(112 days)
Not Found
Not Found
No
The summary describes a woven connector graft, a physical medical device, and contains no mention of AI, ML, or related concepts.
Yes
The device is used for arterial perfusion during cardiopulmonary bypass, which is a medical treatment.
No
The device is a graft intended for arterial perfusion during cardiopulmonary bypass, which is a therapeutic intervention, not a diagnostic process.
No
The device description clearly identifies it as a "Woven Connector Graft," which is a physical, implantable medical 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 describes a device used in vivo (within the body) for arterial perfusion during cardiopulmonary bypass. IVDs are used in vitro (outside the body) to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Description: The description "InterGard Woven Connector Graft" suggests a physical implant or device used in surgery, not a reagent, instrument, or software used for testing biological samples.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples.
- Providing diagnostic information based on test results.
- Reagents, calibrators, or controls.
- Laboratory settings or procedures.
Therefore, the InterGard Woven Connector Graft is a surgical device used for vascular connection, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The InterGard Woven Connector Graft is intended for use in arterial perfusion of the aorta, via femoral or axillary artery, for cardiopulmonary bypass when extracorporeal circulation is required for periods up to six (6.0) hours.
Product codes
DWF
Device Description
InterGard Woven Connector Graft
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
aorta, femoral or axillary artery
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
§ 870.4210 Cardiopulmonary bypass vascular catheter, cannula, or tubing.
(a)
Identification. A cardiopulmonary bypass vascular catheter, cannula, or tubing is a device used in cardiopulmonary surgery to cannulate the vessels, perfuse the coronary arteries, and to interconnect the catheters and cannulas with an oxygenator. The device includes accessory bypass equipment.(b)
Classification. Class II (performance standards).
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" arranged around the perimeter. Inside the circle is a stylized symbol that resembles a caduceus, which is a traditional symbol of medicine and healthcare.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 8 2005
Intervascular c/o Ms. Amy Aulwes Health Policy Associates, Inc. 690 Canton Street, Suite 302 Westwood, MA 02090
K042984 Re:
InterGard Woven Connector Graft Regulation Number: 21 CFR 870.4210 Regulation Number 21 CFR 870.1210
Regulation Name: Cardiopulmonary Bypass Vascular Catheter, Cannula, and Tubing Regulatory Class: Class II (two) Product Code: DWF Dated: January 11, 2005 Received: January 13, 2005
Dear Ms. Aulwes:
We have reviewed your Section 510(k) premarket notification of intent to market the indication we nave reviewed your Section > ro(x) premainer is substantially equivalent (for the indications relerenced above and nave determined live avedicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device American Frank Frank Frank Frye commerce prior to May 26, 1776, the enaoniance with the provisions of the Federal Food, Drug. devices mat have been recalismou in accerazion was a proval approval application (PMA).
and Cosmetic Act (Act) that do not require approval of a premarket approval applicatio and Cosment Act (Act) market the device, subject to the general controls provisions of the Act. The 1 ou may, therefore, market the devices, only of the ments for annual registration, listing of general controls provisions of the rist 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 (see aboro) nits. Existing major regulations affecting your device can thay be subject to suell additions, Title 21, Parts 800 to 898. In addition, FDA may be found in the Ood of I cases oncerning your device in the Federal Register.
1
Page 2 - Ms. Amy Aulwes
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issualies of a but complies with other requirements of the Act
that FDA has made a determination that your device and of a lovel openaise. You mu that FDA has made a decemination that Jour and Jour Federal agencies. You must or any Federal statures and regulations daminitered of not limited to: registration and listing (21 l comply with all the Act S requirements, mercesses on any active requirements as set CFR Part 807), labeling (21 CFR Part 820); and if applicable, the electronic forni in the quality systems (Sections 531-542 of the Act); 21 CFR 1000-1050. product radiation control pro risions (Decline on device as described in your Section 510(k) I his letter will anow you to ocgin maneting your and equivalence of your device to a legally premarket houndation. The PDF maining of basification 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 at not to: your 301) 594-4646. Additionally, for questions on the contact the Office of Compularour device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to (301) 394-4059. Also, picase note to regation may obtain. Other general information on your premarket non really (2) Of ICT all obtained from the Division of Small Manufacturers, Itsponsibilities 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,
Dama R. Victines
/\ Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
PRODUCT INDICATIONS FOR USE (Page 1 of 1)
510(k) Number:
Device Name: InterGard Woven Connector Graft
The InterGard Woven Connector Graft is Indications for Use: intended for use in arterial perfusion of the intorta, via femoral or axillary artery, for cardiopulmonary bypass when extracorporeal circulation is required for periods up to six (6.0) hours.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _____X ____
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ OR
(Per 21 CFR 801.109)
Donna R. Vochmer
(Division Sign-Off) Division of Cardiovascular Devices
ber KC 42984