CenterCross Ultra Catheter

K160681 · Roxwood Medical, Inc. · DQY · Jun 17, 2016 · Cardiovascular

Device Facts

• Record ID: K160681
• Device Name: CenterCross Ultra Catheter
• Applicant: Roxwood Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jun 17, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

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 Story

CenterCross Ultra Catheter is a sterile, single-lumen, over-the-wire support catheter used in coronary and peripheral vasculature. Device features an outer shaft and a removable handle/inner shaft assembly for manual manipulation. A key component is an expandable/retractable nitinol structure; physician deploys this structure to expand against the artery wall, providing enhanced support near the treatment site. Used in conjunction with steerable guidewires to facilitate the placement/exchange of interventional devices like atherectomy catheters, PTCA catheters, or stents. Operated by interventionalists in a clinical setting. Device does not provide direct therapy; it functions solely to facilitate guidewire and device support, aiding in the delivery of therapeutic interventions.

Clinical Evidence

Bench testing only. Non-clinical testing included dimensional inspection, expansion force, simulated use, hydrophilic coating, leak, contrast flush injection, tip flexibility, kink resistance, torque strength, tensile strength, particulate, radiopacity, corrosion, LAL, EO residuals, packaging/shelf-life, and biocompatibility. Results demonstrate the device meets established specifications.

Technological Characteristics

Percutaneous, single-lumen, over-the-wire support catheter. Features an expandable/retractable nitinol scaffold. Materials include nitinol and unspecified shaft materials. Device is sterile. No electronic components, software, or energy sources. Manual operation via handle/inner shaft assembly.

Indications for Use

Indicated for patients requiring access to coronary and peripheral vasculature for the placement and exchange of guidewires and interventional devices.

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

• CenterCross Ultra Catheter (K152456)

Reference Devices

• Turnpike Catheter (K142065)
• MicroCross Catheter (K151082)

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

June 17, 2016

Roxwood Medical, Inc Cathy Mantor Director. Quality & Regulatory 400 Seaport Ct. Suite 103 Redwood City, California 94063

Re: K160681

Trade/Device Name: CenterCross Ultra Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: May 19, 2016 Received: May 20, 2016

Dear Cathy Mantor:

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

for 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) K160681

Device Name CenterCross Ultra Catheter

Indications for Use (Describe)

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.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | <span> <span style="font-size: 10px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> <span style="font-size: 10px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

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#### SECTION 5. 510(k) SUMMARY

#### 510(k) Notification K160681

#### GENERAL INFORMATION

Applicant: Roxwood Medical, Inc. 400 Seaport Court, Suite #103 Redwood City, CA 94063, USA Establishment Registration: #3010034168

#### Contact Person:

Cathy Mantor Director, Quality & Regulatory Phone: [phone] Fax: [phone]

Date Prepared: March 9, 2016

#### 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 Ultra Catheter (K152456) The predicate has not been subject to a design-related recall.

#### REFERENCE DEVICE(S)

Turnpike Catheter (Vascular Solutions, Inc., K142065) MicroCross Catheter (Roxwood Medical, Inc., K151082)

#### INDICATIONS FOR USE

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.

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

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## PRODUCT DESCRIPTION

The CenterCross Ultra Catheter is a sterile, 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 key 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 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.

# TECHNOLOGICAL CHARACTERISTICS

The technological characteristics of the CenterCross Ultra Catheter are similar to the predicate device. The differences arise from minor modifications to the handle, prime port, scaffold diameter, and shaft materials. Performance data is provided to support the determination of substantial equivalence.

## SUBSTANTIAL EQUIVALENCE

The CenterCross Ultra Catheter is substantially equivalent to its predicate device. The minor design and labeling modifications outlined in this Special 510(k) do not 1) affect the intended use nor 2) alter the fundamental scientific technology of the predicate device. The modified device shares the same intended use, indications for use, and 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 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:

- Dimensional Inspection .
- Expansion Force .
- Simulated Use .

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- Hydrophilic Coating .
- Leak .
- Contrast Flush Injection .
- Tip Flexibility & Kink Resistance ●
- Torque Strength ●
- Tensile Strength .
- . Particulate
- Radiopacity .
- Corrosion ●
- LAL .
- . EO Residuals
- Packaging and Shelf-Life .
- Biocompatibility .

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.