(6 days)
Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices.
The system consists of an introducer, a mini-guidewire, and a vessel dilator. The introducer consists of a cannula of co-extruded polyethylene with barium sulfate, a high density polyethylene body, and polyurethane sideport extension. The radiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.
• 4 - 11 French
• 3 - 120 cm length
• .035" - .038' mini guidewire
This document is a 510(k) summary for the Cordis Brite Tip Catheter Sheath Introducer, not a study report. Therefore, it does not contain the detailed information about acceptance criteria, device performance, study design, or ground truth establishment that would typically be found in a clinical study report.
The document states that the Brite Tip CSI's are substantially equivalent to previously cleared Brite Tip CSI's. This implies that the device meets the same performance criteria as its predicate device, but it does not specify what those criteria are or how they were tested in this particular submission.
Here's an attempt to address your questions based on the limited information provided in this 510(k) summary, with many answers indicating that the information is not provided in this document:
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A table of acceptance criteria and the reported device performance
This document does not provide a table of acceptance criteria or reported device performance in the context of a clinical study. The "Summary of Safety and Effectiveness" section focuses on establishing substantial equivalence to a predicate device.
Acceptance Criteria Reported Device Performance Not provided Not provided -
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not provided. This document describes a 510(k) submission based on substantial equivalence, not a clinical study involving a test set of data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. No test set requiring expert ground truth establishment is described in this 510(k) summary.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. No formal test set or adjudication method is described.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/imaging device, nor is an MRMC study described.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm-based device requiring standalone performance testing in that context.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc)
Not applicable. The concept of "ground truth" as it relates to clinical data analysis for performance metrics is not relevant to this 510(k) submission, which relies on the concept of substantial equivalence based on device characteristics and intended use.
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The sample size for the training set
Not applicable. This document does not describe the development of an algorithm or model that would require a training set.
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How the ground truth for the training set was established
Not applicable. As there is no training set described, the method for establishing its ground truth is also not applicable.
In summary: The provided document is a 510(k) summary for a medical device (a catheter sheath introducer) seeking market clearance based on substantial equivalence to existing devices, not a study report detailing clinical performance or algorithm validation. Therefore, most of the requested information regarding acceptance criteria derived from clinical studies, test sets, ground truth, and reader studies is not present. The primary "acceptance criterion" for this submission is that the device is substantially equivalent to predicates concerning its design, materials, and intended use.
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Attachment 4
Summary of Safety and Effectiveness
| GeneralProvisions | Trade Name: Cordis Brite Tip Catheter Sheath IntroducerCommon/Classification Name: Catheter Introducer System |
|---|---|
| Name ofPredicateDevices | Cordis Brite Tip Catheter Sheath Introducer |
| Classification | Class II. |
| PerformanceStandards | Performance standards have not been established by the FDA under section 514 ofthe Food, Drug and Cosmetic Act. |
| Intended Useand DeviceDescription | Cordis Catheter Sheath Introducers are intended for use in arterial and venousprocedures requiring percutaneous introduction of intravascular devices.The device description of the Brite Tip CSI is as follows.The system consists of an introducer, a mini-guidewire, and a vessel dilator. Theintroducer consists of a cannula of co-extruded polyethylene with barium sulfate, ahigh density polyethylene body, and polyurethane sideport extension. Theradiopaque tip is made of a blend of tungsten, polyethylene, and zinc stearate.• 4 - 11 French• 3 - 120 cm length• .035" - .038' mini guidewire |
| Biocompatibility | All materials used in the Brite Tip CSI's are biocompatible. |
| Summary ofSubstantialEquivalence | The Brite Tip CSI's are substantially equivalent to the previously cleared Brite TipCSI's. |
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Image /page/1/Picture/1 description: The image contains the text "Public Health Service". The text is in a simple, sans-serif font and is left-aligned. The text is likely a heading or title, possibly indicating the name of an organization or department.
Image /page/1/Picture/10 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the top half of the circle. In the center of the seal is a stylized image of three lines that resemble a person with their arms outstretched.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 3 1998
Ms. Ariel MacTavish Sr. Requlatory Affairs Associates Cordis Corporation 14420 N.W. 60th Avenue Miami Lakes, FL 33014
Re: K984500 Cordis Brite Tip Catheter Sheath Introducer System Trade Name: Requlatory Class: II Product Code: DYB Dated: December 14, 1998 Received: December 17, 1998
Dear Ms. 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 leqally 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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the qeneral controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, qood 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to A substantially equivalent determination assumes compliance with 895. 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 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 Reqister. Please note: this response to your premarket notification submission does not affect any obligation
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Page 2 - Ms. Ariel MacTavish
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.
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) 594-4586. 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 notification" (21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Thomas J. Allelshan
Thomas J. Callal Director Division of Cardiovascular, Respiratory and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Attachment 2
Indications for Use Statement
| 510(k) Number (if known) | |
|---|---|
| Device Name | Brite Tip Catheter Sheath Introducer |
| Indications for Use | Cordis Catheter Sheath Introducers are intended for use in arterial and venous procedures requiring percutaneous introduction of intravascular devices. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Tu A. Ra-
(Division Sign-Off) Division of Cardiovascular, Respiratory, and Neurological Devices Hygysod 510(k) Number_
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use_
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).