(100 days)
No
The summary describes a standard patient monitoring system and does not mention AI or ML capabilities.
No
The device is described as a "Patient Monitoring System" intended for "monitoring and alarming of physiologic parameters". It does not describe any therapeutic intervention.
No
The device is described as a "Patient Monitoring System" intended for "monitoring and alarming of physiologic parameters." It does not mention providing a diagnosis.
No
The device description explicitly lists multiple hardware components (e.g., NIBP Monitoring Module, Gas Analyzer, SpO2 Oximetry Module, Temperature Scanner) and the performance studies mention hardware verification and validation.
Based on the provided text, the SmartLinx Vitals Plus Patient Monitoring System is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- The SmartLinx Vitals Plus system directly monitors physiological parameters on the patient's body (blood pressure, pulse rate, SpO2, CO2, respiration, temperature). It's a patient monitoring system, not a system that analyzes samples in a lab setting.
The description clearly focuses on real-time, non-invasive monitoring of vital signs on the patient.
N/A
Intended Use / Indications for 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.
Product codes
MWI, DXN, DQA, FLL, CCK
Device Description
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
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
adult, pediatric, and neonatal patients
Intended User / Care Setting
clinical physicians or appropriate medical staff under the direction of physicians.
health care facilities
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
SmartLinx Vitals Plus Patient Monitoring System, K183638, Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02, K171121
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
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
1
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
2
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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3
K200856
Page 1 of 13
510(k) Summary
Per 21 CFR 807.92
| Submitter's Name
and Address | Capsule Technologies, SAS
76-78 avenue de France CS21416
75644 Paris Cedex 13 |
|-------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Peter Kelley
Director Quality & Regulatory
Capsule Tech, Inc
300 Brickstone Square, Suite 203
Andover, MA 01810
Phone: 978-482-2365
e-mail: pkelley@capsuletech.com |
| Date Prepare | March 30, 2020 |
| Device Trade
Name | SmartLinx 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 | Primary: SmartLinx Vitals Plus Patient Monitoring
System, K183638. Cleared April 19, 2019.
Secondary: Masimo NomoLine Infrared Sidestream Gas
Analyzer ISA C02, K171121, (originally K103064).
Cleared April 6, 2011. |
4
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.
5
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
6
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.
7
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.
8
| Attrubute | Predicate SmartLinx
Vitals Plus | Predicate NomoLine ISA
CO2 | Proposed SmartLinx
Vitals Plus | Proposed
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, 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. |
|-----------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Manufacturer | Capsule Technologies | Masimo Corporation | Capsule Technologies | 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), 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. |
| Regulation
Number | 870.2300 | 868.1400 | 870.2300
Same as primary predicate | Predicate
NomoLine ISA
CO2 | 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 other
medical backboard devices for monitoring of breath rate and the following breathing gases:
ISA CO2: CO2
ISA AX+: CO2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA OR+: CO2, O2, N2O, Halothane, Isoflurane, Enflurane, Sevoflurane and Desflurane
ISA CO2, ISA AX+ and ISA OR+ are intended to be connected to a patient breathing circuit for
monitoring of inspired/expired gases during anesthesia, recovery and respiratory care. The
intended environment is the operating suite, intensive care unit and patient room. ISA CO2 is also
intended to be used in road ambulances. The intended patient population is adult, pediatric,
infant, and neonatal patients. |
| Regulation Name | Cardiac monitor (including
cardiotachometer and rate
alarm) | Carbon dioxide gas
analyzer | Cardiac monitor (including
cardiotachometer and rate
alarm) | 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. |
| Product Codes | MWI, DQA, DXN, FLL | CCK | MWI, DQA, DXN, FLL,
CCK
Same as combined
predicates | | |
| 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 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
primary
predicate | |
| | SpO2 Measurement:
Masimo or Nellcor
Continuous SpO2
Monitoring: Pulse tone
pitch xxx, sensor off
alarmSpO2 alarm delay:
Selectable time (secs) for
Masimo, SatSeconds for
Nellcor | | SpO2 Measurement:
Masimo or Nellcor
Continuous SpO2
Monitoring: Pulse tone
pitch xxx, sensor off
alarmSpO2 alarm delay:
Selectable time (secs) for
Masimo, SatSeconds for
Nellcor | Same as
primary
