(266 days)
Not Found
No
The document describes a standard patient monitoring system that collects and displays physiological parameters. There is no mention of AI or ML in the intended use, device description, or performance studies. The inclusion of an "Early Warning Scoring System" could potentially utilize algorithms, but the summary does not indicate if these are AI/ML-based.
No
The device is described as a "Patient Monitoring System" intended for "monitoring and alarming of physiologic parameters." It does not mention any therapeutic action or treatment.
No
This device is described as a "Patient Monitoring System" intended for "monitoring and alarming of physiologic parameters." It measures vital signs like blood pressure, pulse rate, SpO2, CO2, respiration, and temperature. While monitoring can inform diagnosis, the primary stated purpose is monitoring and alarming, not the direct diagnosis of a disease or condition.
No
The device description explicitly lists multiple hardware components, including monitoring modules, gas analyzers, oximetry modules, cables, and a temperature scanner. The performance studies also mention hardware verification and validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to diagnose, monitor, or screen for various health issues.
- Device Function: The Capsule Vitals Plus Patient Monitoring System is described as monitoring and alarming for physiologic parameters directly from the patient (non-invasive blood pressure, pulse rate, SpO2, CO2, respiration, temperature). It does not involve testing samples taken from the body.
- Components: The components listed are sensors and modules that attach to the patient or measure parameters from the patient's breath, not laboratory equipment for analyzing biological samples.
Therefore, the device's function and components clearly indicate it is a patient monitoring system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Capsule Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.
Product codes (comma separated list FDA assigned to the subject device)
MWI, DQA, DXN, FLL, CCK
Device Description
The Capsule Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by.
It operates with the Capsule Medical Device Information Platform (CMDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.
The proposed Capsule Vitals Plus Patient Monitoring System consists of the following components:
- Capsule Neuron Mobile Platforms
- Capsule Vitals Plus Application
- Capsule Vitals Plus NIBP Monitoring Modules
- Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02
- Capsule Capnography Interface Module
- Nellcor SpO2 Oximetry Module
- Masimo uSpO2 Pulse Oximetry Cable
- Exergen TAT-5000S Temperature Scanner
- Capsule Early Warning Scoring System
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.
in 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 Capsule 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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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 contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 19, 2021
Capsule Technologie SAS Peter Kelley Director Quality, Regulatory & Cybersecurity 76 - 78 Avenue de France Paris, 75013 France
Re: K210204
Trade/Device Name: Capsule Vitals Plus Patient Monitoring System Regulation Number: 21 CFR 870.2300 Regulation Name: Cardiac Monitor (Including Cardiotachometer And Rate Alarm) Regulatory Class: Class II Product Code: MWI, DQA, DXN, FLL, CCK Dated: September 14, 2021 Received: September 15, 2021
Dear Peter Kelley:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
LCDR Stephen Browning Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K210204
Device Name
Capsule Vital Plus Patient Monitoring System
Indications for Use (Describe)
The Capsule Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by clinical physicians or appropriate medical staff under the direction of physicians.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/1 description: The image shows the word "capsule" in blue font. The "e" at the end of the word is replaced with a red circle with a white "e" inside. The trademark symbol is located in the upper right corner of the red circle.
510(k) Summary
Per 21 CFR 807.92
| Submitter's Name
and Address | Capsule Technologies, SAS
76-78 avenue de France
Paris, France 75013 |
|-------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name and
Information | Peter Kelley
Director Quality, Regulatory & Cybersecurity
Capsule Tech, Inc
300 Brickstone Square, Suite 203
Andover, MA 01810 |
| | Phone: 978-697-4364
e-mail: pkelley@capsuletech.com |
| Date Prepare | January 22, 2021 |
| Device Trade
Name | Capsule Vitals Plus Patient Monitoring System |
| Common
Name | Physiological or Vital Signs Monitor, Patient Monitor |
| Class and
Classification
Name | Class II, 21 CFR Part 870.2300 - Cardiac monitor
(including cardiotachometer and rate alarm) |
| Product Code | MWI, DXN, DQA, FLL, CCK |
| Predicate Devices | SmartLinx Vitals Plus Patient Monitoring
System, K200856. Cleared July 10, 2020. |
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Image /page/4/Picture/1 description: The image shows the word "capsule" in blue font, with the letter "e" replaced by a red circle with a white "e" inside. The "TM" symbol is located in the upper right corner of the red circle. The word "capsule" is written in a sans-serif font.
