The Performer® Introducer is manufactured using radiopaque tubing with a radiopaque band at the tip. The proximal end consists of a stopcock, connecting tube and the Y-Connector, which connects the sheath to the connecting tube and stopcock; the Y-Connector contains a hemostatic valve. The subject device is available with outside diameters ranging from 5.5 - 7 French and a length of 6 centimeters. The dilator is compatible with wire guides 0.035 inches in diameter. The supplied dilator is designed to extend beyond the tip of the sheath when the dilator is fully inserted through the hemostatic valve of the Y-Connector. The Performer® Introducer is a sterile device intended for single use only.

AI/ML Overview

The provided text describes the 510(k) summary for the Cook Incorporated Performer® Introducer (K173068). It focuses on demonstrating substantial equivalence to a predicate device, primarily through performance testing against established standards rather than clinical studies involving human readers or extensive ground truth adjudication.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility	Predetermined acceptance criteria met (in accordance with ISO 10993-1:2009 for cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemolysis, partial thromboplastin time, and complement activation)	The predetermined acceptance criteria were met.
Dimensional Sheath I.D and Length, and Sheath/Dilator/Wire Guide Compatibility Testing	Sheath inner diameter, sheath length, and sheath/dilator/wire guide compatibility met predetermined acceptance criteria.	The results verified, under the proper clinical use of the subject device, the sheath inner diameter, sheath length, and sheath/dilator/wire guide compatibility met the predetermined acceptance criteria.
Gravity Flow Testing	Y-Connector Clamp able to prevent flow through the connecting tube.	The results verified, under the proper clinical use of the subject device, the Y-Connector Clamp was able to prevent flow through the connecting tube. Thus, the predetermined acceptance criterion was met.
Leakage Testing	No liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E.	The results verified, under the proper clinical use of the subject device, there was no liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E. The predetermined acceptance criteria were met.
Radiopacity Testing	Test articles visible when imaged under fluoroscopy.	The results verified, under the proper clinical use of the subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criteria were met.
Rollback and Kink Testing	No rollback and/or kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A.	Test results verified, under proper clinical use of the subject device, there was no rollback and/or kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A. The predetermined acceptance criteria were met.
Tensile Testing (Joint Strengths)	Bond strengths in accordance with BS EN ISO 11070:2014, Annex C (for Sheath Radiopaque Tip to Shaft Joint, Sheath Shaft to Hub Joint, Hub to Connecting Tube Joint, Connecting Tube to Side-arm Y-Connector Joint, and Dilator Hub to Shaft Joint Strength).	The results verified, under the proper clinical use of the subject device, the bond strengths were in accordance with BS EN ISO 11070:2014, Annex C. The predetermined acceptance criteria were met.
Aged Testing	Respective performance tests (listed above) meet predetermined acceptance criteria after accelerated aging to 3 years.	Accelerated aging to the equivalence of three years was conducted on the Performer® Introducers. Thereafter, the performance testing listed here was conducted again on aged Performer® Introducers in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective aged performance testing were met.

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

The document does not specify exact sample sizes for each test. The testing described is primarily laboratory-based physical and material testing, not human clinical trials or analysis of patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable in the context of this 510(k) summary. The "test set" refers to the manufactured device units subjected to the various physical performance tests.

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

This information is not applicable. The device is a physical medical instrument (catheter introducer), and its performance acceptance criteria are based on engineering standards (e.g., ISO, BS EN ISO) and functional requirements, not on interpretations or diagnoses by medical experts. "Ground truth" for these tests is defined by the objective measurements and adherence to the physical and material properties specified in the standards.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like "2+1" typically refer to reconciling disagreements among multiple human readers in diagnostic studies. Here, the "test set" involves objective physical and material tests with predefined acceptance criteria. The results are either "met" or "not met" based on measurements against those standards.

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

No such study was done. This 510(k) summary is for a physical medical device (catheter introducer), not an AI-powered diagnostic or assistive tool.

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

No such study was done. This device is not an algorithm.

7. The type of ground truth used

The "ground truth" for the Performer® Introducer's performance is based on objective engineering and material test standards (e.g., ISO 10993-1:2009 for biocompatibility, BS EN ISO 11070-1:2014 for leakage and tensile testing, BS EN ISO 11070 for rollback and kink testing) and predetermined functional requirements (e.g., preventing flow, proper dimensions, visibility under fluoroscopy). It is not pathology, expert consensus, or outcomes data in the typical sense of a diagnostic device.

8. The sample size for the training set

This information is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured following a design and tested against established performance standards.

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

This information is not applicable as there is no "training set."

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The logos are displayed side-by-side.

