(90 days)
Not Found
Not Found
No
The summary describes a woven vascular prosthesis and does not mention any AI or ML components or functionalities.
Yes
The device is a vascular prosthesis intended for surgical repair, bypass, or replacement of arteries in the treatment of diseases, which directly addresses a medical condition.
No
The device, InterGard woven vascular prostheses, is indicated for surgical repair, bypass, or replacement of arteries. Its purpose is therapeutic intervention, not diagnosis.
No
The device description clearly states "InterGard™ Woven Collagen Coated Vascular Prostheses," indicating a physical, woven vascular graft, 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 is of a physical prosthesis, not a reagent, instrument, or system used to examine specimens in vitro (outside the body).
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting markers, or providing diagnostic information based on in vitro testing.
IVDs are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a surgical implant used directly on the patient's anatomy.
N/A
Intended Use / Indications for Use
InterGard woven vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
abdominal aorta, visceral arteries, and proximal peripheral arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
surgical repair
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
Not Found
Key Metrics
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
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 caduceus symbol, which features three human profiles in a row, with a wavy line below them. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
5 1997 JUN
Ms. Melissa L. Billman Requlatory Affairs Associate InterVascular, Inc. 16331-Bay Vista Drive Clearwater, Florida 34620 ^
Re: K970843
% InterGard™ Woven Collagen Coated Vascular Prostheses Requlatory Class: II (Two) Product Code: DSY Dated: March 6, 1997 Received: March 7, 1997
Dear Ms. Billman:
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 devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments. You may, therefore, market the device, subject to the general controls provisions of the Federal Food, Drug, and Cosmetic Act (act). The general controls provisions of the act include requirements for registration, listing of devices, good manufacturing practices, and labeling, and prohibitions against 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 Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further 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 section 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlation.
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Page 2 - Ms. Melissa L. Billman
Under Section 522(a) of the act, manufacturers of certain types of devices identified by the Act or designated by FDA are required to conduct postmarket surveillance studies. FDA has identified under Section 522(a) (1) (A) the device cleared for marketing by this letter as requiring postmarket surveillance.
Within thirty (30) days of first introduction or delivery for introduction of this device into interstate commerce you are required to submit to FDA certification of the date of introduction into interstate commerce, a detailed protocol which describes the postmarket surveillance study, and a detailed profile of the study's principal investiqator that clearly establishes the qualifications and experience of the individual to conduct the proposed study. For your information, general guidance on preparing a protocol for a postmarket surveillance study is attached.
Submit five (5) copies to:
Center for Devices and Radiological Health Postmarket Surveillance Studies Document Center Room 3083 (HFZ-544) 1350 Piccard Drive Rockville, Maryland 20850
Within sixty (60) days of receipt of your protocol, FDA will either approve or disapprove it and notify you of the Agency's action in writing. You should not begin your postmarket surveillance study of this device until the protocol has been approved. Data generated under an unapproved protocol may not satisfy your obligation under section 522. Please note that you must continue to collect and report data needed to maintain compliance with Medical Device Reporting regulations (21 CFR 803).
Failure to certify accurately the date of initial introduction of your device into interstate commerce, to submit timely an acceptable protocol, or to undertake and complete and FDA approved postmarket surveillance study consistent with the protocol will be considered violations of section 522. In accordance with the Medical Device Amendments of 1992, failure of a manufacturer to meet its obliqations under section 522 is a prohibited act under section 301(q) (1) (C) of the Act (21 U.S.C. 331 (q) (1) (C) . Further, under section 502 (t) (3) of the act (21 U.S.C. 352(t)(3)), a device is misbranded if there is a failure or refusal to comply with any requirement under section 522 of the act. Violations of sections 301 or 502 may lead to regulatory actions including seizure of your product, injunction, prosecution, or civil money penalties.
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Page 3 - Ms. Melissa L. Billman
If you have questions specifically concerning postmarket surveillance study requirements, contact the Postmarket Surveillance Studies Branch at (301) 594-0639.
In addition, on August 16, 1993, the Final Rule for Device Tracking. was published in the Federal Register, pages 43442-43455"(Jopy enclosed). Be advised that under Section 519(e) of the Act as amended by the Safe Medical Devices Act of 1990, FDA has identified the above device as a device which requires tracking. Because the device is subject to tracking, you are required to adopt a method of tracking that follows the devices through the distribution chain and then identifies and follows the patients who receive them. The specific requirement of the requlation are found in 21 CFR 821 as described in the August 16, 1993 Federal Register beginning on page 43447.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and additionally 809 for in vitro diaqnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Other general information on your responsibilities under the act may be obtained from the Division of Small Manufacturers Assistance at its toll free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.gov/cdrh/dsmamain.html."
Sincerely yours,
Ser of Sace R. Campbell
Thomas J. Callahar, Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosures
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870, 3460 - Vascular Graft Prosthesis of 6 Millime
or Greater Diameter
DSY II
PRODUCT INDICATIONS FOR USE
(Page 1 of 1)
510 (k) Number:
Device Name: Prostheses
InterGard Woven Collagen Coated Vascular
Indications for Use:
InterGard woven vascular prostheses are indicated for surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease of the 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)
Bette R. Simpson, Jr.
Division Sign-Off
n of Cardiovascular, Respiratory, and Neurological Device
510(k) Number K970843
Prescription Use OR Over-The-Counter Use (Per 21 CFR 801, 109)
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