(23 days)
Not Found
No
The summary describes a heart-lung machine and an in-line blood monitoring system with sensors and data display. There is no mention of AI, ML, or any algorithms that would suggest learning or adaptive capabilities. The performance studies focus on electrical safety, EMC, performance testing, and software verification/validation, not AI/ML model performance.
No
The Essenz HLM is a heart-lung machine designed for use during cardiopulmonary bypass procedures, which is a life support device. The Essenz ILBM is an in-line blood monitoring device used with the heart-lung machine; it measures blood parameters but does not provide therapy.
Yes
The Essenz ILBM is indicated for "in-line continuous monitoring of patient's blood parameters" and measures various blood parameters such as oxygen partial pressure, oxygen saturation, hematocrit/hemoglobin, and temperature. These measurements are used to provide information about the patient's physiological state during cardiopulmonary bypass procedures, which falls under the definition of a diagnostic device.
No
The device description explicitly lists numerous hardware components including a central console base, pumps, sensors (bubble, level, temperature, pressure, flow), clamps, and disposable cuvettes. While it includes software for data display and functional connection, it is fundamentally a hardware-based system with integrated software.
Based on the provided information, the Essenz ILBM device is an In Vitro Diagnostic (IVD).
Here's why:
- Measures blood parameters: The Essenz ILBM is specifically designed to measure parameters of the patient's blood (hematocrit/hemoglobin, oxygen saturation, oxygen partial pressure, and temperature).
- In-line monitoring: While the blood is still within the extracorporeal circuit, the measurements are taken directly from the blood itself.
- Diagnostic information: The measured blood parameters provide diagnostic information about the patient's physiological state during cardiopulmonary bypass.
The Essenz HLM itself is a heart-lung machine, which is a life support device, not an IVD. However, the Essenz ILBM is a component that integrates with the Essenz HLM to provide the IVD functionality.
Therefore, while the entire system might not be classified solely as an IVD, the Essenz ILBM component clearly fits the definition of an In Vitro Diagnostic device as it performs tests on biological specimens (blood) to provide diagnostic information.
N/A
Intended Use / Indications for Use
Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal pressure, venous arterial oxygen partial oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six (6) hours.
Product codes
DTQ, DRY
Device Description
Essenz HLM is a modular heart-lung machine. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifugal 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, several control units and Sensor Interface Modules.
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 speed-controlled pumping of flow in the ECC (Extra Corporeal Circulation) using a peristaltic (positive displacement) pump or using a roto-dynamic pump (non-occlusive), 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.
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.
Venous Clamp: The clamp closes automatically when the stop link function to the arterial pump is activated. It can be opened or closed manually by the operator via a connected Control Unit.
Arterial Clamp: 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. Data interface between the 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
Essenz ILBM is used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation when used with a compatible heart-lung machine.
Provided in-line measured parameters of Essenz ILBM are: In the Venous line:
- Haematocrit / Haemoqlobin (Hct/Hb)
- Venous blood oxygen saturation (sO2)
- Venous blood temperature (venT)
In the Arterial line:
- Arterial blood oxygen partial pressure (pO2)
- Arterial blood temperature (artT)
The duration of application is limited to 6 hours of continuous use.
Essenz ILBM consists of the following components / disposables:
- B-Capta Venous and Arterial Sensors
- Essenz ILBM Sensor Module
- B-Capta Venous and Arterial Reference Element Holders
- B-Capta disposable Venous and Arterial Cuvettes
The B-Capta venous sensor is an optical sensor which measures hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the venous blood.
The B-Capta arterial sensor is an optical sensor which measures, partial pressure of oxygen using an optical fluorescence technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the arterial blood.
Both sensors are functionally connected to the compatible heart-lung machine. Data are displayed on the graphical user interface of the compatible heart-lung machine.
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
Not Found
Intended User / Care Setting
Not Found
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)
No animal testing was submitted to support the substantial equivalence of the Essenz HLM and Essenz ILBM to their predicate devices.
In accordance with 21 CFR 820.30, LivaNova Deutschland GmbH. has conducted the following verification and validation testing of the Essenz HLM and Essenz ILBM to ensure that they can provide all the capabilities necessary to operate safely and effectively:
- Electrical safety
- Electromagnetic compatibility (EMC)
- Performance testing
- Software verification and validation
No clinical testing was conducted in support of the Essenz HLM and Essenz ILBM as the technological characteristics and indications for use are equivalent to those of the predicate devices. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with the respective predicate devices.
