The CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals. The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters. Alarms are generated for blood pressure parameters and pulse rate. The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals.

Device Description

The CNAP® Monitor 500 HD 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 (Advantage 2.0 OEM module by SunTech Inc.) is used for intermittent calibration of the continuous blood pressure curve. Medium priority alarming can be set for blood pressure beat values and pulse rate.

AI/ML Overview

Based on the provided text, the CNAP® Monitor 500 HD is a blood pressure and hemodynamic monitoring system. The acceptance criteria and the study proving it meets these criteria are primarily focused on its substantial equivalence to predicate devices rather than independent performance metrics against a defined standard.

Here's the breakdown of the information provided, or lack thereof, regarding a detailed AI/algorithm study:

Key Observation: The document describes a medical device, not an AI/ML algorithm. The performance data section focuses on electrical safety, electromagnetic compatibility, mechanical and acoustical testing, and software verification/validation, along with a claim of substantial equivalence to predicate devices based on clinical testing using "measurement data from different sources." There is no indication of an AI/ML algorithm being developed or studied for this device, nor is there a study described that would fit the typical criteria for AI/ML performance evaluation (e.g., sensitivity, specificity, AUC, human reader improvement studies).

Therefore, I will answer the questions based on the closest relevant information provided, while highlighting where the requested details for an AI/ML study are not applicable or not present in the document.

Acceptance Criteria and Device Performance (based on provided text)

The document focuses on demonstrating substantial equivalence to predicate devices. This is the primary "acceptance criterion" from a regulatory perspective. The performance data presented are primarily related to safety, electromagnetic compatibility, and software verification rather than specific diagnostic accuracy metrics for an AI.

Given the nature of the device (a non-invasive blood pressure and hemodynamic monitor), the key performance "acceptance" would be its accuracy in measuring blood pressure and derived hemodynamic parameters, and its safety. However, the document does not provide a table of precise acceptance criteria with numeric targets (e.g., ±5 mmHg for BP accuracy) or how the specific device performance was measured against such targets for the new device. Instead, it relies on demonstrating comparable performance to predicate devices.

Table of Acceptance "Criteria" (based on regulatory submission principles for this device type) and Reported Device "Performance":

Acceptance Criteria (Inferred from regulatory submission)	Reported Device Performance (from text)
Non-inferiority/Substantial Equivalence to Predicate Devices for Blood Pressure Measurement (accuracy, waveforms, trends, numerics)	"The clinical performance data demonstrates that the CNAP® Monitor 500 HD performs comparable to the predicate devices for the assessed parameters."
Non-inferiority/Substantial Equivalence to Predicate Devices for Derived Hemodynamic Parameters (CO, SV, SVR, CI, SI, SVRI, PPV)	"The technological characteristics regarding the calculation the hemodynamic and variability parameters from the continuous waveform are substantially equivalent in performance to the secondary predicate device."
Electrical Safety & EMC Compliance	Complies with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-8, IEC 80601-2-30. Confirmed by accredited laboratories (OVE AUSTRIAN ELECTOTECHNICAL ASSOCIATION, TÜV Testing Laboratory Vienna, Intertek Testing Services NA, Seibersdorf laboratories).
Biocompatibility Compliance of Patient Contact Materials	All surface materials have biocompatibility approval. Evaluation conducted per FDA Blue Book Memo #G95-1 and ISO 10993-1. Cytotoxicity, Sensitization, Irritation tests performed.
Software Verification & Validation	Conducted and documented as per FDA guidance. Software classified as "major" level of concern.
Mechanical & Acoustical Testing	Conducted (implied by safety standards compliance). No specific results detailed.
Alarm Functionality	Alarms are generated for blood pressure parameters and pulse rate. Medium priority alarming can be set for beat values and pulse rate.

Details Specific to AI/ML Studies (Not Applicable or Not Provided)

