The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for non-vascular use.

Device Description

Cook's Peel-Away® Introducer Sets are single-use, sterile, disposable products that are used to provide initial percutaneous access. They are comprised of a co-axial introducer assembly (peel-away sheath and dilator). Sets may contain a wire guide in a size fitted to the endhole of the dilator and may contain an access needle in a gage that allows the included wire guide to pass through its lumen. Additional set components (e.g., luer-slip syringe, thumb scalpel) are available.

AI/ML Overview

The provided document is a 510(k) premarket notification for a medical device (Peel-Away® Introducer Set). It outlines the device's indications for use, comparison to predicate devices, and technological characteristics, including test results. However, it does not contain information regarding a study that proves the device meets acceptance criteria in the context of an AI/ML powered device. The acceptance criteria and testing described are for the physical properties and biocompatibility of a traditional medical device (catheter introducer set), not for the performance of an algorithm.

Therefore, I cannot provide the requested information for acceptance criteria and a study proving an AI/ML device meets them, as this document describes a traditional device submission.

If this was a misunderstanding and you would like me to extract the acceptance criteria and study results for the physical device described in the document, please let me know.

Summary

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

September 28, 2017

Cook Incorporated Colin Jacob Capital Equipment Specialist, Regulatory Affairs 750 Daniels Way, P.O. Box 489 Bloomington, Indiana 47402

Re: K170020

Trade/Device Name: Peel-Away® Introducer Set Regulation Number: 21 CFR 870.1340 Regulation Name: Catheter Introducer Regulatory Class: Class II Product Code: DYB, KNT Dated: August 28, 2017 Received: August 29, 2017

Dear Colin Jacob:

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 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.

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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,

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) K170020

Device Name Peel-Away Introducer Set

Indications for Use (Describe)

The Peel-Away Introducer Set is intended for the percutaneous introduction of balloon, electrode and closed or nontapered end catheters into central and peripheral vasculature, and for non-vascular use.

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

Peel-Away® Introducer Sets (21 CFR §870.1340, 21 CFR §876.5980) Date Prepared: August 28, 2017

K170020

Submitted By:

Applicant:	Cook Incorporated
Contact:	Colin Jacob
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x 104965
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Peel-Away® Introducer Set
Common Name:	Introducer, Catheter; Tube, Gastro-Enterostomy
Classification Name/Panel:	Catheter Introducer, Gastrointestinal tube and accessories –Gastroenterology/Urology, Cardiovascular
Regulation:	21 CFR §876.5980, 21 CFR §870.1340
Product Code:	DYB, KGC

Predicate Devices:

Primary: Galt Medical Tearaway Introducer Sheath (K153533)
Secondary: Kimberly-Clark Enteral Access Dilation System (K093312)

Device Description:

Indications for Use:

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Cook Incorporated – Traditional 510(k) Peel-Away Introducer Sets August 28, 2017