Device Description
The predicate device, the SmartLinx Vitals Plus Patient Monitoring System, was cleared in K200856.
The Capsule Vitals Plus Patient Monitoring System which is the subject of this submission is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when used by.
It operates with the Capsule Medical Device Information Platform (CMDIP) a Medical Device Data System to present patient information to the clinical user for active monitoring purposes at the point of care.
The proposed Capsule Vitals Plus Patient Monitoring System consists of the following components:
- -Capsule Neuron Mobile Platforms
- Capsule Vitals Plus Application |
- Capsule Vitals Plus NIBP Monitoring Modules -
- Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02 —
- Capsule Capnography Interface Module -
- Nellcor SpO2 Oximetry Module -
- Masimo uSpO2 Pulse Oximetry Cable
- -Exergen TAT-5000S Temperature Scanner
- -Capsule Early Warning Scoring System
SmartLinx Neuron Mobile Platform – Neuron 2
The SmartLinx Neuron (Neuron 2) is a mobile computer which utilizes industry standard PC architecture and components, with touch-screen capabilities, and serial, USB, network, and RFID interfaces and which runs a Microsoft Windows operating system. It is used by healthcare providers through the applications running on it, and it is accessed by IT administrators during management and maintenance. The Neuron 2 provides connectivity to medical devices through isolated serial and USB ports. It also communicates with other IT systems through Ethernet or Wi-Fi network connections. The Neuron 2 is IEC 60601-1 compliant for use in Medical Electrical Systems. The Neuron 2 is utilized as part of an active monitoring system when running the SmartLinx Vitals Plus Application. The Neuron 2 is unchanged from the predicate device.
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Capsule Neuron Mobile Platform – Neuron 3
A new version of the Neuron Mobile Platform (Neuron 3) is being added to the Vitals Plus Patient Monitoring System, in addition to the Neuron 2 of previous 510(k) submissions. Neuron 3 was developed and released under a separate program which was primarily driven by a CPU update. The Neuron 3 is now being added to the Vitals Plus Patient Monitoring System.
The design changes introduced with the Neuron 3 are:
- A new touch screen that uses capacitive versus resistive technology.
- A new display screen that uses a glossy display versus a matte display. ।
- Incorporating the primary audio alarm mechanism and the watchdog । functionality which was formerly implemented in the NIBP Monitoring Module. The new implementation of the primary audio alarm mechanism and the watchdoq functionality re-uses the same electrical design as before, except with a new speaker.
- । Update the operating system to Windows 10.
Capsule Vitals Plus Application
The Capsule Vitals Plus Application is a mobile medical application operating on the Capsule Neuron. The Vitals Plus Application controls the externally integrated vital signs modules through interfaces on the Neuron and the Vital Plus NIBP Monitoring Modules and presents patient information to the user for active monitoring purposes at the point of care. The supported physiological parameters are: NIBP (systolic, diastolic, mean arterial pressure (MAP), pulse rate, SpO2, end-tidal and fractional concentration of inspired CO2, respiration, and temperature. This is unchanged from the predicate device.
The Vitals Plus Application has been modified to include a plethysmography wave display which is derived either from either the Nellcor SpO2 Oximetry Module or the Masimo uSpO2 Pulse Oximetry Cable.
