K Number
K171751
Device Name
SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus License for Spot Monitoring Mode, SmartLinx Vitals Plus Alarm Hub, SmartLinx Vitals Plus License for Advanced Monitoring Mode, Covidien FILAC 3000 - Temperature Module
Date Cleared
2017-10-24

(133 days)

Product Code
Regulation Number
870.2300
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP Authorized
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.
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, 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.
More Information

No
The summary does not mention AI, ML, or any related technologies. The device description focuses on standard vital sign monitoring components and a scoring system, which is not inherently AI/ML.

No
The device is described as a "Patient Monitoring System" intended for "monitoring and alarming of physiologic parameters." There is no indication that it treats or cures any condition.

Yes

The device is intended for "monitoring and alarming of physiologic parameters," which involves assessing a patient's health status based on collected data, aligning with the definition of a diagnostic device that identifies or characterizes a disease or condition.

No

The device description explicitly lists multiple hardware components (NIBP Module, Pulse Oximetry Cable, Thermometers, Alarm Hub, Mobile Platform) in addition to the software application.

Based on the provided information, the SmartLinx Vitals Plus Patient Monitoring System is not an IVD (In Vitro Diagnostic).

Here's why:

  • Intended Use: The intended use clearly states that the system is for "monitoring and alarming of 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 components listed are devices that measure physiological signals (NIBP module, pulse oximetry cable, thermometers). There is no mention of components designed for analyzing samples.
  • Lack of IVD Characteristics: The description does not mention any processes related to analyzing samples (e.g., chemical reactions, microscopic analysis, genetic testing), which are characteristic of IVD devices.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The SmartLinx Vitals Plus system directly monitors the patient's vital signs in real-time.

N/A

Intended Use / Indications for Use

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.

Product codes

MWI, DXN, DQA, FLL

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, 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.

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 hospital environments.

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)

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.

Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)

Not Found

Predicate Device(s)

K130411, K151071

Reference Device(s)

K120907, K150620

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/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)

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| Applicant /
Manufacturer's Name | Capsule Technologie, SAS
76-78 avenue de France
CS21416
75644 Paris Cedex 13 |
|------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | James Hodge Director QA/RA
Capsule Tech, Inc.
300 Brickstone Square, Suite 203
Andover, MA 01810
Phone: 978-482-2362
Email: 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 (including
cardiotachometer and rate alarm) |
| Regulatory Class | II |
| Product Code | MWI, monitor, physiological, patient (without
arrhythmia detection or alarms) |
| Primary Predicate | CASMED 740 Select K130411 |
| Device | This device was selected as the primary predicate since
its monitoring functionality closely matches the
modifications to the SmartLinx Vitals Plus device of this
submission. Likewise, the Covidien FILAC 3000
thermometer integrated with this device is the same
component added to SmartLinx Vitals Plus. This
predicate has not been subject to a design-related recall. |
| Other Predicate
Device | SmartLinx Vitals Plus Patient Monitoring System
K151071 |

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:

    1. Intervals Mode for NIBP (Automatic repetition of NIBP measurements)
    1. 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
    1. Continuous SpO2 monitoring with pulse tone pitches that vary according to oxygen saturation, SpO2 alarm delay, and SpO2 sensor off alarm
    1. 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 Vitals
Plus | SmartLinx Vitals
Plus | Discussion of
Differences |
|----------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K171751 | K151071 | |
| 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. | 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. | Same. |
| NIBP
Measurement | SmartLinx Vitals
Plus NIBP module
using the SunTech
Advantage A+
module of
oscillometric design
for Spot Check and
Intervals Mode
measurement. | SmartLinx Vitals
Plus NIBP module
using SunTech
Advantage A+
module of
oscillometric design
for Spot Check
Mode. | Same except for
addition of NIBP
Intervals Mode to
Vitals Plus, which is
compared to the
CASMED primary
predicate device
(K130411). |
| SpO2
Monitoring | Masimo uSpO2
Oximetry Cable
using Masimo SET
technology
integrated externally
to the Neuron via a
USB connection for
Spot Check
measurements and
Continuous
Monitoring. | Masimo uSpO2
Oximetry Cable
using Masimo SET
technology
integrated
externally to the
Neuron via a USB
connection for Spot
Check
measurements. | Same except for
addition of
Continuous
Monitoring with
associated features,
which is compared to
the CASMED primary
predicate device
(K130411). |
| Temperature
Measurement | Two different
thermometry
options:

