SmartLinx Vitals Plus Patient Monitoring System

K200856 · Capsule Technologie Sas · MWI · Jul 10, 2020 · Cardiovascular

Device Facts

• Record ID: K200856
• Device Name: SmartLinx Vitals Plus Patient Monitoring System
• Applicant: Capsule Technologie Sas
• Product Code: MWI · Cardiovascular
• Decision Date: Jul 10, 2020
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.2300
• Device Class: Class 2
• Attributes: 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), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

Device Story

System integrates multiple vital signs modules into a mobile platform for point-of-care monitoring. Inputs: NIBP (oscillometric), SpO2 (pulse oximetry), CO2 (infrared spectroscopy), and temperature (temporal artery scanner). The SmartLinx Neuron mobile computer (Windows-based) runs the Vitals Plus Application, which controls modules, processes signals, and displays data. Includes an optional Early Warning Scoring System (EWSS) for manual entry/calculation of patient scores. Used by clinicians in healthcare facilities. Output: real-time physiological data, alarms, and aggregate scores. Benefits: centralized monitoring, automated data collection, and clinical decision support via trending and scoring.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, hardware/software verification and validation, and conformance to FDA-recognized consensus standards (e.g., IEC 60601-1, ISO 80601-2-55, ISO 80601-2-61).

Technological Characteristics

Mobile platform (Neuron) using PC architecture, Windows OS, touch-screen, serial/USB/network/RFID interfaces. Modules: SunTech Advantage A+ (NIBP), Masimo/Nellcor (SpO2), Masimo NomoLine (CO2, infrared spectroscopy), Exergen TAT-5000S (temperature). Connectivity: Ethernet/Wi-Fi. Power: Lithium-Ion batteries, AC supply. Standards: IEC 60601-1, IEC 62304, ISO 10993-1, ISO 14971.

Indications for Use

Indicated for monitoring and alarming of physiologic parameters (NIBP, pulse rate, SpO2, CO2, respiration, temperature) in adult, pediatric, and neonatal patients in healthcare facilities.

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 (K183638)
• Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 (K171121)

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). The logo consists of two parts: a symbol on the left and the FDA name and title on the right. The symbol on the left is a stylized representation of a human figure, while the text on the right reads "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue letters.

June 10, 2020

Capsule Technologie SAS Peter Kelley Director, Quality & Regulatory 300 Brickstone Square, Suite 203 Andover, Massachusetts 01810

Re: K200856

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, CCK Dated: June 5, 2020 Received: June 8, 2020

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. 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

LT Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

Enclosure

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### Indications for Use

510(k) Number (if known) K200856

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), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

Type of Use (Select one or both, as applicable)

| <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
|-----------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------|
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K200856
Page 1 of 13

# 510(k) Summary

Per 21 CFR 807.92

| Submitter's Name<br>and Address | Capsule Technologies, SAS<br>76-78 avenue de France CS21416<br>75644 Paris Cedex 13 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and<br>Information | Peter Kelley<br>Director Quality & Regulatory<br>Capsule Tech, Inc<br>300 Brickstone Square, Suite 203<br>Andover, MA 01810<br>Phone: [phone]<br>e-mail: [e-mail] |
| Date Prepare | March 30, 2020 |
| Device Trade<br>Name | SmartLinx Vitals Plus Patient Monitoring System |
| Common<br>Name | Physiological or Vital Signs Monitor, Patient Monitor |
| Class and<br>Classification<br>Name | Class II, 21 CFR Part 870.2300 – Cardiac monitor<br>(including cardiotachometer and rate alarm) |
| Product Code | MWI, DXN, DQA, FLL, CCK |
| Predicate Devices | Primary: SmartLinx Vitals Plus Patient Monitoring<br>System, K183638. Cleared April 19, 2019.<br>Secondary: Masimo NomoLine Infrared Sidestream Gas<br>Analyzer ISA C02, K171121, (originally K103064).<br>Cleared April 6, 2011. |

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# Device Description

The primary predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K183638. The secondary predicate device, the Masimo NomoLine ISA CO2 Gas Analyzer was cleared with the Root Monitoring System and Accessories (K171121).

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), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

The SmartLinx Vitals Plus Patient Monitoring System operates with the SmartLinx Medical Device Information Platform (MDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.