Performance and validation data demonstrate that the subject Essenz HLM and the subject Essenz ILBM are as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Essenz HLM, K221373, B-Capta, K202154
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.4220 Cardiopulmonary bypass heart-lung machine console.
(a)
Identification. A cardiopulmonary bypass heart-lung machine console is a device that consists of a control panel and the electrical power and control circuitry for a heart-lung machine. The console is designed to interface with the basic units used in a gas exchange system, including the pumps, oxygenator, and heat exchanger.(b)
Classification. Class II (performance standards).
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 and Human Services logo on the left and the FDA acronym and name on the right. The FDA acronym and name are in blue, with the acronym in a larger font size than the name. The name is written as "U.S. FOOD & DRUG ADMINISTRATION".
August 24, 2023
LivaNova Deutschland GmbH Julie Leslie Sr. Director, Regulatory Affairs, Cardiopulmonary Lindberghstr. 25 Munich, 80939 Germany
Re: K232291
Trade/Device Name: Essenz HLM, Essenz IBLM Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ, DRY, Dated: July 31, 2023 Received: August 1, 2023
Dear Julie 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.
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
1
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,
Nicole M. Gillette -S
Nicole Gillette Assistant Director DHT2B: Division of Circulatory Support, Structural and Vascular Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
Submission Number (if known)
Device Name
Essenz HILM
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)
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
Indications for Use
510(k) Number (if known)
Device Name Essenz ILBM
Indications for Use (Describe)
Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal arterial oxygen partial pressure, venous oxygen saturation, venous hematocrithemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six hours.
Type of Use (Select one or both, as applicable)
| ☑ Prescription Use (Part 21 CER 801 Subpart D) |
|---|
| ☐ Over-The-Counter Use (21 CER 801 Subpart C) |
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4
K232291
510(k) Summary
SUBMITTER
| Name: | LivaNova Deutschland GmbH |
|---|---|
| Address: | Lindberghstrasse 25 |
| D-80939 München, Germany | |
| Establishment | |
| Registration Number | 9611109 (Manufacturer: LivaNova Deutschland) |
| Contact Person: | Florian Goetz |
| Phone: | +49 89 323 01 236 |
| Email: | florian.goetz@livanova.com |
| Secondary Contact: | Julie E. Leslie, PhD |
| Phone: | +49 89 323 01 141 |
| Email: | julie.leslie@livanova.com |
| Date Prepared: | July 31, 2023 |
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 |
| Device Class: | Class II |
| Proprietary Name: | Essenz ILBM |
|---|---|
| Common Name: | Extracorporeal blood-gas monitor |
| Classification Name: | Cardiopulmonary bypass on-line blood gas monitor |
| Regulation Number: | 21CFR870.4330 |
| Product Code: | DRY |
| Device Class: | Class II |
5
PREDICATE DEVICE INFORMATION
Essenz HLM is substantially equivalent in function and intended use to its predicate Essenz HLM, K221373, LivaNova Deutschland GmbH.
Essenz ILBM is substantially equivalent in function and intended use to its predicate B-Capta, K202154, LivaNova Deutschland GmbH.
INDICATIONS FOR USE
Essenz HLM is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
Essenz ILBM is indicated for supplementary, in-line monitoring of the extracorporeal pressure, venous arterial oxygen partial oxygen saturation, venous hematocrit/hemoglobin, and arterial and venous temperature during cardiopulmonary bypass procedures up to six (6) hours.
DEVICE DESCRIPTION
Essenz HLM is a modular heart-lung machine. The device consists of a central console base for support, positioning mobility and power supply, roller and centrifugal 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, several control units and Sensor Interface Modules.
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 speed-controlled pumping of flow in the ECC (Extra Corporeal Circulation) using a peristaltic 510(k) SUMMARY- Paqe 2 of 6
6
(positive displacement) pump or using a roto-dynamic pump (non-occlusive), 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.
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.
Venous Clamp
The clamp closes automatically when the stop link function to the arterial pump is activated. It can be opened or closed manually by the operator via a connected Control Unit.
Arterial Clamp
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. Data interface between the system components.
