Syntheon LAA Exclusion System, Syntheon LAA Selection Guide

K220305 · Syntheon · PZX · Oct 28, 2022 · General, Plastic Surgery

Device Facts

• Record ID: K220305
• Device Name: Syntheon LAA Exclusion System, Syntheon LAA Selection Guide
• Applicant: Syntheon
• Product Code: PZX · General, Plastic Surgery
• Decision Date: Oct 28, 2022
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.4300
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures. Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.

Device Story

The Syntheon LAA Exclusion System is a sterile, single-use implantable device designed for permanent exclusion of the left atrial appendage (LAA). It consists of a self-closing clip preloaded on a delivery system. The device is used by surgeons in an operating room setting during cardiac surgery. The surgeon uses a sterile, single-use selection guide to determine the appropriate clip size (35mm, 40mm, 45mm, or 50mm). The clip utilizes two internal springs to bias two bars together, applying constant force to the LAA tissue to ensure exclusion. By mechanically isolating the LAA, the device aims to reduce the risk of thrombus formation and subsequent embolic events. The procedure is performed under direct visualization, which may be aided by cameras or endoscopes. The device is MR conditional.

Clinical Evidence

No clinical data provided. Evidence consists of bench-top validation testing, mechanical testing, packaging testing, shelf-life testing, and animal validation testing. All pre-determined acceptance criteria were met.

Technological Characteristics

Implantable clip with two springs biasing two bars; available in 35mm, 40mm, 45mm, and 50mm sizes. Materials assessed per ISO 10993-1:2018. Sterilization via gamma radiation. MR conditional. Single-use, sterile, disposable delivery system. No software or electronic components.

Indications for Use

Indicated for exclusion of the left atrial appendage in patients undergoing cardiac surgical procedures requiring direct visualization of the heart.

Regulatory Classification

Identification

An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.

Predicate Devices

• AtriCure AtriClip LAA Exclusion System (K210293)

Submission Summary (Full Text)

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October 28, 2022

Syntheon % Elena Jugo Regulatory Consultant Caraballo Consulting, LLC 11037 Bitternut Hickory Lane Boynton Beach, Florida 33437

Re: K220305

Trade/Device Name: Syntheon LAA Exclusion System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PZX Dated: September 27, 2022 Received: September 28, 2022

Dear Elena Jugo:

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Rachel Neubrander Assistant 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) K220305

Device Name Syntheon LAA Exclusion System

Indications for Use (Describe)

The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.

| Type of Use (Select one or both, as applicable) |
|----------------------------------------------------------------------------|
| <span> <span></span>Prescription Use (Part 21 CFR 801 Subpart D) </span> |
| <span> <span></span>Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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# 5 - 510(k) Summary

| Date Summary Prepared: | January 31, 2022 |
|------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Submitter: | Syntheon<br>13755 SW 119 Avenue<br>Miami, FL 33186 |
| Primary Submission Contact: | Elena Jugo<br>Regulatory Consultant<br>Caraballo Consulting<br>13755 SW 119 Avenue<br>Miami, FL 33186<br>Telephone: [phone]<br>Facsimile: 1-786-664-0026<br>E-Mail: [e-mail] |
| Secondary Submission Contact: | Toygar Unal<br>Director of Quality<br>Syntheon<br>13755 SW 119 Avenue<br>Miami, FL 33186<br>Telephone: [phone]<br>Facsimile: 1-786-664-0026<br>E-Mail: [e-mail] |
| Trade Name: | LAA Exclusion System |
| Regulation Number: | 21 CFR 878.4300 |
| Device Common or<br>Classification Name: | Left Atrial Appendage Clip, Implantable |
| Product Class: | Class II |
| Product Panel: | Cardiovascular |
| Product Code: | PZX |
| Predicate Device: | K210293, AtriCure AtriClip LAA Exclusion System |

CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.

