The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Device Description

AI/ML Overview

Here's a breakdown of the acceptance criteria and study information for the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Met predetermined acceptance criteria for non-toxicity in accordance with BS EN ISO 10993-1:2009.	The materials and methods used to manufacture the subject device are non-toxic and met the predetermined acceptance criteria for their intended use.
Dimensional Stability and Compatibility	Met predetermined acceptance criteria in accordance with an approved study protocol.	The predetermined acceptance criteria were met.
Dilator and Introducer Sheath Tensile Testing	Peak load values in accordance with BS EN ISO 11070:2014, Annex C.	The predetermined acceptance criteria were met.
Liquid Leakage Under Pressure	No leakage under proper clinical use when tested in accordance with an approved study protocol.	The predetermined acceptance criteria were met.
Valve Leakage Testing Under Pressure	No leakage past the hemostasis valve under proper clinical use when tested in accordance with ISO 11070 Annex E and an approved study protocol.	The predetermined acceptance criteria for the respective testing were met.
Rollback and Kink Resistance	No signs of damage (rollback or cracks at tip) or kinking of the shaft under proper clinical use, in accordance with ISO 11070:2014, Annex A.	The predetermined acceptance criteria for the respective testing were met.
Age Testing	Met predetermined acceptance criteria in accordance with BS EN ISO 11070:2014.	The predetermined acceptance criteria for the respective testing were met.
Acute Performance	Met predetermined acceptance criteria in an animal model.	The predetermined acceptance criteria were met.

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

The document does not explicitly state the specific sample sizes for each test conducted on the device. It generally refers to "test articles" or "devices."

Data Provenance: The document does not specify the country of origin for the data or whether the studies were retrospective or prospective. The testing was conducted internally by Cook Incorporated.

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

This information is not provided in the document. The tests seem to be primarily engineering and performance-based against established standards, rather than requiring expert interpretation for ground truth.

4. Adjudication Method for the Test Set

This information is not applicable and therefore not provided. The testing described is objective performance testing against predefined criteria, not subjective interpretation requiring adjudication.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. This device is a medical instrument (catheter introducer) and not a diagnostic imaging or AI-driven decision support system, so such a study would not be relevant. The study focuses on the device's physical and functional performance.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, a "standalone algorithm performance" study was not done. This device is a physical medical instrument, meaning there is no algorithm or AI component involved.

7. The Type of Ground Truth Used

The ground truth used for performance validation was based on established industry standards and approved study protocols. For instance:

Biocompatibility: BS EN ISO 10993-1:2009
Tensile Testing: BS EN ISO 11070:2014, Annex C
Valve Leakage Testing: ISO 11070 Annex E
Rollback and Kink Resistance: ISO 11070:2014, Annex A
Age Testing: BS EN ISO 11070:2014
Acute Performance: "animal model" (implying physiological outcomes measured against a standard or control)

8. The Sample Size for the Training Set

This information is not applicable as there is no mention of a "training set" for an algorithm or AI model in this device submission. The device is a physical product, not a software or AI application.

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

This information is not applicable for the same reason as point 8.

Summary

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June 4, 2018

Cook Incorporated Jennifer Allman Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47404

Re: K171609

Trade/Device Name: Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB Dated: May 3, 2018 Received: May 4, 2018

Dear Jennifer Allman:

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 - Jennifer Allman

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 comprehensive regulatory information about medical devices and radiation-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) K171609

Device Name

Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set

Indications for Use (Describe)

The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Type of Use (Select one or both, as applicable)
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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

Submitted By:

K171609

Jennifer L. Allman Cook Incorporated 750 Daniels Way P.O. Box 489 Bloomington, IN 47402 Phone: (812) 335-3575 x104280 Fax: (812) 332-0281 Date Prepared: May 30, 2018

Device:

Trade Name:	Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set
Common Name:	Catheter Introducer
Classification Name:	Introducer, Catheter DYB (21 CFR §870.1340)

Indications for Use:

The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Predicate Device:

The predicate device for this submission is the Cook Incorporated Flexor® Radial Hydrophilic Introducer Access Set cleared for commercial distribution under 510(k) number K152044, on August 14, 2015.

Comparison to Predicate Device:

It has been demonstrated that the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is comparable to the predicate device (K152044) in terms of intended use, principles of operation, and basic technological characteristics. The subject device provides additional lengths, fewer diameters, and differing materials as compared to the predicate device (K152044). Additionally, the subject device includes with differing materials and dimensions as compared to the predicate device. The substantial equivalence of the subject device to the predicate device is supported by performance and biocompatibility testing.