	Comparison to Predicates:
	SUBJECT DEVICE	PRIMARY PREDICATE	SECONDARY PREDICATE
	Peel-Away® IntroducerSets	Tearaway Introducer Sheath	Kimberly-Clark EnteralAccess Dilation System
Manufacturer	Cook Incorporated	Galt Medical Corp.	Kimberly-Clark Corporation →Halyard
510(k)	K170020	K153533	K093312
Regulation	21 CFR § 870.1340,21 CFR § 876.5980	21 CFR § 870.1340	21 CFR § 876.5980
Product Code	DYB, KGC	DYB	KGC
Classification	IDENTICAL TOPREDICATES	II	II
Indicationsfor Use	The Peel-Away IntroducerSet is intended for thepercutaneous introductionof balloon, electrode andclosed or non-tapered endcatheters into central andperipheral vasculature, andfor non-vascular use.	Adult Only – TearawayIntroducer Sheath: Theintroducer is used for thepercutaneous introduction ofdiagnostic or therapeuticdevices, such as catheters andpacing leads, into thevasculature.*	The Kimberly-Clark EnteralAccess Dilation System isintended to facilitate stoma tractdilation prior to placement of theKimberly-Clark MIC and MIC-Key brand Enteral FeedingTubes.It is recommended that thesedilator be used only with theKimberly-Clark MIC and MIC-KEY brand Enteral FeedingTubes.
PatientPopulation	Adults	Adults	Adults
Placement	IDENTICAL TOPREDICATES	Percutaneous	Percutaneous
ClinicalApplication	General (i.e., for vascularand non-vascular use)	Vascular use	Non-vascular use (specificallyfor placement of feeding tubes)
Design	IDENTICAL TOPREDICATES	Galt Tearaway Introducersassembly includes outerpeelable sheath and a dilator.Peelable sheath has a wingedhub to facilitate the tear in thesheath.	Kimberly Clark Peel-AwayIntroducers assembly includesouter peelable sheath and adilator. Peelable sheath has awinged hub to facilitate the tearin the sheath.
Shape	IDENTICAL TOPREDICATES	Introducer Sheath: wingedhub, cylindrical cannulaDilator: Round hub,cylindrical cannula	Introducer Sheath: winged hub,cylindrical cannulaDilator: Round hub, cylindricalcannula
		SUBJECT DEVICE	PRIMARY PREDICATE	SECONDARY PREDICATE
		Peel-Away® IntroducerSets	Tearaway Introducer Sheath	Kimberly-Clark EnteralAccess Dilation System
Dimensions	Introducer(Dilator +Sheath)Diameter	3.5-26 Fr	3-16 Fr	16-24 Fr
	DilatorLength	11, 13, 20 cm	Unknown	Unknown
	SheathLength	7, 9, 13, 15.5 cm	Unknown	Unknown
	WireGuideDiameter	0.018, 0.021, 0.025, 0.035,0.038 in	0.008, 0.010, 0.014, 0.018,0.035, 0.038 in	0.025, 0.035 in
	WireGuideLength	30, 50, 70, 100 cm	20, 40, 60 cm	Unknown
Materials	Dilator	3.5 to 12 Fr: RadiopaquePolyethylene13 to 26 Fr: Vinyl	Unknown	Unknown
	Sheath	Thick Wall SheathingRadiopaque TFE (VRTS)	Unknown	High density polyethylene(HDPE)
	WireGuide	Stainless SteelSolder	Unknown	Unknown
Additional SetComponents		Entry access needle, needleholder cup, luer-slipsyringe, serial dilators,thumb scalpel	Entry access needles,additional serial dilators	Entry access needle, syringe,#11 safety scalpel, gauze pads,catheter tip syringe, introducercannula
Duration ofUse		IDENTICAL TOPREDICATES	Single UseLimited Duration (≤ 24 hours)	Single UseLimited Duration (≤ 24 hours)
Shelf Life		3 years	Unknown	Unknown
SterilizationProcess		IDENTICAL TOPREDICATES	Ethylene oxide	Ethylene oxide

Comparison to Predicates:

K153533 was a bundled submission that included 2 to 3 Fr sizes for adult and pediatric use.

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Cook Incorporated – Traditional 510(k)
Peel-Away Introducer Sets
August 28, 2017

Comparison to Predicates (continued):

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Cook Incorporated - Traditional 510(k) Peel-Away Introducer Sets August 28, 2017

Technological Characteristics:

The proposed device, Peel-Away® Introducer Sets, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests are listed below:

. Introducer knob to Shaft Tensile - Test articles must meet the force break requirements. Test results met predetermined criteria.
. Peel Force – Characterization of peel force for various Peel-Away Introducer sheath sizes was successfully performed.
. Dilator Hub to Shaft Tensile - Test articles must statistically demonstrate that 90% of test articles at the 95% confidence can be expected to meet or exceed the requirements of BS EN ISO 11070: 2014. Test results met predetermined criteria.
. Radiopacity Evaluation - Test articles must demonstrate that the shaft gradient shall fall along the gradient of an aluminum X-ray step wedge gauge, following the method described in ASTM F6540-12, "Standard Test Methods For Determining Radiopacity for Medical Use." Test results met predetermined criteria.
. Wire guide Corrosion evaluation - Wire guides should not have any visual evidence of corrosion that could affect their functional performance. Test results met predetermined criteria.
. Wire Guide Fracture evaluation -The wire shall not fracture when wound around an appropriate former for at least three complete turns. Test results met predetermined criteria.
. Wire Guide Flex evaluation -The wire guide should show no signs of defects or damage, including flaking or material loss, when subjected to repeat flexing. Test results met predetermined criteria.
. Wire Guide Tensile Evaluation – Test articles must demonstrate Per the standard, minimum tensile strength for wire guides with having a diameter greater than or equal to 0.55 mm but less than 0.75 mm should have a peak load to failure greater than or equal to 5 N, and wire guides with diameters greater than 0.75 mm should have a peak load to failure greater than 10 N. The standard does not specify tensile strength for wire guide diameters less than 0.55 mm and requires the values to determined based on the risk assessment. Test results met predetermined criteria.

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Cook Incorporated - Traditional 510(k) Peel-Away Introducer Sets August 28, 2017

Biocompatibility Per ISO 10993-1, testing for cytotoxicity, sensitization, . intracutaneous irritation, acute systemic toxicity, thrombogenicity, materialmediated pyrogenicity, and hemocompatibility were performed to ensure the biocompatibility of the subject device set. Test results indicated that all materials are biocompatible.

Conclusion:

The results of these tests show that the Peel-Away® Introducer Sets meet the design input requirements based on the intended use. Further, these results support the conclusion that the Peel-Away® Introducer Sets do not raise new questions of safety or effectiveness and support a determination of substantial equivalence.

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).