The catheters are intended for use in the peripheral and coronary vascular system including the carotid arteries in angiographic procedures by physicians trained and experienced in angiographic techniques. Standard techniques for placement of vascular access sheaths, angiographic catheters and wire guides should be employed.

Device Description

The Beacon® Tip Torcon NB® Advantage Catheters are visually identified by a distal radiopaque tip bonded onto a nylon catheter shaft with braided stainless steel. Beacon® Tip Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, and 6.0 French with lengths measuring 40 to 170 centimeters. The catheter inner lumen is manufactured to accept a 0.035 or 0.038 inch diameter wire guide. These devices are manufactured without sideports and in a variety of distal tip configurations.

The Torcon NB® Advantage Catheters are selective angiographic catheters manufactured with a thinwall radiopaque nylon material and constructed with stainless steel braiding. The Torcon NB® Advantage Catheters are available in 4.0, 4.1, 5.0, 6.0, 7.0 and 8.0 French with lengths measuring 35 to 150 centimeters. The catheter inner lumen is manufactured to accept a 0.025, 0.035, or 0.038 inch diameter wire guide. These devices are manufactured with zero to twelve sideports, depending on the distal curve radius, and are available in a variety of distal tip configurations. These tips may be tapered at the distal endhole, depending upon device specifications. The catheters are also available in a variety of distal tip configurations.

Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are for use in angiographic procedures as a conduit for the delivery of contrast media and can help physicians diagnose occlusion or stenosis. The catheters are designed for percutaneous introduction into the vascular system over an appropriately sized wire guide.

AI/ML Overview

Because medical device approval documents do not typically include detailed clinical study reports found in drug approvals, many of the requested data points (e.g., test set sample size and provenance, number and qualifications of experts, adjudication methods, MRMC study details, training set specifics) are not available in the provided text. The document focuses on demonstrating substantial equivalence through engineering and bench testing, rather than human-in-the-loop performance or clinical outcomes.

Here's the partial information based on the provided text:

Acceptance Criteria and Reported Device Performance for Beacon® Tip Torcon NB® Advantage Catheter and Torcon NB® Advantage Catheter

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criterion	Reported Device Performance
Dynamic Flow Rate and Burst Pressure Evaluation	No specific acceptance criteria (for characterization purposes)	N/A (characterization study)
Static Burst Pressure Testing	Withstood a minimum of 1200 psig static pressure for at least 2 seconds without failure (in accordance with ISO 10555-2:1996(E)).	"The predetermined acceptance criterion was met." (i.e., devices withstood 1200 psig for at least 2 seconds without failure)
Evaluation of Dynamic Pressure During Injection after Three Years Accelerated Aging	Achieved a flow rate of at least 12 mL/sec when pressurized to 1215 psig ± 15 psig without failure.	"The predetermined acceptance criterion was met." (i.e., devices achieved ≥ 12 mL/sec flow rate at 1215 psig ± 15 psig without failure)
Biocompatibility Testing (Per ISO 10993-1:2009)	Biocompatibility deemed acceptable based on a panel of tests.	"The biocompatibility was deemed acceptable" for Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Implantation, Partial Thromboplastin Time, C3a Complement Activation, SC5b-9 Complement Activation, Mutagenicity, Pyrogenicity.
Tensile Testing	Peak load values greater than 10N (in accordance with ISO 10555-1:2009).	"The predetermined acceptance criterion was met." (i.e., peak load values > 10N)
Liquid Leakage Testing	Maintained a pressure of 300 kPa for 30 seconds without leaking between the catheter shaft and hub (in accordance with ISO 10555-1:2013).	"The predetermined acceptance criterion was met." (i.e., no leaking observed at 300 kPa for 30 seconds)
Air Leakage Testing	No leakage of air between the catheter shaft and hub when subjected to a negative pressure for 15 seconds (in accordance with ISO 10555-1:2013).	"The predetermined acceptance criterion was met." (i.e., no air leakage observed under negative pressure for 15 seconds)
Particulate Testing	No specific acceptance criteria (for characterization purposes)	N/A (characterization study)

2. Sample size used for the test set and the data provenance:

Sample Size: Not specified in the document. The tests described are bench tests, so the "sample size" refers to the number of physical devices tested in each category.
Data Provenance: Not explicitly stated, but assumed to be internal laboratory testing by Cook Incorporated.

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

Not applicable. The "ground truth" for these tests is based on objective physical measurements and adherence to international standards (e.g., ISO, FDA regulations) as performed by laboratory technicians/engineers. No expert radiologists/physicians were involved in establishing "ground truth" for the performance of these physical tests.

4. Adjudication method for the test set:

Not applicable. Performance against acceptance criteria for these bench tests is determined by direct measurement and comparison, not by expert adjudication.

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:

No MRMC or human-in-the-loop study was done. This device is a physical medical catheter, not an AI or imaging diagnostic tool.

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

Not applicable. This is a physical medical device, not a software algorithm. The "standalone performance" is the device's performance in bench tests as outlined above.

7. The type of ground truth used:

The "ground truth" for these technical performance tests is based on objective physical measurements and adherence to international standards (e.g., ISO 10555-1, ISO 10555-2, ISO 10993-1).

