Intended to be used for dilating puncture sites or catheter tracts for percutaneous placement of devices for vascular and non-vascular applications such as in the venous, arterial, biliary and renal systems.

Device Description

Cook Dilator Sets may consist of either a single dilator or a group of components that are used percutaneously to dilate puncture sites or catheter tracts, thereby facilitating the placement of other therapeutic or diagnostic devices into a natural body space (e.g., the peritoneal cavity, an artery or vein) for various vascular or non-vascular clinical applications. Some Dilator Set configurations may also include an entry needle and wire guide. The dilator component of the Dilator Sets is available in diameters ranging from 3.0 to 26.0 French and in lengths ranging from 6 to 65 cm. The broad range of dilator sizes accommodates the variation in the size of the devices that could be inserted through the initial access site. All configurations of the Dilator Sets are supplied as packaged, sterile devices, intended for single-patient use.

AI/ML Overview

This document describes the premarket notification for Dilator Sets manufactured by Cook Incorporated. It's a 510(k) submission, meaning the company is demonstrating that their device is "substantially equivalent" to legally marketed predicate devices, rather than proving its safety and effectiveness from scratch like a PMA would entail.

Therefore, the information provided focuses on comparative performance and compliance with relevant standards, not on a full-scale clinical study with human-in-the-loop performance or detailed AI model training/testing.

Here's an analysis of the provided text in response to your request:

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

The document states that the device was subjected to various tests and "The pre-determined acceptance criteria were met" for all of them. However, it does not explicitly list the quantitative acceptance criteria for each test, nor does it provide the specific numerical performance results. It only confirms compliance.

Test Name	Acceptance Criteria (Stated in Document)	Reported Device Performance (Stated in Document)
Biocompatibility	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria
Dilator Hub to Shaft Tensile	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria
Compatibility Testing	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria
Dimensional Verification	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria
Radiopacity Evaluation	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria
Dilator Tip Rollback	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria
Kink Radius	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria
Lubricity Testing	Pre-determined acceptance criteria met	Met the pre-determined acceptance criteria

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

The document does not specify the sample sizes used for any of the tests. Given this is a 510(k) submission for a physical medical device, the "data provenance" would refer to the location and conditions of the lab testing, which are not detailed here. There's no mention of specific patient data, as this is not an AI/software device or a clinical trial report.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

This question is not applicable to the provided document. The "ground truth" in this context is established by engineering standards and validated test methods (e.g., ISO 10993-1, ISO 11070, ASTM F640-12), not by expert consensus on clinical data interpretation. Therefore, there's no mention of experts establishing a "ground truth" for a test set in the way one would for an AI diagnostic device.

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

Not applicable. Adjudication methods like 2+1 or 3+1 are typically used in clinical studies where multiple readers assess and come to a consensus on image interpretation or diagnosis. The tests performed here are engineering and material property tests conducted under specific protocols, not expert clinical reviews.

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

Not applicable. This is a physical medical device (dilator sets), not an AI-assisted diagnostic tool. Therefore, no MRMC studies or human reader improvement analysis were conducted or are relevant to this submission.

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

Not applicable. This is a physical medical device, not an algorithm or software. Its performance is evaluated through physical and material property tests, not through standalone algorithm performance.

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

The "ground truth" for the device's performance is based on established international and industry standards and approved study protocols for medical device testing. For example:

Biocompatibility: ISO 10993-1:2009
Dilator Hub to Shaft Tensile: ISO 11070:2014
Radiopacity: ASTM F640-12
Dilator Tip Rollback: ISO 11070:2014, Annex A.3
Kink Radius: ISO 11070:2014, Annex A

These standards define methods and typically acceptable performance ranges or pass/fail criteria, which serve as the "ground truth" for these engineering tests.

8. The sample size for the training set

Not applicable. This device does not involve machine learning or AI, so there is no concept of a "training set."

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

Not applicable, as there is no training set.

Summary

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters 'FDA' in a blue square, followed by the words 'U.S. FOOD & DRUG ADMINISTRATION' in blue text.

