(111 days)
The Wingman Extendable Tip Support 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.
The Wingman Extendable Tip Support 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 Extendable Tip Support Catheter product line is being extended to add a .035 diameter device configuration.
The provided text describes a medical device, the "Wingman Extendable Tip Support Catheter," and its 510(k) premarket notification for substantial equivalence to a predicate device. However, it does not contain information typically found in a study proving a device meets acceptance criteria related to AI or machine learning performance.
The document is a regulatory submission for a physical medical device (a catheter), not a software or AI/ML-driven device. Therefore, the questions regarding ground truth, expert adjudication, sample sizes for training/test sets, MRMC studies, or standalone algorithm performance are not applicable to this document. The "performance data" section refers to engineering tests on the physical catheter, not AI performance metrics.
Here's the breakdown based on the provided text, indicating what information is not available for an AI/ML context:
1. Table of acceptance criteria and reported device performance:
| Acceptance Criteria Category | Specific Criteria (if available) | Reported Device Performance |
|---|---|---|
| Physical/Mechanical | All specified criteria (implied) | Met all specified criteria |
| Simulated Use | (Not specified) | Performed as intended |
| Tensile Strength | (Not specified) | Met all specified criteria |
| Torque | (Not specified) | Met all specified criteria |
| Pressure Test | (Not specified) | Met all specified criteria |
| Coating verification | (Not specified) | Met all specified criteria |
| Corrosion Test | (Not specified) | Met all specified criteria |
| Dimensional verification | (Not specified) | Met all specified criteria |
| Visual inspections | (Not specified) | Met all specified criteria |
| Sterilization Validation | (Not specified) | Met all specified criteria |
| Biocompatibility | (Not specified) | Met all specified criteria |
| AI/ML Performance | Not Applicable | Not Applicable |
2. Sample sized used for the test set and the data provenance:
- Not applicable for AI/ML. The document states "All testing was performed on test units representative of finished devices." This refers to physical catheter units, not a dataset for an AI model.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. There is no "ground truth" in the context of AI/ML for this physical device.
4. Adjudication method for the test set:
- Not applicable. This relates to AI/ML ground truth establishment.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Not applicable. This is a physical medical device, not an AI-driven one.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This refers to AI algorithm performance.
7. The type of ground truth used:
- Not applicable. There is no "ground truth" as it pertains to AI/ML for this device. The "truth" for the physical device tests would be conformance to engineering specifications and performance as intended.
8. The sample size for the training set:
- Not applicable. This refers to AI model training.
9. How the ground truth for the training set was established:
- Not applicable. This refers to AI model training.
Summary regarding the provided text's limitations for your request:
The provided document is a 510(k) clearance letter for a physical medical device (a catheter). It details the regulatory approval process based on substantial equivalence to a predicate device and outlines various engineering and biocompatibility tests performed on the physical product.
It does not involve any AI or machine learning components, and therefore, all questions related to acceptance criteria, study design, ground truth establishment, or performance metrics for an AI/ML device are not present and cannot be inferred from this document.
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 30, 2014
Reflow Medical Ms. Rebecca Pine VP of Regulatory/Clinical Affairs & Quality Assurance 1003 Calle Sombra San Clemente, CA 92673 US
Re: K141547
Trade/Device Name: Wingman Extendable Tip Support Catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: June 30, 2014 Received: July 02, 2014
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. 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.
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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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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 Small Manufacturers, International and Consumer Assistance 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.
Kenneth J. Cavanaugh -S
for
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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5. Indications for Use Statement
| DEPARTMENT OF HEALTH AND HUMAN SERVICES | Form Approved: OMB No. 0910-0120 |
|---|---|
| Food and Drug Administration | Expiration Date: January 31, 2017 |
| Indications for Use | See PRA Statement below. |
| 510(k) Number (if known) | |
|---|---|
| Device Name | Wingman Extendable Tip Support Catheter |
| Indications for Use (Describe) | The Wingman Extendable Tip Support 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) |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
FOR FDA USE ONLY
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) | |
|---|---|
| ------------------------------------------------------------------------------ | -- |
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PSC Poblishing Struices (300) 443-6740 BBP
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6. 510(k) Summary
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: | June 10, 2014 |
| CONTACT PERSON: | Rebecca K PineReFlow Medical1003 Calle SombraSan Clemente, CA 92673Phone: (760) 809.5178 |
| TRADE NAME: | Wingman Extendable Tip Support Catheter |
| COMMON NAME: | Guide Catheter |
| CLASSIFICATIONNAME: | Percutaneous Catheter |
| DEVICECLASSIFICATION: | Class 2, per 21 CFR 870.1250 |
| PRODUCT CODE | DQY |
Substantially Equivalent To:
The modified Wingman Extendable Tip Support Catheter is substantially equivalent in intended use, principal of operation and technological characteristics to the Wingman Extendable Support Catheter cleared under premarket notification K132420.
PREDICATE DEVICES: Wingman Extendable Support Catheter (K132420)
Description of the Device Subject to Premarket Notification:
The Wingman Extendable Tip Support 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 Extendable Tip Support Catheter product line is being extended to add a .035 diameter device configuration.
Indication for Use:
The Wingman Extendable Tip Support 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
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diagnostic/therapeutic agents.
Technical Characteristics:
The modified Wingman Extendable Tip Support 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: . 035 ●
Performance Data:
All necessary testing has been performed for the Wingman Extendable Tip Support 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 device design was qualified through the following tests:
- Simulated Use ●
- Tensile Strength ●
- Torque ●
- Pressure Test ●
- Coating verification ●
- Corrosion Test
- Dimensional verification and visual inspections
- Sterilization Validation
- Biocompatibility ●
The modified Wingman Extendable Tip Support 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 Extendable Tip Support Catheter is determined by ReFlow Medical, to be substantially equivalent to the Wingman Extendable Tip Support Catheter (K132420).
§ 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).