(100 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI/ML algorithms, data processing, or learning capabilities.
No
A therapeutic device is one that treats or prevents a disease or condition. This device is used during a surgical procedure to maintain hemostasis and facilitate the completion of anastomoses, which are actions taken during surgery rather than treating a disease itself.
No
The device is described as a surgical tool used to maintain hemostasis and facilitate the completion of proximal anastomoses during coronary artery bypass grafting procedures. Its function is to assist in surgical procedures, not to diagnose a condition or disease.
No
The device description clearly outlines physical components (aortic punch, sealing assembly, silicone boundary marker stencil) and performance studies related to hardware (sterilization, packaging, biocompatibility, design verification, animal testing). There is no mention of software as a component or function of the device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for cardiac surgeons during coronary artery bypass grafting procedures to facilitate proximal anastomoses to the aorta. This is a surgical procedure performed directly on the patient's body.
- Device Description: The device is a surgical tool used to create and seal an opening in the aorta. It is not designed to analyze samples of human origin (like blood, urine, or tissue) to provide information about a physiological state, health, or disease.
- Lack of IVD Characteristics: There is no mention of the device being used to test or analyze biological samples, nor does it produce diagnostic information based on such analysis.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens from the human body. This device is used in vivo (inside the body) during a surgical procedure.
N/A
Intended Use / Indications for Use
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.
Product codes
DXC
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:
- A concentric 4 mm aortic punch with a detachable handle.
- A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
- 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Aorta
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Cardiac surgeons during coronary artery bypass grafting procedures
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
- Sterilization Validation per ISO 11135-1:2014 and ISO 10993-7:2008.
- 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).
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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
1
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)
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.
| 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
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.
Technological Characteristics
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:
-
- A concentric 4 mm aortic punch with a detachable handle.
-
- A sealing assembly comprising of a sealing element (which is available in two diameters), a catheter, fixation strap and a handle.
-
- 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
4
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.