SmartLinx Vitals Plus NIBP Monitoring Module for Neuron 2
The SmartLinx Vitals Plus NIBP Monitoring Module for Neuron 2 incorporates the SunTech Medical Advantage A+ OEM NIBP module and associated blood pressure cuffs and hoses. It measures systolic, diastolic and mean arterial blood pressures (MAP), and pulse rates for adult, pediatric and neonatal patients. The module is controlled by the SmartLinx Vitals Plus Application to manage the inflation and deflation of blood pressure cuffs, and to measure blood pressures and pulse rates. The SmartLinx Vital Plus NIBP Monitoring Module for Neuron 2 provides a primary speaker for alarm annunciations with failover to a secondary speaker, watchdog functionality, and a USB hub for expansion. The NIBP Monitoring Module for Neuron 2 is unchanged from the predicate device.
6
Capsule Vitals Plus NIBP Monitorina Module for Neuron 3
A new NIBP Monitoring module has been created that attaches to the Neuron 3 and moves the primary audio alarm mechanism and the watchdog functionality to the Neuron 3. The Neuron 3 NIBP Monitoring Module incorporates the backup alarm speaker which was formerly in the Neuron 2. The rest of the electrical design remains unchanged.
The NIBP Monitoring Module for Neuron 3 incorporates the same SunTech Medical Advantage A+ OEM NIBP module and associated blood pressure cuffs and hoses as the NIBP Monitoring Module for the Neuron 2. It measures svstolic, diastolic and mean arterial blood pressures (MAP), and pulse rates for adult, pediatric and neonatal patients. The module is controlled by the Capsule Vitals Plus Application to manage the inflation and deflation of blood pressure cuffs, and to measure blood pressures and pulse rates. The Neuron 3 NIBP Monitoring Module uses the same SunTech NIBP cuffs as the unchanged Neuron 2 NIBP Monitoring Module.
The NIBP Monitoring Module for Neuron 3 provides a secondary speaker for alarm annunciations and a USB hub for expansion.
Masimo NomoLine Infrared Sidestream Gas Analyzer ISA C02
The Masimo NomoLine ISA™ CO2 Gas Analyzer is a sidestream analyzer intended to be connected to a host instrument for monitoring of CO2 and respiratory rate. NomoLine ISA CO2™ is intended to be connected to a patient breathing circuit for monitoring of inspired/expired gases during anesthesia, recovery, and respiratory care.
NomoLine sampling lines are intended to be used as accessories to the NomoLine ISA™ gas analyzers. They are connected to the nostrils or to the nostrils and mouth and of spontaneously breathing patients and are connected in-line with the airway adapters for sampling of CO2. These are single use accessories provided by the manufacturer and distributed by Capsule. Thev have met required shelf life criteria according to the K171121 Summary, and do not affect the shelf life of the subject device.
The Capsule Vitals Plus Application controls the operation of the ISA CO2 to measure CO2 and respiration rate in adult, pediatric, and neonatal patients which is unchanged from the predicate device. The Masimo NomoLine ISA CO2 analyzer is also unchanged from the predicate device.
Capsule Capnography Interface Module
The Capnography Interface Module (CIM) is an RS-232 serial to USB converter designed to Capsule's specification by a third party. It connects to the ISA CO2 module via a DB-9 connector and to the Neuron via a USB connector. It communicates with the Vitals Plus Application through a Device Driver Interface (DDI) developed by Capsule. The CIM is unchanged from the predicate device.
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Image /page/7/Picture/1 description: The image shows the logo for Capsule Technologies. The logo consists of the word "capsule" in blue, with a red circle containing a white "e" to the right of the word. Below the logo, the text "Nellcor SpO2 Oximetry Module" is written in black.
The Nellcor SpO2 Oximetry Module connects with Nellcor SpO2 Pulse Oximetry sensors and provides functional oxygen saturation (SpO2) and pulse rate and other information via a serial digital interface. The Capsule Vitals Plus Application controls the operation of the Nellcor SpO2 Oximetry Module to measure SpO2 and pulse rate in adult, pediatric, and neonatal patients.
Masimo uSpO2 Pulse Oximetry Cable
The Masimo uSpO2 Pulse Oximetry Cable is a cable with an integrated MS-2000 series circuit board contained in an enclosure that connects to Masimo pulse oximetry sensors and provides functional oxygen saturation (SpO2) and pulse rate and other information via a serial digital interface. The Capsule Vitals Plus Application controls the operation of the uSpO2 to measure SpO2 and pulse rate in adult, pediatric, and neonatal patients.
