MultiCross Catheter

K152957 · Roxwood Medical, Inc. · DQY · Mar 4, 2016 · Cardiovascular

Device Facts

• Record ID: K152957
• Device Name: MultiCross Catheter
• Applicant: Roxwood Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Mar 4, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended 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.

Device Story

MultiCross Catheter is a percutaneous vascular catheter used in coronary and peripheral vasculature. Device consists of inner shaft, outer shaft, and proximal handle for manual manipulation and flushing. Key feature is an expandable/retractable nitinol scaffold; physician deploys scaffold to expand against artery wall, providing support near treatment site. Used by physicians in interventional settings to facilitate guidewire placement; does not provide direct therapeutic benefit. Following guidewire placement, device allows exchange for interventional tools like angioplasty, stent, or atherectomy devices.

Clinical Evidence

Bench testing only. Testing included catheter inspection, open/close force, simulated use, tensile strength, particulate analysis, and EO residuals. Results demonstrate device meets specifications and performs equivalently to the predicate.

Technological Characteristics

Percutaneous catheter featuring an expandable/retractable nitinol scaffold. Components include inner shaft, outer shaft, and proximal handle. Manual operation. Sterilization via ethylene oxide (EO).

Indications for Use

Indicated for patients requiring access to discrete regions of the coronary or peripheral vasculature for guidewire exchange or to facilitate guidewire placement.

Regulatory Classification

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.

Predicate Devices

• MultiCross Catheter (K121763)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|--------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------|
| <span style="font-size: 16px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) | <span style="font-size: 16px;">☐</span> 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: [phone] Fax: [phone]

### Contact Person:

Grace Li Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063 Phone: [phone] Fax: [phone]

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

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.

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.