(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 <111 Kg) during sleep and resting condition.
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 (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).
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K132808 P 1/16
510(k) Summary
[As described in 21 CFR 807.92]
Submitted by: Welch Allyn Inc. 4341 State Street Road Skaneateles Falls, NY 13153-0220
Kevin Crossen
Contact Person:
Director Regulatory Affairs Phone: (315) 685-2609 Fax: (315) 685-2532 E-mail: Kevin.Crossen@welchallyn.com
NOV 2 0 2013
Date Prepared:
Trade Name:
Connex® Vital Signs Monitor 6000 Series
901060 Vital Signs Monitor
September 9, 2013
Common Name:
Classification Reference:
Predicate Device:
Connex® Vital Signs Monitor 6000 Series 510(k) Number: K121013 Electrocardiograph, 21 CFR 870.2300 Class II, MWI
(21 CFR 870.2300, Product Code MWI)
Monitor, physiological, patient (without arrhythmia detection or alarms)
Class II, monitor, physiological, patient (without arrhythmia detection or alarms)
Section 11 510(k) Summary (per 21 CFR 807.92)
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Image /page/1/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, sans-serif font. The logo is black and the background is white.
K132808 P 2/2
Description of the Device:
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 soot 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).
Indications for Use:
The Connex® Vital Signs Monitor 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.
- ー pulse rate,
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and
- l 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, pediatic, and neonal 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 respiration rate. It is intended for use with neonatal, pediatric and adult patients in hospitals and hospital type facilities.
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Image /page/2/Picture/0 description: The image shows the logo for Welch Allyn. The text is in a bold, serif font. The logo is black and the background is white.
K132808 b3/16
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 and pulse rate. The IP is a single index of an adult or pediatic patilatory 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 Conner® Vital Signs Monitor (CVSM) 6000 Series also contains the Welch Allyn Applications Framework ("Framework"). The Framework is general purpose software that allows 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 FarlySense (Fiveron) module is intended for continuous measurement of respiration rate, heart rate in an automatic contact-less manner. in a hospital or clinic setting. The system is indicated for use in children, add adults. The operation of the EarlySense has been studied in children (weight < 10 Kg) durine sleep and resting condition.
This product is available for sale only upon the order of a physician or licensed health care professional.
Contraindications:
This system (all configurations) is not intended to be used:
- · on patients connected to heart/lung machines
- · on patients being transported outside a healthcare facility
- · within the controlled access area of MRI equipment
- · in a hyperbaric chamber
- · in the presence of flammable anesthetics
- · in the presence of electrocauterization devices
Systems configured with EarlySense are not intended to be used:
- · on patients for whom proper positioning cannot be achieved or maintained
- · on patients who do not meet the weight limits tested or specified
Technological Characteristics:
The fundamental hardware and mechanical aspects of the CVSM itself remain the same as the predicate CVSM device cleared under K121013. As noted above, this special 510(k) is for minor software modifications to integrate and display signals from the cleared EarlySense module on the CVSM system. No changes were made to the EarlySense motion sensing technology as cleared; the only changes that are the subject of this submission are the modifications to the CVSM to accommodate integration of the EarlySense module.
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K 132808 P 4/16
Non-Clinical Tests:
.
.
