(114 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 and surgical floors, general hospital, and alternate care environments. Monitoring can be accomplished on the VSM 6000 series bedside monitor itself and the VSM 6000 series bedside monitor also can transmit data continuously for secondary remote viewing and alarming (e.g., at a central station). Secondary remote viewing and alarming features are intended to supplement and not replace patient bedside monitoring.
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 and no 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 pediatric patient's ventilatory 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.
This product is available for sale only upon the order of a physician or licensed health care professional.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is designed to provide a scalable, modular system of components that can be configured to address the needs for vital signs spot check 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 monitoring of noninvasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and body temperature in normal and axillary modes of neonatal, pediatric, and adult patients. Patient monitors equiped with Masimo Rainbow SET® pulse Co-Oximeter modules are also capable of total hemoglobin measurements (SpHb, SpHbv) and acoustic respiration rate (RRa). Patient monitors equiped with Oridion capnography are also capable of carbon dioxide (CO2), respiration rate (RR) and calculation of Integrated Pulmonary Index (IPI). The CVSM can also display and transfer 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 transferred electronically via USB, wired Ethernet, or wireless communications. Ethernet and wireless are intended for communication of vital signs parameters, patient data, and alarms (including continuous and episodic parameters and alarms) to secondary remote viewing and alarming systems. The Welch Allyn Application Framework (Framework) - has been included as a separate subsystem. The Framework is general purpose software that allows medical device and non-medical device software applications to run on the Framework independently of and isolated from the CVSM's vital signs monitoring functionality.
The monitor has an enclosure constructed of engineered plastics with internal steel members for strengthening. A silicone light bar is prominent in a carry handle on the top of the device and illuminates for different alarm conditions. A power button is located on the side of the device. A touch screen display is prominent on the front of the device and provides the primary interface for the user to interact with the device. Internal and external communications are primarily by USB. External host USB connections for accessories are tool accessible. A USB connection for data transfer is on the side of the device, as is a connection to an internal relay for use with nurse call systems. The device contains an internal AC power supply for operating the device and charging the internal Lithium Ion battery.
The monitor can be configured for use in different workflows including desktop, affixed to a mobile stand, or on a wall mount.
Here's an analysis of the provided text regarding the Welch Allyn Connex® Vital Signs Monitor 6000 Series, focusing on acceptance criteria and study details.
Important Note: The provided document is a 510(k) Summary for a medical device. These summaries typically focus on demonstrating substantial equivalence to a predicate device rather than providing detailed clinical trial results for proving novel acceptance criteria. As such, many of the requested details about specific performance metrics, sample sizes, and ground truth establishment from a clinical effectiveness study are not present in this type of document. The document explicitly states "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." (Section 4).
Acceptance Criteria and Reported Device Performance
The document does not provide a table of specific acceptance criteria in terms of numerical performance metrics (e.g., accuracy, sensitivity, specificity) for the device's functions. Instead, it relies on demonstrating compliance with recognized medical device standards and substantial equivalence to predicate devices. The "reported device performance" is thus implied through its compliance with these standards and the assertion of equivalence in technological characteristics and indications for use.
| Feature/Parameter | Acceptance Criteria (Implied by Standards & Equivalence) | Reported Device Performance |
|---|---|---|
| Noninvasive Blood Pressure | Compliance with IEC 60601-2-30: 1999 | Met all relevant standards and demonstrated substantial equivalence to predicate devices. |
| Pulse Rate | Compliance with ISO 9919: 2005 (for pulse oximeters) and general safety/performance standards | Met all relevant standards and demonstrated substantial equivalence to predicate devices, including new RRa function enabled by Masimo Rainbow SET®. |
| Noninvasive Functional Oxygen Saturation (SpO2) | Compliance with ISO 9919: 2005 | Met all relevant standards and demonstrated substantial equivalence to predicate devices. |
| Body Temperature | Compliance with general safety/performance standards | Met all relevant standards and demonstrated substantial equivalence to predicate devices. |
| Total Hemoglobin (SpHb, SpHbv) | Performance as specified by Masimo Rainbow SET® (predicate device K100428). | Demonstrated through the incorporation of Masimo Rainbow SET® module and substantial equivalence. |
| Acoustic Respiration Rate (RRa) | Performance as specified by Masimo Rainbow SET® (predicate device K100428 via K112687). | Demonstrated through the incorporation of Masimo Rainbow SET® module and substantial equivalence. |
| Carbon Dioxide (CO2) Measurement | Compliance with ISO 21647: 2004 | Met all relevant standards and demonstrated substantial equivalence to predicate devices, including new CO2 function enabled by Oridion module. |
| Respiration Rate (RR) (from Capnography) | Compliance with ISO 21647: 2004 | Met all relevant standards and demonstrated substantial equivalence to predicate devices, including new RR function enabled by Oridion module. |
| Integrated Pulmonary Index (IPI) Calculation | Functional correctness of calculation based on specified parameters. | Demonstrated through the incorporation of Oridion module and substantial equivalence. |
| General Safety and Essential Performance | Compliance with IEC 60601-1: 1988, IEC 60601-1-2: 2007, IEC 60601-1-4: 2000, IEC 60601-1-8: 2003, IEC 60601-2-49: 2001, ISO 14971: 2007, IEC 62304: 2006 | All listed non-clinical tests were conducted to ensure safety and effectiveness. |
Explanation of "Reported Device Performance": The document indicates that "Verification and validation were conducted to ensure expected performance of the CVSM 6000 Series with enabled Masimo Rainbow SET® and the Oridion capnography module." This implies that the device meets the functional and safety requirements outlined by the referenced standards and the performance of the integrated predicate modules.
Study Details
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Sample Size: Not applicable. The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety or effectiveness data." (Section 4). The verification and validation were non-clinical, likely involving bench testing and engineering validation.
- Data Provenance: Not applicable for a clinical test set. The validation was based on non-clinical testing against design specifications and international standards.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not applicable as no clinical test set with human-established ground truth was used.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable as no clinical test set requiring human adjudication was used.
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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. An MRMC study was not done. The device is a vital signs monitor, not an AI-assisted diagnostic tool for human interpretation improvement.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done:
- Yes, in a sense. The "performance" was assessed as a standalone device against engineering specifications and relevant standards through non-clinical testing. This isn't an "algorithm only" in the AI sense, but rather the integrated system's performance. The document doesn't detail specific algorithmic performance for features like "Integrated Pulmonary Index" but rather the functional correctness of its calculation.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- The "ground truth" for the non-clinical tests would have been the established gold standards defined by the referenced IEC and ISO standards (e.g., accuracy limits for blood pressure, SpO2, CO2, etc.) and the documented performance of the predicate modules (Masimo, Oridion) that were integrated. For example, a blood pressure measurement device would be tested against a known reference pressure source to verify accuracy within specified tolerances.
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The sample size for the training set:
- Not applicable. This device is a vital signs monitor, not an AI/machine learning model that requires a "training set" in the conventional sense. Its functionality is based on established physiological measurement principles and signal processing, not data-driven learning.
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How the ground truth for the training set was established:
- Not applicable for the same reason as above.
§ 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).