The DuraSheath Introducer Sheath System is indicated to be used for introduction of interventional and diagnostic devices into the human vasculature, including but not limited to femoral access via a contralateral approach to access the popliteal and infrapopliteal arteries.

Device Description

The DuraSheath Introducer Sheath System is a sterile, disposable device consisting of (a) a coil reinforced shaft with an atraumatic tip at the distal end; (b) a hemostasis valve with a side port and color coded 3-way stopcock; and (c) a tapered tip dilator with snap-fit hub at the proximal end. The distal end of the sheath contains a radiopaque marker. Lubricous coating is applied to the distal end of the sheath. The system is packaged inside a sealed Tyvek pouch.

The DuraSheath Introducer Sheath System 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.

AI/ML Overview

This document is a 510(k) Premarket Notification from the FDA regarding the DuraSheath Introducer Sheath System. It details the device's indications for use, comparison to predicate devices, and performance data provided for substantial equivalence, but it does not contain the acceptance criteria or a study proving the device meets specific acceptance criteria in the manner you've requested for AI/diagnostic devices.

Instead, this document focuses on demonstrating that the DuraSheath Introducer Sheath System is "substantially equivalent" to legally marketed predicate devices, meaning it performs similarly and raises no new questions of safety or effectiveness. The performance data provided is primarily non-clinical and related to the physical and material properties of the device, rather than diagnostic accuracy or clinical outcomes as would be seen in studies for AI-powered diagnostic tools.

Therefore, many of your requested points cannot be answered based on the provided text.

Here's how the available information relates to your request:

1. Table of acceptance criteria and the reported device performance

N/A. The document does not provide a table of explicit acceptance criteria with numerical targets for clinical performance (e.g., sensitivity, specificity, AUC) or the device's measured performance against those criteria. Instead, it refers to "non-clinical tests" and "performance data" to demonstrate substantial equivalence to predicate devices in terms of safety and effectiveness, rather than meeting specific quantifiable performance benchmarks.

The "performance data" mentioned falls into these categories:

Mechanical testing: Including tests required under relevant international standards, coating adhesion, particulate testing, and transportation integrity testing. Reported Performance: Performed to verify and validate the design and to demonstrate process capability, with results demonstrating comparable performance to predicates.
Biocompatibility testing: Full range of tests. Reported Performance: Demonstrated biocompatibility.
Sterilization Validation Adoption: To confirm sterility of the device upon exposure to the selected sterilization cycle. Reported Performance: Confirmed sterility.
Accelerated age testing: To confirm product performance and end of shelf life. Reported Performance: Confirmed product performance and end of shelf life.

2. Sample size used for the test set and the data provenance

N/A. The document describes non-clinical engineering and material tests, not tests on patient data sets. Therefore, there is no "test set" in the context of clinical data, sample size, or data provenance (country of origin, retrospective/prospective). These tests are typically conducted in a laboratory setting on manufactured device samples.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

N/A. Since this isn't a diagnostic device and there's no clinical "test set" involving patient data, there's no ground truth established by medical experts in the way that would apply to, for example, an AI image analysis tool.

4. Adjudication method for the test set

N/A. As there is no clinical test set requiring expert adjudication, this is not applicable.

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

N/A. This device (an introducer sheath system) is a physical medical instrument, not an AI-powered diagnostic tool. Therefore, MRMC studies, human reader improvement with AI, or effect sizes are not relevant to its evaluation.

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

N/A. This device does not involve an algorithm.

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

The "ground truth" for this device's evaluation is based on engineering standards, material science, and manufacturing quality control. For example, the ground truth for mechanical testing would be the specified strength or flexibility required by relevant standards, and for biocompatibility, it would be the absence of adverse biological reactions. It's not a clinical "ground truth" derived from patient diagnosis.

8. The sample size for the training set

N/A. The concept of a "training set" applies to machine learning models. This device does not involve AI or machine learning.

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

N/A. As there is no training set, this is not applicable.

In summary: The provided document is an FDA 510(k) clearance letter and summary for a medical device (an introducer sheath). The evaluation framework for such a device focuses on "substantial equivalence" to existing predicate devices, primarily through non-clinical performance data (mechanical, biocompatibility, sterilization, aging). This is fundamentally different from the evaluation criteria and study types used for AI-powered diagnostic tools, which would involve clinical data, ground truth establishment by experts, and statistical performance metrics.