The proposed SmartLinx Vitals Plus Patient Monitoring System consists of the following components:

- . SmartLinx Neuron Mobile Platform
- SmartLinx Vitals Plus Application .
- SmartLinx Vitals Plus NIBP Monitoring Module
- Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 ●
- Nellcor SpO2 Oximetry Module .
- Masimo uSpO2 Pulse Oximetry Cable
- Exergen TAT-5000S Temperature Scanner .
- . SmartLinx Early Warning Scoring System

### SmartLinx Neuron Mobile Platform

The SmartLinx Neuron is a mobile computer which utilizes industry standard PC architecture and components, with touch-screen capabilities, and serial. USB. network and RFID interfaces and which runs a Microsoft Windows operating system. It is used by healthcare providers through the applications running on it, and it is accessed by IT administrators during management and maintenance. The SmartLinx Neuron provides connectivity to medical devices through five isolated serial ports and two isolated USB ports. It also communicates with other IT systems through Ethernet or Wi-Fi network connection. The SmartLinx Neuron is IEC 60601-1 compliant for use in Medical Electrical Systems. The SmartLinx Neuron is utilized as part of an active monitoring system when running the SmartLinx Vitals Plus Application.

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### SmartLinx Vitals Plus Application

The SmartLinx Vitals Plus Application is a mobile medical application operating on the SmartLinx Neuron Mobile Platform. The Vitals Plus Application controls the externally integrated vital signs modules through interfaces on the SmartLinx Neuron and the SmartLinx Vital Plus NIBP Monitoring Module and presents patient information to the user for active monitoring purposes at the point of care. The supported physiological parameters are: non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), temperature, end-tidal and fractional concentration of inspired CO2 and respiration rate.

#### SmartLinx Vitals Plus NIBP Monitoring Module

The SmartLinx Vitals Plus NIBP Monitoring Module integrates the SmartLinx Vitals Plus NIBP Module and the SmartLinx Vitals Plus Alarm Hub into a single 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. 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.

The SmartLinx Vital Plus 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 secondary speaker), watchdog functionality, and a USB hub for expansion.

#### Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02

The Masimo NomoLine ISA™ CO2 Gas Analyzer is part of the ISA product family and is a sidestream analyzer intended to be connected to a host instrument for monitoring of CO2 and respiratory rate. NomoLine ISA CO2™ is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery and respiratory care.

NomoLine sampling cannulas are intended to be used as accessories to the NomoLine ISA™ gas analyzers. They are connected to the nostrils or to the nostrils and mouth of spontaneously breathing patients for sampling of CO2.

The SmartLinx Vitals Plus Application controls the operation of the ISA CO2 to measure COS and respiration rate in adult, pediatric, and neonatal patients.

### Nellcor SpO2 Oximetry Module

The Nellcor SpO2 Oximetry Module connects with Nellcor SpO2 Pulse Oximetry sensors and provides functional oxygen saturation (SpO2) and pulse rate and other information via a serial digital interface. The SmartLinx Vitals Plus

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Application controls the operation of the Nellcor SpO2 Oximetry Module to measure Sp02 and pulse rate in adult, pediatric, and neonatal patients.

#### Masimo uSpO2 Pulse Oximetry Cable

The Masimo uSpO2 Pulse Oximetry Cable is a 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 Temperature Scanner

The Exergen TAT-5000S thermometer is a component of Vitals Plus. 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.

### 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 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 physiological 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.

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## 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), end-tidal and fractional concentration of inspired CO2. respirations, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.

### Comparison of Similarities and Differences

This discussion of substantial equivalence follows the guidelines published in: The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications Guidance for Industry and Food and Drug Administration Staff July 28, 2014. This submission uses two predicate devices, the current SmartLinx Patient Monitoring System (K183638) as the primary predicate, and the Masimo NomoLine ISA CO2 Gas Analyzer as the secondary predicate device. The Masimo NomoLine ISA CO2 Gas Analyzer was cleared with the Root Monitoring System and Accessories (K171121). The proposed device consists of the integration of the secondary predicate device with the first predicate device.

The proposed SmartLinx Vital Plus Patient Monitoring System is substantially equivalent to the combined predicate devices, in terms of classification (Table 1), intended use (Table 2) and technical characteristics (Table 3), as described below.

