The Wingman 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 Description

The Wingman 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. The Wingman Crossing Catheter product line is being extended to add a .018" diameter device configuration.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device, the Wingman Crossing Catheter. It focuses on establishing substantial equivalence to a predicate device rather than presenting a detailed study proving the device meets acceptance criteria. Therefore, most of the requested information regarding acceptance criteria and a study proving its fulfillment is not explicitly available in this document.

However, I can extract what is present and highlight what is missing based on your request.

Here's a breakdown of the information, with explanations for what cannot be provided from this particular document:

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

Acceptance Criteria (Inferred from tests)	Reported Device Performance
Simulated Use: Device performs as intended in simulated clinical scenarios.	Met all specified criteria.
Tensile Strength: Device withstands specified tensile forces without failure.	Met all specified criteria.
Torque: Device can be torqued without adverse effects.	Met all specified criteria.
Pressure Test: Device maintains integrity under specified pressure.	Met all specified criteria.
Coating verification: Coating quality and integrity meet specifications.	Met all specified criteria.
Corrosion Test: Device resists corrosion under specified conditions.	Met all specified criteria.
Dimensional verification and visual inspections: Device dimensions and visual appearance meet specifications.	Met all specified criteria.

Missing Information: The document states that the modified Wingman Crossing Catheter "met all specified criteria," but it does not explicitly define those criteria (e.g., specific tensile strength in Newtons, pressure limits in psi, or detailed visual inspection parameters). It also doesn't provide numerical results for the performance of the device against these criteria, only a qualitative statement of meeting them.

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

Missing Information: The document states "All testing was performed on test units representative of finished devices" but does not specify the sample size for each test, nor does it indicate the provenance of any data (e.g., country of origin, retrospective or prospective). This is typical for a 510(k) summary which focuses on demonstrating substantial equivalence rather than a full clinical study report.

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)

Missing Information: This type of information is not relevant to the engineering and performance testing described in this 510(k) summary. The tests performed (tensile strength, pressure, etc.) are objective physical tests, not evaluations requiring expert interpretation of clinical data or images to establish ground truth.

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

Missing Information: Similar to point 3, adjudication methods are typically used in clinical studies involving human interpretation of data, which is not the type of testing described here. The performance tests are objective engineering measurements.

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

Missing Information: An MRMC comparative effectiveness study is designed for evaluating the impact of a device (often AI-powered) on human performance in diagnostic or interpretive tasks. This document is for a physical medical device (a catheter) and does not involve AI or human readers for its intended use. Therefore, no such study was conducted or reported here.

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

Missing Information: As explained in point 5, this device is a physical catheter, not an algorithm. Therefore, no standalone algorithm performance study was done.

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

Missing Information: The "ground truth" for the engineering performance tests are the pre-defined specifications and industry standards for mechanical properties and material integrity. The document doesn't detail these specific standards or criteria, but implies their existence by stating "met all specified criteria."

8. The sample size for the training set

Missing Information: This concept is relevant for machine learning algorithms. The Wingman Crossing Catheter is a physical medical device, not an AI model. Therefore, there is no "training set" in the context of this device.

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

Missing Information: As explained in point 8, this concept is not applicable to the device described.

Summary of the Study (as described in the document):

The "study" presented here is a series of in-vitro, non-clinical performance tests conducted to demonstrate that the modified Wingman Crossing Catheter (specifically, a new .018" diameter configuration) is substantially equivalent to its predicate devices.

Test Set: "Test units representative of finished devices." The exact sample size for each test is not provided.
Data Provenance: Not specified, but generally, such tests are conducted in a laboratory setting by the manufacturer. Not applicable to clinical retrospective/prospective data.
Tests Conducted: Simulated Use, Tensile Strength, Torque, Pressure Test, Coating verification, Corrosion Test, Dimensional verification and visual inspections.
Results: The document states that the device "met all specified criteria" for each of these tests and "did not raise new safety or performance questions."
Ground Truth: The "ground truth" for these tests are the pre-established engineering specifications and performance criteria that define acceptable functionality and durability for percutaneous catheters. These criteria are not detailed in the document.

Conclusion:

This 510(k) summary provides evidence of substantial equivalence primarily through mechanical and performance testing. It lacks the detailed quantitative acceptance criteria and specific study parameters that would be found in a full test report or clinical study. The device is a physical catheter, not a diagnostic imaging tool or AI software, which explains why many of your detailed questions regarding human readers, AI, or specific types of ground truth (like pathology or expert consensus) are not applicable to the information provided.

Summary

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Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a stylized eagle or bird-like element above them.

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

August 7, 2015

ReFlow Medical Rebecca K. Pine Head of Regulatory Affairs/Quality Assurance 1003 Calle Sombra San Clemente, CA 92673

Re: K151880

Trade/Device Name: Wingman Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 8, 2015 Received: July 9, 2015

Dear Rebecca K. 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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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 Industry and Consumer Education 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. 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 Industry and Consumer Education 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.

Brian D. Pullin -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) K151880

Device Name Wingman Crossing Catheter

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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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:	July 30, 2015
CONTACT PERSON:	Rebecca K PineReFlow Medical1003 Calle SombraSan Clemente, CA 92673Phone: (760) 809.5178
TRADE NAME:	Wingman Crossing 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 (K141547, K132420)

Substantially Equivalent To:

The modified Wingman Crossing Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the Wingman Extendable Support Catheter cleared under premarket notifications K141547 and K132420.

Description of the Device Subject to Premarket Notification:

Indication for Use:

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Technical Characteristics:

The modified Wingman Crossing 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: .018" .

Performance Data:

All necessary testing has been performed for the Wingman Crossing 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 additional product family size was qualified through the following tests:

Simulated Use ●
Tensile Strength ●
Torque ●
. Pressure Test
Coating verification
Corrosion Test
Dimensional verification and visual inspections .

The modified Wingman Crossing 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 Crossing Catheter is determined by ReFlow Medical, to be substantially equivalent to the Wingman Crossing Catheter (K141547, K132420).

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).