VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR

K132808 · Welch Allyn, Inc. · MWI · Nov 20, 2013 · Cardiovascular

Device Facts

• Record ID: K132808
• Device Name: VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR
• Applicant: Welch Allyn, Inc.
• Product Code: MWI · Cardiovascular
• Decision Date: Nov 20, 2013
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Pediatric

Intended 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, - 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, 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 <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.

Device Story

Modular vital signs monitor (CVSM 6000 Series) for spot-check and continuous monitoring; inputs include NIBP, SpO2 (Nellcor/Masimo), temperature, capnography (Oridion), and contact-less sensor (EarlySense). Device processes physiological signals to display vital signs, IPI, and movement data; supports manual/electronic data entry (barcode, weight scales). Used by clinicians in hospitals/clinics; transmits data via USB, Ethernet, or wireless to central stations or EMRs. Provides real-time monitoring and alarming; aids clinical decision-making by alerting to changes in patient status. EarlySense integration enables contact-less monitoring of respiration, heart rate, and movement. Applications Framework allows isolated execution of third-party software.

Clinical Evidence

No clinical studies were utilized. Safety and effectiveness were established through bench testing, including electromagnetic compatibility (IEC 60601-1-2), environmental testing (thermal shock, humidity, vibration, drop), electrical safety (IEC 60601-1), and usability validation (summative testing of the integrated system).

Technological Characteristics

Modular system; LCD touch screen; connectivity via USB, Ethernet, wireless. Sensing: NIBP (oscillatory), SpO2 (pulse oximetry), Temperature (thermistor), Capnography (microstream), EarlySense (contact-less motion/vibration sensing). Power: 100-240V AC or internal Li-ion battery. Software: Applications Framework for isolated app execution. Sterilization: Not supplied sterile.

Indications for Use

Indicated for neonatal, pediatric, and adult patients in hospital/clinical settings for monitoring NIBP, pulse rate, SpO2, body temperature, CO2, respiration rate, total hemoglobin, and IPI. EarlySense module indicated for continuous contact-less monitoring of respiration rate, heart rate, and movement in children (≥10kg) and adults (<111kg) during sleep/rest. Contraindicated for patients on heart/lung machines, transport outside facility, MRI, hyperbaric chambers, or near flammable anesthetics/electrocautery.

Regulatory Classification

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.

Predicate Devices

• Connex® Vital Signs Monitor 6000 Series (K121013)

Reference Devices

• EarlySense (Everon) Module (K120465)

Submission Summary (Full Text)

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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: [phone] Fax: [phone] E-mail: [e-mail]

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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#### 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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#### 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:

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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 Edition<br>1988 | Medical Electrical Equipment - Part 1: General Requirements for Basic Safety<br>and Essential Performance |
| EN/IEC 60601-1-2 | 2007 | Medical Electrical Equipment - Part 1-2: General Requirements for Basic<br>Safety and Essential Performance - Collateral Standard: Electromagnetic<br>Compatibility - Requirements and Tests |
| IEC 60601-1-4 | 1996 | Medical Electrical Equipment - Part 1-4: general requirements for safety:<br>General requirement for programmable Electrical Medical System |
| IEC 60601-2-49 | 2001 | Medical electrical equipment - Part 2-49: Particular requirements for the safety<br>of multifunction patient monitoring equipment |
| IEC 60601-1-8 | 2003 | Medical electrical equipment - Part 1-8: General requirements for safety -<br>Collateral standard: Alarm systems - Requirements, tests and guidances -<br>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 ---<br>Description | Objective of the Test | Conclusions |
|---------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 60054949<br>CVSM ES- 60601-1-2<br>Electromagnetic<br>Compatibility test | Test the device per 60601-1-2 to ensure that the<br>device meets the requirements for Electromagnetic<br>Compatibility | Pass |
| 60054591<br>Mobile Stand Threshold | The purpose of this test is to verify that the product is<br>capable of withstanding the stresses caused by rough<br>handling as defined by IEC 60601-1:2005) | Pass |
| 60056145<br>Mobile Stand Tilt | The purpose of this test is to verify that the product is<br>stable on a stand as defined by IEC 60601-1:2005 | Pass |
| 60056145 Shock and<br>Vibration Test | To verify product safety and performance after<br>exposure to shock and vibration. | Pass |
| 60056405<br>Thermal Shock Test | To verify product performance after the thermal<br>shock conditions specified in Applied standards. | Pass |
| 60056431<br>Operating Environmental<br>Test (Temperature and<br>Humidity) | To verify product safety and performance within the<br>specified temperature and humidity environment. | Pass |
| 60056898<br>Ambient Characterization<br>Test | The purpose of this test is ensure that the module<br>level components do not exceed each of their<br>operating temperatures when integrated into the<br>Platform Device and exposed to the operating<br>temperature limits of that device. | Pass |
| 60056476<br>Functional Drop | To verify product safety and performance after<br>exposure to free fall. | Pass |
| 60055061 EarlySense<br>label wipe Test | To determine whether the chemicals used to clean<br>the EarlySense module will degrade components,<br>materials, or printing. | Pass |
| 60056426<br>VVP Device Weight Test | To verify the configured Platform device weight. | Pass |
| 60056945<br>Device Ship Test ISTA-<br>2A | Ensure device, enclosed in the selected shipping<br>container, meets ISTA 2A 2011 specifications. | Pass |
| 60042214<br>Battery Use Cycles Per<br>Charge- Continuous<br>Monitoring | Verify that the battery shall operate for a minimum of<br>2 hours under the continuous monitoring use case<br>conditions specified in PMP PAS 60028508 Section<br>4.4. | Pass |
| 60054951<br>Electrical Safety test | To confirm the device meets the requirements<br>defined in IEC 60601-1 | Pass |
| 60054952<br>Industrial Design<br>Specification Analysis | The objective of this analysis is to verify via unit and<br>documentation inspection that the CVSM ES Early<br>Sense equipped device has met the requirements of<br>the Industrial Design Specification. | Pass |
| 60054953<br>CVSM ES Shipping<br>Container Labeling<br>Verification | Verify the CVSM ES and ES Sensor device shipping<br>containers are labeled according to the required<br>specifications. | Pass |
| 60042215<br>PMP BOM Verification | The objective of this test is to verify that the released<br>CVSM ES BOM includes the specified components<br>identified within the requirements being tested<br>section of this test. This is not a functional test, it is<br>intended as a device inventory to ensure models can<br>be built that will support the features indicated. | Pass |