Cabinet (Enclosure)
Data interface between external devices and Data Management System, incl. data encryption
7
Mast
Provides structural stability and mounting points for system components and disposables
Essenz ILBM is used for in-line continuous monitoring of patient's blood parameters during procedures requiring extracorporeal circulation when used with a compatible heart-lung machine.
Provided in-line measured parameters of Essenz ILBM are: In the Venous line:
- Haematocrit / Haemoqlobin (Hct/Hb) =
- Venous blood oxygen saturation (sO2)
- 트 Venous blood temperature (venT)
In the Arterial line:
- Arterial blood oxygen partial pressure (pO2)
- 트 Arterial blood temperature (artT)
The duration of application is limited to 6 hours of continuous use.
Essenz ILBM consists of the following components / disposables:
- B-Capta Venous and Arterial Sensors =
- Essenz ILBM Sensor Module
- 트 B-Capta Venous and Arterial Reference Element Holders
- 프 B-Capta disposable Venous and Arterial Cuvettes
The B-Capta venous sensor is an optical sensor which measures hematocrit/hemoglobin and oxygen saturation using an optical reflectance technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the venous blood.
The B-Capta arterial sensor is an optical sensor which measures, partial pressure of oxygen using an optical fluorescence technology when connected to its dedicated disposable cuvette. Infrared technology is used to measure the temperature of the arterial blood.
Both sensors are functionally connected to the compatible heart-lung machine. Data are displayed on the graphical user interface of the compatible heart-lung machine.
8
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE
Essenz HLM and its predicate have the same indications for use, intended use, use environment, intended user, target patient population, principles of operation and technological characteristics. The minor functional differences, including compatibility to LivaNova's Essenz ILBM blood gas monitor and new software and graphical user interface, between the cleared and modified devices do not raise different questions of safety or effectiveness.
Essenz ILBM and its predicate, B-Capta, have the same indications for use, intended use, use environment, intended user, target patient population, principles of operation and technological characteristics.
B-Capta is designed to work integrated with a LivaNova S5 System (K210130). Essenz ILBM, which is a modified B-Capta, is intended to be compatible with LivaNova's Essenz HLM, using the Essenz HLM graphical user interface. The minor differences in interoperability do not raise new issues of safety or effectiveness.
PERFORMANCE DATA - NON-CLINICAL TESTING
No animal testing was submitted to support the substantial equivalence of the Essenz HLM and Essenz ILBM to their predicate devices.
In accordance with 21 CFR 820.30, LivaNova Deutschland GmbH. has conducted the following verification and validation testing of the Essenz HLM and Essenz ILBM to ensure that they can provide all the capabilities necessary to operate safely and effectively:
- Electrical safety ם
- . Electromagnetic compatibility (EMC)
- Performance testing
- Software verification and validation
In support of the determination of substantial equivalence of the Essenz HLM and Essenz ILBM to their predicate devices, the following recognized Standards have been used:
9
| Standard | Title | FDA
recognition
number |
|-------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------|
| IEC 62304 | Medical device software - Software life
cycle processes | 13-79 |
| IEC 60601-1 | Medical electrical equipment - Part 1:
General requirements for basic safety and
essential performance | 19-49 |
| IEC 60601-1-2 | Medical electrical equipment - Part 1-2:
General requirements for basic safety and
essential performance - - Collateral
Standard: Electromagnetic disturbances -
Requirements and tests | 19-36 |
| IEC /TR 60601-4-2 | Medical electrical equipment - Part 4-2:
Guidance and interpretation
Electromagnetic immunity: performance of
medical electrical equipment and medical
electrical systems | 19-19 |
| IEC 62366-1 | Medical devices - Part 1: Application of
usability engineering to medical devices | 5-129 |
PERFORMANCE DATA - CLINICAL TESTING
No clinical testing was conducted in support of the Essenz HLM and Essenz ILBM as the technological characteristics and indications for use are equivalent to those of the predicate devices. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with the respective predicate devices.
SUBSTANTIAL EQUIVALENCE
The Essenz HLM and Essenz ILBM are as safe and effective as the predicate Essenz HLM and B-Capta. Both devices have the same intended use and indications, similar technological characteristics, and the same principles of operation and performance specifications as their predicate devices. The minor technological and functional 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 and the subject Essenz ILBM are as safe and effective as the predicate devices. Thus, the Essenz HLM and Essenz ILBM are substantially equivalent to their predicates.