(57 days)
Not Found
Not Found
No
The summary describes a physical catheter for blood flow, with no mention of software, image processing, or AI/ML terms.
Yes
The device is intended for temporary blood flow to distal arteries during aortic aneurysm repair, which is a therapeutic intervention.
No
Explanation: The device is described as a "temporary perfusion conduit to allow blood flow," which indicates a therapeutic or supportive function rather than a diagnostic one (identifying a disease or condition).
No
The device description and intended use clearly describe a physical catheter, which is a hardware component. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to facilitate blood flow during surgery. IVDs are used in vitro (outside the body) to examine specimens like blood, urine, or tissue to diagnose or monitor conditions.
- Device Description: While the description is "Not Found," the intended use is the primary indicator.
- Other Sections: The absence of information related to image processing, AI/ML, imaging modalities, training/test sets, performance studies, and key metrics further supports that this is not an IVD. These sections are typically relevant for devices that analyze data or images, which is common for some IVDs.
This device is a surgical catheter, which is a medical device used directly on or within a patient.
N/A
Intended Use / Indications for Use
The Distal Perfusion Catheter is intended for use as a temporary perfusion conduit to allow blood flow to the distal arteries during open abdominal and thoracoabdominal aortic aneurysm repair.
Product codes
DWF
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
distal arteries, abdominal and thoracoabdominal aortic
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): 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.
Not Found
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).
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 seal of the Department of Health & Human Services - USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of three human profiles facing to the right, with three horizontal bars above them.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 7 2003
Lemaitre Vascular Inc. c/o Mr. Carlos Chaparro Lemaitre Vascular Inc. 3101 37th Avenue St. Petersburg, FL 33713
K032041 Distal Perfusion Catheter Regulation Number: 21 CFR 870.4210 Regulation Name: Cardiopulmonary bypass vascular catheter, cannula, or tubing Regulatory Class: Class II Product Code: DWF Dated: June 30, 2003 Received: July 11, 2003
Dear Mr. Chaparro:
Re:
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.
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Page 2 - Mr. Carlos Chaparro
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,
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
The Distal Perfusion Catheter is intended for use as a temporary perfusion conduit to allow blood flow to the distal arteries during open abdominal and thoracoabdominal aortic aneurysm repair.
(Division S-Off)
Division of Cardiovascular Devices
510(k) number K032041