### Additional performance Bench Testing:

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Welch Allyn:

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| 60056673<br>Connex Vital Signs<br>Monitor ES Design<br>Validation | The purpose of this document is to describe Pre-<br>Summative Validation and Summative Validation<br>testing that will be performed with the Connex SMS<br>ES System (Connex RMS with the integration of<br>Early Sense Technology). Connex SMS ES is<br>comprised of Connex Central Station (CS ES) and<br>the Connex Vital Signs Monitor (CVSM ES). Pre-<br>Summative Validation will be Phase I and<br>Summative Validation will be Phase II.<br><br>The intent of Phase II is to verify and validate that the<br>Connex SMS ES System meets its usability<br>requirements as defined in the Connex CS Usability<br>Specification (DIR 60042476) and the CVSM<br>Usability Specification Document (DIR 60029496).<br>The software version tested during Phase II will be<br>production equivalent product. This testing also<br>supports the usability and human factors testing<br>requirements for both Connex ES and CVSM ES. | Pass |
|-------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------|
| 60056676<br>Connex Vital Signs<br>Monitor ES Directions<br>For Use Validation | The intent of Phase II is to verify and validate that the<br>Connex SMS ES System (Connex CS with<br>integration of Early Sense Technology and CVSM<br>ES) Directions for Use meets their usability<br>requirements as defined in the Connex CS Usability<br>Specification (DIR 60042476) and the CVSM<br>Usability Specification Document (DIR 60029496).<br>No patients will be enrolled in this study. | Pass |
| 60047144 Thermal Shock<br>- 25 cycle | To identify design flaws or behaviors that may occur<br>as a result of the device being exposed to stimulus<br>beyond what is specified within the device thermal<br>shock 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<br>(including cardiotachometer<br>and rate alarm) | 870.2300 - Cardiac monitor<br>(including cardiotachometer<br>and rate alarm) | Same |
| Indications For Use | Welch Allyn VSM 6000<br>Series<br>The VSM 6000 series of<br>monitors is intended to be<br>used by clinicians and<br>medically qualified personnel<br>for monitoring of neonatal,<br>pediatric, and adult patients<br>for:<br>- noninvasive blood pressure,<br>- pulse rate.<br>- noninvasive functional<br>oxygen saturation of<br>arteriolar hemoglobin<br>(SpO2), and<br>- body temperature in normal<br>and axillary modes.<br>The most likely locations for<br>patients to be monitored are | Welch Allyn Connex ® VSM<br>6000 Series<br>The VSM 6000 series of<br>monitors is intended to be<br>used by clinicians and<br>medically qualified personnel<br>for monitoring of neonatal,<br>pediatric, and adult patients<br>for:<br>- noninvasive blood pressure,<br>- pulse rate,<br>- noninvasive functional<br>oxygen saturation of<br>arteriolar hemoglobin<br>(SpO2), and<br>- body temperature in normal<br>and axillary modes.<br>The most likely locations for<br>patients to be monitored are | Same |
| | Subject Device and Predicate Device Comparison | | |
| Characteristic | Predicate Devices | Subject Device | Differences |
| | floors, general hospital, and<br>alternate care environments. | floors, general hospital, and<br>alternate care environments. | |
