(112 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), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
The predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K180734. The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care. The proposed SmartLinx SmartLinx Vitals Plus Patient Monitoring System is similar to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K180734. The change being proposed is to integrate the SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus Alarm Hub and Nellcor SpO2 Pulse Oximetry Module into one module or backpack configuration; and the alternative Masimo SpO2 pulse oximetry cable will continue to be connected to the same place as with the predicate. There is no change to the performance or functionality of the device. There is no change to the indications for use or intended use.
The provided text describes a 510(k) submission for a patient monitoring system, focusing on a configuration change rather than a new AI algorithm for diagnosis or treatment. Therefore, many of the requested elements for AI-based device studies (like sample sizes for test/training sets, expert ground truth, adjudication methods, or MRMC studies) are not applicable or explicitly mentioned in this document.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
Acceptance Criteria and Reported Device Performance
The core "acceptance criteria" in this submission revolve around demonstrating substantial equivalence to a previously cleared predicate device. This is achieved by showing that the proposed device, despite a configuration change, does not raise new questions of safety and effectiveness and performs equivalently to the predicate.
| Acceptance Criteria | Reported Device Performance (as demonstrated by the study) |
|---|---|
| Same Intended Use/Indications for Use | The intended use for the proposed SmartLinx Vitals Plus Patient Monitoring System is identical to the predicate device. |
| No New Questions of Safety & Effectiveness due to Technological Characteristics (specifically the configuration change) | Performance testing (bench testing, FDA recognized consensus standards, software V&V) confirmed that the configuration change (integrating NIBP Module, Alarm Hub, and Nellcor SpO2 Module into one "Monitoring Module") does not impact the performance or functionality of the device and does not raise different questions of safety and effectiveness. |
| Conformance to Recognized Consensus Standards | The device was tested and found to conform to various FDA recognized consensus standards for: - Electromagnetic Compatibility, Electrical Safety, and Safety Standards (e.g., ANSI AAMI ES 60601-1, IEC 80601-2-30 for NIBP, IEC 60601-1-2 for EMC, IEC 60601-2-49 for multifunction monitoring, ISO 80601-2-61 for pulse oximetry, IEC 60601-1-8 for alarms)- Usability (IEC 60601-1-6, IEC 62366-1)- Software (IEC 62304:2006)- Batteries (IEC 62133:2012) |
| Equivalence in Design, Features, and Functionality to Predicate | The study concluded that the proposed system results in an equivalent design, features, and functionality with "few exceptions that do not raise new questions of safety or effectiveness." |
Study Information (based on provided text):
-
Sample size used for the test set and the data provenance: This information is not provided in the document. The testing described is primarily focused on demonstrating physical and functional equivalence of hardware and software components through bench testing and adherence to standards, rather than evaluating performance against a clinical test set in the way an AI algorithm would be. The document does not specify the number of devices or scenarios used in the "performance testing."
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: This is not applicable to this submission. The device is a patient monitoring system, not an interpretive AI algorithm that requires expert-established ground truth for performance evaluation in a clinical test set.
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Adjudication method (e.g., 2+1, 3+1, none) for the test set: This is not applicable for the reasons mentioned above.
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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: This is not applicable. This submission is for a patient monitoring system with a configuration change, not an AI-assisted diagnostic tool.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: This is not applicable. The device is a monitoring system intended for use by clinical physicians or appropriate medical staff, inherently involving human interaction. The submission does not describe a standalone algorithm performance.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.): For the performance testing conducted, the "ground truth" would be established by the specifications and expected outputs of the individual physiological parameter modules (NIBP, SpO2, Temperature) as defined by their respective recognized standards (e.g., accuracy requirements for NIBP monitors per IEC 80601-2-30). The document refers to "bench testing," "testing to FDA recognized consensus standards," and "software verification and validation testing," inferring that these standards define the expected "truth" or acceptable performance ranges.
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The sample size for the training set: This is not applicable. The device is not an AI/ML model that undergoes a training phase.
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How the ground truth for the training set was established: This is not applicable for the reasons mentioned above.
