ESSENZ Patient Monitor is a modularly structured program package that is exclusively used with LivaNova Heart-Lung Machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.

Device Description

The ESSENZ Patient Monitor is used to collect and view data generated during cardiopulmonary bypass surgery. It interfaces with LivaNova Heart-Lung machines to capture this data.

The ESSENZ Patient Monitor includes the following main components:

Software: The data-recording software installed on the Perfusion System Monitor hardware; known as "ESSENZ Patient Monitor". It is used to save and process the collected data.
Hardware: The Perfusion System Monitor. It is used to display and transfer the collected data.
Hardware: A mast holder to mount the Perfusion System Monitor on a vertical mast of the respective LivaNova HLM.

AI/ML Overview

This document describes the ESSENZ Patient Monitor, a device used with LivaNova Heart-Lung Machines to record, process, and evaluate perfusion data during cardiopulmonary bypass. The information provided is for a 510(k) premarket notification (K212003).

Here's an analysis of the acceptance criteria and supporting studies based on the provided text:

1. Table of Acceptance Criteria and the Reported Device Performance:

The document does not explicitly present a table of acceptance criteria with specific numerical targets. Instead, it states that the device was evaluated against recognized standards and through various non-clinical tests to demonstrate substantial equivalence to a predicate device (Sorin CONNECT, K170460). The general acceptance criterion is that the modified device is "as safe and effective" as the predicate.

For the purpose of this request, we can infer the categories of acceptance criteria from the performed tests and their general outcome:

Acceptance Criteria Category (Inferred)	Reported Device Performance
Electrical Safety	Complies with IEC 60601-1 2005 A1:2012 (Medical electrical equipment - Part 1: General requirements for basic safety and essential performance).
Electromagnetic Compatibility (EMC)	Complies with IEC 60601-1-2 Edition 4.0 2014 (Medical electrical equipment - Part 1-2: General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic disturbances - Requirements and tests).
Software Performance & Reliability	Software verification and validation conducted. Complies with IEC 62304 Edition 1.1 2015 (Medical device software - Software life cycle processes).
Usability & Human Factors	Human Factors testing conducted. Complies with IEC 60601-1-6 Edition 3.2 (Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability) and IEC 62366-1 Edition 1.0 2015 (Medical devices — Part 1: Application of usability engineering to medical devices).
Risk Management	Complies with ISO 14971 Third Edition 2019 (Application of risk management to medical devices).
General Performance	Performance testing conducted.
Shipping & Durability	Performance testing of shipping containers conducted.
Substantial Equivalence	The modified ESSENZ Patient Monitor is determined to be as safe and effective as the cleared Sorin CONNECT, with the same intended use, indications, similar technological characteristics, and same principles of operation.

2. Sample size used for the test set and the data provenance:

Test Set Sample Size: The document does not specify a quantitative "test set sample size" in terms of patient data or specific number of tests. The testing described (Electrical Safety, EMC, Performance, Software V&V, Human Factors, Shipping) is related to hardware and software requirements, not clinical data sets in the typical sense of a diagnostic or therapeutic algorithm.
Data Provenance: The tests conducted are non-clinical hardware and software verification and validation tests performed by the manufacturer, LivaNova Deutschland GmbH. The data provenance is internal to the manufacturer's testing processes. There is no mention of country of origin for a clinical data set because no clinical testing was performed or relied upon. The report states, "No animal testing was submitted to support the substantial equivalence of the modified device to the cleared Sorin CONNECT," and "No clinical testing was conducted in support of ESSENZ Patient Monitor."

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

This information is not applicable to the submitted document. The "ground truth" in this context refers to the compliance with engineering and regulatory standards established through non-clinical testing. These tests are evaluated against predefined specifications and industry standards, not against an expert-established clinical ground truth for a diagnostic outcome.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies for interpretation of images or clinical outcomes, which were not part of this 510(k) submission for the given device. The testing was against engineering specifications and recognized standards.

