(76 days)
The Stöckert SS System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
The S5 System is configurable to user needs with different system components. The main configurable and optional system components consist of: Console, System Panel, Pumps, Bubble detector, Level control, Temperature monitor, Pressure control, Cardioplegia Control, Electronic gas blender, Serial Data interface, Venous line clamps (manual), Electrical venous occlude (EVO).
The provided text is a 510(k) summary for the Stöckert S5 System, a Class II medical device (Heart-Lung Machine). It describes the device, its intended use, and the non-clinical testing performed to demonstrate substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
No specific acceptance criteria (numerical thresholds for performance metrics) or a study proving that the device meets those criteria is explicitly provided in the typical format one would expect for an AI/ML device.
The document is a 510(k) Pre-market Notification, which focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific performance acceptance criteria against a clinical endpoint with defined sensitivity/specificity/accuracy thresholds. The studies described are primarily verification and validation (V&V) testing to ensure the device performs as intended and is safe and effective compared to its predicate.
Therefore, the interpretation below will focus on understanding the "acceptance criteria" through the lens of substantial equivalence and the "study" as the non-clinical testing performed for this purpose.
1. Table of Acceptance Criteria and Reported Device Performance
As noted, the document doesn't provide a typical table of acceptance criteria with numerical targets (e.g., sensitivity, specificity, accuracy). Instead, the "acceptance criteria" are implied by compliance with recognized standards and successful completion of various V&V tests, demonstrating that the device functions correctly and safely. The "reported device performance" is the successful completion of these tests.
| Acceptance Criteria (Implied by V&V) | Reported Device Performance |
|---|---|
| Electrical Safety Compliance | Passed Electrical Safety Tests (IEC 60601-1) |
| Electromagnetic Compatibility (EMC) Compliance | Passed EMC Tests (IEC 60601-1-2) |
| General Performance Requirements | Passed Performance Testing |
| Software Functionality | Passed Software Verification and Validation (IEC 62304) |
| Usability/Human Factors | Passed Human Factors Testing (IEC 62366-1) |
| Alarm System Functionality | Passed Alarm System Tests (IEC 60601-1-8) |
| Risk Management Compliance | Risk Management Process Applied (ISO 14971) |
| Mechanical Integrity of Modifications | Passed Mechanical Testing of Modified Sensor Holder |
| Shipping Container Performance | Passed Performance Testing of Shipping Containers |
| Overall Substantial Equivalence to Predicate | Demonstrated as safe and effective as the cleared S5 System, with same intended use and indications, similar technological characteristics, and same principles of operation. |
Regarding the remaining requested information, it's important to understand that this document describes a hardware/software medical device (a Heart-Lung Machine) and not an AI/ML diagnostic or prognostic algorithm. Therefore, many of the requested fields are not applicable or cannot be answered from the provided text because they relate specifically to AI/ML performance evaluation.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not Applicable / Not Provided: The nature of the testing (electrical safety, EMC, mechanical, software V&V) does not typically involve "test sets" of patient data or data provenance in the way an AI/ML diagnostic device would. These tests are performed on the device itself or its components. The document does not specify sample sizes for these engineering tests (e.g., how many units were tested for electrical safety).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not Applicable: This type of medical device (Heart-Lung Machine) does not involve establishing ground truth from expert interpretation in the context of diagnostic or prognostic tasks. The "ground truth" for its performance is determined by meeting engineering specifications and safety standards.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable: Adjudication methods are relevant for resolving discrepancies in expert interpretations of data, typically in AI/ML performance studies. This is not described for the V&V testing of a Heart-Lung Machine.
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, a MRMC study was not done. This is a non-AI/ML device. The "multi reader multi case" paradigm and "human readers improve with AI" concepts are not applicable to the S5 System as described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable / Not Relevant in the AI/ML sense: The device is a standalone hardware/software system designed to perform its functions. The V&V testing assesses its performance in this standalone capacity. However, this is not equivalent to a "standalone" AI algorithm performance evaluation, as it's an operational medical device with human interaction as part of its intended use.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Engineering Specifications and Recognized Standards: The "ground truth" for the device's performance is compliance with established engineering specifications, design requirements, and recognized international standards (e.g., IEC 60601 series, IEC 62366-1, IEC 62304, ISO 14971) for safety and effectiveness.
