(100 days)
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 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
The provided text does not contain information about acceptance criteria and a study that proves a device meets those criteria. Instead, it describes a "SmartLinx Vitals Plus Patient Monitoring System" which is a medical device data system that integrates various vital signs modules.
The document is a 510(k) premarket notification summary, which focuses on demonstrating substantial equivalence to existing legally marketed predicate devices, rather than proving performance against specific acceptance criteria through a clinical study for a new, novel device.
The "Performance Testing" section mentions adherence to FDA recognized consensus standards (Table 4), which are often general safety and performance standards for similar types of medical devices (e.g., electrical safety, electromagnetic compatibility, usability, software lifecycle, and particular requirements for specific monitoring components like non-invasive blood pressure, pulse oximetry, and respiratory gas monitors). This is a different type of "acceptance criteria" than what might be established for a novel AI/ML-based diagnostic device.
Crucially, the document explicitly states:
- "The subject of this premarket submission, SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence."
Therefore, I cannot extract the specific information requested about acceptance criteria and a study proving the device meets them from this document, as there was no such clinical study performed or required for this 510(k) submission.
To directly answer your numbered points based on the provided text:
- A table of acceptance criteria and the reported device performance: Not available. The document refers to conformance with recognized consensus standards (Table 4) rather than specific performance acceptance criteria for a novel functionality.
- Sample sized used for the test set and the data provenance: Not applicable, as no clinical study was required or performed. Performance testing involved hardware and software verification, validation, and testing against consensus standards, not a "test set" of patient data in the typical sense of an AI/ML study.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable, as no clinical study was required or performed that involved expert-established ground truth on patient data.
- Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
- If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This device is not an AI/ML-based diagnostic or assistive technology that would typically undergo an MRMC study. It is a patient monitoring system integrating existing vital sign modules.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is not an algorithm-only device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable. The device relies on the established accuracy and ground truth of its component modules (e.g., NIBP, SpO2, CO2 sensors) which are themselves regulated and have their own performance specifications.
- The sample size for the training set: Not applicable. This device does not use a "training set" in the context of AI/ML.
- How the ground truth for the training set was established: Not applicable.
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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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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)
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
|---|---|
| ----------------------------------------------------------------------------------------------------------- | ---------------------------------------------------------------------------------------------------------- |
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K200856
Page 1 of 13
510(k) Summary
Per 21 CFR 807.92
| Submitter's Nameand Address | Capsule Technologies, SAS76-78 avenue de France CS2141675644 Paris Cedex 13 |
|---|---|
| Contact Name andInformation | Peter KelleyDirector Quality & RegulatoryCapsule Tech, Inc300 Brickstone Square, Suite 203Andover, MA 01810Phone: 978-482-2365e-mail: pkelley@capsuletech.com |
| Date Prepare | March 30, 2020 |
| Device TradeName | SmartLinx Vitals Plus Patient Monitoring System |
| CommonName | Physiological or Vital Signs Monitor, Patient Monitor |
| Class andClassificationName | Class II, 21 CFR Part 870.2300 – Cardiac monitor(including cardiotachometer and rate alarm) |
| Product Code | MWI, DXN, DQA, FLL, CCK |
| Predicate Devices | Primary: SmartLinx Vitals Plus Patient MonitoringSystem, K183638. Cleared April 19, 2019.Secondary: Masimo NomoLine Infrared Sidestream GasAnalyzer ISA C02, K171121, (originally K103064).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 SmartLinxVitals Plus | Predicate NomoLine ISACO2 | Proposed SmartLinxVitals Plus | ProposedSmartLinx VitalsPlus | The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming ofphysiologic parameters, including non-invasive blood pressure (systolic, diastolic, and meanarterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractionalconcentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatalpatients in health care facilities when used by clinical physicians or appropriate medical staffunder the direction of physicians. |
|---|---|---|---|---|---|
| Manufacturer | Capsule Technologies | Masimo Corporation | Capsule Technologies | PredicateSmartLinx VitalsPlus | The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming ofphysiologic parameters, including non-invasive blood pressure (systolic, diastolic, and meanarterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, onadult, pediatric, and neonatal patients in hospital environments when used by clinical physiciansor appropriate medical staff under the direction of physicians. |
