(59 days)
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.
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.
The provided text describes a 510(k) summary for the Wingman Crossing Catheters. The summary includes information about the device, its intended use, and a brief discussion of a clinical study conducted to demonstrate the safety and effectiveness of the device for crossing Chronic Total Occlusions (CTOs) in infrainguinal arteries.
Here's a breakdown of the requested information based on the provided text, focusing on the clinical study that proves the device meets the acceptance criteria:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria (Primary Endpoints) | Device Performance (Reported Results) |
|---|---|
| Effectiveness: Successful CTO crossing (lower 95% confidence limit sufficient) | 89.5% successful CTO crossing (77 out of 86 lesions). Lower 95% confidence limit: 82.5%. |
| Safety: 30-day rate of Major Adverse Events (MAE), perforation, embolization, or dissection (upper 95% confidence limit sufficient) | 4.8% (4 out of 83) 30-day rate of MAE, perforation, embolization, or dissection. Upper 95% confidence limit: 10.7%. |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: 85 subjects with 86 CTO lesions.
- Data Provenance: The study was "non-randomized, prospective, multi-center, single-arm." It was conducted "both in the United States and outside the United States in Germany and Austria."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
The provided text does not specify the number of experts used to establish ground truth or their qualifications. The study focused on objective endpoints (successful CTO crossing, MAE rates) rather than subjective expert consensus on image interpretation.
4. Adjudication Method for the Test Set
The provided text does not specify an adjudication method. Given the objective nature of the primary effectiveness endpoint (successful crossing of the CTO) and the safety endpoint (occurrence of specific adverse events), a formal adjudication method by experts beyond clinical reporting might not have been implemented in the way it would for, say, image review.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
The provided text indicates this was a "non-randomized, prospective, multi-center, single-arm study." It does not describe an MRMC comparative effectiveness study comparing human readers with and without AI assistance. The study evaluated the device's performance in crossing CTOs, not its impact on human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
The device is a physical medical device (catheter), not an AI algorithm. Therefore, the concept of "standalone (algorithm only)" performance is not applicable in this context. The study evaluates the catheter's ability to facilitate CTO crossing.
7. The Type of Ground Truth Used
The ground truth for the effectiveness endpoint was the objective observation of successful CTO crossing during the interventional procedure. For the safety endpoint, the ground truth was the occurrence of specific clinical events (MAE, perforation, embolization, or dissection) within 30 days, likely determined by clinical follow-up and medical records. This falls under outcomes data and clinical observation.
8. The Sample Size for the Training Set
The provided text describes a clinical study evaluating the device's performance. It does not mention a "training set" in the context of machine learning or AI models. This study is an evaluation of the device itself.
9. How the Ground Truth for the Training Set Was Established
As the device is a physical catheter and not an AI algorithm, the concept of a "training set" and its associated ground truth establishment is not applicable. The study evaluates the device's clinical performance.
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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
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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#100San Clemente, CA 92672Contact person: Krystal SantiagoPhone: (310) 707.5882 |
|---|---|
| Date Prepared | February 8, 2020 |
| Device | Name of the device: Wingman Crossing CatheterCommon of usual name: Percutaneous CatheterClassification name: Percutaneous CatheterRegulatory Class: 2Product Code: PDU, DQY |
| Legally marketed deviceto which your firm isclaiming equivalence | Predicate Device: Medtronic Viance Crossing Catheter K120533Reference Devices: Wingman Crossing CatheterK132420 (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 toprovide additional support to a steerable guidewire when accessingdiscrete regions of the peripheral vasculature.The Wingman Crossing Catheter (14C) is a device intended to provideadditional support to a steerable guidewire when accessing discreteregions of the coronary vasculature and peripheral vasculature.The device consists of a support catheter, with a concealed radiopaquebeveled guide-tip, and activating handle. The through-lumen of thedevice can serve as a conduit for the delivery of diagnostic andtherapeutic agents. |
| Intended use of thedevice | The Wingman Crossing Catheters (14/14C/18/35) are intended to be usedin conjunction with steerable guidewires to access discrete regions of theperipheral vasculature. It may be used to facilitate placement andexchange of guidewires and other interventional devices, includingfacilitation of the intraluminal placement of diagnostic/ interventionaldevices beyond peripheral stenotic lesions (including chronic totalocclusions [CTOs]) and provide a conduit for delivery of saline solutionsor diagnostic/therapeutic agents.The Wingman 14C Crossing Catheter is intended to be used inconjunction with steerable guidewires to access discrete regions of thecoronary vasculature. It may be used to facilitate placement andexchange of guidewires and other interventional devices and provide aconduit for delivery of saline solutions or diagnostic/therapeutic agents.The Wingman 14/18/35 Crossing Catheters are contraindicated for use inthe coronary and cerebral vasculature. The Wingman 14C CrossingCatheter 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.
§ 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).