(149 days)
No
The summary describes a standard vital signs monitoring system that collects and displays physiological parameters. There is no mention of AI/ML in the device description, intended use, performance studies, or any other section. The testing focuses on standard medical device performance and safety, not on the validation of an AI/ML algorithm.
No
This device is described as a "Patient Monitoring System" intended for "monitoring physiologic parameters." Its function is to measure and display vital signs, not to treat a condition.
Yes
The device monitors physiological parameters (blood pressure, pulse rate, SpO2, and temperature) to provide information that can be used for diagnosis or to guide treatment.
No
The device description explicitly states that the system consists of a mobile medical application and externally integrated vital signs modules, a mobile platform, and a roll stand, indicating the presence of hardware components beyond just software.
Based on the provided information, the SmartLinx Vitals Plus Patient Monitoring System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the system is for "monitoring physiologic parameters" such as blood pressure, pulse rate, SpO2, and temperature. These are measurements taken directly from the patient's body, not from samples of bodily fluids or tissues.
- Device Description: The device description details the components, which are all related to taking direct physiological measurements (NIBP module, SpO2 cable, thermometer).
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any other elements typically associated with in vitro diagnostics.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening. The SmartLinx Vitals Plus system directly measures vital signs from the patient, which falls under the category of patient monitoring devices, not IVDs.
N/A
Intended Use / Indications for Use
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring 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 healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.
Product codes
MWI
Device Description
The SmartLinx Vitals Plus Patient Monitoring System consists of the SmartLinx Vitals Plus mobile medical application and externally integrated vital signs modules operating on the SmartLinx Neuron 2 mobile platform. The application controls the modules at the point of care through interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the monitoring purposes. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, mean arterial pressure (MAP)), pulse rate, functional arterial oxygen saturation (SpO2), and temperature.
The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products:
- The SmartLinx Vitals Plus mobile medical application
- The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses
- The Masimo SET uSpO2 Pulse Oximetry Cable
- The Exergen TAT-5000S infrared thermometer
- The SmartLinx Neuron 2 Mobile Platform
- The SmartLinx Vitals Plus Roll Stand
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
clinical physicians or appropriate medical staff under the direction of physicians in healthcare facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards. The SmartLinx Vitals Plus Patient Monitoring System performance testing is summarized in Table 2.
Sterilization Validation: The SmartLinx Vitals Plus Patient Monitoring System is not designed to be sterilized. All patient applied parts used with the SmartLinx Vitals Plus Patient Monitoring System are sourced from the vendors of the vital signs modules. The sterilization issues related to these patient applied parts were addressed in the predicate or reference device submissions, and were cleared by FDA.
Shelf Life Testing: All patient applied parts used with the SmartLinx Vitals Plus Patient Monitoring System are sourced from the vendors of the vital signs modules. The shelf life issues related to these patient applied parts were addressed in the predicate or reference device submissions, and were cleared by FDA. The SmartLinx Neuron battery has a shelf life of three months. This limit applies to batteries that are not in use. The Exergen TAT-5000S uses a 9 volt alkaline battery which typically has a shelf life of seven years.
Biocompatibility Testing: All patient applied parts used with the SmartLinx Vitals Plus Patient Monitoring System are sourced from the vendors of the vital signs modules. The biocompatibility issues related to these patient applied parts were addressed in the predicate or reference device submissions, and were cleared by FDA.
Software Testing: Software for the SmartLinx Vitals Plus Patient Monitoring System was designed and developed in accordance with Capsule Technologie software development processes, and was verified and validated. Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification.
Electrical Safety: The SmartLinx Vitals Plus Patient Monitoring System was tested for patient safety in accordance with the following applicable standards: IEC 60601-1:2005 IEC 60601-1-6:2013 IEC 60601-1-8:2012 IEC 80601-2-30:2013 ISO 80601-2-56:2009 ISO 80601-2-61:2011 ISO 81060-2:2013 IEC 62304:2006 IEC 62366:2014 IEC 62133:2012 Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification.
Electromagnetic Compatibility Testing: The SmartLinx Vitals Plus Patient Monitoring System was tested for EMC in accordance with IEC 60601-1-2:2007. Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification.
Performance Testing - Bench: The SmartLinx Vitals Plus Patient Monitoring System was tested in accordance with internal Capsule Technologie requirements and procedures. Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification. This testing includes performance, functional, reliability, environmental, and packaging testing.
