(70 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.
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 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, 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 Temperature Module measures body temperature in normal and axillary modes of neonatal, pediatric, and adult patients.
- 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 addition of this 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 looks like a 510(k) summary for the Welch Allyn Connex® Vital Signs Monitor 6000 Series (CVSM) that focuses on the addition of the EarlySense module. The submission claims substantial equivalence to a previously cleared device (K121013), not necessarily claiming novel performance that requires significant clinical studies.
Here's an analysis of the provided text regarding acceptance criteria and studies:
Key Takeaway from the Document:
The document explicitly states: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." (Page 8). This means that for the subject device (the CVSM with the integrated EarlySense module), there wasn't a new clinical study to establish its performance. Instead, it relies on substantial equivalence to a predicate device and bench testing for the integration of the EarlySense module. The EarlySense module itself was previously cleared in a separate 510(k) (K120465), and the performance claims for respiration rate, heart rate, and patient movement from that clearance are what are being incorporated.
Therefore, the acceptance criteria and performance data for the overall device are generally based on the predicate device's performance, as well as the previously cleared EarlySense module's performance, and the current submission primarily addresses the safety and effectiveness of the integration via non-clinical testing.
1. Table of Acceptance Criteria and Reported Device Performance
Since no new clinical studies were performed for this specific 510(k), the "reported device performance" for the subject device (CVSM with EarlySense module) relies on the performance characteristics inherited from the predicate device and the previously cleared EarlySense module.
Note: The acceptance criteria for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) are those from its original 510(k) clearance (K120465), which are being appended to the CVSM's indications for use.
| Characteristic | Acceptance Criteria (from predicate/EarlySense module's prior clearance) | Reported Device Performance (Inherited) |
|---|---|---|
| Respiration Rate | 6 to 45 breaths per minute (±4% or ±1.5 breaths per minute, whichever is greater) | 6 to 45 breaths per minute (±4% or ±1.5 breaths per minute, whichever is greater) (Same as cleared by EarlySense in K120465) |
| Heart Rate | 30 to 170 beats per minute (±4% or ±5 beats per minute, whichever is greater) | 30 to 170 beats per minute (±4% or ±5 beats per minute, whichever is greater) (Same as cleared by EarlySense in K120465) |
| Patient Movement | Movement during defined period (percent of time moving in 1.5 minutes): | |
| L = Up to 40% | ||
| M = 40% to 60% | ||
| H = 60% to 80% | ||
| EH = 80% to 100% (Adult: 0 = 100%, L = 100%, M = 81%, H = 100%, EH = 96%) | ||
| (Pediatric: 0 = 100%, L = 100%, M = 81%, H = 86%, EH = 94%) | Movement during defined period (percent of time moving in 1.5 minutes): | |
| L = Up to 40% | ||
| M = 40% to 60% | ||
| H = 60% to 80% | ||
| EH = 80% to 100% (Adult: 0 = 100%, L = 100%, M = 81%, H = 100%, EH = 96%) | ||
| (Pediatric: 0 = 100%, L = 100%, M = 81%, H = 86%, EH = 94%) (Same as cleared by EarlySense in K120465) | ||
| Non-Invasive BP (NIBP) | Systolic: Adult/Pediatric: 30-260 mmHg, Neonate: 20-120 mmHg | |
| Diastolic: Adult/Pediatric: 20-220 mmHg, Neonate: 10-110 mmHg | ||
| Pulse Rate: Adult/Pediatric: 30-200 bpm, Neonate: 35-220 bpm | ||
| Pulse rate accuracy: ±3 bpm | Same (NIBP module not modified) | |
| Thermometer | Temperature range: 80 – 110°F | Same (Thermometer module not modified) |
| SpO2 (% Saturation) | Nellcor: +/- 3 digits (70-100%) | |
| Masimo: +/- 2.0% (70-100%) | Same (SpO2 modules not modified) | |
| SpO2 Pulse Rate Range | Nellcor: 20-250 +/- 3bpm | |
| Masimo: 25-240 +/- 3bpm | Same (SpO2 modules not modified) | |
| Total Hemoglobin (SpHb) | Range 0 – 25 g/dL, Adults/Infants/Pediatrics 8–17 g/dL + 1 g/dL | Same (Masimo Sensor only) |
| Acoustic Respiration Rate (RRa) | Masimo hardware provided and software enabled | Same (Masimo hardware provided and software enabled) |
| Capnography (CO2, RR, IPI) | CO2 accuracy: 0-38 mmHg: ±2 mmHg; 39-150 mmHg: ±2 (5% of reading + 0.08% for every 1 mmHg above 38 mmHg) | |
| RR: 4-70 +/- 1 breath per minute (adults >30kg) | Same (CO2 module not modified) |
2. Sample Size Used for the Test Set and Data Provenance
As explicitly stated: "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data."
Therefore, there is no "test set" in the context of new clinical performance data generated for this 510(k) submission.
The section "Clinical Performance Data" directly states this lack of new clinical studies. The performance of the EarlySense module for respiration rate, heart rate, and patient movement was established in its prior 510(k) (K120465), and the current submission is for the integration of this already-cleared module into the CVSM.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
Not applicable, as no new clinical studies were conducted for this submission that would require establishing a ground truth with experts. The performance data for the EarlySense module itself would have been established during its original K120465 clearance process.
4. Adjudication Method for the Test Set
Not applicable, as no new clinical studies were conducted for this submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done as part of this 510(k) submission. The submission explicitly states "No clinical studies were utilized for the purpose of obtaining safety and effectiveness data." This type of study would be classified as a clinical study.
6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was done
The document indicates that the "EarlySense (Everon) module is intended for continuous measurement of respiration rate, heart rate and movement, in an automatic contact-less manner." This implies a standalone algorithm for these measurements. However, no new standalone performance study was done for this submission. The performance characteristics of the EarlySense module were presumably established during its original K120465 clearance. This 510(k) focuses on the integration of this already-cleared module into the Welch Allyn CVSM.
The "Non-Clinical Tests" section lists several bench tests (e.g., Electromagnetic Compatibility, Shock and Vibration, Thermal Shock, Operating Environmental Test, Battery Use Cycles, Electrical Safety, Industrial Design Specification Analysis, Shipping Container Labeling, BOM Verification, Design Validation, Directions For Use Validation). These are engineering and usability tests to ensure the integrated system functions safely and effectively, but they are not standalone performance studies of the measurement algorithms themselves.
7. The type of ground truth used
Not applicable for this 510(k) submission, as no new clinical studies were conducted. The ground truth for the EarlySense module's measurements (Respiration Rate, Heart Rate, Patient Movement) would have been established during its original K120465 clearance, likely using reference methods or gold standards for vital sign measurement.
8. The sample size for the training set
Not applicable for this 510(k) submission, as no new clinical studies were conducted. Any training data for the EarlySense algorithms would have been part of its original development and clearance (K120465).
9. How the ground truth for the training set was established
Not applicable for this 510(k) submission. This information would pertain to the original development and clearance of the EarlySense module (K120465).
§ 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).