ability to accurately measure vital signs. The Masimo pulse oximeter itself would have undergone its own validation, but this submission focuses on its integration into the VSM 300. The device operates essentially as a standalone measurement system once programmed.
7. The Type of Ground Truth Used
- For vital signs monitoring devices, "ground truth" is typically established by comparison to established reference methods or devices (e.g., a highly accurate, calibrated blood pressure cuff for NIBP, or a co-oximeter for SpO2 calibration). While not explicitly stated in this summary, the underlying validation of the original VSM 300 and the Masimo oximeter would have relied on such reference standards. The document alludes to internal test reports, which would likely detail these comparisons.
8. The Sample Size for the Training Set
- This is not an AI/machine learning device that involves a "training set" in the conventional sense. The "training" for the device's software would come from its design and programming based on established physiological algorithms and hardware specifications.
9. How the Ground Truth for the Training Set Was Established
- As this is not an AI/machine learning device, the concept of "ground truth for a training set" is not applicable. The device's operation is based on established engineering principles and physiological measurement techniques, not on learning from a labeled dataset.
§ 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).