(163 days)
Not Found
No
The summary describes a device for measuring blood pressure and pulse rate based on the Pénaz-Principle and standard clinical studies. There is no mention of AI, ML, or related concepts in the device description, intended use, or performance studies.
No.
The device is intended for measurement and monitoring of physiological parameters (blood pressure, pulse rate, and derived hemodynamic parameters), not for treatment or therapy.
Yes
The device is intended for the "measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters," which are diagnostic measurements used to assess a patient's physiological state.
No
The device description explicitly states that the device consists of several components necessary for operation, including a "Task Force® CORE Main Unit," "Applied parts (detachable components): CNAP® Classic Sensor Unit and TFC NBP Cuffs," and a "TFC I/O Cable." These are physical hardware components, not just software.
Based on the provided information, the Task Force® CORE (TFC) is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information for diagnosis, monitoring, or screening.
- TFC's Function: The TFC measures physiological parameters directly from the patient's body in vivo (within the living body). It measures non-invasive continuous blood pressure, pulse rate, and derived hemodynamic parameters using applied parts on the upper arms and fingers.
- Lack of Specimen Analysis: There is no mention of the TFC analyzing any biological specimens. Its operation is based on physical principles applied to the patient's body.
Therefore, the TFC falls under the category of a non-invasive physiological monitoring device, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters.
The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator.
The TFC contains software which runs on a separate computer and which is used to operate the device. This software includes a basic frontend (Task Force® CORE Viewer) as well as an interface for integration into other software products.
The TFC can provide all signals as well as measured and derived parameters to the analog output interface and can acquire signals from the analog input interface.
Product codes
DXN
Device Description
The medical device Task Force® CORE (TFC) with software version 1.0.7 is a new product, which is intended to be used in professional healthcare facilities and operated only by qualified healthcare professional staff, as described in the Indications for use.
The Task Force® CORE is intended to be used for the non-invasive continuous measurement of blood pressure and pulse rate, and the determination of associated derived hemodynamic parameters. . The principle of a continuous non-invasive measurement of a blood pressure is based on the Pénaz-Principle (vascular unloading).
The TFC consists of several components necessary for the intended operation:
- . Task Force® CORE Main Unit -TFC MU (see Figure 1) connected to an application computer via USB.
- . Applied parts (detachable components): CNAP® Classic Sensor Unit (see Figure 2) and TFC NBP Cuffs (see Figure 3)
- The TFC I/O Cable for using the Analog I/O interface (see Figure 4)
- Task Force® CORE Viewer as graphical user interface (see Figure 5) and TFC Driver, executed ● on an application computer (third - party manufacturer). Please note that the application computer is not a part of the subject device (SD) and therefore not within the scope of this submission.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
fingers, upper arms
Indicated Patient Age Range
adults
Intended User / Care Setting
professional healthcare facilities and operated by qualified healthcare professional staff.
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)
Clinical performance testing
For the Task Force® CORE, performance tests were conducted regarding blood pressure, cardiac output and the parameters inter-beat-interval and pulse rate.
- Clinical performance studies for blood pressure measurements included 42 (22 male, 20 female) adult subjects (age span 21 to 77 years).
- Performance of blood pressure measurement was tested against the gold standard invasive arterial reference and was found to comply with the requirements of ISO 81060-2:2018.
- Clinical studies for cardiac output determination included 44 (37 male, 7 female) adult subjects (age span 54 to 83 years).
- Performance of cardiac output determination was tested against the gold standard thermodilution reference and was found to fulfill the widely accepted Critchley criteria.
- The first clinical study for determination of the pulse rate and inter-beat-interval included 44 (22 male, 22 female) adult subjects (age span 21 to 77 years).
- The second clinical study for determination of the pulse rate and inter-beat-interval included 28 (16 male, 12 female) adult subjects (age span 18 to 66 years).
- Performance of the inter-beat-interval and pulse rate determinations was tested against the gold standard reference electrocardiography and was found to fulfill the requirements derived from IEC 60601-2-25:2011 and ANSI/AAMI EC13:2002, respectively.
When used according to the instructions for use, the Task Force® CORE showed no adverse effects during the clinical performance testing.
The patient population of the clinical performance study is representative of the intended patient population. As mentioned in the indications for use (please refer to Volume 04 Indications for Use Statement), the device is not intended to be used on pediatric patients.
The results obtained from clinical performance testing demonstrate that the Task Force® CORE with SW V1.0.7 and HW V1.0 is substantially equivalent concerning measurement performance to the primary predicate device Finapres NOVA (K173916) and the secondary predicate device CNAP Monitor 500 HD (K183521).
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
Not Found
§ 870.1130 Noninvasive blood pressure measurement system.
