VIOLA clampless proximal anastomosis sealing system is indicated for use by cardiac surgeons during coronary artery bypass grafting procedures to maintain hemostasis and facilitate the completion of proximal anastomoses to the aorta without application of an aortic clamp.

Device Description

The VIOLA is a sterile, single-use device designed to maintain hemostasis and facilitate the completion of multiple proximal anastomoses during a coronary artery bypass grafting procedure, without application of an aortic clamp. The VIOLA system can be used to create up to 4 anastomoses within the same patient.

The VIOLA is comprised of:

1. A concentric 4 mm aortic punch with a detachable handle.
1. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
1. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.

The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

AI/ML Overview

The provided text is a 510(k) summary for the Vascular Graft Solutions, Ltd.'s VIOLA device. It describes the device, its intended use, and substantial equivalence to a predicate device, but it does not contain information about acceptance criteria or a study proving that the device meets specific acceptance criteria in the way typically expected for a detailed performance study with quantifiable metrics and a test set.

The "Performance Data" section lists several types of validation and testing conducted, but these are general categories of testing (e.g., sterilization validation, biocompatibility, design verification, animal testing) rather than a study designed to evaluate performance against specific, pre-defined acceptance criteria for the device's clinical function in humans.

Therefore, many of the requested fields cannot be filled based on the provided document.

Here's a breakdown of what can and cannot be extracted:

1. Table of acceptance criteria and the reported device performance:

This information is not present in the document. The document lists types of performance data (e.g., "Bond Strength Testing," "Sealing Element Crush Resistance Testing"), but it does not provide specific acceptance criterion values (e.g., "Bond strength must be > X N") nor the reported performance values that demonstrate these criteria were met.

2. Sample size used for the test set and the data provenance:

Sample Size for Test Set: Not specified in terms of a clinical or ex-vivo performance test set with a defined sample size for statistical analysis against acceptance criteria. The document mentions "Animal testing," but does not detail the number of animals or the specific test set size derived from this.
Data Provenance (e.g., country of origin of the data, retrospective or prospective): The animal study was conducted in compliance with Good Laboratory Practice (GLP) requirements (21 CFR 58), but the country of origin is not specified. It would be considered prospective for the animal study.

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 present. The document does not describe a clinical or ex-vivo human-based study where experts would establish ground truth for a test set.

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

This information is not present.

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/present. The device is a "Vascular Clamp" and a "clampless proximal anastomosis sealing system," not an AI-assisted diagnostic or imaging interpretation tool that would involve human readers.

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

This information is not applicable/present. The device is a physical medical device, not an algorithm.

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

For the "Animal testing," the ground truth would likely involve direct assessment of surgical outcomes (e.g., hemostasis, anastomosis integrity, tissue reaction) by veterinary or surgical experts following the procedure, possibly supplemented with histopathology. The document doesn't specify the exact type of ground truth.

8. The sample size for the training set:

This information is not applicable/present. The device is a physical medical device, not an algorithm that requires a training set.

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

This information is not applicable/present.

Summary of available information regarding performance:

The document states that the following performance data was generated:

Sterilization Validation per ISO 11135-1:2014 and ISO 10993-7:2008.
Packaging validation for sterile barrier and labeling after transit simulation and accelerated aging.
Biocompatibility testing (material mediated pyrogenicity, cytotoxicity, intracutaneous reactivity, sensitization, acute systemic toxicity, partial thromboplastin time, SC5b-9 complement activation, hemolysis, and thrombogenicity) in accordance with ISO 10993-1.
Design verification testing including Bond Strength Testing, Sealing Element Crush Resistance Testing, Punch Performance Testing, Simulated Use Testing, and Corrosion Resistance Testing.
Animal testing to evaluate the safety, performance, and usability of the device conducted in compliance with Good Laboratory Practice (GLP) requirements (21 CFR 58).

These tests are generally required for medical device clearance to demonstrate functionality, safety, and manufacturing quality, often against internal specifications or industry standards. However, the document does not present them as a study with specific acceptance criteria and detailed quantitative results for clinical or user-related performance, nor does it define a "test set" in the context of clinical evaluation. The conclusion is based on substantial equivalence, which primarily relies on comparing the device's characteristics to a legally marketed predicate device and demonstrating that any differences do not raise new questions of safety or effectiveness.

Summary

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February 17, 2021

Vascular Graft Solutions, Ltd. % Janice Hogan Partner Hogan Lovells US LLP 1735 Market Street, 23rd Floor Philadelphia, Pennsylvania 19103

Re: K203307

Trade/Device Name: Viola Regulation Number: 21 CFR 870.4450 Regulation Name: Vascular Clamp Regulatory Class: Class II Product Code: DXC Dated: February 5, 2021 Received: February 5, 2021

Dear Janice Hogan:

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,

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) K203307

Device Name VIOLA

Indications for Use (Describe)

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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510(k) SUMMARY Vascular Graft Solutions, Ltd.'s VIOLA

Submitter's Name, Address, Telephone Number, Contact Person and Date Prepared

Vascular Graft Solutions, Ltd. 24 Raoul Wallenberg Street Tel-Aviv, Israel 6971921 Phone: +972-54-3073050 Contact Person: Orit Yarden

Date Prepared: November 9, 2020

Name of Device

VIOLA

Common or Usual Name

Vascular Clamp

Classification Name

21 CFR 870.4450, Class II, Product Code DXC

Predicate Devices

MAQUET Cardiovascular LLC's HEARTSTRING III Proximal Seal (K130382)

Intended Use / Indications for Use

Technological Characteristics

The VIOLA is comprised of:

1. A concentric 4 mm aortic punch with a detachable handle.
1. A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
1. A silicone boundary marker stencil for marking the maximal suture line around the aortic incision.

The steps to create a sealed anastomosis hole that enables the surgeon to perform a clampless anastomosis include (1) the creation of a small "needle hole" (performed in the

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center of the boundary marker), (2) insertion and deployment of the sealing element, (3) creation of an anastomosis hole using the VIOLA's punch, and (4) performing the anastomosis.

Performance Data

Sterilization Validation per ISO 11135-1:2014 and ISO 10993-7:2008. ●
o Packaging validation for the sterile barrier and labeling after transit simulation and accelerated aging.
Biocompatibility testing (material mediated pyrogenicity, cytotoxicity, intracutaneous ● reactivity, sensitization, acute systemic toxicity, partial thromboplastin time, SC5b-9 complement activation, hemolysis, and thrombogenicity) in accordance with ISO 10993-1.
Design verification testing including Bond Strength Testing, Sealing Element Crush ● Resistance Testing, Punch Performance Testing, Simulated Use Testing, and Corrosion Resistance Testing.
Animal testing to evaluate the safety, performance, and usability of the device conducted in ● compliance with Good Laboratory Practice (GLP) requirements (21 CFR 58).

Substantial Equivalence

The VIOLA is substantially equivalent to the MAQUET Cardiovascular LLC HEARTSTRING III Proximal Seal System (K130382). The VIOLA has the same intended uses and similar indications, technological characteristics, and principles of operation as its predicate device. The minor technological differences between the VIOLA and its predicate devices raise no new issues of safety or effectiveness. Performance data demonstrate that the VIOLA is as safe and effective as the predicate device.

Conclusions

The VIOLA is substantially equivalent to its predicate device.

Regulation Number and Section

§ 870.4450 Vascular clamp.

(a)
Identification. A vascular clamp is a surgical instrument used to occlude a blood vessel temporarily.(b)
Classification. Class II (performance standards).