(19 days)
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Not Found
No
The provided 510(k) summary contains no mention of AI, ML, image processing, or any other indicators typically associated with AI/ML medical devices. The intended use and anatomical site suggest a structural device for vascular repair.
Yes
The device is described as being used for "repair or replacement of damaged and diseased vessels of the thoracic aorta," which directly indicates a therapeutic purpose.
No
The intended use statement describes the device for "REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE THORACIC AORTA," which indicates a therapeutic or restorative function, not a diagnostic one.
Unknown
The provided 510(k) summary lacks a device description, which is crucial for determining if the device is software-only or includes hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is the "REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE THORACIC AORTA". This describes a surgical or interventional procedure performed directly on a patient's body.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
The description clearly indicates a device used in vivo (within the living body) for treatment, not a device used in vitro (outside the living body) for diagnostic testing of specimens.
N/A
Intended Use / Indications for Use
REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE THORACIC AORTA IN ANEURYSM, DISSECTION OR CASES OF COARCTATION.
Product codes
DSY
Device Description
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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 AORTA
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
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
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
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Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three curved lines representing its body and wings. The eagle is positioned within a circle, and the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES (USA)" is written around the circumference of the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 7 2006
Vascutek Ltd. c/o Dr. Karen Kelso Regulatory Affairs Manager Newmains Avenue Inchinnan Renfrewshire, PA4 9RR Scotland
Re: K060142
Gelweave Siena Collared Ante-Flo and Plexus Vascular Grafts with Radiopaque Markers Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (Two) Product Code: DSY Dated: January 13, 2006 Received: January 19, 2006
Dear Dr. Kelso:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
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); good manufacturing practice requirements as set 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. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, 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/industry/support/index.html.
Sincerely yours,
Donna R. Kirchner
\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known):
Device Name:
VASCUTEK GELWEAVE SIENA COLLARED ANTE-FLO WITH RADIOPAQUE MARKERS
VASCUTEK GELWEAVE SIENA COLLARED PLEXUS WITH RADIOPAQUE MARKERS
Indications For Use:
REPAIR OR REPLACEMENT OF DAMAGED AND DISEASED VESSELS OF THE THORACIC AORTA IN ANEURYSM, DISSECTION OR CASES OF COARCTATION.
X Prescription Use (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use __ (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Dana R. Vachuca
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Numhar 4060142
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