(133 days)
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. SmartLinx Vitals Plus consists of the following components: SmartLinx Vitals Plus Application, SmartLinx Vitals Plus NIBP Module, Masimo uSpO2 Pulse Oximetry Cable, Exergen TAT-5000S Thermometer, Covidien FILAC 3000 Thermometer, SmartLinx Vitals Plus Alarm Hub, SmartLinx Neuron 2 Mobile Platform, and SmartLinx Early Warning Scoring System.
The provided text does not contain enough information about acceptance criteria or a study proving that the device meets specific performance metrics. It primarily focuses on the device's substantial equivalence to predicate devices and adherence to recognized safety and performance standards.
The document discusses:
- Device Description: What the device is and its components.
- New Functionality: The additions to the SmartLinx Vitals Plus Application, such as Intervals Mode for NIBP, physiological alarms, continuous SpO2 monitoring features, and integration of the Covidien FILAC 3000 Thermometer.
- Comparison to Predicate Devices: Tables detailing technical characteristics and their differences, and a discussion of why these differences do not raise new questions of safety or effectiveness.
- Safety and Performance Testing: A list of FDA recognized standards that the device complies with (e.g., for general safety, EMC, usability, alarms, software, NIBP, temperature, SpO2, battery, patient monitoring).
- Clinical Studies: A clear statement that clinical studies were not required to support substantial equivalence.
Therefore, I cannot extract the specifically requested information about acceptance criteria, detailed device performance, sample sizes for test/training sets, data provenance, number of experts for ground truth, adjudication methods, MRMC studies, or standalone performance, because this information is not present in the provided text.
The document states:
- "Extensive performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications."
- "The subject of this premarket submission, the SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."
This indicates that while performance testing was done against specifications, the specific details of those tests, the acceptance criteria used, and the quantitative results are not included in this summary document.
{0}------------------------------------------------
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
October 24, 2017
Capsule Technologie, SAS % Dave Yungvirt CEO Third Party Review Group, LLC The Old Station House 24 Lackawanna Place Millburn, New Jersey 07041
Re: K171751
Trade/Device Name: SmartLinx Vitals Plus Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DXN, DQA, FLL Dated: October 3, 2017 Received: October 5, 2017
Dear Dave Yungvirt:
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. Iisting 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.
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820);
{1}------------------------------------------------
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 Industry and Consumer Education (DICE) at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevicesforYou/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.gov/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 Industry and Consumer Education (DICE) 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,
M.A. Hilleman
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
Indications for Use
510(k) Number (if known) K171751
Device Name
SmartLinx Vitals Plus Patient Monitoring System
Indications for Use (Describe)
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) | |
|---|---|
| Over-The-Counter Use (21 CFR 801 Subpart C) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
| Applicant /Manufacturer's Name | Capsule Technologie, SAS76-78 avenue de FranceCS2141675644 Paris Cedex 13 |
|---|---|
| Official Correspondent | James Hodge Director QA/RACapsule Tech, Inc.300 Brickstone Square, Suite 203Andover, MA 01810Phone: 978-482-2362Email: jhodge@qualcommlife.com |
| Date Prepared | October 3, 2017 |
| Device Trade Name | SmartLinx Vitals Plus Patient Monitoring System |
| Common Name | Physiological or Vital Signs Monitor, Patient Monitor |
| Classification Name | 21 CFR 870.2300 Cardiac monitor (includingcardiotachometer and rate alarm) |
| Regulatory Class | II |
| Product Code | MWI, monitor, physiological, patient (withoutarrhythmia detection or alarms) |
| Primary Predicate | CASMED 740 Select K130411 |
| Device | This device was selected as the primary predicate sinceits monitoring functionality closely matches themodifications to the SmartLinx Vitals Plus device of thissubmission. Likewise, the Covidien FILAC 3000thermometer integrated with this device is the samecomponent added to SmartLinx Vitals Plus. Thispredicate has not been subject to a design-related recall. |
| Other PredicateDevice | SmartLinx Vitals Plus Patient Monitoring SystemK151071 |
{4}------------------------------------------------
Device Description
The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. SmartLinx Vitals Plus consists of the following components:
SmartLinx Vitals Plus Application
The SmartLinx Vitals Plus Application is a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform. The Vitals Plus Application controls the externally integrated vital signs modules and the Alarm Hub through interfaces on the SmartLinx Neuron 2 Mobile Platform, and presents patient information to the user for active monitoring purposes at the point of care. The supported physiological parameters are: NIBP (systolic, diastolic, mean arterial pressure (MAP), Pulse Rate, SpO2, and Temperature.