Summary of the Study:
The "study" in this context is a comprehensive set of performance testing designed to demonstrate that a design configuration change to an existing, cleared patient monitoring system (SmartLinx Vitals Plus Patient Monitoring System, K180734) does not negatively impact its safety, effectiveness, or functionality.
The study involved:
- Bench Testing: To ensure the modified hardware and integrated components perform as expected.
- Software Verification and Validation Testing: To confirm the software (SmartLinx Vitals Plus Application, SmartLinx EWSS) functions correctly with the new configuration.
- Conformance to FDA Recognized Consensus Standards: This involved extensive testing against standards such as those for electrical safety (ANSI AAMI ES 60601-1), NIBP accuracy (IEC 80601-2-30), SpO2 accuracy (ISO 80601-2-61), electromagnetic compatibility (IEC 60601-1-2), usability (IEC 62366-1), alarm systems (IEC 60601-1-8), and software lifecycle processes (IEC 62304).
The document explicitly states: "This Special 510(k) for the proposed SmartLinx Vitals Plus Patient Monitoring System did not require clinical studies to support substantial equivalence." This reinforces that the focus was on technical and functional equivalence through non-clinical testing.
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510(k) Summary of Safety and Effectiveness
per 21 CFR §807.92
1. Administrative Information
| Submitter'sName andAddress | Capsule Technologie, SAS76-78 avenue de France CS2141675644 Paris Cedex 13 |
|---|---|
| Contact NameandInformation | Maylin TruesdellSenior Manager, Regulatory AffairsCapsule Tech, Inc300 Brickstone Square, Suite 203Andover, MA 01810Phone: 978-482-2365e-mail: mtruesde@capsuletech.com |
| Date Prepare | December 20, 2018 |
| 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 |
| PredicateDevices | SmartLinx Vitals Plus Patient Monitoring SystemK180734Cleared August 8, 2018 |
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2. Device Description
The predicate device, SmartLinx Vitals Plus Patient Monitoring System, was cleared in K180734. The SmartLinx Vitals Plus Patient Monitoring System operates on top of the SmartLinx Medical Device Information System (MDIS) to present patient information to the clinical user for active monitoring purposes at the point of care.
SmartLinx Vitals Plus Application o
The SmartLinx Vitals Plus Application is a mobile medical application operating on the SmartLinx Neuron 2 Mobile Platform. The SmartLinx Vitals Plus Application controls the externally integrated vital signs modules and the Alarm Hub through interfaces on the SmartLinx Neuron 2 Mobile Platform, and presents patient information to the user for active monitoring purposes at the point of care:
- Supported physiological parameters: NIBP (systolic, diastolic, mean arterial > pressure (MAP), Pulse Rate, SpO2, and Temperature
-
Intervals mode for Intervals Mode for NIBP (Automatic repetition of NIBP measurements)
- Physiological alarms for NIBP (Sys, Dia, MAP), Pulse Rate, SpO2, and > Temperature; visibly annunciated on the Neuron 2; and audibly annunciated on the SmartLinx Vitals Plus Alarm Hub
-
Continuous Sp02 monitoring with pulse tone pitches that vary according to oxygen saturation, SpO2 alarm delay, and SpO2 sensor off alarm
-
Temperature measurements via the Exergen TAT-5000S or Covidien FILAC 3000 thermometer
- o SmartLinx Vitals Plus NIBP Module
The SmartLinx Vitals Plus NIBP Module incorporates the SunTech Medical Advantage A+ OEM NIBP module and associated blood pressure cuffs and hoses, it measures systolic, diastolic and mean arterial blood pressures (MAP), and pulse rates for adult, pediatric and neonatal patients, including Intervals Mode for NIBP (Automatic repetition of NIBP measurements). The module is controlled by the SmartLinx Vitals Plus Application to manage the inflation and deflation of blood pressure cuffs, and to measure blood pressures and pulse rates.