Performance Testing - Animal: Animal performance testing was not performed and is not necessary to demonstrate safety and effectiveness of the SmartLinx Vitals Plus Patient Monitoring System.
Performance Testing - Clinical: The SmartLinx Vitals Plus Patient Monitoring System was tested for clinical performance in accordance with the following applicable standard: ISO 81060-2:2013. Test results indicated that the SmartLinx Vitals Plus Patient Monitoring System complies with its predetermined specification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
GE Carescape V100 Vital Signs Monitor K102426
Reference Device(s)
Zoll R Series Monitor Defibrillators K120907, Masimo uSpO2 Pulse Oximetry Cable K121914, Exergen TAT-5000S K011291
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo features a stylized image of three human profiles facing right, stacked on top of each other. The profiles are black and have a flowing, ribbon-like design at the bottom. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" is arranged in a circular pattern around the image.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
Capsule Technologie SAS Peter Kelley Director of QA/RA 300 Brickstone Square, Suite 203 Andover, Massachusetts 01810
Re: K151071
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 Dated: August 5, 2015 Received: August 12, 2015
Dear Peter Kelley:
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
1
Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Industry and Consumer Education 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. 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 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,
Mitchell Stein
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):
Device Name: SmartLinx Vitals Plus Patient Monitoring System
Indications for Use:
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring 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 healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians
| Prescription Use | X |
|---|---|
| AND/OR | |
| Over-The-Counter Use | |
| (Part 21 CFR 801 Subpart D) | (21 CFR 801 Subpart C) |
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
3
| Submitter | Capsule Technologie SAS
9 villa Pierre Ginier
75018 Paris, FR |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Peter Kelley Director QA/RA
300 Brickstone Square, Suite 203
Andover, MA 01810
Phone: 978-482-2309
Email: peterk@capsuletech.com |
| Date Prepared | MAY 21, 2015 |
| Device Name | SmartLinx Vitals Plus Patient Monitoring System |
| Common Name | Physiological or Vital Signs Monitor, Patient Monitor |
| Classification Name | Cardiac monitor (including cardiotachometer and rate alarm) |
| Regulatory Class | II |
| Product Code | MWI |
| Predicate Device | GE Carescape V100 Vital Signs Monitor K102426
This predicate has not been subject to a design-related recall |
| Reference Devices | Zoll R Series Monitor Defibrillators K120907
Masimo uSpO2 Pulse Oximetry Cable K121914
Exergen TAT-5000S K011291 |
Device Description
The SmartLinx Vitals Plus Patient Monitoring System consists of the SmartLinx Vitals Plus mobile medical application and externally integrated vital signs modules operating on the SmartLinx Neuron 2 mobile platform. The application controls the modules at the point of care through interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the monitoring purposes. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, mean arterial pressure (MAP)), pulse rate, functional arterial oxygen saturation (SpO2), and temperature.
The SmartLinx Vitals Plus Patient Monitoring System is composed of multiple products:
- The SmartLinx Vitals Plus mobile medical application
- The SmartLinx Vitals Plus NIBP Module with SunTech Medical cuffs and hoses
The Masimo SET uSpO2 Pulse Oximetry Cable
The Exergen TAT-5000S infrared thermometer
The SmartLinx Neuron 2 Mobile Platform
The SmartLinx Vitals Plus Roll Stand
SmartLinx Vitals Plus mobile medical application
The SmartLinx Vitals Plus mobile medical application is a new mobile medical application which operates on the SmartLinx Neuron 2 mobile platform. It provides command/control of user features of vital signs modules, actuators and medical devices. SmartLinx Vitals Plus mobile medical application
4
collects vital signs and medical device data at the point of care through sensor, actuator and medical device interfaces on the SmartLinx Neuron 2 mobile platform and presents this to the user for active monitoring purposes. The supported physiological parameters are: NIBP (systolic, mean arterial pressure (MAP)), Pulse Rate, SpO2 and Temperature. The SmartLinx Vitals Plus mobile medical application is used by healthcare providers.
SmartLinx Vitals Plus NIBP Module
The SmartLinx Vitals Plus NIBP Module is a new hardware component, which incorporates the SunTech Medical Advantage A+ NIBP module and associated blood pressure cuffs and hoses, which measure systolic, diastolic and mean arterial (MAP) blood pressures, and pulse rates for adult, pediatric and neonatal patients. This same module is used in the previously cleared Zoll R Series Monitor Defibrillator (K120907), which is cited as a reference device in this 510(k) filing. The module is controlled by the SmartLinx Vitals Plus mobile medical application to manage the inflation of blood pressure cuffs, and to measure blood pressures and pulse rates. The SmartLinx Vitals Plus NIBP module is used by healthcare providers.