Sample sizes used for the test set and the data provenance:
- The document states "For clinical testing and evaluation measurement data from different sources was used to demonstrate that the device is substantially equivalent to the predicate devices."
- No specific sample size for a "test set" (as understood in AI/ML validation) is provided.
- No data provenance (e.g., country of origin, retrospective/prospective) is specified for this "measurement data." This is typical for a traditional medical device submission focused on equivalence, rather than a novel AI algorithm.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable / Not provided. The device is a monitor that directly measures/derives physiological parameters, not an diagnostic imaging AI that requires expert labeling for ground truth. Ground truth for blood pressure and hemodynamic parameters in a device like this would typically involve invasive measurements (e.g., arterial line for BP) or established reference methods, not expert consensus on image labels. The document does not describe how this "measurement data" was validated against a gold standard.
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable / Not provided. This method is relevant for studies involving human interpretation or labeling of data, especially in AI development for image analysis or diagnostics. It does not apply to a physiological monitoring device undergoing substantial equivalence testing.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable / Not done. An MRMC study is specific to AI-assisted diagnostic tools where human interpretation is part of the workflow. This device is a physiological monitor, not an AI that assists human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable / Not explicitly detailed as an AI algorithm study. The device itself is a "standalone" monitor that performs continuous non-invasive blood pressure and hemodynamic monitoring. The "performance data" section broadly covers its functional performance, but not in the context of an isolated AI algorithm. The device's "algorithms" are for signal processing and calculation of physiological parameters, which are validated as part of the overall device functionality, not typically as distinct "standalone AI" studies in the regulatory sense described.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not explicitly stated in detail. For a non-invasive blood pressure device, the gold standard (ground truth) is typically invasive arterial blood pressure monitoring. For hemodynamic parameters, it would be direct measurement methods like thermodilution (e.g., using a Swan-Ganz catheter). The document only generically refers to "measurement data from different sources."
The sample size for the training set:
- Not applicable / Not provided. This device is not described as involving a machine learning model that would require a distinct "training set" for its primary function. While there might be internal development data used to optimize signal processing algorithms, it is not presented as an AI/ML training regimen.
How the ground truth for the training set was established:
- Not applicable / Not provided. As no AI/ML training set is described, this question is not relevant to the provided text.

Summary

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Image /page/0/Picture/0 description: The image shows 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.

September 11, 2019

CNSystems Medizintechnik GmbH Bernd Wellisch Head of Regulatory Reininghausstrasse 13 Graz, 8020 At

Re: K183521

Trade/Device Name: CNAP Monitor 500 HD Regulation Number: 21 CFR 870.1130 Regulation Name: Noninvasive Blood Pressure Measurement System Regulatory Class: Class II Product Code: DXN, DXG Dated: December 14, 2018 Received: December 19, 2018

Dear Bernd Wellisch:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

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) K183521

Device Name CNAP Monitor 500 HD

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary - CNAP® Monitor 500 HD 5

This 510(k) summary is being submitted in accordance with the requirements of 21 CFR 807.92.

Submission date	08/06/2019
510(k) submitter	CNSystems Medizintechnik GmbHReininghausstrasse 138020 Graz, AustriaTel: 0043-316-7234560E-Mail: regulatory@cnsystems.com
Primary contact person	Bernd Wellisch / Head of Regulatory AffairsTel: 0043-316-723456-702E-Mail: bernd.wellisch@cnsystems.com
Device name	Non-invasive continuous blood pressure andhemodynamic monitoring system
Trade name	CNAP® Monitor 500 HD
Review panel	Cardiovascular devices
Classification regulation	870.1130, 870.1435
Product code	DXN, DXG
Device class	Class II (two)

Submitter´s information 5.1

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Device information 5.2

5.2.1 Primary Predicate Device - CNAP® Monitor 500i, 500at

Clearance number:	K082599
Manufacturer:	CNSystems Medizintechnik AGReininghausstrasse 13, A-8020 Graz, Austria
This predicate device has not been subject to a design-related recall.

5.2.2 Secondary Predicate Device - EV1000 Clinical Platform Non-Invasive (NI) and ClearSight Finger Cuffs or ClearSight System, EV1000 Clinical Platform

Clearance number:	K160552
Manufacturer:	Edwards Lifesciences, LLCOne Edwards Way, Irvine, California 92614
This predicate device has been subject to a design-related recall class 1, event ID 82456. The CNAP® Monitor 500 HD was assessed regarding the assessed cause and hazard and found to be not affected. See Section 10 and 11 for Details.

5.2.3 Third Predicate Device - PulsioFlex Monitoring System

Clearance number:	K172259
Manufacturer:	PULSION Medical Systems SE;Maquet Cardiovascular45 Barbour Pond Drive Wayne, New Jersey 07470
This predicate device has not been subject to a design-related recall.

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Device Description 5.3

Image /page/5/Picture/3 description: The image shows a CNAP Monitor 500 HD and its accessories. The accessories include an NBP cuff, NBP extension hose, CNAP cable, CNAP controller, and CNAP double finger cuff. The monitor has a screen displaying various readings, including 103/71, 4.9, and 72.

