(195 days)
No
The device description and performance studies focus on the material properties and biological compatibility of a bovine pericardium patch, with no mention of computational analysis, algorithms, or data processing that would indicate AI/ML.
Yes
The device is a vascular repair patch used in peripheral vascular reconstruction, which is a medical intervention aimed at treating medical conditions and restoring normal function in patients.
No
Explanation: The device is a vascular repair patch used for reconstruction, implying a therapeutic rather than diagnostic function. It is a physical implant designed to fix or replace tissue.
No
The device description clearly indicates it is a physical patch derived from bovine pericardium, which is a hardware component. The performance studies also focus on physical properties and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "peripheral vascular reconstruction," which is a surgical procedure performed directly on the patient's body. IVDs are used to examine specimens (like blood, urine, or tissue) outside of the body to provide information about a person's health.
- Device Description: The device is a "Vascular Repair Patch" made from bovine pericardium. This is a physical implant used to repair blood vessels. IVDs are typically reagents, instruments, or systems used for testing.
- Lack of Diagnostic Function: There is no mention of this device being used to diagnose, monitor, or screen for any disease or condition by analyzing biological samples.
The VASCU-GUARD Vascular Repair Patch is a surgical implant used for structural repair within the body, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
VASCU-GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, ilias, femoral, profunda and tibial vessels and arteriovenous access revisions.
Product codes
PSQ
Device Description
VASCU-GUARD Vascular Repair Patch (VASCU-GUARD) is derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25° (68-77°F). VASCU-GUARD is terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile. VASCU-GUARD is MR Safe. VASCU-GUARD utilizes animal tissue; patient must be informed prior to any procedure.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vascular (carotid, renal, iliac, femoral, profunda, tibial vessels)
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
The following performance data were provided in support of the substantial equivalence determination:
- Visual
- Suture retention
- Dimensional
- Burst strength
- Collagenase digestion
- Denaturation Temperature
- Water Permeability
- Pliability
- Chemical and heavy metal residuals
- Bioburden
- Pyrogenicity/Endotoxins
- Temperature Excursion Testing
- Biocompatibility Assessment
The results of performance testing demonstrate the modified VASCU-GUARD device is substantially equivalent to the predicate VASCU-GUARD devices.
Biocompatibility: The results of new biocompatibility testing, along with applicable historical testing of the primary predicate device, demonstrate the biocompatibility of the product in accordance with ISO 10993-1 requirements for a permanent long-term implant with tissue/blood contact and equivalence to the predicate devices.
Shelf Life: Synovis has performed aging testing to support a 1 year shelf life claim.
Sterilization and Packaging: Sterilization validation was conducted according to ISO 11137 parts 1 and 2. The modified packaging was designed and evaluated in accordance with ISO 11607-1. The integrity of the sterile barrier is supported by testing conducted in accordance with ASTM F88-15 and ASTM F2096-11.
Validation Studies: Human factors testing was conducted to confirm that the re-designed packaging allows for aseptic transfer of the product to the sterile field without compromising sterility, and that the modified packaging design does not impact the surface of the tissue patch.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 870.3470 Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene.
(a)
Identification. An intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene is a fabric device placed in the heart that is used to repair septal defects, for patch grafting, to repair tissue, and to buttress sutures.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
Synovis Life Technologies, Inc. A Subsidiary of Baxter International, Inc. Sajjad Megan Sr. Manager, Regulatory Affairs 2575 University Avenue West St. Paul, Minnesota 55114
Re: K221032
Trade/Device Name: Vascu-Guard Vascular Repair Patch Regulation Number: 21 CFR 870.3470 Regulation Name: Intracardiac patch or pledget made of polypropylene, polyethylene terephthalate, or polytetrafluoroethylene Regulatory Class: Class II Product Code: PSQ Dated: September 20, 2022 Received: September 20, 2022
Dear Sajjad Megan:
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,
for Rachel Neubrander, PhD 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
2
Indications for Use
510(k) Number (if known) K221032
Device Name VASCU-GUARD Vascular Repair Patch
Indications for Use (Describe)
VASCU-GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, ilias, femoral, profunda and tibial vessels and arteriovenous access revisions.
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) |
| 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
510k SUMMARY: VASCU-GUARD Vascular Repair Patch K221032
I. SUBMITTER
Synovis Life Technologies, Inc. (Synovis) (A Subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Phone: 651-796-7410 Fax: 224-270-4119
Contact Person: Megan Sajjad, Sr. Manager, Regulatory Affairs
Date prepared: October 18, 2022
II. DEVICE
Device Trade Name: VASCU-GUARD
Common Name: Vascular Repair Patch
Classification Name: 21 CFR 870.3470 - Intracardiac Patch Or Pledget, Biologically Derived
Product Code: PSQ
III. PREDICATE DEVICES
Primary: VASCU-GUARD Peripheral Vascular Patch, K142461 Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.)
