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 (CardioGard Cannula) is a sterile, single-use, disposable double lumen arterial cannula. The CardioGard Cannula features a tip configuration that diffuses oxygenated blood from the heart-lung machine into 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 heart-lung machine for filtration while still enabling sufficient blood flow to the patient.

AI/ML Overview

This document describes a 510(k) premarket notification for the CardioGard Emboli Protection Cannula, assessing its substantial equivalence to a previously cleared device (K141465). The focus of the changes in the modified device is to reduce device bulk and improve ease of use, while maintaining safety and effectiveness.

Here's an analysis of the acceptance criteria and supporting studies:

Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparative table (starting on page 5) outlining various design and performance characteristics between the "Cleared Device" (predicate) and the "Modified Device" (current submission). It doesn't explicitly state "acceptance criteria" for each row, but rather describes how the modified device compares to the predicate and notes whether they are "Same" or "Substantially equivalent" with a discussion of differences.

Parameter	Acceptance Criteria (Implied)	Reported Device Performance (Modified Device)
Intended Use	Same as predicate.	Same as predicate.
Use Duration	Same as predicate (≤ 6 hours).	Same as predicate (≤ 6 hours).
Cannula Design	Substantially equivalent to predicate, aiming for reduced bulk and improved ease of use.	Two lumen, curved tip with two ports (aortic perfusion, embolic particle suction). Suction tube angles 90° to reduce cannula profile.
Tip Angle	30° to 60° (same as predicate).	30° to 60° (substantially equivalent).
Tip Shape	Substantially equivalent to predicate, with features for ease of insertion and reduced back pressure.	Angled and tapered with dispersion side holes. Tip tapered for ease of insertion, dispersion side holes added to reduce back pressure.
Flange	Redesigned for ease of suturing.	Redesigned flange to facilitate suturing in place.
Dimensions	Substantially equivalent to predicate, with slight modifications to reduce bulk and improve ease of use.	Tip Size: Starts at 24Fr, ends at 22Fr. Main tube: diameter: 5/16" tapered to 3/8", length: 19–21 cm. Suction tube: diameter: 3/16" tapered to 1/4", length: 18–19 cm. (Slight modifications from predicate for bulk reduction/ease of use).
Connectors	Addition of connector to suction tube for user convenience.	Connectors on both main and suction tubes (added connector to suction tube for user convenience).
Caps	Color-coded caps on both tubes for user convenience.	Caps on both tubes: red for main tube and yellow for suction tube (color-coded for user convenience).
Main (perfusion) Flow Rate	1 - 6 L/min (same as predicate).	1 - 6 L/min (same).
Suction Flow Rate	0 - 1.0 L/min (reduced maximum from predicate to ensure 5 L net forward flow).	0 - 1.0 L/min (substantially equivalent, max suction flow rate reduced to provide for 5 L net forward flow).
Pressure Drop	Within accepted range for aortic cannulas (substantially equivalent to predicate).	Pressure drop for both devices within accepted range for aortic cannulas (graphical comparison indicates substantial equivalence).
Biological Safety - Materials	Biocompatibility confirmed in accordance with ISO 10993.	Tip: Polycarbonate (changed from PVC). Tubes: PVC (Plastisol) with stainless steel inner spring (same). Connectors: Polycarbonate (changed from ABS plastic). Caps: Polyethylene with PVC (Plastisol) outer cover (changed from Polyethylene). Biocompatibility confirmed.
Sterilization	EtO sterilized, single-use, disposable, non-pyrogenic (same method and characteristics).	EtO sterilized, single-use, disposable, non-pyrogenic (same).
EtO Sterilization Validation	SAL 10^-6^ using overkill method, half-cycle technique (EN ISO 11135-1:2008), EO/ECH residuals < ISO 10993-7:2008 limits.	Validated to SAL 10^-6^; EO and ECH residual levels comply with ISO 10993-7.
LAL Endotoxin Testing	Endotoxin levels < 0.5 EU/mL extract or < 20 EU/device.	Verified endotoxin levels well below limits for medical devices in contact with cardiovascular system (≤0.5 EU/mL extract or ≤20 EU/device).
Pyrogenicity Testing	Pyrogen-free.	Verified pyrogen-free.
Biocompatibility Testing	Meet acceptance criteria of applicable standard (ISO 10993-1:2009 for externally communicating devices, <24 hours contact with blood).	All tests (cytotoxicity, irritation, sensitization, acute systemic toxicity, genotoxicity/mutagenicity, hemolysis, partial thromboplastin time, complement activation, in-vivo thrombogenicity) met acceptance criteria.
Packaging Integrity	Meet pre-defined acceptance criteria at all time periods (time 0, env. conditioning, simulated transport, 3-year accelerated aging).	All tests (Peel Strength, Burst, Dye Penetration, Package Label integrity) met pre-defined acceptance criteria.
Device Integrity	Meet pre-defined acceptance criteria at all time periods (time 0, env. conditioning, simulated transport, 3-year accelerated aging).	All tests (Visual Inspection, Dimensional Verification, Force at Break, Tip force at break, Pressure Drop, Back pressure, Liquid Leakage, Tube kinking, Tube bending, Tube hardness, Resistance to clamping, Tube printing ink integrity) met pre-defined acceptance criteria.
Dynamic Hemolysis	Similar gradual increases in plasma free hemoglobin as compared to a commercially available arterial cannula (Medtronic Select 3D II).	Demonstrated similar gradual increases in plasma free hemoglobin to the Medtronic Select 3D II (K043179).
Functional Performance	Substantially equivalent embolic particle capture as compared to the original CardioGard Cannula under simulated use conditions.	Demonstrated substantially equivalent embolic particle capture as compared to the original CardioGard Cannula (K141465) in a simulated use test.

