(156 days)
The Welch Allyn® 1500 Patient Monitor patient monitoring unit is designed for the monitoring of vital parameters such as ECG, SpO2, etCO2, non invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature and respiration of a patient.
The device is intended to be used by qualified doctors or trained medical personnel.
The device is not suitable for transport.
There is no danger for patients with pacemaker.
The device is intended for the monitoring of one patient at a time.
The device is not designed for sterile use nor is it designed for outdoor use.
Do not use this monitor in areas where there is any danger of explosion or in the presence of flammable gases.
The device is classified CF. It is defibrillation protected when the original accessories are used. However, as a safety precaution when possible, remove the electrodes before defibrillation.
This product is not designed for direct cardiac application.
The arrhythmia module is not intended for use with neonatal patients.
The ST-analysis module is not intended for use with neonatal patients.
The Welch Allyn 1500 Patient Monitor is an ultra-flat patient monitor designed for neonates, children, adult and paediatric use. It has a LCD screen for comprehensive vital data monitoring. Mains power supply is used for stationary use. The Welch Allyn 1500 Patient Monitor also provides full vital data monitoring during transport with the built-in battery.
The SCHILLER Welch Allyn 1500 Patient Monitor is a patient monitoring unit designed for monitoring vital parameters such as ECG, SpO2, etCO2, non-invasive blood pressure (NIBP), invasive blood pressure (IBP), temperature, and respiration of a patient.
Here's an analysis of the provided information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document doesn't explicitly state quantitative acceptance criteria or performance metrics for the Welch Allyn 1500 Patient Monitor. Instead, it relies on demonstrating substantial equivalence to previously FDA-cleared predicate devices. The "performance" is implicitly tied to compliance with various medical device standards, indicating that the device meets the safety and performance levels expected under those standards.
| Parameter/Aspect | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| 12-lead Rest-ECG Analysis | Substantial equivalence to SCHILLER ARGUS LCM (K053207) | The 12-lead Rest-ECG Analysis algorithm used in the 1500 Patient Monitor has been FDA-cleared in the SCHILLER ARGUS LCM (K053207). |
| Patient Temperature | Substantial equivalence to SCHILLER ARGUS LCM (K053207) | The Patient Temperature parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER ARGUS LCM (K053207). |
| Respiration | Substantial equivalence to SCHILLER ARGUS LCM (K053207) | The Respiration parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER ARGUS LCM (K053207). |
| Non-Invasive Blood Pressure (NIBP) | Substantial equivalence to SCHILLER BP-200plus (K063814) | The NIBP parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER BP-200plus (K063814). |
| Invasive Blood Pressure (IBP) | Substantial equivalence to SCHILLER ARGUS LCM (K053207) | The Invasive Blood Pressure parameter circuitry and algorithm used has been FDA-cleared in the SCHILLER ARGUS LCM (K053207). |
| Pulse Oximetry (SpO2) | Substantial equivalence to Nellcor Oximax NPB-40 (K051352) | The SpO2 parameter circuitry and algorithm used has been FDA-cleared in the Nellcor Oximax NPB-40 Pulse Oximeter (K051352). |
| ECG Arrhythmia / ST-segment Analysis | Substantial equivalence to Datascope Passport 2 (K020550) | The Mortara ECG Arrhythmia and ST-segment analysis algorithm used has been FDA-cleared in the Datascope Passport 2 Vital Signs Monitor (K020550). |
| End-tidal CO2 (etCO2) | Substantial equivalence to Oridion Capnostream10 (K060065) | The end-tidal CO2 parameter circuitry and algorithm used has been FDA-cleared in the Oridion Capnostream10 Bedside Monitor (K060065). |
| Electrical Safety | Compliance with IEC 60601-1, IEC 60601-1-4, IEC 60601-1-6, etc. | Tested and found to comply with IEC 60601-1 (Protection Class I Type CF), IEC 60601-1-4, IEC 60601-1-6, IEC 60601-2-27, IEC 60601-2-30, IEC 60601-2-34, IEC 60601-2-49, ISO 9919. |
| EMC (Electromagnetic Compatibility) | Compliance with IEC/EN 60601-1-2 (class A) | Tested and found to comply with IEC/EN 60601-1-2 (class A). |
| Software Quality | Compliance with "reviewer guidance for computer controlled medical devices undergoing 510 (k) review" | Software development process reviewed, and device software requirements, structure, development, revision, identification, verification, validation, and testing are described in attached data. The Quality System conforms to 21 CFR 820 and is Certified to ISO 9001:2008 and ISO 13485:2003. |
| Risk Analysis | Hazards identified, mitigated, verified/validated | A risk analysis, identifying potential hazards and documenting mitigation, has been developed and verified/validated as part of SCHILLER AG product development procedures. |
The study described is primarily a substantial equivalence demonstration to predicate devices for each specific parameter. This means the performance of the Welch Allyn 1500 Patient Monitor's individual components (e.g., ECG analysis, SpO2 sensor) is considered acceptable because they utilize algorithms and circuitry that have previously received FDA clearance in other devices.
