Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.

Device Description

The Vanguard Blood Cardioplegia Systems are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.

They are cardiopulmonary bypass devices allowing cardioplegia fluid delivery; they also regulate cardioplegia fluid temperature and trap air emboli.

Vanguard devices are indicated for use for patients undergoing surgical procedures requiring cardiopulmonary bypass procedures.

These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours.

The Vanguard Blood Cardioplegia Systems are the modified version of the disposables currently marketed in the SORIN BLOOD CARDIOPLEGIA SYSTEM (K934763) and the NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS (K934847).

AI/ML Overview

The provided document is an FDA 510(k) approval letter for the VANGUARD Blood Cardioplegia Systems. It focuses on demonstrating substantial equivalence to previously marketed predicate devices rather than proving performance against specific acceptance criteria through novel clinical studies.

Therefore, many of the requested sections regarding acceptance criteria, new study design, sample sizes for test sets, expert ground truth establishment, MRMC studies, and training set details are not applicable to this type of regulatory submission and are not present in the document.

The document emphasizes a non-clinical performance evaluation to demonstrate equivalence, primarily focusing on material changes and updated technical specifications, without conducting new clinical trials.

Here's an analysis based on the provided text, indicating where information is not present or not applicable:

Acceptance Criteria and Device Performance

Since this is a 510(k) submission demonstrating substantial equivalence to predicate devices, there are no explicit "acceptance criteria" defined as performance metrics that the device must meet in a novel clinical trial. Instead, the "acceptance" is based on demonstrating that the modified devices perform equivalently to the existing, cleared predicate devices through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria (Implied)	Reported Device Performance
Functional Equivalence: Device performs cardioplegia fluid delivery, regulates temperature, and traps air emboli equivalently to predicate.	Confirmed: "The Vanguard Blood Cardioplegia Systems have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices." (Page 7)
Material Biocompatibility/Safety: New materials (PVC without DEHP, new PP, new Versapor) are safe and do not negatively impact device performance.	Confirmed: "The tubing and connectors of the Vanguard devices made of PVC materials were changed within the modified Vanguard Blood Cardioplegia Systems in order to remove the diethylhexyl phthalate (DEHP)...the rigid connectors...were changed...to remove the DOTE...PP Purell material...was replaced with another PP material (Bormed); and the mesh Versapor material...was replaced with another kind of Versapor material." (Page 7) "No other design changes have been made to the devices." (Page 7)
Compliance with Standards: Device complies with applicable voluntary standards.	Confirmed: "The Vanguard Blood Cardioplegia Systems comply with all the applicable voluntary standards related to cardiovascular systems. The devices passed all the testing in accordance with national and international standards." (Page 7)
No New Safety/Effectiveness Questions: Changes do not raise new questions regarding safety and effectiveness compared to predicates.	Confirmed: "The Vanguard Blood Cardioplegia Systems, as designed and manufactured, do not raise new questions regarding safety and effectiveness as compared to their predicate devices and are determined to be substantially equivalent to their predicate devices listed above." (Page 7)
Duration of Use: Device maintains performance for 6 hours or less.	Confirmed: "These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours." (Page 6) And "The devices are intended to be used for 6 hours or less." (Page 4 & 6)

2. Sample size used for the test set and the data provenance:

The document explicitly states: "No clinical testing was conducted in support of the Vanguard Blood Cardioplegia Systems..." (Page 7).
The "test set" for performance evaluation was based on non-clinical verification and validation testing. The specific sample sizes for these tests (e.g., number of devices tested for material compatibility, flow rates, temperature regulation, etc.) are not detailed in this summary document.
Data provenance is also not specified regarding country of origin or whether it was retrospective/prospective, as it pertains to internal lab testing for device verification.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. Since no clinical testing was performed, there was no need for experts (e.g., radiologists) to establish a clinical "ground truth" for a test set. The validation was based on engineering and performance criteria against standards.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Not applicable. As there was no clinical test set requiring expert interpretation or adjudication, no such method was employed.

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:

Not applicable. This device is a hardware system (cardioplegia set), not an AI/software device. No MRMC study was done, and the concept of "human readers improving with AI assistance" is irrelevant here.

