Peel-Away Introducer Set

• K Number: K170020
• Device Name: Peel-Away Introducer Set
• Manufacturer: Cook Incorporated
• Date Cleared: 2017-09-28 ( 268 days)
• Product Code: DYB KNT
• Regulation Number: 870.1340

Intended Use

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.

Predicate Devices

K153533, K093312

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The device description and performance studies focus on the physical properties and functionality of a mechanical introducer set, with no mention of AI or ML.

Therapeutic

No
This device is an introducer set, intended for the introduction of other catheters, not for providing therapy itself.

Diagnostic

No

Explanation: The device is an introducer set used for percutaneous introduction of catheters, not for diagnosing a condition or disease.

SaMD (Software as a Medical Device)

No

The device description and performance studies clearly indicate a physical medical device (introducer set, wire guide, needle, syringe, scalpel) with associated hardware testing (tensile strength, peel force, radiopacity, corrosion, fracture, flex, biocompatibility). There is no mention of software as the primary or sole component.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

• Intended Use: The intended use clearly states the device is for the "percutaneous introduction of balloon, electrode and closed or non-tapered end catheters into central and peripheral vasculature, and for non-vascular use." This describes a surgical or interventional procedure, not a diagnostic test performed on samples taken from the body.
• Device Description: The description details a physical device used for access and introduction of other medical devices. It does not mention any components or functions related to analyzing biological samples (like blood, urine, tissue, etc.).
• Performance Studies: The performance studies focus on the physical properties and performance of the device itself (tensile strength, peel force, radiopacity, wire guide properties, biocompatibility). These are typical tests for medical devices used in procedures, not for IVDs which would involve studies on diagnostic accuracy (sensitivity, specificity, etc.).

IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

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.

Product codes

DYB, KGC

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.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

Central and peripheral vasculature, and non-vascular use.

Indicated Patient Age Range

Adults

Intended User / Care Setting

Not Found

Description of the training set, sample size, data source, and annotation protocol

Not Found

Description of the test set, sample size, data source, and annotation protocol

Not Found

Summary of Performance Studies

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

Key Metrics

Not Found

Predicate Device(s)

K153533, K093312

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

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).

Summary

0

Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, stacked on top of each other.

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.

1

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 [phone] or [phone] 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 [phone] or [phone] 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

2

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)

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 the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff [e-mail]

"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

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 Incorporated
750 Daniels Way
Bloomington, IN 47404
Contact Phone Number:	[phone] x 104965
Contact Fax Number:	[phone]

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:

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.

Indications for Use:

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.

4

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

	Comparison to Predicates:
	SUBJECT DEVICE	PRIMARY PREDICATE	SECONDARY PREDICATE
	Peel-Away® Introducer
Sets	Tearaway Introducer Sheath	Kimberly-Clark Enteral
Access 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 TO
PREDICATES	II	II
Indications
for Use	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.	Adult Only – Tearaway
Introducer Sheath: The
introducer is used for the
percutaneous introduction of
diagnostic or therapeutic
devices, such as catheters and
pacing leads, into the
vasculature.*	The Kimberly-Clark Enteral
Access Dilation System is
intended to facilitate stoma tract
dilation prior to placement of the
Kimberly-Clark MIC and MIC-
Key brand Enteral Feeding
Tubes.
It is recommended that these
dilator be used only with the
Kimberly-Clark MIC and MIC-
KEY brand Enteral Feeding
Tubes.
Patient
Population	Adults	Adults	Adults
Placement	IDENTICAL TO
PREDICATES	Percutaneous	Percutaneous
Clinical
Application	General (i.e., for vascular
and non-vascular use)	Vascular use	Non-vascular use (specifically
for placement of feeding tubes)
Design	IDENTICAL TO
PREDICATES	Galt Tearaway Introducers
assembly includes outer
peelable sheath and a dilator.
Peelable sheath has a winged
hub to facilitate the tear in the
sheath.	Kimberly Clark Peel-Away
Introducers assembly includes
outer peelable sheath and a
dilator. Peelable sheath has a
winged hub to facilitate the tear
in the sheath.
Shape	IDENTICAL TO
PREDICATES	Introducer Sheath: winged
hub, cylindrical cannula
Dilator: Round hub,
cylindrical cannula	Introducer Sheath: winged hub,
cylindrical cannula
Dilator: Round hub, cylindrical
cannula
		SUBJECT DEVICE	PRIMARY PREDICATE	SECONDARY PREDICATE
		Peel-Away® Introducer
Sets	Tearaway Introducer Sheath	Kimberly-Clark Enteral
Access Dilation System
Dimensions	Introducer
(Dilator +
Sheath)
Diameter	3.5-26 Fr	3-16 Fr	16-24 Fr
	Dilator
Length	11, 13, 20 cm	Unknown	Unknown
	Sheath
Length	7, 9, 13, 15.5 cm	Unknown	Unknown
	Wire
Guide
Diameter	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
	Wire
Guide
Length	30, 50, 70, 100 cm	20, 40, 60 cm	Unknown
Materials	Dilator	3.5 to 12 Fr: Radiopaque
Polyethylene
13 to 26 Fr: Vinyl	Unknown	Unknown
	Sheath	Thick Wall Sheathing
Radiopaque TFE (VRTS)	Unknown	High density polyethylene
(HDPE)
	Wire
Guide	Stainless Steel
Solder	Unknown	Unknown
Additional Set
Components		Entry access needle, needle
holder cup, luer-slip
syringe, serial dilators,
thumb scalpel	Entry access needles,
additional serial dilators	Entry access needle, syringe,
#11 safety scalpel, gauze pads,
catheter tip syringe, introducer
cannula
Duration of
Use		IDENTICAL TO
PREDICATES	Single Use
Limited Duration (≤ 24 hours)	Single Use
Limited Duration (≤ 24 hours)
Shelf Life		3 years	Unknown	Unknown
Sterilization
Process		IDENTICAL TO
PREDICATES	Ethylene oxide	Ethylene oxide

Comparison to Predicates:

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

5

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

Comparison to Predicates (continued):

6

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.

7

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.