K Number
K182302
Device Name
CardioGard Emboli Protection Cannula
Date Cleared
2019-05-17

(266 days)

Product Code
Regulation Number
870.4210
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdparty
Intended 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.
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.
More Information

No
The description focuses on the mechanical function of the cannula and does not mention any AI or ML components.

Yes.
The device is intended for the removal of particulate emboli during surgical procedures, which constitutes a therapeutic function.

No.

The device describes itself as an "Emboli Protection Cannula" intended for "perfusion of the ascending aorta" and for "removal of particulate emboli." It's a therapeutic device designed to prevent embolism through mechanical removal of debris during cardiac surgery, not to diagnose a condition.

No

The device description clearly outlines a physical, sterile, single-use, disposable double lumen arterial cannula with a suction mechanism, indicating it is a hardware device.

Based on the provided information, the CardioGard Emboli Protection Cannula is not an In Vitro Diagnostic (IVD) device.

Here's why:

  • Intended Use: The intended use is for the perfusion of the ascending aorta during cardiopulmonary bypass and the removal of particulate emboli during these procedures. This is a direct intervention on the patient's circulatory system.
  • Device Description: The device is a cannula designed to be inserted into the body to manage blood flow and remove debris.
  • Lack of In Vitro Testing: While there are performance studies, they focus on the device's physical properties, biocompatibility, and functional performance in a simulated blood loop and simulated use. There is no mention of testing patient samples (blood, tissue, etc.) outside of the body to diagnose a condition or provide information about a patient's health status.

IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. The CardioGard Emboli Protection Cannula is a therapeutic and interventional device used in vivo (inside the body).

N/A

Intended Use / Indications 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 ( verified that the endotoxin levels were well below the limits required for medical devices in contact with the cardiovascular system ( 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 (

§ 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).

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the FDA name on the right. The symbol on the left is a stylized image of a human figure, while the FDA name on the right is written in blue letters. The words "U.S. FOOD & DRUG ADMINISTRATION" are written in a clear, sans-serif font.

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.

The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term ( ☑ 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 LLC
P.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:

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.

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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.

The CardioGard Emboli Protection Cannula is intended for perfusion of the ascending aorta during short term ( 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 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 (