The FlexSeal™ Introducer Sheath with Hydrophilic Coating is intended to be placed in the peripheral vasculature to provide a conduit for the introduction of diagnostic or interventional devices and to minimize blood loss associated with such insertions.

Device Description

The FlexSeal™ Introducer Sheath with Hydrophilic Coating contains the following disposable components:

o One sterile introducer sheath with an active spring loaded hemostatic valve
o One sterile radiopaque dilator

The FlexSeal™ Introducer Sheath with Hydrophilic Coating consists of an introducer sheath with hydrophilic coating and a dilator. The devices sizes are 14F, 16F and 18F. Three different lengths (20 cm, 28 cm and 35 cm) are available for each FlexSeal introducer size. An active hemostatic valve is integrated into the sheath.

AI/ML Overview

The provided document describes a medical device called the "FlexSeal Introducer Sheath with Hydrophilic Coating" and outlines its clearance process with the FDA. However, the document does not contain information about AI/ML device performance, acceptance criteria, or a study involving human readers or ground truth determination as would be expected for an AI/ML medical device.

The document is a 510(k) summary for a traditional medical device (an introducer sheath), which is a physical product, not a software algorithm. Therefore, the questions related to AI/ML device performance, sample sizes for test/training sets, expert adjudication, MRMC studies, or specific types of ground truth are not applicable to the content provided.

The performance data presented focuses on physical and biocompatibility testing of the introducer sheath, to demonstrate its safety and effectiveness compared to a predicate device.

Here's the information that can be extracted from the document, tailored as closely as possible to your request, but acknowledging the device type:

1. Table of Acceptance Criteria and Reported Device Performance

For a traditional medical device like the FlexSeal Introducer Sheath, the "acceptance criteria" are typically defined by engineering specifications and regulatory standards. The reported performance indicates that the device met these criteria.

Acceptance Criteria (Test Performed)	Reported Device Performance (Results)
Visual surface inspection	Meets all specifications
Dimensions	Meets all specifications
Radiopacity visualization	Meets all specifications
Guidewire compatibility	Meets all specifications
Hemostasis valve leakage	Meets all specifications
Kink resistance	Meets all specifications
Bond tensile strength	Meets all specifications
Hydrophilic coating integrity	Meets all specifications
Luer compliance	Meets all specifications
Cracking pressure	Meets all specifications
USP particulate test	Meets all specifications
Packaging tests	Meets all specifications
Distribution tests	Meets all specifications
Usability studies	Meets all specifications
Biocompatibility: Cytotoxicity	Meets Requirements
Biocompatibility: Sensitization	Meets Requirements
Biocompatibility: Irritation/Intracutaneous Reactivity	Meets Requirements
Biocompatibility: Systemic (Acute) Toxicity	Meets Requirements
Biocompatibility: Genotoxicity	Meets Requirements
Biocompatibility: Hemocompatibility	Meets Requirements
Sterilization (Ethylene Oxide)	SAL 10-5 level achieved

Regarding the AI/ML-specific questions (2-9):

The provided document describes a physical medical device (introducer sheath), not an AI/ML algorithm. Therefore, the following points are not applicable and cannot be answered from the provided text:

Sample size used for the test set and the data provenance: Not applicable for a physical device where "test set" refers to physical samples tested.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an introducer sheath's physical properties is established by engineering standards and validated lab tests, not expert consensus on data.
Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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 device does not involve human readers interpreting data with/without AI assistance.
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This is a physical device, not an algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc): For the physical tests, the "ground truth" is defined by the technical specifications and accepted standards for each test (e.g., a specific tensile strength value, a certain level of hemocompatibility).
The sample size for the training set: Not applicable. There is no AI/ML training set for this device.
How the ground truth for the training set was established: Not applicable. There is no AI/ML training set for this device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol. The logo is black and white.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

July 15, 2016

Libra Medical Inc. % Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313

Re: K161659

Trade/Device Name: FlexSeal Introducer Sheath with Hydrophilic Coating Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: June 14, 2016 Received: June 16, 2016

Dear Mark Job:

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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in

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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 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" (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 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,

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

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Indications for Use

510(k) Number (if known)

K161659

Device Name

FlexSealTM Introducer Sheath with Hydrophilic Coating.

