Who is the manufacturer of Capsule Vitals Plus Patient Monitoring System?

Capsule Technologie Sas filed the 510(k) submission for Capsule Vitals Plus Patient Monitoring System (K210204).

What is the FDA product code for Capsule Vitals Plus Patient Monitoring System?

MWI. It is classified under 21 CFR 870.2300 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Capsule Vitals Plus Patient Monitoring System?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like Capsule Vitals Plus Patient Monitoring System?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Capsule Vitals Plus Patient Monitoring System

K210204 · Capsule Technologie Sas · MWI · Oct 19, 2021 · Cardiovascular

Device Facts

Record ID	K210204
Device Name	Capsule Vitals Plus Patient Monitoring System
Applicant	Capsule Technologie Sas
Product Code	MWI · Cardiovascular
Decision Date	Oct 19, 2021
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.2300
Device Class	Class 2
Attributes	Pediatric

Intended Use

The Capsule 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 monitors physiologic parameters (NIBP, pulse rate, SpO2, CO2, respiration, temperature) at point-of-care. Inputs: NIBP modules, gas analyzers, oximetry modules, temperature scanners. Neuron mobile platform (PC-based) processes data via Vitals Plus Application; displays patient info; provides alarm annunciation. Used by clinicians in healthcare facilities. Includes optional Early Warning Scoring System (EWSS) for manual data aggregation/trending. Benefits: centralized monitoring, automated data collection, clinical decision support via trending/scoring.

Clinical Evidence

No clinical data required; substantial equivalence supported by bench testing, hardware/software verification and validation, and conformance to FDA-recognized consensus standards.

Technological Characteristics

Mobile platform (Neuron 2/3) running Windows 7/10; PC architecture. Modules: SunTech NIBP, Masimo/Nellcor SpO2, Masimo NomoLine CO2, Exergen temperature. Connectivity: Serial, USB, Ethernet, Wi-Fi. Alarms: IEC 60601-1-8 compliant. Materials: MABS (airway adapter), PVC (cannula). Power: Li-ion batteries. Software: Vitals Plus Application for data integration/display.

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 (K200856)

Related Devices

K200856 — SmartLinx Vitals Plus Patient Monitoring System · Capsule Technologie Sas · Jul 10, 2020
K171751 — 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 · Capsule Technologie Sas · Oct 24, 2017
K180734 — SmartLinx Vitals Plus Patient Monitoring System · Capsule Technologie · Aug 8, 2018
K183638 — SmartLinx Vitals Plus Patient Monitoring System · Capsule Technologie · Apr 17, 2019
K171621 — Welch Allyn Connex Vital Signs Monitor, Welch Allyn Connex Integrated Wall System, 901060 Vital Signs Monitor · Welch Allyn, Inc. · Jun 30, 2017