5. 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:

No MRMC study was conducted or is relevant to this device's submission. The ESSENZ Patient Monitor is a data management system for perfusion data during cardiopulmonary bypass; it is not an AI-assisted diagnostic tool that would involve human readers or image interpretation.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

The concept of "standalone performance" for an algorithm often applies to diagnostic or predictive AI. In this case, the "standalone performance" can be considered as the device's ability to accurately record, process, and evaluate perfusion data according to its specifications and in compliance with the relevant standards (IEC 60601-1, IEC 60601-1-2, IEC 62304, etc.) without human intervention in the data handling itself. The software verification and validation, along with performance testing, would cover this aspect. However, the device is explicitly used "with LivaNova Heart-Lung Machines" and the data can be "recorded automatically or entered manually," implying it is part of a larger system where human interaction remains.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical testing of the ESSENZ Patient Monitor is compliance with established engineering and safety standards (e.g., IEC 60601 series, IEC 62304, ISO 14971). The ground truth for its functional performance (data recording, processing, evaluation) would be derived from comparisons against expected computational and display outputs based on defined inputs, ensuring accuracy and reliability as specified in the device's design.

8. The sample size for the training set:

This information is not applicable. The ESSENZ Patient Monitor is a data management system, not a machine learning or AI model that requires a "training set." The software is re-engineered from a legacy version and verified/validated against specifications.

9. How the ground truth for the training set was established:

This information is not applicable, as there is no "training set" for this device.

Summary

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November 10, 2021

LivaNova Deutschland GmbH Florian Goetz Senior Specialist Regulatory Affairs Lindberghstr. 25 Munich, Bavaria 80939 Germany

Re: K212003

Trade/Device Name: ESSENZ Patient Monitor Regulation Number: 21 CFR 870.2450 Regulation Name: Medical Cathode-Ray Tube Display Regulatory Class: Class II Product Code: DXJ Dated: October 14, 2021 Received: October 15, 2021

Dear Florian Goetz:

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

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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

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Indications for Use

510(k) Number (if known) K212003

Device Name ESSENZ Patient Monitor

Indications for Use (Describe)

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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7.0 510(K) SUMMARY

ESSENZ Patient Monitor

Applicant

LivaNova Deutschland GmbH Lindberghstr. 25 80939 Munich Germany

Contact information
Primary contact person	Alternate contact person
Florian GoetzSpecialist Regulatory AffairsFlorian.Goetz@LivaNova.com	Mattia RonchettiDirector Regulatory AffairsMattia.Ronchetti@LivaNova.com

Date Prepared: June 25, 2021

Application Correspondent

LivaNova USA, Inc. 14401 West 65th Way Arvada, CO 80004 USA

Contact information

Celeste Kreul Senior Manager, Quality Engineering Tel: (303) 467-6476 E-mail: Celeste.Kreul@livanova.com

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Device Information

Proprietary Name:	ESSENZ Patient Monitor
Common/Usual Name:	Data Management System
Classification Name:	Medical cathode-ray tube display
Classification Panel:	Cardiovascular
Device Class:	Class II
Regulation Number:	21 CFR § 870.2450
Product Code:	DXJ

Predicate Device Information

The modified ESSENZ Patient Monitor is substantially equivalent in function and intended use to the Sorin CONNECT cleared in Premarket Notification K170460.

Indications for Use

The device is a modularly structured program package that is exclusively used with LivaNova/Stockert heart lung machines. The system allows detailed recording of perfusion data during cardiopulmonary bypass as well as the processing and evaluation of this data. The data may be recorded automatically or entered manually.

Device Description

The ESSENZ Patient Monitor is used to collect and view data generated during cardiopulmonary bypass surgery. It interfaces with LivaNova Heart-Lung machines to capture this data.

The ESSENZ Patient Monitor includes the following main components:

트 Software: The data-recording software installed on the Perfusion System Monitor hardware; known as "ESSENZ Patient Monitor". It is used to save and process the collected data.
l Hardware: The Perfusion System Monitor. It is used to display and transfer the collected data.