  1. Covidien FILAC
    3000 probe.
  2. Exergen TAT-
    5000S infrared
    scanner. | Exergen TAT-
    5000S infrared
    scanner. | Same except for
    addition of Covidien
    FILAC 3000 probe
    thermometer, which
    compared to the
    CASMED primary
    predicate device
    (K130411). |
    | Alarms | Configuration,
    annunciation, and
    acknowledgement
    of physiological and
    technical alarms for
    (Sys, Dia, MAP,
    Pulse Rate, SpO2,
    and Temp).
    Alarms are visibly
    annunciated and
    acknowledged on
    the screen.
    Alarms are audibly
    annunciated via two
    possible speaker
    configurations:
  3. One speaker for
    non-Advanced
    Monitoring
    configurations,
    using the single
    speaker inside
    the Neuron 2. | Configuration,
    annunciation, and
    acknowledgement
    of technical alarms
    for (Sys, Dia, MAP,
    Pulse Rate, SpO2,
    and Temp).
    Alarms are visibly
    annunciated and
    acknowledged on
    the screen.
    Alarms are audibly
    annunciated via a
    single speaker
    inside the Neuron
  1.                                                                                                                                                                                                              | Vitals Plus supports
    

the same single
speaker configuration
of K151071 for non-
Advanced Monitoring
Mode. It also adds
the Alarm Hub with
its primary speaker
and watchdog
processor for
Advanced Monitoring
Mode. The two
speaker configuration
for Advanced
Monitoring Mode is
compared to the
CASMED primary
predicate device
(K130411). |
| | 2) Two speakers for
Advanced
Monitoring
configurations,
using the
speaker inside
the Alarm Hub as
the primary, and
the speaker
inside the
Neuron 2 as a
backup. | | |
| Applied Parts | SunTech Durable
One-Piece,
Disposable, and
Vinyl blood
pressure NIBP
cuffs, and GE
CRITIKON SOFT-
CUF cuffs in
neonate through
adult thigh sizes.
Masimo LNCS
family of reusable
and disposable
SpO2 sensors.
Covidien FILAC
3000 Probe Covers.
Exergen disposable
probe covers and
sheaths. | SunTech Durable
One-Piece,
Disposable, and
Vinyl blood
pressure NIBP
cuffs in neonate
through adult thigh
sizes.
Masimo LNCS
family of reusable
and disposable
SpO2 sensors.
Exergen disposable
probe covers and
sheaths. | NIBP cuffs are the
same except for the
addition of two new
sizes in the SunTech
Disposable cuffs and
the addition of the
GE CRITIKON
SOFT-CUFs.
FILAC probe covers
are new to Vitals
Plus and are
compared to the
CASMED primary
predicate device
(K130411). |
| Energy
Source | Main Battery
Neuron 2: Lithium-
lon 3S1P 2600 mAh
or 3050 mAh.
Extended Battery
Neuron 2: Lithium-
lon 3S2P 5200 mAh
or 6100 mAh (1 or 2
depending on use
of Dual Battery | Main Battery
Neuron 2: Lithium-
lon 3S1P 2600
mAh.
Extended Battery
Neuron 2: Lithium-
lon 3S2P 5200
mAh (1 or 2
depending on use
of Dual Battery | Vitals Plus supports
new larger battery
capacities and uses
a Class I power
supply as the
expressed
preference of most
hospitals for this
category of device. |