New functionality added to the Vitals Plus Application since the initial clearance of Vitals Plus in K151071 includes:
-
- Intervals Mode for NIBP (Automatic repetition of NIBP measurements)
-
- Physiological alarms for NIBP (Sys, Dia, MAP), Pulse Rate, SpO2, and Temperature, which are visibly annunciated on the Neuron 2 and audibly annunciated on the SmartLinx Vitals Plus Alarm Hub
-
- Continuous SpO2 monitoring with pulse tone pitches that vary according to oxygen saturation, SpO2 alarm delay, and SpO2 sensor off alarm
-
- Temperature measurements with the Covidien FILAC 3000 Thermometer
SmartLinx Vitals Plus NIBP Module
The SmartLinx Vitals Plus NIBP Module is the same hardware component previously cleared in K151071. Incorporating the SunTech Medical Advantage A+ OEM NIBP module and associated blood pressure cuffs and hoses, it measures systolic, diastolic and mean arterial blood pressures (MAP), and pulse rates for adult, pediatric and neonatal patients. The module is controlled by the SmartLinx Vitals Plus Application to manage the inflation and deflation of blood pressure cuffs, and to measure blood pressures and pulse rates.
Masimo uSp02 Pulse Oximetry Cable
The Masimo uSpO2 Pulse Oximetry Cable is a patient cable with an integrated MS-2000 series circuit board contained in an enclosure that connects to Masimo pulse oximetry sensors and provides functional oxygen saturation (SpO2) and pulse rate and other information via a serial digital interface. This is the same component as
{5}------------------------------------------------
Traditional 510(k) — K171751
was previously cleared with the SmartLinx Vitals Plus Patient Monitoring System in K151071. The SmartLinx Vitals Plus Application controls the operation of the uSpO2 to measure SpO2 and pulse rate in adult, pediatric, and neonatal patients.
Exergen TAT-5000S Thermometer
The Exergen TAT-5000S thermometer is the same component previously cleared in K151071. The TAT-5000S is designed for accurate, noninvasive temperature assessment by scanning the temporal artery. The thermometer operates independently, but communicates its results to the SmartLinx Vitals Plus Application for display and monitoring.
Covidien FILAC 3000 Thermometer
The Covidien FILAC 3000 Thermometer is a new component of Vitals Plus. The FILAC 3000 acquires temperature measurements through the application of a probe at Oral, Axillary, and Rectal sites. The typical measurement mode of the thermometer is a Predictive Mode that returns a measurement in 6-10, 8-12, and 10-14 seconds respectively for Oral, Axillary, and Rectal sites. The thermometer also has a Direct Mode (simulating a standard thermometer) and a Cold Mode (a predictive mode for patients at a lower temperature).
SmartLinx Vitals Plus Alarm Hub
The Alarm Hub is a new component of SmartLinx Vitals Plus that is used with the optional Advanced Monitoring license for the Vitals Plus Application. The Alarm Hub offers a primary speaker for alarm annunciations (with failover to a backup speaker), watchdog functionality, and a USB hub for expansion.
SmartLinx Neuron 2 Mobile Platform
The SmartLinx Neuron 2 Mobile Platform is a mobile computer utilizing industry standard PC architecture and the Microsoft Windows operating system, that is used within the SmartLinx Medical Device Information System and IEC 60601-1 Medical Electrical Systems for collection, transmission, conversion, storage and display of medical device data. The Neuron 2 runs different SmartLinx applications depending upon the care area and desired functionality, including SmartLinx Vitals Stream, SmartLinx Chart Xpress, and SmartLinx Vitals Plus. The Neuron 2 is utilized as part of an active monitoring system when running the SmartLinx Vitals Plus Application.
SmartLinx Early Warning Scoring System
The SmartLinx Early Warning Scoring System (EWSS) is an optional software component that integrates with the SmartLinx Vitals Plus Application and runs on the
Page 3 of 14
{6}------------------------------------------------
SmartLinx Neuron 2 Mobile Platform. The EWSS component is unchanged from that described in the cleared K151071 Vitals Plus submission.
