(9 days)
Not Found
Not Found
No
The summary contains no mention of AI, ML, image processing, or any other indicators of AI/ML technology. The device description is also not available.
Yes
The device is intended for "bypass or reconstruction of occluded or diseased arterial blood vessels," which directly addresses a health problem (occluded or diseased vessels) through intervention, making it a therapeutic device.
No
The Intended Use describes the creation of conduits for blood access, bypass, or reconstruction of vessels, which are interventional or therapeutic procedures, not diagnostic ones.
Unknown
The provided 510(k) summary lacks a device description, making it impossible to determine 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 "CREATION OF SUBCUTANEOUS CONDUITS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS." This describes a surgical procedure performed on the body (in vivo) to modify blood vessels.
- IVD Definition: In vitro diagnostics (IVDs) are tests performed outside the body (in vitro) on specimens such as blood, urine, or tissue to diagnose diseases or other conditions.
The device's function is directly related to surgical intervention on the patient's circulatory system, not to analyzing biological samples in a lab setting.
N/A
New Section
Intended Use / Indications for Use
CREATION OF SUBCUTANEOUS CONDUITS ARTERIOVENOUS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.
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
Not Found
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
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
Image /page/0/Picture/2 description: The image is a seal for the Department of Health & Human Services - USA. The seal is circular and contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. The bottom half of the circle contains a symbol that resembles an eagle or bird-like figure.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN - 5 2005
Vascutek Ltd. c/o Dr. Karen Kelso Newmains Avenue Inchinnan, Renfrewshire PA4 9RR Scotland
Re: K043552
PTFE Supported Vascular Prosthesis Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: December 20, 2004 Received: December 27, 2004
Dear Ms. Kelso:
We have reviewed your Section 510(k) premarket notification of intent to market the indication We have reviewed your Section 9 ro(t) premaine is substantially equivalent (for the indications for use stated in the enclosure) the arress of essess of esses of the success on interstate for use stated in the encrosure) to regary manced people Medical Device Amendments, or to
commerce prior to May 28, 1976, the enactment date of the Federal Food. Drug commerce prior to May 28, 1976, the enaculture with the provisions of the Federal Food, Drug, devices that have been recadsined in accession will af a premarket approval application (PMA).) and Cosment Act (Act) that do not require subject to the general controls provisions of the Act. The You may, therefore, market the device, beljeveres to the connual registration, listing of
general controls provisions of the Act include requirements for annual registration general controls provisions of the Fields requirements of the management 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 (secure) into existing major regulations affecting your device can
may be subject to such additional controls. Existing major may be subject to such additional controller Entralians, Title 21, Parts 800 to 898. In addition, FDA may be found in the Code of Peacharing.
publish further announcements concerning your device in the Federal Register.
1
Page 2 - Dr. Karen Kelso
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 (301) 594-4648. 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/dsma/dsmamain.html
Sincerely yours.
Bhimimar 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): | K043552 |
|---|---|
| Device Name: | VASCUTEK PTFE SUPPORTED ePTFE VASCULAR |
| PROSTHESES | |
| Indications For Use: | CREATION OF SUBCUTANEOUS |
BCUTANEOUS Indications For Use: CREATION CONDUITS ARTERIOVENOUS FOR BLOOD ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.
Prescription Use _____________________________________________________________________________________________________________________________________________________________
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(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)
Abimimano
(Division Sign-Off) Division of Cardlovascular Devices 510(K) Number_Ko43552
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