Table 1 Comparison With SmartLinx Vitals Plus (K151071)

Page 5 of 14

8

9

10

| Exergen: 9V
alkaline. | Exergen: 9V
alkaline. |
|-------------------------------------------------------------|------------------------------------------------------------------|
| 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 Vitals
Plus | CASMED 740
Select | Discussion of
Differences |
|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k)
Number | K171751 | K130411 | |
| 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. | The 740 Select is
indicated for use as
a bedside, portable
device for use by
healthcare
professionals,
clinicians and
medically qualified
personnel for spot
checking,
continuous
monitoring and
recording of adult,
pediatric of adult,
pediatric and
neonatal patients.
The monitor
features world class
technology to
facilitate the
monitoring of non-
invasive blood
pressure, pulse
rate, functional
arterial oxygen
saturation (SpO2)
and body
temperature in a
variety of clinical
environments. | None in terms of
practical meaning. |
| NIBP
Measurement | SmartLinx Vitals
Plus NIBP module
using the SunTech
Advantage A+
module of
oscillometric design
for Spot Check and
Intervals Mode
measurements. | MAXNIBP module
of oscillometric
design for Spot
Check and Intervals
Mode
measurements. | Different module
suppliers. |
| SpO2
Monitoring | Masimo uSpO2
Oximetry Cable
using Masimo SET
technology
integrated externally
to the Neuron via a
USB connection for
Spot Check
measurements and
Continuous
Monitoring with the
following features:

  1. Pulse tone pitch
    varying with
    oxygen
    saturation
  2. SpO2 alarm
    delay
  3. SpO2 sensor off
    alarm | Masimo Rainbow
    SET OEM board
    integrated inside
    the monitor for
    Continuous
    Monitoring with the
    following features:
    Pulse tone pitch

varying with
oxygen
saturation
2)
SpO2 alarm
delay
SpO2 sensor off
3)
alarm | Both devices use the
same core Masimo
SET technology for
measuring SpO2.
pulse rate, and
perfusion index.
Vitals Plus also offers
the clinical user the
convenience of a
Spot Check mode. |
| Temperature
Measurement | Two different
thermometry
options:

  1. Covidien FILAC
    3000 probe.
  2. Exergen TAT-
    5000S infrared
    scanner. | Covidien FILAC
    3000 probe. | Only Vitals Plus
    offers the Exergen
    TAT-5000S, but this
    is the same
    component used in
    the Vitals Plus
    predicate device
    (K151071). |
    | Alarms | Configuration,
    annunciation, and
    acknowledgement
    of physiological and
    technical alarms for
    (Sys, Dia, MAP, | Configuration,
    annunciation, and
    acknowledgement
    of physiological and
    technical alarms for
    (Sys, Dia, MAP, | Same except for
    speaker
    configurations. Non-
    Advanced Monitoring
    configurations of
    Vitals Plus may be |
    | Pulse Rate, SpO2,
    and Temp). | Pulse Rate, SpO2,
    and Temp). | safely used with only
    the single speaker.
    Advanced Monitoring
    configurations of
    Vitals Plus require
    the Alarm Hub. | |
    | Alarms are visibly
    annunciated and
    acknowledged on
    the screen. | Alarms are visibly
    annunciated and
    acknowledged on
    the screen. | | |
    | Alarms are audibly
    annunciated via two
    possible speaker
    configurations:
  3. One speaker for
    non-Advanced
    Monitoring
    configurations,
    using the single
    speaker inside
    the Neuron 2 for
    technical alarms. | Alarms are audibly
    annunciated via two
    speakers inside the
    monitor. Alarms
    first annunciate on
    a primary speaker,
    and then with a
    different tone on a
    backup speaker. | | |
    | 2) Two speakers for
    Advanced
    Monitoring
    configurations,
    using the
    speaker inside
    the Alarm Hub as
    the primary, and
    the speaker
    inside the
    Neuron 2 as a
    backup. | | | |
    | Applied Parts | | | |
    | SunTech Durable
    One-Piece,
    Disposable, and
    Vinyl NIBP cuffs,
    and GE CRITIKON
    SOFT-CUF cuffs in
    neonate through
    adult thigh sizes.
    Masimo LNCS
    family of reusable
    and disposable
    SpO2 sensors. | Softcheck
    Disposable and
    Ultracheck
    Reusable NIBP
    cuffs in infant
    through adult thigh
    sizes.
    Masimo M-LNCS
    family of reusable
    and disposable
    SpO2 sensors | Each device uses its
    own set of NIBP cuffs
    that conform to IEC
    80601-2-30 when
    used with the device.
    Masimo sensors are
    the same except for
    the connector used.
    Exergen covers and
    sheaths are unique
    to Vitals Plus, but are
    the same
    components used in | |
    | | Covidien FILAC
    3000 Probe Covers | | |
    | | Covidien FILAC
    3000 Probe Covers.
    Exergen disposable
    probe covers and
    sheaths. | | the Vitals Plus
    predicate device
    (K151071). |
    | Energy
    Source | Main Battery
    Neuron 2: Lithium-
    Ion 3S1P 2600 mAh
    or 3050 mAh. | Main Battery:
    Lithium-Ion 10.8
    VDC 7800 mAh. | Each device uses a
    battery appropriate to
    its design and
    desired autonomy. |
    | | Extended Battery
    Neuron 2: Lithium-
    Ion 3S2P 5200 mAh
    or 6100 mAh (1 or 2
    depending on use
    of Dual Battery
    Dock).
    Exergen: 9V
    alkaline.
    Power Supply: 100-
    240 VAC, 2.0-1.0 A,
    50-60 Hz, Class I. | Power Supply:
    100-240 VAC, 1.2
    A Max (1.2A to 0.50
    A), 50-60 Hz, Class
    II. | The Exergen 9V
    battery is unique to
    Vitals Plus, but is the
    same component
    used in the Vitals
    Plus predicate device
    (K151071).
    Vitals Plus uses a
    Class I power supply
    as the expressed
    preference of most
    hospitals for this
    category of device. |

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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

    1. 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.
    1. 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.

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    1. 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.

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.

| Performance
Characteristic | FDA Recognized
standard | 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 safety
and essential performance (IEC
60601-1:2005, MOD |
| EMC | IEC 60601-1-2:2007 | Medical electrical equipment – Part
1-2: General requirements for basic
safety and essential performance -
Collateral standard: Electromagnetic
compatibility - Requirements and
tests |
| Usability | IEC 60601-1-6:2013 | Medical electrical equipment - Part
1-6: General requirements for basic
safety and essential performance -
Collateral standard: Usability |
| Alarms | IEC 60601-1-8:2012 | General requirements for basic safety
and essential performance –
Collateral Standard: General
requirements, tests and guidance for
alarm systems in medical electrical
equipment and medical electrical
systems |
| Software | IEC 62304:2006 | Medical device software—Software
life cycle processes |
| Usability | IEC 62366:2014 | Medical devices – Application of
usability engineering to medical
devices |
| NIBP | IEC 80601-2-30:2013 | Medical electrical equipment –
Part 2-30: Particular requirements for
the basic safety and essential
performance of automated non-
invasive sphygmomanometers |
| | ISO 81060-2:2013 | Non-invasive sphygmomanometers
Part 2: Clinical investigation of
automated measurement type |
| Temp | ISO 80601-2-56:2009 | Medical electrical equipment
Part 2-56: Particular requirements for
basic safety and essential
performance of clinical thermometers
for body temperature measurement |
| | SpO2 | ISO 80601-2-61:2011 |
| Battery | | IEC 62133:2012 |
| Patient
Monitoring | IEC 60601-2-49:2011 | Medical electrical equipment |

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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.

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