Cordis Angiographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

Device Description

The SUPER TORQUE® MB Angiographic Catheter is a thin plastic tube which is inserted into an artery through a small incision in the skin. The catheter is guided to the area being examined, and contrast material is injected through the tube and images are captured using a small dose of ionizing radiation (x-rays). Each SUPER TORQUE® MB Angiographic Catheter consists of a braided Polyurethane body and a non-braided Polyurethane tip section having multiple, radiopaque marker bands.

AI/ML Overview

This document is a 510(k) Premarket Notification for a medical device called the SUPER TORQUE® MB Angiographic Catheter. It is not an AI/ML device, and therefore the concepts of acceptance criteria and a study to prove the device meets those criteria (in the context of AI/ML performance metrics) do not apply in the traditional sense.

The document describes a submission seeking substantial equivalence to a legally marketed predicate device (K992347). For such devices, the "acceptance criteria" are generally that the new device is as safe and effective as the predicate device. This is typically demonstrated through a comparison of technological characteristics, and often, non-clinical (bench) testing. Clinical studies are not always required if substantial equivalence can be shown otherwise.

Here's why the requested information cannot be provided in the context of AI/ML device evaluation:

No AI/ML Component: The SUPER TORQUE® MB Angiographic Catheter is a physical medical device (a thin plastic tube for angiography), not a software algorithm or an AI/ML system.
No "Performance Metrics" in the AI Sense: The performance of this device is assessed by its physical characteristics, material properties, and functionality (e.g., ability to deliver contrast, radiopacity of marker bands), not by metrics like sensitivity, specificity, AUC, or reader performance improvement often used for AI.
No "Training/Test Sets" for AI: The concept of training sets and test sets with ground truth established by experts is irrelevant for a physical catheter.

However, I can extract and present the available information in a slightly adapted format, focusing on how substantial equivalence was demonstrated, which is the closest analog to "meeting acceptance criteria" for this type of device.

1. A table of acceptance criteria and the reported device performance

For this physical angiographic catheter, "acceptance criteria" relate to demonstrating substantial equivalence to a predicate device. The performance is assessed through bench testing and comparison of fundamental technological characteristics.

Acceptance Criterion (for Substantial Equivalence)	Reported Device Performance/Comparison
Intended Use: Same as predicate device.	The proposed SUPER TORQUE® MB Angiographic Catheter and the predicate device have the same intended use: to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system. (A new contraindication was added, but the intended use remains the same).
Technological Characteristics: Same fundamental technology.	The device is described as "the same device as that of the currently cleared device" with a new contraindication. Both the proposed and predicate devices are inserted into an artery, contain a luer connector, braided catheter body, and an atraumatic tip. The materials of construction are listed and appear consistent with the predicate's technology.
Performance: Device meets established performance characteristics.	"The testing previously conducted, and the additional testing provided in this 510(k) confirm that the SUPER TORQUE® MB Angiographic Catheter meets established performance characteristics." (This refers to bench testing, as detailed below.)
Safety: Device is as safe as the predicate.	Implied through substantial equivalence to a device cleared for safety and effectiveness. Minor manufacturing updates and additional biocompatibility testing were performed (see below).
Effectiveness: Device is as effective as the predicate.	Implied through substantial equivalence.

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

Not applicable in the context of AI/ML. For a physical device, testing is typically done on manufactured samples. The document states "No new testing was required to be conducted due to addition of contraindication in the IFU." It also mentions "minor manufacturing updates were made, additional biocompatibility testing was performed, and additional sterilization facilities were qualified." This implies some level of physical testing (bench testing) on device samples, but specific sample sizes for these tests are not detailed in this submission. Data provenance would be from laboratory test reports.

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

Not applicable. This is not an AI/ML device requiring expert adjudication for ground truth.

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

Not applicable. This is not an AI/ML device requiring 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

Not applicable. This is not an AI/ML device. No MRMC study was performed. The document explicitly states: "No clinical data was required in support of the proposed change to the predicate device cleared under K992347."

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

Not applicable. This is not an AI/ML device, so there is no algorithm to evaluate in standalone mode.

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

Not applicable. For a physical device, "ground truth" would be engineering specifications and validated test methods for material properties, dimensions, and mechanical performance.

8. The sample size for the training set

Not applicable. This is not an AI/ML device.

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

Not applicable. This is not an AI/ML device.