| RegulationNumber | 870.2300 | 868.1400 | 870.2300Same as primary predicate | PredicateNomoLine ISACO2 | The optional ISA product family consists of three types of sidestream gas analyzers (ISA CO2,ISA AX+ and ISA OR+) and accessories including Nomoline, intended to be connected to othermedical backboard devices for monitoring of breath rate and the following breathing gases:ISA CO2: CO2ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and DesfluraneISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and DesfluraneISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit formonitoring of inspired/expired gases during anesthesia, recovery and respiratory care. Theintended environment is the operating suite, intensive care unit and patient room. ISA CO2 is alsointended to be used in road ambulances. The intended patient population is adult, pediatric,infant, and neonatal patients. |
| Regulation Name | Cardiac monitor (includingcardiotachometer and ratealarm) | Carbon dioxide gasanalyzer | Cardiac monitor (includingcardiotachometer and ratealarm) | Discussion | The proposed SmartLinx Vital Plus Patient Monitoring System intended use incorporates all thepredicate Vitals Plus intended use plus the monitoring of inspired and expired CO2 intended useof the ISA CO2 predicate device. The differences between the proposed and predicate intendeduse are not critical for the intended use of the proposed device, and do not affect the safety andeffectiveness of the device when used as labeled. |
| Product Codes | MWI, DQA, DXN, FLL | CCK | MWI, DQA, DXN, FLL,CCKSame as combinedpredicates | ||
| 510(k) Number | K183638 | K171121 | K200856 | ||
| Class | II | II | II | ||
| Attribute | Primary Predicate:SmartLinx Vitals Plus | Secondary Predicate:NomoLine ISA CO2 | Proposed Device:SmartLinx Vitals Plus | Discussion | |
| Design | Intervals Mode for NIBP(Automatic repetition ofNIBP measurements):SmartLinx Vitals PlusNIBP Module usingSunTech Advantage A+oscillometric OEM NIBPmodule with intervals at1, 2, 3, 4, 5, 10,15, 30,60, 90, 120 and 240minutes | Intervals Mode for NIBP(Automatic repetition ofNIBP measurements):SmartLinx Vitals PlusNIBP Module usingSunTech Advantage A+oscillometric OEM NIBPmodule with intervals at1, 2, 3, 4, 5, 10,15, 30,60, 90, 120 and 240minutes | Same asprimarypredicate | ||
| SpO2 Measurement:Masimo or NellcorContinuous SpO2Monitoring: Pulse tonepitch xxx, sensor offalarmSpO2 alarm delay:Selectable time (secs) forMasimo, SatSeconds forNellcor | SpO2 Measurement:Masimo or NellcorContinuous SpO2Monitoring: Pulse tonepitch xxx, sensor offalarmSpO2 alarm delay:Selectable time (secs) forMasimo, SatSeconds forNellcor | Same asprimarypredicate | |||
| Alarms: Configuration,annunciation, andacknowledgement ofphysiological (Sys, Dia,MAP, Pulse Rate, SpO2,and TEMP) and technicalalarms | Alarms: Configuration,annunciation, andacknowledgement ofphysiological (Sys, Dia,MAP, Pulse Rate, SpO2,and TEMP) and technicalalarms | Same asprimarypredicate | |||
| Attribute | Primary Predicate:SmartLinx Vitals Plus | Secondary Predicate:NomoLine ISA CO2 | Proposed Device:SmartLinx Vitals Plus | Discussion | |
| TEMP: Exergen TAT-5000S temporal arteryscanner thermometer | TEMP: Exergen TAT-5000S temporal arteryscanner thermometer | Same asprimarypredicate | |||
| CO2: Infraredspectroscopy | CO2: Infraredspectroscopy | Same assecondarypredicate | |||
| Applied Parts | NIBP: SunTech DurableOne-Piece, Disposable,and Vinyl blood pressurecuffs and hoses, and GECRITIKON SOFT-CUFcuffs | NIBP: SunTech DurableOne-Piece, Disposable,and Vinyl blood pressurecuffs and hoses, and GECRITIKON SOFT-CUFcuffs | Same asprimarypredicate | ||
| SpO2: Masimo LNCSfamily of reusable anddisposable SpO2 sensors | SpO2: Masimo LNCSfamily of reusable anddisposable SpO2 sensors | Same asprimarypredicate | |||
| Masimo® or Nellcor®SpO2 algorithms(optional)-both sensorsand signal processing | Masimo® or Nellcor®SpO2 algorithms(optional)-both sensorsand signal processing | Same asprimarypredicate | |||
| TEMP: Exergendisposable probe coversand sheaths | TEMP: Exergendisposable probe coversand sheaths | Same asprimarypredicate | |||
| CO2 Canulla:Soft PVC | CO2 Canulla:Soft PVC | Same assecondarypredicate | |||
| Attribute | Primary Predicate:SmartLinx Vitals Plus | Secondary Predicate:NomoLine ISA CO2 | Proposed Device:SmartLinx Vitals Plus | Discussion | |
| SmartLinx Vitals Plus | Co2: Airway Adapter:Hard plastic; methylmethacrylate-acrylonitrite-butadiene-styrene (MABS) | Co2: Airway Adapter:Hard plastic; methylmethacrylate-acrylonitrite-butadiene-styrene (MABS) | Same assecondarypredicate | ||
| Energy Source | Main Battery Neuron 2:Lithium-Ion 3S1P 2600mAh or 3050 mAh | Main Battery Neuron 2:Lithium-Ion 3S1P 2600mAh or 3050 mAh | |||
| Extended Battery Neuron2: Lithium-Ion 3S2P 5200mAh or 6100 mAh (1 or 2depending on use of DualBattery Dock) | Extended Battery Neuron2: Lithium-Ion 3S2P 5200mAh or 6100 mAh (1 or 2depending on use of DualBattery Dock) | Same asprimarypredicate | |||
| Exergen: 9V alkaline | Exergen: 9V alkaline | Same asprimarypredicate | |||
| Power Supply: 100-240 VAC, 2.0-1.0 A, 50-60 Hz,65 W max, Class I | Power Supply: 100-240 VAC, 2.0-1.0 A, 50-60 Hz,65 W max, Class I | Same asprimarypredicate | |||
| NomoLine: 5V, 160mAtypical, 800mA peak. | NomoLine: 5V, 160mAtypical, 800mA peak. | Same assecondarypredicate |
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.
