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.
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 deliver saline 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 in working lengths of 150cm and 155cm and is compatible with 0.014" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.
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.

AI/ML Overview

The provided text describes the MicroCross Catheter, a percutaneous catheter, and its substantial equivalence to a predicate device. However, it does not describe any clinical studies involving AI algorithms or human readers. The acceptance criteria and testing summarized are for the physical device itself, not for an AI's performance.

Therefore, I cannot provide information on the following points for an AI device based on this document:

A table of acceptance criteria and the reported device performance for an AI.
Sample size used for the test set and data provenance for an AI.
Number of experts used to establish ground truth for the test set and their qualifications for an AI.
Adjudication method for an AI test set.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done, or the effect size of how much human readers improve with AI vs without AI assistance.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.) for an AI.
The sample size for the training set for an AI.
How the ground truth for the training set was established for an AI.

However, I can provide the acceptance criteria and a summary of the study for the physical device as presented in the document:

1. Table of Acceptance Criteria and Reported Device Performance (for the MicroCross Catheter)

The document lists various non-clinical tests performed to demonstrate the device's performance and substantial equivalence. The "acceptance criteria" are implied to be the established specifications met by the device during these tests, leading to a conclusion of proper functioning and substantial equivalence. Specific quantitative acceptance criteria or detailed numerical performance metrics for each test are not provided in this summary. Instead, the document states that the device "meets the established specifications necessary for consistent performance."

Acceptance Criteria Category (Implied)	Reported Device Performance
Physical/Mechanical Properties	Met established specifications; consistent performance. Functions to its specifications and intended use.
Dimensional Accuracy	Met established specifications.
Hydrophilic Coating Performance	Met established specifications.
Leak Resistance	Met established specifications.
Torque Strength	Met established specifications.
Kink Resistance & Flexibility	Met established specifications.
Tensile Strength	Met established specifications.
Luer Compliance	Met established specifications.
Functional Performance	Met established specifications; consistent performance.
Simulated Use	Met established specifications.
Contrast Flush Injection	Met established specifications.
Pressurized Flow Rate	Met established specifications.
Material & Biocompatibility	Met established specifications.
Corrosion Resistance	Met established specifications.
Particulate Matter	Met established specifications.
LAL (Limulus Amebocyte Lysate)	Met established specifications.
Biocompatibility	Met established specifications.
Sterilization & Shelf-Life	Met established specifications.
Sterilization Adoption	Met established specifications for a validated sterilization process.
Packaging and Shelf-life	Met established specifications.

Study Proving Device Meets Acceptance Criteria:

The study was a series of extensive non-clinical (bench) tests conducted on the MicroCross Catheter.

Summary of the Study:

The study involved various tests designed to evaluate the physical, mechanical, functional, and biological performance characteristics of the MicroCross Catheter. These tests are listed in the table above and include assessments such as dimensional inspection, hydrophilic coating, simulated use, contrast flush injection, leak, torque strength, kink resistance & flexibility, pressurized flow rate, tensile strength, Luer compliance, corrosion, particulate, LAL, biocompatibility, sterilization adoption, and packaging and shelf-life.

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

Sample Size: Not specified quantitatively in the document. The general term "extensive bench testing" is used.
Data Provenance: Not applicable in terms of geographical origin or retrospective/prospective clinical data, as these were lab-based bench tests performed by the manufacturer, Roxwood Medical, Inc.

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

This is not applicable as the "ground truth" for these physical device tests is based on engineering specifications, recognized standards, and direct measurement/observation of physical properties and performance, not expert human interpretation of medical images or patient data.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 typically refer to expert review of medical cases where ambiguity exists. For bench testing, results are typically determined by established test methods and direct measurement against predefined specifications, not by consensus among human adjudicators.

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

No, this was not done as the document describes a physical medical device, not an AI algorithm.

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

No, this was not done as the document describes a physical medical device, not an AI algorithm.

7. The Type of Ground Truth Used:

The "ground truth" for the non-clinical testing was based on:

Established engineering specifications
Recognized industry standards (e.g., for biocompatibility, sterility)
Direct physical measurements and functional performance evaluations (e.g., flow rates, tensile strength).

8. The Sample Size for the Training Set:

Not applicable. This device is a physical catheter, not an AI algorithm that requires a training set.

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

Not applicable. There is no training set for this physical device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, stacked on top of each other.

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

April 14, 2015

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

Re: K143744 Trade/Device Name: MicroCross Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: March 4, 2015 Received: March 6, 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 (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,

Bram D. Zuckerman -S

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

510(k) Notification K143744

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: December 30, 2014

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) Valet Micro Catheter (Volcano Corporation, K112035)

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INDICATIONS FOR USE

PRODUCT DESCRIPTION

The MicroCross Catheter consists of a catheter shaft and a proximal hub that provides strain relief. The MicroCross Catheter is offered in working lengths of 150cm and 155cm and is compatible with 0.014" diameter guidewires, 5F guide catheters, and 4F introducer sheaths.

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 the Valet Micro Catheter (Volcano Corporation, K112035). The subject device and the predicate devices are percutaneous catheters. The proposed indications for the MicroCross 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 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 .
Luer Compliance ●
. Corrosion
Particulate .
LAL .
Biocompatibility ●
Sterilization adoption into a validated sterilization process ●
Packaging and shelf-life .

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).