(29 days)
Not Found
No
The 510(k) summary describes a mechanical catheter and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is primarily intended to provide support for guidewires and other interventional devices, facilitating access and delivery of agents, rather than directly treating a condition.
No
Explanation: The device is primarily used to provide support for guidewires, facilitate placement of devices, and deliver agents, which are interventional and therapeutic functions, not diagnostic. While it can deliver "diagnostic/therapeutic agents," the device itself is not performing a diagnostic function; it's a conduit for the delivery of substances that might be used for diagnosis.
No
The device description clearly states it is a physical catheter with a handle and a radiopaque tip, 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 describes a device used within the body (in vivo) to access and facilitate procedures in the peripheral vasculature. IVDs are used to examine specimens from the body (in vitro) to provide diagnostic information.
- Device Description: The description details a physical catheter designed to be inserted into blood vessels. This is consistent with an in vivo device, not an in vitro diagnostic.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
The device is clearly intended for interventional procedures performed directly on the patient's circulatory system.
N/A
Intended Use / Indications for Use
The Wingman Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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.
Product codes
DQY
Device Description
The Wingman Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the 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 Wingman Crossing Catheter product line is being extended to add a .018" diameter device configuration.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Peripheral 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
All necessary testing has been performed for the Wingman Crossing Catheter to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.
The additional product family size was qualified through the following tests:
- Simulated Use
- Tensile Strength
- Torque
- Pressure Test
- Coating verification
- Corrosion Test
- Dimensional verification and visual inspections
The modified Wingman Crossing Catheter met all specified criteria and did not raise new safety or performance questions.
Key Metrics
Not Found
Predicate Device(s)
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/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a symbol. The symbol consists of three stylized human profiles facing right, with a stylized eagle or bird-like element above them.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
August 7, 2015
ReFlow Medical Rebecca K. Pine Head of Regulatory Affairs/Quality Assurance 1003 Calle Sombra San Clemente, CA 92673
Re: K151880
Trade/Device Name: Wingman Crossing Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DQY Dated: July 8, 2015 Received: July 9, 2015
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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
1
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" (21CFR 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
2
Indications for Use
510(k) Number (if known) K151880
Device Name Wingman Crossing Catheter
Indications for Use (Describe)
The Wingman Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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.
| 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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This 510(k) summary information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
| APPLICANT: | ReFlow Medical |
|---|---|
| DATE PREPARED: | July 30, 2015 |
| CONTACT PERSON: | Rebecca K Pine |
| ReFlow Medical | |
| 1003 Calle Sombra | |
| San Clemente, CA 92673 | |
| Phone: (760) 809.5178 | |
| TRADE NAME: | Wingman Crossing Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATION | |
| NAME: | Percutaneous Catheter |
| DEVICE | |
| CLASSIFICATION: | Class 2, per 21 CFR 870.1250 |
| PRODUCT CODE | DQY |
PREDICATE DEVICES: Wingman Extendable Support Catheter (K141547, K132420)
Substantially Equivalent To:
The modified Wingman Crossing Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the Wingman Extendable Support Catheter cleared under premarket notifications K141547 and K132420.
Description of the Device Subject to Premarket Notification:
The Wingman Crossing Catheter is a device intended to provide additional support to a steerable guidewire when accessing discrete regions of the 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 Wingman Crossing Catheter product line is being extended to add a .018" diameter device configuration.
Indication for Use:
The Wingman Crossing Catheter is intended to be used in conjunction with steerable guidewires to access discreet regions of the peripheral 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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Technical Characteristics:
The modified Wingman Crossing Catheter has similar physical and technical characteristics to the predicate device. The modified Wingman and predicate Wingman devices differ in the following:
- Product line extension; new diameter: .018" .
Performance Data:
All necessary testing has been performed for the Wingman Crossing Catheter to assure substantial equivalence to the predicate device and demonstrate the device performs as intended. All testing was performed on test units representative of finished devices.
The additional product family size was qualified through the following tests:
- Simulated Use ●
- Tensile Strength ●
- Torque ●
- . Pressure Test
- Coating verification
- Corrosion Test
- Dimensional verification and visual inspections .
The modified Wingman Crossing Catheter met all specified criteria and did not raise new safety or performance questions.
Basis for Determination of Substantial Equivalence:
The Indication/Intended Use and the fundamental scientific technology of the modified device have not been changed and are the same as those described in the unmodified predicate device. The modified Wingman Crossing Catheter is determined by ReFlow Medical, to be substantially equivalent to the Wingman Crossing Catheter (K141547, K132420).