The Wingman 18 Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary 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 agents.

Device Description

The Wingman 18 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary 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

This document is a 510(k) Premarket Notification from the FDA regarding the "Wingman 18 Crossing Catheter." It focuses on demonstrating substantial equivalence to predicate devices, not on proving new clinical effectiveness or safety in a comprehensive standalone study like an AI algorithm would require.

Therefore, many of the requested elements for describing the acceptance criteria and the study that proves the device meets them (especially those pertaining to AI algorithms, clinical trials with human readers, and detailed ground truth establishment) are not applicable to this type of medical device submission.

Here's an attempt to answer the questions based on the provided document, highlighting where information is not available or not relevant to a 510(k) for a physical medical device like a catheter:

Acceptance Criteria and Device Performance for Wingman 18 Crossing Catheter (K160848)

As this is a 510(k) submission for a physical medical device (catheter) and not an AI algorithm, the "acceptance criteria" discussed are primarily related to demonstrating substantial equivalence to legally marketed predicate devices through engineering and performance testing, rather than complex clinical outcomes or AI performance metrics.

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

The document states:
"The Wingman 18 Crossing Catheter met all specified criteria and did not raise new safety or performance questions."
"Based on the performance testing the Wingman 18 Crossing Catheter was found to be equivalent to the predicate device."
"The design testing performed for the Wingman 18 Crossing Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices."

However, the specific quantitative acceptance criteria and detailed reported performance metrics are not provided in this summary document. Typically, these would be detailed in the full submission, but only the types of performance data are listed.

Acceptance Criteria Category	Reported Device Performance
Material/Component Safety	Met all specified criteria. Did not raise new safety questions.
Functional Performance (e.g., crossing, guidewire support, patency)	Met all specified criteria. Performance found to be equivalent/equal to predicate devices.
Biocompatibility (Implied by standard medical device requirements)	Met all specified criteria.
Sterility (Implied by standard medical device requirements)	Met all specified criteria.
Particulate Characterization	Met all specified criteria.
Simulated Use	Met all specified criteria.
Predicate Device Comparison Evaluation	Performance found to be equivalent/equal to predicate devices.

2. Sample size used for the test set and the data provenance

The document does not specify the sample sizes for the "Particulate Characterization," "Simulated Use," or "Predicate Device Comparison Evaluation."

Regarding data provenance: These are likely laboratory/engineering tests performed by the manufacturer, Reflow Medical, Inc., in the United States, as the company is based in San Clemente, California. The studies are prospective in the sense that they are conducted specifically to support this regulatory submission, testing the device under controlled conditions. This is not clinical data provenance in the sense of patient cohorts.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

This concept is not applicable to this type of device submission. "Ground truth" established by experts (e.g., radiologists, pathologists) is relevant for diagnostic devices or AI algorithms that interpret medical images/data. For a physical device like a catheter, performance is evaluated through engineering bench testing and simulated use, not through expert interpretation of clinical "truths."

4. Adjudication method for the test set

This concept is not applicable. Adjudication methods (like 2+1, 3+1) are used in clinical trials, especially for medical imaging or AI studies, where human expert disagreement on interpretation needs a defined resolution process. For physical device performance testing, predefined engineering specifications and measurement techniques are used.

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

No, an MRMC comparative effectiveness study was not conducted and is not applicable for this device. This type of study is specifically designed for diagnostic aids, particularly AI algorithms, to measure their impact on human reader performance. The Wingman 18 Crossing Catheter is a physical interventional tool, not a diagnostic aid or AI.

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

No, a standalone algorithm performance study was not done and is not applicable. This device is a physical catheter, not an algorithm.

7. The type of ground truth used

The "ground truth" for this device's performance relies on pre-defined engineering specifications, material properties, and functional benchmarks established through testing and comparison with predicate devices. This involves:

Engineering specifications: Meeting dimensions, material strength, radiopacity, and other design parameters.
Performance metrics: Demonstrating successful navigation, guidewire support, fluid delivery capability, and resistance to kinking or damage during simulated use.
Predicate device equivalence: Showing that its performance is comparable to an established, legally marketed device for the same intended use.

It is not based on expert consensus, pathology, or clinical outcomes data in the way an AI diagnostic device would be.

8. The sample size for the training set

This concept is not applicable. "Training set" refers to data used to train machine learning models. This device is a physical product, not an AI, so there is no training set.

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

This concept is not applicable as there is no training set for this physical device.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized caduceus or a representation of the human form.

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

July 14, 2016

Reflow Medical, Inc. Rebecca K. Pine Vice President, Regulatory, Quality and Clinical Affairs 1003 Calle Sombra San Clemente, California 92673

Re: K160848

Trade/Device Name: Wingman 18 Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: June 10, 2016 Received: June 13, 2016

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 devicerelated 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.

{1}------------------------------------------------

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" (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 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K160848

Device Name Wingman 18 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)

CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

510(k) Summary

I. SUBMITTER

ReFlow Medical, Inc. 1003 Calle Sombra San Clemente, CA 92673

Contact person: Rebecca K Pine Phone: (760) 809-5178 Fax: (760) 290.3216 Date prepared: June 9, 2016

II. DEVICE

Name of the device: Wingman 18 Crossing Catheter Common of usual name: Support Catheter Classification name: Percutaneous Catheter Regulatory Class: 2 Product Code: DQY

III. PREDICATE DEVICE

Gopher Support Catheter (K091345) This predicate has not been subject to a design-related recall Quickcross Support Catheter (K072750) This predicate has not been subject to a design-related recall The Wingman 18 Crossing Catheter (K151880) was used as a reference predicate in this submission.

IV. DEVICE DESCRIPTION

The Wingman 18 Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and coronary vasculature.

V. INDICATIONS FOR USE

The Wingman Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral and/or coronary 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.

{4}------------------------------------------------

VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

The technological characteristics of the Wingman 18 Crossing Catheter remain unchanged from the previously cleared (K151880) version of the device.

At a high level, the subject and predicate devices are based on the following same technological elements:

all delivered to the target site using an over-the-wire percutaneous technique
all have a through lumen to allow passage and exchange of guidewires
all have a smooth inner lumen to provide reduced friction for guidewire movement
. all have a polymer catheter shaft with specific geometry to control the torque and push movements associated with lesion crossing
I all use a specialized distal tip to facilitate crossing of the lesion

The following technological differences exist between the subject and predicate devices:

. The Wingman 18 Crossing Catheters (subject device and cleared device) have beveled guide tips, while the Gopher catheter uses a threaded tip, and the QuickCross relies on a tapered tip.

VII. PERFORMANCE DATA

The following performance data were provided in support of the substantial equivalence.

. Particulate Characterization
I Simulated Use
Predicate Device Comparison Evaluation ■

The Wingman 18 Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 18 Crossing Catheter was found to be equivalent to the predicate device.

VIII. CONCLUSIONS

The design testing performed for the Wingman 18 Crossing Catheter demonstrated that the performance of the device is equal to the legally marketed predicate devices.

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).