(82 days)
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Not Found
No
The summary describes a mechanical infusion catheter and does not mention any software, algorithms, or AI/ML capabilities.
Yes
The device is described as delivering solutions, including thrombolytic agents, to the coronary and peripheral vasculature, which indicates a therapeutic purpose rather than just diagnostic or supportive.
No
The device is intended to deliver solutions and agents, which is a therapeutic function, not a diagnostic one.
No
The device description clearly describes a physical catheter with an over-the-wire design, a distal infusion region, a proximal hub, and a radiopaque marker band. This indicates a hardware medical device, not a software-only one.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information about a person's health. This testing is done outside of the body.
- Device Function: The Cordis Endeavor Infusion Catheter is designed to deliver solutions directly into the coronary and peripheral vasculature within the body. It's an interventional device used for treatment, not for analyzing samples taken from the body.
The description clearly states its purpose is to deliver substances to the vasculature, which is an in-vivo (within the living organism) application, not an in-vitro (in glass/outside the body) diagnostic test.
N/A
Intended Use / Indications for Use
The Cordis Endeavor Infusion Catheter is intended to deliver solutions, such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
QEY, KRA
Device Description
The Endeavor Infusion Catheter is intended to deliver solutions to the coronary and peripheral vasculature. The device is an over-the-wire design with a distal infusion region and a proximal hub. The infusion region is indicated by a central radiopaque marker band.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and peripheral vasculature
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)
A series of in vitro and in vivo tests were performed to assure that the introduction of the Endeavor Infusion Catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications.
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.
SciMed Dispatch and Dispatch Gold Infusion Catheters, LocalMed InfusaSleeve and InfusaSleeve II Infusion Catheters, Interventional Innovations Segue Infusion Catheter
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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§ 870.5150 Embolectomy catheter.
(a)
Identification. An embolectomy catheter is a balloon-tipped catheter that is used to remove thromboemboli, i.e., blood clots which have migrated in blood vessels from one site in the vascular tree to another.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a symbol representing the Department of Health & Human Services - USA, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The FDA logo is a symbol of the agency's role in protecting public health by ensuring the safety, efficacy, and security of human and veterinary drugs, biological products, and medical devices.
January 7, 2022
Cordis Corp. Tamara Yount Regulatory & Clinical Affairs, Mgr. 14201 N.w. 60th Ave. Miami Lakes, Florida 33014
Re: K970842
Trade/Device Name: Cordis Endeavor Infusion Catheter Regulation Number: 21 CFR 870.5150 Regulation Name: Embolectomy catheter Regulatory Class: Class II Product Code: QEY, KRA
Dear Tamara Yount:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated May 28, 1997. Specifically, FDA is updating this SE Letter as an administrative correction because FDA has created a new product code to better categorize your device technology.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Gregory O'Connell, OHT2: Office of Cardiovascular Devices, (301) 796-6075, Gregory.Oconnell(@FDA.HHS.gov.
Sincerely,
Gregory W. Digitally signed by Gregory W. O'connell -S O'connell -S Date: 2022.01.07
13:56:39-05'00'
Gregory O'Connell Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1997
Ms.. Tamara Yount Cordis Corporation P.O. Box 025700 Miami, Florida 33014
Re: K970842 Cordis Endeavor Infusion Catheter Regulatory Class: II (two) Product Code: 74 KRA Dated: March 6, 1997 March 7, 1997 Received:
Dear Ms. Yount:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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, qood manufacturing practice, labelinq, and prohibitions aqainst misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval) , 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 895. A substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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Page 2 - Ms. Tamara Yount
This letter will allow you to begin marketing your device as described in your 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket motification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Thomas J. Callahan
Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Statement of Intended Use Cordis Endeavor Infusion Catheter
The intended use statement of this product is:
The Cordis Endeavor Infusion Catheter is intended to deliver solutions, such as heparinized saline, and thrombolytic agents, such as urokinase, to the coronary and peripheral vasculature.
510(k) number
(To be assigned by FDA)
Tia to the
(Divisic Division
4
Section 513(i) of the Federal Food, Drug and Cosmetic Act Summary of Safety and Effectiveness
MAY 28 1997
March 5, 1997
General Provisions l
Common or Usual name: Infusion Catheter
Proprietary name: Cordis Endeavor Infusion Catheter
Name and Address of Applicant:
Cordis Corporation Miami Lakes Operation Center 14201 NW 60 Avenue Miami Lakes, FL 33014
Name of Predicate Devices ം
ഇവയുടെ
അതിനു താരങ്ങൾ
തന്ത്രിക്കുന്നത് തുടങ്ങു
SciMed Dispatch and Dispatch Gold Infusion Catheters LocalMed InfusaSleeve and InfusaSleeve II Infusion Catheters Interventional Innovations Segue Infusion Catheter
Classification 【】.
Infusion catheters are class II devices according to 21 CFR 870.1210.
【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【"】【" Performance Standards
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
.
مهي Intended Use and Device Description
The Endeavor Infusion Catheter is intended to deliver solutions to the coronary and peripheral vasculature. The device is an over-the-wire design with a distal infusion region and a proximal hub. The infusion region is indicated by a central radiopaque marker band.
لقطع المستوى
منتخب المنتخب المنتخب Biocompatibility
All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Endeavor Infusion Catheter.
5
In vitro Testing ,【【。
A series of in vitro and in vivo tests were performed to assure that the introduction of the Endeavor Infusion Catheters does not raise new issues of safety and effectiveness. All test results met or exceeded established specifications.
VIII. Summary of Substantial Equivalence
The Endeavor Infusion Catheter is designed for the infusion of solutions to the coronary and peripheral vasculature. The Endeavor Infusion Catheters have similar intended uses, design characteristics and dimensions as the predicate devices.