8. The sample size for the training set
- Not Applicable: This device is not an AI/ML system that uses a "training set" of data.
9. How the ground truth for the training set was established
- Not Applicable: This device is not an AI/ML system that uses a "training set" of data.
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Image /page/0/Picture/1 description: The image contains the logos of the U.S. Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, featuring a stylized eagle emblem. To the right of it is the FDA logo, which includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with "ADMINISTRATION" written in a smaller font size below.
LivaNova Deutschland GmbH Florian Goetz Specialist Regulatory Affairs Lindberghstr. 25 Munich, Bavaria 80939 Germany
Re: K210130
Trade/Device Name: S5 System Regulation Number: 21 CFR 870.4220 Regulation Name: Cardiopulmonary Bypass Heart-Lung Machine Console Regulatory Class: Class II Product Code: DTQ Dated: March 18. 2021 Received: March 22, 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/cdrl/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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
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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
for Fernando Aguel 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
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Indications for Use
510(k) Number (if known) K210130
Device Name Stöckert S5 System
Indications for Use (Describe)
The Stöckert SS System 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)
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
Stöckert S5 System
APPLICANT
LivaNova Deutschland GmbH Lindberghstr. 25 80939 Munich Germany
| Contact information | |
|---|---|
| Primary contact person | Alternate contact person |
| Florian Goetz | Mattia Ronchetti |
| Specialist Regulatory Affairs | Director Regulatory Affairs |
| Florian.Goetz@LivaNova.com | Mattia. Ronchetti@LivaNova.com |
Date Prepared: March 18, 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: | Stöckert S5 System |
|---|---|
| Common/Usual Name: | Heart-Lung Machine |
| Classification Name: | Console, Heart-Lung Machine,Cardiopulmonary Bypass Console |
| Classification Panel: | 74 Cardiovascular |
| Device Class: | Class II |
| Regulation Number: | 21 CFR §870.4220 |
| Product Code: | DTQ |
PREDICATE DEVICE INFORMATION
The modified Stöckert S5 System is substantially equivalent in function and intended use to the Stöckert S5 System cleared in Premarket Notification K071318.
INDICATIONS FOR USE
The Stöckert S5 System is intended to be used during cardiopulmonary bypass for procedures lasting six (6) hours or less.
COMPARISON OF THE INDICATIONS FOR USE
It is noted that the 510(k) Summary of K071318 (the predicate S5 System) provides Indications for Use that are specific to the Pulse Mode Control module that was introduced with K071318 in addition to the Indications for Use for the entire S5 System.
The predicate S5 System as last cleared with K071318 on 07/06/2007 was found to be substantially equivalent to the previously cleared S5 System (K062396 on 09/28/2006) and the originally cleared S5 System (K060053 on 06/02/2006). The Indications for Use for the S5 System did not substantially change due to the additional wording specific to Pulse Mode Control.
Therefore, the modified S5 System's Indications for Use are the same as the predicate S5 System, with the exception that the Pulse Mode Control specific wording is not included, thus returning the Indication for Use to its original verbiage.
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DEVICE DESCRIPTION
The S5 System 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 functional units that allow the speed-controlled pumping of blood and accessories for monitoring and safety.
System Panel
The S5 system panel contains the display and control modules for all of the monitoring, control and measuring devices and is, alongside the pump control panel, another interface between the operator and the S5 System.
Pumps
Pumps may be console or mast mounted and either 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 detector
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 control
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 monitor
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 control
The pressure sensor module is used to measure and display the pressure in the extracorporeal circuit.
Display, alarm generation and pump speed requlation based on measurement of pressure in the ECC.
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Cardioplegia Control
The Cardioplegia control unit can be used with the roller pumps RP 150 or a DRP 85 to deliver cardioplegic solutions or blood cardioplegia during an operation to the patient.
Electronic gas blender
May be connected to allow the operator to set, monitor, and display the gas flows required for ECC.
Serial Data interface
Transfer of data from non-proprietary external devices to a proprietary data management system.
Venous line clamps (manual)
Provides a separate control unit and line clamp.
