The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery. The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (≤ 6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.

Device Description

The CardioGard Emboli Protection Cannula, shown below, is a disposable 24 French double lumen arterial cannula. The cannula functions to deliver oxygenated blood to the heart during procedures requiring cardiopulmonary bypass (CPB), while at the same time suctioning blood and embolic matter away from the surgical field. The arterial cannula is inserted centrally in the ascending aorta. The CardioGard Emboli Protection Cannula features a tip configuration which diffuses oxygenated blood from the heart-lung machine to the ascending aorta through the Cannula Outlet, while also aspirating blood and embolic matter through the Suction Lumen Inlet. The flow rates through the two cannula lumens are carefully controlled so that emboli are suctioned back to the CPB machine for filtration while still enabling sufficient blood flow into the aorta.

AI/ML Overview

Based on the provided text, the device being discussed is the CardioGard Emboli Protection Cannula. It's important to note that this document is a 510(k) summary for a medical device and not a submission for an AI/ML-based device. Therefore, the questions about "AI vs without AI assistance," "standalone algorithm performance," and "ground truth establishment for training set" are not directly applicable in the context of this device's approval process as described.

However, I can extract information related to the device's acceptance criteria and the study that proves it meets them, adapting the requested structure to fit the available details.

The core of the "acceptance criteria" here is "substantial equivalence" to a predicate device, demonstrated through various non-clinical and clinical tests.

Acceptance Criteria and Device Performance for CardioGard Emboli Protection Cannula

The acceptance criteria for the CardioGard Emboli Protection Cannula are primarily demonstrated through its substantial equivalence (safety and effectiveness) to predicate devices, namely the Embol-X Access Device/Aortic Cannula and the Embol-X Intra-Aortic Filter. This equivalence is shown through comparative testing against specific performance attributes.

1. Table of Acceptance Criteria and Reported Device Performance

Note: The document describes "acceptance criteria" primarily through comparative performance to a predicate device and meeting pre-defined thresholds in various non-clinical tests. "Reported device performance" here refers to the outcomes of these tests. As this is not an AI/ML context, metrics like sensitivity/specificity are not applicable.

Acceptance Criteria (Demonstrated Substantial Equivalence / Performance Threshold)	Reported Device Performance (CardioGard Emboli Protection Cannula)
Intended Use Equivalence: Combines arterial perfusion and embolic particle capture during CPB.	Functionally equivalent to the combined Embol-X Aortic Cannula and Intra-Aortic Filter. Intended for perfusion of ascending aorta during short term (≤ 6 hours) CPB procedures, with the suction lumen intended for removal of particulate emboli.
Use Duration Equivalence: Capable of use for the entire duration of CPB surgery (≤ 6 hours).	Can be used for the entire duration of CPB surgery (≤ 6 hours), similar to the Embol-X Cannula. (This is a differentiating factor from the Embol-X filter, which has a 60-minute limit).
Design Similarity & Functionality: Curved tip with two ports (perfusion + embolic particle removal).	Two lumen, curved tip with two ports: one for aortic perfusion, one for suction of embolic particles. Main difference is the method of embolic particle removal (suction vs. filter). In vitro side-by-side comparison testing demonstrated substantial equivalence of these two methods.
Dimensions Equivalence: Similar tip size, length, and tube diameters.	Tip Size: 24Fr, Length: 30cm, Main tube diameter: 3/8", Suction tube diameter: 1/4". These are similar to the predicate Embol-X Access Device/Aortic Cannula (Tip Size: 24Fr; 20 Fr effective flow, Length: 28 cm, Main tube diameter: 3/8").
Pressure Drop Performance: Acceptable pressure drop for arterial perfusion.	Demonstrated smaller (better) pressure drop compared to the predicate Embol-X Cannula at all measured flow rates (3, 4, 5, and 6 l/min) in in vitro side-by-side comparison testing.
Back Pressure Equivalence: Acceptable back pressure performance.	Demonstrated substantially equivalent back pressure compared to the predicate Embol-X Cannula in side-by-side comparison testing.
Hemolysis Potential Equivalence: Acceptable levels of blood damage.	Demonstrated substantially equivalent hemolysis potential compared to the Embol-X Cannula and Filter under worst-case conditions (highest flow rates, simulating 6-hour CPB).
Embolic Particle Capture Efficacy: Effective removal of embolic particles.	Demonstrated substantially higher embolic particle capture compared to the Embol-X Cannula and Filter under test conditions simulating a 6-hour CPB procedure. Additionally, an animal study showed capture of a mean of 77% of injected osseous embolic particles.
Biocompatibility: Materials are safe for contact with blood.	Materials (PVC, Nirosta, ABS) are commonly used in medical devices and confirmed biocompatible according to ISO 10993-1:2009 for externally communicating devices in contact with circulating blood for limited (<24 hours) duration. All tests (cytotoxicity, irritation, sensitization, acute systemic toxicity, mutagenicity/genotoxicity, hemocompatibility) passed.
Sterilization: Device is sterile, non-pyrogenic, and single-use.	EtO sterilized to an SAL of 10⁻⁶ (overkill method, half-cycle technique in accordance with EN ISO 11135-1:2008). LAL test verified pyrogen-free. Single-use, disposable.
Shelf Life: Maintain functionality and package integrity for specified duration.	Accelerated aging equivalent to 2 years passed functionality (Visual Inspection, Dimensional Verification, Back Pressure, Pressure Drop, Air Leakage, Liquid Leakage, Force at Break) and package (Peel Strength, Burst Test, Dye Penetration Test) testing, supporting a 2-year labeled shelf life.
Clinical Safety & Efficacy: Comparable safety profile and effective in clinical use, demonstrating benefit in reducing brain lesions.	Safety: Similar type and incidence rates of adverse events and serious adverse events compared to control group. Most were isolated and not unexpected for cardiac surgery. Efficacy: CardoGard device effectively removed measurable quantities of embolic particles. Fewer CardioGard subjects exhibited new brain lesions post-surgery (42.8% vs. 66.7% for control), with statistically significant difference (p<0.05). Average and total volume of new brain lesions significantly smaller for CardioGard subjects (p<0.05).