The Welch Allyn Connex® Vital Signs Monitor 6000 Series was tested to evaluate its safety and effectiveness based on the following standards:
| Standard | Version | Title |
|---|---|---|
| EN/IEC 60601-1 | 2nd Edition1988 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safetyand Essential Performance |
| EN/IEC 60601-1-2 | 2007 | Medical Electrical Equipment - Part 1-2: General Requirements for BasicSafety and Essential Performance - Collateral Standard: ElectromagneticCompatibility - Requirements and Tests |
| IEC 60601-1-4 | 1996 | Medical Electrical Equipment - Part 1-4: general requirements for safety:General requirement for programmable Electrical Medical System |
| IEC 60601-2-49 | 2001 | Medical electrical equipment - Part 2-49: Particular requirements for the safetyof multifunction patient monitoring equipment |
| IEC 60601-1-8 | 2003 | Medical electrical equipment - Part 1-8: General requirements for safety -Collateral standard: Alarm systems - Requirements, tests and guidances -General requirements and guidelines for alarm systems in medical equipment |
| IEC 62304 | 2006 | Medical Device Software - Software Life Cycle Processes |
| EN/ISO 14971 | 2007 | Medical Devices - Application of Risk Management to Medical Devices |
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,
K132808
| Report DIR ---Description | Objective of the Test | Conclusions |
|---|---|---|
| 60054949CVSM ES- 60601-1-2ElectromagneticCompatibility test | Test the device per 60601-1-2 to ensure that thedevice meets the requirements for ElectromagneticCompatibility | Pass |
| 60054591Mobile Stand Threshold | The purpose of this test is to verify that the product iscapable of withstanding the stresses caused by roughhandling as defined by IEC 60601-1:2005) | Pass |
| 60056145Mobile Stand Tilt | The purpose of this test is to verify that the product isstable on a stand as defined by IEC 60601-1:2005 | Pass |
| 60056145 Shock andVibration Test | To verify product safety and performance afterexposure to shock and vibration. | Pass |
| 60056405Thermal Shock Test | To verify product performance after the thermalshock conditions specified in Applied standards. | Pass |
| 60056431Operating EnvironmentalTest (Temperature andHumidity) | To verify product safety and performance within thespecified temperature and humidity environment. | Pass |
| 60056898Ambient CharacterizationTest | The purpose of this test is ensure that the modulelevel components do not exceed each of theiroperating temperatures when integrated into thePlatform Device and exposed to the operatingtemperature limits of that device. | Pass |
| 60056476Functional Drop | To verify product safety and performance afterexposure to free fall. | Pass |
| 60055061 EarlySenselabel wipe Test | To determine whether the chemicals used to cleanthe EarlySense module will degrade components,materials, or printing. | Pass |
| 60056426VVP Device Weight Test | To verify the configured Platform device weight. | Pass |
| 60056945Device Ship Test ISTA-2A | Ensure device, enclosed in the selected shippingcontainer, meets ISTA 2A 2011 specifications. | Pass |
| 60042214Battery Use Cycles PerCharge- ContinuousMonitoring | Verify that the battery shall operate for a minimum of2 hours under the continuous monitoring use caseconditions specified in PMP PAS 60028508 Section4.4. | Pass |
| 60054951Electrical Safety test | To confirm the device meets the requirementsdefined in IEC 60601-1 | Pass |
| 60054952Industrial DesignSpecification Analysis | The objective of this analysis is to verify via unit anddocumentation inspection that the CVSM ES EarlySense equipped device has met the requirements ofthe Industrial Design Specification. | Pass |
| 60054953CVSM ES ShippingContainer LabelingVerification | Verify the CVSM ES and ES Sensor device shippingcontainers are labeled according to the requiredspecifications. | Pass |
| 60042215PMP BOM Verification | The objective of this test is to verify that the releasedCVSM ES BOM includes the specified componentsidentified within the requirements being testedsection of this test. This is not a functional test, it isintended as a device inventory to ensure models canbe built that will support the features indicated. | Pass |
Additional performance Bench Testing:
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Welch Allyn:
. : . .