General safety and performance acceptance criteria for the entire device assembly are met through compliance with various national and international performance, safety, and electromagnetic compatibility standards, as listed in the "Non-Clinical Tests B1" section.
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state a specific sample size for a test set used to evaluate the overall Welch Allyn 1500 Patient Monitor. Instead, it relies on the pre-existing FDA clearances of the embedded components and their respective studies.
For the predicate devices/algorithms:
- Data Provenance: Not explicitly stated for each predicate device's original clearance, but these devices would have undergone their own testing, likely including both clinical and non-clinical studies. Given the context of medical devices, data would generally originate from diverse patient populations to ensure broad applicability. The submitting company (SCHILLER AG) is based in Switzerland.
- Retrospective or Prospective: Not specified.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document as it describes a substantial equivalence submission relying on previously cleared components and adherence to standards, rather than a de novo clinical study with new ground truth establishment for the combined device. For the individual predicate devices, this information would have been part of their original 510(k) submissions.
4. Adjudication Method for the Test Set
Since a specific test set and ground truth establishment for the Welch Allyn 1500 Patient Monitor itself (beyond component equivalence and standard compliance) are not detailed, an adjudication method is not mentioned.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
There is no mention of an MRMC comparative effectiveness study being performed for the Welch Allyn 1500 Patient Monitor. The submission focuses on device parameters being substantially equivalent to existing FDA-cleared devices, meaning it's not comparing human readers with and without AI assistance specific to this new integrated monitor.
6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study
The submission details that the algorithms for 12-lead Rest-ECG Analysis, Patient Temperature, Respiration, NIBP, IBP, SpO2, ECG Arrhythmia/ST-segment Analysis, and etCO2 are the same as those present in previously FDA-cleared devices. This implies that the standalone performance of these algorithms would have been established during the original clearance of those predicate devices. The current submission focuses on the integration and overall safety/effectiveness of the combined unit.
- For instance, the ECG Arrhythmia and ST-segment analysis algorithm is the "Mortara ECG Arrhythmia and ST-segment analysis algorithm used in the 1500 Patient Monitor has been FDA-cleared in the Datascope Passport 2 Vital Signs Monitor (K020550)." This indicates a standalone performance study (without human in the loop) for that algorithm would have been conducted as part of the K020550 submission.
7. Type of Ground Truth Used
The type of ground truth used for the underlying algorithms in the predicate devices is not explicitly stated in this document. However, for physiological monitoring devices, ground truth for parameters like ECG interpretation, arrhythmia detection, blood pressure, SpO2, and CO2 typically involves:
- Expert Consensus: For ECG and arrhythmia interpretation by cardiologists.
- Reference Standards/Devices: Calibrated reference instruments for parameters like blood pressure, temperature, SpO2, and CO2.
- Pathology/Clinical Outcomes Data: Less direct for these specific vital signs but could be relevant for validating the clinical significance of detected arrhythmias or ST changes.
8. Sample Size for the Training Set
The document does not provide information regarding the sample size of training sets for any of the algorithms. This information would have been part of the original 510(k) submissions for the predicate devices where these algorithms were first cleared.
9. How the Ground Truth for the Training Set Was Established
Similar to point 8, the document does not provide information on how the ground truth for the training sets of the constituent algorithms was established. This would have been detailed in the respective 510(k) submissions for the predicate devices.
§ 870.1025 Arrhythmia detector and alarm (including ST-segment measurement and alarm).
(a)
Identification. The arrhythmia detector and alarm device monitors an electrocardiogram and is designed to produce a visible or audible signal or alarm when atrial or ventricular arrhythmia, such as premature contraction or ventricular fibrillation, occurs.(b)
Classification. Class II (special controls). The guidance document entitled “Class II Special Controls Guidance Document: Arrhythmia Detector and Alarm” will serve as the special control. See § 870.1 for the availability of this guidance document.