(a)
Identification. A noninvasive blood pressure measurement system is a device that provides a signal from which systolic, diastolic, mean, or any combination of the three pressures can be derived through the use of tranducers placed on the surface of the body.(b)
Classification. Class II (performance standards).
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in a stacked format.
April 12, 2023
CNSystems Medizintechnik GmbH Raphael Gunacker Head of Quality Reininghausstrasse 13 Graz, 8020 Austria
Re: K223332
Trade/Device Name: Task Force CORE Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, Dated: October 21, 2022 Received: October 31, 2022
Dear Raphael Gunacker:
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,
Robert T. Kazmierski - S
for
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
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Indications for Use
510(k) Number (if known) K223332
Device Name Task Force® CORE
Indications for Use (Describe)
The Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters.
The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator.
The TFC contains software which runs on a separate computer and which is used to operate the device. This software includes a basic frontend (Task Force® CORE Viewer) as well as an interface for integration into other software products.
The TFC can provide all signals as well as measured and derived parameters to the analog output interface and can acquire signals from the analog input interface.
| 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 logo for CN Systems. The text "cn" is in red, and the text "systems" is in gray. To the right of the text is a red drawing of a dress form.
510(k) Summary 5
This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.
Submitter's Information 5.1
| 510(k) submitter | CNSystems Medizintechnik GmbH
Reininghausstrasse 13
8020 Graz, Austria
Tel: 0043-316-723456-0
e-Mail: regulatory@cnsystems.com
Establishment Registration Number: 3006113127 |
|--------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Primary contact person | Raphael Gunacker/ Head of Quality
Tel: 0043-316-723456-701
E-Mail: raphael.gunacker@cnsystems.com |
| Alternate contact person | Tijana Rajcevic/ Regulatory Affairs & Quality Manager
Tel: 0043-316-723456-703
E-Mail: tijana.rajcevic@cnsystems.com |
| Date prepared | March 6th, 2023 |
Device Information 5.2
| Trade/Device name | Task Force® CORE |
|---|---|
| Common name | Measurement system for continuous non-invasive blood pressure, |
| pulse rate and hemodynamics | |
| Regulation number | 21 CFR 870.1130 |
| Regulation name | Noninvasive blood pressure measurement system |
| Regulatory class | Class II |
| Product code | DXN |
| Review panel | Cardiovascular devices |
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Image /page/4/Picture/1 description: The image shows the logo for CN Systems. The text "cnsystems" is displayed in a sans-serif font, with "cn" in red and "systems" in gray. To the right of the text is a red silhouette of a dress form or mannequin, suggesting a connection to fashion or design.
5.4 Predicate Devices
5.4.1 Primary predicate device (PPD): Finapres NOVA: K173916
Manufacturer:
Finapres Medical Systems B.V. Hogehilweg 8, 1101 CC Amsterdam, The Netherlands
The Finapres NOVA is a medical device for continuous and non-invasive blood pressure measurement and further hemodynamic parameters derived from the measured signals. The Task Force® CORE and the Finapres NOVA share the same intended use and the same fields of application in the market.
Secondary predicate device (SPD): CNAP® Monitor 500 HD: 5.4.2 K183521
Manufacturer: CNSystems Medizintechnik GmbH
Graz, Austria
The CNAP® Monitor 500HD is a stand-alone device for continuous non-invasive blood pressure and hemodynamic monitoring with alarming functionality. The continuous non-invasive blood pressure is measured on the patient's finger using a double finger cuff. The oscillometric blood pressure measurement function is used for intermittent calibration of the continuous blood pressure curve.
The Task Force® CORE and the CNAP® Monitor 500 HD utilize the same measurement (CNAP®) technology and share functionality and sensors, with exception for alarming functionality (according to IEC 60601-1-8) of the CNAP Monitor 500HD, which the Task Force CORE does not have.
5.5 Device Description
The medical device Task Force® CORE (TFC) with software version 1.0.7 is a new product, which is intended to be used in professional healthcare facilities and operated only by qualified healthcare professional staff, as described in the Indications for use.
The Task Force® CORE is intended to be used for the non-invasive continuous measurement of blood pressure and pulse rate, and the determination of associated derived hemodynamic parameters. . The principle of a continuous non-invasive measurement of a blood pressure is based on the Pénaz-Principle (vascular unloading).
The TFC consists of several components necessary for the intended operation:
- . Task Force® CORE Main Unit -TFC MU (see Figure 1) connected to an application computer via USB.
- . Applied parts (detachable components): CNAP® Classic Sensor Unit (see Figure 2) and TFC NBP Cuffs (see Figure 3)
- The TFC I/O Cable for using the Analog I/O interface (see Figure 4)
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Image /page/5/Picture/0 description: The image shows the logo for CN Systems. The letters "cn" are in red, while the word "systems" is in gray. To the right of the text is a red silhouette of a woman's torso.