Masimo uSp02 Pulse Oximetry Cable
The Masimo uSpO2 Pulse Oximetry Cable, and associated sensors are an in-line patient cable that provides continuous noninvasive monitoring of functional oxygen saturation (SpO2) and pulse rate when installed in a compatible OEM host system, and has its own requlatory clearance (K121914). The SmartLinx Vitals Plus application will control the uSpO2 to measure SpO2 in adult, pediatric and neonatal patients. The uSpO2 is used by healthcare providers.
Exergen TAT-5000S
The Exergen TAT-5000S is an infrared thermometer which has its own requlatory clearances (K011291). It is capable of being used independently or through an interface with other products. The SmartLinx Vitals Plus application will control the operation of the TAT-5000S to measure temperatures in adult, pediatric and neonatal patients. The TAT-5000S is used by healthcare providers.
SmartLinx Neuron 2 Mobile Platform
The SmartLinx Neuron 2 is a mobile computer which utilizes industry standard PC architecture and components, with touch-screen capabilities, and serial. USB, network and Bluetooth interfaces for device connectivity, and which runs a Microsoft Windows operating system. It provides connectivity for SmartLinx applications to vital signs modules and medical devices.
SmartLinx Vitals Plus Roll Stand
The SmartLinx Vitals Plus Roll Stand is an accessory provided to allow the users to ergonomically move and manage the SmartLinx Vitals Plus System and its components. It provides a platform for mounting the Neuron 2 and mechanical interfaces to all of the system components.
Indications for Use
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring 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 healthcare facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.
5
Comparison of the Subject and Predicate Devices
| Table 1 Technological Characteristics Comparison | |||
|---|---|---|---|
| -- | -- | -------------------------------------------------- | -- |
| Characteristic | SmartLinx Vitals Plus | GE Carescape V100 | Discussion of
Differences | |
|---------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The SmartLinx Vitals Plus
Patient Monitoring
System is intended for
monitoring 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
healthcare facilities when
used by clinical
physicians or appropriate
medical staff under the
direction of physicians. | The CARESCAPE VI00 Vital
Signs Monitor is intended to
monitor a single adult, pediatric
or neonatal patient's vital signs
at the bedside or during intra-
hospital transport. Vital signs
parameters include non-
invasive blood pressure
(systolic, diastolic, and mean
arterial pressure), pulse rate,
and/or oxygen saturation (pulse
oximetry) and/or temperature.
The portable device is designed
for use in numerous clinical
settings in various hospital
departments such as
emergency, radiology, recovery,
medical/surgical, labor and
delivery, endoscopy, cardiac
step-down. The CARESCAPE
VI00 Vital Signs Monitor can
also be used in satellite areas,
physicians' office, or alternate
care settings. | Same | |
| | Design | NIBP: Suntech
Advantage A+
oscillometric OEM NIBP
technology module. | NIBP: Proprietary oscillometric
design. | The NIBP functions use
the same mechanism
of action, oscillimetry.
Both devices have the
same questions of
safety and
effectiveness regarding
energy transfer to the
patient. |
| | | SP02: Masimo uSpO2
Oximetry Cable using
SET pulse oximetry
technology. | SPO2: Masimo SET pulse
oximetry technology. | Same |
| TEMP: Exergen TAT-
5000S temporal artery
scanner thermometer | | TEMP: Exergen TAT-5000
temporal artery scanner
thermometer | Same | |
| Applied Part
Materials | NIBP: SunTech Durable,
Disposable, and Vinyl
blood pressure cuffs and
hoses | NIBP: GE CRITIKON Blood
Pressure Cuffs and hoses | The applied parts in
both devices have the
same questions of
safety and
effectiveness regarding | |
6
| Characteristic | SmartLinx Vitals Plus | GE Carescape V100 | Discussion of
Differences |
|------------------|------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | | | biocompatibility of
patient applied parts. |
| | SPO2: Masimo LNCS
and LNOP family of SpO2
sensors | SPO2: Masimo LNCS and
LNOP family of SpO2 sensors | Same |
| | TEMP: Exergen TAT-
5000S temporal artery
scanner thermometer | TEMP: Exergen TAT-5000
temporal artery scanner
thermometer | Same |
| Energy
Source | 12.6V, 2600 mAh,
Lithium-Ion Battery Pack.
