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 Description

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.

AI/ML Overview

The provided text describes a 510(k) summary for the ReFlow Medical Wingman Extendable Tip Support Catheter. It outlines the device's characteristics, intended use, and the testing performed to demonstrate substantial equivalence to a predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Acceptance Criteria / Test Performed	Reported Device Performance
Simulated Use	Met specified criteria
Tensile Strength	Met specified criteria
Torque	Met specified criteria
Pressure Test	Met specified criteria
Coating/Plating verification	Met specified criteria
Corrosion Test	Met specified criteria
Dimensional verification	Met specified criteria
Visual inspections	Met specified criteria

2. Sample Size Used for the Test Set and Data Provenance:

The document states that "All testing was performed on test units representative of finished devices." However, it does not specify the exact sample size for each test or the overall test set. The data provenance is not explicitly mentioned but can be inferred as originating from internal testing conducted by ReFlow Medical, a US-based company, as part of their 510(k) submission to the FDA. The testing is prospective as it's for a new or modified device to demonstrate performance.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications:

This information is not applicable or provided in the context of this device. The tests performed are engineering and material science-based, not clinical studies requiring expert interpretation of medical images or data for ground truth.

4. Adjudication Method for the Test Set:

This information is not applicable or provided for the type of engineering and material performance tests described. Adjudication methods are typically relevant for clinical studies with subjective interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size:

No, an MRMC comparative effectiveness study was not done. This type of study is for evaluating the impact of an AI system on human reader performance, which is not relevant to the physical performance testing of a catheter.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

No, a standalone performance study was not done. This device is a physical medical device (catheter), not an AI algorithm. The performance evaluation is based on its physical properties and function.

7. The Type of Ground Truth Used:

The "ground truth" for the tests performed is the pre-defined acceptance criteria or specifications for each engineering and material test (e.g., a specific tensile strength value, acceptable pressure resistance, etc.). The device's performance was compared directly against these established criteria.

8. The Sample Size for the Training Set:

This information is not applicable or provided. The concept of a "training set" is relevant for machine learning algorithms, which is not what this device is. The device's design and manufacturing likely involved iterative development and testing, but not in the context of machine learning training data.

9. How the Ground Truth for the Training Set Was Established:

This information is not applicable or provided as there is no "training set" in the context of this device's development and testing. The "ground truth" for the design and performance specifications would have been established through engineering principles, regulatory requirements, and industry standards for similar medical devices.

Summary

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2013

Section 6

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:	August 1, 2013
CONTACT PERSON:	Rebecca K PineReFlow Medical1003 Calle SombraSan Clemente, CA 92673Phone: (760) 809.5178
TRADE NAME:	Wingman Extendable Tip Support Catheter
COMMON NAME:	Guide Catheter
CLASSIFICATION NAME:	Percutaneous Catheter
DEVICE CLASSIFICATION:	Class 2, per 21 CFR 870.1250
PRODUCT CODE	DQY
	PREDICATE DEVICES: Wingman Extendable Support Catheter (K120178)

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 K120178.

Description of the Device Subject to Premarket Notification:

Indication for Use:

ReFlow Medical Modified Wingman Extendable Tip Support Catheter

Page 20 of 61 Premarket Notification

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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 lengths: 65cm, 150cm .
Modified strain-relief .

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/Plating verification o
Corrosion Test .
Dimensional verification and visual inspections .

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 (K120178).

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Image /page/2/Picture/0 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird with three stylized wing shapes.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

September 19, 2013

Food and Drig Administration 10903 New Hampshire Avenue Document Contral Center - WO60-G609 Silver Spring, MD 20993-0002

Reflow Medical, Inc. c/o Ms. Rebecca K. Pine Head of Regulatory Affairs/Quality Assurance 1003 Calle Sombra San Clemente, CA 92673

Re: K132420

Trade/Device Name: Wingman Extendable Tip Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutancous Catheter Regulatory Class: Class II Product Code: DQY Dated: August 1, 2013 Received: August 5, 2013

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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Page 2 - Ms. Rebecca K. Pine

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 contact the Division of Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 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" (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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Bram D. Zuckerman -S

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 Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known):

Device Name: Wingman Extendable Tip Support Catheter

Indications for Use:

AND/OR

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

Page _________________________________________________________________________________________________________________________________________________________________________

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Bram D. Zuckerman -S 2013.09.19 13:39:59 -04'00'

Regulation Number and Section

§ 870.1250 Percutaneous catheter.

(a)
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.(b)
Classification. Class II (performance standards).