November 17, 2017

Cook Incorporated Mr. Reuben Lidster Regulatory Affairs Specialist 750 Daniels Way, P.O. Box 489 Bloomington, IN47402

Re: K173068

Trade/Device Name: Performer Introducer Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: September 28, 2017 Received: September 29, 2017

Dear Mr. Lidster:

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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);

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Page 2 - Mr. Reuben Lidster

and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

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) K173068

Device Name Performer Introducer

Indications for Use (Describe)

Performer introducers and guiding sheaths are intended to introduce therapeutic devices into the vasculature.

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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5.0 510(k) SUMMARY

COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 OMINGTON, IN 47402-0489 WW.COOKMEDI

K173068 Page 1 of 3

Performer® Introducer 21 CFR §807.92 Date Prepared: September 28, 2017

Submitted By:

Applicant:	Cook Incorporated
Contact:	Reuben G. Lidster
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x104866
Contact Fax Number:	(812) 332-0281

Subject Device Information:

Trade Name:	Performer® Introducer
Common Name:	Catheter Introducer
Classification Name:	Catheter Introducer
Regulation/Product Code:	21 CFR §870.1340/DYE
Device Class/Panel:	Class II/Cardiovascular

Predicate Device:

The Performer® Introducer (COOK, Inc. K171999) was cleared for commercial distribution on July 31, 2017.

Subject Device Description:

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Cook Incorporated - Traditional 510(k) Performer® Introducer September 28, 2017

hemostatic valve of the Y-Connector. The Performer® Introducer is a sterile device intended for single use only.

Intended Use:

Performer Introducers and Guiding Sheaths are intended to introduce therapeutic or diagnostic devices into the vasculature.

Comparison to the Predicate:

The indication for use for both the predicate device and the subject device are identical. The predicate device includes a broader scope of diameters and length as compared to the subject device. Furthermore, the subject device is similar to the predicate device in terms of design, the fundamental technological characteristics and method of operation. These differences do not raise additional questions of safety or effectiveness.

Reference Device:

The subject device is similar in design and identical in fundamental technological characteristics and method of operation to the reference device, the Prelude® Short Sheath Introducer (K082063).

Technological Characteristics:

The following tests were performed to demonstrate the Performer® Introducer met the applicable design and performance requirements and these tests support a determination of substantial equivalence.

Biocompatibility Testing - The following tests were performed in accordance with ISO 10993-1:2009 - cytotoxicity, sensitization, intracutaneous reactivity, acute systemic toxicity, pyrogenicity, hemolysis, partial thromboplastin time, and compliment activation. The predetermined acceptance criteria were met.
Dimensional Sheath I.D and Length, and Sheath/Dilator/Wire Guide Compatibility Testing - The results verified, under the proper clinical use of the subject device, the sheath inner diameter, sheath length and sheath/dilator/wire guide compatibility met the predetermined acceptance criteria.

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Gravity Flow Testing - The results verified, under the proper clinical use of the subject device, the Y-Connector Clamp was able to prevent flow through the connecting tube. Thus, the predetermined acceptance criterion was met.
= Leakage Testing - The results verified, under the proper clinical use of the subject device, there was no liquid leakage when tested in accordance with BS EN ISO 11070-1:2014, Annex D and/or E. The predetermined acceptance criteria were met.
. Radiopacity Testing - The results verified, under the proper clinical use of the subject device, the test articles were visible when imaged under fluoroscopy. The predetermined acceptance criteria were met.
. Rollback and Kink Testing - Test results verified, under proper clinical use of the subject device, there was no rollback and/or kink of the sheath when tested in accordance with BS EN ISO 11070, Annex A. The predetermined acceptance criteria were met.
Tensile Testing of the Sheath Radiopaque Tip to Shaft Joint Strength, Sheath Shaft to Hub Joint Strength, Hub to Connecting Tube Joint Strength, Connecting Tube to Side-arm Y-Connector Joint Strength and Dilator Hub to Shaft Joint Strength - The results verified, under the proper clinical use of the subject device, the bond strengths were in accordance with BS EN ISO 11070:2014, Annex C. The predetermined acceptance criteria were met.
. Aged Testing - Accelerated aging to the equivalence of three years was conducted on the Performer® Introducers. Thereafter, the performance testing listed here was conducted again on aged Performer® Introducers in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective aged performance testing were met.

Conclusion:

The results of the tests support the conclusion, the Performer® Introducer met the design input requirements based on the intended use. These results also support the conclusion that the intended use, design and material differences for the subject device, when compared to the predicate device, the Performer® Introducer (K171999), do not raise new questions 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).