Sample sizes used for the test set and data provenance:
- Functional Performance (Simulated Use Test): The document states "The functional performance of the modified CardioGard Cannula was validated a simulated use test set-up with direct comparison to the predicate device." It does not specify the numerical sample size for this test. It refers to "test conditions simulating aortic manipulation, maximum flow rates, and typical flow rates."
- Dynamic Hemolysis Testing: Conducted in an "in vitro blood loop with bovine blood circulating at a net forward flow of 5 L/min for 6 hours." No specific numerical sample size for devices is given.
- Packaging and Device Integrity Tests: Performed at "time 0 and after environmental conditioning, simulated transportation, and 3-year accelerated aging." No specific numerical sample size for devices is given.
- Provenance: All nonclinical data appears to be from in-vitro laboratory testing or simulated environments, not from human or animal subjects, therefore data provenance in terms of country of origin or retrospective/prospective clinical study is not applicable in the usual sense.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Not applicable. The tests performed are non-clinical (laboratory and simulated use tests), not involving human interpretation or clinical ground truth established by medical experts for a "test set" as typically understood in AI/imaging studies.
Adjudication method for the test set:

Not applicable, as this is not a study requiring expert adjudication of results.
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, an MRMC comparative effectiveness study was not done. This device is a medical cannulation tool, not an AI software/diagnostic device that would involve human readers or AI assistance in interpretation.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:

Not applicable. This is a physical medical device, not an algorithm or AI system. The "functional performance" mentioned refers to the device's physical ability to capture particles in a simulated environment.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

The "ground truth" for the non-clinical tests is established by:
- Standardized testing methodologies: Adherence to international standards (e.g., EN ISO 11135-1:2008 for sterilization, ISO 10993-7:2008 for residuals, USP <85> for endotoxins, USP <151> for pyrogenicity, ISO 10993-1:2009 for biocompatibility).
- Direct comparison to a legally marketed predicate device: For dynamic hemolysis and functional performance (embolic particle capture), the performance of the modified device was compared against the predicate device (K141465) or another commercially available arterial cannula (Medtronic Select 3D II).
- Pre-defined acceptance criteria: For packaging and device integrity, explicit acceptance criteria were used.
The sample size for the training set:

Not applicable. This is a physical medical device, not an AI/machine learning system that requires a "training set."
How the ground truth for the training set was established:

Not applicable, as no training set was used.

Summary

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May 17, 2019

CardioGard Medical Ltd % Sheila Hemeon-Heyer President and Founder Heyer Regulatory Solutions, LLC 125 Cherry Lane Amherst, Massachusetts 01002

Re: K182302

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: NCP Dated: April 19, 2019 Received: April 22, 2019

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. 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 located 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.

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

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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 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 Ibrahim 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

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Indications for Use

510(k) Number (if known) K182302

Device Name

CardioGard Emboli Protection Cannula

Indications for Use (Describe)

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.

