(79 days)
Not Found
No
The summary describes a mechanical catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No
The device facilitates the placement and exchange of guidewires and other interventional devices and can deliver saline or diagnostic agents, but it does not directly treat a disease or condition for therapeutic purposes itself.
No
The device description and intended use state that it facilitates the placement and exchange of guidewires and other interventional devices and can provide a conduit for the delivery of solutions or diagnostic agents. It does not perform any diagnostic function itself.
No
The device description clearly outlines physical components (support catheter, guide-tip, activating handle) and the performance studies focus on physical characteristics and testing (biocompatibility, tensile strength, flow rate, etc.), indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The Wingman 14C Crossing Catheter is a medical device used within the body (in vivo) to facilitate access and delivery of other devices or substances in the peripheral and coronary vasculature. It is an interventional device, not a diagnostic test performed on a sample outside the body.
- Intended Use: The intended use clearly describes its function in accessing and navigating blood vessels, not analyzing biological samples.
- Device Description: The description details its physical components and how it interacts with guidewires and delivers substances into the body.
- Performance Studies: The performance studies listed focus on the physical and mechanical properties of the catheter and its ability to function as intended within the body, not on the accuracy or reliability of a diagnostic test.
Therefore, based on the provided information, the Wingman 14C Crossing Catheter is an interventional medical device, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Wingman 14C 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 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or 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
The following performance data were provided in support of the substantial equivalence.
- Biocompatibility Testing
- Particulate Characterization Testing
- Simulated Use Testing
- Corrosion Resistance Testing
- Flexibility and Kink
- Flow Rate
- Dimensional Verification
- Tensile Strength
- Torque Strength
The Wingman 14C Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 14C Crossing Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.
Key Metrics
Not Found
Predicate Device(s)
Wingman 14C Crossing Catheter (K170996)
Reference Device(s)
Not Found
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/0 description: The image shows the logo for the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. Food & Drug Administration" in blue.
May 9, 2019
ReFlow Medical, Inc. Rebecca Pine Official Correspondent 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K190393
Trade/Device Name: Wingman 14C Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: April 9, 2019 Received: April 10, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 of medical device-related adverse events) (21 CFR 803) for
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devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Kenneth J. Cavanaugh, Ph.D. Director (Acting) DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K190393
Device Name Wingman 14C Crossing Catheter
Indications for Use (Describe)
The Wingman 14C 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. 208 Avenida Fabricante #100 San Clemente, CA 92672
Contact person: Rebecca K Pine Phone: (760) 809-5178 Fax: (760) 290.3216 Date prepared: April 15, 2019
II. DEVICE
Name of the device: Wingman 14C Crossing Catheter Common of usual name: Support Catheter Classification name: Percutaneous Catheter Regulatory Class: 2 Product Code: DQY
- III. PREDICATE DEVICE Wingman 14C Crossing Catheter (K170996) This predicate has not been subject to a design-related recall
IV. DEVICE DESCRIPTION The Wingman 14C Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral and/or 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 14C 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 14C Crossing Catheter is highly analogous to the technological characteristics of the Wingman 14C Wingman Crossing Catheter previously cleared (K170996) version of the device.
At a high level, the subject and predicate devices are based on the following same technological elements:
- I 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
- I 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
- . all use a specialized beveled distal tip to facilitate crossing of the lesion
The following technological differences exist between the subject and predicate devices:
- I The extendable tip component of the subject Wingman 14C Crossing Catheter is coated with parylene
VII. PERFORMANCE DATA
The following performance data were provided in support of the substantial equivalence.
- l Biocompatibility Testing
- Particulate Characterization Testing
- Simulated Use Testing
- I Corrosion Resistance Testing
- . Flexibility and Kink
- Flow Rate
- I Dimensional Verification
- I Tensile Strength
- I Torque Strength
The Wingman 14C Crossing Catheter met all specified criteria and did not raise new safety or performance questions. Based on the performance testing the Wingman 14C Crossing Catheter was found to have a safety and effectiveness profile that is similar to the predicate device.
VIII. CONCLUSIONS
I
The design testing performed for the Wingman 14C Crossing Catheter demonstrated that the performance of the device is substantially equivalent to the legally marketed predicate devices.