(59 days)
No
The summary describes a mechanical crossing catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
Yes
The device is described as facilitating the intraluminal placement of diagnostic/interventional devices and providing a conduit for the delivery of diagnostic/therapeutic agents, indicating its role in enabling therapeutic interventions.
No.
The device facilitates the placement of diagnostic/interventional devices but is not a diagnostic device itself. Its primary function is to provide support for guidewires and deliver agents.
No
The device description clearly states it consists of a physical catheter with a guide-tip and activating handle, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used in vivo (within the body) to access and navigate blood vessels (peripheral and coronary vasculature). It facilitates the placement of other devices and the delivery of substances into the body.
- Device Description: The description details a physical catheter designed to be inserted into the body and manipulated with a guidewire.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens from the body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
IVD devices are used to perform tests on samples taken from the body, while this device is used to directly interact with the body's internal structures.
N/A
Intended Use / Indications for Use
The Wingman Crossing Catheters (14/14C/18/3) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.
Product codes (comma separated list FDA assigned to the subject device)
PDU, DOY
Device Description
The Wingman Crossing Catheter (14/18/35) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the peripheral vasculature.
The Wingman Crossing Catheter (14C) is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the coronary vasculature and 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
peripheral vasculature, 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)
This was a non-randomized, prospective, multi-center, single-arm study designed to evaluate the safety and effectiveness of the Wingman device to cross CTOs in infrainguinal arteries. The study was conducted both in the United States and outside the United States in Germany and Austria.
Among 85 subjects with 86 CTO lesions that could not be traversed with standard guidewires and techniques, 77 (89.5%) were successfully crossed with the Wingman study device. Both the primary endpoints were met, suggesting that the Wingman study device was safe and effective for crossing CTO lesions unable to be traversed with standard guidewires and techniques.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
The lower 95% confidence limit for successful CTO crossing (the primary effectiveness endpoint) was 82.5%, meeting the primary effectiveness endpoint.
These results were achieved with a 4.8% (4/83) 30-day rate of MAE, perforation, embolization, or dissection; the primary safety endpoint. The upper 95% confidence limit for the primary safety endpoint was 10.7%, meeting the primary safety endpoint.
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Medtronic Viance Crossing Catheter K120533
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
K132420, K190393, K160848, K173661
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
February 20, 2020
Krystal Santiago Director RA/QA 208 Avenida Fabricante #100 San Clemente, California 92672
Re: K193596
Trade/Device Name: Wingman 14, Wingman 14C, Wingman 18, Wingman 35 Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: PDU, DOY Dated: December 20, 2019 Received: December 23, 2019
Dear Krystal Santiago:
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
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Interventional Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
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Indications for Use
510(k) Number (if known) K193596
Device Name Wingman Crossing Catheters
Indications for Use (Describe)
The Wingman Crossing Catheters (14/14C/18/3) are intended to be used in conjunction with steerable guidewires to access discrete regions of the peripheral vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices, including facilitation of the intraluminal placement of diagnostic/ interventional devices beyond peripheral stenotic lesions (including chronic total occlusions [CTOs]) and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14C Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discrete regions of the coronary vasculature. It may be used to facilitate placement and exchange of guidewires and other interventional devices and provide a conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14, 18, & 35 Crossing Catheter is contraindicated for use in the coronary and cerebral vasculature. The Wingman 14C Crossing Catheter is contraindicated for use in the cerebral vasculature.
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
| Submitter | Reflow Medical, Inc.
208 Avenida Fabricante
#100
San Clemente, CA 92672
Contact person: Krystal Santiago
Phone: (310) 707.5882 |
|--------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared | February 8, 2020 |
| Device | Name of the device: Wingman Crossing Catheter
Common of usual name: Percutaneous Catheter
Classification name: Percutaneous Catheter
Regulatory Class: 2
Product Code: PDU, DQY |
| Legally marketed device
to which your firm is
claiming equivalence | Predicate Device: Medtronic Viance Crossing Catheter K120533
Reference Devices: Wingman Crossing Catheter
K132420 (Wingman 14)
K190393 (Wingman 14C)
K160848 (Wingman 18)
K173661 (Wingman 35) |
| Description of the device | The Wingman Crossing Catheter (14/18/35) is a device intended to
provide additional support to a steerable guidewire when accessing
discrete regions of the peripheral vasculature.