Masimo uSp02 Pulse Oximetry Cable o
The Masimo uSpO2 Pulse Oximetry Cable is a patient cable with an integrated MS-2000 series circuit board contained in an enclosure that connects to Masimo pulse oximetry sensors and provides functional oxygen saturation (SpO2) and pulse rate and other information via a serial digital interface. The SmartLinx Vitals Plus Application controls the operation of the uSpO2 to measure SpO2 and pulse rate in adult, pediatric, and neonatal patients.
- Nellcor Sp02 Pulse Oximetry Module o
The Nellcor SpO2 Oximetry Module is a module that connects with the Nellcor SpO2 Pulse Oximetry sensors and provides functional oxygen saturation
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(SpO2) and pulse rate and other information via a serial digital interface. The SmartLinx Vitals Plus Application measure SpO2 and pulse rate in adult, pediatric, and neonatal patients.
Exergen TAT-5000S Thermometer o
The Exergen TAT-5000S is designed for accurate, noninvasive temperature assessment by scanning the temporal artery. The thermometer operates independently, but communicates its results to the SmartLinx Vitals Plus Application for display and monitoring.
Covidien FILAC 3000 Thermometer o
The Covidien FILAC 3000 acquires temperature measurements through the application of a probe at Oral, Axillary, and Rectal sites. The typical measurement mode of the thermometer is a Predictive Mode that returns a measurement in 6-10. 8-12, and 10-14 seconds respectively for Oral, Axillary, and Rectal sites. The thermometer also has a Direct Mode (simulating a standard thermometer) and a Cold Mode (a predictive mode for patients at a lower temperature).
o SmartLinx Vitals Plus Alarm Hub
The Alarm Hub is used with the optional Advanced Monitoring license for the Vitals Plus Application. The Alarm Hub offers a primary speaker for alarm annunciations (with failover to a backup speaker), watchdog functionality, and a USB hub for expansion. The Vitals Plus App running on the Neuron 2 alone evaluates current vital signs values versus upper and lower limits in order to evaluate alarm conditions. When an alarm condition is found to be true, a visual alarm signal is annunciated within the app user interface and on the Neuron LED, and the app sends a command to the directly attached Alarm Hub to make an audible annunciation so long as the condition is true or until the clinical user acknowledges the alarm by touching the screen.
SmartLinx Neuron 2 Mobile Platform o
The SmartLinx Neuron 2 Mobile Platform is a mobile computer utilizing industry standard PC architecture and the Microsoft Windows operating system that is used within the SmartLinx Medical Device Information System and IEC 60601-1 Medical Electrical Systems for collection, transmission, conversion, storage and display of medical device data. The Neuron 2 runs different SmartLinx applications depending upon the care area and desired functionality, including SmartLinx Vitals Stream, SmartLinx Chart Xpress, and SmartLinx Vitals Plus. The Neuron 2 is utilized as part of an active monitoring system when running the SmartLinx Vitals Plus Application.
SmartLinx Early Warning Scoring System o
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 nursing observations. The resulting aggregate score is displayed on the Vitals Plus Application, and may be communicated to other
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healthcare information systems. EWSS requires the clinical user to attend the patient in order to function. There is no automatic or continuous scoring. The specific scoring method used within SmartLinx EWSS to calculate a patient's score is determined by the customer.
The current SmartLinx Vitals Plus Patient Monitoring System consists of the following components:
- · SmartLinx Vitals Plus Application
- · SmartLinx Vitals Plus NIBP Module
- · Masimo SET uSpO2 Pulse Oximetry Cable
- · Nellcor SpO2 Pulse Oximetry Module
- · Exergen TAT-5000S Thermometer
- · Covidien FILAC 3000 Thermometer
- · SmartLinx Vitals Plus Alarm Hub
- · SmartLinx Neuron 2 Mobile Platform
- · SmartLinx Early Warning Scoring System
The proposed SmartLinx SmartLinx Vitals Plus Patient Monitoring System is similar to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K180734. The change being proposed is to integrate the SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus Alarm Hub and Nellcor SpO2 Pulse Oximetry Module into one module or backpack configuration; and the alternative Masimo SpO2 pulse oximetry cable will continue to be connected to the same place as with the predicate. There is no change to the performance or functionality of the device. There is no change to the indications for use or intended use.