Exergen TAT-5000S Temperature Sensor
The Exergen TAT-5000S temperature sensor is designed for noninvasive temperature assessment by scanning the temporal artery. The thermometer operates independently but communicates its results to the Vitals Plus Application for display and monitoring.
Capsule Early Warning Scoring System
The Capsule Early Warning Scoring System (EWSS) is an optional software component that integrates with the Capsule Vitals Plus Application and runs on the Capsule Neuron. Capsule EWSS performs a medical calculation that aids clinical users in patient assessment and condition trending. This calculation, which would otherwise be completed manually, produces an aggregate patient score from a set of sub-scores determined from the values of measured vital signs and manually entered physiological observations. The resulting aggregate score is displayed on the Vitals Plus Application and may be communicated to other healthcare information systems. EWSS requires the clinical user to attend the patient in order to function. There is no automatic or continuous scoring. The specific scoring method used within Capsule EWSS to calculate a patient's score is determined by the customer.
Intended Use
The Capsule Vitals Plus Patient Monitoring System is intended for monitoring and alarming of physiologic parameters, including non-invasive blood pressure (systolic, diastolic, and mean arterial pressure), pulse rate, functional arterial oxygen saturation (SpO2), end-tidal and fractional concentration of inspired CO2, respiration, and temperature, on adult, pediatric, and neonatal patients in health care facilities when
8
capsu
used by clinical physicians or appropriate medical staff under the direction of physicians.
Comparison of Similarities and Differences
This discussion of substantial equivalence follows the guidelines published in: "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications Guidance for Industry and Food and Drug Administration Staff July 28, 2014." This submission uses one predicate device, the current SmartLinx Vitals Plus Patient Monitoring System (K200856). The proposed Capsule Vital Plus Patient Monitoring System is substantially equivalent to the predicate device, in terms of classification (Table 1), intended use (Table 2) and technical characteristics (Table 3), as described below.
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Image /page/9/Picture/1 description: The image shows the word "capsule" in blue font. To the right of the word is a red circle with a white "e" inside. The "e" is stylized with a horizontal line through the middle. There is a trademark symbol in the upper right corner of the red circle.
Table 1 Comparison of Classification of Proposed Device to Predicate Devices
| Attribute | Predicate SmartLinx Vitals Plus | Proposed Capsule Vitals Plus | Discussion |
|---|---|---|---|
| Manufacturer | Capsule Technologie, SAS | Capsule Technologie, SAS | Same as predicate |
| Regulation Number | 870.2300 | 870.2300 | Same as predicate |
| Regulation Name | Cardiac monitor (including cardiotachometer and rate alarm) | Cardiac monitor (including cardiotachometer and rate alarm) | Same as predicate |
| Product Codes | MWI, DQA, DXN, FLL, CCK | MWI, DQA, DXN, FLL, CCK | Same as predicate |
| 510(k) Number | K200856 | Pending | |
| Class | II | II | Same as predicate |
Table 2 Comparison of Intended Use of Proposed Device to Predicate Devices
Intended Use / Indications for Use
| Proposed
Capsule Vitals
Plus | The Capsule Vitals Plus Patient Monitoring System is intended for
monitoring and alarming of physiologic parameters, including non-
invasive blood pressure (systolic, diastolic, and mean arterial
pressure), pulse rate, functional arterial oxygen saturation (SpO2),
end-tidal and fractional concentration of inspired CO2, respiration,
and temperature, on adult, pediatric, and neonatal patients in
health care facilities when used by clinical physicians or
appropriate medical staff under the direction of physicians. |
|---------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Predicate
SmartLinx Vitals
Plus | The SmartLinx Vitals Plus Patient Monitoring System is intended
for monitoring and alarming of physiologic parameters, including
non-invasive blood pressure (systolic, diastolic, and mean arterial
pressure), pulse rate, functional arterial oxygen saturation (SpO2),
end-tidal and fractional concentration of inspired CO2, respirations,
and temperature, on adult, pediatric, and neonatal patients in
health care facilities when used by clinical physicians or
appropriate medical staff under the direction of physicians. |
| Discussion | The proposed Capsule Vital Plus Patient Monitoring System
intended use is the same as the predicate other than changing the
brand name. |
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Image /page/10/Picture/1 description: The image shows the word "capsule" in blue font, with the letter "e" replaced by a red circle with a white "e" inside. The "TM" symbol is located in the upper right corner of the red circle. The word "capsule" is written in a sans-serif font.
