The SMAR, T® BCD Vanguard™ Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.

Device Description

The SMAR, T BCD Vanguard System is a cardioplegia heat exchanger with integral bubble trap, available with various tubing ratio configurations connected to the heat exchanger assembly. Surface-modifying materials have been added to the primary blood contact surfaces of the heat exchanger, tubing and connectors to improve the blood compatibility of the system. The product is sterilized by ethylene oxide, is for single use only, and has nonpyrogenic fluid pathways.

The heat exchanger assembly (heat exchanger with bubble trap) contains a hydrophobic membrane, a one-way valve, a pressure relief valve, a filter screen, a temperature monitoring port and a pressure monitoring port. The housing is designed such that air entering the device rises to the membrane and is vented to the atmosphere. The one-way valve keeps air from entering the device. The pressure relief valve is designed to relieve excess pressure in the event of outlet line clamping, and has tubing attached to it to vent the solution to the cardiotomy reservoir. The temperature monitoring port is used to measure the temperature of the blood cardionlegia mixture, and the pressure monitoring line is connected to either a pressure manometer or a transducer to measure pressure.

AI/ML Overview

The provided text describes a Special 510(k) Pre-Market Notification for the SMAR,T® BCD Vanguard™ Blood Cardioplegia System, which is a modified version of an existing device. The acceptance criteria and the study that proves the device meets these criteria are not explicitly detailed in the provided document.

However, based on the information given, we can infer some aspects of the "study" conducted and the implicit acceptance criteria:

Implicit Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Inferred)	Reported Device Performance (Inferred)
Functional Equivalence: The modified device (SMAR,T® BCD Vanguard™) performs the same functions as the predicate device (BCD Vanguard™ Blood Cardioplegia System).	The SMAR,T® BCD Vanguard™ Blood Cardioplegia System has the "same intended use" as the predicate device. It is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours, and also allows monitoring of temperature and pressure, traps bubbles, and removes air. This suggests its functional performance is deemed equivalent to the predicate.
Material Biocompatibility/Safety Equivalence: The new surface-modifying materials and packaging materials do not introduce new safety concerns or adverse effects compared to the predicate.	"In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847)." This implies the in-vitro tests covered safety and biocompatibility aspects relevant to the material changes. The FDA's substantial equivalence determination confirms this was met.
Mechanical/Physical Integrity: The changes in materials and surface modification do not compromise the device's structural integrity or performance within its intended use.	"In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847)." This would typically include tests to ensure the device's physical properties and mechanical performance remained acceptable after the modifications.

"Study" Information (Inferred/Not Provided)

The document primarily focuses on demonstrating "substantial equivalence" to a predicate device (Sorin Biomedica BCD Vanguard™ Blood Cardioplegia System, K934847) rather than reporting a comprehensive clinical study. The only "study" mentioned is:

Sample Size used for the test set and the data provenance: Not specified. The document only mentions "In-Vitro tests." These tests were likely laboratory-based, comparing the new device's performance characteristics (e.g., blood compatibility, heat exchange efficiency with new surfaces, pressure relief, bubble trapping) against the predicate device's established performance or accepted standards. The data provenance would be from laboratory testing.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable/Not specified. For in-vitro tests, the "ground truth" is typically defined by engineering specifications, regulatory standards, or predetermined performance benchmarks for the predicate device, rather than expert consensus on patient data.
Adjudication method: Not applicable/Not specified. This is more relevant for studies involving human interpretation or clinical endpoints.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, not mentioned. This type of study is more common for diagnostic imaging AI systems or scenarios where human reader variability is a significant factor.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a medical device, not an algorithm.
The type of ground truth used: For the "In-Vitro tests," the ground truth would be based on objective measurements against established engineering specifications, performance standards, and comparison with the predicate device's known performance characteristics. The goal was to prove the modified device was "substantially equivalent."
The sample size for the training set: Not applicable. This is not an AI/machine learning algorithm, so there is no training set mentioned or implied.
How the ground truth for the training set was established: Not applicable.

Summary of Device Changes and Justification for Substantial Equivalence:

The core of the submission (K021830) is a modification to an existing device (BCD Vanguard™ Blood Cardioplegia System, K934847). The changes are:

Addition of surface-modifying material (Mimesys) to the heat exchanger.
Substitution of SMAR,T Surface Modified Tubing and Connectors for various tubing and connectors.
Substitution of High Impact Polystyrene (HIPS) for PolyEthylene Terephthalate Glycol (PETG) as the packaging material.

The document states that "In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847)." This means the "study" was focused on proving that these modifications did not alter the fundamental safety or effectiveness of the device as compared to the previously cleared predicate device.