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| 60056673Connex Vital SignsMonitor ES DesignValidation | The purpose of this document is to describe Pre-Summative Validation and Summative Validationtesting that will be performed with the Connex SMSES System (Connex RMS with the integration ofEarly Sense Technology). Connex SMS ES iscomprised of Connex Central Station (CS ES) andthe Connex Vital Signs Monitor (CVSM ES). Pre-Summative Validation will be Phase I andSummative Validation will be Phase II.The intent of Phase II is to verify and validate that theConnex SMS ES System meets its usabilityrequirements as defined in the Connex CS UsabilitySpecification (DIR 60042476) and the CVSMUsability Specification Document (DIR 60029496).The software version tested during Phase II will beproduction equivalent product. This testing alsosupports the usability and human factors testingrequirements for both Connex ES and CVSM ES. | Pass |
|---|---|---|
| 60056676Connex Vital SignsMonitor ES DirectionsFor Use Validation | The intent of Phase II is to verify and validate that theConnex SMS ES System (Connex CS withintegration of Early Sense Technology and CVSMES) Directions for Use meets their usabilityrequirements as defined in the Connex CS UsabilitySpecification (DIR 60042476) and the CVSMUsability Specification Document (DIR 60029496).No patients will be enrolled in this study. | Pass |
| 60047144 Thermal Shock- 25 cycle | To identify design flaws or behaviors that may occuras a result of the device being exposed to stimulusbeyond what is specified within the device thermalshock requirements. | Pass |
:
:
:
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K132808 P 8/16
Clinical Performance Data:
No clinical studies were utilized for the purpose of obtaining safety and effectiveness data.
Device Comparison Table:
The Welch Allyn Connex® Vital Signs Monitor 6000 Series is substantially equivalent in operation and performance to the Welch Allyn Vital Signs Monitor 6000 Series monitor (K121013).
| Subject Device and Predicate Device Comparison | |||
|---|---|---|---|
| Characteristic | Predicate Devices | Subject Device | Differences |
| Device Name | Connex® VSM 6000 Series | Connex® VSM 6000 Series | Same |
| Manufacturer | Welch Allyn, Inc., | Welch Allyn, Inc., | Same |
| 510(k) Number | K121013 | N/A | N/A |
| Product Code | MWI | MWI | Same |
| Regulation Name | 870.2300 - Cardiac monitor(including cardiotachometerand rate alarm) | 870.2300 - Cardiac monitor(including cardiotachometerand rate alarm) | Same |
| Indications For Use | Welch Allyn VSM 6000SeriesThe VSM 6000 series ofmonitors is intended to beused by clinicians andmedically qualified personnelfor monitoring of neonatal,pediatric, and adult patientsfor:- noninvasive blood pressure,- pulse rate.- noninvasive functionaloxygen saturation ofarteriolar hemoglobin(SpO2), and- body temperature in normaland axillary modes.The most likely locations forpatients to be monitored are | Welch Allyn Connex ® VSM6000 SeriesThe VSM 6000 series ofmonitors is intended to beused by clinicians andmedically qualified personnelfor monitoring of neonatal,pediatric, and adult patientsfor:- noninvasive blood pressure,- pulse rate,- noninvasive functionaloxygen saturation ofarteriolar hemoglobin(SpO2), and- body temperature in normaland axillary modes.The most likely locations forpatients to be monitored are | Same |
| Subject Device and Predicate Device Comparison | |||
| Characteristic | Predicate Devices | Subject Device | Differences |
| floors, general hospital, andalternate care environments. | floors, general hospital, andalternate care environments. | ||
| The optional MasimoRainbow SET® Pulse CO-Oximeter and accessories areindicated for the continuousnoninvasive monitoring offunctional oxygen saturationof arterial hemoglobin (SpO2),pulse rate, total hemoglobinconcentration (SpHb), and/orrespiration rate (RRa). TheMasimo Rainbow SET®Radical 7R Pulse CO-Oximeter and accessories areindicated for use with adult,pediatric, and neonatalpatients during both motionand no motion conditions, andfor patients who are well orpoorly perfused in hospitalsand hospital-type facilities. | The optional MasimoRainbow SET® Pulse CO-Oximeter and accessories areindicated for the continuousnoninvasive monitoring offunctional oxygen saturationof arterial hemoglobin (SpO2),pulse rate, total hemoglobinconcentration (SpHb), and/orrespiration rate (RRa). TheMasimo Rainbow SET®Radical 7R Pulse CO-Oximeter and accessories areindicated for use with adult,pediatric, and neonatalpatients during both motionand no motion conditions, andfor patients who are well orpoorly perfused in hospitalsand hospital-type facilities. | ||
