(33 days)
Not Found
Not Found
No
The summary describes a vascular graft, a passive implantable device, and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is intended for arterial vascular reconstruction and bypass, which are therapeutic medical procedures.
No
Explanation: The device is a graft intended for surgical reconstruction and bypass, which are therapeutic procedures, not diagnostic ones. It does not perform any function related to identifying or characterizing a disease or condition.
No
The device description clearly identifies it as a "Graft," 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 is for "arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access." This describes a surgical implant used directly within the body to repair or create blood vessel connections.
- Device Description: The description is "Atrium Graduated Wall Flixene Graft," which is consistent with a surgical implant.
- Lack of IVD Characteristics: The information does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.) in vitro (outside the body).
- Providing diagnostic information based on the analysis of these samples.
- Reagents, calibrators, or controls used for testing.
IVDs are used to examine specimens obtained from the human body to provide information for the diagnosis, monitoring, or treatment of diseases or conditions. This device is a surgical implant used in vivo (within the body) for structural repair and access.
N/A
Intended Use / Indications for Use
The Atrium Graduated Wall Flixene Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Product codes
DSY
Device Description
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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 shows a logo for the U.S. Department of Health & Human Services. The logo features a stylized representation of three human profiles facing to the right. The profiles are stacked on top of each other, creating a sense of depth. The logo is surrounded by the text "U.S. DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 1 4 2007
Atrium Medical Corp. c/o Ms. Karen Hall 5 Wentworth Drive Hudson, NH 03051
Re: K071923
PTFE Flixene Graduated Wall Graft Regulation Number: 21 CFR 870.3460 Regulation Name: Vascular Prosthesis > 6mm Regulatory Class: Class II Product Code: DSY Dated: July 10, 2007 Received: July 12, 2007
Dear Ms. Hall:
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
Page 2 - Ms. Karen Hall
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Pretmarket, Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours
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):_____________________________________________________________________________________________________________________________________________________
Device Name: Atrium Graduated Wall Flixene Graft
Indications For Use:
The Atrium Graduated Wall Flixene Graft is intended for use in arterial vascular reconstruction, segmental bypass, and for arteriovenous vascular access.
Prescription Use X
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)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K071923 |
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CONFIDENTIAL
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