Electrical venous occlude (EVO)
The clamp closes automatically when the stop link function to the arterial pump is activated.
A schematic of S5 System is provided on the following page.
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Image /page/7/Figure/0 description: The image shows a medical device with several labeled parts. The device is on wheels and has a control panel with multiple screens. There are also several IV poles attached to the device, along with other components such as pumps and a central display unit. The numbers in the image point to specific parts of the device.
Figure 1: Schematic of S5 System
| Item | Name | Function |
|---|---|---|
| 1 | S5 System | Perform, control and monitor extracorporeal bloodcirculation |
| 2 | S5 console | Contains the electronic/power supply pack as well as thefan and batteries for the emergency power supply |
Table 1: Components of S5 System
Schematic
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| Item | Name | Function |
|---|---|---|
| 3 | S5 console table | Supports up to 4 pump housings or units (depending on the type of console) |
| 4 | Main switch | Switches the power for the entire S5 system on and off |
| 5 | S5 mast retaining flange (left/right) | Side components for supporting the sliding T-bar handles and telescopic masts |
| 6 | Push bar | Mounting for the system panel (14) |
| 7 | Telescope mast with Infusion rack | Mounting for additional equipment |
| 9 | Telescope mast, movable with infusion rack | Mounting for disposable items/devices |
| 10 | Horizontal mast | Stabilizes the mast system |
| 11 | Crossbar for movable mast | Permanently mounted on the back of the console for supporting the movable telescope mast |
| 12 | Console casters with Parking brakes | Transporting the S5 system |
| 14 | S5 system panel | Display and control modules, available in 3, 4 (standard), 5 or 6 module slots |
| 15 | S5 electronics and power (E/P) pack | System connection panel (shown with cover closed) for connecting power supply, pumps, devices, etc. |
| 16 | S5 roller pump | Available as single or double pump configuration, pumps |
| 17 | S5 double roller pump | blood through the CPB circuit |
TECHNOLOGICAL CHARACTERISTICS
The technological characteristics (i.e., design, material, performance, energy source) of the modified S5 System are similar to the cleared S5 System (K071318), with minor modifications to the hardware, software and labeling of the device.
Both devices employ mains electricity (AC-powered) console with roller pumps, centrifugal pumps, control panels, accessories and sensory equipment to provide mechanical circulatory support during open-heart surgery. The following are the technological differences between the subject and predicate devices:
- The Blood Level Sensor has been changed to improve electromagnetic compatibility. ● The sensor holder and holder pads were modified to accommodate the new sensor.
- Modifications to the graphical user interface were made to introduce new icons. .
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PERFORMANCE DATA - NON-CLINICAL TESTING
No animal testing was submitted to support the substantial equivalence of the modified S5 System to the cleared S5 System.
In accordance with 21 CFR 820.30, LivaNova Deutschland GmbH. has conducted the following verification and validation testing of the S5 System design modifications 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)
- Performance testing .
- Software verification and validation .
- . Human Factors testing
- Mechanical testing of the modified Sensor Holder .
- Performance testing of shipping containers .
In support of the determination of substantial equivalence of the modified S5 System to the cleared S5 System, the following recognized Standards have been complied with:
| Standard | Title | FDA recognition number |
|---|---|---|
| IEC 60601-1 2005 A1:2012 | Medical electrical equipment - Part 1: General requirements for basic safety and essential performance | 19-4 |
| 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 | 19-8 |
| IEC 62366-1 Edition 1.0 2015 | Medical devices — Part 1: Application of usability engineering to medical devices | 5-114 |
| 60601-1-8:2006 and A1:2012 | Medical electrical equipment - Part 1-8: General requirements for basic safety and essential performance - Collateral Standard: General requirements, tests and guidance for alarm systems in medical electrical equipment and medical electrical systems | 5-76 |
| IEC 62304 Edition 1.1 2015 | Medical device software — Software life cycle processes | 13-79 |
| ISO 14971 Third Edition 2019 | Application of risk management to medical devices | 5-125 |
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SUMMARY
The modified S5 System is as safe and effective as the cleared S5 System. The modified S5 System 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 S5 System is as safe and effective as the predicate device. Thus, the modified S5 System is substantially equivalent to its predicate.
§ 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).