CardioGard Emboli Protection Cannula

K182302 · Cardiogard Medical, Ltd. · DWF · May 17, 2019 · Cardiovascular

Device Facts

• Record ID: K182302
• Device Name: CardioGard Emboli Protection Cannula
• Applicant: Cardiogard Medical, Ltd.
• Product Code: DWF · Cardiovascular
• Decision Date: May 17, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.4210
• Device Class: Class 2
• Attributes: Therapeutic

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 Story

Sterile, single-use, double-lumen arterial cannula; used in cardiac surgery during cardiopulmonary bypass (CPB). Device features main perfusion lumen and suction lumen; main lumen delivers oxygenated blood from heart-lung machine to ascending aorta; suction lumen aspirates blood and embolic debris from aortic arch back to heart-lung machine for filtration. Operated by surgical team; flow rates controlled to maintain net forward flow while maximizing embolic capture. Modified design includes tapered tip, dispersion side holes, and redesigned flange to reduce bulk and improve ease of insertion. Benefits patient by reducing embolic load during CPB. Output is physical perfusion and suction; healthcare provider monitors flow rates and cannula placement during procedure.

Clinical Evidence

Bench testing only. Included sterilization validation (ISO 11135-1), biocompatibility (ISO 10993-1), and device integrity testing. Dynamic hemolysis testing in an in vitro blood loop (6 hours, 5 L/min flow) showed similar plasma free hemoglobin increases compared to Medtronic Select 3D II. Simulated use testing confirmed substantially equivalent embolic particle capture performance compared to the predicate device under conditions simulating aortic manipulation and standard CPB flow rates.

Technological Characteristics

Double-lumen cannula; materials include polycarbonate (tip/connectors), PVC/Plastisol with stainless steel inner spring (tubes), and polyethylene (caps). EtO sterilized. Dimensions: 19-21 cm main tube, 18-19 cm suction tube. Flow rates: 1-6 L/min (main), 0-1.0 L/min (suction). Connectivity: manual connection to heart-lung machine tubing. No software/algorithm.

Indications for Use

Indicated for patients undergoing short-term (<6 hours) cardiopulmonary bypass (CPB) procedures requiring perfusion of the ascending aorta and removal of particulate emboli.

Regulatory Classification

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.

Predicate Devices

• CardioGard Emboli Protection Cannula (K141465)

Reference Devices

• Medtronic Select 3D II (K043179)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 (<6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.

| Type of Use (Select one or both, as applicable) |
|---------------------------------------------------------------------------------------------------------------------|
| <div> <span> <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> |
| <div> <span> <span style="font-size: 16px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

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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<br>P.O. Box 2151 |
|---------------|-------------------------------------------------|
| | Amherst, MA 01004-2151 |
| | Contact: Sheila Hemeon-Heyer |
| | [e-mail] |

- B. Manufacturer Contact: CardioGard Medical Ltd. 6 Yoni Netanyahu Street : 6037604 Or-Yehuda, Israel Contact: Doug Post CEO, CardioGard, Inc. Tel: [phone] [e-mail]
#### 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 (<6 hours) cardiopulmonary bypass (CPB) procedures. The CardioGard suction lumen is intended for the removal of particulate emboli during surgical procedures that require CPB.

