(223 days)
Not Found
No
The device description and performance studies focus on mechanical and material properties, with no mention of AI or ML.
No
The device, an introducer access kit, facilitates the placement of a guide catheter for percutaneous catheterization. It does not directly treat a disease or condition but serves as an accessory to a procedure.
No
The device is described as an access kit used to facilitate placing a guide catheter through the skin into a vein or artery for percutaneous catheterization procedures. Its function is to gain vascular access and allow the delivery of a guide catheter; it does not mention any diagnostic capabilities such as gathering or analyzing data to identify a medical condition.
No
The device description explicitly lists physical components like a needle, guidewire, and introducer made of materials like PEEK and Pebax, 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 is to facilitate placing a guide catheter through the skin into a vein or artery for percutaneous catheterization procedures. This is a surgical/interventional procedure, not a diagnostic test performed on samples taken from the body.
- Device Description: The components and function of the device (needle, guidewire, introducer/dilator) are all related to gaining vascular access and delivering a catheter into the body. They are not used to analyze biological samples outside the body.
- Lack of IVD Characteristics: There is no mention of analyzing blood, tissue, or any other biological sample. There are no reagents, assays, or other components typically associated with in vitro diagnostics.
The device is clearly intended for use in a clinical setting to perform a medical procedure on a patient, which falls under the category of a medical device but not specifically an IVD.
N/A
Intended Use / Indications for Use
The Flip Introducer access kit is used to facilitate placing a guide catheter through the skin into a vein or artery, including but not limited to the radial artery.
Product codes
DYB
Device Description
The Flip Introducer access kit is used to gain vascular access and allow placement of a guide catheter (not included). The Flip Introducer access kit contains the following components:
. 21G x 4 cm percutaneous entry needle
. 0.018" x 180 cm guidewire with a Nitinol mandrel and curved tungsten tip
. Flip Introducer
The Flip Introducer functions as a dilator to gain vascular access, allowing sheathless delivery of a guide catheter into a vein or artery to perform a percutaneous catheterization procedure. The Flip introducer consists of a hollow PEEK extruded tube with a tapered distal end that has a radiopaque marker band and a hydrophilic-coated Pebax funnel. A tuohy borst is provided on the proximal end of the device. The Flip Introducer is 130 cm long and compatible with 0.018" guidewires. The Flip Introducer is available in two sizes for use with 6F and 7F guide catheters.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vein or artery, radial artery
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Technological differences between the subject and predicate device have been evaluated through biocompatibility and mechanical tests to provide evidence of safe and effective use of the Flip Introducer. Verification test results met the specified acceptance criteria and did not raise new safety or performance issues.
Mechanical tests conducted:
. Fluoroscopy visualization
. Dilator length
. Dilator shaft OD
. Dilator/guidewire compatibility
. Dilator insertion force
. Dilator prolapse
. Dilator bond strength
Biocompatibility tests performed (as recommended by ISO 10993-1):
. Cytotoxicity
. Sensitization
. Irritation/Intracutaneous Reactivity
. Acute Systemic Toxicity
. Hemocompatibility
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K082644 – Glidesheath introducer sheath (Terumo Corporation)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc)
Not Found
§ 870.1340 Catheter introducer.
(a)
Identification. A catheter introducer is a sheath used to facilitate placing a catheter through the skin into a vein or artery.(b)
Classification. Class II (performance standards).
0
APR 1 7 2014
2 510(k) Summary
[As required by 21 CFR 807.92]
Date Prepared: September 5, 2013
K132789 510(k) Number:
Submitter's Name / Contact Person
Manufacturer Contact Person Vascular Solutions, Inc. Ellie Gillespie 6464 Sycamore Court North Sr. Regulatory Product Specialist Minneapolis, MN 55369 USA Tel: 763-656-4300 Establishment Registration # 2134812 Fax: 763-656-4253
General Information
| Trade Name | Flip Introducer access kit |
|---|---|
| Common / Usual Name | access kit |
| Classification Name | 870.1340, DYB - Catheter introducer, Class II |
| Predicate Device | K082644 – Glidesheath introducer sheath (Terumo Corporation) |
Device Description
The Flip Introducer access kit is used to gain vascular access and allow placement of a guide catheter (not included). The Flip Introducer access kit contains the following components:
- . 21G x 4 cm percutaneous entry needle
- . 0.018" x 180 cm guidewire with a Nitinol mandrel and curved tungsten tip
- . Flip Introducer
The Flip Introducer functions as a dilator to gain vascular access, allowing sheathless delivery of a guide catheter into a vein or artery to perform a percutaneous catheterization procedure. The Flip introducer consists of a hollow PEEK extruded tube with a tapered distal end that has a radiopaque marker band and a hydrophilic-coated Pebax funnel. A tuohy borst is provided on the proximal end of the device. The Flip Introducer is 130 cm long and compatible with 0.018" guidewires. The Flip Introducer is available in two sizes for use with 6F and 7F guide catheters.
Intended Use / Indications
The Flip Introducer access kit is used to facilitate placing a guide catheter through the skin into a vein or artery, including but not limited to the radial artery.
1
Technological Characteristics
The Flip Introducer is similar in design to the predicate device as they are both single lumen dilators that are used to gain vascular access. Both the subject and predicate devices have tapered distal tips and hydrophilic coating. The Flip Introducer has a polymer cuff that covers the distal tip of the guide catheter during insertion to allow sheathless insertion of the guide catheter.
Substantial Equivalence and Summary of Studies
Technological differences between the subject and predicate device have been evaluated through biocompatibility and mechanical tests to provide evidence of safe and effective use of the Flip Introducer. The Flip Introducer is substantially equivalent to the specified predicate device based on comparisons of the device functionality, technological characteristics, and indications for use.
The subject device design has been verified through the following mechanical tests:
- . Fluoroscopy visualization
- . Dilator length
- Dilator shaft OD ●
- . Dilator/guidewire compatibility
- Dilator insertion force .
- . Dilator prolapse
- . Dilator bond strength
The following biocompatibility tests were performed as recommended by ISO 10993-1:
- . Cytotoxicity
- . Sensitization
- . Irritation/Intracutaneous Reactivity
- . Acute Systemic Toxicity
- . Hemocompatibility
Verification test results met the specified acceptance criteria and did not raise new safety or performance issues. Therefore, the Flip Introducer is substantially equivalent to the predicate device.
2
April 17, 2014
Vascular Solutions, Inc. Ellie Gillespie Senior Regulatory Product Specialist 6464 Sycamore Court North Minneapolis, MN 55369
Re: K132789
Trade/Device Name: Flip Introducer access kit Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: April 10, 2014 Received: April 11, 2014
Dear Ms. Gillespie:
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 111 (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
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring MD 20993-0002
3
Page 2 - Ellie Gillespie
device-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 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" (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 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,
Bram D. Zuckerman -S
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
510(k) Number (if known):
Device Name: Flip Introducer access kit
Indications for Use:
The Flip Introducer access kit is used to facilitate placing a guide catheter through the skin into a vein or artery, including but not limited to the radial artery.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Bram D. Zuckerman 2014.04.17 06:11:22