SmartLinx Vitals Plus Patient Monitoring System

K180734 · Capsule Technologie · MWI · Aug 8, 2018 · Cardiovascular

Device Facts

• Record ID: K180734
• Device Name: SmartLinx Vitals Plus Patient Monitoring System
• Applicant: Capsule Technologie
• Product Code: MWI · Cardiovascular
• Decision Date: Aug 8, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: Software as a Medical Device, Pediatric

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 Story

System monitors physiologic parameters (NIBP, pulse rate, SpO2, temperature) at point-of-care. Inputs: NIBP module (SunTech Advantage A+), SpO2 sensors (Masimo or Nellcor), and thermometers (Exergen TAT-5000S or Covidien FILAC 3000). Device runs on SmartLinx Neuron 2 Mobile Platform (PC architecture, Windows OS). Application manages sensor data, evaluates vital signs against user-defined limits, and triggers visual/audible alarms via Alarm Hub. Optional Early Warning Scoring System (EWSS) calculates aggregate scores from vitals and manual observations to aid clinical assessment. Output displayed on Neuron 2 interface; data may be sent to eMR. Used by clinicians to track patient condition and trend data; supports clinical decision-making through real-time monitoring and automated scoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, software verification and validation, and conformance to FDA-recognized consensus standards (e.g., IEC 60601-1, ISO 80601-2-61, IEC 62304).

Technological Characteristics

Mobile platform (Neuron 2) using PC architecture/Windows OS. Parameters: NIBP (oscillometric), SpO2 (Masimo/Nellcor), Temperature (temporal/probe). Connectivity: Serial digital interface for sensors, USB for Alarm Hub, eMR integration. Power: Li-Ion batteries (Neuron 2), 9V alkaline (Exergen). Standards: IEC 60601-1, IEC 60601-1-2, IEC 60601-2-49, ISO 80601-2-61, IEC 62304, IEC 62366-1.

Indications for Use

Indicated for monitoring and alarming of physiologic parameters (NIBP, pulse rate, SpO2, temperature) in adult, pediatric, and neonatal patients in hospital environments.

Regulatory Classification

Identification

A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.

Predicate Devices

• SmartLinx Vitals Plus Patient Monitoring System (K171751)

Reference Devices

• Zoe Medical's 740 Select (K130411)
• Nellcor (K141518)
• Nellcor (K012891)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

August 8, 2018

Capsule Technologie Maylin Truesdell Senior Manager, Regulatory Affairs 300 Brickstone Square, Suite 203 Andover, Massachusetts 01810

Re: K180734

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: April 25, 2018 Received: April 25, 2018

## Dear Maylin Truesdell:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

M.A. Wilhelm

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K180734

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) | |
|---------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------|
| <div> <span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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# 510(k) Summary

# 1. Administrative Information

| Applicant /<br>Manufacturer's Name | Capsule Technologie, SAS<br>76-78 avenue de France<br>CS21416<br>75644 Paris Cedex 13 |
|------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent | Maylin Truesdell Sr. Regulatory Affairs Manager<br>Capsule Tech, Inc.<br>300 Brickstone Square, Suite 203<br>Andover, MA 01810<br>Phone: [phone]<br>Email: [e-mail] |
| Date Prepared | August 7, 2018 |
| Device Trade 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, monitor, physiological, patient (without arrhythmia detection or alarms) |
| Predicate Device | SmartLinx Vitals Plus Patient Monitoring System, K171751<br>This device was selected as the predicate since this submission seeks marketing clearance for design changes implemented in this device, SmartLinx Vitals Plus Patient Monitoring System, cleared under K171751. The intended use and fundamental operating principle for the proposed SmartLinx Vitals Plus are identical to the cleared predicate SmartLinx Vitals Plus<br>The predicate SmartLinx has not been subject to a design-related recall |

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Reference Devices Zoe Medical's 740 Select. K130411 This device was selected as a reference device since it served as the primary predicate device for K171751. and it supports the functionality of the Nellcor and Masimo SpO2 Modules This reference device has not been subject to a design-related recall. Nellcor K141518 and K012891

## 2. Device Description

The legally marketed, predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K171751. 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 Application .
The SmartLinx Vitals Plus Application is a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform. The SmartLinx 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:

- > Supported physiological parameters: NIBP (systolic, diastolic, mean arterial pressure (MAP), Pulse Rate, SpO2, and Temperature
- Intervals mode for Intervals Mode for NIBP (Automatic repetition of NIBP > measurements)
- > Physiological alarms for NIBP (Sys, Dia, MAP), Pulse Rate, SpO2, and Temperature: 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 via the Exergen TAT-5000S or Covidien FILAC 3000 thermometer
- SmartLinx Vitals Plus NIBP Module .

