WINGMAN EXTENDABLE TIP SUPPORT CATHETER

K141547 · Reflow Medical · DQY · Sep 30, 2014 · Cardiovascular

Device Facts

• Record ID: K141547
• Device Name: WINGMAN EXTENDABLE TIP SUPPORT CATHETER
• Applicant: Reflow Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Sep 30, 2014
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1250
• Device Class: Class 2

Intended Use

The Wingman Extendable Tip Support 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

Support catheter for peripheral vasculature access; used with steerable guidewires. Features concealed radiopaque beveled guide-tip and activating handle. Provides additional support to guidewires; facilitates device placement/exchange; serves as conduit for diagnostic/therapeutic agents. Operated by physicians in interventional settings. Device line extension adds .035 diameter configuration to existing product line. Output is physical support and delivery channel for interventional procedures.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included simulated use, tensile strength, torque, pressure testing, coating verification, corrosion testing, dimensional verification, sterilization validation, and biocompatibility.

Technological Characteristics

Percutaneous support catheter with concealed radiopaque beveled guide-tip and activating handle. Features .035 diameter configuration. Mechanical device; no energy source or software. Sterilization validation performed.

Indications for Use

Indicated for use in conjunction with steerable guidewires to access peripheral vasculature; facilitates placement/exchange of guidewires and interventional devices; provides conduit for delivery of saline or 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 Extendable Support Catheter (K132420)

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

September 30, 2014

Reflow Medical Ms. Rebecca Pine VP of Regulatory/Clinical Affairs & Quality Assurance 1003 Calle Sombra San Clemente, CA 92673 US

Re: K141547

> Trade/Device Name: Wingman Extendable Tip Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 30, 2014 Received: July 02, 2014

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.

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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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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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# 5. Indications for Use Statement

| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|-----------------------------------------|-----------------------------------|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below. |

| 510(k) Number (if known) | |
|-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Wingman Extendable Tip Support Catheter |
| Indications for Use (Describe) | The Wingman Extendable Tip Support 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> Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |

PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.

FOR FDA USE ONLY

| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|------------------------------------------------------------------------------|--|
|------------------------------------------------------------------------------|--|

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Page 1 of 1

PSC Poblishing Struices [phone] BBP

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### 6. 510(k) Summary

This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.

| APPLICANT: | ReFlow Medical |
|---------------------------|----------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | June 10, 2014 |
| CONTACT PERSON: | Rebecca K Pine<br>ReFlow Medical<br>1003 Calle Sombra<br>San Clemente, CA 92673<br>Phone: [phone] |
| TRADE NAME: | Wingman Extendable Tip Support Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATION<br>NAME: | Percutaneous Catheter |
| DEVICE<br>CLASSIFICATION: | Class 2, per 21 CFR 870.1250 |
| PRODUCT CODE | DQY |

### Substantially Equivalent To:

The modified Wingman Extendable Tip Support Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the Wingman Extendable Support Catheter cleared under premarket notification K132420.

PREDICATE DEVICES: Wingman Extendable Support Catheter (K132420)

# Description of the Device Subject to Premarket Notification:

The Wingman Extendable Tip Support 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. The Wingman Extendable Tip Support Catheter product line is being extended to add a .035 diameter device configuration.

#### Indication for Use:

The Wingman Extendable Tip Support 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

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diagnostic/therapeutic agents.

### Technical Characteristics:

The modified Wingman Extendable Tip Support Catheter has similar physical and technical characteristics to the predicate device. The modified Wingman and predicate Wingman devices differ in the following:

- Product line extension; new diameter: . 035 ●
# Performance Data:

All necessary testing has been performed for the Wingman Extendable Tip Support Catheter to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.

The device design was qualified through the following tests:

- Simulated Use ●
- Tensile Strength ●
- Torque ●
- Pressure Test ●
- Coating verification ●
- Corrosion Test
- Dimensional verification and visual inspections
- Sterilization Validation
- Biocompatibility ●

The modified Wingman Extendable Tip Support Catheter met all specified criteria and did not raise new safety or performance questions.

# Basis for Determination of Substantial Equivalence:

The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified Wingman Extendable Tip Support Catheter is determined by ReFlow Medical, to be substantially equivalent to the Wingman Extendable Tip Support Catheter (K132420).