(28 days)
The VSM 6000 series of monitors is intended to be used by clinicians and medically qualified personnel for monitoring of neonatal, pediatric, and adult patients for:
- noninvasive blood pressure,
- pulse rate.
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- body temperature in normal and axillary modes.
The most likely locations for patients to be monitored are general medical floors, general hospital, and alternate care environments.
The optional Masimo Rainbow SET® Pulse CO-Oximeter and accessories are indicated for the continuous noninvasive monitoring of functional oxygen saturation of arterial hemoglobin (SpO2), pulse rate, total hemoglobin concentration (SpHb), and/or respiration rate (RRa). The Masimo Rainbow SET® Radical 7R Pulse CO-Oximeter and accessories are indicated for use with adult, pediatric, and neonatal patients during both motion conditions, and for patients who are well or poorly perfused in hospitals and hospital-type facilities.
The optional Oridion module and accessories are intended for the continuous non invasive measurement and monitoring of carbon dioxide concentration of the expired and inspired breath and respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.
The optional Oridion module also provides the clinician with an integrated pulmonary index (IPI). The IPI is based on four parameters provided by the monitor; end tidal carbon dioxide, respiration rate, oxygen saturation and pulse rate. The IPI is a single index of an adult or pentilatory status displayed on a scale of 1 - 10, where 10 indicates optimal pulmonary status. IPI monitoring displays a single value that represents the patient's pulmonary parameters and alerts clinicians to changes in the patient's pulmonary status.
The IPI is an adjunct to, and is not intended to replace, vital sign monitoring.
Optional compatible weight scales (e.g., Health o meter®) can be used for height, weight, and BMI input.
The Welch Allyn Connex® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows medical device and non-medical device software applications to be run on the CVSM independently of, and isolated from, the CVSM's vital signs monitoring functionality. All such applications are intended to be used on the CVSM by trained professionals in a health care setting.
The EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement. in an automatic contact-less manner, in a hospital or clinic setting. The system is indicated for use in children, adolescents and adults. The operation of the EarlySense has been studied in children (weight > 10 Kg) and adults (weight
The Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) is designed to provide a scalable, modular system of components which can be configured to address the needs for vital signs spot checking and continuous monitoring.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series monitor is intended to be used by clinicians and medically qualified personnel for measuring or monitoring patient vital signs. The particular vital sign measurements available are determined by the sensor/processing modules installed into the base unit including;
- NIBP Module provides measurements of noninvasive blood pressure and pulse rate,
- SpO2 Modules from Nellcor and Masimo provide pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin,
- The Masimo SpO2 Module can also provide hemoglobin measurements (SpHb, SpHbv) and acoustic ● respiration rate (RRa),
- . The SureTemp Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Temperature can also be measured IR ear thermometer.
- . The Oridion Capnography Module equipped systems are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI) measurements,
- The EarlySense Module provide users the option of continuous and contact-less monitoring of respiration rate, heart rate and patient movement.
- The Global Instruments module provides 3 -5 lead ECG/Impedance Respiration. The ECG modules is for continuous measurement of respiration rate, heart rate and detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation of this Global Instruments Module is the subject of this 510(k)
The CVSM can also display and transmit patient data that is electronically or manually entered from external and accessory devices, e.g., weight and height data, barcode scanner, IR temperature, and other patient or facility information. Data can be transmitted electronically via USB, wired Ethernet, or wireless communications, including, for example, to electronic record systems and for remote display and alarming (e.g., central station).
This document is a 510(k) premarket notification for the Welch Allyn Connex® Vital Signs Monitor 6000 Series, specifically addressing the integration and display of signals from the Global Instruments ECG module. The filing asserts substantial equivalence to previously cleared devices rather than providing detailed acceptance criteria and a study report as would be typical for proving performance de novo.
Therefore, the information traditionally found under "acceptance criteria and the study that proves the device meets the acceptance criteria" (as per new device development) is not explicitly present in the provided text. Instead, the document focuses on demonstrating that the modified device (CVSM with integrated ECG module) remains as safe and effective as its predicate devices.
However, I can extract the closest equivalents to the requested information based on the provided text, particularly from the "Non-Clinical Tests" and "Device Comparison Table" sections.
Acceptance Criteria and Device Performance (based on "Non-Clinical Tests" and "Device Comparison Table"):
Given that this is a 510(k) submission for a software modification to integrate an already cleared ECG module into an already cleared vital signs monitor, the "acceptance criteria" are primarily related to maintaining the safety and effectiveness of the existing device and ensuring proper integration of the new module, without introducing new risks or compromising existing performance. The "performance" is demonstrated through compliance with recognized standards and successful completion of various engineering and functional tests.