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

Non-Clinical In Vitro Testing: Not explicitly stated for each test (e.g., number of devices tested for pressure drop, hemolysis, embolic capture).
Animal Testing: 10 pigs (7 using CardioGard, 3 controls using commercially available aortic perfusion cannula).
Clinical Testing: A prospective, randomized, multi-center, double-blind clinical study. The exact number of subjects is not explicitly stated in the provided abstract, but comparison percentages (42.8% vs 66.7%) imply a sufficient sample size to achieve statistical significance (p<0.05).
Data Provenance: The manufacturer is CardioGard Medical Ltd. in Israel. The clinical study is described as "multi-center," which typically implies data from various institutions, potentially in different geographical locations, but the specific countries are not mentioned. It was a prospective study.

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

For Clinical Study: "Core-lab evaluators" are mentioned for the diffusion weighted magnetic resonance imaging (DW-MRI) evaluation of new brain lesions. The number and qualifications of these evaluators are not specified in the provided text.

4. Adjudication Method for the Test Set

The clinical study was "double-blind (subject and core-lab evaluators)," suggesting independent evaluation. However, the specific adjudication method (e.g., 2+1, 3+1 consensus) for discrepancies among evaluators is not described. For non-clinical tests, "acceptance criteria" imply objective measurements rather than expert consensus adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done

No. This is not an AI/ML-based device where human reader improvement with AI assistance would be relevant. The clinical study compares device effectiveness in patients (CardioGard vs. control cannulas), not human reader performance.

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

Not applicable. This is a physical medical device (cannula), not an algorithm or software. Its "standalone" performance is assessed through its physical properties and function in in-vitro, animal, and clinical settings.

7. The Type of Ground Truth Used

Non-Clinical/Bench Testing: The "ground truth" is based on objective physical measurements and validated testing protocols (e.g., standardized methods for pressure drop, flow rates, hemolysis levels, particle capture rates).
Animal Study: The "ground truth" for embolic particle capture was the direct measurement of injected osseous embolic particles captured.
Clinical Study: The "ground truth" for efficacy was based on quantitative and qualitative assessment of diffusion weighted magnetic resonance imaging (DW-MRI) for new brain lesions, and adverse event reporting for safety. This is a form of outcomes data (imaging markers and clinical events).

8. The Sample Size for the Training Set

Not applicable. This is a physical device, not an AI/ML model that requires a training set. The "development" and "validation" involve engineering design, material science, and testing, not model training.

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

Not applicable. See point 8.

