(98 days)
Not Found
Not Found
No
The summary describes a vascular prosthesis made of ePTFE and does not mention any AI or ML components or functionalities.
Yes
The device is described as a vascular prosthesis for the creation of conduits or reconstruction of occluded/diseased arterial blood vessels, which directly addresses a medical condition to restore normal function.
No
The device description indicates it is a vascular prosthesis intended for surgical reconstruction of blood vessels, not for diagnosing conditions.
No
The device description explicitly states "VASCUTEK ePTFE WRAPPED ePTFE VASCULAR PROSTHESES," indicating a physical, implantable device made of ePTFE, which is a material used in vascular grafts. 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 procedure involving the creation of conduits for blood access, bypass, or reconstruction of blood vessels. This is a therapeutic or surgical intervention, not a diagnostic test performed on samples taken from the body.
- Device Description: The device is a vascular prosthesis, which is an implantable medical device used to replace or repair blood vessels. This is consistent with a surgical device, not a diagnostic one.
- Lack of IVD Characteristics: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's health status.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
SUBCUTANEOUS OF CREATION CONDUITS FOR BLOOD ARTERIOVENOUS ACCESS, BYPASS OR RECONSTRUCTION OF OCCLUDED OR DISEASED ARTERIAL BLOOD VESSELS.
Product codes
DSY
Device Description
VASCUTEK ePTFE WRAPPED ePTFE 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
ARTERIAL BLOOD VESSELS
Indicated Patient Age Range
Not Found
Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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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.)
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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).
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§ 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 & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol that resembles three parallel lines curving upwards and to the right, creating a sense of movement or progress.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 2004
Vascutek Ltd. c/o Mr. Steven Arick Terumo Cardiovascular Systems Corporation 6200 Jackson Road Ann Arbor, MI 48103-9300
Re: K041528
Vascutek ePTFE Wrapped ePTFE Vascular Prosthesis Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular Graft Prosthesis Regulatory Class: Class II (two) Product Code: DSY Dated: June 3, 2004 Received: June 8, 2004
Dear Mr. Arick:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave leviewed your becaller of the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the enolosure) is regars the Medical Device Amendments, or to conninered provided to may 20, 1978, in accordance with the provisions of the Federal Food, Drug, devices mat have been roomsomed in avere approval of a premarket approval application (PMA). and Cosmetic Trol (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions 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 If your device is classified (600 world) als. Existing major regulations affecting your device can may be subject to such additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ourcements concerning your device in the Federal Register.
1
Please be advised that FDA's issuance of a substantial equivalence determination does not mean i loase oc advised that I Dr unation that your device complies with other requirements of the Act that I Dri has made a cond regulations administered by other Federal agencies. You must or any 1 coolar statuates and states and the mot limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set CFA in the quality systems (DS) regulation (21 CFR Part 820); and if applicable, the electronic form in the quality byections (Sections 531-542 of the Act); 21 CFR 1000-1050. product lastiall control probegin marketing your device as described in your Section 510(k) I ms letter will and w yours of substantial equivalence of your device to a legally premaince notification. The Pressession 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 If you desire specific acripliance at (301) 594-4648. Also, please note the regulation entitled, Connact the Office of Count of Court (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general miorination of your corporation in its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address
(301) +45-0597 of arts international dsmamain. html
Sincerely yours,
Duura R. Vochner
(A 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):___KOY / 528
VASCUTEK ePTFE WRAPPED ePTFE VASCULAR Device Name:__________________________________________________________________________________________________________________________________________________________________ PROSTHESES
Indications For Use:
SUBCUTANEOUS OF CREATION CONDUITS FOR BLOOD ARTERIOVENOUS 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)
Duma R. Schmer
Page 1 of 1_
(Division Sign-Off) Division Orginal Cardiovascular Devices
510(k) Number_K041528