Wingman 35 Crossing Catheter

K173661 · Reflow Medical, Inc. · DQY · Apr 18, 2018 · Cardiovascular

Device Facts

• Record ID: K173661
• Device Name: Wingman 35 Crossing Catheter
• Applicant: Reflow Medical, Inc.
• Product Code: DQY · Cardiovascular
• Decision Date: Apr 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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.

Device Story

Wingman 35 Crossing Catheter is a support catheter used in peripheral vasculature procedures; provides additional support to steerable guidewires. Device features a concealed radiopaque beveled guide-tip and an activating handle; through-lumen serves as conduit for saline or diagnostic/therapeutic agents. Operated by physicians during interventional procedures. Beveled tip facilitates crossing of lesions; polymer shaft provides torque and push control. Benefits include improved guidewire support and lesion crossing capability.

Clinical Evidence

Bench testing only. Evidence includes biocompatibility analysis, simulated use testing, component/assembly integrity testing, and corrosion resistance testing. Device met all specified criteria.

Technological Characteristics

Support catheter with concealed radiopaque beveled guide-tip and activating handle. Features polymer catheter shaft for torque/push control and through-lumen for guidewire exchange/fluid delivery. UV stabilizer content is 0.2%.

Indications for Use

Indicated for patients requiring access to discrete regions of the peripheral vasculature to facilitate guidewire placement, exchange of interventional devices, or delivery of diagnostic/therapeutic 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

• Wingman 35 Crossing Catheter (K141547)

Submission Summary (Full Text)

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April 18, 2018

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

Re: K173661

Trade/Device Name: Wingman 35 Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: February 20, 2018 Received: February 21, 2018

Dear Ms. 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

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) K173661

Device Name Wingman 35 Crossing Catheter

### Indications for Use (Describe)

The Wingman 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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.

Type of Use (Select one or both, as applicable)

| <span style="font-size:100%;"><b> ☑ Prescription Use (Part 21 CFR 801 Subpart D)</b> </span> |
|------------------------------------------------------------------------------------------------------------------|
| <span style="font-size:100%;"><b> ☐ Over-The-Counter Use (21 CFR 801 Subpart C)</b> </span> |

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## K173661

## 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: March 31, 2017

#### II. DEVICE

Name of the device: Wingman 35 Crossing Catheter Common of usual name: Support Catheter Classification name: Percutaneous Catheter Regulatory Class: 2 Product Code: DQY

- III. PREDICATE DEVICE Wingman 35 Crossing Catheter (K141547) This predicate has been subject to a design-related recall
#### IV. DEVICE DESCRIPTION

The Wingman 35 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral 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 35 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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.

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

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The technological characteristics of the Wingman 35 Crossing Catheter is highly analogous to the technological characteristics of the Wingman 35 Crossing Catheter previously cleared (K141547) 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
- I all have a through lumen to allow passage and exchange of guidewires
- all have a smooth inner lumen to provide reduced friction for guidewire I movement
- . all have a polymer catheter shaft with specific geometry to control the torque and push movements associated with lesion crossing
- all use a specialized beveled distal tip to facilitate crossing of the lesion ■

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

- I The Wingman 35 Crossing Catheter UV stabilizer percentage has been changed to 0.2% (from 0.1%)
- Reduction of shelf life of device components and finished device

#### VII. PERFORMANCE DATA

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

- ' Biocompatibility Analysis
- I Simulated Use Testing
- I Component/Assembly Integrity Testing
- I Corrosion Resistance Testing

The Wingman 35 Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 35 Crossing Catheter was found to be substantially equivalent to the predicate device.

#### VIII. CONCLUSIONS

The design testing performed for the Wingman 35 Crossing Catheter demonstrated that the performance of the device is substantially equivalent to the legally marketed predicate device.