The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/ interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

Device Description

The ELITECROSS™ Support Catheter is a single-use, 5F sheath-compatible sterile catheter designed to provide additional support to the distal portion of ancillary diagnostic/interventional devices, including the FRONTRUNNER® XP CTO Catheter, as well as to deliver saline or contrast medium. After crossing the occlusion with the ancillary device, the ELITECROSS™ may be used to facilitate placing a guide wire across the occlusion.

The ELITECROSS™ Support Catheter device is a single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded by a stainless steel braid, which is further encompassed by a polymer jacket, and features a final external hydrophilic coating on the distal 40 cm of the catheter body. The proximal end utilizes a molded hub with a luer fitting for flushing, with winged tabs designed to facilitate maneuvering and torqueing in the vasculature, while the distal tip contains a radiopaque marker band for visibility under fluoroscopy. The ELITECROSS™ Support Catheter will be available in various configurations and several lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

AI/ML Overview

This document is a 510(k) Pre-market Notification for the ELITECROSS Support Catheter. It seeks to demonstrate substantial equivalence to a predicate device, the Cordis Micro Guide Catheter ELITE. Therefore, the information provided focuses on the substantial equivalence and performance testing compared to the predicate, rather than a standalone study proving the device meets de novo acceptance criteria for an AI/ML device.

Because this is a submission for a medical device (catheter) and not an AI/ML device, the typical acceptance criteria and study design elements you've requested for AI/ML performance (e.g., sample size for test sets, data provenance, number of experts for ground truth, MRMC studies, standalone performance) are not applicable in the context of this document.

Instead, the "acceptance criteria" for a medical device like this are generally related to its functional performance, physical dimensions, material properties, and biological safety, demonstrating that it performs as intended and is as safe and effective as a legally marketed predicate device.

Here's how to interpret the provided information in relation to your request, keeping in mind the device type:

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

Based on the document, the "acceptance criteria" are implied by the performance characteristics tested, demonstrating equivalence to the predicate and ensuring the device functions as intended. The reported performance is that the device "meets applicable performance requirements" and "continues to meet all previous performance specifications" of the predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Material & Design Equivalence: Identical design, materials, dimensions, configurations, operating principle, control mechanism, and site of manufacture to the predicate.	The subject device is identical to the predicate in these aspects.
Intended Use Equivalence: Same intended use as the predicate.	The subject device has the same intended use as the predicate.
Labeling Changes Justification: Labeling modifications (trade name, sheath compatibility, Indications for Use edits) do not alter fundamental technology, operating principles, mechanism of action, or intended use, and do not raise new questions of safety and effectiveness.	Supported by: Verification and validation activities, risk analyses, similarities to cleared reference device. Additional testing supported 5F CSI compatibility and delivery of saline/contrast. Labeling modifications do not raise new questions of safety and effectiveness.
Functional Performance (Specific Tests): Catheter Sheath Introducer (CSI) Compatibility	Meets requirements; additional testing supported 5F CSI compatibility.
Functional Performance (Specific Tests): Static Burst Testing	Meets applicable performance requirements.
Functional Performance (Specific Tests): Flow Rate Performance Testing	Meets applicable performance requirements.
Overall Performance (Equivalence to Predicate): Continues to meet previous performance specifications of the predicate; critical clinical performance parameters unchanged.	The ELITECROSS™ continues to meet all previous performance specifications for Micro Guide Catheter ELITE, and none of the critical clinical performance parameters have changed.

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

Sample Size: Not specified in the provided document. For physical device testing, sample sizes are typically determined by statistical methods or industry standards but are not usually detailed in this summary section of a 510(k).
Data Provenance: Not specified nor is it typically relevant for this type of physical device performance testing. The tests are benchtop, laboratory evaluations.

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 where expert consensus on interpretations or diagnoses would be required for ground truth. Ground truth for a catheter involves objective physical and functional measurements (e.g., burst pressure, flow rate, dimensions).

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

Not Applicable. As above, this is for AI/ML interpretative tasks, not for physical device performance validation.

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 a physical medical device (catheter), not an AI/ML diagnostic or assistive tool. MRMC studies are not relevant here.

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

Not Applicable. This is a physical medical device. There is no algorithm or "standalone" performance in the AI/ML sense.

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

Objective Technical Measurements: The "ground truth" for this type of device testing consists of objective, quantifiable measurements of physical properties and performance characteristics (e.g., dimensions, burst pressure, flow rates, compatibility with other devices). These are typically verified against engineering specifications and industry standards.

8. The sample size for the training set

Not Applicable. This is a physical medical device, not an AI/ML device that requires a training set.

