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 the Wingman Extendable Tip Support Catheter and its substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria, device performance metrics, detailed study designs, or ground truth establishment relevant to AI/ML device evaluation.

Instead, the document focuses on the regulatory submission for a medical device (a catheter) and aims to demonstrate its substantial equivalence to existing legally marketed predicate devices, which is a different evaluation paradigm than that for AI/ML-driven diagnostic or assistive tools.

Therefore, most of the requested fields cannot be filled from the provided text.

Here's a breakdown of what can and cannot be extracted:

Acceptance Criteria and Device Performance for Wingman Extendable Tip Support Catheter

Acceptance Criteria (Not explicitly stated as numerical targets)	Reported Device Performance (Summary)
Functional Equivalence to predicate devices	"All necessary verification and validation testing has been performed... to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended."
Safety and Efficacy comparable to predicate devices	"Upon reviewing the safety and efficacy information... the Wingman Extendable Tip Support Catheter is determined by ReFlow Medical, to be substantially equivalent to existing legally marketed devices."
Physical and Technical Characteristics similar to predicates	"The Wingman Extendable Tip Support Catheter has similar physical and technical characteristics to the predicate devices."
Simulated Use Performance	"Comparative simulated use testing demonstrated that the Wingman Extendable Tip Support Catheter is substantially equivalent to the predicate devices." (No specific metrics or thresholds for "substantial equivalence" are provided here).

Unavailable Information (Not present in the provided text):

Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective): The text mentions "comparative simulated use testing" and "all necessary verification and validation testing" but does not specify sample sizes for these tests, nor the origin or nature (retrospective/prospective) of any data used.
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 is not relevant to a medical device (catheter) substantial equivalence submission, which relies on engineering and performance testing rather than expert-labeled image data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable for this type of device submission.
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: Not applicable. This device is not an AI/ML diagnostic or assistive tool for human readers.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical medical device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For a physical catheter, "ground truth" would relate to its physical properties, mechanical performance, and safety in simulated use, not diagnostic outcomes based on expert consensus or pathology. The text implies performance against engineering specifications and comparison to predicate device performance.
The sample size for the training set: Not applicable, as this is not an AI/ML device that requires a training set.
How the ground truth for the training set was established: Not applicable for the same reason as above.

Summary

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6. 510(k) Summary of safety and effectiveness

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
TRADE NAME:	Wingman Extendable Tip Support Catheter
COMMON NAME:	Guide Catheter
CLASSIFICATIONNAME:	Percutaneous Catheter	AUG 1 1 2010
DEVICECLASSIFICATION:	Class 2, per 21 CFR 870.1250
PRODUCT CODE	DQY
PREDICATE DEVICES:	Outback Catheter (K001577)QuickCross Support Catheter (K 072750)Gopher Support Catheter (K091345)

Substantially Equivalent To:

The Wingman Extendable Tip Support Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the Outback Catheter, the QuickCross Support Catheter and the Gopher Support Catheter.

Description of the Device Subject to Premarket Notification:

Indication for Use:

Technical Characteristics:

The Wingman Extendable Tip Support Catheter has similar physical and technical characteristics to the predicate devices.

ReFlow Medical	Page 11 of 70
Wingman Extendable Tip SupportCatheter		Premarket Notification

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Performance Data:

All necessary verification and validation testing has been performed for the Wingman Extendable Tip Support Catheter to assure substantial equivalence to the predicate devices and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices. Comparative simulated use testing demonstrated that the Wingman Extendable Tip Support Catheter is substantially equivalent to the predicate devices.

Basis for Determination of Substantial Equivalence:

Upon reviewing the safety and efficacy information provided in this submission and comparing intended use, principle of operation and overall technological characteristics. the Wingman Extendable Tip Support Catheter is determined by ReFlow Medical, to be substantially equivalent to existing legally marketed devices.

ReFlow Medical Wingman Extendable Tip Support Catheter

Page 12 of 70 Premarket Notification

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DEPARTMENT OF HEALTH & HUMAN SERVICES

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

Reflow Medical c/o Ms. Rebecca K. Pine Head of Regulatory Affairs/Quality Assurance 5311 Foxhound Way San Diego, CA 92130

AUG 1 1 2010

Re: K101479

Trade Name: Wingman Extendable Support Catheter Regulation Number: 21 CFR§ 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 15, 2010 Received: July 16, 2010

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.

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Page 2 - Ms. Rebecca K. Pine

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 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 yours,

Bram D. Zuckerman, M.D. Director Division of Cardiovascular Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Indications for Use Statement

K 101479

INDICATIONS FOR USE STATEMENT

AUG 1 1 2010

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)

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Page of

(Division Sign-Off)
Division of Cardiovascu
510(k) Number K101479

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).