The MicroCross Catheter is intended for use as a conduit for the exchange/support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter is also intended to infuse and contrast agents.

Device Description

The MicroCross Catheter is a sterile, single lumen over-the-wire catheter to be used for the exchange and support of guidewires in the peripheral and coronary vasculatures. The MicroCross Catheter also infuses and delivers saline and contrast agents.

The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered with a working length of 155cm and is compatible with 0.018" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.

AI/ML Overview

This document describes the premarket notification (510(k)) for the Roxwood Medical, Inc. MicroCross Catheter. The submission aims to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance

The document does not explicitly provide a table of acceptance criteria with numerical targets and reported performance values for each criterion. It lists several non-clinical tests performed, implying that the device met internal specifications for each. These tests are:

Acceptance Criteria (Implied)	Reported Device Performance
Dimensional Inspection	Met established specifications
Hydrophilic Coating	Met established specifications
Simulated Use	Met established specifications
Contrast Flush Injection	Met established specifications
Leak	Met established specifications
Torque Strength	Met established specifications
Kink Resistance & Flexibility	Met established specifications
Pressurized Flow Rate	Met established specifications
Tensile Strength	Met established specifications
Particulate	Met established specifications
LAL (Limulus Amebocyte Lysate)	Met established specifications

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

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

The document does not specify the exact sample sizes used for each non-clinical test. The testing is described as "extensive bench testing," and the data provenance is implicitly from laboratory (bench) testing, not human or animal subjects. Details such as country of origin are not applicable as this relates to bench testing.

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

This information is not applicable. The device is a physical medical catheter, and "ground truth" in the context of expert review for medical image analysis or similar diagnostic devices is not relevant here. Performance was assessed via engineering and material testing standards.

4. Adjudication Method for the Test Set

This information is not applicable for non-clinical bench testing of a physical medical device. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies or for establishing ground truth in diagnostic performance evaluations, which is not the case here.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance

This information is not applicable. The MicroCross Catheter is a physical catheter, not an AI-powered diagnostic or assistive technology. Therefore, an MRMC study related to human reader performance with or without AI assistance was not conducted.

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

This information is not applicable. The MicroCross Catheter is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device's performance is established through adherence to recognized engineering and material standards, as well as the specifications required for the device's intended function. For example, for "Dimensional Inspection," the ground truth would be the design specifications, and the device's measured dimensions would be compared against these. For "Tensile Strength," the ground truth would be the specified minimum tensile strength, and the device's tested strength would need to meet or exceed this.

8. The Sample Size for the Training Set

This product is a physical medical device, not an AI/ML algorithm. Therefore, there is no "training set."

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

This information is not applicable, as there is no training set for this physical medical device.

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

June 7, 2015

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

Re: K151082

Trade/Device Name: MicroCross Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: May 18, 2015 Received: May 19, 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

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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 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,

M.A. Willehemen

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)

Device Name MicroCross 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: K151082

GENERAL INFORMATION

Applicant:

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

Contact Person:

Grace Li Roxwood Medical, Inc. 400 Seaport Ct., Suite #103 Redwood City, CA 94063 Phone: (650) 779-4555 FAX: (650) 779-4554

Date Prepared: April 21, 2015

DEVICE INFORMATION

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

Trade Name:

MicroCross Catheter

Generic/Common Name:

Percutaneous Catheter

Classification:

21 CFR§870.1250, Class II

Product Code: DQY

PREDICATE DEVICE(S) MicroCross Catheter (K143744)

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INDICATIONS FOR USE

PRODUCT DESCRIPTION

Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MicroCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MicroCross Catheter is similar in its design and it achieves its intended use by means of the same mechanisms as the predicate device.

TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the MicroCross Catheter are similar to the predicate device. Performance data is provided to support the determination of substantial equivalence.

SUBSTANTIAL EQUIVALENCE

The MicroCross Catheter is substantially equivalent to its predicate device. The minor design modifications outlined in this Special 510(k) do not 1) affect the indications for use or 2) alter the fundamental scientific technology of the predicate device. The modified device shares the same intended use, the same technological characteristics and the same principles of operation as the predicate device. Any differences in the technological characteristics between the devices do not raise any new issues of safety or effectiveness. Thus, the MicroCross Catheter is substantially equivalent to the predicate device.

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TESTING IN SUPPORT OF SUBSTANTIAL EQUIVALENCE DETERMINATION

Extensive bench testing was conducted on the MicroCross 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 .
. Kink Resistance & Flexibility
Pressurized Flow Rate .
Tensile Strength .
Particulate ●
. LAL

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

CONCLUSION

The MicroCross 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 MicroCross Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter. The MicroCross 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 MicroCross Catheter.

SUMMARY

The MicroCross 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).