The CenterCross Ultra Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices.

Device Description

The CenterCross Ultra Catheter is a sterile, single-use, single lumen over-the-wire support catheter to be used in conjunction with steerable guidewires to access discrete regions of the coronary and peripheral vasculature to facilitate exchange of guidewires and other interventional devices.

The CenterCross Ultra Catheter consists of an outer shaft and a removable handle/inner shaft assembly that allows for manual device manipulation. A kev element of the device is an expandable and retractable nitinol structure, which, when deployed by the physician, expands to the artery wall to aid interventionalists in establishing greater support near the treatment site.

Subsequent to conventional guidewire placement, atherectomy devices, PTCA catheters, and/or stents may be used to provide therapeutic benefit. The CenterCross Ultra Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire and device support. The CenterCross Ultra Catheter is similar in its design and achieves its intended use by means of the same mechanisms as the predicate device.

AI/ML Overview

The provided text describes a 510(k) premarket notification for the CenterCross Ultra Catheter. The submission aims to demonstrate substantial equivalence to a predicate device, the CenterCross Catheter (K140910). The information provided is primarily focused on non-clinical bench testing to show that the new device performs to specifications and is comparable to the predicate.

Here's an analysis based on the categories requested:

1. Table of Acceptance Criteria and Reported Device Performance

The document does not provide specific quantitative acceptance criteria or detailed numerical performance results for the CenterCross Ultra Catheter. Instead, it states that "All testing was performed in accordance with recognized standards" and "The collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device."

Summary of Tested Aspects:

Test Aspect	Reported Device Performance
Dimensional Inspection	Meets established specifications for consistent performance.
Hydrophilic Coating	Meets established specifications for consistent performance.
Simulated Use	Meets established specifications for consistent performance.
Contrast Flush Injection	Meets established specifications for consistent performance.
Leak	Meets established specifications for consistent performance.
Torque Strength	Meets established specifications for consistent performance.
Tip Flexibility & Kink Resistance	Meets established specifications for consistent performance.
Pressurized Flow Rate	Meets established specifications for consistent performance.
Tensile Strength	Meets established specifications for consistent performance.
Particulate	Meets established specifications for consistent performance.
Shelf-life	Meets established specifications for consistent performance.

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

The document only mentions "Extensive bench testing" but does not specify the sample sizes (n) for each of the non-clinical tests conducted.
The data provenance is non-clinical bench testing, meaning it was performed in a laboratory setting. There is no information regarding country of origin or whether the data is retrospective or prospective, as these terms are typically relevant for clinical studies.

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

This section is not applicable as the document describes non-clinical bench testing, not a study involving human subjects or expert assessment for ground truth determination. The "ground truth" for these tests would be the established engineering specifications and recognized standards themselves.

4. Adjudication Method for the Test Set

This section is not applicable as the document describes non-clinical bench testing. Adjudication methods are typically used in clinical studies for resolving discrepancies in expert opinions or outcomes.

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

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted. The submission focuses on non-clinical bench testing to demonstrate substantial equivalence, not a clinical study involving human readers and AI assistance.

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

This section is not applicable. The device is a medical catheter, not an algorithm or AI. The testing described is bench testing of the physical device.

7. The Type of Ground Truth Used

For the non-clinical bench tests, the "ground truth" is implicitly the established engineering specifications and recognized industry standards that the device was tested against. The document states, "All testing was performed in accordance with recognized standards."

8. The Sample Size for the Training Set

This section is not applicable. The device is a physical medical catheter, not an AI model that requires a training set.

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

This section is not applicable for the same reason as above; it is a physical device, not an AI model.

Summary

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

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

January 26, 2016

Roxwood Medical, Inc. Grace Li Director, QA 400 Seaport Ct. Suite #103 Redwood City, California 94063

Re: K152456

Trade/Device Name: CenterCross Ultra Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: December 23, 2015 Received: December 28, 2015

Dear Grace Li:

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

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

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,

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

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

Indications for Use

510(k) Number (if known)

K152456

Device Name CenterCross Ultra 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.

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 SECTION 5.

510(k) Notification K152456

GENERAL INFORMATION

Applicant:

Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063 Phone: (650) 779-4555 Fax: (650) 779-4554

Contact Person:

Grace Li Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063 Phone: (650) 779-4559 Fax: (650) 779-4554

Date Prepared: August 26, 2015

DEVICE INFORMATION

The CenterCross Ultra Catheter is a percutaneous catheter for use in the coronary and peripheral vasculature.

Trade Name:

CenterCross Ultra Catheter

Generic/Common Name:

Percutaneous Catheter

Classification:

21 CFR§870.1250, Class II

Product Code: DQY

PREDICATE DEVICE(S) CenterCross Catheter (Roxwood Medical, Inc., K140910)

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

INDICATIONS FOR USE

PRODUCT DESCRIPTION

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the CenterCross Ultra Catheter are similar to the predicate device. The technological characteristic distinctive to the CenterCross Ultra is that the handle/inner shaft assembly is removable, allowing introduction of larger interventional devices. Performance data is provided to support the determination of substantial equivalence.

SUBSTANTIAL EQUIVALENCE

The CenterCross Ultra Catheter is substantially equivalent to the CenterCross Catheter (Roxwood Medical. Inc., K140910). The subject device and the predicate devices are percutaneous catheters. The proposed indications for use for the CenterCross Ultra Catheter are substantially equivalent to the indications for use for the predicate device. Any differences in the technological characteristics between the devices do not raise any

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

new issues of safety or effectiveness. Thus, the CenterCross Ultra Catheter is substantially equivalent to the predicate device.

TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Extensive bench testing was conducted on the CenterCross Ultra Catheter to evaluate the performance of the device and to support a determination of substantial equivalence to the predicate device. Non-clinical testing assessed the following aspects of the device:

Nonclinical Testing Summary:

. Dimensional Inspection
Hydrophilic Coating .
Simulated Use ●
Contrast Flush Injection ●
Leak ●
Torque Strength ●
Tip Flexibility & Kink Resistance .
Pressurized Flow Rate ●
Tensile Strength ●
Particulate ●
. Shelf-life

All testing was performed in accordance with recognized standards. The collective results of the non-clinical testing demonstrate that the CenterCross Ultra Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device.

CONCLUSION

The CenterCross Ultra Catheter is a percutaneous vascular catheter and shares its design and mechanism of action with the identified predicate device. The results of the performance testing confirm that the CenterCross Ultra Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter. The CenterCross Ultra Catheter is substantially equivalent to the predicate device in terms of technological characteristics, intended use and performance. No new issues of safety or effectiveness are raised by the CenterCross Ultra Catheter.

SUMMARY

The CenterCross Ultra Catheter is substantially equivalent 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).