- Task Force® CORE Viewer as graphical user interface (see Figure 5) and TFC Driver, executed ● on an application computer (third - party manufacturer). Please note that the application computer is not a part of the subject device (SD) and therefore not within the scope of this submission.
Image /page/5/Picture/3 description: The image shows a Task Force Core device, which is a medical device used for cardiovascular monitoring. The device is white and has a variety of ports and connectors on the front panel, including a USB port, an analog I/O port, and a power connector. The device also has a logo on the top panel that says "TASK FORCE CORE".
Figure 1: Task Force Core® Main Unit
Image /page/5/Figure/5 description: The image shows a TFC (Tanscutaneous Functional Connectivity) system. The system includes a TFC fingersensor, a TFC forearm controller, a TFC forearm controller clamp, and a TFC forearm controller fixing strap. The system also includes a TFC CNAP Classic Adapter and a TFC cable that is 2.5 meters long, and a connection to the TFC Main Unit.
Figure 2: Components and setup of the CNAP® Classic Sensor Unit
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Image /page/6/Picture/1 description: The image shows the logo for CN Systems. The letters "cn" are in red, and the word "systems" is in gray. To the right of the word "systems" is a red outline of a woman's body.
Image /page/6/Picture/2 description: The image shows a blood pressure cuff. The cuff is labeled "TASK FORCE CORE" and "TFC NBP Cuff MEDIUM". The reference number is TFC10014 and the lot number is 20DA15. The expiration date is 2020-04-15.
Figure 3: TFC NBP Cuffs
Image /page/6/Picture/4 description: The image shows a bundle of eight fiber optic cables. The cables are arranged in a parallel fashion, fanning out from a single connector on the left side of the image. Each cable has a connector on the right side of the image.
Figure 4: TFC I/O Cable
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Image /page/7/Picture/0 description: The image shows the logo for CN Systems. The letters "cn" are in red, and the word "systems" is in gray. To the right of the text is a red outline of a dress form.
Image /page/7/Figure/2 description: The image shows a CNSystems vital sign monitoring interface. A graph displays time on the x-axis, ranging from 13 to 27, and mmHg on the y-axis, ranging from 50 to 140. On the right side of the interface, there are indicators for SYS, DIA, (MAP), and PULSE, but all values are currently blank. The interface also displays a message indicating that CNAP Measurement is stopped.
Figure 5: Task Force® CORE Viewer
Detailed description of the device is to be found in Volume 10 (Device Description).
5.5.1 TFC Touchable Components
The TFC components, which are deemed to be in direct contact with patient during measurements, are defined as the touchable components (TFC Fingersensor, TFC Forearm Controller Fixing Strap, TFC NBP Cuff and TFC Armsling). These components are intended to be in contact only with intact skin surfaces for a cumulative sum of duration of contact up to 24h.
The full description of the touchable components and the materials they are made of is included in Volume 15 (Biocompatibility).
Indications for Use 5.6
The Task Force® CORE (TFC) is intended for the measurement of non-invasive continuous blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters.
The TFC is intended to be used in professional healthcare facilities and operated by qualified healthcare professional staff. The TFC is intended to be used for adults and under uninterrupted surveillance of the operator.
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Image /page/8/Picture/1 description: The image shows the logo for CN Systems. The text "cnsystems" is written in a modern sans-serif font, with "cn" in red and "systems" in gray. To the right of the text is a stylized red figure of a woman in a dress, possibly representing fashion or design.
The TFC contains software which runs on a separate computer and which is used to operate the device. This software includes a basic frontend (Task Force® CORE Viewer) as well as an interface for integration into other software products. The TFC can provide all signals, as well as measured and derived parameters, to the analog output interface and can acquire signals from the analog input interface.
5.7 Comparison of technological characteristics with the predicate device
The SD (Task Force® CORE), as well as the PPD (Finapres NOVA) and the SPD (CNAP® Monitor 500 HD) provide a continuous non-invasive blood pressure measurement based on the Pénaz-Principle (vascular unloading), and therefore calculate the patients' blood pressure continuously via an optopneumatic sensor, which is applied to a patient's finger.
The Task Force® CORE and the CNAP® Monitor 500 HD utilize the same CNAP® technology and share functionality and sensors, with exception for alarming functionality (according to IEC 60601-1-8) of the CNAP Monitor 500HD, which the Task Force CORE does not have..
While both predicate devices have integrated displays, the Task Force® CORE uses an external (thirdparty manufacturer) application computer.