Indications for Use (Describe)

Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)	Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) SUMMARY 1

ADMINISTRATIVE INFORMATION 1.1

Date of Summary Preparation: July 15, 2016

1.2 NAME/ADDRESS OF SPONSOR

Belinda Jackson Freudenberg Medical MIS, Inc 2301 Centennial Boulevard Jeffersonville, Indiana 47130 Tel: 805-576-5308 Fax: 812-280-2325 Email: Belinda.Jackson@freudenbergmedical.com

1.3 CONTACT INFORMATION

Primary Submission Contact	Sew-Wah Tay, PhDRegulatory Consultant,Libra Medical Inc.
Secondary Submission Contact	Ming-Cheng ChewRegulatory Consultant,

1.4 DEVICE INFORMATION

Trade Name	FlexSeal™ Introducer Sheath with HydrophilicCoating
Common Name	Introducer Sheath
Classification Name	Catheter Introducer
Classification Regulation	870.1340
Class	II
Panel	Cardiovascular
Product Code	DYB

Libra Medical Inc.

1.5 510(K) TYPE AND REASON FOR SUBMISSION

This 510(k) is a traditional 510(k) and is submitted to obtain marketing clearance for a new device - the FlexSeal™ Introducer Sheath with Hydrophilic Coating.

1.6 PREDICATE DEVICE

The FlexSeal™ Introducer Sheath with Hydrophilic Coating is substantially equivalent to the DrySeal devices (K121234).

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1.7 DEVICE DESCRIPTION

The FlexSeal™ Introducer Sheath with Hydrophilic Coating contains the following disposable components:

o One sterile introducer sheath with an active spring loaded hemostatic valve
o One sterile radiopaque dilator

1.8 INDICATIONS FOR USE

1.9 TECHNOLOGICAL CHARACTERISTICS

The sheath shaft's is radiopaque and its external surface has a hydrophilic coating to facilitate introduction into the cardiovascular system. The introducer sheath is radiopaque and has a tapered leading tip and a marker band within the tip for visualization.

The distal end of the sheath features a platinum/iridium radiopaque marker for visualization under fluoroscopy. Proximal to the shaft is a housing that contains an extension tube with a 3way stopcock. The hub is an active valve which can be manually open for device introduction to provide hemostasis and minimize blood loss. The dilator is radiopaque with a tapered distal tip. It's lumen is compatible with a 0.035" guidewire.

The technological characteristics of the device is similar to the predicate device. Both device are introducer sheaths with radiopaque shaft with hydrophilic coating and a hemostatic valve designed specifically to minimize blood loss. The design of the hemostatic valves are different but this difference does not affect the safety or efficacy of the device.

1.10 PERFORMANCE DATA

The FlexSeal™ Introducer Sheath with Hydrophilic Coating has been tested to meet the device intended use and to ensure conformance to the product specifications.

The FlexSeal™ Introducer Sheath with Hydrophilic Coating has been tested and meets all its physical and performance specifications on the bench including:

Visual surface inspection
Dimensions ●
Radioapacity visualization o
Guidewire compatibility ●
Hemostasis valve leakage ●

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Kink resistance ●
Bond tensile strength ●
Hydrophilic coating integrity ●
Luer compliance ●
Cracking pressure ●
USP particulate test
Packaging tests ●
Distribution tests ●
Usability studies

In addition, the FlexSeal™ Introducer Sheath with Hydrophilic Coating was tested for biocompatibility per ISO 10993-1 for short duration contact with circulating blood (<24 hours). The testing showed that the device meets all the requirements. The list of tests performed is provided below.

Family of Biocompatibility TestsPerformed	Results
Cytotoxicity	Meets Requirements
Sensitization	Meets Requirements
Irritation/Intracutaneous Reactivity	Meets Requirements
Systemic (Acute) Toxicity	Meets Requirements
Genotoxicity	Meets Requirements
Hemocompatibility	Meets Requirements

The device is sterilized by ethylene oxide to an SAL 105 level. These performances are similar to that described by the predicate device.

1.11 SUBSTANTIAL EQUIVALENCE

The FlexSeal™ Introducer Sheath with Hydrophilic Coating is substantially equivalent to the DrySeal device (K121234). The technological characteristics of the device is similar to the predicate device. Both device are introducer sheaths with radiopaque shaft with hydrophilic coating and a hemostatic valve designed specifically to minimize blood loss. The design of the hemostatic valves are different but this difference does not affect the safety or efficacy of the device.

The conclusions drawn from the nonclinical testing demonstrate that the device is as safe, as effective, and performs as well as the legally marketed device (DrySeal devices (K121234)).

1.12 CONCLUSION

Based on the test data the FlexSeal™ Introducer Sheath with Hydrophilic Coating is found to be substantially equivalent to its predicate.

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).