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 nonvascular use.

Device Description

The Peel-Away Introducer Set is a single-use, sterile, disposable product that is used to provide initial percutaneous access. It is comprised of a co-axial introducer assembly (peel-away sheath and dilator). Set 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) are available.

AI/ML Overview

The provided text describes a 510(k) premarket notification for a medical device called the "Peel-Away Introducer Set." This submission aims to demonstrate substantial equivalence to a legally marketed predicate device, rather than proving the device meets specific acceptance criteria through a clinical study with performance metrics in the way an AI/ML device submission would.

Therefore, much of the requested information (such as sample size for test set, number of experts for ground truth, adjudication method, MRMC studies, standalone performance, sample size for training set, and how ground truth for training set was established) is not applicable to this type of device submission as it does not involve AI/ML or diagnostic performance evaluation against a defined ground truth.

However, I can extract the acceptance criteria and reported "performance" in the context of the engineering and biocompatibility tests conducted.

Here's the information that can be extracted or derived:

1. A table of acceptance criteria and the reported device performance

Test Type	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing	Materials and methods must be nontoxic and meet acceptance criteria for intended use (in accordance with BS EN ISO 10993-1:2003).	Met the acceptance criteria for their intended use.
Introducer Assembly (Radiopacity)	Shaft gradient must fall along the gradient of an aluminum X-ray step wedge gauge (following ASTM F6540-12).	Test results met predetermined criteria.
Introducer Dilator (Tensile Testing)	90% of test articles at 95% confidence must meet or exceed the requirements of BS EN ISO 11070: 2014.	Test results met predetermined criteria.
Introducer Sheath (Peel Force)	(Implied: Successful characterization of peel force across various sheath sizes, indicating consistent and appropriate peeling characteristics.) Specific numerical criteria not explicitly stated in this summary.	Characterization of peel force for various Peel-Away Introducer sheath sizes was successfully performed.
Wire Guide (Corrosion, Flex, Fracture, and Tensile Testing)	Shall not show signs of corrosion, defect, damage, or fracture that could affect functional performance. Must demonstrate minimal tensile strength for wire guides of a certain diameter as per standard.	Test articles did not show signs of corrosion, defect, damage, or fracture. Test results met predetermined criteria for tensile strength.

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

The document does not specify exact sample sizes for each of the engineering tests (e.g., number of introducer assemblies, dilators, or wire guides tested). The tests are performed on the device components themselves, not on patient data. Therefore, data provenance (country of origin, retrospective/prospective) is not applicable.

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

Not applicable. These are engineering and material tests, not clinical performance or diagnostic studies requiring expert review of a "ground truth" established from patient data.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable, as this refers to clinical or diagnostic study adjudication of patient cases, which is not described here.

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. This device is an introducer set, not an AI/ML diagnostic device. Therefore, MRMC studies and AI assistance metrics are not relevant.

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

No. This is not an AI/ML device.

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

For the engineering tests, the "ground truth" is defined by established international standards (e.g., BS EN ISO 10993-1:2003, ASTM F6540-12, BS EN ISO 11070: 2014) and predetermined internal criteria for physical properties and material safety.

8. The sample size for the training set

Not applicable, as this is not an AI/ML device.

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

Not applicable, as this is not an AI/ML device.

Summary

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Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the seal of the Department of Health & Human Services. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the FDA logo is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

December 20, 2017

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

Re: K173685

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: November 30, 2017 Received: December 1, 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 of medical device-related 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.

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K173685

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 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

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K173685

Device Name Peel-Away Introducer Set

Indications for Use (Describe)

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.

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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

Image /page/3/Picture/1 description: The image shows the Cook Medical logo. The logo is a red square with the word "COOK" in white, sans-serif font on the top half of the square. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font. The word "MEDICAL" is smaller than the word "COOK".

510(K) SUMMARY

Submitted By:

Applicant: Contact: Applicant Address:

K173685

Cook Incorporated Colin Jacob Cook Incorporated P.O. Box 489 750 Daniels Way Bloomington, IN 47402 (812) 335-3575 x 104965 (812) 332-0281

Device Information:

Contact Fax Number:

Contact Phone Number:

Trade Name: Classification Name: Panel: Regulation: Regulation name: Product Code:

Peel-Away Introducer Set Introducer, Catheter Cardiovascular 21 CFR § 870.1340 Catheter introducer DYB; KNT

Predicate Device:

Peel-Away Introducer Set (K170020)

Device Description:

Indications for Use:

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Image /page/4/Picture/0 description: The image shows the logo for Cook Medical. The logo is set against a red background. The word "COOK" is in large, white, sans-serif font, and the word "MEDICAL" is in a smaller, white, sans-serif font below the word "COOK".