Another technological difference is the fact that the PPD relies on a height correction unit to account for hydrostatic pressure differences occurring due to movements of the finger sensor relative to the heart. On the other hand, the SP (TFC) and the SPD (CNAP® Monitor 500 HD) use algorithms for artifact detection (including movements of the sensor relative to the heart) and warnings and instructions (to recalibrate) in the instructions for use.
The present technological differences do not raise questions of safety and effectiveness.
For more details on comparison of technological characteristics between the Task Force® CORE and predicate devices, please refer to Volume 12 (Substantial equivalence discussion) of this submission.
5.8 Performance data
5.8.1 System testing
All system verification tests based on system requirements were passed, demonstrating conformance with design and performance specifications.
5.8.2 Biocompatibility testing
Biocompatibility evaluation was performed according to FDA's guideline "Use of International Standard ISO10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process", dated September 4th 2020 and ISO 10993-1:2018.
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The Task Force® CORE is intended to contact intact skin on the upper arms and fingers of a patient, for a limited contact duration of up to 24 hours with touchable TFC components (TFC Fingersensor, TFC Forearm Controller Fixing Strap, TFC Armsling, and TFC NBP cuffs). All materials in patient contact of the Task Force® CORE are evaluated to be safe for the intended contact with intact skin and for a limited time. For more information, please refer to Volume 15 (Biocompatibility).
5.8.3 Electrical safety and electromagnetic compatibility (EMC)
Electrical safety of the Task Force® CORE was demonstrated by type testing according to IEC 60601-1 Edition 3.1 2012 in combination with IEC 80601-2-30: Edition 2.0 2018-03.
Electromagnetic compatibly of the Task Force® CORE was demonstrated by system testing according to IEC 60601-1-2 Edition 4.0 2014-02, considering exception of recognition on subclause 8.9.
All tests on electrical safety and electromagnetic compatibility were passed. The respective test reports are attached in Volume 17 (Electromagnetic Compatibility and Electrical Safety).
5.8.4 Software verification and validation testing
For the Task Force® CORE, according to its software safety classification as B (Moderate Concern) according to IEC 62304 Edition 1.1 2015-06, all required software lifecycle activities were conducted, including system and unit level verification. Volume 16 contains the proposed content as per FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices". Fulfillment of IEC 62304 Edition 1.1 2015-06 is also demonstrated by type testing, performed according to IEC 60601-1 Edition 3.1 2012 and IEC 62304 Edition 1.1 2015-06.
5.8.5 Clinical performance testing
For the Task Force® CORE, performance tests were conducted regarding blood pressure, cardiac output and the parameters inter-beat-interval and pulse rate.
- . Clinical performance studies for blood pressure measurements included 42 (22 male, 20 female) adult subjects (age span 21 to 77 years),
- . Clinical studies for cardiac output determination included 44 (37 male, 7 female) adult subjects (age span 54 to 83 years),
- . The first clinical study for determination of the pulse rate and inter-beat-interval included 44 (22 male, 22 female) adult subjects (age span 21 to 77 years).
- The second clinical study for determination of the pulse rate and inter-beat-interval included 28 (16 male, 12 female) adult subjects (age span 18 to 66 years).
The patient population of the clinical performance study is representative of the intended patient population. As mentioned in the indications for use (please refer to Volume 04 Indications for Use Statement), the device is not intended to be used on pediatric patients.
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Image /page/10/Picture/1 description: The image shows the logo for CN Systems. The logo consists of the text "cnsystems" in a sans-serif font. The "cn" portion of the text is in red, while the "systems" portion is in gray. To the right of the text is a red abstract figure of a person.
Performance of blood pressure measurement was tested against the gold standard invasive arterial reference and was found to comply with the requirements of ISO 81060-2:2018.
Performance of cardiac output determination was tested against the gold standard thermodilution reference and was found to fulfill the widely accepted Critchley criteria.
Performance of the inter-beat-interval and pulse rate determinations was tested against the gold standard reference electrocardiography and was found to fulfill the requirements derived from IEC 60601-2-25:2011 and ANSI/AAMI EC13:2002, respectively.
When used according to the instructions for use, the Task Force® CORE showed no adverse effects during the clinical performance testing.
The results obtained from clinical performance testing demonstrate that the Task Force® CORE with SW V1.0.7 and HW V1.0 is substantially equivalent concerning measurement performance to the primary predicate device Finapres NOVA (K173916) and the secondary predicate device CNAP Monitor 500 HD (K183521).
5.9 Conclusion
The subject device and the two predicate devices share intended use and similar technological characteristics. Thus, the subject device is regarded to be substantially equivalent to the legally marketed predicates.
The Task Force® CORE successfully passed safety, functional and performance testing, including software verification and validation and bench tests.
The information submitted within the premarket notification confirms that the Task Force® CORE is as safe, as effective and performs as well as or better than the predicate devices.