| The optional Oridion moduleand accessories are intendedfor the continuous noninvasive measurement andmonitoring of carbon dioxideconcentration of the expiredand inspired breath andrespiration rate. It is intendedfor use with neonatal, pediatricand adult patients in hospitalsand hospital type facilities.concentration of the expiredand inspired breath andrespiration rate. It is intendedfor use with neonatal,pediatric, and adult patients inhospitals and hospital typefacilities. | The optional Oridion moduleand accessories are intendedfor the continuous noninvasive measurement andmonitoring of carbon dioxideconcentration of the expiredand inspired breath andrespiration rate. It is intendedfor use with neonatal,pediatric and adult patients inhospitals and hospital typefacilities. concentration of theexpired and inspired breathand respiration rate. It isintended for use withneonatal, pediatric, and adultpatients in hospitals andhospital type facilities. | Same | |
| The optional Oridion modulealso provides the clinicianwith an integrated pulmonaryindex (IPI). The IPI is basedon four parameters providedby the monitor: end tidalcarbon dioxide, respirationrate, oxygen saturation andpulse rate. The IPI is a singleindex of an adult or pediatric | The optional Oridion modulealso provides the clinicianwith an integrated pulmonaryindex (IPI). The IPI is basedon four parameters providedby the monitor: end tidalcarbon dioxide, respirationrate, oxygen saturation andpulse rate. The IPI is a singleindex of an adult or pediatric | ||
| Subject Device and Predicate Device Comparison | |||
| Characteristic | Predicate Devices | Subject Device | Differences |
| patient's ventilatory statusdisplayed on a scale of 1 - 10,where 10 indicates optimalpulmonary status. IPImonitoring displays a singlevalue that represents thepatient's pulmonaryparameters and alertsclinicians to changes in thepatient's pulmonary status. | patient's ventilatory statusdisplayed on a scale of 1 - 10,where 10 indicates optimalpulmonary status. IPImonitoring displays a singlevalue that represents thepatient's pulmonaryparameters and alertsclinicians to changes in thepatient's pulmonary status. | Same (Thebase intendeduse remainsthe monitoringof patient vitalsigns. As withprevioussubmissions,the EarlySenseEveronModule'sclearedindications foruse statementis appendedunchangedinto theCVSM'sclearedindications foruse statement,as shown bythe bold text inthe column tothe left. TheEarlySense(Everon)Module waspreviouslycleared inEarly Sense's510(k)K120465). | |
| The IPI is an adjunct to, and isnot intended to replace, vitalsign monitoring. | The IPI is an adjunct to, and isnot intended to replace, vitalsign monitoring. | ||
| Optional compatible weightscales (e.g., Health o meter®)can be used for height, weight,and BMI input. | Optional compatible weightscales (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 theWelch Allyn ApplicationsFramework ("Framework").The Framework is generalpurpose software that allowsmedical device and non-medical device softwareapplications to be run on theCVSM independently of, andisolated from, the CVSM'svital signs monitoringfunctionality. All suchapplications are intended to beused on the CVSM by trainedprofessionals in a health caresetting. | The Welch Allyn Connex®Vital Signs Monitor (CVSM)6000 Series also contains theWelch Allyn ApplicationsFramework ("Framework").The Framework is generalpurpose software that allowsmedical device and non-medical device softwareapplications to be run on theCVSM independently of, andisolated from, the CVSM'svital signs monitoringfunctionality. All suchapplications are intended to beused on the CVSM by trainedprofessionals in a health caresetting. | ||