SmartLinx EWSS performs a medical calculation that aids clinical users in patient assessment and condition trending. This calculation, which would otherwise be completed manually, produces an aggregate patient score from a set of sub-scores determined from the values of measured vital signs and manually entered nursing observations. The resulting aggregate score is displayed on the Vitals Plus Application, and may be communicated to other healthcare information systems. EWSS requires the clinical user to attend the patient in order to function. There is no automatic or continuous scoring. The specific scoring method used within SmartLinx EWSS to calculate a patient's score is determined by the customer.
Intended Use
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
Comparison of Technical Characteristics with the Predicate Device
The SmartLinx Vitals Plus Patient Monitoring System features design characteristics and technologies that are substantially equivalent to those of the predicate devices. As discussed in Table 1 and Table 2, the differences in technological characteristics do not raise different questions of safety or effectiveness.
Do the devices have the same technological characteristics?
- No. The proposed modifications to SmartLinx Vitals Plus have similar technological characteristics compared to its predicate devices with some differences as shown in Table 1 and Table 2.
{7}------------------------------------------------
| SmartLinx VitalsPlus | SmartLinx VitalsPlus | Discussion ofDifferences | |
|---|---|---|---|
| 510(k)Number | K171751 | K151071 | |
| Intended Use | The SmartLinxVitals Plus PatientMonitoring Systemis intended formonitoring andalarming ofphysiologicparameters,including non-invasive bloodpressure (systolic,diastolic, and meanarterial pressure),pulse rate,functional arterialoxygen saturation(SpO2), andtemperature, onadult, pediatric, andneonatal patients inhospitalenvironments whenused by clinicalphysicians orappropriate medicalstaff under thedirection ofphysicians. | The SmartLinxVitals Plus PatientMonitoring Systemis intended formonitoringphysiologicparameters,including non-invasive bloodpressure (systolic,diastolic, and meanarterial pressure),pulse rate,functional arterialoxygen saturation(SpO2), andtemperature, onadult, pediatric, andneonatal patients inhealthcare facilitieswhen used byclinical physiciansor appropriatemedical staff underthe direction ofphysicians. | Same. |
| NIBPMeasurement | SmartLinx VitalsPlus NIBP moduleusing the SunTechAdvantage A+module ofoscillometric designfor Spot Check andIntervals Modemeasurement. | SmartLinx VitalsPlus NIBP moduleusing SunTechAdvantage A+module ofoscillometric designfor Spot CheckMode. | Same except foraddition of NIBPIntervals Mode toVitals Plus, which iscompared to theCASMED primarypredicate device(K130411). |
| SpO2Monitoring | Masimo uSpO2Oximetry Cableusing Masimo SETtechnologyintegrated externallyto the Neuron via aUSB connection forSpot Checkmeasurements andContinuousMonitoring. | Masimo uSpO2Oximetry Cableusing Masimo SETtechnologyintegratedexternally to theNeuron via a USBconnection for SpotCheckmeasurements. | Same except foraddition ofContinuousMonitoring withassociated features,which is compared tothe CASMED primarypredicate device(K130411). |
| TemperatureMeasurement | Two differentthermometryoptions:1) Covidien FILAC3000 probe.2) Exergen TAT-5000S infraredscanner. | Exergen TAT-5000S infraredscanner. | Same except foraddition of CovidienFILAC 3000 probethermometer, whichcompared to theCASMED primarypredicate device(K130411). |