| FDARecognition# | StandardNumber | Standard Edition /Date | Title |
|---|---|---|---|
| 19-10 | UL 1642 | 5th Edition | Lithium Batteries |
| 19-11 | UL 2054 | 2nd Edition | Household and CommercialBatteries |
| 19-13 | IEC 62133 | Edition 2.0 2012-12 | Secondary cells and batteriescontaining alkaline or other non-acid electrolytes - Safetyrequirements for portable sealedsecondary cells, and for batteriesmade from them, for use inportable applications [Including:Corrigendum 1 (2013)] |
| 19-23 | IEC 60086-4Edition 4.02014-09 | Edition 4.0 2014-09 | Primary batteries - Part 4: Safetyof lithium |
| 19-4 | ANSI AAMIES60601-1 | 2005/(R)2012 andA1:2012 | C1:2009/(R)2012 andA2:2010/(R)2012 (ConsolidatedText) Medical electrical equipment- Part 1: General requirements forbasic safety and essentialperformance (IEC 60601-1:2005,MOD) |
| FDARecognition# | StandardNumber | Standard Edition /Date | Title |
| 19-8 | IEC 60601-1-2 | Edition 4.0 2014-02 | Medical electrical equipment - Part1-2: General requirements forbasic safety and essentialperformance - Collateral Standard:Electromagnetic disturbances -Requirements and tests |
| 5-89 | IEC 60601-1-6 | Edition 3.1 2013-10 | Medical electrical equipment - Part1-6: General requirements forbasic safety and essentialperformance - Collateral standard:Usability |
| 5-76 | IEC 60601-1-8 | Edition 2.1 2012-11 | Medical electrical equipment - Part1-8: General requirements forbasic safety and essentialperformance - Collateral Standard:General requirements, tests andguidance for alarm systems inmedical electrical equipment andmedical electrical systems |
| 5-114 | IEC 62366-1 | Edition 1.0 2015-02 | Medical devices - Part 1:Application of usability engineeringto medical devices |
| 13-79 | IEC 62304 | Edition 1.1 2015-06CONSOLIDATEDVERSION | Medical device software -Software life cycle processes |
| 3-123 | IEC 80601-2-30 | Edition 2.0 2018-03 | Medical electrical equipment Part2-30: Particular requirements forbasic safety and essentialperformance of automated typenon-invasivesphygmomanometers |
| 6-403 | ISO 80601-2-56 | Second edition 2017-03 | Medical electrical equipment - Part2-56: Particular requirements forbasic safety and essentialperformance of clinicalthermometers for bodytemperature measurement. |
| 1-139 | ISO 80601-2-61 | Second edition 2017-12 (Corrected version2018-02) | Medical electrical equipment - Part2-61: Particular requirements forbasic safety and essentialperformance of pulse oximeterequipment |
| FDARecognition# | StandardNumber | Standard Edition /Date | Title |
| 1-140 | ISO 80601-2-55 | Second edition 2018-02 | Medical electrical equipment - Part 2-55: Particular requirements forthe basic safety and essentialperformance of respiratory gasmonitors |
| 2-220 | ISO 10993-1 | Fourth edition 2009-10-15 | Biological evaluation of medicaldevices - Part 1: Evaluation andtesting within a risk managementprocess [Including: TechnicalCorrigendum 1 (2010)] |
| 5-40 | ISO 14971 | Second edition2007/(R)2010 | Medical devices - Application ofrisk management to medicaldevices |
Table 4 FDA Recognized Consensus Performance Standards
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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.
§ 870.2300 Cardiac monitor (including cardiotachometer and rate alarm).
(a)
Identification. A cardiac monitor (including cardiotachometer and rate alarm) is a device used to measure the heart rate from an analog signal produced by an electrocardiograph, vectorcardiograph, or blood pressure monitor. This device may sound an alarm when the heart rate falls outside preset upper and lower limits.(b)
Classification. Class II (performance standards).