Essenz HLM

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: 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 smaller font. March 9, 2023 LivaNova Deutschland GmbH Julia Leslie Senior Director, Regulatory Affairs Lindberghstr. 25 Munich, Bavaria 80939 Germany Re: K221373 Trade/Device Name: Essenz HLM Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ, DWA, DWF Dated: January 18, 2023 Received: January 27, 2023 Dear Julia Leslie: 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. {1}------------------------------------------------ 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 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 medical devices and radiation-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. # Rachel E. Neubrander -S for Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K221373 Device Name Essenz HLM Indications for Use (Describe) Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. | Type of Use (Select one or both, as applicable) | | |---------------------------------------------------------------------------------------------------------------------------------------------------------|--| | <span style="font-size: 10pt;"> <b> <span style="font-family: Symbol;">☑</span> </b> Prescription Use (Part 21 CFR 801 Subpart D) </span> | | | <span style="font-size: 10pt;"> <b> <span style="font-family: Symbol;">☐</span> </b> Over-The-Counter Use (21 CFR 801 Subpart C) </span> | | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ # K221373 # 510(k) SUMMARY # I. SUBMITTER | Name: | LivaNova Deutschland GmbH | |--------------------------------------|-------------------------------------------------| | Address: | Lindberghstrasse 25<br>D-80939 München, Germany | | Establishment<br>Registration Number | 9611109 (Manufacturer: LivaNova Deutschland) | | Contact Person: | Julia E. Leslie, PhD | | Phone: | +49 89 323 01 141 | | Email: | julie.leslie@livanova.com | | Secondary Contact: | Florian Goetz | | Phone: | +49 89 323 01 236 | | Email: | florian.goetz@livanova.com | | Date Prepared: | March 3, 2023 | # II. DEVICE | Proprietary Name: | Essenz HLM | |-----------------------------|-----------------------------------------------------| | Common Name: | Heart-Lung Machine | | Classification Name: | Console, Heart-Lung Machine, Cardiopulmonary Bypass | | Classification Panel: | 74 Cardiovascular | | Regulation Number: | 21CFR870.4220 | | Product Code: | DTQ | | Secondary Product<br>Codes: | DWA, DWF | | Device Class: | Class II | {4}------------------------------------------------ ## III. PREDICATE DEVICE INFORMATION Primary predicate: - Stöckert S5 System, Heart-Lung Machine (K210130) ● Secondary predicates: - Sorin Centrifuqal Pump 5 (CP5) (K112225) ● - . Electrical Venous Occluder (EVO) (K082344) # IV. INDICATIONS FOR USE Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less. # V. DEVICE DESCRIPTION Essenz HLM is a modular heart-lung machine like its primary predicate Stöckert S5 System. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifuqal pumps, user interface displays, controls, clamps and sensors for the monitoring of extracorporeal perfusion. The Essenz HLM is configurable to user needs with different system components. The main configurable and optional system components consist of: ## Console The Console provides a mobile chassis containing the power supply and several control units. ## Cockpit The Essenz HLM Cockpit contains the display and control modules for monitoring, control and measuring devices and is the central user interface between the operator and the Essenz HLM. ## Control Units/ Console Control Units Control and independent supervision of connected pump drive or EVO via local CAN, incl. dual (alternative) actuator management for leftmost CCU. #### Pumps Pumps may be roller or centrifugal pump type. Pumps provide speedcontrolled pumping of flow in the ECC (Extra Corporeal Circulation) using a peristaltic (positive displacement) pump or using a roto-dynamic pump (nonocclusive), automatic clamping and pump control according to measured flow rate and direction ## Bubble sensor Monitoring device that detects air bubbles and microbubbles in the ECC - if detected, a visual and acoustic alarm is triggered, and the pump stops. {5}------------------------------------------------ #### Level sensor The level monitor controls the blood level in the oxygenator/reservoir. Display, alarm generation and pump speed requlation based on detection of blood level in a venous reservoir within the ECC. #### Temperature sensor The temperature monitor allows the simultaneous measurement and display of up to four temperatures, as measured by connected temperature probes. Display and alarm generation based on measurement of temperature of flow within the ECC. #### Pressure sensor The pressure sensor module is used to measure and display the pressure in the extracorporeal circuit. Display, alarm generation and pump speed regulation based on measurement of pressure in the ECC. #### Flow Sensor The flow sensor monitors flow in tubing. Display, alarm generation and pump regulation based on measurement of flow in the ECC. #### Manual Venous Occluder Provides a separate control unit and line clamp. #### Electrical venous occluder (EVO) The clamp closes automatically when the stop link function to the arterial pump is activated. #### Arterial Clamp/ Electric Remote Control Clamp arterial line upon centrifugal pump stop / min rpm to fully stop the flow, prevent gravitational backflow in tubing and prevent air delivery to the patient #### EP-Pack/ Power Pack Provide power to system components #### Cabinet (Enclosure) Data interface between external devices and Data Management System, incl. data encryption #### Mast Provides structural stability and mounting points for system components and disposables {6}------------------------------------------------ # VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE LivaNova's Essenz HLM and its predicates have the same indications for use, intended use, use environment, intended user, target patient population, principles of operation and technological characteristics. The minor technological differences, including minor updates to pumps, and new software and graphical user interface, between the cleared and modified devices do not raise different questions of safety or effectiveness. # VII. PERFORMANCE DATA # NON-CLINICAL TESTING In accordance with 21 CFR 820.30, LivaNova Deutschland GmbH. has conducted the following verification and validation testing of the Essenz HLM to ensure that it can provide all the capabilities necessary to operate safely and effectively: - Electrical safety . - Electromagnetic compatibility (EMC) - 트 Performance testing - " Software verification and validation - Human Factors testing . - . Mechanical testing - Performance testing of shipping containers I In support of the determination of substantial equivalence of the Essenz HLM to its predicate devices, the following recognized Standards have been used: | Standard | Title | FDA<br>recognition<br>number | |-----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------| | IEC 60601-1 2005<br>A1:2012 | Medical electrical equipment - Part 1:<br>General requirements for basic safety and<br>essential performance | 19-4 | | IEC 60601-1-2 Edition 4.0<br>2014 | Medical electrical equipment - Part 1-2:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>Electromagnetic disturbances<br>Requirements and tests | 19-8 | | IEC 62366-1 Edition 1.0<br>2015 | Medical devices — Part 1: Application of<br>usability engineering to medical devices | 5-114 | | 60601-1-8:2006 and<br>A1:2012 | Medical electrical equipment - Part 1-8:<br>General requirements for basic safety and<br>essential performance - Collateral Standard:<br>General requirements, tests and guidance | 5-76 | {7}------------------------------------------------ | | for alarm systems in medical electrical<br>equipment and medical electrical systems | | |---------------------------------|-------------------------------------------------------------------------------------|-------| | IEC 62304 Edition 1.1<br>2015 | Medical device software - Software life<br>cycle processes | 13-79 | | ISO 14971 Third Edition<br>2019 | Application of risk management to medical<br>devices | 5-125 | # CLINICAL TESTING None required. # ANIMAL TESTING None required. # VIII. SUBSTANTIAL EQUIVALENCE The Essenz HLM is as safe and effective as the predicate S5 System. The Essenz HLM has the same intended use and indications, similar technological characteristics, and the same principles of operation as its predicate devices. The minor technological differences between the cleared and modified devices do not raise different questions of safety or effectiveness. Performance and validation data demonstrate that the subject Essenz HLM is as safe and effective as the predicate devices.