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.

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.

AI/ML Overview

The provided text describes the "Flip Introducer access kit," a medical device used for vascular access. The submission focuses on demonstrating substantial equivalence to a predicate device through mechanical and biocompatibility testing.

Here's an analysis of the acceptance criteria and study information based solely on the provided text:

1. A table of acceptance criteria and the reported device performance

The document mentions that "Verification test results met the specified acceptance criteria." However, it does not explicitly list the quantitative acceptance criteria for each test. Instead, it lists the types of tests performed.

Test Category	Specific Test Conducted	Reported Device Performance	Acceptance Criteria (from text)
Mechanical Tests	Fluoroscopy visualization	Met acceptance criteria	Not explicitly stated (e.g., "clearly visible under standard fluoroscopy conditions")
	Dilator length	Met acceptance criteria	Not explicitly stated (e.g., "within +/- X mm of specified length")
	Dilator shaft OD	Met acceptance criteria	Not explicitly stated (e.g., "within +/- X mm of specified diameter")
	Dilator/guidewire compatibility	Met acceptance criteria	Not explicitly stated (e.g., "smooth passage of guidewire without kinking")
	Dilator insertion force	Met acceptance criteria	Not explicitly stated (e.g., "requires less than X N force to insert")
	Dilator prolapse	Met acceptance criteria	Not explicitly stated (e.g., "no prolapse when subjected to X force")
	Dilator bond strength	Met acceptance criteria	Not explicitly stated (e.g., "bond withstands X N tensile force")
Biocompatibility Tests	Cytotoxicity	Met acceptance criteria (as recommended by ISO 10993-1)	Not explicitly stated (e.g., "non-cytotoxic, passes ISO 10993-5")
	Sensitization	Met acceptance criteria (as recommended by ISO 10993-1)	Not explicitly stated (e.g., "non-sensitizing, passes ISO 10993-10")
	Irritation/Intracutaneous Reactivity	Met acceptance criteria (as recommended by ISO 10993-1)	Not explicitly stated (e.g., "non-irritating, passes ISO 10993-10")
	Acute Systemic Toxicity	Met acceptance criteria (as recommended by ISO 10993-1)	Not explicitly stated (e.g., "non-systemically toxic, passes ISO 10993-11")
	Hemocompatibility	Met acceptance criteria (as recommended by ISO 10993-1)	Not explicitly stated (e.g., "hemocompatible, passes ISO 10993-4")

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not provide any information regarding sample sizes for the mechanical or biocompatibility tests. It also does not specify the data provenance (e.g., country of origin, retrospective or prospective). These tests are typically conducted in a controlled lab environment.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This section is not applicable to the type of studies described. The "Flip Introducer access kit" is a physical medical device, and its performance is evaluated through objective mechanical and biological tests, not through expert interpretation of data like in an AI-based diagnostic tool. Therefore, there's no "ground truth" established by human experts in the context of this submission.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

This is not applicable as the studies are mechanical and biocompatibility tests, not clinical studies requiring adjudication of human reader interpretations. The results would be based on predefined metrics and instrumental readings.

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

This is not applicable. The device is a physical medical instrument, not an AI-assisted diagnostic tool.

6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done

This is not applicable. The device is a physical medical instrument, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

As explained in point 3, the concept of "ground truth" (in the sense of expert consensus, pathology, or outcomes data) is not applicable to the studies performed for this device. The "ground truth" for these tests are the objective measurements and pass/fail criteria for each mechanical and biocompatibility parameter.

8. The sample size for the training set

This is not applicable. As a physical medical device, there is no "training set" in the context of machine learning.

9. How the ground truth for the training set was established

This is not applicable as there is no training set for this device.

Summary

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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.

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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.

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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

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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

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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

Regulation Number and Section

§ 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).