The 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 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 to accommodate different sizes of LAA. The 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

The provided text describes a 510(k) premarket notification for a medical device called the "LAA Exclusion System." This document is a submission to the FDA demonstrating that the modified device is substantially equivalent to a previously cleared predicate device.

The essential information related to acceptance criteria and performance data is found under the "Performance Data" section. However, it's crucial to understand that this document does not contain the detailed study results, specific numerical acceptance criteria, or the methodology (like sample size, number of experts, ground truth establishment) for proving the device meets these criteria in the way one would expect for an AI/ML medical device submission.

This document describes a mechanical device (an implantable clip and delivery system), not an AI/ML diagnostic or prognostic tool. Therefore, the questions related to MRMC studies, training/test set sample sizes for algorithms, number of experts for ground truth, and adjudication methods for AI models are not applicable to this type of device submission.

The "acceptance criteria" for this mechanical device are performance specifications met through engineering verification tests, not clinical performance metrics based on diagnostic accuracy.

Here's an attempt to answer the questions based on the provided text, acknowledging the limitations due to the nature of the device:

1. A table of acceptance criteria and the reported device performance

The document states that "All pre-determined acceptance criteria were met" for the following tests, indicating successful performance. The specific numerical acceptance criteria themselves are not detailed in this summary document, only the types of tests performed.

Acceptance Criteria Category (Test Performed)	Reported Device Performance
Bent Shaft Functional Check	Met acceptance criteria
Trigger Actuation Force	Met acceptance criteria
Deployment/Recapture	Met acceptance criteria
Clip Orientation	Met acceptance criteria
One Pin Mis-Capture	Met acceptance criteria
Recapture Indicator	Met acceptance criteria
Implant Tip Opening	Met acceptance criteria
Implant Root Opening	Met acceptance criteria
Implant Deployment Force	Met acceptance criteria
Implant Recapture Force	Met acceptance criteria
Implant Retention Strength	Met acceptance criteria
Implant Forced Pull-Off	Met acceptance criteria
Max Dose Sterilization	Met acceptance criteria (implicitly, as part of "All pre-determined...")

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

The document does not specify the sample size used for each of these engineering verification tests, nor does it explicitly state the data provenance (e.g., country) or whether the testing was retrospective or prospective. These are typically internal design verification tests conducted by the manufacturer.

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 question is not applicable to this type of mechanical device verification. Ground truth in this context is based on engineering specifications and measurements, not expert clinical interpretation.

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

This question is not applicable. Adjudication methods like 2+1 or 3+1 are used for establishing ground truth in clinical imaging studies, typically for AI/ML performance evaluation, not for mechanical device testing.

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

No, an MRMC study was not done. This device is a mechanical implantable clip and delivery system, not an AI-assisted diagnostic tool. Therefore, effects on human reader performance are not relevant or measured here.

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

No, a standalone algorithm performance evaluation was not done. This is a mechanical device, not an algorithm.

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

The "ground truth" for this device's performance demonstration relies on engineering specifications and physical measurements validated against those specifications. For example, "Implant Tip Opening" would be measured directly and compared to a pre-defined minimum opening distance. It's not based on expert consensus, pathology, or outcomes data in the clinical diagnostic sense.

8. The sample size for the training set

This question is not applicable. This device is not an AI/ML algorithm that requires a training set.

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

This question is not applicable, as there is no training set for an AI/ML model for this mechanical device.

Summary of Inapplicability due to Device Type:
The provided document describes a 510(k) submission for a mechanical medical device (LAA Exclusion System), focused on demonstrating substantial equivalence to a predicate device based on engineering performance specifications and biocompatibility. The framework of your questions (e.g., sample size for AI test/training sets, expert readers, ground truth for AI models, MRMC studies) is primarily relevant to the FDA's evaluation of Artificial Intelligence/Machine Learning (AI/ML) based medical devices. Since the device in question is not an AI/ML product, many of your specific inquiries are not addressed in this type of submission document.

