(113 days)
No
The summary describes a vascular prosthesis for surgical repair and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is indicated for "surgical repair, bypass, or replacement of arteries in the treatment of aneurysmal and occlusive disease," which are therapeutic interventions.
No
Explanation: The device is a vascular prosthesis intended for surgical repair, bypass, or replacement of arteries, which is a treatment or replacement function, not a diagnostic one.
No
The device description clearly indicates it is a "Collagen Coated Vascular Prostheses," which is a physical implantable device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes the device as a vascular prosthesis for surgical repair, bypass, or replacement of arteries. This is a surgical implant used in vivo (within the body) during a procedure.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) outside the body to provide information for diagnosis, monitoring, or screening.
The description clearly indicates a device used directly on the patient's vascular system during surgery, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
InterGard HemaBridge and InterGard Aortic Arch 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
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
thoracic and abdominal aorta, visceral arteries, and proximal 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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 and Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 7 2002
Mr. Amy Aulwes Intervascular c/o Health Policy Associates, Inc. 20 Walnut Street, Suite 12 Wellesley, MA 02481
Re: K013651
K013031
InterGard HemaBridge and InterGard Aortic Arch Collagen Coated Vascular Prosthesis Regulation Number: 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: II (two) Product Code: DSY Dated: January 18, 2002 Received: January 31, 2002
Dear Mr. Aulwes:
We have reviewed your Section 510(k) premarket notification of intent to market the device We nave reviewed your Section 910(t) premier is substantially equivalent (for the indications ferenced above and nave determined with marketed predicate devices marketed in interstate for use stated in the encrosule) to regard to togen. I the Medical Device Amendments, or to conimetee prior to May 20, 1978, are excerdance with the provisions of the Federal Food, Drug, devices that have been recuired in assee approval of a premarket approval application (PMA). and Cosmetic Act (Act) that do not requent of the general controls provisions of the Act. The I ou may, therefore, thanker the act include requirements for annual registration, listing of general controls provisions of the 110 labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA). it If your device is classified (600 a00 10) als. Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulations an may be subject to sach additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the overning your device in the Federal Register.
1
Page 2 - Mr. Amy Aulwes
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loast of advised that I Drivesantes a your device complies with other requirements of the Act that I Dri has Intact a aver a word regulations administered by other Federal agencies. You must or any I cochar statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the role of countinents) ; good manufacturing practice requirements as set Of IT at 6077, laboring (21 CER regulation (21 CFR Part 820); and if applicable, the electronic form in the quarty byeveline (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) I mis letter will anow you to begal finding of substantial equivalence of your device to a legally premarket notineation. "The 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 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of additionally 21 Of It Fax 646. Additionally, for questions on the promotion and advertising of Compinance at (301) 27 - 1 the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Other general mionnalion turers, International and Consumer Assistance at 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,
Deale Tule
Bram D. Zuckerman, M.D. Acting Director Division of Cardiovascular and Respiratory Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PRODUCT INDICATIONS FOR USE (Page 1 of 1)
510(k) Number:
Device Names:
Coated Vascular HemaBridge Collagen InterGard Prosthesis
Collagen Coated Vascular InterGard Aortic Arch Prosthesis
- HemaBridge and InterGard Aortic Arch Indications for Use: InterGard 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.
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
ﻟﺴ Prescription Use 1 (Per 21 CFR 801.109)
Over-The-Counter Use _
Denkt Hell
Division of Cardiovascular & Respiratory Devices
510(k) Number K013651
000005