The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

Device Description

The SMARxT Tubing and Connectors, subjects of this application are part of the Heart/Lung Perfusion Pack (K881330), a customized system of tubing and other devices built to user specifications designed for use during surgery requiring cardiopulmonary bypass.

AI/ML Overview

This is a 510(k) summary for the SMARxT Tubing and Connectors, a medical device used in cardiopulmonary bypass. The document states that the modified device, which uses a different surface treatment material (Tegomer additive material is changing from Tegomer H-Si6441 P), is substantially equivalent to its predicate device. This determination is based on non-clinical testing.

Here's the detailed breakdown:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Test	Acceptance Criteria	Reported Device Performance
Biological Evaluation	Cytotoxicity	In accordance with ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process`"	Successfully met all acceptance criteria.
	Direct and Indirect Hemolysis ("Hemolysis")	In accordance with ISO 10993-1 and FDA guidance "Use of International Standard ISO 10993-1, `Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process`"	Successfully met all acceptance criteria.
Functional / Performance Testing	Blood pathway integrity and coverage	Ensure the blood pathway remains intact and adequately covered, presumably to prevent leaks or biological interaction. Specific quantitative criteria are not provided in this summary.	Successfully met all acceptance criteria.
	Surface Modification Integrity	Ensure the integrity and proper adhesion/presence of the surface modification (Tegomer) throughout the expected use. Specific quantitative criteria are not provided in this summary.	Successfully met all acceptance criteria.
	Connection testing	Ensure secure and functional connections between tubing and connectors. Specific quantitative criteria are not provided in this summary.	Successfully met all acceptance criteria.
	Life to failure testing	Evaluate the device's durability and ability to withstand stress over its intended lifespan (up to six hours in this case). Specific quantitative criteria are not provided in this summary.	Successfully met all acceptance criteria.
	Spallation	Evaluate the shedding of particles from the material, which is critical in devices directly contacting blood. Specific quantitative criteria are not provided in this summary.	Successfully met all acceptance criteria.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: The document does not specify the exact sample sizes (number of units tested) for each of the in vitro tests. It only states that "in vitro testing was performed."
Data Provenance: The data provenance is retrospective in the sense that it's a submission for regulatory clearance based on testing already completed. The tests were performed by Livanova USA Inc., presumably in a controlled laboratory environment. The country of origin of the data is not explicitly stated but can be inferred to be from the manufacturer's testing facilities, likely in the US or Europe given Livanova's global presence.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

This section is not applicable as the evaluation was based on non-clinical (in vitro) testing against established standards and internal performance specifications, not human expert interpretation of data.

4. Adjudication Method for the Test Set

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 multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is hardware (tubing and connectors) and does not involve AI or human readers for its function.

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

No, a standalone (algorithm only) performance study was not conducted. This device is hardware and does not involve an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device, in the context of its substantial equivalence determination, was established through adherence to recognized medical device standards and rigorous in vitro performance testing. This includes:

International Standard ISO 10993-1: "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process."
FDA Guidance Document: "Use of International Standard ISO 10993-1, Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process of September 4, 2020."
Internal performance specifications/requirements: The specific acceptance criteria for "Blood pathway integrity and coverage," "Surface Modification Integrity," "Connection testing," "Life to failure testing," and "Spallation" would have been defined by the manufacturer based on the predicate device's performance and clinical requirements for cardiopulmonary bypass tubing.

Essentially, the ground truth is that the device must perform equivalently to its predicate and meet established safety and performance benchmarks for its intended use.

8. The Sample Size for the Training Set

Not Applicable. This device is hardware and does not involve machine learning or an AI algorithm, therefore, there is no "training set."

9. How the Ground Truth for the Training Set was Established

Not Applicable. As there is no training set.

