The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal arteries while maintaining hemostasis during diagnostic and interventional procedures.

Device Description

The Fortress Introducer Sheath System is a sterile, disposable device. It is a prescription medical device that is used only in healthcare facilities or hospitals. The device is placed in patients for up to 24 hours.

The Fortress Introducer Sheath System consists of an introducer sheath with hemostasis valve and side port, as well as a dilator with a tapered tip and luer lock at the proximal end. The main introducer sheath tubing is connected at the proximal end to a hemostasis valve with side port tubing that is connected to a plastic 3-way stopcock valve. The side port is used for flushing the introducer sheath. The introducer sheath is introduced into the vascular system with the aid of the dilator. The hemostasis valve at the proximal end of the introducer sheath conforms and seals around guide wires and catheters to reduce blood leakage from the introducer sheath. A radiopaque marker helps identify the distal end of the introducer sheath. The introducer sheath (5F and 6F sizes) has a hydrophobic silicone coating on the outer surface of the distal 30cm portion.

The System consists of the following components:

A One Introducer Sheath with hemostasis valve
A Two dilators: 5F and 6F 100cm version
A One dilator: 5F and 6F 45cm version

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the Fortress Introducer Sheath System. It details the device's indications for use, comparison to a predicate device, and the testing performed to demonstrate substantial equivalence.

Here's the breakdown of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

The acceptance criteria for each test are implicitly stated as "Passed," indicating that the device met the pre-defined requirements for each test. The actual numerical or descriptive criteria for "passing" are not explicitly listed in this summary, but the "Test Result" column confirms that all tests were successfully completed according to their respective acceptance criteria.

Test Name	Test Method	Reported Device Performance (Acceptance Criteria)
Balloon Pull Back Test (Robustness Test)	Visual InspectionDimensional InspectionInsertion Force TestPull Back Force TestDestructive Pull Test	Passed
Accelerated Aging	Visual InspectionCoating IntegritySheath Liquid Leakage - (Pressure Test)Sheath System Insertion ForceSheath Pull Out TestSheath Kink ResistanceSheath Creep To BreakSheath Force At BreakDilator Force At Break	Passed
Valve Leak Test	Pressure Test	Passed
Particulates Evaluation Test	Membrane Filtration	Passed
Biological Risk Assessment	Qualitative Evaluation	Passed
Cytotoxicity	Quantitative Evaluation	Passed
Pig Skin Test	Insertion Force Test	Passed
Visibility under X-ray	X-Ray Test	Passed
Packaging Integrity Validation	Visual InspectionDye Penetration TestPeel TestBalloon Pull Back TestKink TestCreep TestPull Test	Passed
Sterilization Validation	LAL - Pyrogenicity TestingBioburdenBioburden Recovery Factor DeterminationEO/ECH Residuals	Passed
LAL Validation	Gel Clot Method	Passed

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample sizes used for each of the tests. The tests performed are primarily performance and safety tests on the device itself (e.g., mechanical testing, material compatibility, sterilization), not clinical studies with human subjects. Therefore, typical data provenance details like "country of origin" or "retrospective/prospective" are not applicable in the way they would be for a clinical trial. The testing appears to be laboratory-based verification and validation.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

Not applicable. The tests performed are laboratory-based engineering and biological compatibility tests, not evaluations requiring expert consensus on clinical imagery or patient data. The "ground truth" for these tests would be established by the industry standards and methodologies followed (e.g., ISO standards, ASTM standards, FDA guidance documents) by qualified laboratory personnel.

4. Adjudication Method for the Test Set

Not applicable. The tests are objective measurements and evaluations against pre-defined engineering and safety specifications, not subjective assessments requiring adjudication among multiple observers.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and effect size

No, an MRMC comparative effectiveness study was not done. The document focuses on demonstrating substantial equivalence through non-clinical performance and safety testing. The device is an introducer sheath system, which is a physical medical device, not an AI software or imaging diagnostic tool that would typically undergo MRMC studies.

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

Not applicable. The Fortress Introducer Sheath System is a physical medical device, not an algorithm or AI software. Therefore, the concept of "standalone algorithm performance" (without human-in-the-loop) does not apply.

7. The Type of Ground Truth Used

The ground truth used for these tests is based on established engineering principles, material science, biological compatibility standards, and regulatory guidance documents. For instance:

Mechanical tests: "Ground truth" is defined by the device's design specifications and performance limits (e.g., strength, kink resistance, insertion force) derived from engineering analysis and comparison to predicate devices, verified through physical measurements.
Biological tests (Cytotoxicity, LAL, Sterilization): "Ground truth" is defined by accepted biological safety standards and validated testing protocols to ensure the device is non-toxic, non-pyrogenic, and sterile.
Visibility under X-ray: "Ground truth" is the device's observable radiopacity under X-ray imaging.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical instrument, not an AI or machine learning model. Therefore, there is no "training set" in the context of data-driven model development.

9. How the Ground Truth for the Training Set was Established

Not applicable, as there is no "training set" for this type of device.

