The CES FG Infusion Catheter is intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.

Device Description

CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the CES FG Infusion Catheter:

Based on the provided text, the submission is a 510(k) premarket notification for a Class II medical device, an infusion catheter. The text primarily focuses on establishing substantial equivalence to predicate devices, rather than presenting a performance study with detailed acceptance criteria and reported device performance in the way one might expect for a diagnostic or AI-based device.

Therefore, the information you've requested regarding direct performance metrics, sample sizes for test/training sets, expert qualifications, and MRMC studies is largely not present in the provided document, as it's not typically required for a 510(k) submission for this type of device.

However, I can extract the information that is available and highlight what is missing.

Acceptance Criteria and Study Information for CES FG Infusion Catheter

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria Category	Specific Criteria	Reported Device Performance	Comments
Biocompatibility	Compatibility with biological tissue as stipulated in FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1) test protocols.	Met acceptance criteria.	The document states "The catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria stipulated in the test protocols."
Substantial Equivalence	Equivalence in basic design, construction, indications for use, performance characteristics, packaging, and sterilization to other commercially available infusion catheters.	Determined to be substantially equivalent to predicate devices.	The FDA letter confirms the device is "substantially equivalent (for the indications of use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976." The summary also states, "The CES FG Infusion Catheter is substantially equivalent in its basic design, construction, indications for use, performance characteristics, packaging and sterilization to other commercially available infusion catheters."
Intended Use	To be used as a mechanism for selective infusion of various diagnostic, embolic, and therapeutic agents into peripheral, coronary, and neurovasculatures.	Intended use matches description and is similar to predicate devices.	The intended use is clearly stated and is a basis for comparison to predicate devices.

Missing Information for a Performance Study (Not applicable for this type of 510(k) submission):

Specific numerical performance metrics (e.g., sensitivity, specificity, accuracy, precision, recall)
Quantitative thresholds for these metrics

2. Sample Size Used for the Test Set and Data Provenance

This information is not provided in the document.

For biocompatibility, the phrase "Entire FG Infusion Catheters were subjected to biocompatibility testing" implies that samples of the finished device were used, but a specific number is not given.
For the substantial equivalence claim, no specific test set sample size or data provenance (country, retrospective/prospective) is detailed, as this is typically based on design comparison and existing data from predicate devices or general clinical performance history for this device type, rather than a novel clinical trial with a defined test set.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This information is not provided in the document, as it did not involve a study requiring expert-established ground truth for performance evaluation in the context of a diagnostic or AI device.

4. Adjudication Method for the Test Set

This information is not provided in the document, as it did not involve a study requiring an adjudication method for performance evaluation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done or at least is not reported in this document. This type of study is typically associated with diagnostic imaging devices or AI-assisted diagnostic tools, not an infusion catheter seeking substantial equivalence.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study (in the context of an algorithm) was not done or is not reported in this document. This device is a physical medical instrument, not a software algorithm.

7. The Type of Ground Truth Used

For biocompatibility: The "ground truth" was established by the specified ISO-10993 (Blue Book Memorandum G95-1) test protocols and their acceptance criteria for biological compatibility.
For substantial equivalence: The "ground truth" is essentially the established safety and effectiveness of the legally marketed predicate devices. The claim is that the new device is functionally identical or very similar in all critical aspects to these already approved devices.

8. The Sample Size for the Training Set

This information is not provided in the document, as it is not relevant for this type of device and submission. There is no "training set" in the context of a machine learning model for this physical medical device.

9. How the Ground Truth for the Training Set Was Established

This information is not provided in the document, as it is not relevant for this type of device and submission.

Summary

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1971306

0-000036

SUMMARY OF SAFETY AND EFFECTIVENESS

I. General Provisions

JUL 1 4 1997

Common or Usual Name: Diagnostic, Intravascular Catheter FG Infusion Catheter Proprietary Name:

II. Name of Predicate Devices

MAGIC Infusion Catheter - K923368 Balt, distributed by Target Therapeutics Product Code: 74DQO Predicate for design, intended use and packaging

CES Infusion Catheters - K965181 Cordis Endovascular Systems, Inc. Product Code: 74KRA Predicate for design, intended use, sterilization and packaging

EDDY Infusion Catheter Medi-tech - Boston Scientific Corporation Product Code: 74KRA Predicate for design and intended use and packaging

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

CES Infusion Catheters are intended to be used as a mechanism for the selective infusion of various diagnostic, embolic and therapeutic agents into the peripheral, coronary and neurovasculatures.

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VI. Biocompatibility

Entire FG Infusion Catheters were subjected to biocompatibility testing based on the FDA modified matrix of ISO-10993 (Blue Book Memorandum G95-1). The catheters demonstrated compatibility with biological tissue by meeting the acceptance criteria stipulated in the test protocols.

VII. Summary of Substantial Equivalence

The CES FG Infusion Catheter is substantially equivalent in its basic design, construction, indications for use, performance characteristics, packaging and sterilization to other commercially available infusion catheters.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and wings. The text "DEPARTMENT OF HEALTH & H." is arranged vertically on the left side of the logo, and the text "AN SERVICES - USA" is arranged horizontally along the top of the logo.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Lisa Wells Manager, Requlatory Affairs and Clinical Research and Clinical Research
Cordis Endovascular Systems, Inc. JUL | 4 |997
P Systems, 205700 P.O. Box 025700 . Miami, Florida 33102-5700 ־¨¨ ¯¯

K971306 Re: FG Infusion Catheter Regulatory Class: II (two) Product Code: KRA Dated: June 26, 1997 Received: June 30, 1997

Dear Ms. Wells:

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, 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirement, 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 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. Callahan

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

Enclosure

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510(k) Number:

Indications For Use

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use_ (Per 21 CFR 801.109)

Over-The-Counter Usc_

Tn A. h

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

510(k) Number K471306

Regulation Number and Section

§ 870.1210 Continuous flush catheter.

(a)
Identification. A continuous flush catheter is an attachment to a catheter-transducer system that permits continuous intravascular flushing at a slow infusion rate for the purpose of eliminating clotting, back-leakage, and waveform damping.(b)
Classification. Class II (performance standards).