Here's a table summarizing the "acceptance criteria" (implied through standards compliance and comparative performance) and "reported device performance" (via test results and stated equivalence):
| Acceptance Criteria Category (Implied) | Reported Device Performance (as stated in the document) |
|---|---|
| General Safety and Performance | Passed (per IEC 60601-1, IEC 60601-1-2 (EMC), IEC 60601-1-6 (Usability), IEC 62366, IEC 60601-2-49, IEC 60601-1-8 (Alarms), IEC 62304 (Software Life Cycle), IEC 80601-2-30 (NIBP), ISO 80601-2-55 (Respiratory Gas), ISO 80601-2-56 (Thermometers), ISO 80601-2-61 (Pulse Oximeter), EN/ISO 14971 (Risk Management)). Specific non-clinical tests all "Pass". |
| ECG Module Integration | Verified that the ECG module functions when integrated into the platform device (Report 60072154). Fidelity of data transfers tested in design control process. ECG module operates with the CVSM via USB communications using the same software communication format as other modules. |
| ECG Specific Performance (from Predicate) | Respiration Rate: 6 to 45 breaths per minute (±4% or ±1.5 breaths per minute, whichever is greater). Heart Rate: 30 to 170 beats per minute (±4% or ±5 beats per minute, whichever is greater). Detection of cardiac standstill (asystole), ventricular tachycardia and ventricular fibrillation. Display of 3-5 Lead ECG. (Stated as "Same as cleared by Global Instruments in K152701"). |
| Known Vital Signs Performance (from Predicate) | NIBP: Systolic: Adult 30-260 mmHg, Pediatric 30-260 mmHg, Neonate 20-120 mmHg. Diastolic: Adult 20-220 mmHg, Pediatric 20-220 mmHg, Neonate 10-110 mmHg. Pulse Rate: Adult 30-200 bpm, Pediatric 30-200 bpm, Neonate 35-220 bpm. Pulse Rate Accuracy: ±3 bpm. (Same as predicate, NIBP module not modified). |
| Thermometer: Temp Range: 80-110°F. Predictive or Direct Mode. Oral, axillary, rectal. (Same as predicate, Thermometer module not modified). | |
| SpO2: Masimo/Nellcor Sensor. SpO2 saturation percentage, pulse amplitude display, perfusion index, Sat Seconds. Pulse Rate Range/Accuracy: 20-250 +/- 3bpm (Nellcor), 25-240 +/- 3bpm (Masimo). O2 Saturation Range/Accuracy: +/- 3 digits between 70-100% (Nellcor), +/- 2.0% between 70-100% (Masimo). Total Hemoglobin: 0-25 g/dL, Adults/Infants/Pediatrics 8-17 g/dL + 1 g/dL. Acoustic Respiration Rate: 4-70 +/- 1 breath per minute (adults >30kg). (Same as predicate, SpO2 modules not modified). | |
| Capnography (CO2): CO2 accuracy: 0-38 mmHg: ±2 mmHg; 39-150 mmHg: ±2 (5% of reading + 0.08% for every 1 mmHg above 38 mmHg). Flow rate: 50 (42.5 ≤ flow ≤ 65) ml/min. Initialization time: 40 seconds. System response time: 2.9 seconds. (Same as predicate, CO2 module not modified). | |
| EarlySense Module: Continuous measurement of respiration rate, heart rate and movement. Movement (% time moving): 0 (0%), L (up to 40%), M (40-60%), H (60-80%), EH (80-100%). (Same as predicate). |
Detailed Study Information:
It's important to reiterate that this is a 510(k) submission, relying on substantial equivalence to existing devices. As such, it does not describe a de novo clinical study proving the ECG module's performance, but rather the integration of an already cleared module.
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A table of acceptance criteria and the reported device performance:
See table above. The "acceptance criteria" are implied by compliance with various IEC/ISO standards and the claimed substantial equivalence to predicate devices, meaning the new configuration must perform "as well as" the existing cleared devices. The "reported device performance" is documented as "Pass" for all listed non-clinical tests and as "Same" when compared to the performance characteristics of the predicate devices for each vital sign parameter. -
Sample sizes used for the test set and the data provenance:
The document does not specify "sample sizes" in terms of patient data for clinical studies, as "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." (page 12). The testing mentioned (e.g., thermal shock, functional drop, abuse testing) are engineering and bench tests performed on the device itself.- Data Provenance: Not applicable as no clinical study data is presented. The tests are non-clinical/bench tests.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
Not applicable, as no clinical studies with expert-adjudicated ground truth were performed for this submission. The "ground truth" for the non-clinical tests would be the established engineering specifications and regulatory standards. -
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable, as no clinical studies requiring expert adjudication were performed. -
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 done, nor is AI assistance mentioned as a feature of this device. This device is a vital signs monitor, not an AI-assisted diagnostic tool. -
If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
The document does not describe standalone algorithm performance in the context of this 510(k). The ECG module itself (Global Instruments ECG module, K152701) would have had its own performance data for its 510(k) clearance, but that data is not detailed here, only referenced. The current submission focuses on integrating this cleared module into another cleared system. -
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
For the non-clinical bench testing, the "ground truth" would be the established engineering specifications, design requirements, and the pass/fail criteria derived from the referenced IEC and ISO standards. For the performance characteristics of the various vital sign modules, the "ground truth" refers to the validated performance of the predicate devices to which the current device claims substantial equivalence. -
The sample size for the training set:
Not applicable. The device is not an AI/ML device that requires a training set in the conventional sense. The "training" in this context would be the engineering and software development process leading to the integration of the ECG module. -
How the ground truth for the training set was established:
Not applicable. See point 8.
§ 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.