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

Not applicable. This device is not an algorithm or software. It is a physical medical device.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):

For the non-clinical performance data, the "ground truth" (or reference) would be engineering specifications, regulatory standards, and the established performance characteristics of the predicate devices. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.

8. The sample size for the training set:

Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set."

9. How the ground truth for the training set was established:

Not applicable. As there is no training set for this device.

Summary regarding the Study:

The "study" that proves the device meets the (implied) acceptance criteria is a non-clinical verification and validation testing program. This means the manufacturer conducted a series of tests in their labs to ensure the modified device functions as intended, meets design specifications, is biocompatible with the new materials, and performs equivalently to the predicate devices, all in accordance with relevant national and international standards. This type of evidence is common for 510(k) submissions, particularly when changes are made to materials or manufacturing processes of existing device types where substantial equivalence can be demonstrated without new clinical data.

Summary

FDA Approval Letter - VANGUARD Blood Cardioplegia Systems

Page 1

U.S. Food & Drug Administration

10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

May 30, 2025

Sorin Group Italia S.r.l.
Martina Carlini
Regulatory Affairs Specialist
Via Statale 12 Nord, 86
Mirandola (Modena), IT 41037
Italy

Re: K250150
Trade/Device Name: VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt); VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)
Regulation Number: 21 CFR 870.4240
Regulation Name: Cardiopulmonary bypass heat exchanger
Regulatory Class: Class II
Product Code: DTR
Dated: January 18, 2025
Received: January 21, 2025

Dear Martina Carlini:

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.

Page 2

K250150 - Martina Carlini Page 2

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).

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 (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-reporting-combination-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.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

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-devices/medical-device-safety/medical-device-reporting-mdr-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/medical-devices/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-devices/device-advice-comprehensive-regulatory-

Page 3

K250150 - Martina Carlini Page 3

assistance/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,

for 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

Page 4

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

Indications for Use

Form Approved: OMB No. 0910-0120
Expiration Date: 06/30/2023
See PRA Statement below.

510(k) Number (if known)
K250150

Device Name
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set);
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt);
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

Indications for Use (Describe)
Vanguard 4:1 Blood cardioplegia sets are cardiopulmonary bypass devices allowing cardioplegia fluid delivery. They also regulate cardioplegia fluid temperature and trap air emboli. The devices are intended to be used for 6 hours or less.

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)

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."

Page 5

510(k) Summary

(in accordance with 21 CFR 807.92)

510(k) Number: K250150

I. Applicant Information

Applicant:
SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola, MO 41037 Italy

Contact Person: Martina Carlini
Regulatory Affairs Specialist
Tel: +39 0535 29811
e-mail: martina.carlini@livanova.com

Application Correspondent:
SORIN GROUP ITALIA S.R.L.
Via Statale 12 Nord, 86
Mirandola, MO 41047 Italy

Contact Person: Martina Carlini
Regulatory Affairs Specialist
Tel: +39 0535 29811
e-mail: martina.carlini@livanova.com

Date Prepared: May 30th 2025

II. Subject Device Identification

Device Trade Name:

VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set);
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood cardioplegia set with shunt);
VANGUARD Blood cardioplegia Systems (Vanguard 4:1 Blood Cardioplegia Set Mini)

Classification Name: Heat-Exchanger, Cardiopulmonary Bypass
Regulation Number: 21 CFR 870.4240
Product Code: DTR
Classification: Class II
Classification Panel: Cardiovascular

Page 6

III. Predicate Device

The Vanguard Blood Cardioplegia Systems are substantially equivalent to the following cleared predicate devices. Both modified and unmodified models have the same fundamental scientific technology and intended use:

Vanguard 4:1 Blood cardioplegia set (with and without shunt)
510(k) Number: K934763
Device Trade Name: SORIN BLOOD CARDIOPLEGIA SYSTEM
Classification Name: Reservoir, Blood, Cardiopulmonary Bypass
Regulation Number: 21 CFR 870.4400
Product Code: DTN
Classification: Class II
Classification Panel: Cardiovascular

Vanguard 4:1 Blood Cardioplegia Set Mini
510(k) Number: K934847
Device Trade Name: NGBCD & NGBCDP CARDIOPLEGIA DELIVERY SYSTEMS
Classification Name: Reservoir, Blood, Cardiopulmonary Bypass
Regulation Number: 21 CFR 870.4400
Product Code: DTN
Classification: Class II
Classification Panel: Cardiovascular

Note: These 2 predicates were classified as Reservoir, Blood, Cardioplumonary Bypass linked to the regulation number 21 CFR 870.4400 and to the product code DTN, but since the subject products are cardioplegia systems containing heath-exchangers, we believe that the correct classification should be Heat-Exchanger, Cardiopulmonary Bypass linked to the regulation number 21 CFR 870.4240 and to the product code DTR.