Summary

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

January 11, 2016

Contract Medical International, GmbH c/o Ms. Jan Kloboucnik Director, RA/QA Lauensteiner Straße 37 01277 Dresden, Germany

Re: K153197

Trade/Device Name: Fortress Introducer Sheath System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, DRE Dated: December 11, 2015 Received: December 14, 2015

Dear Ms. Kloboucnik:

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 device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set

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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

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.

of Surveillance and Biometrics/Division of Postmarket Surveillance.

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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Indications for Use

510(k) Number (if known)

K153197

Device Name Fortress Introducer Sheath System

Indications for Use (Describe)

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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510(k) SUMMARY

1.1 Submitter

Submitter:

Submitter:	Contract Medical GmbHLauensteiner Strasse 3701277 DresdenGermany
Contact Person:	Jan Kloboucnik, Director RAQA
Phone:	+420 494 949 564
Email:	jkloboucnik@contract-medical.com
Date Summary Prepared:	11th January 2016

1.2 Device

Device Trade Name: Fortress Introducer Sheath System Device Common Name: Introducer Sheath Classification Name: Introducer Catheter 21CFR Part 870.1340, and Dilator, Vessel, For Percutaneous Catheterization 21CFR Part 870.1310 Device Class: -Product Code: DYB, and DRE

1.3 Predicate Device

The predicate device is the 4F size of the Fortress Introducer Sheath System (K100799)

1.4 Device Description

The System consists of the following components:

A One Introducer Sheath with hemostasis valve
A Two dilators: 5F and 6F 100cm version
A One dilator: 5F and 6F 45cm version

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1.5 Indications for Use

The Fortress Introducer Sheath System is intended to provide access and to facilitate percutaneous introduction of guide wires, catheters and other devices into the femoral, popliteal and infrapopliteal arteries while maintaining hemostasis during diagnostic and interventional procedures.

This is the same intended use as for the previously cleared 4F Fortress Introducer Sheath System, model numbers 358813, 358814 and 358815 (K100799).

1.6 Comparison of Technological Characteristics with the Predicate Device

The 5F and the 6F size of the Fortress Introducer Sheath System is a manually operated, sterile, single patient use sheath system made predominantly of thermoplastic polymers. The sheath is reinforced with a stainless steel coil in order to provide kink resistance when passed through tortuous paths. With regard to the design, device features, method of sterilization, and mode of operation, the 5F and 6F Fortress Introducer Sheath System does not differ from the predicate device.

Materials used for manufacture of the 5Fand 6F Fortress Introducer Sheath System are the same or very similar as those contained in the predicate device. Technological characteristics of the subject device differ from those of the predicates only with respect to addition of lubricious coating on the sheath. The hydrophobic coating applied to the distal end of the sheath is commonly used in medical devices, including introducer sheaths and catheters. Differences in technological characteristics between the subject device and the predicate do not raise and concerns of safety and effectiveness, as demonstrated by the data collected.

1.7 Substantial Equivalence

Verification and validation tests were designed and performed in accordance with Design Controls as per 21 CFR §820.30. The following tests were conducted per guidance documents and standards to determine appropriate methods for evaluating the performance of the device and determine substantial equivalence:

Test Name	Test Method	Test Result
Balloon Pull Back Test (Robustness Test)	Visual InspectionDimensional InspectionInsertion Force TestPull Back Force TestDestructive Pull Test	Passed
Accelerated Aging	Visual InspectionCoating IntegritySheath Liquid Leakage - (Pressure Test)Sheath System Insertion ForceSheath Pull Out TestSheath Kink ResistanceSheath Creep To BreakSheath Force At BreakDilator Force At Break	Passed

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Test Name	Test Method	Test Result
Valve Leak Test	Pressure Test	Passed
Particulates Evaluation Test	Membrane Filtration	Passed
Biological Risk Assessment	Qualitative Evaluation	Passed
Cytotoxicity	Quantitative Evaluation	Passed
Pig Skin Test	Insertion Force Test	Passed
Visibility under X-ray	X-Ray Test	Passed
Packaging Integrity Validation	Visual InspectionDye Penetration TestPeel TestBalloon Pull Back TestKink TestCreep TestPull Test	Passed
Sterilization Validation	LAL - Pyrogenicity TestingBioburdenBioburden Recovery Factor DeterminationEO/ECH Residuals	Passed
LAL Validation	Gel Clot Method	Passed

Acceptance criteria were met for all performed tests, the results showed that the modifications do not have negative impact on the device safety and effectiveness of the device.

1.8 Conclusions

The results of performed testing based on risk analysis demonstrate that the 5F and 6F Fortress Introducer Sheath System performs comparably with the predicate and other legally marketed devices.

The 5F and 6F Fortress Introducer Sheath System is substantially equivalent to the predicate device in terms of intended use, design and materials, technological characteristics, and principle of operation. Any differences between the subject device and the predicate do not raise any issues of safety or effectiveness.

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).