(83 days)
Not Found
Not Found
No
The summary describes a physical vascular prosthesis and does not mention any software, algorithms, or AI/ML components.
Yes
The device is used for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease, indicating a therapeutic purpose.
No
Explanation: The device is a surgical implant (vascular prosthesis) for repair or replacement of arteries, not for diagnosing medical conditions.
No
The device description clearly states "InterGard Woven Collagen Coated Vascular Prostheses," indicating a physical, implantable medical device made of woven material and coated with collagen. This is not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a surgical implant for repairing or replacing arteries. This is a therapeutic device used in vivo (within the body).
- Device Description: The description confirms it's a vascular prosthesis, which is a medical implant.
- Lack of IVD Characteristics: There is no mention of analyzing samples from the human body (like blood, urine, tissue) to provide diagnostic information. IVDs are used to diagnose, monitor, or screen for diseases or conditions outside the body.
Therefore, the InterGard Woven collagen coated vascular prosthesis is a surgical implant, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
InterGard Woven collagen coated vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Product codes
DSY
Device Description
InterGard Woven Collagen Coated Vascular Prostheses
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name written around the perimeter. Inside the circle is a stylized image of an eagle with three human profiles incorporated into its design. The eagle's wings are represented by the profiles, symbolizing the department's focus on health and human well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 2 1999
Mr. James S. Miller Director Director
Regulatory Affairs and Quality Assurance InterVascular, Inc. 16331 Bay Vista Drive Clearwater, FL 34620
Re : K984294 Rooms Requlatory Class: II Product Code: DSY Dated: November 30, 1998 Received: December 1, 1998
Dear Mr. Miller:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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 aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in In addition, FDA may publish further requlatory action. announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
1
Page 2 - Mr. James S. Miller
This letter will allow you to begin marketing your device as Inis lecter will arrow you oo boyer management. The FDA finding described in your stority promises of your device to a legally marketed of Subscancial equivalence on possification for your device and production as a read to proceed to the market.
If you desire specific advice for your device on our labeling II you desire specific advice for paintionally 809.10 for in viron regulation (21 crk rare our and active of Compliance at Glaghostic devices), proase y, for questions on the promotion and (Joi) 391 1010. The device, please contact the Office of auvertising or your actise/9. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 807.97). Other general information on your (21CFK 807.97). Octice general in ormacobtained from the Division responsibilities and one one of its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsma/dsmamain.html."
Sincerely yours,
Thomas J. Callehan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PRODUCT INDICATIONS FOR USE (Page 1 of 1)
- K Q8 4294 510(k) Number:
- InterGard Woven Collagen Coated Vascular Prostheses Device Name:
- Indications for Use: InterGard Woven collagen coated vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the thoracic and abdominal aorta, visceral arteries, and proximal peripheral arteries. Due to the low porosity of the grafts, these products are recommended for use in patients requiring heparinization prior to or during surgery.
Concurrence of CDRH, Office of Device Evaluation (ODE)
y Over-The-Counter Use Prescription Use OR (Per 21 CFR 801.109)
Bert R. Groulx
(Division Sign-Off)
Division of Cardiovascular, Respiratory,
and Neurological Devices
510(k) Number K984294