# 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 Device<br>CardioGard Emboli<br>Protection Cannula –<br>K141465 | Modified Device<br>CardioGard Emboli<br>Protection Cannula | Same or<br>Discussion of<br>Differences |
|----------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| Intended use | The CardioGard Emboli<br>Protection Cannula combines<br>the function of a standard<br>arterial cannula with an added<br>suction mechanism to capture<br>debris that may result from<br>cardiac surgery. The<br>CardioGard Emboli Protection<br>Cannula is intended for<br>perfusion of the ascending<br>aorta during short term (≤ 6<br>hours) cardiopulmonary<br>bypass (CPB) procedures.<br>The CardioGard suction lumen<br>is intended for the removal of<br>particulate emboli during<br>surgical procedures that<br>require CPB. | The CardioGard Emboli<br>Protection Cannula combines<br>the function of a standard<br>arterial cannula with an added<br>suction mechanism to capture<br>debris that may result from<br>cardiac surgery. The<br>CardioGard Emboli Protection<br>Cannula is intended for<br>perfusion of the ascending<br>aorta during short term (≤ 6<br>hours) cardiopulmonary<br>bypass (CPB) procedures.<br>The CardioGard suction<br>lumen is intended for the<br>removal of particulate emboli<br>during surgical procedures<br>that require CPB. | Same |
| Use duration | For the length of the CPB<br>surgery (≤ 6 hours) | For the length of the CPB<br>surgery (≤ 6 hours) | Same |
| Cannula<br>Design | Two lumen, curved tip with two<br>ports. One port is for aortic<br>perfusion of oxygenated blood<br>to the patient. The second<br>port is for suction of embolic<br>particles from the aortic arch. | Two lumen, curved tip with<br>two ports. One port is for<br>aortic perfusion of oxygenated<br>blood to the patient. The<br>second port is for suction of<br>embolic particles from the<br>aortic arch.<br>Suction tube angles 90°<br>around the tip. | Substantially<br>equivalent.<br>Placement of<br>suction tube<br>angled to<br>reduce cannula<br>profile |
| Tip Angle | 30° to 60° | 30° to 60° | Substantially<br>equivalent. |
| Tip Shape | Angled | Angled and tapered with<br>dispersion side holes | Tip tapered for<br>ease of<br>insertion |
| Flange | Flange for suturing tip in place | Redesigned flange to facilitate<br>suturing in place | Dispersion side<br>holes added to<br>reduce back<br>pressure<br>Redesigned<br>flange for ease<br>of use |
| | Cleared Device<br>CardioGard Emboli<br>Protection Cannula –<br>K141465 | Modified Device<br>CardioGard Emboli<br>Protection Cannula | Same or<br>Discussion of<br>Differences |
| Dimensions | Tip Size: 24Fr<br>Main tube diameter: 3/8"<br>Suction tube diameter: 1/4"<br>Length: 30cm (both tubes<br>same length) | Tip Size: Starts at 24Fr, ends<br>at 22 Fr (at the insertion tip)<br>Main tube:<br>diameter: 5/16" tapered to<br>3/8"<br>length: 19 – 21 cm<br>Suction tube:<br>diameter: 3/16" tapered to<br>1/4"<br>length: 18 – 19 cm | Substantially<br>equivalent.<br>Slight<br>modifications<br>made to<br>reduce cannula<br>bulk and<br>improve ease<br>of use |
| Connectors | Connector to heart-lung<br>machine tubing on main tube | Connectors on both main and<br>suction tubes | Substantially<br>equivalent.<br>Added<br>connector to<br>suction tube for<br>user<br>convenience |
| Caps | Vented cap on main tube | Caps on both tubes: red for<br>main tube and yellow for<br>suction tube | Substantially<br>equivalent.<br>Color coded<br>caps on both<br>tubes for user<br>convenience |
| Main<br>(perfusion)<br>flow rate range | 1 - 6 L/min | 1 - 6 L/min | Same |
| Suction flow<br>rate range | 0 - 1.5 L/min | 0 – 1.0 L/min | Substantially<br>equivalent.<br>Max suction<br>flow rate<br>reduced to<br>provide for 5 L<br>net forward<br>flow. |
| Pressure Drop | Image: Pressure drop graph | Image: CardioGard Emboli protection cannula Gen 2 Pressure drop vs. Flow graph | Substantially<br>equivalent.<br>Pressure drop<br>for both<br>devices within<br>accepted range<br>for aortic<br>cannulas |
| | Cleared Device<br>CardioGard Emboli<br>Protection Cannula –<br>K141465 | Modified Device<br>CardioGard Emboli<br>Protection Cannula | Same or<br>Discussion of<br>Differences |
| Biological<br>Safety | Tip: PVC<br>Tubes: PVC (Plastisol) with<br>stainless steel inner spring<br>Connector: ABS plastic<br>Cap: Polyethylene | Tip: Polycarbonate<br>Tubes: PVC (Plastisol) with<br>stainless steel inner spring<br>Connectors: Polycarbonate<br>Caps: Polyethylene with PVC<br>(Plastisol) outer cover | Substantially<br>equivalent.<br>Biocompatibility confirmed for<br>both devices in<br>accordance<br>with testing<br>under<br>ISO10993. |
| Sterilization | EtO sterilized, single-use,<br>disposable, non-pyrogenic | EtO sterilized, single-use,<br>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.