Summary

{0}------------------------------------------------

Public Health Service

Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three lines forming the wings and a snake winding around a staff. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2015

Cardiogard Medical Ltd % Sheila Hemeon-Heyer President Heyer Regulatory Solutions 125 Cherry Lane Armherst, Massachusetts 01002

Re: K141465

Trade/Device Name: Cardiogard Emboli Protection Cannula Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, Or Tubing Regulatory Class: Class II Product Code: DWF Dated: December 10, 2014 Received: December 11, 2014

Dear Sheila Hemeon-Heyer,

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, 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

{1}------------------------------------------------

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 devicerelated adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

M.G. Hillebrand

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

510(k) Number: K141465

CardioGard Emboli Protection Cannula Device Name:

Indications for Use:

Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (Part 21 CFR 807 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

{3}------------------------------------------------

510(k) Summary

This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of 21 CFR 807.92.

A. Submitter:	Heyer Regulatory Solutions LLCP.O. Box 2151Amherst, MA 01004-2151Contact: Sheila Hemeon-HeyerSheila@heyer-regulatory.com
---------------	------------------------------------------------------------------------------------------------------------------------------------------

B. Manufacturer/ CardioGard Medical Ltd. 510(k) Applicant: 6 Yoni Netanyahu Street 6037604 Or-Yehuda lsrael Contact: Walid Haddad, PhD Chief Operating Officer +972 (3) 546 7163 walid@cardiogard.com
C. Date Prepared: January 9, 2015

Device Name and Classification Information: D.

Trade Name:	CardioGard Emboli Protection Cannula
Classification Name:	Catheter, Cannula and Tubing, Vascular,Cardiopulmonary Bypass
Product Code, CFR:	DWF, 21 CFR 870.4210
Review Panel:	Cardiovascular Devices
Class:	II
Predicate Device(s):	Embol-X Access Device / Aortic Cannula,cleared under K102420 and K020693, andEmbol-X Intra-Aortic Filter cleared underK062429, K031946, and K022071

F. Device Description:

{4}------------------------------------------------

bypass (CPB), while at the same time suctioning blood and embolic matter away from the surgical field. The arterial cannula is inserted centrally in the ascending aorta.

The CardioGard Emboli Protection Cannula features a tip configuration which diffuses oxygenated blood from the heart-lung machine to the ascending aorta through the Cannula Outlet, while also aspirating blood and embolic matter through the Suction Lumen Inlet. The flow rates through the two cannula lumens are carefully controlled so that emboli are suctioned back to the CPB machine for filtration while still enabling sufficient blood flow into the aorta.

Image /page/4/Picture/3 description: The image shows two diagrams related to the CardioGard device. The left diagram, labeled "CardioGard Features," illustrates the components of the CardioGard device, including the suction tube, main tube, suction lumen inlet, and cannula outlet. The right diagram, titled "CardioGard Inserted in the Heart-Lung Circuit," depicts how the CardioGard device is integrated into the heart-lung circuit during a medical procedure.

G. Indication for Use:

The CardioGard Emboli Protection Cannula combines the function of a standard arterial cannula with an added suction mechanism to capture debris that may result from cardiac surgery.

The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term (≤ 6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.

{5}------------------------------------------------

H. Technical Comparison with Predicate Devices and Discussion of Similarities and Differences

Information for the predicate device was obtained from the 510(k) Summary and other publicly available sources.

