WINGMAN EXTENDABLE TIP SUPPORT CATHETER

K120178 · Reflow Medical · DQY · Feb 8, 2012 · Cardiovascular

Device Facts

• Record ID: K120178
• Device Name: WINGMAN EXTENDABLE TIP SUPPORT CATHETER
• Applicant: Reflow Medical
• Product Code: DQY · Cardiovascular
• Decision Date: Feb 8, 2012
• Decision: SESE
• Submission Type: Special
• 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 with concealed radiopaque beveled guide-tip and activating handle; used in peripheral vasculature to provide additional support to steerable guidewires. Physician operates device to facilitate guidewire/interventional device placement and exchange; serves as conduit for saline or diagnostic/therapeutic agents. Device enhances access to discrete vascular regions.

Clinical Evidence

Bench testing only. Device design qualified through simulated use, tensile strength, torque, dimensional verification, and comprehensive biocompatibility testing (cytotoxicity, irritation, sensitization, acute systemic toxicity, materials-mediated pyrogens, and hemocompatibility).

Technological Characteristics

Percutaneous catheter with concealed radiopaque beveled guide-tip and activating handle. Features through-lumen for agent delivery. Materials and sterilization method modified from predicate. Class II device (21 CFR 870.1250).

Indications for Use

Indicated for use in conjunction with steerable guidewires to access peripheral vasculature, facilitate placement/exchange of guidewires and interventional devices, and deliver 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 (K101479)

Submission Summary (Full Text)

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## Section 6

## 510(k) Summary

#### 6. 510(k) Summary

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

| APPLICANT: | ReFlow Medical |
|---------------------------|----------------------------------------------------------------------------------------------------------|
| DATE PREPARED: | February 3, 2012 |
| 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 |
| PREDICATE DEVICES: | Wingman Extendable Support Catheter (K101479) |

#### 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 K 101479.

### 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.

#### 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 diagnostic/therapeutic agents.

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K120178 page 2 of 2

## Section 6

### 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:

- Catheter materials .
- Sterilization method .

### 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 .

·

- Dimensional verification and visual inspections �
- Biocompatibility .
- o Cytotoxicity
- o Irritation
- · Sensitization
- o Acute Systemic Toxicity
- Materials Mediated Pyrogens o
- o Hemocompatibility

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 (K101479).

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is circular, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is an abstract symbol that resembles an eagle or bird in flight.

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

FEB - 8 2012

Reflow Medical c/o Ms. Rebecca Pine 1003 Calle Sombra San Clemente, CA 92673

Re: K120178

Trade/Device Name: Wingman Extendable Tip Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous catheter Regulatory Class: Class II (two) Product Code: DQY Dated: January 19, 2012 Received: January 20, 2012

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

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Page 2 - Ms. Rebecca Pine

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/Resourcesfor You/Industry/default.htm.

Sincerely vours.

M.A. Killebrew

್ಕ್, 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
#### INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120178

# Device Name: Wingman Extendable Tip Support Catheter

Indications 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 diagnostic/therapeutic agents.

AND/OR

X Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C)

# (PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

M. A. Killebrew

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(Division Sign-Off) Division of Cardiovascular Devices

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