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
primary
predicate | |
| Attribute | Primary Predicate:
SmartLinx Vitals Plus | Secondary Predicate:
NomoLine ISA CO2 | Proposed Device:
SmartLinx Vitals Plus | Discussion | |
| | TEMP: Exergen TAT-
5000S temporal artery
scanner thermometer | | TEMP: Exergen TAT-
5000S temporal artery
scanner thermometer | Same as
primary
predicate | |
| | | CO2: Infrared
spectroscopy | CO2: Infrared
spectroscopy | Same as
secondary
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
primary
predicate | |
| | SpO2: Masimo LNCS
family of reusable and
disposable SpO2 sensors | | SpO2: Masimo LNCS
family of reusable and
disposable SpO2 sensors | Same as
primary
predicate | |
| | Masimo® or Nellcor®
SpO2 algorithms
(optional)-both sensors
and signal processing | | Masimo® or Nellcor®
SpO2 algorithms
(optional)-both sensors
and signal processing | Same as
primary
predicate | |
| | TEMP: Exergen
disposable probe covers
and sheaths | | TEMP: Exergen
disposable probe covers
and sheaths | Same as
primary
predicate | |
| | | CO2 Canulla:
Soft PVC | CO2 Canulla:
Soft PVC | Same as
secondary
predicate | |
| 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; methyl
methacrylate-
acrylonitrite-butadiene-
styrene (MABS) | Co2: Airway Adapter:
Hard plastic; methyl
methacrylate-
acrylonitrite-butadiene-
styrene (MABS) | Same as
secondary
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 |
| 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
primary
predicate | |
| Exergen: 9V alkaline | | | Exergen: 9V alkaline | Same as
primary
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
primary
predicate | |
| | NomoLine: 5V, 160mA
typical, 800mA peak. | | NomoLine: 5V, 160mA
typical, 800mA peak. | Same as
secondary
predicate | |
Table 1 Comparison of Classification of Proposed Device to Predicate Devices
9
Table 2 Comparison of Intended Use of Proposed Device to Predicate Devices
Intended Use / Indications for Use
10
K200856 Page 8 of 13
Table 3 Comparison of Technical Characteristics of Proposed Device to Predicate Devices
11
12
13
Discussion
The proposed SmartLinx Vital Plus Patient Monitoring System intended use incorporates all the predicate Vitals Plus intended use plus the monitoring of inspired and expired CO2 intended use of the ISA CO2 predicate device. The differences between the proposed and predicate intended use are not critical for the intended use of the proposed device, and do not affect the safety and effectiveness of the device when used as labeled.
Performance Testing
Performance testing assures that essential device characteristics have been appropriately implemented to provide safe and effective function and performance for the device's intended use. The performance testing consists of hardware and software verification and validation, as well as testing to FDA recognized consensus standards.
The SmartLinx Vitals Plus Patient Monitoring System conforms with FDA recognized consensus standards listed in Table 4 below.
| FDA
Recognition
| Standard
Number | Standard Edition /
Date | Title |
|-------------------------|---------------------------------------|-----------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-10 | UL 1642 | 5th Edition | Lithium Batteries |
| 19-11 | UL 2054 | 2nd Edition | Household and Commercial
Batteries |
| 19-13 | IEC 62133 | Edition 2.0 2012-12 | 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 [Including:
Corrigendum 1 (2013)] |
| 19-23 | IEC 60086-4
Edition 4.0
2014-09 | Edition 4.0 2014-09 | Primary batteries - Part 4: Safety
of lithium |
| 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) |
| FDA
Recognition
| Standard
Number | Standard Edition /
Date | Title |
| 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 |
| 5-76 | 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 |
| 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 |
| 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 |
| 6-403 | ISO 80601-2-
56 | Second edition 2017-
03 | 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 |
| FDA
Recognition
| Standard
Number | Standard Edition /
Date | Title |
| 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 |
| 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 |
Table 4 FDA Recognized Consensus Performance Standards
14
15
Clinical Studies
The subject of this premarket submission, SmartLinx Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence.
Conclusions
Substantial equivalence of the proposed SmartLinx Vitals Plus Patient Monitoring System is demonstrated through performance testing and conformance with FDA recognized consensus standards. The proposed SmartLinx Vitals Plus Patient Monitoring System results in equivalent design, features and functionality as compared with the two predicate devices with few exceptions that do not raise any new questions of safety or effectiveness. Capsule Technologies therefore views the proposed SmartLinx Vitals Plus Patient Monitoring System to be eligible for a decision of substantial equivalence when compared to the primary predicate device, the SmartLinx Vitals Plus Patient Monitoring System and the secondary predicate device, the Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02.