Table 3 Comparison of Technical Characteristics of Proposed Device to Predicate Devices
| Attribute | Predicate Device:
SmartLinx Vitals Plus | Proposed Device:
Capsule Vitals Plus | Discussion |
|--------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------|
| Design | Intervals Mode for NIBP
(Automatic repetition of NIBP
measurements): SmartLinx
Vitals Plus NIBP Module
using SunTech Advantage
A+ oscillometric OEM NIBP
module with intervals at 1, 2,
3, 4, 5, 10,15, 30, 60, 90,
120 and 240 minutes | Intervals Mode for NIBP
(Automatic repetition of NIBP
measurements): SmartLinx
Vitals Plus NIBP Module
using SunTech Advantage
A+ oscillometric OEM NIBP
module with intervals at 1, 2,
3, 4, 5, 10,15, 30, 60, 90,
120 and 240 minutes | Same as
predicate |
| | Sp02 Measurement:
Masimo or Nellcor
Continuous SpO2
Monitoring: Pulse tone pitch,
sensor off alarmSpO2 alarm
delay: Selectable time (secs)
for Masimo, SatSeconds for
Nellcor | Sp02 Measurement:
Masimo or Nellcor
Continuous SpO2
Monitoring: Pulse tone pitch,
sensor off alarmSpO2 alarm
delay: Selectable time (secs)
for Masimo, SatSeconds for
Nellcor | Same as
predicate |
| | Alarms: Configuration,
annunciation, and
acknowledgement of
physiological (Sys, Dia,
MAP, Pulse Rate, SpO2,
and TEMP) and technical
alarms | Alarms: Configuration,
annunciation, and
acknowledgement of
physiological (Sys, Dia,
MAP, Pulse Rate, SpO2,
and TEMP) and technical
alarms | Same as
predicate |
| | TEMP: Exergen TAT-5000S
temporal artery scanner
thermometer | TEMP: Exergen TAT-5000S
temporal artery scanner
thermometer | Same as
predicate |
| | CO2: Infrared spectroscopy | CO2: Infrared spectroscopy | Same as
predicate |
| Applied
Parts | NIBP: SunTech Durable
One-Piece, Disposable, and
Vinyl blood pressure cuffs
and hoses, and GE
CRITIKON SOFT-CUF cuffs | NIBP: SunTech Durable
One-Piece, Disposable, and
Vinyl blood pressure cuffs
and hoses, and GE
CRITIKON SOFT-CUF cuffs | Same as
predicate |
| | SpO2: Masimo LNCS and
Nellcor families of reusable
and disposable SpO2
sensors | SpO2: Masimo LNCS and
Nellcor families of reusable
and disposable SpO2
sensors | Same as
predicate |
| | | | |
| Attribute | Predicate Device:
SmartLinx Vitals Plus | Proposed Device:
Capsule Vitals Plus | Discussion |
| | Masimo® or Nellcor® SpO2
algorithms (optional)—both
sensors and signal
processing | Masimo® or Nellcor® SpO2
algorithms (optional)—both
sensors and signal
processing | Same as
predicate |
| | TEMP: Exergen disposable
probe covers and sheaths | TEMP: Exergen disposable
probe covers and sheaths | Same as
predicate |
| | CO2 Cannula:
Soft PVC | CO2 Cannula:
Soft PVC | Same as
predicate |
| | Co2: Airway Adapter: | Co2: Airway Adapter: | Same as |
| | Hard plastic; methyl
methacrylate-acrylonitrite-
butadiene-styrene (MABS) | Hard plastic; methyl
methacrylate-acrylonitrite-
butadiene-styrene (MABS) | predicate |
| Energy
Source | Main Battery Neuron 2:
Lithium-Ion 3S1P 2600 mAh