IV. Device Description

The Vanguard Blood Cardioplegia Systems are single-use, non-toxic, non-pyrogenic and supplied sterile in individual packs.

They are cardiopulmonary bypass devices allowing cardioplegia fluid delivery; they also regulate cardioplegia fluid temperature and trap air emboli.

Vanguard devices are indicated for use for patients undergoing surgical procedures requiring cardiopulmonary bypass procedures.

These Vanguard Blood Cardioplegia Systems are circuits designed to administer cardioplegic solution and they can be used up to 6 hours.

V. Indications for Use

Page 7

VI. Summary of Technical Characteristics

The Vanguard Blood Cardioplegia Systems have the same fundamental technological characteristics, principles of operation and control mechanisms as the unmodified devices.

The tubing and connectors of the Vanguard devices made of PVC materials were changed within the modified Vanguard Blood Cardioplegia Systems in order to remove the diethylhexyl phthalate (DEHP) used as plasticizer currently present in the device.

Moreover, the rigid connectors of the Vanguard devices made of PVC materials were changed within the modified Vanguard Blood Cardioplegia Systems in order to remove the DOTE used as thermal stabilizer.

Then, the PP Purell material of line clamps of the Vanguard devices was replaced within the modified Vanguard Blood Cardioplegia Systems with another PP material (Bormed); and the mesh Versapor material for the vented spike component of the Vanguard devices was replaced within the modified Vanguard Blood Cardioplegia Systems with another kind of Versapor material.

Additionally, some technical specifications for Vanguard Blood Cardioplegia Systems were updated and tested to better reflect the state of the art of the devices.

No other design changes have been made to the devices.

The devices are ethylene oxide sterilized and have a non-pyrogenic fluid path. They are for single use only.

VII. Non-Clinical Performance Data

Sorin Group Italia S.r.l. has conducted extensive verification and validation testing of the Vanguard Blood Cardioplegia Systems, as disposables used to administer cardioplegic solution during surgical procedures requiring cardiopulmonary bypass procedures.

The Vanguard Blood Cardioplegia Systems comply with all the applicable voluntary standards related to cardiovascular systems. The devices passed all the testing in accordance with national and international standards.

VIII. Clinical Performance Data

No clinical testing was conducted in support of the Vanguard Blood Cardioplegia Systems, as the indications for use and technical characteristics are equivalent to those of the predicate devices, which have been on the market for several years with proven safety and efficacy of use. The non-clinical testing summarized in this submission supports the substantial equivalence of the subject devices with the predicate devices when used according to their intended use.

IX. Statement of Substantial Equivalence

Based on equivalent intended use and technological characteristics, as well as on equivalent performance testing, the Vanguard Blood Cardioplegia Systems can be deemed to be substantially equivalent to their predicate devices:

the unmodified NGBCW4 Warm Blood Cardioplegia Delivery System 4:1 blood-to-crystalloid ratio and NGBCW4C Warm Blood Cardioplegia Delivery System 4:1 blood-to-crystalloid ratio with shunt for delivering 100% blood, cleared under K934763;
the unmodified NGBCDP Reduced Priming Volume Blood Cardioplegia Delivery System 4:1 blood-to-crystalloid ratio, cleared under K934847;

The Vanguard Blood Cardioplegia Systems, as designed and manufactured, do not raise new questions regarding safety and effectiveness as compared to their predicate devices and are determined to be substantially equivalent to their predicate devices listed above.

Regulation Number and Section

§ 870.4240 Cardiopulmonary bypass heat exchanger.

(a)
Identification. A cardiopulmonary bypass heat exchanger is a device, consisting of a heat exchange system used in extracorporeal circulation to warm or cool the blood or perfusion fluid flowing through the device.(b)
Classification. Class II (performance standards).