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COOK INCORPORATED 750 DANIELS WAY, P.O. BOX 489 BLOOMINGTON, IN 47402-0489 U.S.A. 2.339.2235 TOLL FREE: 800.457.4500 www.cookmedical.com

Device Description:

The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a Class II device according to 21 CFR §870.1340; product code DYB (Catheter Introducer). The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is composed of an introducer sheath and dilator. The subject device also includes additional procedural components such as a wire guide and a 21 gage needle with a 4 inch length. Some subject device configurations also include a luer locking syringe. Table 1 of this 510(k) Summary provides a product matrix of the subject device components. The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is intended to introduce diagnostic and interventional devices in radial artery access procedures.

Introducer OutsideDiameter (French)	IntroducerLength (cm)	Dilator Tip InsideDiameter (inches)	Wire Guide (cm)
			Diameter (inches)	Length (cm)
4.0	5.5	0.018	0.018	30
	13		0.018	40
	23		0.018	40
5.0	5.5	0.018	0.018	25
	7		0.018	30
	13		0.018	40
	23		0.018	80
6.0	5.5	0.018	0.018	25
	7		0.018	25
	13		0.018	40
	23		0.018	80

Table 1: Dimensional Variants of the Subject Device
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Table 2: Comparison of Technological Characteristics

Technological Characteristic		PREDICATE DEVICEFlexor Radial HydrophilicIntroducer Access Set(K152044)	SUBJECT DEVICECheck-Flo® Performer™Introducer Micropuncture®Radial Artery Access Set
		Introducer
Outside Diameter (French)	Length (cm)
4.0	5.5		X
4.0	7		X
4.0	13	X	X
4.0	23	X	X
5.0	5.5		X
5.0	7	X	X
5.0	13	X	X
5.0	23	X	X
6.0	5.5		X
6.0	7	X	X
6.0	13	X	X
6.0	23	X	X
7.0	13	X
7.0	23	X
Check-Flo Valve Assembly		X	X
Wire Guide
Diameter (inch)	0.018	X	X
Needle
Diameter (gage)	21	X	X

The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set is a packaged, sterile device intended for single patient use.

There are no prior submissions for the subject device.

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COOK
INCORPORATED
750 DANIELS WAY, P.O. BOX 489
BLOOMINGTON, IN 47402-0489 U.S.A.
PHONE: 812.339.2235 TOLL FREE: 800.457.4500
WWW.COOKMEDICAL.COM

Test Data:

The Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests were conducted to ensure reliable design and performance:

Biocompatibility Testing Testing was performed in accordance with . BS EN ISO 10993-1:2009, the materials and methods used to manufacture the subject device are non-toxic and met the predetermined acceptance criteria for their intended use.
Dimensional Stability Dimensional Stability and Compatibility Testing of the Check-. Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set was performed in accordance with an approved study protocol. The predetermined acceptance criteria were met.
. Dilator and Introducer Sheath Tensile Testing – Tensile testing verified that under proper clinical use of the dilator and introducer sheath, the peak load values shall be in accordance with BS EN ISO 11070:2014. Annex C. The predetermined acceptance criteria were met.
Liquid leakage under pressure Leakage testing verified that under proper clinical use . the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set shall not leak when tested in accordance with an approved study protocol. The predetermined acceptance criteria were met.
Valve leakage testing under pressure testing Valve leakage testing verified that under . proper clinical use the Check-Flo® Performer™ Introducer Micropuncture® Radial Artery Access Set shall not leak past the hemostasis valve when tested in accordance with ISO 11070 Annex E. and an approved study protocol. The predetermined acceptance criteria for the respective testing were met.
Rollback and Kink Resistance Insertion testing of the Cook Inc. Check-Flo® . Performer™ Introducer Micropuncture® Radial Artery Access Set in accordance with ISO 11070:2014. Annex A verified that under proper clinical use of the dilator and introducer sheath, each test article shall show no signs of damage such as rollback or cracks at the tip and/or signs of kinking of the shaft. The predetermined acceptance criteria for the respective testing were met.

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Age Testing Performance testing was conducted on aged Check-Flo® Performer™ . Introducer Micropuncture® Radial Artery Access Set devices in accordance with BS EN ISO 11070:2014. The predetermined acceptance criteria for the respective testing were met.
Acute Performance Acute Performance Evaluation of the Check-Flo® Performer™ . Introducer Micropuncture® Radial Artery Access Set was performed in an animal model. The predetermined acceptance criteria were met.

In conclusion, the results of these tests support a determination of substantial equivalence to the predicate device.

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).