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| Attrubute | Predicate SmartLinx<br>Vitals Plus | Predicate NomoLine ISA<br>CO2 | Proposed SmartLinx<br>Vitals Plus | Proposed<br>SmartLinx Vitals<br>Plus | The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of<br>physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean<br>arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional<br>concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal<br>patients in health care facilities when used by clinical physicians or appropriate medical staff<br>under the direction of physicians. |
|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Capsule Technologies | Masimo Corporation | Capsule Technologies | Predicate<br>SmartLinx Vitals<br>Plus | The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of<br>physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean<br>arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on<br>adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians<br>or appropriate medical staff under the direction of physicians. |
| Regulation<br>Number | 870.2300 | 868.1400 | 870.2300<br>Same as primary predicate | Predicate<br>NomoLine ISA<br>CO2 | The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2,<br>ISA AX+ and ISA OR+) and accessories including Nomoline, intended to be connected to other<br>medical backboard devices for monitoring of breath rate and the following breathing gases:<br>ISA CO2: CO2<br>ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane<br>ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane<br>ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for<br>monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The<br>intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also<br>intended to be used in road ambulances. The intended patient population is adult, pediatric,<br>infant, and neonatal patients. |
| Regulation Name | Cardiac monitor (including<br>cardiotachometer and rate<br>alarm) | Carbon dioxide gas<br>analyzer | Cardiac monitor (including<br>cardiotachometer and rate<br>alarm) | Discussion | The proposed SmartLinx Vital Plus Patient Monitoring System intended use incorporates all the<br>predicate Vitals Plus intended use plus the monitoring of inspired and expired CO2 intended use<br>of the ISA CO2 predicate device. The differences between the proposed and predicate intended<br>use are not critical for the intended use of the proposed device, and do not affect the safety and<br>effectiveness of the device when used as labeled. |
| Product Codes | MWI, DQA, DXN, FLL | CCK | MWI, DQA, DXN, FLL,<br>CCK<br>Same as combined<br>predicates | | |
| 510(k) Number | K183638 | K171121 | K200856 | | |
| Class | II | II | II | | |
| Attribute | Primary Predicate:<br>SmartLinx Vitals Plus | Secondary Predicate:<br>NomoLine ISA CO2 | Proposed Device:<br>SmartLinx Vitals Plus | Discussion | |
| Design | Intervals Mode for NIBP<br>(Automatic repetition of<br>NIBP measurements):<br>SmartLinx Vitals Plus<br>NIBP Module using<br>SunTech Advantage A+<br>oscillometric OEM NIBP<br>module with intervals at<br>1, 2, 3, 4, 5, 10,15, 30,<br>60, 90, 120 and 240<br>minutes | | Intervals Mode for NIBP<br>(Automatic repetition of<br>NIBP measurements):<br>SmartLinx Vitals Plus<br>NIBP Module using<br>SunTech Advantage A+<br>oscillometric OEM NIBP<br>module with intervals at<br>1, 2, 3, 4, 5, 10,15, 30,<br>60, 90, 120 and 240<br>minutes | Same as<br>primary<br>predicate | |
