(69 days)
No
The summary describes a physical vascular graft made of synthetic materials and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is designed to "repair or replace peripheral arteries" and "provide vascular access," which are actions intended to treat or manage a medical condition.
No
The device, FUSION Vascular Grafts, is designed for the repair or replacement of peripheral arteries and for vascular access. Its description as a synthetic vascular graft for surgical implantation indicates a therapeutic, not diagnostic, purpose.
No
The device description clearly states it is a synthetic vascular graft constructed of physical materials (ePTFE, polyester textile, polycarbonate urethane adhesive), indicating it is a hardware device, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "repair or replace peripheral arteries and to provide vascular access." This is a surgical/implantable device used directly on the patient's body.
- Device Description: The description details a synthetic vascular graft made of ePTFE and polyester, designed to be implanted.
- Lack of IVD Characteristics: An IVD is a medical device used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not perform any such analysis of bodily specimens.
- Performance Studies: The performance study mentioned is "Burst After Repeated Puncture," which is a mechanical test of the graft's durability, not an in-vitro diagnostic test.
Therefore, based on the provided information, the FUSION Vascular Graft is a surgical implant, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.
Product codes
DSY
Device Description
FUSION Vascular Grafts are synthetic vascular grafts constructed of two layers. The inner layer is comprised of extruded, expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate urethane adhesive.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
Performance testing - Burst After Repeated Puncture
The results of the in-vitro tests conducted demonstrate that the functionality and performance characteristics of the device are comparable to the currently marketed FUSION Vascular Graft.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3450 Vascular graft prosthesis.
(a)
Identification. A vascular graft prosthesis is an implanted device intended to repair, replace, or bypass sections of native or artificial vessels, excluding coronary or cerebral vasculature, and to provide vascular access. It is commonly constructed of materials such as polyethylene terephthalate and polytetrafluoroethylene, and it may be coated with a biological coating, such as albumin or collagen, or a synthetic coating, such as silicone. The graft structure itself is not made of materials of animal origin, including human umbilical cords.(b)
Classification. Class II (special controls). The special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510(k) Submissions.”
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol, composed of three overlapping profiles facing to the right. The profiles are silhouetted in black. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 16, 2016
Maquet Cardiovascular, LLC Mark Dinger Sr. Regulatory Affairs Specialist 45 Barbour Pond Drive Wayne, NJ 07470
Re: K153523
Trade/Device Name: FUSION Vascular Graft Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II Product Code: DSY Dated: December 1, 2015 Received: December 9, 2015
Dear Mark Dinger:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
1
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K153523
Device Name FUSION Vascular Grafts
Indications for Use (Describe)
FUSION Vascular Grafts are designed to repair or replace peripheral arteries and to provide vascular access.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Image /page/3/Picture/1 description: The image shows the logo for Maquet Getinge Group. The word "MAQUET" is in large, bold, blue letters. Below that, the words "GETINGE GROUP" are in smaller, gray letters. The logo is simple and modern.
FUSION Vascular Graft AV Access Indication 510(k) Summary Prepared in accordance with 21 CFR Part 807.92
510(k) Number: K153523 Date Prepared: 1 December 2015 Device Owner: MAQUET Cardiovascular LLC 45 Barbour Pond Drive Wayne, New Jersey 07470 Contact Personnel: Mark Dinger Sr. Regulatory Affairs Specialist Title: Email: mark.dinger@maquet.com Phone: 973-709-7691 Fax: 973-909-9954 Trade Name: FUSION Vascular Grafts Device Generic Name: Vascular Graft According to 21 CFR 870.3450 of the Federal Food, Drug Classification: and Cosmetic Act, the device classification is Class II, Product code DSY. K131778 FUSION Vascular Grafts Predicate Devices: (SE: 14 November 2013) K962433 EXXCEL ePTFE Vascular Graft (SE: 1 April 1997) FUSION Vascular Grafts are synthetic vascular grafts Device Description: constructed of two layers. The inner layer is comprised of extruded, expanded polytetrafluoroethylene (ePTFE). The outer layer is comprised of knit polyester textile. These two layers are fused together with a proprietary polycarbonate urethane adhesive. FUSION Vascular Grafts are designed to repair or replace Indications for Use: peripheral arteries and to provide vascular access.
4
| Technological
Characteristics | The Proposed FUSION and the predicate FUSION
device have the following similarities:
the same operating principles, incorporate the same basic design, sterilized using the same materials and processes, has same packaging, the same biocompatibility. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | The Proposed FUSION and the predicate FUSION devices
have the following differences:
Vascular Access Indication for Use |
| | The Proposed FUSION Vascular Graft and the predicate
EXXCEL ePTFE Vascular Graft have the similar Vascular
Access Indication and share the same substrate. |
| | The difference is not considered a technological difference
and is substantially equivalent to the predicate devices. |
| Safety and
Performance: | MAQUET Cardiovascular's development process required
that the following activity be:
Performance testing - Burst After Repeated Puncture |
| | The results of the in-vitro tests conducted demonstrate that
the functionality and performance characteristics of the
device are comparable to the currently marketed FUSION
Vascular Graft. |
| Conclusion: | Based on the technological characteristics and performance
testing, the FUSION Vascular Grafts have been shown to
be substantially equivalent to the predicate device for the
intended use. |