9V alkaline battery
powers the optional
Exergen TAT-5000s | 6V, 3300 mAh, sealed lead acid
battery powers the main unit. A
9V alkaline battery powers the
Exergen TAT-5000 | Questions of safety
related to lithium ion
batteries are the same
as for lead acid and
alkaline batteries, and
thus do not raise
different questions of
safety and
effectiveness. |
Performance Testing
Performance testing ensures that the SmartLinx Vitals Plus Patient Monitoring System performs as well as the indicated predicate device and meets all of its functional requirements and performance specifications. Safety testing assures that the device complies with applicable sections of recognized industry and safety standards. The SmartLinx Vitals Plus Patient Monitoring System performance testing is summarized in Table 2.
| Category | Testing Summary |
|---|---|
| Sterilization | |
| Validation | The SmartLinx Vitals Plus Patient Monitoring System is not designed to be |
| sterilized. | |
| All patient applied parts used with the SmartLinx Vitals Plus Patient | |
| Monitoring System are sourced from the vendors of the vital signs modules. | |
| The sterilization issues related to these patient applied parts were addressed | |
| in the predicate or reference device submissions, and were cleared by FDA. | |
| Shelf Life Testing | |
| All patient applied parts used with the SmartLinx Vitals Plus Patient | |
| Monitoring System are sourced from the vendors of the vital signs modules. | |
| The shelf life issues related to these patient applied parts were addressed in | |
| the predicate or reference device submissions, and were cleared by FDA. | |
| The SmartLinx Neuron battery has a shelf life of three months. This limit | |
| applies to batteries that are not in use. | |
| The Exergen TAT-5000S uses a 9 volt alkaline battery which typically has a | |
| shelf life of seven years. | |
| Biocompatibility | |
| Testing | All patient applied parts used with the SmartLinx Vitals Plus Patient |
| Monitoring System are sourced from the vendors of the vital signs modules. | |
| The biocompatibility issues related to these patient applied parts were | |
| addressed in the predicate or reference device submissions, and were | |
| cleared by FDA. | |
| Software Testing | Software for the SmartLinx Vitals Plus Patient Monitoring System was |
| designed and developed in accordance with Capsule Technologie software | |
| development processes, and was verified and validated. Test results | |
| indicated that the SmartLinx Vitals Plus Patient Monitoring System complies | |
| with its predetermined specification. | |
| Electrical Safety | The SmartLinx Vitals Plus Patient Monitoring System was tested for patient |
| safety in accordance with the following applicable standards: | |
| IEC 60601-1:2005 IEC 60601-1-6:2013 IEC 60601-1-8:2012 IEC 80601-2-30:2013 ISO 80601-2-56:2009 ISO 80601-2-61:2011 ISO 81060-2:2013 IEC 62304:2006 IEC 62366:2014 IEC 62133:2012 Test results indicated that the SmartLinx Vitals Plus Patient Monitoring | |
| System complies with its predetermined specification. | |
| Electromagnetic | |
| Compatibility | |
| Testing | The SmartLinx Vitals Plus Patient Monitoring System was tested for EMC in |
| accordance with IEC 60601-1-2:2007. Test results indicated that the | |
| SmartLinx Vitals Plus Patient Monitoring System complies with its | |
| predetermined specification. | |
| Performance | |
| Testing - Bench | The SmartLinx Vitals Plus Patient Monitoring System was tested in |
| accordance with internal Capsule Technologie requirements and procedures. | |
| Test results indicated that the SmartLinx Vitals Plus Patient Monitoring | |
| System complies with its predetermined specification. This testing includes | |
| performance, functional, reliability, environmental, and packaging testing . | |
| Performance | |
| Testing - Animal | Animal performance testing was not performed and is not necessary to |
| demonstrate safety and effectiveness of the SmartLinx Vitals Plus Patient | |
| Monitoring System. | |
| Performance | |
| Testing - Clinical | The SmartLinx Vitals Plus Patient Monitoring System was tested for clinical |
| performance in accordance with the following applicable standard: | |
| ISO 81060-2:2013 Test results indicated that the SmartLinx Vitals Plus Patient Monitoring | |
| System complies with its predetermined specification. |
Table 2 SmartLinx Vitals Plus Patient Monitoring System Performance Testing
7
8
Conclusions
Capsule Technologie SAS considers the SmartLinx Vitals Plus Patient Monitoring System to be as safe, as effective, and its performance is substantially equivalent to the predicate device.