| | SpO2 Measurement:<br>Masimo or Nellcor<br>Continuous SpO2<br>Monitoring: Pulse tone<br>pitch xxx, sensor off<br>alarmSpO2 alarm delay:<br>Selectable time (secs) for<br>Masimo, SatSeconds for<br>Nellcor | | SpO2 Measurement:<br>Masimo or Nellcor<br>Continuous SpO2<br>Monitoring: Pulse tone<br>pitch xxx, sensor off<br>alarmSpO2 alarm delay:<br>Selectable time (secs) for<br>Masimo, SatSeconds for<br>Nellcor | Same as<br>primary<br>predicate | |
| | Alarms: Configuration,<br>annunciation, and<br>acknowledgement of<br>physiological (Sys, Dia,<br>MAP, Pulse Rate, SpO2,<br>and TEMP) and technical<br>alarms | | Alarms: Configuration,<br>annunciation, and<br>acknowledgement of<br>physiological (Sys, Dia,<br>MAP, Pulse Rate, SpO2,<br>and TEMP) and technical<br>alarms | Same as<br>primary<br>predicate | |
| Attribute | Primary Predicate:<br>SmartLinx Vitals Plus | Secondary Predicate:<br>NomoLine ISA CO2 | Proposed Device:<br>SmartLinx Vitals Plus | Discussion | |
| | TEMP: Exergen TAT-<br>5000S temporal artery<br>scanner thermometer | | TEMP: Exergen TAT-<br>5000S temporal artery<br>scanner thermometer | Same as<br>primary<br>predicate | |
| | | CO2: Infrared<br>spectroscopy | CO2: Infrared<br>spectroscopy | Same as<br>secondary<br>predicate | |
| Applied Parts | NIBP: SunTech Durable<br>One-Piece, Disposable,<br>and Vinyl blood pressure<br>cuffs and hoses, and GE<br>CRITIKON SOFT-CUF<br>cuffs | | NIBP: SunTech Durable<br>One-Piece, Disposable,<br>and Vinyl blood pressure<br>cuffs and hoses, and GE<br>CRITIKON SOFT-CUF<br>cuffs | Same as<br>primary<br>predicate | |
| | SpO2: Masimo LNCS<br>family of reusable and<br>disposable SpO2 sensors | | SpO2: Masimo LNCS<br>family of reusable and<br>disposable SpO2 sensors | Same as<br>primary<br>predicate | |
| | Masimo® or Nellcor®<br>SpO2 algorithms<br>(optional)-both sensors<br>and signal processing | | Masimo® or Nellcor®<br>SpO2 algorithms<br>(optional)-both sensors<br>and signal processing | Same as<br>primary<br>predicate | |
| | TEMP: Exergen<br>disposable probe covers<br>and sheaths | | TEMP: Exergen<br>disposable probe covers<br>and sheaths | Same as<br>primary<br>predicate | |
| | | CO2 Canulla:<br>Soft PVC | CO2 Canulla:<br>Soft PVC | Same as<br>secondary<br>predicate | |
| Attribute | Primary Predicate:<br>SmartLinx Vitals Plus | Secondary Predicate:<br>NomoLine ISA CO2 | Proposed Device:<br>SmartLinx Vitals Plus | Discussion | |
| | SmartLinx Vitals Plus | Co2: Airway Adapter:<br>Hard plastic; methyl<br>methacrylate-<br>acrylonitrite-butadiene-<br>styrene (MABS) | Co2: Airway Adapter:<br>Hard plastic; methyl<br>methacrylate-<br>acrylonitrite-butadiene-<br>styrene (MABS) | Same as<br>secondary<br>predicate | |
| | | Energy Source | Main Battery Neuron 2:<br>Lithium-Ion 3S1P 2600<br>mAh or 3050 mAh | | Main Battery Neuron 2:<br>Lithium-Ion 3S1P 2600<br>mAh or 3050 mAh |
| Extended Battery Neuron<br>2: Lithium-Ion 3S2P 5200<br>mAh or 6100 mAh (1 or 2<br>depending on use of Dual<br>Battery Dock) | | | Extended Battery Neuron<br>2: Lithium-Ion 3S2P 5200<br>mAh or 6100 mAh (1 or 2<br>depending on use of Dual<br>Battery Dock) | Same as<br>primary<br>predicate | |
| Exergen: 9V alkaline | | | Exergen: 9V alkaline | Same as<br>primary<br>predicate | |
| Power Supply: 100-240 V<br>AC, 2.0-1.0 A, 50-60 Hz,<br>65 W max, Class I | | | Power Supply: 100-240 V<br>AC, 2.0-1.0 A, 50-60 Hz,<br>65 W max, Class I | Same as<br>primary<br>predicate | |
| | NomoLine: 5V, 160mA<br>typical, 800mA peak. | | NomoLine: 5V, 160mA<br>typical, 800mA peak. | Same as<br>secondary<br>predicate | |