Summary

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

February 17, 2022

Image /page/0/Picture/1 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

Cordis Corporation Vidya Venkataraghavan Principal Specialist, Regulatory Affairs 14201 N.W. 60th Avenue Miami Lakes, Florida 33014

Re: K212977

Trade/Device Name: SUPER TORQUE MB Angiographic Catheter with Radiopaque markerbands Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 20, 2021 Received: December 21, 2021

Dear Vidya Venkataraghavan:

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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

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

801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

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

Indications for Use

510(k) Number (if known) K212977

Device Name SUPER TORQUE® MB Angiographic Catheter

Indications for Use (Describe)

Cordis Anglographic Catheters with Marker Bands are designed to provide angiographic visualization and linear measurement of the vasculature when combined with the delivery of radiopaque contrast media to selected sites in the vascular system.

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)
-----------------------------------------------------------------------------------------	----------------------------------------------------------------------------------------

||X| Prescription Use (Part 21 CFR 801 Subpart D)

_ | Over-The-Counter Use (21 CFR 801 Subpart C)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

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

510(k) Summary

I. SUBMITTER

Applicant: Cordis US Corp. 14201 North West 60th Avenue Miami Lakes, Florida 33014 USA Establishment Reqistration: 1016427

Contact: Vidya Venkataraghavan Cordis US Corp. Tel: (408) 718-1348 vidya.venkataraghavan@cordis.com

Date Prepared: December 20, 2021

II. DEVICE

Name of Device: SUPER TORQUE® MB Angiographic Catheter Common Name: Angiographic Catheter Classification Name: Diagnostic Intravascular Catheter (21 CFR 870.1200), Class II Product Code: DQO

III. PREDICATE DEVICE

SUPER TORQUE®MB Angiographic Catheter with Radiopaque Marker Bands cleared on October 8, 1999 under K992347.

IV. DEVICE DESCRIPTION

Each SUPER TORQUE® MB Angiographic Catheter consists of a braided Polyurethane body and a non-braided Polyurethane tip section having multiple, radiopaque marker bands.

It is available in the following configurations:

Catalog Numbers
532598A
532598B
532598C
SRD7040MB

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

The materials of construction of the SUPER TORQUE® MB Angiographic Catheter are as follows:

Component	Materials	PatientContact
Catheter Body	Pellethane, Barium Sulphate, Stainlesssteel wire	Direct
Catheter Tip	Pellethane, Barium Sulphate	Direct
Marker Bands	Gold-alloy marker	Direct
Strain Relief	Combination of various polyurethanegrades	Indirect
Hub	Isoplast	Indirect
Coating	51-3 solution	Direct

IV. INDICATIONS FOR USE

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The proposed SUPER TORQUE® MB Angiographic Catheter and the predicate device cleared under K992347 are inserted into the artery through a small incision in the skin. Both contain a luer connector, braided catheter body and an atraumatic tip.

The proposed SUPER TORQUE® MB Angiographic Catheter is the same device as that of the currently cleared device with an addition of below labeling contraindication.

'Do not use the SUPER TORQUE MB catheter in procedures where entrapment of the catheter between endovascular devices and the vessel wall may occur, for example endovascular aortic repair (EVAR) procedures. "

VII. PERFORMANCE DATA

Bench Testing

No new testing was required to be conducted due to addition of contraindication in the IFU. However, since the clearance of the original 510(k), minor manufacturing updates were made, additional biocompatibility testing was performed, and additional sterilization facilities were qualified.

{5}------------------------------------------------

The testing previously conducted, and the additional testing provided in this 510(k) confirm that the SUPER TORQUE® MB Angiographic Catheter meets established performance characteristics.

Clinical Studies

No clinical data was required in support of the proposed change to the predicate device cleared under K992347.

VIII. CONCLUSIONS

The information presented in this Premarket Notification demonstrates the following for the SUPER TORQUE® MB Angiographic Catheter:

SUPER TORQUE® MB Angiographic Catheter has a legally-marketed predicate
SUPER TORQUE® MB Angiographic Catheter has the same Intended Use as the ● predicate
. SUPER TORQUE® MB Angiographic Catheter incorporates the same fundamental technology as the predicate
Accepted scientific methods and international standards were used to evaluate substantial equivalence of the SUPER TORQUE®MB Angiographic Catheter relative to the predicate
. Performance characteristics of the SUPER TORQUE® MB Angiographic Catheter are equivalent to the predicate device.

Based on the intended use, technological characteristics, and safety and performance testing, the SUPER TORQUE® MB Angiographic Catheter has been shown to be appropriate for its intended use and is considered substantially equivalent to the predicate SUPER TORQUE® MB Angiographic Catheter with Radiopaque Marker Bands (K992347).

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).