| This product is available forsale only upon the order of aphysician or licensed healthcare professional. | The optional EarlySense®(Everon) System is intendedfor continuous measurementof respiration rate, heartrate, and movement in anautomatic contact-lessmanner, in a hospital orclinic setting. The system isindicated for use in children,adolescents, and adults. Theoperation of the EarlySensehas been studied in children(weight ≥ 10 Kg) and adults(weight <111 Kg) during | ||
| Subject Device and Predicate Device Comparison | |||
| Characteristic | Predicate Devices | Subject Device | Differences |
| sleep and resting condition. | |||
| Basic Description | The Welch Allyn Connex®Vital Signs Monitor 6000Series is designed to provide ascalable, modular system ofcomponents that could beconfigured to address the needsfor vitals signs spot check andmonitoring. It also provides aFramework that can runmedical device and nonmedical software applicationsThe CVSM 6000 Series ofmonitors are intended to beused by clinicians andmedically qualified personnelfor monitoring of noninvasiveblood pressure, pulse rate,noninvasive functional oxygensaturation of arteriolarhemoglobin (SpO2), and bodytemperature in normal andaxillary modes of neonatal,pediatric, and adult patients.Electronic transmission of datefrom external accessorydevices is supported includingtemperature, Weight, Height,and BMI. When equippedwith Masimo Rainbow SET®Pulse Co-oximeter andaccessories may be used forcontinuous noninvasivemonitoring of totalhemoglobin concentration andacoustic respiration rate(RRa). Patient monitorsequiped with Oridioncapnography are also capableof carbon dioxide (CO2),respiration rate (RR) andcalculation of Integrated | This product is available forsale only upon the order of aphysician or licensed healthcare professional.The Welch Allyn Connex®Vital Signs Monitor 6000Series is designed to provide ascalable, modular system ofcomponents that could beconfigured to address theneeds for vitals signs spotcheck and monitoring.The CVSM 6000 Series ofmonitors are intended to beused by clinicians andmedically qualified personnelfor monitoring of noninvasiveblood pressure, pulse rate,noninvasive functionaloxygen saturation of arteriolarhemoglobin (SpO2), and bodytemperature in normal andaxillary modes of neonatal,pediatric, and adult patients.Electronic transmission ofdate from external accessorydevices is supported includingtemperature, Weight, Height,and BMI. When equippedwith Masimo Rainbow SET®Pulse Co-oximeter andaccessories may be used forcontinuous noninvasivemonitoring of totalhemoglobin concentration andacoustic respiration rate(RRa). Patient monitorsequipped with Oridioncapnography are also capableof carbon dioxide (CO2),respiration rate (RR) andcalculation of IntegratedPulmonary Index (IPI).Patient monitors equippedwith the EarlySense Module | Addition ofthe EarlySense(Everon)Module tomeasurerespirationrate, heart rate,and movementin anautomaticcontact-lessmanner usingEarly Sensesensors.(cleared byEarlySense inK120465) |
| Subject Device and Predicate Device Comparison | |||
| Characteristic | Predicate Devices | Subject Device | Differences |
| Pulmonary Index (IPI). | can measure respiration rate,heart rate, and movement inan automatic contact-lessmanner using EarlySensesensors. | ||
| Target Population | Neonatal, Pediatric, and AdultPatients of any gender. | Neonatal, Pediatric, and AdultPatients of any gender. | Same |
| Where Used | The product is intended foruse in a clinical environmentgeneral medical and surgicalfloors, general hospital, andalternate care environments. | The product is intended foruse in a clinical environmentgeneral medical and surgicalfloors, general hospital, andalternate care environments. | Same |
| Design/Technology | Modular | Modular | Same |
| Alarms | • Can configure, observe, andrespond to an alarmcondition. | • Can configure, observe, andrespond to an alarmcondition. | Same |
| Nurse Call(wired) | • Can connect to customernurse call system. ProvidesNO/NC relay. | • Can connect to customernurse call system. ProvidesNO/NC relay. | Same |