January 10, 2019

Cook Incorporated David Lehr Regulatory Affairs Manager 750 Daniels Way Bloomington, Indiana 47404

Re: K183036

Trade/Device Name: Dilator Sets Regulation Number: 21 CFR 870.1310 Regulation Name: Vessel dilator for percutaneous catheterization Regulatory Class: Class II Product Code: DRE, FGE Dated: December 21, 2018 Received: December 26, 2018

Dear Mr. Lehr:

This letter corrects our substantially equivalent letter of December 20, 2018.

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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions 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 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,

Misti L. Malone -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) K183036

Device Name Dilator Sets

Indications for Use (Describe)

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

As required by 21 CFR §807.92 Date Prepared: December 21, 2018

Submitted By:
Applicant:	Cook Incorporated
Contact:	David Lehr, RAC
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x102309
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name: Common Name:

Classification Panel: Regulation: Product Code:

Dilator Sets Dilator, vessel, for percutaneous catheterization/ Stents, drains and dilators for the biliary ducts Cardiovascular/Gastroenterology/Urology 21 CFR §870.1310, 21 CFR §876.5010 DRE, FGE

Predicate Devices:

Medcomp® Vessel Dilator (Medcomp®, K162389) l
l PBN Dilators (Medical Device Technologies, Inc., K990808)

Reference Devices:

Peel-Away Introducer Set (Cook Inc., K170020)
l Royal Flush Catheter (Cook Inc., K171264)
I CrossCath Support Catheter (Cook Inc., K161801)

Device Description:

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devices that could be inserted through the initial access site. All configurations of the Dilator Sets are supplied as packaged, sterile devices, intended for single-patient use.

Intended Use:

Comparison of Technological Characteristics to Predicate:

The Dilator Sets and the predicate devices have the same basic intended use. The subject device is similar in technological characteristics (i.e., design and materials) to those of the predicate devices, with the addition of a smaller dilator diameter of 3.0 Fr and a broader scope of lengths (6 to 65 cm) as compared to the predicate devices, which have a combined scope of lengths ranging from 15 to 35 cm. Some configurations of the subject device are also supplied with additional kit components (i.e., entry needle and wire guide) as compared to the predicate devices.

Technological Characteristics:

The subject device. Dilator Sets, was subjected to applicable testing to assure reliable design and performance under the testing parameters. The tests performed are listed below:

Biocompatibility Tested in accordance with ISO 10993-1:2009. The pre-determined . acceptance criteria were met.
Dilator Hub to Shaft Tensile Tested in accordance with ISO 11070:2014. The pre-. determined acceptance criteria were met.
. Compatibility Testing – Tested in accordance with an approved study protocol. The predetermined acceptance criterial were met.
Dimensional Verification Testing Tested in accordance with an approved study . protocol. The pre-determined acceptance criteria were met.
Radiopacity Evaluation Tested in accordance with ASTM F640-12. The pre-determined . acceptance criteria were met.
Dilator Tip Rollback Testing Tested in accordance with ISO 11070:2014, Annex A.3. . The pre-determined acceptance criteria were met.
Kink Radius Testing Tested in accordance with ISO 11070:2014, Annex A. The pre-■ determined acceptance criteria were met.

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Lubricity Testing Tested in accordance with an approved study protocol. The pre-. determined acceptance criterial were met.

Conclusion:

The results of these tests support a conclusion that the Dilator Sets, subject of this submission, met the design input requirements based on the devices' intended use and support the conclusion these devices do not raise new questions of safety and/or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate devices, the Medcomp® Vessel Dilator (Medcomp®, K162389) and the PBN Dilators (Medical Device Technologies, Inc., K990808).

Regulation Number and Section

§ 870.1310 Vessel dilator for percutaneous catheterization.

(a)
Identification. A vessel dilator for percutaneous catheterization is a device which is placed over the guide wire to enlarge the opening in the vessel, and which is then removed before sliding the catheter over the guide wire.(b)
Classification. Class II (performance standards).