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

Not Applicable. No training set is involved.

Summary

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Public Health Service

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

May 19, 2015

Cordis Corporation, a Johnson & Johnson Company Michelle Ragozzino Rodgers, Ph.D. Senior Regulatory Affairs Specialist 6500 Paseo Padre Parkway Fremont, California 94555

Re: K150187

Trade/Device Name: ELITECROSS Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU Dated: April 13, 2015 Received: April 14, 2015

Dear Dr. Rodgers:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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the quality systems (OS) 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,

Kenneth J. Cavanaugh -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) K150187

Device Name ELITECROSS™ Support 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)

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510(K) SUMMARY

I. SUBMITTER

Cordis Corporation 6500 Paseo Padre Parkway Fremont, CA 94555

Contact Person: Michelle Ragozzino Rodgers, Ph.D. Tel: (510) 248-2450 Fax: (510) 248-2533

Date Prepared: January 23, 2015

II. DEVICE

Name of Device: ELITECROSS™ Support Catheter Common Name: Percutaneous catheter Classification Name: Catheter for Crossing Total Occlusions (21 CFR §870.1250) Regulatory Class: Class II Product Code: PDU

III. PREDICATE DEVICE

Primary Predicate: Cordis Micro Guide Catheter ELITE, previously cleared on 11/14/2014 under K140438. Regulation Number: 21 CFR §870.1250. Product Code: PDU This predicate has not been the subject of a recall.

Reference Device: Cook CXI Support Catheter (K122796) Regulation Number: 21 CFR §870.1210 Product Code: KRA

DEVICE DESCRIPTION IV.

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lengths. The ELITECROSS™ Support Catheter is provided sterile (by EO) and intended for single use only.

V. INDICATIONS FOR USE

The Cordis ELITECROSS™ Support Catheter is intended to facilitate the intraluminal placement of diagnostic/interventional devices beyond stenotic lesions (including chronic total occlusions) in the peripheral vasculature prior to further percutaneous intervention, and to deliver saline or contrast medium. Additionally, ELITECROSS™ can be used as an accessory with the FRONTRUNNER® XP CTO Catheter.

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The subject ELITECROSS™ Support Catheter device is identical to the predicate Micro Guide Catheter ELITE with respect to intended use, design, materials, dimensions, configurations, operating principle, control mechanism, and site of manufacture of the device. The subject and predicate devices are based on the following same technological elements:

Catheter-Facilitates placement of and provides support to ancillary diagnostic/interventional devices, including Frontrunner® XP CTO Catheter
Single lumen torqueable tube containing a full-length PTFE inner liner that is surrounded 0 by a stainless steel braid, which is further encompassed by a polymer jacket
Use of hydrophilic coating for distal lubricity to advance through lesion
Use of marker bands and radiopaque materials for fluoroscopic visualization of ● catheter tip
Use of a standard male luer fitting for flush port
o EO sterilized, single use device

Relative to the predicate, changes are limited to the labeling of ELITECROSS™ Support Catheter, including the trade name, labeled sheath compatibility (with no dimensional changes to the device), and edits to the Indications for Use statement (with no change to the Intended Use of the device). Additional testing supported the labeling of ELITECROSS for 5F Catheter Sheath Introducer (CSI) compatibility, with no dimensional changes to the subject device relative to the predicate. The labeling of ELITECROSS for the delivery of saline or contrast was supported by verification and validation activities, risk analyses, and similarities to the cleared reference device. The labeling modifications do not raise new questions of safety and effectiveness.

VII. PERFORMANCE DATA

Device Dimensional and Functional Testing

Catheter Sheath Introducer (CSI) Compatibility ●
Static Burst Testing ●
o Flow Rate Performance Testing

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VIII. CONCLUSIONS

The subject ELITECROSS Support™ Catheter has the same design and intended use as the predicate, Micro Guide Catheter ELITE. The labeling modifications to the ELITECROSS™ product family do not alter the fundamental scientific technology, operating principles, mechanism of action, or intended use of device. Design verification and validation testing demonstrate that the ELITECROSS™ Support Catheter meets applicable performance requirements. The labeling modifications do not raise new questions of safety and effectiveness. The ELITECROSS™ continues to meet all previous performance specifications for Micro Guide Catheter ELITE, and none of the critical clinical performance parameters have changed. ELITECROSS Support™ Catheter can be used according to its intended use and in an equivalent manner to the predicate device.

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
Identification. A percutaneous catheter is a device that is introduced into a vein or artery through the skin using a dilator and a sheath (introducer) or guide wire.(b)
Classification. Class II (performance standards).