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image contains 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. October 19, 2021 Capsule Technologie SAS Peter Kelley Director Quality, Regulatory & Cybersecurity 76 - 78 Avenue de France Paris, 75013 France Re: K210204 Trade/Device Name: Capsule 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, DQA, DXN, FLL, CCK Dated: September 14, 2021 Received: September 15, 2021 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 {1}------------------------------------------------ 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) 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 (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 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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, LCDR 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 {2}------------------------------------------------ #### Indications for Use 510(k) Number (if known) K210204 Device Name Capsule Vital Plus Patient Monitoring System #### Indications for Use (Describe) The Capsule 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) | | |--------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------| | <div> ☑ Prescription Use (Part 21 CFR 801 Subpart D) </div> | <div> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </div> | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K210204 Image /page/3/Picture/1 description: The image shows the word "capsule" in blue font. The "e" at the end of the word is replaced with a red circle with a white "e" inside. The trademark symbol is located in the upper right corner of the red circle. ## 510(k) Summary Per 21 CFR 807.92 | Submitter's Name and Address | Capsule Technologies, SAS 76-78 avenue de France Paris, France 75013 | |-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------| | Contact Name and Information | Peter Kelley Director Quality, Regulatory & Cybersecurity Capsule Tech, Inc 300 Brickstone Square, Suite 203 Andover, MA 01810 | | | Phone: 978-697-4364 e-mail: pkelley@capsuletech.com | | Date Prepare | January 22, 2021 | | Device Trade Name | Capsule Vitals Plus Patient Monitoring System | | Common Name | Physiological or Vital Signs Monitor, Patient Monitor | | Class and Classification Name | Class II, 21 CFR Part 870.2300 - Cardiac monitor (including cardiotachometer and rate alarm) | | Product Code | MWI, DXN, DQA, FLL, CCK | | Predicate Devices | SmartLinx Vitals Plus Patient Monitoring System, K200856. Cleared July 10, 2020. | {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows the word "capsule" in blue font, with the letter "e" replaced by a red circle with a white "e" inside. The "TM" symbol is located in the upper right corner of the red circle. The word "capsule" is written in a sans-serif font. #### Device Description The predicate device, the SmartLinx Vitals Plus Patient Monitoring System, was cleared in K200856. The Capsule Vitals Plus Patient Monitoring System which is the subject of this submission 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. It operates with the Capsule Medical Device Information Platform (CMDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care. The proposed Capsule Vitals Plus Patient Monitoring System consists of the following components: - -Capsule Neuron Mobile Platforms - Capsule Vitals Plus Application | - Capsule Vitals Plus NIBP Monitoring Modules - - Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 — - Capsule Capnography Interface Module - - Nellcor SpO2 Oximetry Module - - Masimo uSpO2 Pulse Oximetry Cable - -Exergen TAT-5000S Temperature Scanner - -Capsule Early Warning Scoring System #### SmartLinx Neuron Mobile Platform – Neuron 2 The SmartLinx Neuron (Neuron 2) 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 Neuron 2 provides connectivity to medical devices through isolated serial and USB ports. It also communicates with other IT systems through Ethernet or Wi-Fi network connections. The Neuron 2 is IEC 60601-1 compliant for use in Medical Electrical Systems. The Neuron 2 is utilized as part of an active monitoring system when running the SmartLinx Vitals Plus Application. The Neuron 2 is unchanged from the predicate device. {5}------------------------------------------------ #### Capsule Neuron Mobile Platform – Neuron 3 A new version of the Neuron Mobile Platform (Neuron 3) is being added to the Vitals Plus Patient Monitoring System, in addition to the Neuron 2 of previous 510(k) submissions. Neuron 3 was developed and released under a separate program which was primarily driven by a CPU update. The Neuron 3 is now being added to the Vitals Plus Patient Monitoring System. The design changes introduced with the Neuron 3 are: - A new touch screen that uses capacitive versus resistive technology. - A new display screen that uses a glossy display versus a matte display. । - Incorporating the primary audio alarm mechanism and the watchdog । functionality which was formerly implemented in the NIBP Monitoring Module. The new implementation of the primary audio alarm mechanism and the watchdoq functionality re-uses the same electrical design as before, except with a new speaker. - । Update the operating system to Windows 10. #### Capsule Vitals Plus Application The Capsule Vitals Plus Application is a mobile medical application operating on the Capsule Neuron. The Vitals Plus Application controls the externally integrated vital signs modules through interfaces on the Neuron and the Vital Plus NIBP Monitoring Modules 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, end-tidal