| Alarms | Configuration,annunciation, andacknowledgementof physiological andtechnical alarms for(Sys, Dia, MAP,Pulse Rate, SpO2,and Temp).Alarms are visiblyannunciated andacknowledged onthe screen.Alarms are audiblyannunciated via twopossible speakerconfigurations:1) One speaker fornon-AdvancedMonitoringconfigurations,using the singlespeaker insidethe Neuron 2. | Configuration,annunciation, andacknowledgementof technical alarmsfor (Sys, Dia, MAP,Pulse Rate, SpO2,and Temp).Alarms are visiblyannunciated andacknowledged onthe screen.Alarms are audiblyannunciated via asingle speakerinside the Neuron2. | Vitals Plus supportsthe same singlespeaker configurationof K151071 for non-Advanced MonitoringMode. It also addsthe Alarm Hub withits primary speakerand watchdogprocessor forAdvanced MonitoringMode. The twospeaker configurationfor AdvancedMonitoring Mode iscompared to theCASMED primarypredicate device(K130411). |
| 2) Two speakers forAdvancedMonitoringconfigurations,using thespeaker insidethe Alarm Hub asthe primary, andthe speakerinside theNeuron 2 as abackup. | |||
| Applied Parts | SunTech DurableOne-Piece,Disposable, andVinyl bloodpressure NIBPcuffs, and GECRITIKON SOFT-CUF cuffs inneonate throughadult thigh sizes.Masimo LNCSfamily of reusableand disposableSpO2 sensors.Covidien FILAC3000 Probe Covers.Exergen disposableprobe covers andsheaths. | SunTech DurableOne-Piece,Disposable, andVinyl bloodpressure NIBPcuffs in neonatethrough adult thighsizes.Masimo LNCSfamily of reusableand disposableSpO2 sensors.Exergen disposableprobe covers andsheaths. | NIBP cuffs are thesame except for theaddition of two newsizes in the SunTechDisposable cuffs andthe addition of theGE CRITIKONSOFT-CUFs.FILAC probe coversare new to VitalsPlus and arecompared to theCASMED primarypredicate device(K130411). |
| EnergySource | Main BatteryNeuron 2: Lithium-lon 3S1P 2600 mAhor 3050 mAh.Extended BatteryNeuron 2: Lithium-lon 3S2P 5200 mAhor 6100 mAh (1 or 2depending on useof Dual Battery | Main BatteryNeuron 2: Lithium-lon 3S1P 2600mAh.Extended BatteryNeuron 2: Lithium-lon 3S2P 5200mAh (1 or 2depending on useof Dual Battery | Vitals Plus supportsnew larger batterycapacities and usesa Class I powersupply as theexpressedpreference of mosthospitals for thiscategory of device. |
Table 1 Comparison With SmartLinx Vitals Plus (K151071)
Page 5 of 14
{8}------------------------------------------------
{9}------------------------------------------------
{10}------------------------------------------------
| Exergen: 9Valkaline. | Exergen: 9Valkaline. |
|---|---|
| Power Supply: 100-240 VAC, 2.0-1.0 A,50-60 Hz, Class I. | Power Supply: 100-240 VAC, 2.0-1.0 A, 50-60 Hz,Class II. |
| Table 2 Comparison With Primary Predicate CASMED 740 Select (K130411) | ||
|---|---|---|
| -- | ----------------------------------------------------------------------- | -- |
| SmartLinx VitalsPlus | CASMED 740Select | Discussion ofDifferences | |
|---|---|---|---|
| 510(k)Number | K171751 | K130411 | |
| Intended Use | The SmartLinxVitals Plus PatientMonitoring Systemis intended formonitoring andalarming ofphysiologicparameters,including non-invasive bloodpressure (systolic,diastolic, and meanarterial pressure),pulse rate,functional arterialoxygen saturation(SpO2), andtemperature, onadult, pediatric, andneonatal patients inhospitalenvironments whenused by clinicalphysicians orappropriate medicalstaff under thedirection ofphysicians. | The 740 Select isindicated for use asa bedside, portabledevice for use byhealthcareprofessionals,clinicians andmedically qualifiedpersonnel for spotchecking,continuousmonitoring andrecording of adult,pediatric of adult,pediatric andneonatal patients.The monitorfeatures world classtechnology tofacilitate themonitoring of non-invasive bloodpressure, pulserate, functionalarterial oxygensaturation (SpO2)and bodytemperature in avariety of clinicalenvironments. | None in terms ofpractical meaning. |
| NIBPMeasurement | SmartLinx VitalsPlus NIBP moduleusing the SunTechAdvantage A+module ofoscillometric designfor Spot Check andIntervals Modemeasurements. | MAXNIBP moduleof oscillometricdesign for SpotCheck and IntervalsModemeasurements. | Different modulesuppliers. |