| Patient datamanagement | • Change patient type (adult,pediatric, neonate)• View and enter manualparameters (height, weight,pain, respiration)• Manage patient vitals record• Assign patient and clinicianID to readings• Automated data input ofweight, height, and BMI• Connectivity to ElectronicRecords Managementsystems for transfer of patientdata.• Connectivity to CentralStation for continuous patientmonitoring and distributedalarms | • Change patient type (adult,pediatric, neonate)• View and enter manualparameters (height, weight,pain, respiration)• Manage patient vitals record• Assign patient and clinicianID to readings• Automated data input ofweight, height, and BMI• Connectivity to ElectronicRecords Managementsystems for transfer of patientdata.• Connectivity to CentralStation for continuous patientmonitoring and distributedalarms | Same |
| Memory | • Save patient data to devicememory - (300) readings | • Save patient data to devicememory - (300) readings | Same |
| Printer | Yes - 57mm Internal Thermal | Yes - 57mm Internal Thermal | Same |
| Non-InvasiveBlood Pressure(NIBP) | • Display systolic, diastolic,and MAP measurements• Manual and automatic NIBPmeasurements• Can measure blood pressureas the cuff is inflating• Can measure blood pressureas the cuff is inflating | • Display systolic, diastolic,and MAP measurements• Manual and automatic NIBPmeasurements• Can measure blood pressureas the cuff is inflating• Can measure blood pressureas the cuff is inflating | Same - theNIBP modulehas not beenmodified |
Section 11 510(k) Summary (per 21 CFR 807.92)
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Section 11 510(k) Summary (per 21 CFR 807.92)
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Section 11 510(k) Summary (per 21 CFR 807.92)
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Section 11 510(k) Summary (per 21 CFR 807.92)
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Section 11 510(k) Summary (per 21 CFR 807.92)
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1
| Subject Device and Predicate Device Comparison | |||
|---|---|---|---|
| Characteristic | Predicate Devices | Subject Device | Differences |
| Algorithm | • Oscillatory BP Algorithm• Fast BP Algorithm | • Oscillatory BP Algorithm• Fast BP Algorithm | Same |
| Systolic range | • Adult: 30 to 260 mmHg• Pediatric: 30 to 260 mmHg• Neonate: 20 to 120 mmHg | • Adult: 30 to 260 mmHg• Pediatric: 30 to 260 mmHg• Neonate: 20 to 120 mmHg | Same |
| Diastolic range | • Adult: 20 to 220 mmHg• Pediatric: 20 to 220 mmHg• Neonate: 10 to 110 mmHg | • Adult: 20 to 220 mmHg• Pediatric: 20 to 220 mmHg• Neonate: 10 to 110 mmHg | Same |
| Pulse rate rangeusing BP | • Adult: 30 to 200 bpm• Pediatric: 30 to 200 bpm• Neonate: 35 to 220 bpm | • Adult: 30 to 200 bpm• Pediatric: 30 to 200 bpm• Neonate: 35 to 220 bpm | Same |
| Pulse rate accuracy | • ±3 bpm | • ±3 bpm | Same |
| Thermometer(Thermister probe) | • Welch Allyn SureTemp Plustechnology• Temperature range: 80 –110°F• Either the Predictive(Normal) or Direct (Monitor)Mode• °C or °F• Oral, axillary, rectal | • Welch Allyn SureTemp Plustechnology• Temperature range: 80 –110°F• Either the Predictive(Normal) or Direct(Monitor) Mode• °C or °F• Oral, axillary, rectal | Same – theThermometermodule hasnot beenmodified |
| SpO2 | • Masimo Sensor• Nellcor Sensor• SpO2 saturation percentageand the pulse amplitudedisplay• Perfusion index• Sat Seconds | • Masimo Sensor• Nellcor Sensor• SpO2 saturation percentageand the pulse amplitudedisplay• Perfusion index• Sat Seconds | Same – theSpO2 moduleshave not beenmodified |
| Pulse rate Rangeand accuracy usingSpO2 determination | • 20 - 250 +/- 3bpm, basedwith Nellcor SpO2parameter• 25 - 240 +/- 3bpm, based onMasimo SpO2 parameter | • 20 - 250 +/- 3bpm, basedwith Nellcor SpO2parameter• 25 - 240 +/- 3bpm, based onMasimo SpO2 parameter | Same |
| O2 SaturationRange andaccuracy | • Nellcor O₂ sat (%) valuesshall be +/- 3 digits betweenthe range of 70 - 100%• Masimo O₂ sat (%) valuesshall be +/- 2.0% of thevalues set between the rangeof 70 - 100% | • Nellcor O₂ sat (%) valuesshall be +/- 3 digits betweenthe range of 70 - 100%• Masimo O₂ sat (%) valuesshall be +/- 2.0% of thevalues set between the rangeof 70 - 100% | Same |
| Total Hemoglobinrange and accuracy(SpHb g/dL) | • Masimo Sensor only –Range 0 – 25 g/dLAdults/Infants/Pediatrics 8–17 g/dL + 1 g/dL | • Masimo Sensor only –Range 0 – 25 g/dLAdults/Infants/Pediatrics 8–17 g/dL + 1 g/dL | Same |
| AcousticRespiration Rate(RRa) | Masimo hardware providedand software enabled | Masimo hardware providedand software enabled | Same |
.