### Table 1 Comparison of Classification of Proposed Device to Predicate Devices

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### Table 2 Comparison of Intended Use of Proposed Device to Predicate Devices

#### Intended Use / Indications for Use

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#### K200856 Page 8 of 13

### Table 3 Comparison of Technical Characteristics of Proposed Device to Predicate Devices

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### Discussion

The proposed SmartLinx Vital Plus Patient Monitoring System intended use incorporates all the predicate Vitals Plus intended use plus the monitoring of inspired and expired CO2 intended use of the ISA CO2 predicate device. The differences between the proposed and predicate intended use are not critical for the intended use of the proposed device, and do not affect the safety and effectiveness of the device when used as labeled.

# 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.

The SmartLinx Vitals Plus Patient Monitoring System conforms with FDA recognized consensus standards listed in Table 4 below.

| FDA<br>Recognition<br># | Standard<br>Number | Standard Edition /<br>Date | Title |
|-------------------------|---------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-10 | UL 1642 | 5th Edition | Lithium Batteries |
| 19-11 | UL 2054 | 2nd Edition | Household and Commercial<br>Batteries |
| 19-13 | IEC 62133 | Edition 2.0 2012-12 | Secondary cells and batteries<br>containing alkaline or other non-<br>acid electrolytes - Safety<br>requirements for portable sealed<br>secondary cells, and for batteries<br>made from them, for use in<br>portable applications [Including:<br>Corrigendum 1 (2013)] |
| 19-23 | IEC 60086-4<br>Edition 4.0<br>2014-09 | Edition 4.0 2014-09 | Primary batteries - Part 4: Safety<br>of lithium |
| 19-4 | ANSI AAMI<br>ES60601-1 | 2005/(R)2012 and<br>A1:2012 | C1:2009/(R)2012 and<br>A2:2010/(R)2012 (Consolidated<br>Text) Medical electrical equipment<br>- Part 1: General requirements for<br>basic safety and essential<br>performance (IEC 60601-1:2005,<br>MOD) |
| FDA<br>Recognition<br># | Standard<br>Number | Standard Edition /<br>Date | Title |
| 19-8 | IEC 60601-1-2 | Edition 4.0 2014-02 | Medical electrical equipment - Part<br>1-2: General requirements for<br>basic safety and essential<br>performance - Collateral Standard:<br>Electromagnetic disturbances -<br>Requirements and tests |
| 5-89 | IEC 60601-1-6 | Edition 3.1 2013-10 | Medical electrical equipment - Part<br>1-6: General requirements for<br>basic safety and essential<br>performance - Collateral standard:<br>Usability |
| 5-76 | IEC 60601-1-8 | Edition 2.1 2012-11 | Medical electrical equipment - Part<br>1-8: General requirements for<br>basic safety and essential<br>performance - Collateral Standard:<br>General requirements, tests and<br>guidance for alarm systems in<br>medical electrical equipment and<br>medical electrical systems |
| 5-114 | IEC 62366-1 | Edition 1.0 2015-02 | Medical devices - Part 1:<br>Application of usability engineering<br>to medical devices |
| 13-79 | IEC 62304 | Edition 1.1 2015-06<br>CONSOLIDATED<br>VERSION | Medical device software -<br>Software life cycle processes |
| 3-123 | IEC 80601-2-<br>30 | Edition 2.0 2018-03 | Medical electrical equipment Part<br>2-30: Particular requirements for<br>basic safety and essential<br>performance of automated type<br>non-invasive<br>sphygmomanometers |
| 6-403 | ISO 80601-2-<br>56 | Second edition 2017-<br>03 | Medical electrical equipment - Part<br>2-56: Particular requirements for<br>basic safety and essential<br>performance of clinical<br>thermometers for body<br>temperature measurement. |
| 1-139 | ISO 80601-2-<br>61 | Second edition 2017-<br>12 (Corrected version<br>2018-02) | Medical electrical equipment - Part<br>2-61: Particular requirements for<br>basic safety and essential<br>performance of pulse oximeter<br>equipment |
| FDA<br>Recognition<br># | Standard<br>Number | Standard Edition /<br>Date | Title |
| 1-140 | ISO 80601-2-<br>55 | Second edition 2018-<br>02 | Medical electrical equipment - Part 2-55: Particular requirements for<br>the basic safety and essential<br>performance of respiratory gas<br>monitors |
| 2-220 | ISO 10993-1 | Fourth edition 2009-<br>10-15 | Biological evaluation of medical<br>devices - Part 1: Evaluation and<br>testing within a risk management<br>process [Including: Technical<br>Corrigendum 1 (2010)] |
| 5-40 | ISO 14971 | Second edition<br>2007/(R)2010 | Medical devices - Application of<br>risk management to medical<br>devices |

### Table 4 FDA Recognized Consensus Performance Standards

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

{15}------------------------------------------------

### Clinical Studies

The subject of this premarket submission, SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence.

### 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 equivalent design, features and functionality as compared with the two predicate devices with few exceptions that do not raise any new questions of safety or effectiveness. Capsule Technologies therefore views the proposed SmartLinx Vitals Plus Patient Monitoring System to be eligible for a decision of substantial equivalence when compared to the primary predicate device, the SmartLinx Vitals Plus Patient Monitoring System and the secondary predicate device, the Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02.