Secondary: VASCU-GUARD Peripheral Vascular Patch, K983602 Manufacturer: Synovis Life Technologies, Inc. (A Subsidiary of Baxter International Inc.)
Additionally, Synovis PERI-STRIPS DRY Staple Line Reinforcement with VERITAS Collagen Matrix with SECURE GRIP Technology (K192615) serves as a Reference device for this 510k.
DEVICE DESCRIPTION IV.
VASCU-GUARD Vascular Repair Patch (VASCU-GUARD) is derived from bovine pericardium procured from cattle originating in the United States. The pericardium is cross-linked with glutaraldehyde and treated with 1 molar sodium hydroxide for a minimum of 60 minutes at 20-25° (68-77°F).
4
VASCU-GUARD is terminally sterilized using gamma irradiation and packaged within a sterile double-pouch system. The contents of the unopened, undamaged outer pouch are sterile.
VASCU-GUARD is MR Safe.
VASCU-GUARD utilizes animal tissue; patient must be informed prior to any procedure.
See Table 1 for VASCU-GUARD product models and sizes.
| VASCU-GUARD Model Number | Size (cm) |
|---|---|
| VG0106 | 1 x 6 |
| VG0108 | 0.8 x 8 |
| VG0110 | 1 x 10 |
| VG0209 | 2 x 9 |
| VG0114 | 1 x 14 |
| VG01510 | 1.5 x 10 |
| VG02515 | 2.5 x 15 |
Table 1 - VASCU-GUARD Product Models and Sizes
V. INTENDED USE/INDICATIONS FOR USE
Statement of Intended Use:
VASCU-GUARD is intended to be used as an intracardiac patch.
Indications for Use
VASCU-GUARD Vascular Repair Patch is used in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial vessels and arteriovenous access revisions.
COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH VI. THE PREDICATE DEVICES
VASCU-GUARD Vascular Repair Patch is substantially equivalent to the predicate VASCU-GUARD devices based on having the same fundamental technology and intended use. The changes between the subject and predicate devices include packaging and sterilization changes and new product sizes. The safety and performance of VASCU-GUARD Vascular Repair Patch has been evaluated through non-clinical testing.
The subject and predicate devices are identical in the following respects:
- . Intended Use (both predicates)
5
- Indication for use (primary predicate) ●
- Viral inactivation processing steps (both predicates) ●
- Sterilization method (primary predicate)
- Strength specifications (both predicates) .
- Chemical and physical specifications (secondary predicate) .
The following technological differences exist between the subject and predicate devices:
- Modified packaging design
- Same sterilization method but modified sterilization parameters and ● packaging for sterilization compared to the primary predicate
- New product sizes .
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence determination:
- Visual ●
- Suture retention ●
- Dimensional ●
- Burst strength
- Collagenase digestion ●
- Denaturation Temperature
- Water Permeability
- . Pliability
- Chemical and heavy metal residuals
- Bioburden ●
- Pyrogenicity/Endotoxins ●
- Temperature Excursion Testing ●
- . Biocompatibility Assessment
The results of performance testing demonstrate the modified VASCU-GUARD device is substantially equivalent to the predicate VASCU-GUARD devices.
Biocompatibility
The results of new biocompatibility testing, along with applicable historical testing of the primary predicate device, demonstrate the biocompatibility of the product in accordance with ISO 10993-1 requirements for a permanent long-term implant with tissue/blood contact and equivalence to the predicate devices.
Shelf Life
Synovis has performed aging testing to support a 1 year shelf life claim.
6
Sterilization and Packaging
Sterilization validation was conducted according to ISO 11137 parts 1 and 2.
The the modified packaging was designed and evaluated in accordance with ISO 11607-1. The integrity of the sterile barrier is supported by testing conducted in accordance with ASTM F88-15 and ASTM F2096-11.
Validation Studies
Human factors testing was conducted to confirm that the re-designed packaging allows for aseptic transfer of the product to the sterile field without compromising sterility, and that the modified packaging design does not impact the surface of the tissue patch.
VIII. CONCLUSION
The subject VASCU-GUARD device shares the same intended use and technological characteristics as the predicate VASCU-GUARD devices. The physical, functional and performance specifications for the devices are substantially equivalent. Testing supports that the subject device is as safe and effective as the predicate devices when used according to its labeling.