and fractional concentration of inspired CO2, respiration, and temperature. This is unchanged from the predicate device. The Vitals Plus Application has been modified to include a plethysmography wave display which is derived either from either the Nellcor SpO2 Oximetry Module or the Masimo uSpO2 Pulse Oximetry Cable. #### SmartLinx Vitals Plus NIBP Monitoring Module for Neuron 2 The SmartLinx Vitals Plus NIBP Monitoring Module for Neuron 2 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 NIBP Monitoring Module for Neuron 2 provides a primary speaker for alarm annunciations with failover to a secondary speaker, watchdog functionality, and a USB hub for expansion. The NIBP Monitoring Module for Neuron 2 is unchanged from the predicate device. {6}------------------------------------------------ ## Capsule Vitals Plus NIBP Monitorina Module for Neuron 3 A new NIBP Monitoring module has been created that attaches to the Neuron 3 and moves the primary audio alarm mechanism and the watchdog functionality to the Neuron 3. The Neuron 3 NIBP Monitoring Module incorporates the backup alarm speaker which was formerly in the Neuron 2. The rest of the electrical design remains unchanged. The NIBP Monitoring Module for Neuron 3 incorporates the same SunTech Medical Advantage A+ OEM NIBP module and associated blood pressure cuffs and hoses as the NIBP Monitoring Module for the Neuron 2. It measures svstolic, diastolic and mean arterial blood pressures (MAP), and pulse rates for adult, pediatric and neonatal patients. The module is controlled by the Capsule Vitals Plus Application to manage the inflation and deflation of blood pressure cuffs, and to measure blood pressures and pulse rates. The Neuron 3 NIBP Monitoring Module uses the same SunTech NIBP cuffs as the unchanged Neuron 2 NIBP Monitoring Module. The NIBP Monitoring Module for Neuron 3 provides a secondary speaker for alarm annunciations and a USB hub for expansion. #### Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 The Masimo NomoLine ISA™ CO2 Gas Analyzer 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 lines 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 and of spontaneously breathing patients and are connected in-line with the airway adapters for sampling of CO2. These are single use accessories provided by the manufacturer and distributed by Capsule. Thev have met required shelf life criteria according to the K171121 Summary, and do not affect the shelf life of the subject device. The Capsule Vitals Plus Application controls the operation of the ISA CO2 to measure CO2 and respiration rate in adult, pediatric, and neonatal patients which is unchanged from the predicate device. The Masimo NomoLine ISA CO2 analyzer is also unchanged from the predicate device. #### Capsule Capnography Interface Module The Capnography Interface Module (CIM) is an RS-232 serial to USB converter designed to Capsule's specification by a third party. It connects to the ISA CO2 module via a DB-9 connector and to the Neuron via a USB connector. It communicates with the Vitals Plus Application through a Device Driver Interface (DDI) developed by Capsule. The CIM is unchanged from the predicate device. {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows the logo for Capsule Technologies. The logo consists of the word "capsule" in blue, with a red circle containing a white "e" to the right of the word. Below the logo, the text "Nellcor SpO2 Oximetry Module" is written in black. 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 Capsule Vitals Plus Application controls the operation of the Nellcor SpO2 Oximetry Module to measure SpO2 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 Capsule 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 Sensor The Exergen TAT-5000S temperature sensor is designed for noninvasive temperature assessment by scanning the temporal artery. The thermometer operates independently but communicates its results to the Vitals Plus Application for display and monitoring. #### Capsule Early Warning Scoring System The Capsule Early Warning Scoring System (EWSS) is an optional software component that integrates with the Capsule Vitals Plus Application and runs on the Capsule Neuron. Capsule 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 Capsule EWSS to calculate a patient's score is determined by the customer. #### Intended Use The Capsule 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 {8}------------------------------------------------ # capsu 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 one predicate device, the current SmartLinx Vitals Plus Patient Monitoring System (K200856). The proposed Capsule Vital Plus Patient Monitoring System is substantially equivalent to the predicate device, in terms of classification (Table 1), intended use (Table 2) and technical characteristics (Table 3), as described below. {9}------------------------------------------------ Image /page/9/Picture/1 description: The image shows the word "capsule" in blue font. To the right of the word is a red circle with a white "e" inside. The "e" is stylized with a horizontal line through the middle. There is a trademark symbol in the upper right corner of the red circle. ### Table 1 Comparison of Classification of Proposed Device to Predicate Devices | Attribute | Predicate SmartLinx Vitals Plus | Proposed Capsule Vitals Plus | Discussion | |-------------------|-------------------------------------------------------------|-------------------------------------------------------------|-------------------| | Manufacturer | Capsule Technologie, SAS | Capsule Technologie, SAS | Same as predicate | | Regulation Number | 870.2300 | 870.2300 | Same as predicate | | Regulation Name | Cardiac monitor (including cardiotachometer and rate alarm) | Cardiac monitor (including cardiotachometer and rate alarm) | Same as predicate | | Product Codes | MWI, DQA, DXN, FLL, CCK | MWI, DQA, DXN, FLL, CCK | Same as predicate | | 510(k) Number | K200856 | Pending | | | Class | II | II | Same as predicate | #### Table 2 Comparison of Intended Use of Proposed Device to Predicate Devices #### Intended Use / Indications for Use | Proposed Capsule Vitals Plus | The Capsule 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. | |---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Predicate SmartLinx Vitals Plus | 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. | | Discussion | The proposed Capsule Vital Plus Patient Monitoring System intended use is the same as the predicate other than changing the brand name. | {10}------------------------------------------------ Image /page/10/Picture/1 description: The image shows the word "capsule" in blue font, with the letter "e" replaced by a red circle with a white "e" inside. The "TM" symbol is located in the upper right corner of the red circle. The word "capsule" is written in a sans-serif font. #### Table 3 Comparison of Technical Characteristics of Proposed Device to Predicate Devices | Attribute | Predicate Device: SmartLinx Vitals Plus | Proposed Device: Capsule Vitals Plus | Discussion | |--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------| | Design | Intervals Mode for NIBP (Automatic repetition of NIBP measurements): 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 | Intervals Mode for NIBP (Automatic repetition of NIBP measurements): 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 | Same as predicate | | | Sp02 Measurement: Masimo or Nellcor Continuous SpO2 Monitoring: Pulse tone pitch, sensor off alarmSpO2 alarm delay: Selectable time (secs) for Masimo, SatSeconds for Nellcor | Sp02 Measurement: Masimo or Nellcor Continuous SpO2 Monitoring: Pulse tone pitch, sensor off alarmSpO2 alarm delay: Selectable time (secs) for Masimo, SatSeconds for Nellcor | Same as predicate | | | Alarms: Configuration, annunciation, and acknowledgement of physiological (Sys, Dia, MAP, Pulse Rate, SpO2, and TEMP) and technical alarms | Alarms: Configuration, annunciation, and acknowledgement of physiological (Sys, Dia, MAP, Pulse Rate, SpO2, and TEMP) and technical alarms | Same as predicate | | | TEMP: Exergen TAT-5000S temporal artery scanner thermometer | TEMP: Exergen TAT-5000S temporal artery scanner thermometer | Same as predicate | | | CO2: Infrared spectroscopy | CO2: Infrared spectroscopy | Same as predicate | | Applied Parts | NIBP: SunTech Durable One-Piece, Disposable, and Vinyl blood pressure cuffs and hoses, and GE CRITIKON SOFT-CUF cuffs | NIBP: SunTech Durable One-Piece, Disposable, and Vinyl blood pressure cuffs and hoses, and GE CRITIKON SOFT-CUF cuffs | Same as predicate | | | SpO2: Masimo LNCS and Nellcor families of reusable and disposable SpO2 sensors | SpO2: Masimo LNCS and Nellcor families of reusable and disposable SpO2 sensors | Same as predicate | | | | | | | Attribute | Predicate Device: SmartLinx Vitals Plus | Proposed Device: Capsule Vitals Plus | Discussion | | | Masimo® or Nellcor® SpO2 algorithms (optional)—both sensors and signal processing | Masimo® or Nellcor® SpO2 algorithms (optional)—both sensors and signal processing | Same as predicate | | | TEMP: Exergen disposable probe covers and sheaths | TEMP: Exergen disposable probe covers and sheaths | Same as predicate | | | CO2 Cannula: Soft PVC | CO2 Cannula: Soft PVC | Same as predicate | | | Co2: Airway Adapter: | Co2: Airway Adapter: | Same as | | | Hard plastic; methyl methacrylate-acrylonitrite- butadiene-styrene (MABS) | Hard plastic; methyl methacrylate-acrylonitrite- butadiene-styrene (MABS) | predicate | | Energy Source | Main Battery Neuron 2: Lithium-Ion 3S1P 2600 mAh or 3050 mAh | Main Battery Neuron 2: Lithium-Ion 3S1P 2600 mAh or 3050 mAh | Same as predicate | | | | Main Battery Neuron 3: Lithium-Ion 3S1P 3350 mAh | Same as predicate, except provides longer operating time | | | Extended Battery Neuron 2: Lithium-Ion 3S2P 5200 mAh or 6100 mAh (1 or 2 depending on use of Dual Battery Dock) | Extended Battery Neuron 2: Lithium-Ion 3S2P 5200 mAh or 6100 mAh (1 or 2 depending on use of Dual Battery Dock) | Same as predicate | | | Exergen: 9V alkaline | Exergen: 9V alkaline | Same as predicate | | | Power Supply: 100-240 V AC, 2.0-1.0 A, 50-60 Hz, 65 W max, Class I | Power Supply: 100-240 V AC, 2.0-1.0 A, 50-60 Hz, 65 W max, Class I | Same as predicate | | | NomoLine: 5V, 160mA typical, 800mA peak | NomoLine: 5V, 160mA typical, 800mA peak | Same as predicate | | Attribute | Predicate Device: SmartLinx Vitals Plus | Proposed Device: Capsule Vitals Plus | Discussion | | Computing Platform | Neuron 2 PC running Windows 7 operating System | Neuron 2 PC running Windows 7 operating System | Same as predicate | | | Neuron 3 PC running Windows 10 operating system | Essentially same as predicate | | | Matte display screen | Neuron 2: Matte display screen | Same as predicate | | | | Neuron 3: Glossy display screen | Operationally equivalent. Verified and validated against the same specifications | | | Resistive technology touch screen | Neuron 2: Resistive technology touch screen | Same as predicate | | | | Neuron 3: Capacitive technology touch