(67 days)
No
The 510(k) summary describes a mechanical crossing catheter and does not mention any AI or ML components or functionalities. The performance studies listed are standard for a mechanical device.
No.
The device facilitates placement and exchange of other devices and delivery of fluids, but does not itself provide a therapeutic effect. While it can serve as a conduit for therapeutic agents, it is not described as a therapeutic device.
No
The device is intended to facilitate the placement and exchange of guidewires and other interventional devices, and to provide a conduit. It can deliver diagnostic agents, but its primary function is not diagnostic.
No
The device description clearly outlines physical components like a support catheter, guide-tip, and activating handle, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information for diagnosis, monitoring, or screening.
- Device Function: The Wingman 14C Crossing Catheter is a physical device used within the body (in the peripheral and/or coronary vasculature) to facilitate the placement of other devices and deliver substances. It does not analyze biological specimens in vitro.
- Intended Use: The intended use clearly describes a procedural function within the body, not a diagnostic test performed on a sample outside the body.
The description and intended use of the Wingman 14C Crossing Catheter align with a medical device used for interventional procedures, not an in vitro diagnostic device.
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. The Wingman 14C Crossing Catheter has an OD of ~ 0.035" with an ID compatible with 0.014" guidewires. The Wingman 14C Crossing Catheter is available in 90cm, 135cm and 150cm lengths.
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.
- Sterilization Validation
- Biocompatibility Testing
- Particulate Characterization Testing
- Simulated Use Testing
- Component/Assembly Integrity Testing
- Corrosion Resistance Testing
- Lubricity Testing
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 18 Crossing Catheter (K160848)
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).
0
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
June 9, 2017
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
ReFlow Medical, Inc. Rebecca Pine VP of Regulatory/Clinical Affairs & Quality Assurance 1003 Calle Sombra San Clemente, California 92673
Re: K170996
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: May 10, 2017 Received: May 11, 2017
Dear Rebecca 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 device
1
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 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,
Fernando
Aguel
Fernando
Aguel-S
for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K170996
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
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: May 9, 2017
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 18 Crossing Catheter (K160848) This predicate has not been subject to a design-related recall The Gopher Support Catheter (K081345) and Quickcross Support Catheter (K072750) were used as reference predicates in this submission
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. The Wingman 14C Crossing Catheter has an OD of ~ 0.035" with an ID compatible with 0.014" guidewires. The Wingman 14C Crossing Catheter is available in 90cm, 135cm and 150cm lengths.
- 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.
4
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 18 Crossing Catheter previously cleared (K160848) 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 beveled distal tip to facilitate crossing of the lesion
The following technological differences exist between the subject and predicate devices:
- The Wingman 14C Crossing Catheter incorporates a platinum marker . band at the distal end of the outer catheter and gold plating on the extendable tip for increased radiovisibility.
- I The handle of the Wingman 14C incorporates natural (white) nose guide and body components.
| The summary table below illustrates these similarities and differences. | |
|---|---|
| ------------------------------------------------------------------------- | -- |
| | Wingman 14C Crossing
Catheter | Wingman 18 Crossing
Catheter (K160848) |
|---------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------|
| Delivery technique | Over-the-wire, percutaneous | Over-the-wire, percutaneous |
| Thru-lumen channel | Yes | Yes |
| Inner lumen surface | Smooth | Smooth |
| Catheter Shaft | Polymer;
varying stiffness shaft; braid
reinforced; PTFE lining ),
hydrophilic coating, Pt/Ir RO
marker band, barium sulfate
impregnated tip | Polymer;
varying stiffness shaft; braid
reinforced; PTFE lining ),
hyrdophilic coating, tungsten
impregnated tip |
| Extendable Tip | Beveled, 17-7 stainless steel,
gold plated | Beveled, 304 stainless steel |
| Activating Handle | Yes, tip deployment
mechanism
Black/white | Yes, tip deployment
mechanism
Black |
VII. PERFORMANCE DATA
5
The following performance data were provided in support of the substantial equivalence.
- Sterilization Validation l
- Biocompatibility Testing
- I Particulate Characterization Testing
- Simulated Use Testing
- I Component/Assembly Integrity Testing
- l Corrosion Resistance Testing
- I Lubricity Testing
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
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