Wingman 18 Crossing Catheter

K160848 · Reflow Medical, Inc. · DQY · Jul 14, 2016 · Cardiovascular

Device Facts

• Record ID: K160848
• Device Name: Wingman 18 Crossing Catheter
• Applicant: Reflow Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Jul 14, 2016
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Wingman 18 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

Device Story

Support catheter for peripheral and coronary vasculature; used with steerable guidewires. Features concealed radiopaque beveled guide-tip and activating handle. Operates via over-the-wire percutaneous technique; provides conduit for guidewire exchange and delivery of saline or diagnostic/therapeutic agents. Used by physicians in interventional settings. Beveled tip facilitates lesion crossing; polymer shaft provides torque and push control. Output is physical access to target vasculature; assists in navigating complex lesions. Benefits patient by enabling successful guidewire placement in difficult-to-access regions.

Clinical Evidence

Bench testing only. Performance data included particulate characterization, simulated use testing, and predicate device comparison evaluation. The device met all specified criteria, demonstrating performance equivalent to legally marketed predicates.

Technological Characteristics

Polymer catheter shaft; concealed radiopaque beveled guide-tip; activating handle; through-lumen for guidewire/agent delivery. Over-the-wire percutaneous delivery. No software or electronic components.

Indications for Use

Indicated for patients requiring access to peripheral and/or coronary vasculature for guidewire placement, exchange, or delivery of saline/diagnostic agents.

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

• Gopher Support Catheter (K091345)
• Quickcross Support Catheter (K072750)

Reference Devices

• Wingman 18 Crossing Catheter (K151880)

Submission Summary (Full Text)

{0}------------------------------------------------

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" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

July 14, 2016

Reflow Medical, Inc. Rebecca K. Pine Vice President, Regulatory, Quality and Clinical Affairs 1003 Calle Sombra San Clemente, California 92673

Re: K160848

Trade/Device Name: Wingman 18 Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 10, 2016 Received: June 13, 2016

Dear Rebecca K. Pine:

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.

{1}------------------------------------------------

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,

# Brian D. Pullin -S

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

## Indications for Use

510(k) Number (if known) K160848

Device Name Wingman 18 Crossing Catheter

### Indications for Use (Describe)

The Wingman 18 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic agents.

| Type of Use (Select one or both, as applicable) | |
|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|
| <div> <span> <svg fill="none" height="16" viewbox="0 0 16 16" width="16" xmlns="http://www.w3.org/2000/svg"> <path d="M13.7817 2.21826C14.0746 2.51113 14.0746 2.98887 13.7817 3.28174L6.28174 10.7817C5.98887 11.0746 5.51113 11.0746 5.21826 10.7817L2.21826 7.78174C1.92539 7.48887 1.92539 7.01113 2.21826 6.71826C2.51113 6.42539 2.98887 6.42539 3.28174 6.71826L5.75 9.25L12.7183 2.21826C13.0111 1.92539 13.4889 1.92539 13.7817 2.21826Z" fill="black"></path> </svg> Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> <input type="checkbox"/> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

### 510(k) Summary

#### I. SUBMITTER

ReFlow Medical, Inc. 1003 Calle Sombra San Clemente, CA 92673

Contact person: Rebecca K Pine Phone: [phone] Fax: [phone] Date prepared: June 9, 2016

#### II. DEVICE

Name of the device: Wingman 18 Crossing Catheter Common of usual name: Support Catheter Classification name: Percutaneous Catheter Regulatory Class: 2 Product Code: DQY

#### III. PREDICATE DEVICE

Gopher Support Catheter (K091345) This predicate has not been subject to a design-related recall Quickcross Support Catheter (K072750) This predicate has not been subject to a design-related recall The Wingman 18 Crossing Catheter (K151880) was used as a reference predicate in this submission.

#### IV. DEVICE DESCRIPTION

The Wingman 18 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature.

The device consists of a support catheter, with a concealed radiopaque beveled guide-tip, and activating handle. The through-lumen of the device can serve as a conduit for the delivery of diagnostic and therapeutic agents.

#### V. INDICATIONS FOR USE

The Wingman Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for the delivery of saline solutions or diagnostic/therapeutic agents.

{4}------------------------------------------------

### VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the Wingman 18 Crossing Catheter remain unchanged from the previously cleared (K151880) version of the device.

At a high level, the subject and predicate devices are based on the following same technological elements:

- all delivered to the target site using an over-the-wire percutaneous technique
- all have a through lumen to allow passage and exchange of guidewires
- all have a smooth inner lumen to provide reduced friction for guidewire movement
- . all have a polymer catheter shaft with specific geometry to control the torque and push movements associated with lesion crossing
- I all use a specialized distal tip to facilitate crossing of the lesion

The following technological differences exist between the subject and predicate devices:

- . The Wingman 18 Crossing Catheters (subject device and cleared device) have beveled guide tips, while the Gopher catheter uses a threaded tip, and the QuickCross relies on a tapered tip.
#### VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence.

- . Particulate Characterization
- I Simulated Use
- Predicate Device Comparison Evaluation ■

The Wingman 18 Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 18 Crossing Catheter was found to be equivalent to the predicate device.

#### VIII. CONCLUSIONS

The design testing performed for the Wingman 18 Crossing Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices.