(82 days)
Not Found
No
The summary describes a mechanical catheter and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML.
No.
The document describes the device as a guide extension catheter used to facilitate placement and exchange of other interventional devices within the vasculature, rather than directly providing a therapeutic effect itself.
No
The device description and intended use indicate that the TrapLiner catheter is used to facilitate the placement and exchange of interventional devices, and to maintain guidewire position within the vasculature. These are procedural functions, not diagnostic ones. There is no mention of the device being used to identify, measure, or monitor a medical condition.
No
The device description clearly describes a physical catheter with various material components (stainless steel, polymer), a balloon, and radiopaque markers. This indicates a hardware device, not software only.
Based on the provided information, the TrapLiner catheter is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used within the body (in the coronary and/or peripheral vasculature) to facilitate procedures and device placement. IVDs are used to examine specimens from the body (like blood, urine, tissue) outside the body to provide information about a person's health.
- Device Description: The description details a catheter with a balloon and other components designed for insertion into blood vessels. This is consistent with an interventional medical device, not an IVD.
- Anatomical Site: The specified anatomical site is the coronary and/or peripheral vasculature, which are internal body structures.
- Performance Studies: The performance studies described are bench tests evaluating physical properties and performance of the device itself, not tests on biological samples.
In summary, the TrapLiner catheter is an interventional medical device used in vivo, not an in vitro diagnostic device used in vitro.
N/A
Intended Use / Indications for Use
The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature.
Product codes
DOY
Device Description
The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The trapping balloon is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
coronary and/or 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
The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence that the TrapLiner catheter is substantially equivalent to the predicate device. The device design has been verified through the following tests:
- Track Force
- . Guide Catheter Backup Support
- Balloon Fatigue
- Pushwire-to-Shaft Tensile
- Liquid Leak
- Backbone Weld Bend
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).
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: a symbol on the left and the text "FDA U.S. FOOD & DRUG ADMINISTRATION" on the right. The symbol on the left is a stylized image of a human figure, while the text on the right is written in a bold, sans-serif font. The word "FDA" is in a blue square, and the rest of the text is in blue.
April 4, 2018
Vascular Solutions, Inc. Beka Vite Sr. Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, Minnesota 55369
Re: K180088
Trade/Device Name: TrapLiner catheter Regulation Number: 21 CFR 870.1250 Regulation Name: Percutaneous Catheter Regulatory Class: Class II Product Code: DOY Dated: March 5, 2018 Received: March 6, 2018
Dear Beka Vite:
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 Mav 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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Page 2 - Beka Vite
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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
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
2
Indications for Use
510(k) Number (if known) K180088
Device Name TrapLiner catheter
Indications for Use (Describe)
The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the 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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3
510(K) SUMMARY
[As required by 21 CFR 807.92] Date Prepared: Apr 3, 2018
510(k) Number: K180088
Submitter's Name / Contact Person
Manufacturer Vascular Solutions, Inc. 6464 Sycamore Court North Minneapolis, MN 55369 USA Establishment Registration # 2134812 Contact Person Beka Vite Sr. Regulatory Product Specialist Tel: 763-656-4300 Fax: 763-656-4253
General Information
| Trade Name | TrapLiner catheter |
|---|---|
| Common / Usual Name | Catheter |
| Product Code | DQY |
| Classification Name | 21 CFR 870.1250 – percutaneous catheter |
| Predicate Device | K161901, TrapLiner Catheter (Vascular Solutions, Inc. – cleared |
| February 3, 2017) |
Device Description
The TrapLiner catheter is a rapid-exchange guide extension catheter with a trapping balloon on the distal end of the pushrod. The stainless steel pushrod is covered on the distal end by a semi-circular polymer ('half-pipe') and transitions to a hydrophilic coated full-round polymer guide extension section. There are two radiopaque marker bands on the guide extension segment, one on the distal tip and one on the collar. The trapping balloon is located proximal to the half-pipe and has a single radiopaque gold marker under the proximal end of the balloon.
Intended Use
The TrapLiner catheter is intended for use in conjunction with guide catheters to access discrete regions of the coronary and/or peripheral vasculature, to facilitate placement of interventional devices, and to facilitate the exchange of an interventional device while maintaining the position of a guidewire within the vasculature.
Technological Characteristics Comparison
The subject TrapLiner catheter is similar in design and identical in intended use to the predicate TrapLiner device. Compared to the predicate device, the design difference is a geometry improvement at the distal end of the pushrod.
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The technological differences between the subject and predicate devices have been evaluated through bench tests to provide evidence that the TrapLiner catheter is substantially equivalent to the predicate device. The device design has been verified through the following tests:
- Track Force
- . Guide Catheter Backup Support
- Balloon Fatigue
- Pushwire-to-Shaft Tensile
- Liquid Leak
- Backbone Weld Bend
Substantial Equivalence Conclusion
The subject TrapLiner catheter is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use. The design change and results of subsequent design verification tests do not raise new or different questions of safety or effectiveness; the TrapLiner catheter is substantially equivalent to the predicate device.