The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.

Device Description

The catheters included in this submission are 5 F and 6 F in diameter with a braided proximal shaft and a variety of tip configurations.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Cordis Infiniti Angiographic Catheters:

Summary of Device and Context:

The submission describes a modification to existing Cordis Infiniti Angiographic Catheters (5 F and 6 F diameter) for delivering radiopaque contrast medium to selected sites in the vascular system. The key aspect of this submission is that it's a modification to existing devices, and the approval is based on demonstrating substantial equivalence to previously cleared predicate devices. This implies that extensive new performance studies for efficacy might not have been required if the changes were deemed minor and within established safety and performance envelopes.

Acceptance Criteria and Device Performance:

Based on the provided document, specific quantitative acceptance criteria or detailed performance metrics are not explicitly stated or presented in a table format. This is common for 510(k) submissions focusing on substantial equivalence, especially for modifications to devices with well-established safety and performance profiles.

Instead of a table of acceptance criteria, the document focuses on demonstrating substantial equivalence to predicate devices. The implicit "acceptance criterion" is that the modified device performs comparably to the predicate devices and maintains the same safety profile.

The document states:

"The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially angiographic catheters."
"All appropriate biocompatibility tests were previously performed on the materials used for the 5 F and 6 F Infiniti® Angiographic Catheters. No new tests were performed, since all materials had been successfully tested on previously concurred devices."

Therefore, a table of explicit acceptance criteria and device performance based solely on this document cannot be generated. The document indicates that the device met acceptance implicitly by demonstrating equivalence to previously approved devices.

Study Details (Based on available information):

Given the nature of a 510(k) for a device modification and the information provided, it's highly unlikely that a standalone clinical study with detailed performance metrics, ground truth establishment, or human reader effectiveness was conducted and reported within this summary. The reliance is on prior validation of the predicate devices.

1. Sample sized used for the test set and the data provenance:

Sample Size (Test Set): Not specified.
Data Provenance: Not specified. Given the focus on substantial equivalence, any "testing" would likely involve comparing the modified design/materials to the predicate. The document mentions "All appropriate biocompatibility tests were previously performed on the materials used... No new tests were performed." This implies reliance on historical data and material testing rather than a new "test set" in the context of a clinical study.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

Number of Experts: Not applicable/Not specified.
Qualifications of Experts: Not applicable/Not specified. Ground truth establishment, in the sense of expert review for diagnostic accuracy, is not relevant to this type of submission.

3. Adjudication method (e.g. 2+1, 3+1, none) for the test set:

Adjudication Method: Not applicable/None specified. No clinical test set requiring adjudication is described.

4. 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:

MRMC Study: No.
Effect Size: Not applicable. This is not an AI/diagnostic imaging device where human reader improvement with AI assistance would be relevant.

5. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

Standalone Performance: No. This is a physical medical device (catheter), not an algorithm.

6. The type of ground truth used (expert concensus, pathology, outcomes data, etc):

Type of Ground Truth: Not applicable in the context of a diagnostic or AI device. The "ground truth" for this catheter's performance is its ability to safely and effectively deliver contrast medium, which would be assessed through engineering testing, material compatibility, and comparison to existing predicate devices.

7. The sample size for the training set:

Sample Size (Training Set): Not applicable. This is not a machine learning or AI device that requires a training set.

8. How the ground truth for the training set was established:

Ground Truth Establishment (Training Set): Not applicable.

Conclusion:

The provided document describes a 510(k) submission for a modification to an existing angiographic catheter, seeking approval based on substantial equivalence to previously cleared predicate devices. The focus is on demonstrating that the modified catheters maintain similar design, construction, indications for use, and performance characteristics, and utilize materials already proven biocompatible.

Therefore, the submission does not contain information about a traditional performance study involving a large test set, expert readers, or ground truth establishment in the way one would expect for a novel diagnostic device or AI algorithm. Instead, the "study" is the demonstration of equivalence through technical specifications, material comparisons, and reliance on the safety and effectiveness data of the predicate devices.

Summary

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00-00034

PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification

K970854

SEP 30 1997

SUMMARY OF SAFETY AND EFFECTIVENESS

General Provisions l.

Common or Usual Name: Angiographic Catheter Proprietary Name: Cordis 5 F Infiniti® Angiographic Catheter Cordis 6 F Infiniti® Angiographic Catheter

11. Name of Predicate Devices

4 F Infiniti® Angiographic Catheter, K960975, April 02, 1996 6 F Paragon (Infiniti® ) Angiographic Catheter, K921310/A, Sept. 17, 1992

III. Classification

Class II

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 Cordis 5 F and 6 F Infiniti® Angiographic Catheters are indicated for the delivery of radiopaque contrast medium to selected sites in the vascular system.

The catheters included in this submission are 5 F and 6 F in diameter with a braided proximal shaft and a variety of tip configurations.

VI. Biocompatibility

All appropriate biocompatibility tests were previously performed on the materials used for the 5 F and 6 F Infiniti® Angiographic Catheters. No new tests were performed, since all materials had been successfully tested on previously concurred devices.

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PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification

VII. Summary of Substantial Equivalence

The Cordis 5 F and 6 F Infiniti® Angiographic Catheters are similar in design, construction, indication for use, and performance characteristics to other commercially angiographic catheters.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract image of an eagle.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20856

SEP 3 0 1997

Elena S. Juqo, M.D. Cordis Corporation P.O. Box 025700 Miami, Florida 33102-5700

K970854 Re:

5 Fr and 6 Fr Infiniti® Angiographic Catheters Requlatory Class: II (two) Product Code: DOO Dated: July 2, 1997 Received: July 3, 1997

Dear Dr. Jugo:

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, 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 Requlation (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 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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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 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. Callahon

Thomas J. Cal ahan Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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00-0.0053

PREMARKET NOTIFICATION 510(k) Cordis Corporation Infiniti® Angiographic Catheters Modification

510(k) Number (if known): ___________

Device Name: _________________________________________________________________________________________________________________________________________________________________

Indications for Use:

Cordis Angiographic Catheters are designed to deliver radiopaque contrast medium to selected sites in the vascular system.

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IS NEEDED

Concurrence of CDRH, Office of Device Evaluation (ODE)

Ta. Re

(Division Sign-Off) (Division Sign-Olt)
Division of Cardiovascular, Respiratory,
Division of Cardiovascular, Respiratory, Division of Given and Neurological Devices

510(k) Number .

Prescription Use

Over-The-Counter Use

(Per 21 CFR 801.109)

Regulation Number and Section

§ 870.1200 Diagnostic intravascular catheter.

(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).