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#### 5.1 Device Description

The Syntheon LAA Exclusion System consists of a single use, sterile, self-closing, implantable Clip preloaded on a single use delivery system. When closed, the implant applies pressure to ensure exclusion of the left atrial appendage (LAA). Once the clip is deployed, it remains as a permanent implant. The implantable clip is available in lengths of 35mm. 40mm, 45mm, and 50mm to accommodate different sizes of LAA. The Syntheon LAA Selection Guide is a sterile, single use, disposable surgical accessory device to assist the physician in selecting the appropriately sized clip implant for each individual patient.

### 5.2 Indications for Use

The Syntheon LAA Exclusion System is indicated for the exclusion of the heart's left atrial appendage, performed under direct visualization and in conjunction with other cardiac surgical procedures.

Direct visualization, in this context, requires that the surgeon is able to see the heart directly, with or without assistance from a camera, endoscope, etc., or any other appropriate viewing technology.

#### 5.3 Technological Characteristics and Basis for Substantial Equivalence

The Syntheon LAA Exclusion System, subject of this 510(k) submission, is substantially equivalent in its intended use/indications for use, technology/principal of operation, biocompatibility of materials, sterilization method and performance to the predicate device, the AtriCure AtriClip LAA Exclusion System.

A comparison of the technological characteristics of the subject device and the predicate device is summarized in Table 5.3.1.

CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.

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| Parameter | Subject Device<br>Syntheon LAA Exclusion<br>System | Predicate Device<br>AtriCure AtriClip LAA<br>Exclusion System<br>510(k) # K210293 | Equivalence<br>Comparison |
|---------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use | The Syntheon LAA Exclusion<br>System is indicated for the<br>exclusion of the heart's left atrial<br>appendage, performed under<br>direct visualization and in<br>conjunction with other cardiac<br>surgical procedures.<br>Direct visualization, in this<br>context, requires that the surgeon<br>is able to see the heart directly,<br>with or without assistance from a<br>camera, endoscope, etc., or other<br>appropriate viewing technologies. | The AtriClip LAA Exclusion<br>System is indicated for the<br>exclusion of the heart's left<br>atrial appendage, performed<br>under direct visualization and<br>in conjunction with other<br>cardiac surgical procedures.<br>Direct visualization, in this<br>context, requires that the<br>surgeon is able to see the heart<br>directly, with or without<br>assistance from a camera,<br>endoscope, etc., or other<br>appropriate viewing<br>technologies. | Same |
| Product Code | PZX | PZX | Same |
| Regulation No. | 21CFR878.4300 | 21CFR878.4300 | Same |
| Classification | Class II | Class II | Same |
| Components | Implantable clip and disposable<br>clip applier (delivery system) | Implantable clip and disposable<br>clip applier | Same |
| Principle of<br>Operation | The clip is comprised of two<br>springs biasing two bars together<br>with constant force for the<br>exclusion of the left atrial<br>appendage. | The clip is comprised of two<br>springs biasing two bars<br>together with constant force for<br>the exclusion of the left atrial<br>appendage. | Same |
| Clip Size | Clip Size LAA Size Range:<br>• 35 mm: 29-35 mm<br>• 40 mm: 34-40 mm<br>• 45 mm: 39-45 mm<br>• 50 mm: 44-50 mm | Clip Size LAA Size Range:<br>• 35 mm: 29-35 mm<br>• 40 mm: 34-40 mm<br>• 45 mm: 39-45 mm<br>• 50 mm: 44-50 mm | Same |
| Clip Opening | Tip opens to a minimum of 12<br>mm at the distal end. | Gillinov-Cosgrove Clip: Opens<br>12.5 mm $\pm$ 1.5 mm as<br>measured between the beams of<br>the clip.<br>PROV Clip: Opens to a<br>minimum of 12 mm at the<br>distal end and 4 mm at the<br>proximal end of the clip. | Same as PROV, design<br>verification testing for the<br>Syntheon LAA Exclusion<br>system has demonstrated<br>a proximal opening >4<br>mm for all implant sizes.<br>The implant functions as<br>intended. |
| Biocompatibility | Materials have been assessed<br>based on ISO 10993 and are | Materials have been assessed<br>based on ISO 10993 and are | Same |

| Table 5.3.1 - Comparison Between the Syntheon LAA Exclusion System and Predicate Device | |
|-----------------------------------------------------------------------------------------|--|
| | |

CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.