The Wingman Crossing Catheter (14C) is a device intended to provide
additional support to a steerable guidewire when accessing discrete
regions of the coronary vasculature and 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. |
| Intended use of the
device | The Wingman Crossing Catheters (14/14C/18/35) are intended to be used
in conjunction with steerable guidewires to access discrete regions of the
peripheral vasculature. It may be used to facilitate placement and
exchange of guidewires and other interventional devices, including
facilitation of the intraluminal placement of diagnostic/ interventional
devices beyond peripheral stenotic lesions (including chronic total
occlusions [CTOs]) and provide a conduit for delivery of saline solutions
or diagnostic/therapeutic agents.
The Wingman 14C Crossing Catheter is intended to be used in
conjunction with steerable guidewires to access discrete regions of the
coronary vasculature. It may be used to facilitate placement and
exchange of guidewires and other interventional devices and provide a
conduit for delivery of saline solutions or diagnostic/therapeutic agents.
The Wingman 14/18/35 Crossing Catheters are contraindicated for use in
the coronary and cerebral vasculature. The Wingman 14C Crossing
Catheter is contraindicated for use in the cerebral vasculature. |
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Summary of the technological characteristics of your device compared to the predicate device
The technological characteristics of the subject Wingman Crossing Catheter are identical to the technological characteristics of the Wingman Crossing Catheter previously cleared K132420 (Wingman 14), K190393 (Wingman 14C), K160848 (Wingman 18), K173661 (Wingman 35) version of the device. The Wingman device is clinically substantially equivalent to the Medtronic Viance Crossing Catheter (K120533).
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
- . all use a specialized distal tip to facilitate crossing of the lesion
The following technological differences exist between the subject and predicate devices:
- . The subject Wingman device has a slightly differing distal tip configuration in comparison to the Medtronic Viance catheter, however both tip designs have been shown to achieve the same clinical outcomes.
- The subject Wingman Crossing Catheters are available in a wider product range encompassing ● 0.014-0.035" guidewire compatibility vs the standard 0.014" Medtronic Viance Catheter.
A brief discussion of the nonclinical tests submitted
No additional nonclinical tests are submitted.
A brief discussion of the clinical data submitted
This was a non-randomized, prospective, multi-center, single-arm study designed to evaluate the safety and effectiveness of the Wingman device to cross CTOs in infrainguinal arteries. The study was conducted both in the United States and outside the United States in Germany and Austria.
At baseline, the mean age of the study subjects was 71.4 ± 9.3 years, and 65.9% (56/85) was male. The mean body mass index (BMI) was 27.7 ± 5.3. A history of smoking was elicited in 76.5% (65/85) of subjects, and 30.6% (26/85) diabetic. A history of peripheral interventions was reported in 63.5% (54/85) of subjects and the most common Rutherford Category was 3, present in 70.6% (60/85) of subjects.
Among 85 subjects with 86 CTO lesions that could not be traversed with standard guidewires and techniques, 77 (89.5%) were successfully crossed with the Wingman study device. The lower 95% confidence limit for successful CTO crossing (the primary effectiveness endpoint) was 82.5%, meeting the primary effectiveness endpoint.
These results were achieved with a 4.8% (4/83) 30-day rate of MAE, perforation, embolization, or dissection; the primary safety endpoint. The upper 95% confidence limit for the primary safety endpoint was 10.7%, meeting the primary safety endpoint.
Both the primary endpoints were met, suggesting that the Wingman study device was safe and effective for crossing CTO lesions unable to be traversed with standard guidewires and techniques.
Conclusions
The conclusions drawn from the nonclinical and clinical tests demonstrate that the device is as safe, as effective, and performs as well as or better than the legally marketed devices identified.