The SmartLinx Vitals Plus NIBP Module incorporates 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, including Intervals Mode for NIBP (Automatic repetition of NIBP measurements). 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.

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#### 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. 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 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 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 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. The Vitals Plus App running on the Neuron 2 alone evaluates current vital signs values versus upper and lower limits in order to evaluate alarm conditions. When an alarm condition is found to be true, a visual alarm signal is annunciated within the app user interface and on the Neuron LED, and the app sends a command to the directly attached Alarm Hub to make an audible annunciation so long as the condition is true or until the clinical user acknowledges the alarm by touching the screen.

. 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, 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

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SmartLinx Neuron 2 Mobile Platform. 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

The proposed SmartLinx Vitals Plus Patient Monitoring System is identical to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K171751, with the exception of:

- Changes to add the option of Nellcor SpO2 Pulse Oximetry solution, Rev. 1.0 .
- . Changes to upgrade SmartLinx Vitals Plus Patient Monitoring System from version 2.2.1 to version 2.3
- Changes to upgrade SmartLinx Vitals Plus Application from version 9.0.3 to version . 9.2
- Software modifications to the SmartLinx Vital Plus Patient Monitoring System cleared . in K171751, documented to file

The function of the proposed device is the same as the predicate SmartLinx Vitals Plus Patient Monitoring System in that the SmartLinx Vitals Plus Application enables collection of vital signs data. To do so, various sensors are connected to the SmartLinx Neuron 2 Mobile Platform, a mobile computer utilizing industry standard PC architecture and the Microsoft (MS) Windows operating system. The SmartLinx Neuron 2 collects the vital signs data from sensors and serves as the user interface for the medical staff and supports connectivity with the electronic medical record (eMR).

## 3. 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 intended use of the proposed SmartLinx Vitals Plus Patient Monitoring System is identical to the intended use for the predicate SmartLinx Vitals Plus Patient Monitoring System, which serves as the primary predicate device.

## 4. Comparison of Similarities and Differences

As previously stated, the modifications to the SmartLinx Vitals Plus Patient Monitoring System consist of:

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- Changes to add the option of Nellcor SpO2 Pulse Oximetry solution, Rev. 1.0 .
- Changes to upgrade SmartLinx Vitals Plus Patient Monitoring System from version . 2.2.1 to version 2.3
- . Changes to upgrade SmartLinx Vitals Plus Application from version 9.0.3 to version 9.2
- . Software modifications to the SmartLinx Vital Plus Patient Monitoring System cleared in K171751, documented to file

The proposed SmartLinx Vitals Plus Patient Monitoring System features design characteristics and technologies that are substantially equivalent to those of the predicate SmartLinx Vitals Plus Patient Monitoring System, as the predicate device, and 740 Select, the reference device.

The reference device, 740 Select cleared in K130411, is manufactured and marketed by Zoe Medical supports both the Nellcor cleared in K141518 and K012891 and Masimo SpO2 Modules.

According to the 740 Select 510(k) Summary, the reference device is a portable and-rugged noninvasive multi-parameter device used for spot checking, continuous monitoring, and recording-of blood pressure, pulse rate, functional oxygen saturation (%SpO2), and predictive body temperature in-a variety of clinical environments. The Monitor includes features that are optional or configurable.

Table 1 shows the similarities and differences between the proposed and predicate SmartLinx Vitals Plus Patient Monitoring System (primary predicate device) and the 740 Select (reference device).

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### Table 1: Comparison of Similarities and Differences

