(265 days)
No
The summary describes a system of tubing and connectors for cardiopulmonary bypass, with no mention of AI or ML capabilities. The performance studies focus on material properties and mechanical performance.
No
Explanation: The device is tubing and connectors used in extracorporeal support systems during surgery. While part of a system that supports life functions, the tubing and connectors themselves do not directly treat or cure a disease or condition; they facilitate the operation of other therapeutic components.
No
The device is described as "tubing and connectors" for "extracorporeal support" during surgery requiring "cardiopulmonary bypass." Its function is to facilitate the flow of fluids, not to diagnose a condition.
No
The device description explicitly states it is "tubing and connectors," which are physical hardware components, not software. The performance studies also focus on physical properties and testing of these hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "surgical procedures requiring extracorporeal support for periods of up to six hours." This describes a device used during a surgical procedure on a patient, not a test performed on a sample from a patient to diagnose a condition.
- Device Description: The device is described as "part of the Heart/Lung Perfusion Pack... designed for use during surgery requiring cardiopulmonary bypass." This further reinforces its use in a surgical setting.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information. The testing performed is focused on the physical and biological compatibility of the tubing and connectors with blood flow, which is typical for devices used in extracorporeal circulation.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
DWE
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.
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
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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).
1
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
2
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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3
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) | |
|---|---|---|
| ---------------------------- | -- | --------------------- |
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.
| 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) | |
|---|---|---|
| -------------------------- | -- | --------------------- |
4
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.