(82 days)
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.
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.
The provided text is a 510(k) premarket notification for the Cordis Endeavor Infusion Catheter, which is an Embolectomy catheter. This type of regulatory submission focuses on demonstrating substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria based on a clinical study for novel performance claims.
Therefore, the document does not contain the information requested regarding:
- A table of acceptance criteria and reported device performance.
- Sample size used for the test set and data provenance.
- Number of experts used to establish ground truth and their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.).
- Sample size for the training set.
- How the ground truth for the training set was established.
Instead, the document focuses on:
- Intended Use: To deliver solutions (e.g., heparinized saline, thrombolytic agents) to the coronary and peripheral vasculature.
- Device Description: Over-the-wire design with a distal infusion region and a proximal hub, and a central radiopaque marker band.
- Predicate Devices: SciMed Dispatch and Dispatch Gold Infusion Catheters, LocalMed InfusaSleeve and InfusaSleeve II Infusion Catheters, Interventional Innovations Segue Infusion Catheter.
- Testing Performed:
- Biocompatibility Testing: "All appropriate biocompatibility testing was performed, and successfully passed, on the materials used for the Endeavor Infusion Catheter." (No specific criteria or results are given).
- In vitro and In vivo 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." (Again, no specific criteria or results are provided, nor details on the study design or sample sizes).
- Conclusion: The device is substantially equivalent to the predicate devices due to similar intended uses, design characteristics, and dimensions.
In summary, for a 510(k) submission, the "acceptance criteria" are generally demonstrating that the device is as safe and effective as a legally marketed predicate, rather than meeting specific performance metrics derived from a clinical trial with ground truth established by experts.
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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
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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
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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
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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.
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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.
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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.
§ 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).