| | UNM DIFIED Device<br>SmartLinx Vitals Plus Patient Monitoring<br>System | MODIFIED Device<br>SmartLinx Vitals Plus Patient Monitoring<br>System | Reference Device<br>740 Select |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Capsule Tech | Capsule Tech | Zoe Medical |
| Regulation Name | Cardiac monitor (including<br>cardiotachometer and rate alarm) | Same as predicate device | Cardiac monitor (including<br>cardiotachometer and rate alarm) |
| Regulation<br>Number | 21 CFR 870.2300 | Same as predicate device | 21 CFR 870.2300 |
| Product Code | MWI, DXN, DQA, FLL | Same as predicate device | MWI |
| 510(k) # | K171751 | Pending | K130411 |
| Intended Use /<br>Indication for<br>Use | The SmartLinx Vitals Plus Patient<br>Monitoring System is intended for<br>monitoring and alarming of physiologic<br>parameters, including non-invasive<br>blood pressure (systolic, diastolic, and<br>mean arterial pressure), pulse rate,<br>functional arterial oxygen saturation<br>(SpO2), and temperature, on adult,<br>pediatric, and neonatal patients in<br>hospital environments when used by<br>clinical physicians or appropriate<br>medical staff under the direction of<br>physicians. | Identical to predicate device | The 740 Select is indicated for use as a<br>bedside, portable device for use by<br>healthcare professionals, clinicians and<br>medically qualified personnel for spot<br>checking, continuous monitoring and<br>recording of adult, pediatric of adult,<br>pediatric and neonatal patients. The<br>monitor features world class technology<br>to facilitate the monitoring of non-<br>invasive blood pressure, pulse rate,<br>functional arterial oxygen saturation<br>(SpO2) and body temperature in a<br>variety of clinical environments. |
| Technological Characteristics | | | |
| Design | Intervals Mode for NIBP (Automatic<br>repetition of NIBP measurements): | Same as predicate device and similar<br>to reference device | Intervals Mode for NIBP (Automatic<br>repetition of NIBP Measurements): |
| | UNMODIFIED Device<br>SmartLinx Vitals Plus Patient Monitoring<br>System | MODIFIED Device<br>SmartLinx Vitals Plus Patient Monitoring<br>System | Reference Device<br>740 Select |
| Design,<br>continued | SpO2 Measurement: Masimo uSpO2<br>Oximetry Cable with Masimo SET<br>technology. Continuous SpO2<br>Monitoring: Pulse tone pitch varying<br>with oxygen saturation, SpO2 alarm<br>delay, and SpO2 sensor off alarm.<br>Optional: Nellcor® SpO2 algorithms | Different from predicate device with<br>respect to optional Nellcor® SpO2<br>algorithms; same as reference device<br>for optional Nellcor® SpO2 algorithms | Continuous SpO2 Monitoring, Masimo®<br>or Nellcor® SpO2 algorithms (optional) –<br>same as proposed device |
| | Alarms: Configuration, annunciation,<br>and acknowledgement of physiological<br>(Sys, Dia, MAP, Pulse Rate, SpO2, and<br>TEMP) and technical alarms. | Same as predicate device and<br>reference device | Physiological Alarms: same as<br>predicate and proposed device |
| | Temporal Artery TEMP Measurement:<br>Exergen TAT-5000S Thermometer<br>(temporal) | Same as predicate device and<br>reference device | Probe TEMP Measurement: same as<br>predicate and proposed device |
| | Probe TEMP Measurement: FILAC<br>3000 Thermometer (oral / axillary /<br>rectal) | Same as predicate device and same<br>as reference device | Probe TEMP Measurement: same as<br>predicate and proposed device |
| | N/A | Minor software / hardware changes<br>under Design Control program | N/A |
| Applied Part<br>Materials | NIBP: SunTech Durable One-Piece,<br>Disposable, and Vinyl blood pressure<br>cuffs and hoses, and GE CRITIKON<br>SOFT-CUF cuffs | Same as predicate device and similar<br>to reference device | NIBP:<br>• Oscillometric step-deflation<br>• Manual, Auto and STAT modes<br>• Systolic, diastolic, MAP & pulse<br>pressure<br>• Adaptive NIBP measurement<br>• Start BP options for spot-checking or<br>continuous workflow<br>• NIBP Signal Quality Status indicator<br>(SQS) |
| | SpO2: Masimo LNCS family of reusable<br>and disposable SpO2 sensors | Same as predicate device and<br>reference device | SpO2: same as predicate and<br>proposed device |
| | UNMODIFIED Device<br>SmartLinx Vitals Plus Patient Monitoring<br>System | MODIFIED Device<br>SmartLinx Vitals Plus Patient Monitoring<br>System | Reference Device<br>740 Select |
| Applied Parts,<br>continued | SpO2: Nellcor OxiMax family of<br>reusable and disposable SpO2 sensors | Different from predicate device but<br>same as reference device | Masimo® or Nellcor® SpO2 algorithms<br>(optional)—both sensors and signal<br>processing |
| | TEMP: Exergen disposable probe<br>covers and sheaths | Same as predicate device and<br>reference device | TEMP: same as predicate and<br>proposed device |
| | Probe TEMP Measurement: Covidien<br>FILAC probe covers | Same as predicate device and<br>reference device | TEMP: same as predicate and<br>proposed device |
| Energy Source | Main Battery Neuron 2: Lithium-Ion<br>3S1P 2600 mAh or 3050 mAh | Same as predicate device and similar<br>to reference device | Li-Ion battery: 12 hour run time<br>(continuous SpO2, NIBP/ temperature<br>every 15 minutes); similar to the<br>predicate and proposed device |
| | Extended Battery Neuron 2: Lithium-Ion<br>3S2P 5200 mAh or 6100 mAh (1 or 2<br>depending on use of Dual Battery Dock) | Same as predicate device and similar<br>to reference device | N/A |
| | Exergen: 9V alkaline | Same as predicate device and<br>reference device | Exergen: same as predicate and<br>proposed device |
| | Power Supply: 100-240 V AC, 2.0-1.0<br>A, 50-60 Hz, 65 W max, Class I | Same as predicate device and<br>reference device | Power Supply: same as predicate<br>and proposed device |