	CardioGard Emboli Protection Cannula	Embol-X Access Device / AorticCannula(K102420, K020693)	Embol-X Intra-Aortic Filter(K062429, K031946, K022071)
Intendeduse	The CardioGard Emboli ProtectionCannula combines the function of astandard arterial cannula with an addedsuction mechanism to capture debris thatmay result from cardiac surgery. TheCardioGard Emboli Protection Cannula isintended for perfusion of the ascendingaorta during short term (≤ 6 hours)cardiopulmonary bypass (CPB)procedures. The CardioGard suctionlumen is intended for the removal ofparticulate emboli during surgicalprocedures that require CPB.	The EMBOL-X Access Device/AorticCannula is indicated for the perfusion ofthe ascending aorta during short-term (≤ 6hours) cardiopulmonary bypass (CPB)surgery where procedures may require thehemostatic introduction and removal ofcompatible intravascular devices into thevascular system.	The Embol-X Intra-aortic filter isindicated for use with the Embol-XAccess Device/Aortic Cannula in firsttime, non-emergent cardiac surgeryprocedures requiring aorticcrossclamp, to capture and removeparticulate emboli from the ascendingaorta and heart in patients aged 18years and older.
Useduration	For the length of the CPB surgery (≤ 6hours)	For the length of the CPB surgery (≤ 6hours)	The filter may remain in situ for up to60 minutes.
Design	Two lumen, curved tip with two ports.One port is for aortic perfusion ofoxygenated blood to the patient. Thesecond port is for suction of embolicparticles from the aortic arch.	Two lumen, curved tip with two ports. Oneport is for aortic perfusion of oxygenatedblood to the patient. The second port is forinsertion of the EMBOL-X filter device,intended to remove embolic particles fromthe aortic arch.	A cartridge that locks into the filterlumen of the EMBOL-X Cannula. Thefilter then opens to fill the diameter ofthe ascending aorta. The filter isintended to be inserted temporarilyduring CPB. Filters are manufacturedin 5 sizes to conform to patientanatomy.
	CardioGard Emboli Protection Cannula	Embol-X Access Device / AorticCannula(K102420, K020693)	Embol-X Intra-Aortic Filter(K062429, K031946, K022071)
Dimensions	Tip Size: 24FrLength: 30cmMain tube diameter: 3/8"Suction tube diameter: 1/4"	Tip Size: 24Fr; 20 Fr effective flowLength: 28 cmMain tube diameter: 3/8"Embolic filter port diameter: unknown	Five sizes available for aortas from 2.2 cm to 4.0 cm. Filter opens to fill the diameter of the ascending aorta.
Schematicof device	Image: CardioGard Emboli Protection Cannula	Image: Embol-X Access Device / Aortic Cannula	Image: Embol-X Intra-Aortic Filter
	CardioGard Emboli Protection Cannula	Embol-X Access Device / AorticCannula(K102420, K020693)	Embol-X Intra-Aortic Filter(K062429, K031946, K022071)
PressureDrop	Image: CardioGard Emboli Protection Cannula Pressure Drop Graph	Image: Embol-X Access Device / Aortic Cannula Pressure Drop Graph	N/A
BiologicalSafety	Tip material: PVCTubing: PVC + Nirosta.Connector: ABSBiocompatibility has been confirmed inaccordance with testing under ISO10993.	Polymeric tubesBiocompatible	Conventional medical grade materialsand processesBiocompatible
Sterilization	EtO sterilized, single-use, disposable,non-pyrogenic	EtO sterilized, single-use, disposable, non-pyrogenic	Gamma radiation, single-use,disposable, non-pyrogenic

{6}------------------------------------------------

{7}------------------------------------------------

{8}------------------------------------------------

Discussion of Similarities and Differences

Intended Use: The intended use of the CardioGard Cannula is essentially the same as that of the combined Embol-X Aortic Cannula and Intra-Aortic filter. The Embol-X Intra-Aortic Filter can only be used with the Embol-X Aortic Cannula, and the two devices are sold together as the Embol-X Glide System. Both the CardioGard and Embol-X devices are intended for arterial perfusion and embolic particle capture during cardiopulmonary bypass (CPB) surgery.

Use Duration: The CardioGard Cannula is similar to the Embol-X Cannula in that both can be used for the entire duration of the CPB surgery (≤ 6 hours). The duration of use for the Embol-X filter is limited to 60 minutes, and it is intended primarily for use during periods of aortic manipulation (i.e., clamps removal).

Design and Dimensions: The designs of the CardioGard and Embol-X Cannulas are very similar. Both have curved tips with two ports: one for arterial perfusion and one for removal of embolic particles. Both devices are 24Fr with 3/8" diameter for the main tube, and similar tube lengths. Cannula insertion for both devices is per standard surgical practice for arterial perfusion cannulas. The main difference between the two device designs is the method of embolic particle removal: The CardioGard uses suction through the second portal located behind the perfusion portal, while the Embol-X uses a mesh filter inserted into the aorta through the second portal located behind the perfusion portal. In vitro side-by-side comparison testing of the two devices demonstrated the substantial equivalence of these two methods of embolic particle removal.

Pressure Drop:

The pressure drop (difference between the inlet and outlet pressures) testing was conducted for both the CardioGard and Embol-X cannulas under the same protocol. This in vitro side-by-side comparison pressure drop testing demonstrated that the CardioGard cannulas have a smaller, and therefore better, pressure drop as compared to the predicate device at all measured flow rates (3, 4, 5, and 6 l/min).

Biological Safety: The CardioGard Cannula is substantially equivalent to the Embol-X devices in that all are made of materials commonly used in medical devices and are biocompatible for short term contact with circulating blood.

