The Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Device Description

The Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are visually identified by a distal radiopaque tip bonded onto a stainless steel braided catheter shaft. Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are manufactured in lengths of 40. 60. 65. 75. 80. 90. 100. 125. 135 and 150 centimeters and have no distal sideports. Each catheter is manufactured with either a plastic winged hub. mounted on the proximal end of the catheter, indicating the catheter French size and relative endhole diameter, or a translucent hub with a strain relief. The catheters are manufactured with a 4.0, 4.1, 4.5, 5.0, 5.5 or 6.5 French catheter shaft that is designed with an inner lumen tapered to a 0.035 or a 0.038 inch endhole diameter. These catheters. are manufactured in a variety of distal tip configurations.

AI/ML Overview

The provided document is a 510(k) summary for a medical device modification, specifically for the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter. This type of submission focuses on demonstrating substantial equivalence to a predicate device rather than providing extensive clinical study data.

Therefore, many of the requested items related to clinical studies (e.g., sample size, data provenance, number of experts, adjudication methods, MRMC studies, standalone AI performance, training set details) are not applicable as this document describes physical performance testing, not a clinical study.

Here's the information that can be extracted:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Predetermined Acceptance Criteria	Reported Device Performance
Tensile Strength	In conformance with the applicable sections of ISO 10555-1	The predetermined acceptance criteria were met. Testing shows the tensile strength during proper clinical use should not fracture or rupture the catheter.
Leakage	In conformance with the applicable sections of ISO 10555-1	The predetermined acceptance criteria were met. Testing shows there would be no leakage from the catheter during proper clinical use.
Biocompatibility	In conformance with the applicable sections of ISO 10993-1	The predetermined acceptance criteria were met. Testing shows the device is biocompatible.

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable for this submission type. The document describes physical and biocompatibility testing, not clinical data from a "test set" of patients. The tests mentioned are laboratory-based engineering and biological evaluations.

3. 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. Ground truth in the context of clinical expert consensus is not relevant for the physical and biocompatibility tests performed. Standards (ISO 10555-1, ISO 10993-1) define the "ground truth" for acceptance.

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

Not applicable. Adjudication is relevant for interpreting clinical data, not for the straightforward physical and biocompatibility tests described.

5. 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 device is a catheter, not an AI-powered diagnostic tool. No MRMC study was conducted.

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

Not applicable. This device is a catheter, not an algorithm.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For Tensile Strength and Leakage: The ground truth is defined by the technical specifications and performance limits set forth in ISO 10555-1 (Intravascular catheters - Sterile single-use catheters - Part 1: General requirements).
For Biocompatibility: The ground truth is defined by the toxicological and biological safety requirements outlined in ISO 10993-1 (Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process).

8. The sample size for the training set

Not applicable. This document describes physical testing of a medical device, not a machine learning model, so there is no training set.

9. How the ground truth for the training set was established

Not applicable. As above, no training set or machine learning model is involved.

Summary

{0}------------------------------------------------

K122937 - page 1 of 2

Special 510(k): Device Modification Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Cook Incorporated 21 September 2012

510(k) SUMMARY

Submitted By:

Amber Brown Cook Incorporated 750 Daniels Way Bloomington, IN 47404

Device:

Trade Name:

Proposed Classification:

Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Catheter, Diagnostic Intravascular DOO (21 CFR $870.1200)

Indications for Use:

The Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Predicate and Reference Devices:

Cook Incorporated's Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters are similar in terms of intended use and similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate and reference devices. The devices, subject of this submission, are substantially equivalent to the Slip-Coat™ Catheters manufactured by Cook Incorporated, which are cleared under. 510(k) number K882796 and the reference device. Cantata Microcatheter, which is cleared under 510(k) number K101450.

Comparison to Predicate and Reference Devices:

It has been demonstrated that the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cathe Catheter are comparable to the predicate and reference devices in terms of design, intended use, materials, fundamental technology, and principles of operation.

Device Description:

:29

DEC 1 4 2012

{1}------------------------------------------------

Special 510(k): Device Modification Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Cook Incorporated 21 September 2012

manufactured with a 4.0, 4.1, 4.5, 5.0, 5.5 or 6.5 French catheter shaft that is designed with an inner lumen tapered to a 0.035 or a 0.038 inch endhole diameter. These catheters. are manufactured in a variety of distal tip configurations.

Test Data:

The following tests were performed to demonstrate that the Slip-Cath® Beacon® Tip Catheters and Shuttle Select Slip-Cath® Catheters meet applicable design and performance requirements and support a determination of substantial equivalence. Additionally, appropriate engineering tests were performed on aged product to ensure that the Slip-Cath® Beacon® Tip Catheters and Shuttle® Select Slip-Cath® Catheters meet the performance reguirements throughout the duration of shelf life.

. Tensile Strength - Testing shows the tensile strength during proper clinical use should not fracture or rupture the catheter. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
Leakage Testing shows there would be no leakage from the catheter during . proper clinical use. In conformance with the applicable sections of ISO 10555-1, the predetermined acceptance criteria were met.
Biocompatibility Testing shows the device is biocompatible. In conformance . with the applicable sections of ISO 10993-1, the predetermined acceptance criteria were met.

In conclusion, the results of these tests provide reasonable assurance that the device is as safe and effective as the predicate and reference devices and supports a determination of substantial equivalence.

{2}------------------------------------------------

Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of two main elements: the department's name arranged in a circular fashion around the left side and a stylized symbol on the right. The symbol is a stylized representation of an eagle or bird-like figure, with three curved lines forming its body and wings.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

Cook, Inc. Ms. Amber Brown Regulatory Affairs Specialist 750 Daniels Way Bloomington. IN 47404

DEC 1 4 2012

Re: K122937

Trade Name: Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DQO Dated: November 14, 2012 Received: November 15, 2012

Dear Ms. Brown:

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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to 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.

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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

{3}------------------------------------------------

Page 2 – Ms. Amber Brown

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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

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

Enclosure

{4}------------------------------------------------

ial 510(k): Device Modification athe Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter k Incorporated

21 September 2012

Indications for Use

122937 510(k) Number (if known):

Device Name:

Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-Cath® Catheter

Indications for Use for the Slip-Cath® Beacon® Tip Catheter and Shuttle® Select Slip-. Cath® Catheter:

The catheters are intended for use in angiographic procedures by physicians trained and experienced in angiographic techniques.

Prescription Use XX (Part 21 CFR 801 Subpart D) OR Over-the-Counter Use (21 CFR 801 Subpart C)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-On)
Division of Cardiovascular Devices
510(k) Number	K122937

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).