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 Wingman Extendable Tip Support Catheter, focusing on demonstrating substantial equivalence to a predicate device. It details the device's characteristics and the performance testing conducted.

Here's an analysis of the requested information based on the provided text:

1. A table of acceptance criteria and the reported device performance

The document lists several tests conducted and states that the updated device "met all specified criteria." However, specific numerical acceptance criteria (e.g., minimum tensile strength value, maximum torque value, cytotoxicity limits, etc.) are not explicitly provided in this document. The table below represents the tests performed and the general performance statement provided.

Test Performed	Acceptance Criteria (Not Explicitly Stated)	Reported Device Performance
Simulated Use	(Implied: Device functions as intended in a simulated clinical environment)	Met all specified criteria
Tensile Strength	(Implied: Withstands expected tensile forces)	Met all specified criteria
Torque	(Implied: Withstands expected torsional forces during use)	Met all specified criteria
Dimensional verification	(Implied: Conforms to design specifications)	Met all specified criteria; visual inspections performed
Visual inspections	(Implied: No visual defects that would impact safety or performance)	Met all specified criteria; visual inspections performed
Biocompatibility: Cytotoxicity	(Implied: Non-toxic to cells)	Met all specified criteria
Biocompatibility: Irritation	(Implied: Non-irritating to tissues)	Met all specified criteria
Biocompatibility: Sensitization	(Implied: Does not induce allergic reactions)	Met all specified criteria
Biocompatibility: Acute Systemic Toxicity	(Implied: Does not cause acute systemic harm)	Met all specified criteria
Biocompatibility: Materials Mediated Pyrogens	(Implied: Does not induce fever from material components)	Met all specified criteria
Biocompatibility: Hemocompatibility	(Implied: Compatible with blood, does not cause adverse blood reactions)	Met all specified criteria

2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document states: "All testing was performed on test units representative of finished devices." However, it does not specify the sample size for any of the tests conducted. The data provenance (country of origin, retrospective/prospective) is also not mentioned.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the provided document. The tests performed are related to the physical and biological characteristics of a medical device (catheter), not to diagnostic image interpretation or expert-driven clinical assessment where ground truth would be established by human experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This section is not applicable. The type of testing performed (simulated use, tensile strength, biocompatibility, etc.) does not involve adjudication by multiple experts in the sense of clinical decision-making.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This section is not applicable. The document describes the technical and biological testing of a physical medical device (catheter), not an AI-powered diagnostic tool, and therefore no MRMC study or AI assistance evaluation was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

This section is not applicable. The device is a physical catheter, not an algorithm, so standalone algorithm performance is not relevant.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

For the performance tests described (e.g., tensile strength, torque, biocompatibility), the "ground truth" or reference values are typically established by recognized industry standards, internal design specifications, and regulatory requirements (e.g., ISO standards for medical devices, ASTM standards for material properties, or specific FDA guidance documents for biocompatibility). The document implies that these tests were conducted against such "specified criteria." It is not based on expert consensus, pathology, or outcomes data in a clinical sense.

8. The sample size for the training set

This section is not applicable. The device is a physical catheter, not a machine learning model, so there is no "training set."

9. How the ground truth for the training set was established

This section is not applicable for the same reason as point 8.

Summary

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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 PineReFlow Medical1003 Calle SombraSan Clemente, CA 92673Phone: (760) 809.5178
TRADE NAME:	Wingman Extendable Tip Support Catheter
COMMON NAME:	Guide Catheter
CLASSIFICATIONNAME:	Percutaneous Catheter
DEVICECLASSIFICATION:	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:

Indication for Use:

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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 (800) 638-2041 or (301) 796-7100 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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1. Indications for Use Statement

INDICATIONS FOR USE STATEMENT

510(k) Number (if known): K120178

Device Name: Wingman Extendable Tip Support Catheter

Indications for Use:

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

Page 1 of 1

(Division Sign-Off) Division of Cardiovascular Devices

510(k) Number_LI I 2 ol 7 8

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).