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Hardware: A mast holder to mount the Perfusion System Monitor on a vertical mast of the respective LivaNova HLM.
A description of the modules comprising the ESSENZ Patient Monitor is provided below:

Component	Description
ESSENZ Patient Monitor Software	Sample view of Home-screen:
Perfusion System Monitor	ESSENZ Perfusion System Monitor comes complete with an AC/DC power adapter with lockable DC connector.
Perfusion System Monitor holder	The mechanical holder allows Perfusion System Monitor to be mounted on a vertical mast of a compatible LivaNova Heart-Lung Machine.

Table 7-1: ESSENZ Patient Monitor System components

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Technological Characteristics

The modified ESSENZ Patient Monitor has the same fundamental technological characteristics, principles of operation, and control mechanisms as the unmodified device. The device modifications are described below.

Reengineering of the CONNECT legacy software
" Use of a new hardware monitor to replace the CONNECT Datapad
" Adaptation of wording in the indications for use statement to reflect the company name change from "Sorin" to "LivaNova" (the rewording does not affect the substance or meaning of the indications for use)
Introduction of a new brand name (before: "Sorin CONNECT", after: "Essenz Patient Monitor")

Performance Data - Non-Clinical Testing

No animal testing was submitted to support the substantial equivalence of the modified device to the cleared Sorin CONNECT.

In accordance with 21 CFR 820.30, LivaNova Deutschland GmbH. has conducted the following verification and validation testing of the ESSENZ Patient Monitor design modifications, using well-established methods, to ensure that it can provide all the capabilities necessary to operate safely and effectively and that unchanged functions of the device continue to operate as intended:

. Electrical safety
. Electromagnetic compatibility (EMC)
I Performance testing
I Software verification and validation
I Human Factors testing
I Performance testing of shipping containers

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In support of the determination of substantial equivalence of the modified device to the cleared Sorin CONNECT, the following recognized Standards have been complied with:

Standard	Title	FDArecognitionnumber
IEC 60601-1 2005A1:2012	Medical electrical equipment - Part 1:General requirements for basic safety andessential performance	19-4
IEC 60601-1-2 Edition 4.02014	Medical electrical equipment - Part 1-2:General requirements for basic safety andessential performance - CollateralStandard: Electromagnetic disturbances -Requirements and tests	19-8
IEC 60601-1-6 Edition 3.2	Medical electrical equipment - Part 1-6:General requirements for basic safety andessential performance - Collateralstandard: Usability	5-132
IEC 62366-1 Edition 1.02015	Medical devices — Part 1: Application ofusability engineering to medical devices	5-114
IEC 62304 Edition 1.12015	Medical device software - Software lifecycle processes	13-79
ISO 14971 Third Edition2019	Application of risk management to medicaldevices	5-125

Performance Data - Clinical Testing

No clinical testing was conducted in support of ESSENZ Patient Monitor, as the technological characteristics and indications for use are equivalent to those of the predicate device, which has been on the market for several years with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with the respective predicate device in relation to the changes that are subject of this submission.

Substantial Equivalence

The modified ESSENZ Patient Monitor is as safe and effective as the cleared Sorin CONNECT. The modified device has the same intended use and indications, similar technological characteristics, and the same principles of operation as its predicate device. The minor technological differences between the cleared and modified device do not raise different questions of safety or effectiveness. Performance and validation data demonstrate that the subject ESSENZ Patient Monitor is as safe and effective as the predicate device. Thus, the modified ESSENZ Patient Monitor is substantially equivalent to its predicate.

Regulation Number and Section

§ 870.2450 Medical cathode-ray tube display.

(a)
Identification. A medical cathode-ray tube display is a device designed primarily to display selected biological signals. This device often incorporates special display features unique to a specific biological signal.(b)
Classification. Class II (performance standards).