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| Parameter | Subject Device<br>Syntheon LAA Exclusion<br>System | Predicate Device<br>AtriCure AtriClip LAA<br>Exclusion System<br>510(k) # K210293 | Equivalence<br>Comparison |
|-------------------|----------------------------------------------------|-----------------------------------------------------------------------------------|---------------------------|
| | commonly employed in tissue<br>contacting devices. | commonly employed in tissue<br>contacting devices. | |
| Single Use Only | Yes | Yes | Same |
| Sterilization | Gamma Radiation | Gamma Radiation | Same |
| Pyrogenicity | Nonpyrogenic | Nonpyrogenic | Same |
| MRI Compatibility | MR Conditional | MR Conditional | Same |

Table 5.3.1 - Comparison Between the Syntheon LAA Exclusion System and Predicate Device

#### 5.4 Performance Data

Design verification and validation were performed to ensure that the Syntheon LAA Exclusion System meets its performance specifications and demonstrates substantial equivalence to the predicate device. There are no known performance standards for this device. The following tests were conducted to demonstrate equivalence to the predicate device:

- o Mechanical Testing
- Packaging Testing 0
- o Shelf-life Testing
- Bench-top Validation Testing ●
- Animal Validation Testing

All pre-determined acceptance criteria were met. The data demonstrate that the Syntheon LAA Exclusion System is substantially equivalent to the predicate device.

### 5.5 Biocompatibility Testing

The Syntheon LAA Exclusion System was assessed for biocompatibility in accordance with ISO 10993-1:2018, "Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process". The clip component of the LAA Exclusion System is an implantable device that is in long-term contact with the body (> 30 days), while the clip delivery system has limited contact (< 24 hours). Table 5.5.1 lists the tests performed to ensure that each component is biocompatible. The Syntheon LAA Exclusion System biocompatibility testing met all requirements.

CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.

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| Test | Implant, Long-Term Contact (> 30 days) | Delivery System -<br>External Communicating, Limited<br>Contact (≤ 24 hours) |
|---------------------------------------------------------------------------------|----------------------------------------|------------------------------------------------------------------------------|
| Chemical Characterization | ✓ | ✓ |
| Cytotoxicity | ✓ | ✓ |
| Sensitization | ✓ | ✓ |
| Irritation | ✓ | ✓ |
| Acute Systemic Toxicity | ✓ | ✓ |
| Pyrogenicity | ✓ | ✓ |
| Sub-Acute/Sub-Chronic Toxicity | ✓ | ✓ |
| Genotoxicity<br>• Ames Mutagenicity<br>• In Vitro Mouse Lymphoma<br>Mutagenesis | ✓ | N/A |
| Implantation<br>• 1-, 4-, and 13-weeks | ✓ | |

Table 5.5.1 - Biocompatibility Tests Performed on the LAA Exclusion System

#### 5.6 Conclusion

Review of the verification and validation test data as well as comparison of the device classification, indications for use, operating principle, technological characteristics, sterility, and biocompatibility, demonstrate that the subject device, the Syntheon LAA Exclusion System, is substantially equivalent to the predicate AtriCure AtriClip LAA Exclusion System, K210293, cleared on March 3th, 2021. Any differences between the predicate devices do not raise any issues of safety and effectiveness.

CONFIDENTIAL AND PROPRIETARY DATA: This document and the information contained herein may not be reproduced, used, or disclosed without written permission from Syntheon, LLC.