| SpO2Monitoring | Masimo uSpO2Oximetry Cableusing Masimo SETtechnologyintegrated externallyto the Neuron via aUSB connection forSpot Checkmeasurements andContinuousMonitoring with thefollowing features:1) Pulse tone pitchvarying withoxygensaturation2) SpO2 alarmdelay3) SpO2 sensor offalarm | Masimo RainbowSET OEM boardintegrated insidethe monitor forContinuousMonitoring with thefollowing features:Pulse tone pitch1)varying withoxygensaturation2)SpO2 alarmdelaySpO2 sensor off3)alarm | Both devices use thesame core MasimoSET technology formeasuring SpO2.pulse rate, andperfusion index.Vitals Plus also offersthe clinical user theconvenience of aSpot Check mode. |
| TemperatureMeasurement | Two differentthermometryoptions:1) Covidien FILAC3000 probe.2) Exergen TAT-5000S infraredscanner. | Covidien FILAC3000 probe. | Only Vitals Plusoffers the ExergenTAT-5000S, but thisis the samecomponent used inthe Vitals Pluspredicate device(K151071). |
| Alarms | Configuration,annunciation, andacknowledgementof physiological andtechnical alarms for(Sys, Dia, MAP, | Configuration,annunciation, andacknowledgementof physiological andtechnical alarms for(Sys, Dia, MAP, | Same except forspeakerconfigurations. Non-Advanced Monitoringconfigurations ofVitals Plus may be |
| Pulse Rate, SpO2,and Temp). | Pulse Rate, SpO2,and Temp). | safely used with onlythe single speaker.Advanced Monitoringconfigurations ofVitals Plus requirethe Alarm Hub. | |
| Alarms are visiblyannunciated andacknowledged onthe screen. | Alarms are visiblyannunciated andacknowledged onthe screen. | ||
| Alarms are audiblyannunciated via twopossible speakerconfigurations:1) One speaker fornon-AdvancedMonitoringconfigurations,using the singlespeaker insidethe Neuron 2 fortechnical alarms. | Alarms are audiblyannunciated via twospeakers inside themonitor. Alarmsfirst annunciate ona primary speaker,and then with adifferent tone on abackup speaker. | ||
| 2) Two speakers forAdvancedMonitoringconfigurations,using thespeaker insidethe Alarm Hub asthe primary, andthe speakerinside theNeuron 2 as abackup. | |||
| Applied Parts | |||
| SunTech DurableOne-Piece,Disposable, andVinyl NIBP cuffs,and GE CRITIKONSOFT-CUF cuffs inneonate throughadult thigh sizes.Masimo LNCSfamily of reusableand disposableSpO2 sensors. | SoftcheckDisposable andUltracheckReusable NIBPcuffs in infantthrough adult thighsizes.Masimo M-LNCSfamily of reusableand disposableSpO2 sensors | Each device uses itsown set of NIBP cuffsthat conform to IEC80601-2-30 whenused with the device.Masimo sensors arethe same except forthe connector used.Exergen covers andsheaths are uniqueto Vitals Plus, but arethe samecomponents used in | |
| Covidien FILAC3000 Probe Covers | |||
| Covidien FILAC3000 Probe Covers.Exergen disposableprobe covers andsheaths. | the Vitals Pluspredicate device(K151071). | ||
| EnergySource | Main BatteryNeuron 2: Lithium-Ion 3S1P 2600 mAhor 3050 mAh. | Main Battery:Lithium-Ion 10.8VDC 7800 mAh. | Each device uses abattery appropriate toits design anddesired autonomy. |
| Extended BatteryNeuron 2: Lithium-Ion 3S2P 5200 mAhor 6100 mAh (1 or 2depending on useof Dual BatteryDock).Exergen: 9Valkaline.Power Supply: 100-240 VAC, 2.0-1.0 A,50-60 Hz, Class I. | Power Supply:100-240 VAC, 1.2A Max (1.2A to 0.50A), 50-60 Hz, ClassII. | The Exergen 9Vbattery is unique toVitals Plus, but is thesame componentused in the VitalsPlus predicate device(K151071).Vitals Plus uses aClass I power supplyas the expressedpreference of mosthospitals for thiscategory of device. |
{11}------------------------------------------------
Page 9 of 14
{12}------------------------------------------------
Page 10 of 14
{13}------------------------------------------------
Do the different technological characteristics of the device raise different questions of safety and effectiveness?
- No. The different technological characteristics of the proposed Vitals Plus device do not raise different questions of safety and effectiveness as discussed below.
Safety
-
- Biocompatibility
The applied parts in used in the proposed Vitals Plus and both predicate devices raise the same questions regarding biocompatibility of patient applied parts. All components conform to ISO 10993-1 series requirements.