The proposed SmartLinx Vitals Plus Patient Monitoring System consists of the following components:
- · Monitoring Module (with swappable Nellcor SpO2 module)
- · SmartLinx Vitals Plus Application
- · Masimo SET uSpO2 Pulse Oximetry Cable
- · Exergen TAT-5000S Thermometer
- · Covidien FILAC 3000 Thermometer
- · SmartLinx Neuron 2 Mobile Platform
- · SmartLinx Early Warning Scoring System
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3. Intended Use
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
The intended use of the proposed SmartLinx Vitals Plus Patient Monitoring System is identical to the intended use for the predicate SmartLinx Vitals Plus Patient Monitoring System, which serves as the primary predicate device.
4. Comparison of Similarities and Differences
As previously, the proposed SmartLinx Vitals Plus Patient Monitoring System is similar to the predicate SmartLinx Vitals Plus Patient Monitoring System, cleared in K180734. The change being proposed is to integrate the SmartLinx Vitals Plus NIBP Module, SmartLinx Vitals Plus Alarm Hub and Nellcor SpO2 Pulse Oximetry Module into one module or backpack configuration; and the alternative Masimo SpO2 pulse oximetry cable will continue to be connected to the same place as with the predicate. There is no change to the performance or functionality of the device. There is no change to the indications for use or intended use.
The proposed SmartLinx Vitals Plus Patient Monitoring System consists of the following components:
- · Monitoring Module (with swappable Nellcor SpO2 module)
- · SmartLinx Vitals Plus Application
- · Masimo SET uSpO2 Pulse Oximetry Cable
- · Exergen TAT-5000S Thermometer
- · Covidien FILAC 3000 Thermometer
- · SmartLinx Neuron 2 Mobile Platform
- · SmartLinx Early Warning Scoring System
Table 1 shows the similarities and differences between the proposed and predicate SmartLinx Vitals Plus Patient Monitoring System.
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| Attribute | Proposed SmartLinx Vitals Plus | Predicate SmartLinx Vitals PlusLABELING | Similarities & Differences |
|---|---|---|---|
| Intended Use/Indications for Use | The SmartLinx Vitals Plus Patient MonitoringSystem is intended for monitoring and alarming ofphysiologic parameters, including non-invasiveblood pressure (systolic, diastolic, and mean arterialpressure), pulse rate, functional arterial oxygensaturation (SpO2), and temperature, on adult,pediatric, and neonatal patients in hospitalenvironments when used by clinical physicians orappropriate medical staff under the direction ofphysicians. | The SmartLinx Vitals Plus Patient MonitoringSystem is intended for monitoring and alarming ofphysiologic parameters, including non-invasiveblood pressure (systolic, diastolic, and mean arterialpressure), pulse rate, functional arterial oxygensaturation (SpO2), and temperature, on adult,pediatric, and neonatal patients in hospitalenvironments when used by clinical physicians orappropriate medical staff under the direction ofphysicians. | No change |
| TECHNOLOGICAL CHARACTERISTICS | |||
| Design | Intervals Mode for NIBP (Automatic repetition ofNIBP measurements): SmartLinx Vitals Plus NIBPModule using SunTech Advantage A+ oscillometricOEM 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 ofNIBP measurements): SmartLinx Vitals Plus NIBPModule using SunTech Advantage A+ oscillometricOEM NIBP module with intervals at 1, 2, 3, 4, 5, 10,15, 30, 60, 90, 120 and 240 minutes | No change |
| SpO2 Measurement: Masimo or NellcorContinuous SpO2 Monitoring: Pulse tone pitch xxx,sensor off alarm | SpO2 Measurement: Masimo or NellcorContinuous SpO2 Monitoring: Pulse tone pitch xxx,sensor off alarm | No change | |
| SpO2 alarm delay: Selectable time (secs) forMasimo, SatSeconds for Nellcor | SpO2 alarm delay: Selectable time (secs) forMasimo, SatSeconds for Nellcor | No change | |
| Alarms: Configuration, annunciation, andacknowledgement of physiological (Sys, Dia, MAP,Pulse Rate, SpO2, and TEMP) and technical alarms | Alarms: Configuration, annunciation, andacknowledgement of physiological (Sys, Dia, MAP,Pulse Rate, SpO2, and TEMP) and technical alarms | No change | |
| Probe TEMP Measurement: FILAC 3000Thermometer (oral / axillary / rectal) | Probe TEMP Measurement: FILAC 3000Thermometer (oral / axillary / rectal) | No change | |
