(84 days)
Not Found
No
The device description and performance studies focus on the material properties and biological compatibility of a bovine pericardium patch, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
VASCU-GUARD is intended for use in peripheral vascular reconstruction, which is a medical intervention to treat or improve the function of blood vessels, indicating it serves a therapeutic purpose.
No
VASCU-GUARD is described as a material (bovine pericardium patch) used for peripheral vascular reconstruction, indicating it is a therapeutic or reconstructive device, not for diagnostic purposes.
No
The device description clearly states that VASCU-GUARD is prepared from bovine pericardium and is a physical patch, indicating it is a hardware medical device, not software.
Based on the provided information, VASCU-GUARD is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that VASCU-GUARD is for use in "peripheral vascular reconstruction," which is a surgical procedure performed in vivo (within the living body).
- Device Description: The description details a patch made from bovine pericardium, designed to be implanted into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples in vitro (outside the body), such as blood, urine, or tissue, to diagnose a condition or monitor a patient's health status.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening. VASCU-GUARD is a surgical implant used to repair blood vessels.
N/A
Intended Use / Indications for Use
VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
Product codes
DXZ
Device Description
VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. VASCU-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. VASCU-GUARD is terminally sterilized using gamma irradiation.
VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
carotid, renal, iliac, femoral, profunda, and tibial blood 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 safety and performance of VASCU-GUARD Peripheral Vascular Patch was evaluated through non-clinical testing.
The bench and pre-clinical testing assessed the following aspects of the device:
- Suture retention ●
- Thickness ●
- Burst strength ●
- Tensile strength ●
- Collagenase digestion ●
- Chemical residuals ●
- Pyrogenicity/ LAL ●
- Sterilization validation ●
- Packaging and shelf-life ●
- Biocompatibility ●
- Animal studies ●
Bench testing results support the performance requirements for VASCU-GUARD Peripheral Vascular Patch. Biocompatibility testing was performed in accordance to ISO 10993-1:2009 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process). Various animal studies were conducted to support the safety and efficacy of VASCU-GUARD Peripheral Vascular Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/1 description: The image contains the logo for the U.S. Department of Health and Human Services. The logo features the department's name in a circular arrangement around a stylized emblem. The emblem consists of a graphic representation of human profiles facing to the right, suggesting a sense of community and service.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
November 25, 2014
Synovis Life Technologies, Inc. Jodi Jorgenson Manager, Regulatory Affairs 2575 University Ave W. St. Paul, MN 55129
Re: K142461 Trade/Device Name: VASCU-GUARD Peripheral Vascular 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: DXZ Dated: August 28, 2014 Received: September 02, 2014
Dear Ms. Jorgenson:
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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.
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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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) K142461
Device Name
VASCU-GUARD Peripheral Vascular Patch
Indications for Use (Describe)
VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda, and tibial blood vessels and arteriovenous access revisions.
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)
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5.0 510(K) SUMMARY
Applicant:
Synovis Life Technologies, Inc. (a subsidiary of Baxter International Inc.) 2575 University Avenue West St. Paul, MN 55114-1024 Tel: 651-796-7300 Fax: 651-642-9018
Contact Person:
Jodi Jorgenson Manager, Regulatory Affairs At address above
Date Prepared: August 28, 2014
Device Trade Name: VASCU-GUARD Peripheral Vascular Patch
Common Name:
Intracardiac patch
Classification Name:
Intracardiac patch or pledget 21 CFR 870.3470 Product Code: DXZ
Predicate Devices:
Synovis Life Technologies, VASCU-GUARD Peripheral Vascular Patch: K983602
Device Description:
VASCU-GUARD is prepared from bovine pericardium which is cross-linked with glutaraldehyde. VASCU-GUARD has been treated with 1 molar sodium hydroxide for 60-75 minutes at 20-25°C. VASCU-GUARD is terminally sterilized using gamma irradiation.
VASCU-GUARD is packaged between two pieces of foam within a double sterile barrier pouch system. The contents of the unopened, undamaged package are sterile.
4
Statement of Intended Use:
VASCU-GUARD is intended for use in peripheral vascular reconstruction including the carotid, renal, iliac, femoral, profunda and tibial blood vessels and arteriovenous access revisions.
Summary/Comparison of Technological Characteristics:
VASCU-GUARD Peripheral Vascular Patch is acting as its own predicate and is therefore substantially equivalent, having the same technological characteristics and intended use with the exception of the packaging and method of sterilization, which is the subject of this premarket notification submission.
The safety and performance of VASCU-GUARD Peripheral Vascular Patch was evaluated through non-clinical testing.
The bench and pre-clinical testing assessed the following aspects of the device:
- Suture retention
- Thickness ●
- Burst strength ●
- Tensile strength
- Collagenase digestion ●
- Chemical residuals
- Pyrogenicity/ LAL ●
- Sterilization validation ●
- Packaging and shelf-life
- Biocompatibility
- Animal studies ●
Bench testing results support the performance requirements for VASCU-GUARD Peripheral Vascular Patch. Biocompatibility testing was performed in accordance to ISO 10993-1:2009 (Biological Evaluation of medical devices – Part 1: Evaluation and testing within a risk management process). Various animal studies were conducted to support the safety and efficacy of VASCU-GUARD Peripheral Vascular Patch. The bench and preclinical studies indicate that the device is biocompatible and is substantially equivalent to the referenced predicate device.
Conclusions:
The safety and performance of VASCU-GUARD Peripheral Vascular Patch was evaluated through biocompatibility, bench testing and animal studies. VASCU-GUARD Peripheral Vascular Patch is substantially equivalent to the predicate device.