Summary

{0}------------------------------------------------

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus. The logo is simple and professional, reflecting the department's role in public health and human services.

Public Health Service

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

June 24, 2015

Contract Medical International GmbH Jan Kloboucnik Director, Regulatory and Quality Affairs Lauensteiner Str, 37 Dresden, 01277 DE

Re: K142357

Trade/Device Name: DuraSheath Introducer Sheath System Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB. DRE Dated: May 21, 2015 Received: May 26, 2015

Dear Jan 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

{1}------------------------------------------------

Part 807); labeling (21 CFR Part 801); medical device reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in 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 yours,

M.A. Hillebrenner

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

Indications for Use

510(k) Number (if known) K142357

Device Name DuraSheath Introducer Sheath System

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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
	This section applies only to requirements of the Paperwork Reduction Act of 1995.DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including thetime to review instructions, search existing data sources, gather and maintain the data needed and completeand review the collection of information. Send comments regarding this burden estimate or any other aspectof this information collection, including suggestions for reducing this burden, to:
	Food and Drug AdministrationOffice of Chief Information OfficerPaperwork Reduction Act (PRA) StaffPRAStaff(@fda.hhs.gov	Department of Health and Human Services

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

K142357 - 510(k) Summary

1.1 Submitter

Submitter:	Contract Medical International GmbHLauensteiner Straße 3701277 DresdenGermany
Contact Person:	Jan Kloboucnik, Director, RA/QA
Phone:	+420 494 949 564
Fax:	+420 494 949 565
Email:	jkloboucnik@contract-medical.com
Date Prepared:	24 June 2015

1.2 Device

Device Trade Name:	DuraSheath Introducer Sheath System
Device Common Name:	Introducer Sheath
Classification Name:	Introducer, Catheter; andDilator, Vessel, For Percutaneous Catheterization
Regulatory Class:	II
Product Code:	DYB; andDRE

Predicate Device 1.3

Primary Predicate Device:	Pinnacle Destination Guiding Sheath(K091329)
Second Predicate Device:	Fortress Introducer Sheath System(K100799)

1.4 Device Description

The DuraSheath Introducer Sheath System 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.

{4}------------------------------------------------

1.5 Indications for Use

The Indications for Use statement for the DuraSheath Introducer Sheath System is not identical to that of the two predicate devices; however, the differences do not alter the intended use of the device nor do they affect the safety and effectiveness of the device relative to the predicate devices. The DuraSheath Introducer Sheath System and the two predicate devices each have the same intended use, namely to support the introduction of interventional and diagnostic devices.

1.6 Comparison of Technological Characteristics with the Predicate Device

The DuraSheath 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 DuraSheath Introducer Sheath System does not differ from the predicate devices. Materials used for manufacture of the DuraSheath Introducer Sheath System are the same or very similar to those contained in the predicate devices. Technological characteristics of the subject device differ from those of the predicates only with respect to materials for selected components and the choice of lubricious coating on the sheath. Both the polyurethane used for the outer layer and the hydrophobic coating applied to the distal end of the sheath of the DuraSheath Introducer Sheath System are commonly used in medical devices, including introducer sheaths and catheters. Differences in technological characteristics between the subject device and the predicates do not raise and concerns of safety and effectiveness, as demonstrated by the performance data collected.

1.7 Performance Data

Nonclinical and clinical performance data demonstrate that the DuraSheath Introducer Sheath System is safe and effective and performs substantially equivalent to the predicates. The following performance data from non-clinical tests are being provided in support of the substantial equivalence determination:

Mechanical testing, including tests required under relevant international standards, coating adhesion and particulate testing, and transportation integrity testing, performed to verify and validate the design and to demonstrate process capability.
Full range of Biocompatibility testing to demonstrate biocompatibility. ●
Sterilization Validation Adoption to confirm sterility of the device upon exposure to the selected sterilization cycle.
. Accelerated age testing to confirm product performance and end of shelf life.

{5}------------------------------------------------

1.8 Conclusions

Results demonstrate that the DuraSheath Introducer Sheath System performs comparably with predicates and other legally marketed devices. The DuraSheath Introducer Sheath System is substantially equivalent to the two predicates devices in terms of intended use, design and materials, technological characteristics, and principle of operation. Any differences between the subject device and the predicates 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).