| Attribute | Proposed SmartLinx Vitals Plus | Predicate SmartLinx Vitals PlusTECHNOLOGICALCHARACTERISTICS (continued) | Similarities & Differences |
| Applied Part Materials | 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 | No change |
| SpO2: Masimo LNCS family of reusable and disposable SpO2 sensors | SpO2: Masimo LNCS family of reusable and disposable SpO2 sensors | No change | |
| Masimo® or Nellcor® SpO2 algorithms (optional)—both sensors and signal processing | No change | ||
| TEMP: Exergen disposable probe covers and sheaths | No change | ||
| Probe TEMP Measurement: CovidienFILAC probe covers | No change | ||
| Configuration | NIBP Monitoring Module, “backpack” configuration, with embedded NIBP Monitoring and Alarm Hub | NIBP Module, Alarm Hub Module, and Nellcor module (provided separately) | Proposed device has a configuration change where one monitoring module houses both the NIBP module and Alarm Hub, and includes a Nellcor module that can be swappable into the monitoring module. |
| 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 | No change |
| 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) | No change | |
| Exergen: 9V alkaline | Exergen: 9V alkaline | No change | |
| 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 | No change |
able 1: Comparison of Similarities and Difference
K183638
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The discussion of similarities and differences is structured in accordance with FDA's guidance document "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications Guidance for Industry and Food and Drug Administration Staff", July 28, 2014.
Decision 1: Is the predicate device legally marketed?
YES: the predicate device SmartLinx Vitals Plus Patient Monitoring System is legally marketed and was cleared in K180734.
Decision 2: Do the devices have the same intended use?
YES: as shown in Table 1 above, the intended use/indication statement for the proposed SmartLinx Vitals Plus Patient Monitoring System is identical to the indication statement for the predicate, primary predicate device SmartLinx Vitals Plus Patient Monitoring System.
Decision 3: Do the devices have the same technological characteristics?
NO: the proposed SmartLinx Vitals Plus Patient Monitoring System does not have the same technological characteristics as the predicate SmartLinx Vitals Plus Patient Monitoring System as follows:
The proposed device has a confiquration change where one monitoring module now houses both the NIBP module and Alarm Hub and includes a Nellcor module that can be swappable into the monitoring module. Whereas, the predicate offered these modules separately.
Decision 4: Do the different technological characteristics of the device raise different questions of safety and effectiveness?
NO: the design changes as described in this Special 510(k) resulting in the proposed SmartLinx Vitals Plus Patient Monitoring System do not raise different questions of safety and effectiveness compared to the predicate SmartLinx Vitals Plus Patient Monitoring System. The change does not impact the performance and functionality of the device.
Decision 5a: Are the proposed scientific methods for evaluating new/different characteristics' effects on safety and effectiveness acceptable?
YES: the safety and effectiveness of the proposed SmartLinx Vitals Plus Patient Monitoring System have been confirmed through performance testing, i.e., bench testing, testing to FDA recognized consensus standards, and software verification and validation testing.
Decision 5b: Are the proposed scientific methods for evaluating new/different characteristics' effects on safety and effectiveness acceptable?
YES: The proposed scientific methods for evaluating new/different characteristics' effects on safety and effectiveness are drawn from a robust Design Control, Risk Management, Software Development programs, and testing to FDA recognized consensus standards.
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Decision 6: Do the data demonstrate substantial equivalence?
YES: The results from performance testing of safety and effectiveness demonstrate that the proposed SmartLinx Vitals Plus Patient Monitoring System is substantially equivalent to the predicate SmartLinx Vitals Plus Patient Monitoring System.
