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 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.

AI/ML Overview

This document describes the Syntheon LAA Exclusion System and its substantial equivalence to a predicate device, focusing on various performance and safety aspects rather than an AI/ML component. Therefore, several of the requested categories for AI/ML device studies are not applicable.

Here's the summary of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Clip Opening	Proximal opening >4 mm for all implant sizes (specifically, "Same as PROV, design verification testing for the Syntheon LAA Exclusion system has demonstrated a proximal opening >4 mm for all implant sizes. The implant functions as intended.")	Met (implied by "All pre-determined acceptance criteria were met.")
Mechanical Testing	Not explicitly stated what the specific acceptance criteria were, but the general goal was to ensure the device meets performance specifications and demonstrates substantial equivalence to the predicate device.	Met (implied by "All pre-determined acceptance criteria were met. The data demonstrate that the Syntheon LAA Exclusion System is substantially equivalent to the predicate device.")
Packaging Testing	Not explicitly stated.	Met (implied by "All pre-determined acceptance criteria were met.")
Shelf-life Testing	Not explicitly stated.	Met (implied by "All pre-determined acceptance criteria were met.")
Bench-top Validation Testing	Not explicitly stated.	Met (implied by "All pre-determined acceptance criteria were met.")
Animal Validation Testing	Not explicitly stated.	Met (implied by "All pre-determined acceptance criteria were met.")
Biocompatibility (various tests)	Met requirements of ISO 10993-1:2018 for implantable devices (>30 days contact) and delivery system (<24 hours contact). Specific tests include Chemical Characterization, Cytotoxicity, Sensitization, Irritation, Acute Systemic Toxicity, Pyrogenicity, Sub-Acute/Sub-Chronic Toxicity, Genotoxicity (Ames Mutagenicity, In Vitro Mouse Lymphoma Mutagenesis for implant), Implantation (1-, 4-, and 13-weeks for implant).	Met (explicitly stated: "The Syntheon LAA Exclusion System biocompatibility testing met all requirements.")

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

This information is not provided in the given document. The document refers to "design verification and validation" and "animal validation testing" but does not detail sample sizes or data provenance for these tests.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that requires expert-established ground truth from interpretative data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that undergoes adjudication for interpretative data.

5. 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

This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)

For the performance and validation tests mentioned (e.g., mechanical testing, biocompatibility, animal studies), the "ground truth" would be established by physical measurements, biological responses, and observed clinical outcomes in the animal models, rather than expert consensus on interpretative data or pathology in the context of an AI/ML algorithm.

8. The sample size for the training set

This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that requires a training set.

9. How the ground truth for the training set was established

This information is not applicable as the document describes a medical device (implantable clip) and its related performance testing, not an AI/ML algorithm that requires a training set.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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.

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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5 - 510(k) Summary

Date Summary Prepared:	January 31, 2022
Submitter:	Syntheon13755 SW 119 AvenueMiami, FL 33186
Primary Submission Contact:	Elena JugoRegulatory ConsultantCaraballo Consulting13755 SW 119 AvenueMiami, FL 33186Telephone: 1-305-510-4398Facsimile: 1-786-664-0026E-Mail: Elena@Caraballoconsulting.com
Secondary Submission Contact:	Toygar UnalDirector of QualitySyntheon13755 SW 119 AvenueMiami, FL 33186Telephone: 1-973-997-8532Facsimile: 1-786-664-0026E-Mail: tunal@syntheon.com
Trade Name:	LAA Exclusion System
Regulation Number:	21 CFR 878.4300
Device Common orClassification 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

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.

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 DeviceSyntheon LAA ExclusionSystem	Predicate DeviceAtriCure AtriClip LAAExclusion System510(k) # K210293	EquivalenceComparison
Indications forUse	The Syntheon LAA ExclusionSystem is indicated for theexclusion of the heart's left atrialappendage, performed underdirect visualization and inconjunction with other cardiacsurgical procedures.Direct visualization, in thiscontext, requires that the surgeonis able to see the heart directly,with or without assistance from acamera, endoscope, etc., or otherappropriate viewing technologies.	The AtriClip LAA ExclusionSystem is indicated for theexclusion of the heart's leftatrial appendage, performedunder direct visualization andin conjunction with othercardiac surgical procedures.Direct visualization, in thiscontext, requires that thesurgeon is able to see the heartdirectly, with or withoutassistance from a camera,endoscope, etc., or otherappropriate viewingtechnologies.	Same
Product Code	PZX	PZX	Same
Regulation No.	21CFR878.4300	21CFR878.4300	Same
Classification	Class II	Class II	Same
Components	Implantable clip and disposableclip applier (delivery system)	Implantable clip and disposableclip applier	Same
Principle ofOperation	The clip is comprised of twosprings biasing two bars togetherwith constant force for theexclusion of the left atrialappendage.	The clip is comprised of twosprings biasing two barstogether with constant force forthe exclusion of the left atrialappendage.	Same
Clip Size	Clip Size LAA Size Range:• 35 mm: 29-35 mm• 40 mm: 34-40 mm• 45 mm: 39-45 mm• 50 mm: 44-50 mm	Clip Size LAA Size Range:• 35 mm: 29-35 mm• 40 mm: 34-40 mm• 45 mm: 39-45 mm• 50 mm: 44-50 mm	Same
Clip Opening	Tip opens to a minimum of 12mm at the distal end.	Gillinov-Cosgrove Clip: Opens12.5 mm $\pm$ 1.5 mm asmeasured between the beams ofthe clip.PROV Clip: Opens to aminimum of 12 mm at thedistal end and 4 mm at theproximal end of the clip.	Same as PROV, designverification testing for theSyntheon LAA Exclusionsystem has demonstrateda proximal opening >4mm for all implant sizes.The implant functions asintended.
Biocompatibility	Materials have been assessedbased on ISO 10993 and are	Materials have been assessedbased 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 DeviceSyntheon LAA ExclusionSystem	Predicate DeviceAtriCure AtriClip LAAExclusion System510(k) # K210293	EquivalenceComparison
	commonly employed in tissuecontacting devices.	commonly employed in tissuecontacting 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 -External Communicating, LimitedContact (≤ 24 hours)
Chemical Characterization	✓	✓
Cytotoxicity	✓	✓
Sensitization	✓	✓
Irritation	✓	✓
Acute Systemic Toxicity	✓	✓
Pyrogenicity	✓	✓
Sub-Acute/Sub-Chronic Toxicity	✓	✓
Genotoxicity• Ames Mutagenicity• In Vitro Mouse LymphomaMutagenesis	✓	N/A
Implantation• 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.

Regulation Number and Section

§ 878.4300 Implantable clip.

(a)
Identification. An implantable clip is a clip-like device intended to connect internal tissues to aid healing. It is not absorbable.(b)
Classification. Class II.