{9}------------------------------------------------

Sterilization: The CardioGard Cannula is substantially equivalent to the Embol-X devices in that all are provided sterile, are non-pvrogenic, and are intended for single use only.

. Nonclinical Data:

The following nonclinical testing was provided in this 510(k):

Sterilization Validation: EtO sterilization was validated to an SAL of 10° using the overkill method, half-cycle technique in accordance with EN ISO 11135-1:2008 Sterilization of health care products - Ethylene Oxide - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. The LAL test was used to verify that the EtO sterilized CardioGard is pyrogen-free.

Shelf Life Testing: Functionality and package integrity testing was conducted on finished, EtO sterilized devices after accelerated aging equivalent to 2 years. All tests passed, supporting a 2 year labelled shelf life. Functionality tests included:

Visual Inspection and Dimensional Verification ●
Back Pressure ●
Pressure Drop .
Air Leakage ●
Liquid Leakage ●
Force at Break ●

Package tests included:

. Peel Strength (Tensile) Test
Burst Test ●
Dye Penetration Test .

Biocompatibility Testing -Biocompatibility testing was conducted in accordance with ISO 10993-1:2009, "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing," for externally communicating devices in contact with circulating blood for limited (<24 hours) duration. Tests included cytotoxicity, irritation, sensitization, acute systemic toxicity, mutagenicity/genotoxicity and hemocompatibility. All tests passed.

{10}------------------------------------------------

In Vitro Performance Testing: Comprehensive bench tests were conducted and are listed below. All tests passed the pre-defined acceptance criteria, where applicable.

A series of numerical analyses to establish the device hemodynamic . parameters
. In vitro testing in a silicone model of the aorta to establish the distribution profiles of embolic particles with the CardioGard used at different forward flow and backwards suction rates as compared to two commercially available aortic cannulas
Mechanical performance testing for final design validation of device dimensions, back pressure, pressure drop, air leakage, liquid leakage, and force at break
Side-by-side comparison testing of the CardioGard Cannula to the . Embol-X Aortic Perfusion Cannula and Intra-Aortic Filter demonstrating:
- o Substantially lower pressure drop for CardioGard as compared to the Embol-X Cannula
- o Substantially equivalent back pressure for CardioGard as compared to the Embol-X Cannula
- o Substantially equivalent hemolysis potential for CardioGard as compared to the Embol-X Cannula and Filter when used in accordance with the instructions for use under test conditions simulating a 6 hour cardiopulmonary bypass procedure under worst case conditions (highest flow rates)
- Substantially higher embolic particle capture for CardioGard as o compared to the Embol-X Cannula and Filter when used in accordance with the instructions for use under test conditions simulating a 6 hour cardiopulmonary bypass procedure

Animal Testing: An acute animal study conducted in10 pigs (7 using the CardioGard Emboli Protection Cannula and 3 controls using a commercially available aortic perfusion cannula) demonstrated that the CardioGard device functioned well as an aortic perfusion cannula and captured a mean of 77% of injected osseous embolic particles when using the CardioGard Cannula suction feature at 1.0 or 1.5 L/min flow rates.

Clinical Testing: A prospective, randomized, multi-center, double-blind (subject and core-lab evaluators) clinical study was conducted to compare the safety and efficacy of the CardioGard Emboli Protection Cannula to

{11}------------------------------------------------

commercially available aortic perfusion cannulas during cardiac surgeries requiring cardiopulmonary bypass. The CardioGard device effectively removed measurable quantities of embolic particles throughout the surgery duration. Fewer CardioGard subjects exhibited new brain lesions following surgery, as evaluated by diffusion weighted magnetic resonance imaging (DW-MRI), compared to the subjects treated with the control cannulas (42.8% vs 66.7%, respectively), and this difference was statistically significant (p<0.05). Moreover, the average and total volume of new brain lesions were both significantly smaller for the CardioGard subjects as compared to Control (p<0.05). The CardioGard and Control groups were similar with regards to the type and incidence rates of adverse events and serious adverse events, most of which were isolated incidents and not unexpected during serious cardiac surgery requiring cardiopulmonary bypass.

I. Conclusion

The information and testing presented in this 510(k) demonstrates that the CardioGard Emboli Protection Cannula is substantially equivalent to the Embol-X Access Device / Aortic Cannula when used for aortic perfusion and when used together with the Embol-X Intra-aortic filter for removal of embolic particles during cardiopulmonary bypass surgery.

Regulation Number and Section

§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.

(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).