(108 days)
No
The summary does not mention AI, ML, or any related concepts, and the device description is purely mechanical.
No
The device is described as facilitating the placement and exchange of guidewires and other interventional devices and providing a conduit for the delivery of saline solutions or diagnostic agents. It also states its through-lumen can serve as a conduit for the delivery of diagnostic and therapeutic agents, but the device itself is not a therapeutic agent.
Yes
Explanation: The "Intended Use / Indications for Use" section states that the device can "provide a conduit for the delivery of saline solutions or diagnostic agents." This indicates it has a role in diagnostic procedures by delivering diagnostic agents.
No
The device description clearly outlines a physical catheter with a radiopaque tip and activating handle, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The description clearly states the Wingman 18 Crossing Catheter is used in conjunction with guidewires to access and navigate within the peripheral and coronary vasculature. It facilitates placement of other devices and can deliver solutions into the body.
- Lack of Sample Testing: There is no mention of this device being used to test samples from the body. Its function is entirely focused on accessing and manipulating structures within the body.
Therefore, the Wingman 18 Crossing Catheter is an interventional device used within the body, not an IVD used for testing samples outside the body.
N/A
Intended Use / Indications for Use
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.
Product codes
DQY
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral and/or coronary vasculature
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
- Particulate Characterization
- Simulated Use
- Predicate Device Comparison Evaluation
Key results: 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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.
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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
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Indications for Use
510(k) Number (if known) K160848
Device Name Wingman 18 Crossing Catheter
Indications for Use (Describe)
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.
| 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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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.
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.
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.
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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.