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| Subject Device and Predicate Device Comparison | |||
|---|---|---|---|
| Characteristic | Predicate Devices | Subject Device | Differences |
| Capnography forcarbon dioxide(CO2), respirationrate (RR)measurements andcalculation ofIntegratedPulmonary Index(IPI). | 4 - 70 +/- 1 breath per minute, adults (>30kg) CO2 accuracy:0 to 38 mmHg: ±2 mmHg39 to 150 mmHg: ±2 (5% ofreading + 0.08% for every 1mmHg above 38 mmHg)Flow rate:50 (42.5 ≤ flow ≤ 65) ml/min,flow measured by volumeInitialization time:40 seconds (typical, includespower-up andinitialization time)System response time:2.9 secondsCompensation:BTPS (standard correctionused by Microstreamcapnography during allmeasurement procedures forbody temperature, pressure,and saturation) | 4 - 70 +/- 1 breath per minute, adults (>30kg) CO2 accuracy:0 to 38 mmHg: ±2 mmHg39 to 150 mmHg: ±2 (5% ofreading + 0.08% for every 1mmHg above 38 mmHg)Flow rate:50 (42.5 ≤ flow ≤ 65) ml/min,flow measured by volumeInitialization time:40 seconds (typical, includespower-up andinitialization time)System response time:2.9 secondsCompensation:BTPS (standard correctionused by Microstreamcapnography during allmeasurement procedures forbody temperature, pressure,and saturation) | Same - theCO2 modulehas not beenmodified |
| EarlySense Module | No | Yes | Subject of thissubmission |
| Respiration rate | Also provided by Masimo andOridion Modules | 6 to 45 breaths per minute(±4% or ±1.5 breaths perminute, whichever is greater) | Same ascleared byEarlySense inK120465. |
| Heart Rate | Also provided by NIBP,Nellcor, and Masimo Modules | 30 to 170 beats per minute(±4% or ±5 beats per minute,whichever is greater) | Same ascleared byEarlySense inK120465. |
| Patient Movement | Not previously available. | Movement during definedperiod (percent of timemoving in 1.5 minutes)0 = 0% | Same ascleared byEarlySense inK120465. |
.