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) 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 2151
	Amherst, MA 01004-2151
	Contact: Sheila Hemeon-Heyer
	Sheila@heyer-regulatory.com

B. Manufacturer Contact: CardioGard Medical Ltd. 6 Yoni Netanyahu Street : 6037604 Or-Yehuda, Israel Contact: Doug Post CEO, CardioGard, Inc. Tel: (707) 481-0602 doug@cardiogard.com

C. Date Prepared: May 15, 2019

D. Device Name and Classification Information:

Trade Name:	CardioGard Emboli Protection Cannula
Classification Name:	Catheter, Cannula and Tubing, Vascular,
	Cardiopulmonary Bypass
Product Code, CFR:	NCP, 21 CFR 870.4210
Review Panel:	Cardiovascular Devices
Class:	II

E. Predicate Device: K141465 CardioGard Emboli Protection Cannula

F. Device Description:

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During routine use, maximum flow rates should be ≤ 5.5 L/min (main) and ≤ 0.5 L/min (suction), for a net flow of ≤ 5 L/min. During periods of increased particle release, e.g., clamping and declamping, flows can be increased up to 6 L/min (main) and 1.0 L/min (suction) for not more than 10 minutes each hour.

Image /page/4/Picture/3 description: In the image, there are three clear tubes that are connected together. The tubes are made of a flexible material and have a ribbed texture. The tubes are connected by clear plastic connectors. The tubes are likely used for medical or scientific purposes.

Image /page/4/Picture/4 description: This image shows a diagram of a heart-lung machine. The diagram shows the heart connected to a machine with red and blue tubes. The red tubes carry blood from the heart to the machine, and the blue tubes carry blood from the machine back to the heart. The machine has a series of pumps that help to circulate the blood.

Cannula outlet

CardioGard Features

Suction inlet

CardioGard Inserted in the Heart-Lung Circuit

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.

H. Technical Comparison with Predicate Device

The modified CardioGard Cannula has the same intended use and same indications for use as the original CardioGard Cannula cleared under K141465. The device dimensions, tip design, and suction tube orientation have been modified to reduce device bulk and improve ease of use without changing the device safety or effectiveness profile. The table below provides a side-by-side comparison of the modified to legally marketed CardioGard Cannula.

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	Cleared DeviceCardioGard EmboliProtection Cannula –K141465	Modified DeviceCardioGard EmboliProtection Cannula	Same orDiscussion ofDifferences
Intended use	The CardioGard EmboliProtection Cannula combinesthe function of a standardarterial cannula with an addedsuction mechanism to capturedebris that may result fromcardiac surgery. TheCardioGard Emboli ProtectionCannula is intended forperfusion of the ascendingaorta during short term (≤ 6hours) cardiopulmonarybypass (CPB) procedures.The CardioGard suction lumenis intended for the removal ofparticulate emboli duringsurgical procedures thatrequire CPB.	The CardioGard EmboliProtection Cannula combinesthe function of a standardarterial cannula with an addedsuction mechanism to capturedebris that may result fromcardiac surgery. TheCardioGard Emboli ProtectionCannula is intended forperfusion of the ascendingaorta during short term (≤ 6hours) cardiopulmonarybypass (CPB) procedures.The CardioGard suctionlumen is intended for theremoval of particulate emboliduring surgical proceduresthat require CPB.	Same
Use duration	For the length of the CPBsurgery (≤ 6 hours)	For the length of the CPBsurgery (≤ 6 hours)	Same
CannulaDesign	Two lumen, curved tip with twoports. One port is for aorticperfusion of oxygenated bloodto the patient. The secondport is for suction of embolicparticles from the aortic arch.	Two lumen, curved tip withtwo ports. One port is foraortic perfusion of oxygenatedblood to the patient. Thesecond port is for suction ofembolic particles from theaortic arch.Suction tube angles 90°around the tip.	Substantiallyequivalent.Placement ofsuction tubeangled toreduce cannulaprofile
Tip Angle	30° to 60°	30° to 60°	Substantiallyequivalent.
Tip Shape	Angled	Angled and tapered withdispersion side holes	Tip tapered forease ofinsertion
Flange	Flange for suturing tip in place	Redesigned flange to facilitatesuturing in place	Dispersion sideholes added toreduce backpressureRedesignedflange for easeof use
	Cleared DeviceCardioGard EmboliProtection Cannula –K141465	Modified DeviceCardioGard EmboliProtection Cannula	Same orDiscussion ofDifferences
Dimensions	Tip Size: 24FrMain tube diameter: 3/8"Suction tube diameter: 1/4"Length: 30cm (both tubessame length)	Tip Size: Starts at 24Fr, endsat 22 Fr (at the insertion tip)Main tube:diameter: 5/16" tapered to3/8"length: 19 – 21 cmSuction tube:diameter: 3/16" tapered to1/4"length: 18 – 19 cm	Substantiallyequivalent.Slightmodificationsmade toreduce cannulabulk andimprove easeof use
Connectors	Connector to heart-lungmachine tubing on main tube	Connectors on both main andsuction tubes	Substantiallyequivalent.Addedconnector tosuction tube foruserconvenience
Caps	Vented cap on main tube	Caps on both tubes: red formain tube and yellow forsuction tube	Substantiallyequivalent.Color codedcaps on bothtubes for userconvenience
Main(perfusion)flow rate range	1 - 6 L/min	1 - 6 L/min	Same
Suction flowrate range	0 - 1.5 L/min	0 – 1.0 L/min	Substantiallyequivalent.Max suctionflow ratereduced toprovide for 5 Lnet forwardflow.
Pressure Drop	Image: Pressure drop graph	Image: CardioGard Emboli protection cannula Gen 2 Pressure drop vs. Flow graph	Substantiallyequivalent.Pressure dropfor bothdevices withinaccepted rangefor aorticcannulas
	Cleared DeviceCardioGard EmboliProtection Cannula –K141465	Modified DeviceCardioGard EmboliProtection Cannula	Same orDiscussion ofDifferences
BiologicalSafety	Tip: PVCTubes: PVC (Plastisol) withstainless steel inner springConnector: ABS plasticCap: Polyethylene	Tip: PolycarbonateTubes: PVC (Plastisol) withstainless steel inner springConnectors: PolycarbonateCaps: Polyethylene with PVC(Plastisol) outer cover	Substantiallyequivalent.Biocompatibility confirmed forboth devices inaccordancewith testingunderISO10993.
Sterilization	EtO sterilized, single-use,disposable, non-pyrogenic	EtO sterilized, single-use,disposable, non-pyrogenic	Same

