The Cxi Support Catheter consists of a 2.6 French catheter with hydrophilic coating. The catheter includes four (4) radiopaque markers to assist in fluoroscopic visualization of the catheter during use. The inner diameter allows acceptance of a 0.018-inch (0.45mm) wire guide. The catheter is available in two lengths, 90 and 150 cm, with a straight or angled distal tip.

AI/ML Overview

The provided text is a 510(k) Premarket Notification for the Cxi Support Catheter. It describes the device, its intended use, and its substantial equivalence to predicate devices, but does not describe an AI/ML powered device, an algorithm, or a study involving human readers or expert ground truthing.

Therefore, I cannot provide information on:

Acceptance criteria for an AI/ML device or its reported performance. The "acceptance criteria" discussed in the document refer to design verification tests for a physical medical catheter.
Sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC comparative effectiveness study, standalone performance, type of ground truth for an AI/ML device. These concepts are not applicable to the physical catheter described.
Sample size for training set or how ground truth was established for a training set. Again, these relate to AI/ML development, which is not the subject of this document.

However, I can extract the information relevant to the medical device (Cxi Support Catheter) as presented in the document, which pertains to its physical and functional characteristics.

Here's the relevant information from the document regarding the device's testing:

1. Table of Acceptance Criteria (Test Performed) and Reported Device Performance (Implied as "Met")

The document lists the tests performed, implying that the device met the requirements for these tests to assure reliable design and performance. Specific numerical acceptance criteria or detailed performance metrics are not provided in this summary.

Test Category	Specific Test Performed	Reported Device Performance
Performance Testing	Freedom of Leakage	"assure reliable design and performance" (implies met criteria)
Performance Testing	Burst Pressure	"assure reliable design and performance" (implies met criteria)
Performance Testing	Tensile Strength	"assure reliable design and performance" (implies met criteria)
Performance Testing	Bending	"assure reliable design and performance" (implies met criteria)
Performance Testing	Flow Rate	"assure reliable design and performance" (implies met criteria)
Biocompatibility	Biocompatibility	"assure reliable design and performance" (implies met criteria)

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

Sample Size: The document does not specify the sample size used for any of the listed tests.
Data Provenance: The tests were conducted by Cook Incorporated. The document does not specify the country of origin of the data beyond that it was generated internally by the manufacturer for regulatory submission in the USA. These appear to be retrospective tests conducted on manufactured product samples.

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

This concept is not applicable. The tests performed are engineering and biocompatibility tests on a physical device, not interpretative tasks requiring expert consensus for ground truth.

4. Adjudication Method for the Test Set

This concept is not applicable. Adjudication is typically for interpretative clinical data, not for objective engineering or material property tests.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human reader performance, not for a physical catheter.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

This concept is not applicable. The device is a physical catheter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the tests involved engineering specifications, material standards, and possibly biological safety standards. For example:

Freedom of Leakage, Burst Pressure, Tensile Strength, Bending, Flow Rate: These would be compared against pre-defined engineering design specifications and performance limits.
Biocompatibility: This would be assessed against recognized biocompatibility standards (e.g., ISO 10993 series), potentially using in vitro or in vivo testing to determine lack of toxicity, irritation, etc.

8. The Sample Size for the Training Set

This concept is not applicable. There is no AI/ML model or "training set" for a physical catheter.

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

This concept is not applicable.

Summary

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NOV @ 9 2007

Special 510(k) Premarket Notification MiraFlex 18 Microcatheter COOK INCORPORATED

510(k) Summary

Submitted By:

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235

Device:

Trade Name:
Proposed Classification:

Cxi Support Catheter Catheter, Continuous Flush KRA (21 CFR §870.1250)

Indications for Use:

Intended for use in small vessel or superselective anatomy for diagnostic and interventional procedures including peripheral use.

Predicate Devices:

The Cxi Support Catheter is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for use in small vessel or superselective anatomy for diagnostic and interventional procedures.

Device Description:

Substantial Equivalence:

The Cxi Support Catheter is similar to catheters in commercial distribution for use in small vessel or superselective anatomy for diagnostics and interventional procedures. The device most similar is the MiraFlex 18 Microcatheter cleared for marketing on December 8, 2005 (D.C.#K052841) and March 6, 2006 (D.C.#K060224).

The similar indications for use, principles of operation, technological characteristics and performance testing results for the Cxi Support Catheter as compared to the predicate device supports a determination of substantial equivalency.

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Test Data:

The Cxi Support Catheter was subjected to the following tests to assure reliable design and performance under specified testing parameters. These tests were comprised of:

Freedom of Leakage 1.
1. Burst Pressure
1. Tensile Strength
1. Bending
1. Flow Rate
Biocompatibility 6.

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a catheter guide wire.

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Image /page/2/Picture/2 description: The image shows the logo for the Department of Health & Human Services (HHS) in the USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized graphic of an abstract human figure, represented by three curved lines that suggest a head, body, and legs.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

NOV 0 9 2007

Cook Inc. c/o Ms. Karen Bradburn Senior Regulatory Affairs Specialist P.O. Box 489 Bloomington, IN 47402-0489

Re: K072724 CXI Support Catheter Regulation Number: 21 CFR 870.1210 Regulation Name: Continuous Flush Catheter Regulatory Class: II (Two) Product Code: KRA Dated: October 31, 2007 Received: November 1, 2007

Dear Ms. Bradburn:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally 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, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA), 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Page 2 - Ms. Karen Bradburn

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 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), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers. International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.

Sincerely yours,

R. bohner

A Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Special 510(k) Premarket Notification MiraFlex 18 Microcatheter COOK INCORPORATED

510(k) Number (if known):

Kozary

Device Name: Cxi Support Catheter

Intended for use in small vessel or superselective anatomy for diagnostic Indications for Use: and interventional procedures including peripheral use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

suna R. barner (Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_K072724

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).