5. Performance Testing
Performance testing assures that essential device characteristics have been appropriately implemented to provide safe and effective function and performance for the device's intended use. The performance testing consists of hardware and software verification and validation, as well as testing to FDA recognized consensus standards.
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The SmartLinx Vitals Plus Patient Monitoring System conforms with FDA recognized consensus standards listed in the Table 2 below.
Table 2: Applicable Recognized Consensus Standards
| Category | Standard Reference | Standards Title |
|---|---|---|
| ElectromagneticCompatibility,Electrical Safetyand SafetyStandards | ANSI AAMI ES 60601-1:2005/ (R):2012 &A1:2012 &C1:2009/ (R):2012 &A2:2010/ (R):2012 | Medical electrical equipment - Part 1: Generalrequirements for basic safety and essential performance(IEC 60601-1:2005, MOD) |
| IEC 80601-2-30:2013 | Medical electrical equipment -- Part 2-30: Particularrequirements for basic safety and essential performanceof automated non-invasive sphygmomanometers | |
| IEC 60601-1-2:2007 | Medical electrical equipment - Part 1-2: Generalrequirements for basic safety and essential performance- Collateral standard: Electromagnetic compatibility –Requirements and tests | |
| IEC 60601-2-49:2011 | Medical electrical equipment - Part 2-49: Particularrequirements for the basic safety and essentialperformance of multifunction patient monitoringequipment | |
| ISO 80601-2-61:2011 | Medical electrical equipment -- Part 2-61: Particularrequirements for basic safety and essential performanceof pulse oximeter equipment | |
| Usability | IEC 60601-1-6:2013 | Medical electrical equipment - Part 1-6: Generalrequirements for basic safety and essential performance- Collateral standard: Usability |
| IEC 62366-1:2015 | Medical devices - Part 1: Application of usabilityengineering to medical devices | |
| Software | IEC 62304:2006 | Medical device software—Software life cycle processes13-32 Declaration of Conformity |
| Batteries | IEC 62133:2012 | Secondary Cells And Batteries Containing Alkaline OrOther Non-Acid Electrolytes - Safety RequirementsFor Portable Sealed Secondary Cells, And For BatteriesMade From Them, For Use In Portable Applications[Including: Corrigendum 1 (2013)] |
| Alarms | IEC 60601-1-8:2012 | Medical electrical equipment - Part 1-8: Generalrequirements for basic safety and essential performance- Collateral Standard: General requirements, tests andguidance for alarm systems inmedical electrical equipment and medical electricalsystems |
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6. Clinical Studies
This Special 510(k) for the proposed SmartLinx Vitals Plus Patient Monitoring System did not require clinical studies to support substantial equivalence.
7. Conclusions
Substantial equivalence of the proposed SmartLinx Vitals Plus Patient Monitoring System is demonstrated through performance testing and conformance with FDA recognized consensus standards. The proposed SmartLinx Vitals Plus Patient Monitoring System results in an equivalent design, features and functionality as compared to the predicate SmartLinx Vitals Plus Patient Monitoring System with few exceptions that do not raise new questions of safety or effectiveness. Capsule Tech, therefore, views the proposed SmartLinx Vitals Plus Patient Monitoring System to be eligible for a decision of substantial equivalence when compared to the predicate SmartLinx Vitals Plus Patient Monitoring System.
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Image /page/11/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol representing the Department of Health & Human Services on the left, and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue on the right. The text is arranged in three lines, with "FDA" in a larger font size and a blue square behind it.
April 17, 2019
Capsule Technologie Maylin Truesdell Sr. Regulatory Affairs Manager 300 Brickstone Square, Suite 203 Andover, Massachusetts 01810
Re: K183638
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, DOA, FLL Dated: March 19, 2019 Received: March 20, 2019
Dear Maylin Truesdell:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K183638
Device Name
SmartLinx Vitals Plus Patient Monitoring System
Indications for Use (Describe)
The SmartLinx Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), and temperature, on adult, pediatric, and neonatal patients in hospital environments when used by clinical physicians or appropriate medical staff under the direction of physicians.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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§ 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).