SmartLinx Vitals Plus NIBP Module using SunTech Advantage A+ oscillometric OEM NIBP module with intervals at 1, 2, 3, 4, 5, 10, 15, 30, 60, 90, 120 and 240 minutes

Proprietary oscillometric design with intervals at 1, 2, 3, 4, 5, 10, 15, 30, 60 and 90 minutes; similar to predicate and proposed

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The discussion of similarities and differences is structured in accordance with FDA's quidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications Guidance for Industry and Food and Drug Administration Staff", July 28, 2014.

Decision 1: Is the predicate device legally marketed?

YES: the unmodified, primary predicate device SmartLinx Vitals Plus Patient Monitoring System is legally marketed and was cleared in K171751.

YES: the reference device, the 740 Select is legally marketed and was cleared in K130411.

Decision 2: Do the devices have the same intended use?

YES: as shown in Table 6 above, the intended use/indication statement for the proposed SmartLinx Vitals Plus Patient Monitoring System is identical to the indication statement for the predicate, primary predicate device SmartLinx Vitals Plus Patient Monitoring System.

Although the intended use / indications for use of the reference device, the 740 Select is worded differently from that of the predicate and proposed SmartLinx Vitals Plus Patient Monitoring System, the intended use is similar in that both devices are used by healthcare professionals for monitoring of neonatal, pediatric and adult patients for non-invasive blood pressure, pulse rate, noninvasive functional oxygen saturation of arteriolar hemoglobin (SpO2) and body temperature.

Decision 3: Do the devices have the same technological characteristics?

NO: the proposed SmartLinx Vitals Plus Patient Monitoring System does not have the same technological characteristics as the predicate SmartLinx Vitals Plus Patient Monitoring System as follows:

- . Changes to add the option of Nellcor SpO2 Pulse Oximetry solution, Rev. 1.0
- . Changes to upgrade SmartLinx Vitals Plus Patient Monitoring System from version 2.2.1 to version 2.3
- Changes to upgrade SmartLinx Vitals Plus Application from version 9.0.3 to . version 9.2
- Software modifications to the SmartLinx Vital Plus Patient Monitoring System . cleared in K171751, documented to file

The proposed SmartLinx Vitals Plus Patient Monitoring System can be configured with either the previously cleared Masimo SpO2 solution or with the Nellcor SpO2 solution, subject of this Special 510(k), whereas the unmodified SmartLinx Vitals Plus Patient Monitoring System can only be configured with the Masimo SpO2 solution.

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The technological characteristics of the proposed SmartLinx Vitals Plus Patient Monitoring System are similar to those of the reference device, 740 Select.

Importantly, the proposed SmartLinx Vitals Plus Patient Monitoring System is the same as the reference device, the 740 Select, in that both devices support the Nellcor SpO2 solution.

Decision 4: Do the different technological characteristics of the device raise different questions of safety and effectiveness?

NO: the design changes as described in this Special 510(k) resulting in the proposed SmartLinx Vitals Plus Patient Monitoring System do not raise different questions of safety and effectiveness compared to the predicate SmartLinx Vitals Plus Patient Monitoring System. The predicate device supports the Masimo SpO2 solution which raised the question of safety regarding energy transfer to the patient. The energy transfer properties of the Nellcor SpO2 solution would be expected to raise the same question of safety concerning energy transfer to the patient. The reference device as mentioned under Decision 3 above also supports the Nellcor SpO2 solution and thus, the same question of safety regarding energy transfer properties is raised.