or 3050 mAh | Main Battery Neuron 2:
Lithium-Ion 3S1P 2600 mAh
or 3050 mAh | Same as
predicate |
| | | Main Battery Neuron 3:
Lithium-Ion 3S1P 3350 mAh | Same as
predicate,
except
provides
longer
operating
time |
| | Extended Battery Neuron 2:
Lithium-Ion 3S2P 5200 mAh
or 6100 mAh (1 or 2
depending on use of Dual
Battery Dock) | Extended Battery Neuron 2:
Lithium-Ion 3S2P 5200 mAh
or 6100 mAh (1 or 2
depending on use of Dual
Battery Dock) | Same as
predicate |
| | Exergen: 9V alkaline | Exergen: 9V alkaline | Same as
predicate |
| | Power Supply: 100-240 V
AC, 2.0-1.0 A, 50-60 Hz, 65
W max, Class I | Power Supply: 100-240 V
AC, 2.0-1.0 A, 50-60 Hz, 65
W max, Class I | Same as
predicate |
| | NomoLine: 5V, 160mA
typical, 800mA peak | NomoLine: 5V, 160mA
typical, 800mA peak | Same as
predicate |
| Attribute | Predicate Device:
SmartLinx Vitals Plus | Proposed Device:
Capsule Vitals Plus | Discussion |
| Computing
Platform | Neuron 2 PC running
Windows 7 operating
System | Neuron 2 PC running
Windows 7 operating
System | Same as
predicate |
| | Neuron 3 PC running
Windows 10 operating
system | Essentially
same as
predicate | |
| Matte display screen | Neuron 2: Matte display
screen | Same as
predicate | |
| | Neuron 3: Glossy display
screen | Operationally
equivalent.
Verified and
validated
against the
same
specifications | |
| Resistive technology touch
screen | Neuron 2: Resistive
technology touch screen | Same as
predicate | |
| | Neuron 3: Capacitive
technology touch screen | Operationally
equivalent.
Verified and
validated
against the
same
specifications | |
11
capsula
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Discussion
The only difference between the proposed Capsule Vital Plus intended use and the predicate SmartLinx Vitals Plus intended use is the brand name. There are no differences in classification. The main battery for Neuron 3 is new but uses the same technologies as the predicate Neuron 2. The new touch screen and display technologies, hardware computing platform and operating system of the Neuron 3 have all been verified and validated according to standard protocol against the same specifications as the Neuron 2 and have been found to be operationally equivalent.
These differences between the proposed and predicate devices are not critical for the intended use of the proposed device, and do not affect the safety and effectiveness of the device when used as labeled.
Performance Testing
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capsule
Performance testing assures that essential device characteristics have been appropriately implemented to provide safe and effective function and performance for the device's intended use. The performance testing consists of hardware and software verification and validation, as well as testing to FDA recognized consensus standards.
The Capsule Vitals Plus Patient Monitoring System conforms with FDA recognized consensus standards listed in Table 4 below.