8. The sample size for the training set:

Not applicable. This is a physical medical device, not a machine learning model. There is no "training set."

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

Not applicable. There is no "training set" for this type of device.

Summary

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 9, 2015

Cook, Inc. David Chadwick, PhD, RAC Director, Regulatory Affairs/Regulatory Science 750 Daniels Way Bloomington, Indiana 47404

Re: K133130

Trade/Device Name: Beacon Tip Torcon NB Advantage Catheter, Torcon NB Advantage Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: DOO Dated: December 8, 2014 Received: December 9, 2014

Dear David Chadwick, Phd., Rac,

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

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related adverse events) (21 CFR 803); 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education 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. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education 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,

Melissa A. Torres -S

For 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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Indications for Use

510(k) Number (if known) K133130

Device Name

Beacon® Tip Torcon NB® Advantage Catheter and Torcon NB® Advantage Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
-------------------------------------------------

	☑ Prescription Use (Part 21 CFR 801 Subpart D)
	☐ Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

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COOK INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

510(k) SUMMARY

Submitted By:

Applicant:	Cook Incorporated
Address:	750 Daniels WayBloomington, IN 47404
Contact:	David E. Chadwick, Ph.D., RAC, FRAPS
Email:	david.chadwick@cookmedical.com
Contact Phone Number:	(812) 335-3575 x102330
Contact Fax Number:	(812) 332-0281
Device Information:

Trade Name:

Common Name: Classification Name:

Class: Device Panel: Date Prepared:

Indications for Use:

Beacon® Tip Torcon NB® Advantage Catheter and Torcon NB® Advantage Catheter Diagnostic Intravascular Catheter Catheter, Diagnostic Intravascular DQO (21 CFR §870.1200) Class II Cardiovascular January 5. 2015

Predicate Devices:

Cook Incorporated's Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters have an identical intended use and are similar in terms of principles of operation, materials of construction, and technological characteristics to the predicate devices. The devices, subject of this submission, are substantially equivalent to the Slip-Cath® Beacon Tip Catheters and the Shuttle® Select Slip-Cath® Catheters, and the Slip-Coat™ Catheters manufactured by Cook Incorporated, which are cleared under 510(k) numbers K122937 and K882796. respectively. They are also substantially equivalent to the Imager II 5F Selective Angiography Catheter manufactured by Boston Scientific Corporation, which is cleared under 510(k) number K121694.

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Comparison to Predicate Devices:

It has been demonstrated that the Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters are comparable to the predicate devices in terms of design, intended use, materials, fundamental technology, and principles of operation.

Device Description:

Test Data:

The following tests were performed to demonstrate that the Beacon® Tip Torcon NB® Advantage Catheters and Torcon NB® Advantage Catheters met applicable design and performance requirements and support a determination of substantial equivalence.

Dynamic Flow Rate and Burst Pressure Evaluation - This study is for characterization purposes; therefore no acceptance criteria apply.
Static Burst Pressure Testing - Testing verified that, in accordance with ISO 10555-2:1996(E), the test articles withstood a minimum of 1200 psig static pressure for at least 2 seconds without failure. The predetermined acceptance criterion was met.
Evaluation of Dynamic Pressure During Injection after Three Years Accelerated . Aging – Testing verified that the test articles achieved a flow rate of at least

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Image /page/5/Picture/0 description: The image is a logo for Cook Medical. The logo is a red rectangle with the word "COOK" in white, sans-serif font on the top half of the rectangle. There is a registered trademark symbol after the word "COOK". The bottom half of the rectangle has a smaller red rectangle that is angled to the left. The word "MEDICAL" is in white, sans-serif font on the smaller rectangle.

12 mL/sec when pressurized to 1215 psig ± 15 psig without failure. The predetermined acceptance criterion was met.

Biocompatibility Testing Per ISO 10993-1:2009, the proposed devices were ● classified as external communicating devices in contact with circulating blood for a limited (≤ 24 hours) duration. The following tests were completed and the biocompatibility was deemed acceptable: Cytotoxicity, Sensitization, Irritation/Intracutaneous Reactivity, Systemic Toxicity, Hemolysis, Implantation, Partial Thromboplastin Time, C3a Completement Activation, SC5b-9 Complement Activation, Mutagenicity, Pyrogenicity.
. Tensile testing - Testing verified that, under proper clinical use, the peak load values would be greater than 10N, in accordance with ISO 10555-1:2009. The predetermined acceptance criterion was met.
Liquid Leakage Testing Testing verified that, in accordance with ISO 10555-● 1:2013, the catheter maintained a pressure of 300 kPa for 30 seconds without leaking between the catheter shaft and hub. The predetermined acceptance criterion was met.
Air Leakage Testing Testing verified that, in accordance with ISO 10555-● 1:2013, there was no leakage of air between the catheter shaft and hub when subjected to a negative pressure for 15 seconds. The predetermined acceptance criterion was met.
Particulate Testing This study is for characterization purposes; therefore no ● acceptance criteria apply.

In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.

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).