- Biocompatibility
-
- Energy Transfer
The proposed Vitals Plus and both predicate devices raise the same questions with respect to energy transfer to the patient. The NIBP functions use the same mechanism of action, oscillometry. The SpO2 functions use the same Masimo technology. The temperature functions both use the same FILAC and Exergen technology.
- Energy Transfer
Page 11 of 14
{14}------------------------------------------------
-
- Energy Source
Both devices raise the same questions of safety related to lithium ion batteries including heat, fire, explosion and exposure to potentially noxious gases.
- Energy Source
Effectiveness
Both the proposed Vitals Plus and the CASMED 740 Select primary predicate raise the same questions of effectiveness concerning the new functionality added to Vitals Plus since its initial clearance.
Are the proposed scientific methods for evaluating new/different characteristics' effects on safety and effectiveness acceptable?
- Yes. The proposed scientific methods for evaluating new/different characteristics' effects on safety and effectiveness are acceptable.
Safety and Performance Testing
Safety testing assures that the device complies with applicable sections of recognized industry and safety standards. Extensive performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate devices and meets all of its functional requirements and performance specifications. The SmartLinx Vitals Plus Patient Monitoring System complies with the voluntary standards listed in the table below.
| PerformanceCharacteristic | FDA Recognizedstandard | Standard Title |
|---|---|---|
| General | ANSI AAMI ES 60601-1:2005/ (R):2012& A1:2012& C1:2009/(R):2012& A2:2010/(R):2012 | Medical electrical equipment - Part 1:General requirements for basic safetyand essential performance (IEC60601-1:2005, MOD |
| EMC | IEC 60601-1-2:2007 | Medical electrical equipment – Part1-2: General requirements for basicsafety and essential performance -Collateral standard: Electromagneticcompatibility - Requirements andtests |
| Usability | IEC 60601-1-6:2013 | Medical electrical equipment - Part1-6: General requirements for basicsafety and essential performance -Collateral standard: Usability |
| Alarms | IEC 60601-1-8:2012 | General requirements for basic safetyand essential performance –Collateral Standard: Generalrequirements, tests and guidance foralarm systems in medical electricalequipment and medical electricalsystems |
| Software | IEC 62304:2006 | Medical device software—Softwarelife cycle processes |
| Usability | IEC 62366:2014 | Medical devices – Application ofusability engineering to medicaldevices |
| NIBP | IEC 80601-2-30:2013 | Medical electrical equipment –Part 2-30: Particular requirements forthe basic safety and essentialperformance of automated non-invasive sphygmomanometers |
| ISO 81060-2:2013 | Non-invasive sphygmomanometersPart 2: Clinical investigation ofautomated measurement type | |
| Temp | ISO 80601-2-56:2009 | Medical electrical equipmentPart 2-56: Particular requirements forbasic safety and essentialperformance of clinical thermometersfor body temperature measurement |
| SpO2 | ISO 80601-2-61:2011 | |
| Battery | IEC 62133:2012 | |
| PatientMonitoring | IEC 60601-2-49:2011 | Medical electrical equipment |
{15}------------------------------------------------
{16}------------------------------------------------
Part 2-49: Particular requirements for the basic safety and essential performance
Reference Devices
The Zoll R Series Monitor Defibrillator cleared in K120907 is used as a reference device, just as it was in the original K151071 clearance of SmartLinx Vitals Plus. The R Series incorporates the same SunTech Advantage A+ oscillometric OEM NIBP module and uses the same firmware built into the Advantage A+ to control automatic repetition of interval blood pressure measurements as the modified SmartLinx Vitals Plus Application of this submission.
The modified CASMED 740 Select device cleared in K150620 is also used as a reference device. The Exergen TAT-5000S thermometer was added to the 740 Select with this clearance, which removes the only significant difference from the modified Vitals Plus of this submission.
Clinical Studies
The subiect of this premarket submission, the SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence.
Conclusions
Substantial equivalence of the SmartLinx Vitals Plus Patient Monitoring System is demonstrated through conformance with recognized consensus standards. The modifications to the SmartLinx Vitals Plus Patient Monitoring System results in an equivalent design, features and functionality as the predicate devices with few exceptions, and these exceptions do not affect the safety or effectiveness of the system.
No new questions of safety or effectiveness are raised as a result of the differences when compared to the predicate devices, and the data provided in the submission show that the subject device can be considered substantially equivalent.
Page 14 of 14
§ 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).