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| Subject Device and Predicate Device Comparison | |||
|---|---|---|---|
| Characteristic | Predicate Devices | Subject Device | Differences |
| 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%) | |||
| External DeviceCommunicationProtocol | WACP | WACP | Same |
| Communicationwith electronicrecord systems foralarming andremote monitoring | Patient date uploadedepisodically to electronicrecord systems. | Patient date uploadedepisodically to electronicrecord systems. | Same exceptincludesmodifiedinterface thatallows |
| (e.g., centralstation) | SpO2 and Pulse Ratecontinuous monitoring andinterval measurements ofNIBP and Temperature | SpO2 and Pulse Ratecontinuous monitoring andinterval measurements ofNIBP and Temperature. | clinicians tomanually enterpatient notes. |
| Interface also allows clinicianto manually enter Patientnotes. | |||
| Display type | LCD | LCD | Same |
| Touch Screen | Touch Screen | ||
| Barcode scanner | Yes | Yes | Same |
| The monitor enables thescanning of patients' and/orclinicians' barcodes to enteridentification information. Thebarcode scanner supportslinear and 2D barcodes. | The monitor enables thescanning of patients' and/orclinicians' barcodes to enteridentification information.The barcode scanner supportslinear and 2D barcodes. | ||
| Sterility | Device not supplied Sterile | Device not supplied Sterile | Same |
| Power source | 100 -240 V ac 50/60 Hz | 100 -240 V ac 50/60 Hz | Same |
| Battery Power | • Yes• Level of Charge indicator• Lithium ion | • Yes• Level of Charge indicator• Lithium ion | Same |
.
.
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K132808 P 16/16
Conclusion
Based on the information presented in this 510(k) premarket notification the Connex® Vital Signs Monitor 6000 Series(CVSM) is considered substantially equivalent (as safe, as effective and performs as well as) the currently marketed devices (K121013) citied in this submission. The differences noted between the CVSM and the predicate devices do not impact safety or effectiveness based on the successfully conducted testing of the modified device. The hardware, software, and mechanical aspects of the CVSM itself remain the same as the cleared device (Vital Signs Monitor - VSM 6000 Series, K 121013, S.E. date July 26, 2012) except as described below. The modification is to make the EarlySense module available on the CVSM to provide continuous and contact-less monitoring of respiration rate, heart rate, and movement. The software of the CVSM has been modified to enable display of the Early Sense measurements, which are received by CVSM via the same USB communications used to receive data from the currently available module is the same form factor as the current modules. EarlySense has incorporated sensor processing system into this format of a Connex Vital Signs Monitor 6000 Series module. EarlySense changed the case of their components to fit the Connex® Vital Signs Monitor 6000 Series platform. It follows the same software communication format as our currently available modules. The fidelity of these data transfers were tested in our design control process. Like the predicate CVSM device, this version of the CVSM can transfer acquired data electronically via USB, wired Ethernet, or wireless communications to other locations. Like the CVSM cleared in K121013, this version of the CVSM can transmit data continuously for secondary remote viewing and alarming (e.g., central station). Also included in this version of CVSM are minor software and connectivity enhancements to improve performance and customer experience.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
November 20, 2013
Welch Allyn, Inc. Mr. Kevin Crossen Director of Regulatory Affairs 4341 State St. Rd. P.O. Box 220 Skaneateles Falls, NY 13153-0220 US
Re: K132808
Trade/Device Name: Connex Vital Signs Monitor Regulation Number: 21 CFR 870.2300 Regulation Name: Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) Regulatory Class: II (two) Product Code: MWI Dated: October 24, 2013 Received: October 25, 2013
Dear Mr. Kevin Crossen:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
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Page 2 - Mr. Kevin Crossen
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97), For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.goy/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Owen P. Faris -S
for Bram D. Zuckerman, Ph.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K K
Device Name: Welch Allyn Connex® Vital Signs Monitor 6000 Series
Indications for Use:
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, l
- pulse rate, l
- noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2), and l
- 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 (SpOZ), 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, pediatic and adult patients in hospitals and hospital type facilities.
AND/OR
| Prescription Use(Part 21 CFR 801 Subpart D) | x |
|---|---|
| ------------------------------------------------- | --- |
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Digitally signed by Owen P.
Faris -5
Date: 2013.11.20 10:37:53
-05'00'
Page 6-2
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K132808 P 2/2
Indications for Use (Continued)
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 i - 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 <111 Kg) during sleep and resting condition.
This product is available for sale only upon the order of a physician or licensed health care professional.
§ 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).