Summary

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August 30, 2023

Syntheon, LLC Toygar Unal Director of Quality 13755 SW 119 Avenue Miami, Florida 33186

Re: K232295

Trade/Device Name: LAA Exclusion System Regulation Number: 21 CFR 878.4300 Regulation Name: Implantable clip Regulatory Class: Class II Product Code: PZX Dated: July 26, 2023 Received: August 1, 2023

Dear Toygar Unal:

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 statutes and regulations administered by other Federal agencies. You must comply with all the Act's

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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 (OS) 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 mediation-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,

Katherine N. Trivedi -S

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) K232295

Device Name LAA Exclusion System

Indications for Use (Describe)

The 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)	☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)
☑ Prescription Use (Part 21 CFR 801 Subpart D)	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date Summary Prepared: July 26, 2023

Applicant:

Syntheon 13755 SW 119 Avenue Miami, FL 33186

Contact Person:

Toygar Unal Director of Quality Syntheon 13755 SW 119 Avenue Miami, FL 33186 Telephone: 1-973-997-8532 Email: tunal@syntheon.com

Trade Name:

LAA Exclusion System

Device Common or Classification Name:

Left Atrial Appendage Clip, Implantable

Review Panel:

Cardiovascular

Product Class:

Class II

Product Code:

PZX

Predicate Device:

K220305, Syntheon LAA Exclusion System

Device Description:

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Indications for Use:

The 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.

Comparison of Technological Characteristics with the Predicate Device (LAA Exclusion System, K220305):

The modifications to the LAA Exclusion System include minor changes to the following, dimensional and shape changes to the release wire, an increase in the recapture force specification, addition of a new specification around recapture without depressing the release trigger, and an update to the IFU instructions for use to instruct the user to depress the release trigger during recapture. A comparison of the technological characteristics of the subject device is summarized in Table 1.

Table 1: Comparison of Technological Characteristics
Characteristic	Subject DeviceLAA Exclusion System	Predicate DeviceLAA Exclusion System(K220305)	Rationale forSubstantialEquivalence
Indications forUse	The LAA Exclusion System isindicated for the exclusion ofthe heart's left atrialappendage, performed underdirect visualization and inconjunction with other cardiacsurgical 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.	The LAA Exclusion System isindicated for the exclusion ofthe heart's left atrialappendage, performed underdirect visualization and inconjunction with other cardiacsurgical procedures.Direct visualization, in thiscontext, requires that thesurgeon is able to see theheart directly, with or withoutassistance from a camera,endoscope, etc., or otherappropriate viewingtechnologies.	Identical
Product Code	PZX	PZX	Identical
Regulation No.	21CFR878.4300	21CFR878.4300	Identical
Classification	Class II	Class II	Identical
Components	Implantable clip and disposableclip applier (delivery system)	Implantable clip anddisposable clip applier(delivery system)	Identical
Principle ofOperation	The clip is comprised of twosprings biasing two barstogether with constant force forthe exclusion of the left atrialappendage.	The clip is comprised of twosprings biasing two barstogether with constant forcefor the exclusion of the leftatrial appendage.	Identical
Clip Size	Clip Size LAA Size Range:	Clip Size LAA Size Range:	Identical

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Table 1: Comparison of Technological Characteristics
Characteristic	Subject DeviceLAA Exclusion System	Predicate DeviceLAA Exclusion System(K220305)	Rationale forSubstantialEquivalence
	35 mm: 39-35 mm 40 mm: 34-40 mm 45 mm: 39-45 mm 50 mm: 44-50 mm	35 mm: 39-35 mm 40 mm: 34-40 mm 45 mm: 39-45 mm 50 mm: 44-50 mm
Clip Opening	Tip opens to a minimum of 12 mm at the distal end.	Tip opens to a minimum of 12 mm at the distal end.	Identical
Biocompatibility	Materials have been assessed based on ISO 10993 and are commonly employed in tissue contacting devices.	Materials have been assessed based on ISO 10993 and are commonly employed in tissue contacting devices.	Identical
Single Use Only	Yes	Yes	Identical
Sterilization	Gamma Radiation	Gamma Radiation	Identical
Pyrogenicity	Nonpyrogenic	Nonpyrogenic	Identical
MRI Compatibility	MR Conditional	MR Conditional	Identical

Performance Data:

Design verification testing was performed to ensure that the modified LAA Exclusion System continues to meet its performance specifications. The following tests were conducted to demonstrate equivalence to the predicate device.

Bent Shaft Functional Check
Trigger Actuation Force
. Deployment/Recapture
. Clip Orientation
One Pin Mis-Capture ●
Recapture Indicator
Implant Tip Opening
Implant Root Opening
Implant Deployment Force
Implant Recapture Force
Implant Retention Strength
Implant Forced Pull-Off
. Max Dose Sterilization

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

Conclusion:

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Review of the design verification test data as well as comparison of the indications for use, operating principle, technological characteristics, sterility, and biocompatibility demonstrate that the modified LAA Exclusion System is substantially equivalent to the predicate LAA Exclusion System cleared under K220305.

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.