Figure 1 CNAP® Monitor 500 HD with external components

Indications for use / Intended use 5.4

The CNAP® Monitor 500 HD is intended for the non-invasive continuous monitoring of blood pressure, pulse rate, and the determination of associated derived hemodynamic parameters including cardiac output within hospitals. The device displays the blood pressure waveform, trends, and numeric for blood pressure, pulse rate, and associated derived hemodynamic parameters, Alarms are generated for blood pressure parameters and pulse rate.

The CNAP® Monitor 500 HD is to be used for adults and is to be operated by healthcare professionals.

Comparison of technological characteristics with the predicate device 5.5

The hardware of the CNAP® Monitor 500 HD is very similar to the primary predicate CNAP® Monitor 500i, 500at, with following modifications:

Changes to hardware:

Exchange of the display and adaption of related components (e.g. ferrite) ●
Exchange of components and pressure sensors in the CNAP® Controller ● and related redesign of the printed circuit board (PCB).
Additional symbol stickers on the housing of the CNAP® Monitor 500 HD ●

Functional improvements and additional parameters:

New variability parameter derived from blood pressure curve: PPV. ●

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New hemodynamic parameters derived from blood pressure curve: CO, ● SV, SVR, CI, SI, SVRI, and subsequently modified screen layout.
Improved controllers for the continuous blood pressure measurement . function and startup sequence for the continuous blood pressure measurement function.

Performance data 5.6

The Design verification and validation has demonstrated that the CNAP® Monitor 500 HD performs within its specifications and within the limits of the applied performance standards.

The design verification and validation activities for the CNAP® Monitor 500 HD consists of:

. Requirement verification
Code reviews ●
Static code analysis ●
Regression testing
Verification of applicable product standards and Product Requirements ●
(Clinical) Performance Validation and (Summative) Usability Validation ●

Biocompatibility testinq 5.6.1

All surface materials have a biocompatibility approval. The materials are not modified during assembling and therefore all certificates remain valid, a new assessment for biocompatibility is not necessary.

The biocompatibility evaluation for CNAP® Monitor 500 HD device was conducted in accordance with the FDA Blue Book Memorandum #G95-1 "Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and International Standard ISO 10993-1 "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing Within a Risk Management Process", as recognized by FDA.

Cytotoxicity, Sensitization, Irritation tests were performed.

5.6.2 Electrical safety and electromagnetic compatibility (EMC), Mechanical and acoustical testing

The Electromagnetic Compatibility and Electrical Safety, according to applicable product standards:

IEC 60601-1:2005+A1:2012 ●
IEC 60601-1-2:2014 ●
IEC 60601-1-8:2006+A1:2012 ●
IEC 80601-2-30:2009 .

confirmed by the accredited laboratories OVE AUSTRIAN are ELECTOTECHNICAL ASSOCIATION, TÜV Testing Laboratory Vienna, Intertek Testing Services NA and Seibersdorf laboratories.

Section 5 510(k) Summary

DocName: 005 510(k) Summary.pdf

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5.6.3 Software Verification and Validation Testing

Software verification and validation testing were conducted and documentation was provided as recommended by FDA's Guidance for Industry and FDA Staff, "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices."

The software for this device was considered as a "major" level of concern, since the CNAP® Monitor 500 HD is a stand-alone non-invasive blood pressure monitoring device with an alarming system.

5.6.4 Animal Testing

Not applicable.

5.6.5 Clinical Testing

For clinical testing and evaluation measurement data from different sources was used to demonstrate that the device is substantially equivalent to the predicate devices.

5.6.6 Performance Data - Conclusion

The clinical performance data demonstrates that the CNAP® Monitor 500 HD performs comparable to the predicate devices for the assessed parameters.

Conclusion for Substantial Equivalence 5.7 -

CNSystems has concluded that the technological characteristics of the CNAP® Monitor 500 HD are substantial equivalent to the primary predicate device, as it relies on the same hardware platform and measurement principle.

In addition, the technological characteristics regarding the calculation the hemodynamic and variability parameters from the continuous waveform are substantially equivalent in performance to the secondary predicate device.

CNSystems has conducted risk analysis and performed necessary verification and validation activities to demonstrate that the design output of the new device meets the design input requirements.

The CNAP® Monitor 500 HD has been shown to be safe and effective. It is substantial equivalent to the predicate devices for their respective intended uses.

Section 5 510(k) Summary DocName: 005 510(k) Summary.pdf

Regulation Number and Section

§ 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).