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1. Nonclinical Data:

All testing was conducted on finished, sterilized devices.

EtO sterilization was validated to SAL 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. EO and ECH residual levels were confirmed to comply with the limits under ISO 10993-7:2008. LAL Endotoxin testing to USP <85> verified that the endotoxin levels were well below the limits required for medical devices in contact with the cardiovascular system (≤0,5 EU/mL extract or ≤20 EU/device). Material-mediated pyrogenicity testing to USP <151> verified that the EtO sterilized CardioGard is pyrogen-free.

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, genotoxicity/mutagenicity, hemolysis, partial thromboplastin time, complement activation, and in-vivo thrombogenicity. All tests met the acceptance criteria of the applicable standard.

Packaging and device integrity tests were conducted at time 0 and after environmental conditioning, simulated transportation, and 3-year accelerated aging. All tests met the pre-defined acceptance criteria at all time periods.

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Package integrity testing included the following:

Peel Strength (Tensile) Test ●
. Burst Test
Dye Penetration Test ●
Package Label integrity .

Device integrity testing included the following:

Visual Inspection and Dimensional Verification
Force at Break
Tip force at break ●
Pressure Drop ●
Back pressure ●
Liquid Leakage ●
Tube kinking
Tube bending ●
. Tube hardness
Resistance to clamping ●
. Tube printing ink integrity

Dynamic hemolysis testing was conducted in an in vitro blood loop with bovine blood circulating at a net forward flow of 5 L/min for 6 hours. Test results demonstrated similar gradual increases in plasma free haemoglobin for the modified CardioGard Cannula as compared to a commercially available arterial cannula, the Medtronic Select 3D II (K043179).

The functional performance of the modified CardioGard Cannula was validated a simulated use test set-up with direct comparison to the predicate device. The results of this testing demonstrated substantially equivalent embolic particle capture for the modified CardioGard Cannula as compared to the original CardioGard Cannula when used in accordance with the instructions for use under test conditions simulating aortic manipulation, maximum flow rates, and typical flow rates used during the cardiopulmonary bypass procedure.

I. Conclusion

The information and testing presented in this 510(k) demonstrates that the modified CardioGard Emboli Protection Cannula is substantially equivalent to the original device cleared under K141465 because it has the same intended use, indications for use, mechanism of action, and principles of operation. Testing provided in this 510(k) confirms that the technological changes from the originally cleared CardioGard Cannula do not significantly affect the safety or efficacy of the device.

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).