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

Comparison to Predicates:

The Peel-Away Introducer Set and the predicate device, Peel-Away Introducer Set (K170020), are substantially equivalent in that these devices have intended use and principle of operation, basic design, and functional characteristics. The only differences between the subject and predicate device are the materials and additional lengths as stated in the comparison table below.

		Predicate Device	Subject Device
		Peel-Away Introducer Set(K170020)	Peel-Away Introducer Set
	Manufacturer	Cook Incorporated	IDENTICAL TO PREDICATE
	Regulation	21 CFR § 870.1340,21 CFR § 876.5980	IDENTICAL TO PREDICATE
	Product Code	DYB, KNT	IDENTICAL TO PREDICATE
	Classification	II	IDENTICAL TO PREDICATE
Indications for Use		The Peel-Away Introducer Set isintended for the percutaneousintroduction of balloon, electrode andclosed or nontapered end cathetersinto central and peripheralvasculature, and for non-vascularuse.	IDENTICAL TO PREDICATE
Fundamental ScientificTechnology		Initial percutaneous access fortemporary working channel	IDENTICAL TO PREDICATE
	Duration of use	Limited (≤ 24 hours)	IDENTICAL TO PREDICATE
Design		Introducer assembly includes anouter peelable sheath and an innerdilator. Peelable sheath has a wingedhub to facilitate a tear in the sheath.	IDENTICAL TO PREDICATE

Shape		Outer sheath: wingedhub, cylindrical cannula	IDENTICAL TO PREDICATE
		Inner Dilator: Round hub, cylindricalcannula	IDENTICAL TO PREDICATE
Dimensions	Introducer AssemblyDiameter	3.5-26 Fr	3.5-18 Fr
	Sheath Length	7, 9, 13, 15.5 cm	8, 9, 10, 24, 30, 47 cm
	Dilator Length	11, 13, 20 cm	13.5, 16, 16.5, 20, 35, 37, 51.5
	Wire Guide Diameter	0.018, 0.021, 0.025, 0.035, 0.038 in	0.018 and 0.038 in
	Wire Guide Length	30, 50, 70, 100 cm	50, 65, 85 cm
Materials	Sheath	Thick Wall Sheathing RadiopaqueTFE (VRTS)	6.0 to 18 Fr -VAD[-CVI]modification: Thick Wall SheathingRadiopaque TFE (VRTS)3.5 to 7.5 Fr -DENNY modification:TFE
	Dilator	3.5 to 12 Fr: RadiopaquePolyethylene13 to 26 Fr: Vinyl	3.5 to 7.5 Fr -DENNY modification:Radiopaque Polyethylene6.0 to 18 Fr -VAD[-CVI]modification: TFE RadiopaqueTubing
		Predicate Device	Subject Device
		Peel-Away Introducer Set(K170020)	Peel-Away Introducer Set

Wire Guide		Stainless Steel Solder	Stainless Steel / SolderNitinol / Platinum / Solder
Additional Set Components		Entry access needle, needle holdercup, luer-slip syringe, serial dilators,thumb scalpel	Entry access needle and luer-slipsyringe
Shelf Life		Three years	IDENTICAL TO PREDICATE
Sterilization Process		Ethylene Oxide	IDENTICAL TO PREDICATE
Sterility Assurance Level		10-6	IDENTICAL TO PREDICATE

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

Image /page/5/Picture/11 description: The image shows the Cook Medical logo. The word "COOK" is in white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in white, sans-serif font on a darker red background.

Technological Characteristics:

The subject device. Peel-Away Introducer Set, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The following tests have been conducted to ensure reliable design and performance under the specified testing parameters.

. Biocompatibility Testing – Testing was performed in accordance with BS EN ISO 10993-1:2003, the material and methods used to manufacture the subject device are nontoxic and met the acceptance criteria for their intended use.
. Introducer Assembly (Radiopacity – Accelerated) - 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.
Introducer Dilator (Tensile Testing Accelerated) Test article must demonstrate that . 90% of test articles at the 95% confidence can be expected to meet or exceed therequirements of BS EN ISO 11070: 2014. Test results met predetermined criteria.
. Introducer Sheath (Peel Force Testing – Accelerated) - Characterization of peel force for various Peel-Away Introducer sheath sizes was successfully performed.
Wire Guide (Corrosion, Flex, Fracture and Tensile Testing Accelerated)- Test article . must shall not show signs of corrosion, defect, damage, fracture that could affect their functional performance. Test articles must also demonstrate per the standard, minimal tensile strength for wire guides with having a certain diameter size. Test results met predetermined criteria.

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).