The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.

Device Description

The MultiCross Catheter consists of an inner shaft, outer shaft, and a proximal handle that allows for manual device manipulation and a means for flushing the catheter lumen. A key element of the device is an expandable and retractable nitinol scaffold, which, when deployed by the physician, expands to the artery wall to aid the user in establishing greater support near the treatment site.

AI/ML Overview

This document describes a 510(k) premarket notification for the MultiCross Catheter, a medical device. The information provided is primarily focused on demonstrating substantial equivalence to a predicate device, rather than meeting specific performance criteria typically associated with AI/ML-based medical devices.

Therefore, many of the requested categories for AI/ML device acceptance criteria and study details (such as sample size for test/training sets, expert qualifications, ground truth establishment, MRMC studies, or standalone performance metrics) are not applicable or are not explicitly detailed in this type of FDA submission for a Class II device relying on substantial equivalence to a predicate from manual modifications.

However, I can provide information based on what is available in the document regarding the acceptance criteria and the study that proves the device meets them, understanding that the context is a conventional medical device, not an AI/ML product.

Acceptance Criteria and Device Performance for Roxwood Medical, Inc. MultiCross Catheter (K152957)

This submission relies on demonstrating substantial equivalence of the MultiCross Catheter to its predicate device (MultiCross Catheter K121763) through bench testing rather than clinical study of the device's diagnostic performance (which would be relevant for AI/ML devices). The "acceptance criteria" here refer to meeting established specifications through non-clinical testing.

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria (Test/Characteristic)	Reported Device Performance (Summary)
Catheter Inspection	Performed; results demonstrate the device meets established specifications.
Open/Close Force	Performed; results demonstrate the device meets established specifications.
Simulated Use	Performed; results demonstrate the device meets established specifications necessary for consistent performance for its intended use.
Tensile Strength	Performed; results demonstrate the device meets established specifications.
Particulate	Performed; results demonstrate the device meets established specifications.
EO Residuals	Performed; results demonstrate the device meets established specifications.

Overall Conclusion: "The collective results of the non-clinical testing demonstrate that the MultiCross Catheter meets the established specifications necessary for consistent performance for its intended use and is substantially equivalent to the predicate device." And, "The results of the performance testing confirm that the MultiCross Catheter functions to its specifications and intended use and exhibit the appropriate characteristics of a percutaneous vascular catheter."

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

Sample Size: The document does not specify the sample size for any of the non-clinical bench tests. It broadly states "Extensive bench testing was conducted."
Data Provenance: The data is from non-clinical bench testing (simulated environments), not patient data. No country of origin is specified for the data itself, but the applicant is Roxwood Medical, Inc. based in Redwood City, California, USA. The testing would have been conducted by or for the manufacturer. The testing is retrospective in that it was completed prior to submission.

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

Not Applicable. For a device demonstrating substantial equivalence through bench testing, "ground truth" as it pertains to clinical outcomes or expert consensus on image interpretation is not relevant. The "ground truth" here is meeting engineering and performance specifications. The experts involved would be the engineers and quality control personnel performing and evaluating the bench tests.

4. Adjudication Method for the Test Set

Not Applicable. Adjudication methods (like 2+1 or 3+1) are used for reconciling discordant expert interpretations in clinical studies. This document reports on bench testing, where performance is measured against predefined specifications, not subjective interpretation.

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

No. An MRMC study was not performed, nor is it relevant for this specific type of 510(k) submission focused on mechanical and material performance of a catheter. MRMC studies are typically for evaluating the diagnostic performance of imaging devices or AI algorithms with human readers.

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

Not Applicable. This is a physical medical device (catheter), not an algorithm or AI product. Therefore, standalone algorithm performance is not relevant.

7. The Type of Ground Truth Used

The "ground truth" in this context refers to pre-established engineering specifications and performance benchmarks. The device's characteristics (e.g., tensile strength, open/close force, absence of particulate) are measured against these objective, quantifiable standards. There is no clinical or pathological "ground truth" in the sense of patient outcomes or diagnoses.

8. The Sample Size for the Training Set

Not Applicable. There is no "training set" in the context of this 510(k) submission for a non-AI/ML device. The device design and manufacturing processes are refined through engineering development, not machine learning training.

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

Not Applicable. As there is no training set, this question is not relevant.

Summary

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

March 4, 2016

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

Re: K152957

Trade/Device Name: MultiCross Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: February 3, 2016 Received: February 4, 2016

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 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.

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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) K152957

Device Name MultiCross Catheter

Indications for Use (Describe)

The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.

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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SECTION 5. 510(k) SUMMARY

510(k) Notification K152957

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: October 6, 2015

DEVICE INFORMATION

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

Trade Name:

MultiCross Catheter

Generic/Common Name:

Percutaneous Catheter

Classification:

21 CFR§870.1250, Class II

Product Code: DQY

PREDICATE DEVICE(S)

MultiCross Catheter (K121763) This predicate has not been subject to a design-related recall.

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INDICATIONS FOR USE

The MultiCross Support Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary or peripheral vasculature and for guidewire exchange.

The Indications for Use statement is identical to the predicate device.

PRODUCT DESCRIPTION

Subsequent to conventional guidewire placement, interventional tools such as angioplasty, stent, and atherectomy devices, may be used to provide therapeutic benefit. The MultiCross Catheter in and of itself does not provide therapeutic benefit beyond simple facilitation of guidewire support. The MultiCross 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 MultiCross Catheter are similar to the predicate device. Performance data is provided to support the determination of substantial equivalence.

SUBSTANTIAL EQUIVALENCE

The MultiCross 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 MultiCross 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 MultiCross 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:

. Catheter Inspection
Open/Close Force .
Simulated Use ●
Tensile Strength ●
Particulate ●
EO Residuals .

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

CONCLUSION

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

SUMMARY

The MultiCross 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).