The FDA's letter states: "We have reviewed your Section 510(k) premarket notification... and have determined the device is substantially equivalent... You may, therefore, market the device..." This indicates that the "In-Vitro tests" successfully demonstrated that the new device met the implicit acceptance criteria for substantial equivalence to the predicate.

Summary

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021830
PAGE 1 OF 2

Special 510(k) Pre-Market Notification: SMAR,T® BCD Vanguard™ Blood Cardioplegia System COBE Cardiovascular, Inc.

JUL - 2 2002

SUBMITTER:	COBE Cardiovascular, Inc.14401 W. 65th WayArvada, CO 80004
CONTACT PERSON:	Shawn RiedelPhone:(303) 467-6521Fax: (303) 467-6525
DATE PREPARED:	28 May 2002
DEVICE TRADE NAME:	Sorin Biomedica SMARₓT® BCD Vanguard™Surface Modified Blood Cardioplegia System
COMMON/USUAL NAME:	Cardioplegia Heat Exchanger
CLASSIFICATION NAME:	Cardiopulmonary Bypass Heat Exchanger
PREDICATE DEVICE:	Sorin Biomedica BCD Vanguard™ Blood Cardioplegia System

DEVICE DESCRIPTION:

INDICATIONS FOR USE

The SMAR, T BCD Vanguard Blood Cardioplegia System is intended to mix, cool, warm and deliver oxygenated blood and cardioplegic solution for periods up to six hours. The device also allows monitoring of temperature and pressure, traps bubbles, and removes air. Blood and cardioplegic solution are delivered to the patient by a single 100 % occlusive roller pump, through the extension line and appropriate cannula.

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Page 2 of 2 Special 510(k) Pre-Market Notification: SMAR T® BCD Vanguard" Blood Cardioplegia System COBE Cardiovascular, Inc.

17

STATEMENT OF TECHNICAL CHARACTERISTICS COMPARISON

The SMAR.T BCD Vanguard Surface Modified Blood Cardioplegia System has the same intended use as the Sorin BCD Vanguard Blood Cardioplegia System. Unless noted below the , materials, components, design, sterilization and manufacturing processes for the two devices are the same. The new device will be called the Sorin Biomedica SMAR T® BCD Vanguard™ Surface Modified Blood Cardioplegia System.

The changes in the two devices: 1) the SMAR, T BCD Vanguard contains a surface-modifying material. Mimesys which coats the heat exchanger (not including the bubble trap) of the System, 2) Substituting SMAR, T Surface Modified Tubing and Connectors (K981613) for various tubing and connectors within the circuit configurations and 3) Substituting High Impact Polystyrene (HIPS) for PolyEthylene Terephthalate Glycol (PETG) as the packaging material.

In-Vitro tests were performed to demonstrate that the SMAR-T BCD Vanguard Blood Cardioplegia System described in this submission is substantially equivalent to the BCD Vanguard Blood Cardioplegia System (K934847).

Truthful and Accurate Statement

A statement attesting to the truthfulness and accuracy of the information contained in this submission is attached as Appendix 5.

Further Information

In the event additional information is required, please contact:

Shawn Riedel Regulatory/Quality Manager COBE Cardiovascular, Inc. 14401 West 65th Way Arvada, Colorado 80004 USA Phone: (303) 467-6521 Fax: (303) 467-6525

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services USA. The seal is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with three human profiles incorporated into its design. The eagle's head and neck are formed by the profiles, creating a symbolic representation of health and human services.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

COBE Cardiovascular, Inc. c/o Mr. Shawn Riedel Regulatory/Quality Manager 14401 W. 65th Way Arvada, CO 80004-3599

JUL = 2 2002

Re: K021830

Device Name: Sorin Biomedica SMART® BCD Vanguard™ Surface Modified Blood Cardioplegia System Regulation Number: 21 CFR 870.4240 Regulation Name: Cardiopulmonary bypass heat exchanger. Regulatory Class: Class II (two) Product Code: DTR Dated: June 3, 2002 Received: June 4, 2002

Dear Mr. Riedel:

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. The general controls provisions of the Act include requirements for annual registration. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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

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Page 2 - Mr. Shawn Riedel

CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4646. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97), Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

· Sincerely yours,

Donna Dee Tillman, Ph.D.

onna-Bea Tillman, Ph.D. Acting Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Pre-Market Notification: SMARy1® BCD Vanguard™ Blood Cardioplegia System COBE Cardiovascular, Inc.

Indications For Use

510(k) Number (If known): K021832

Device Name:

Sorin Biomedica SMAR, T® BCD Vanguard™ Surface Modified Blood Cardioplegia System

Indications For Use:

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Q. Carter

510(k) Number K021830

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Over-The-Counter Use

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).