screen | Operationally equivalent. Verified and validated against the same specifications | | {11}------------------------------------------------ # capsula {12}------------------------------------------------ #### Discussion The only difference between the proposed Capsule Vital Plus intended use and the predicate SmartLinx Vitals Plus intended use is the brand name. There are no differences in classification. The main battery for Neuron 3 is new but uses the same technologies as the predicate Neuron 2. The new touch screen and display technologies, hardware computing platform and operating system of the Neuron 3 have all been verified and validated according to standard protocol against the same specifications as the Neuron 2 and have been found to be operationally equivalent. These differences between the proposed and predicate devices 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 {13}------------------------------------------------ ## capsule 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 Capsule Vitals Plus Patient Monitoring System conforms with FDA recognized consensus standards listed in Table 4 below. | FDA Recognition # | Standard Number | Standard Edition / Date | Title | |----------------------|----------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 19-4 | ANSI AAMI ES60601-1 | 2005/(R)2012 and A1:2012 | C1:2009/(R)2012 and A2:2010/(R)2012 (Consolidated Text) Medical electrical equipment - Part 1: General requirements for basic safety and essential performance (IEC 60601- 1:2005, MOD) | | 19-8 | IEC 60601- 1-2 | Edition 4.0 2014-02 | Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests | | 5-89 | IEC 60601- 1-6 | Edition 3.1 2013-10 | Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability | | 5-114 | IEC 62366- 1 | Edition 1.0 2015-02 | Medical devices - Part 1: Application of usability engineering to medical devices | | 13-79 | IEC 62304 | Edition 1.1 2015-06 CONSOLIDATED VERSION | Medical device software - Software life cycle processes | | FDA Recognition # | Standard Number | Standard Edition / Date | Title | | 5-76 | IEC 60601- 1-8 | Edition 2.1 2012-11 | Medical electrical equipment - Part 1-8: 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 | | 19-33 | IEC 62133- 2 | Edition 1.0 2017-02 | Secondary cells and batteries containing alkaline or other non-acid electrolytes - Safety requirements for portable sealed secondary cells, and for batteries made from them, for use in portable applications - Part 2: Lithium systems | | 3-123 | IEC 80601- 2-30 | Edition 2.0 2018-03 | Medical electrical equipment Part 2-30: Particular requirements for basic safety and essential performance of automated type non-invasive sphygmomanometers | | 6-421 | ISO 80601- 2-56 | Second edition 2018 | Medical electrical equipment - Part 2-56: Particular requirements for basic safety and essential performance of clinical thermometers for body temperature measurement. | | 1-139 | ISO 80601- 2-61 | Second edition 2017-12 (Corrected version 2018-02) | Medical electrical equipment - Part 2-61: Particular requirements for basic safety and essential performance of pulse oximeter equipment | | 1-140 | ISO 80601- 2-55 | Second edition 2018-02 | Medical electrical equipment - Part 2-55: Particular requirements for the basic safety and essential performance of respiratory gas monitors | | 19-10 | UL 1642 | 5th Edition | Lithium Batteries | | FDA Recognition # | Standard Number | Standard Edition / Date | Title | | 19-11 | UL 2054 | 2nd Edition | Household and Commercial Batteries | | 19-23 | IEC 60086- 4 | Edition 4.0 2014-09 | Primary batteries - Part 4: Safety of lithium batteries | | 2-220 | ISO 10993- 1 | Fourth edition 2009- 10-15 | Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process [Including: Technical Corrigendum 1 (2010)] | | 5-40 | ISO 14971 | Second edition 2007/(R)2010 | Medical devices - Application of risk management to medical devices | | 19-30 | AIM Standard 7351731 | Rev. 2.00 2017-02- 23 | Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers - An AIM Standard | #### Table 4 FDA Recognized Consensus Performance Standards {14}------------------------------------------------ Image /page/14/Picture/1 description: The image shows the word "capsule" in a logo format. The first seven letters are in blue, and the last letter, "e", is white and inside a red circle. There is a trademark symbol to the right of the red circle. {15}------------------------------------------------ Image /page/15/Picture/1 description: The image shows the logo for Capsule. The word "capsule" is written in blue, with the exception of the "e" at the end, which is white and inside of a red circle. There is a small trademark symbol in the upper right corner of the logo. #### Clinical Studies The subject of this premarket submission, Capsule Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence. #### Conclusions Substantial equivalence of the proposed Capsule Vitals Plus Patient Monitoring System is demonstrated through performance testing and conformance with FDA recognized consensus standards. The proposed Capsule Vitals Plus Patient Monitoring System results in equivalent design, features and functionality as compared with the predicate device with few exceptions that do not raise any new questions of safety or effectiveness. Capsule Technologies therefore views the proposed Capsule Vitals Plus Patient Monitoring System to be eligible for a decision of substantial equivalence when compared to the predicate device, the SmartLinx Vitals Plus Patient Monitoring System.