(79 days)
Not Found
Not Found
No
The summary describes a physical vascular prosthesis and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is a vascular prosthesis intended for surgical repair, bypass, or replacement of arteries in the treatment of diseases, which directly addresses a medical condition.
No
Explanation: The device is a vascular prosthesis intended for surgical repair, bypass, or replacement of arteries, which is a therapeutic function, not a diagnostic one.
No
The device is a vascular prosthesis, which is a physical implant, 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 is for "surgical repair, bypass or replacement of arteries." This describes a surgical procedure performed directly on the patient's body.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Lack of IVD Characteristics: The description doesn't mention any analysis of biological samples or providing diagnostic information based on such analysis.
The device is a surgical implant used to replace or repair blood vessels, which falls under the category of medical devices used in vivo (within the living body).
N/A
Intended Use / Indications for Use
Woven Collagen Coated Vascular Prostheses are indicated forsurgical repair, bypass or replacement of arteries in thetreatment of aneurysmal and occlusive diseases of the aorta,both thoracic and abdominal, visceral arteries, and proximalperipheral arteries . Due to the low porosity of Woven vasculargrafts, these products are recommended for use in patientsrequiring 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
Aorta, both thoracic and abdominal, 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)
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle or bird symbol with three curved lines representing its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room-WO66-G609 Silver Spring, MD 20993-0002
InterVascular S.A.S. c/o Mr. Philippe Bensimon Director, Regulatory & Clinical Affairs and Quality Assurance Zone Industrielle Athelia I Laciotat France 13705
FEB - 2 2011
11:10 P
Re: K103347
Trade/Device Name: CardioRoot Woven Collagen Coated Vascular Prostheses Regulation Number: 21 CFR 870.3450 Regulation Name: Vascular graft prosthesis Regulatory Class: Class II Product Code: DS Y Dated: December 28, 2010 Received: January 3, 2011
Dear Mr. Bensimon:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave reviewed your becarely be 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 encrosure) to tegains and the Medical Device Amendments, or to connineres phor to May 20, 1978, are exactiance with the provisions of the Federal Food, Drug, devices that have been recuire approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The You may, therefore, mance me device, overenents for annual registration, listing of general controls provisions of the : 107 labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability adulteration. Ficase note: CDACT does not evaluation must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or classion on be II your device is classified (300 a0070). Existing major regulations affecting your device can be may be subject to additional controls: Entrally and Parts 800 to 898 . In addition, FDA may round in the Code of I ederal resguiner in the Federal Register.
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
that FDA has made a determination that your device complies. You must that FDA has made a determination that your active Federal agencies. You must giations actively as ministration of the program of the
1
Page 2 - Mr. Bensimon
comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Ashley B. Bour
$\gamma a$
Bram 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): | K103347 |
|---|---|
| Device Name: | CardioRoot Woven Collagen Coated Vascular Prostheses |
| Indications For Use: | Woven Collagen Coated Vascular Prostheses are indicated for |
| surgical repair, bypass or replacement of arteries in the | |
| treatment of aneurysmal and occlusive diseases of the aorta, | |
| both thoracic and abdominal, visceral arteries, and proximal | |
| peripheral arteries . Due to the low porosity of Woven vascular | |
| grafts, these products are recommended for use in patients | |
| requiring heparinization prior to or during surgery. |
Prescription Use __ X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Antilei Boum for BDZ
Page 1 of 1
(Division Sign-Off) Division of Cardiovascular Devices
510(k) Number_K 103347