Summary

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August 8, 2024

Livanova USA Inc Tatjana Kuntschik Principal Regulatory Affairs Specialist 14401 West 65th Way Arvada, Colorado 80004

Re: K233702

Trade/Device Name: SMARxT Tubing and Connectors Regulation Number: 21 CFR 870.4390 Regulation Name: Cardiopulmonary bypass pump tubing Regulatory Class: Class II Product Code: DWE Dated: November 17, 2023 Received: July 10, 2024

Dear Tatjana Kuntschik:

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 (the 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 available 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.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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

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Indications for Use

510(k) Number (if known) K233702

Device Name SMARxT Tubing and Connectors

Indications for Use (Describe)

The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

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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510(k) #: K233702

510(k) Summary Prepared on: 2024-08-08

Contact Details		21 CFR 807.92(a)(1)
-----------------	--	---------------------

Applicant Name	LIVANOVA USA INC
Applicant Address	14401 WEST 65th WAY Arvada CO 80004 United States
Applicant Contact Telephone	+49 89 32301-31
Applicant Contact	Tatjana Kuntschik
Applicant Contact Email	tatjana.kuntschik@livanova.com

Device Name		21 CFR 807.92(a)(2)
-------------	--	---------------------

Device Trade Name	SMARxT Tubing and Connectors
Common Name	Cardiopulmonary bypass pump tubing
Classification Name	Tubing, Pump, Cardiopulmonary Bypass
Regulation Number	870.4390
Product Code	DWE

Legally Marketed Predicate Devices		21 CFR 807.92(a)(3)
------------------------------------	--	---------------------

Predicate #	Predicate Trade Name (Primary Predicate is listed first)	Product Code
K981613	SMARxT Tubing and Connectors	DWE

Device Description Summary		21 CFR 807.92(a)(4)
----------------------------	--	---------------------

Intended Use/Indications for Use		21 CFR 807.92(a)(5)
----------------------------------	--	---------------------

The SMARxT Tubing and Connectors, a part of the Heart/Lung Perfusion Pack, are intended to be used in surgical procedures requiring extracorporeal support for periods of up to six hours.

Indications for Use Comparison		21 CFR 807.92(a)(5)
--------------------------------	--	---------------------

The SMARxT Tubings and Connectors (modified device) are substantially equivalent to its cleared predicate device. SMARxT Tubing and Connectors (modified device) and its cleared predicate device have the same indication for use. Minor wording updates do not change the intent and scope of the indication for use.

Technological Comparison		21 CFR 807.92(a)(6)
--------------------------	--	---------------------

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The SMARxT Tubing and Connectors subject device has the same principles of operation and design as the SMARxT Tubing and Connectors unmodified device.

The SMARxT Tubing and Connectors modified device and the SMARxT Tubing and Connectors unmodified device share the same fundamental technological characteristics except for the surface treatment that does not affect the basic device function. Teqomer additive material is changing from Tegomer H-Si6441 P blended into a polymeric resin for connectors and in polyvinylchloride (PVC) tubing which are components used in cardiopulmonary surgery perfusion circuits.

The two Tegomer products behave similarly when blended with PVC tubing.

Chemical analysis indicates that the two materials are chemically equivalent, and this is confirmed also by the performance testing and toxicological assessment.

Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807 92(b)

The subject device was tested to ensure that it can provide all the capabilities necessary to operate safely and effectively. Applicable tests were carried out in accordance with the requirements of ISO 1099-1 standard as well as in compliance with the FDA quidance document Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process" of September 4, 2020.

In vitro testing was performed to evaluate the impact of the different material in the modified SMARxT Tubing and Connectors version, specifically the following tests were carried out:

Blood pathway integrity and coverage
Surface Modification Integrity
Hemolysis
Connection testing
Life to failure testing
Spallation
Cytotoxicity
Direct and indirect Hemolysis

The modified device successfully met all acceptance criteria.

No clinical testing was conducted in support of the SMARxT Tubing and Connectors.

The results of in vitro studies demonstrate that the subject SMARxT Tubing and Connectors performs in a manner substantially equivalent to the unmodified SMARxT Tubing and Connectors predicate device with respect to the relevant functional parameters. The non-clinical testing summarized in this submission supports the substantial equivalence of these devices with their respective predicates.

Regulation Number and Section

§ 870.4390 Cardiopulmonary bypass pump tubing.

(a)
Identification. A cardiopulmonary bypass pump tubing is polymeric tubing which is used in the blood pump head and which is cyclically compressed by the pump to cause the blood to flow through the cardiopulmonary bypass circuit.(b)
Classification. Class II (performance standards).