(70 days)
Not Found
No
The summary describes a physical medical device (catheter) for delivering solutions and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device is intended to deliver solutions and agents, which is a delivery mechanism rather than a direct therapeutic action on the body's condition.
No
The device is described as an infusion catheter intended to deliver solutions and agents, which is a therapeutic function, not a diagnostic one. There is no mention of it being used to identify or analyze diseases or conditions.
No
The device description clearly describes a physical catheter with a distal infusion region, proximal hub, and radiopaque marker band, indicating it is a hardware device.
Based on the provided information, the Cordis Endeavor Infusion Catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to "deliver solutions... to the coronary and peripheral vasculature." This describes a device used within the body for therapeutic purposes (delivering substances), not for testing samples outside the body to diagnose conditions.
- Device Description: The description of an "over-the-wire design with a distal infusion region and a proximal hub" is consistent with a catheter used for delivering substances directly into blood vessels.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information based on testing these samples.
Therefore, the Cordis Endeavor Infusion Catheter is a medical device used for therapeutic delivery, not an in vitro diagnostic device.
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
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)
VII. In vitro Testing
A series of in vitro tests were performed to assure that the introduction of the two new sizes of Endeavor Infusion Catheter 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)
Cordis Infusion Catheters (3.0 - 3.5 mm), SciMed Dispatch Gold Infusion Catheters1
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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 the Department of Health & Human Services logo, which features a stylized human figure. To the right of this is the FDA logo, with the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.
January 21, 2022
Cordis Corp. Ariel MacTavish Regulatory And Clinical Affairs Associate 14201 N.W.60th Ave. Miami Lakes, Florida 33014
Re: K972110
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 Ariel MacTavish:
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 August 14, 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,
Digitally signed by Gregory W. Gregory W. O'connell -S O'connell -S Date: 2022.01.21 09:54:21 -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 serpent entwined around it, overlaid on a circular seal. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the upper portion of the circular seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856
AUG 1 4 1997
Mr. Ariel MacTavish Regulatory and Clinical Affairs Associate Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
Re: K972110 Endeavor Infusion Catheter Requlatory Class: II (two) Product Code: 74 KRA Dated: June 4, 1997 Received: June 5, 1997
Dear Mr. MacTavish:
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, Druq, 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, good 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 requlations 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 current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such Failure to comply with the GMP regulation may result in assumptions. 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 - Mr. Ariel MacTavish ----
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 leqally 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 requlation entitled, "Misbranding by reference to premarket notification" (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, 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
K972110 (To be assigned by FDA)
Tu. A. Re
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices 510(k) Number
000038
4
Section 513(j) of the Federal Food, Drug and Cosmetic Act Summary of Safety and Effectiveness
06/03/97
AUG 1 4 1997
General Provisions
I.
| 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 |
II. Name of Predicate Devices
Cordis Infusion Catheters (3.0 - 3.5 mm) SciMed Dispatch Gold Infusion Catheters1
III. Classification
Infusion catheters are class II devices according to 21 CFR 870.1210.
IV. Performance Standards
Performance standards have not been established by the FDA under Section 514 of the Food, Drug and Cosmetic Act.
V. Intended Use and Device Description
The Endeavor Infusion Catheter is intended to deliver solutions to the coronary and The device is an over-the-wire design with a distal infusion peripheral vasculature. region and a proximal hub. The infusion region is indicated by a central radiopaque marker band.
A statement of substantial equivalence to another product is required by 21 CFR 807.87, and relates only to whether the present product can be marketed without prior reclassification or clinical approval. The present submission is therefore not related to the coverage of any patent and is not to be interpreted as an admission or used as evidence in a patent infringement lawsuit. As the commissioner of the FDA has stated, "A determination of substantial equivalence under the Federal Food, Drug and Cosmetic Act related to the fact that the product can be lawfully marketed without pre-market approval or reclassification. This determination is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. 42, 520 et seq. (1977).
5
VI. Biocompatibility
All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Endeavor Infusion Catheter.
In vitro Testing VII.
A series of in vitro tests were performed to assure that the introduction of the two new sizes of Endeavor Infusion Catheter 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.