| | The optional Masimo<br>Rainbow SET® Pulse CO-<br>Oximeter and accessories are<br>indicated for the continuous<br>noninvasive monitoring of<br>functional oxygen saturation<br>of arterial hemoglobin (SpO2),<br>pulse rate, total hemoglobin<br>concentration (SpHb), and/or<br>respiration rate (RRa). The<br>Masimo Rainbow SET®<br>Radical 7R Pulse CO-<br>Oximeter and accessories are<br>indicated for use with adult,<br>pediatric, and neonatal<br>patients during both motion<br>and no motion conditions, and<br>for patients who are well or<br>poorly perfused in hospitals<br>and hospital-type facilities. | The optional Masimo<br>Rainbow SET® Pulse CO-<br>Oximeter and accessories are<br>indicated for the continuous<br>noninvasive monitoring of<br>functional oxygen saturation<br>of arterial hemoglobin (SpO2),<br>pulse rate, total hemoglobin<br>concentration (SpHb), and/or<br>respiration rate (RRa). The<br>Masimo Rainbow SET®<br>Radical 7R Pulse CO-<br>Oximeter and accessories are<br>indicated for use with adult,<br>pediatric, and neonatal<br>patients during both motion<br>and no motion conditions, and<br>for patients who are well or<br>poorly perfused in hospitals<br>and hospital-type facilities. | |
| | The optional Oridion module<br>and accessories are intended<br>for the continuous non<br>invasive measurement and<br>monitoring of carbon dioxide<br>concentration of the expired<br>and inspired breath and<br>respiration rate. It is intended<br>for use with neonatal, pediatric<br>and adult patients in hospitals<br>and hospital type facilities.<br>concentration of the expired<br>and inspired breath and<br>respiration rate. It is intended<br>for use with neonatal,<br>pediatric, and adult patients in<br>hospitals and hospital type<br>facilities. | The optional Oridion module<br>and accessories are intended<br>for the continuous non<br>invasive measurement and<br>monitoring of carbon dioxide<br>concentration of the expired<br>and inspired breath and<br>respiration rate. It is intended<br>for use with neonatal,<br>pediatric and adult patients in<br>hospitals and hospital type<br>facilities. concentration of the<br>expired and inspired breath<br>and respiration rate. It is<br>intended for use with<br>neonatal, pediatric, and adult<br>patients in hospitals and<br>hospital type facilities. | Same |
| | The optional Oridion module<br>also provides the clinician<br>with an integrated pulmonary<br>index (IPI). The IPI is based<br>on four parameters provided<br>by the monitor: end tidal<br>carbon dioxide, respiration<br>rate, oxygen saturation and<br>pulse rate. The IPI is a single<br>index of an adult or pediatric | The optional Oridion module<br>also provides the clinician<br>with an integrated pulmonary<br>index (IPI). The IPI is based<br>on four parameters provided<br>by the monitor: end tidal<br>carbon dioxide, respiration<br>rate, oxygen saturation and<br>pulse rate. The IPI is a single<br>index of an adult or pediatric | |
| Subject Device and Predicate Device Comparison | | | |
| Characteristic | Predicate Devices | Subject Device | Differences |
| | patient's ventilatory status<br>displayed on a scale of 1 - 10,<br>where 10 indicates optimal<br>pulmonary status. IPI<br>monitoring displays a single<br>value that represents the<br>patient's pulmonary<br>parameters and alerts<br>clinicians to changes in the<br>patient's pulmonary status. | patient's ventilatory status<br>displayed on a scale of 1 - 10,<br>where 10 indicates optimal<br>pulmonary status. IPI<br>monitoring displays a single<br>value that represents the<br>patient's pulmonary<br>parameters and alerts<br>clinicians to changes in the<br>patient's pulmonary status. | Same (The<br>base intended<br>use remains<br>the monitoring<br>of patient vital<br>signs. As with<br>previous<br>submissions,<br>the EarlySense<br>Everon<br>Module's<br>cleared<br>indications for<br>use statement<br>is appended<br>unchanged<br>into the<br>CVSM's<br>cleared<br>indications for<br>use statement,<br>as shown by<br>the bold text in<br>the column to<br>the left. The<br>EarlySense<br>(Everon)<br>Module was<br>previously<br>cleared in<br>Early Sense's<br>510(k)<br>K120465). |
| | The IPI is an adjunct to, and is<br>not intended to replace, vital<br>sign monitoring. | The IPI is an adjunct to, and is<br>not intended to replace, vital<br>sign monitoring.…