| FDA
Recognition # | Standard
Number | Standard Edition /
Date | Title |
|----------------------|----------------------------|----------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 19-4 | ANSI AAMI
ES60601-1 | 2005/(R)2012 and
A1:2012 | C1:2009/(R)2012 and
A2:2010/(R)2012
(Consolidated Text) Medical
electrical equipment - Part 1:
General requirements for basic
safety and essential
performance (IEC 60601-
1:2005, MOD) |
| 19-8 | IEC 60601-
1-2 | Edition 4.0 2014-02 | Medical electrical equipment -
Part 1-2: General requirements
for basic safety and essential
performance - Collateral
Standard: Electromagnetic
disturbances - Requirements
and tests |
| 5-89 | IEC 60601-
1-6 | Edition 3.1 2013-10 | Medical electrical equipment -
Part 1-6: General requirements
for basic safety and essential
performance - Collateral
standard: Usability |
| 5-114 | IEC 62366-
1 | Edition 1.0 2015-02 | Medical devices - Part 1:
Application of usability
engineering to medical devices |
| 13-79 | IEC 62304 | Edition 1.1 2015-06
CONSOLIDATED
VERSION | Medical device software -
Software life cycle processes |
| FDA
Recognition # | Standard
Number | Standard Edition /
Date | Title |
| 5-76 | IEC 60601-
1-8 | Edition 2.1 2012-11 | Medical electrical equipment -
Part 1-8: General requirements
for basic safety and essential
performance - Collateral
Standard: General
requirements, tests and
guidance for alarm systems in
medical electrical equipment
and medical electrical systems |
| 19-33 | IEC 62133-
2 | Edition 1.0 2017-02 | Secondary cells and batteries
containing alkaline or other
non-acid electrolytes - Safety
requirements for portable
sealed secondary cells, and for
batteries made from them, for
use in portable applications -
Part 2: Lithium systems |
| 3-123 | IEC 80601-
2-30 | Edition 2.0 2018-03 | Medical electrical equipment
Part 2-30: Particular
requirements for basic safety
and essential performance of
automated type non-invasive
sphygmomanometers |
| 6-421 | ISO 80601-
2-56 | Second edition
2018 | Medical electrical equipment -
Part 2-56: Particular
requirements for basic safety
and essential performance of
clinical thermometers for body
temperature measurement. |
| 1-139 | ISO 80601-
2-61 | Second edition
2017-12 (Corrected
version 2018-02) | Medical electrical equipment -
Part 2-61: Particular
requirements for basic safety
and essential performance of
pulse oximeter equipment |
| 1-140 | ISO 80601-
2-55 | Second edition
2018-02 | Medical electrical equipment -
Part 2-55: Particular
requirements for the basic
safety and essential
performance of respiratory gas
monitors |
| 19-10 | UL 1642 | 5th Edition | Lithium Batteries |
| FDA
Recognition # | Standard
Number | Standard Edition /
Date | Title |
| 19-11 | UL 2054 | 2nd Edition | Household and Commercial
Batteries |
| 19-23 | IEC 60086-
4 | Edition 4.0 2014-09 | Primary batteries - Part 4:
Safety of lithium batteries |
| 2-220 | ISO 10993-
1 | Fourth edition 2009-
10-15 | Biological evaluation of
medical devices - Part 1:
Evaluation and testing within a
risk management process
[Including: Technical
Corrigendum 1 (2010)] |
| 5-40 | ISO 14971 | Second edition
2007/(R)2010 | Medical devices - Application
of risk management to medical
devices |
| 19-30 | AIM
Standard
7351731 | Rev. 2.00 2017-02-
23 | Medical Electrical Equipment
and System Electromagnetic
Immunity Test for Exposure to
Radio Frequency Identification
Readers - An AIM Standard |
Table 4 FDA Recognized Consensus Performance Standards
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Image /page/15/Picture/1 description: The image shows the logo for Capsule. The word "capsule" is written in blue, with the exception of the "e" at the end, which is white and inside of a red circle. There is a small trademark symbol in the upper right corner of the logo.
Clinical Studies
The subject of this premarket submission, Capsule Vitals Plus Patient Monitoring System, did not require clinical studies to support substantial equivalence.
Conclusions
Substantial equivalence of the proposed Capsule Vitals Plus Patient Monitoring System is demonstrated through performance testing and conformance with FDA recognized consensus standards. The proposed Capsule Vitals Plus Patient Monitoring System results in equivalent design, features and functionality as compared with the predicate device with few exceptions that do not raise any new questions of safety or effectiveness. Capsule Technologies therefore views the proposed Capsule Vitals Plus Patient Monitoring System to be eligible for a decision of substantial equivalence when compared to the predicate device, the SmartLinx Vitals Plus Patient Monitoring System.