Decision 5a: Are the proposed scientific methods for evaluating new/different characteristics' effects on safety and effectiveness acceptable?

YES: the safety and effectiveness of the proposed SmartLinx Vitals Plus Patient Monitoring System have been confirmed through performance testing, i.e., bench testing, testing to FDA recognized consensus standards, and software verification and validation testing.

Decision 5b: 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 drawn from a robust Design Control, Risk Management, Software Development programs, and testing to FDA recognized consensus standards.

Decision 6: Do the data demonstrate substantial equivalence?

YES: The results from performance testing of safety and effectiveness demonstrate that the proposed SmartLinx Vitals Plus Patient Monitoring System is substantially equivalent to the predicate SmartLinx Vitals Plus Patient Monitoring System, and the reference device, the 740 Select, with respect to the Nellcor SpO2 solution,

### 5. Performance Testing

Performance testing assures that essential device characteristics have been appropriately implemented to provide safe and effective function and performance for the device's intended use. The performance testing consists of hardware and software verification and validation, as well as testing to FDA recognized consensus standards.

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The SmartLinx Vitals Plus Patient Monitoring System conforms with FDA recognized consensus standards listed in the table below.

| Category | Standard | Title |
|-----------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Electromagnetic<br>Compatibility,<br>Electrical Safety<br>and Safety<br>Standards | ANSI AAMI ES 60601-<br>1:2005/ (R):2012<br>& A1:2012<br>& C1:2009/ (R):2012<br>& A2:2010/ (R):2012 | Medical electrical equipment - Part 1: General<br>requirements for basic safety and essential<br>performance (IEC 60601-1:2005, MOD) |
| | IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: General<br>requirements for basic safety and essential<br>performance - Collateral standard:<br>Electromagnetic compatibility - Requirements and<br>tests |
| | IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particular<br>requirements for the basic safety and essential<br>performance of multifunction patient monitoring<br>equipment |
| | ISO 80601-2-61:2011 | Medical electrical equipment - Part 2-61:<br>Particular requirements for basic safety and<br>essential performance of pulse oximeter<br>equipment |
| Usability | IEC 60601-1-6:2013 | Medical electrical equipment - Part 1-6: General<br>requirements for basic safety and essential<br>performance - Collateral standard: Usability |
| | IEC 62366-1:2015 | Medical devices - Part 1: Application of usability<br>engineering to medical devices |
| Software | IEC 62304:2006 | Medical device software-Software life cycle<br>processes 13-32 Declaration of Conformity |
| Batteries | IEC 62133:2012 | Secondary Cells And Batteries Containing Alkaline<br>Or Other Non-Acid Electrolytes - Safety<br>Requirements For Portable Sealed Secondary<br>Cells, And For Batteries Made From Them, For<br>Use In Portable Applications [Including:<br>Corrigendum 1 (2013)] |
| Alarms | IEC 60601-1-8:2012 | Medical electrical equipment - Part 1-8: General<br>requirements for basic safety and essential<br>performance - Collateral Standard: General<br>requirements, tests and guidance for alarm<br>systems in medical electrical equipment and<br>medical electrical systems |

Table 2: FDA Recognized Consensus Standards

{14}------------------------------------------------

# 6. Clinical Studies

This Traditional 510(k) for the proposed SmartLinx Vitals Plus Patient Monitoring System did not require clinical studies to support substantial equivalence.

## 7. Conclusions

Substantial equivalence of the proposed SmartLinx Vitals Plus Patient Monitoring System is demonstrated through performance testing and conformance with FDA recognized consensus standards. The proposed SmartLinx Vitals Plus Patient Monitoring System results in an equivalent design, features and functionality as compared to the predicate SmartLinx Vitals Plus Patient Monitoring System (primary predicate device) and 740 Select (reference device) with few exceptions that do not raise new questions of safety or effectiveness.

Capsule Tech, therefore, views the proposed SmartLinx Vitals Plus Patient Monitoring System to be eligible for a decision of substantial equivalence when compared to the predicate SmartLinx Vitals Plus Patient Monitoring System (primary predicate device) and 740 Select with Nellcor SpO2 solution (reference device)