Disposable Reuter Tip Deflecting Wire Guides are intended for use in curving or deflecting catheter tips for pulmonary angiography, selective angiography, translumbar aortography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

Reuter Tip Deflecting Wire Guides are intended for use with the Reuter Tip Deflecting Handle assembly for curving or deflecting catheter tips for pulmonary angiography, translumbar aortography, bronchography, bronchography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

Device Description

The Reuter Tip Deflecting Wire Guides, subject of this submission, are Class II devices according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject devices are available with outer diameters of 0.025 and 0.035 inches, lengths of 80 - 145 centimeters, and a curved tip.

The subject device includes two configurations indicated by prefixes TDW and DTDW. Both configurations are constructed with stainless steel mandrils, coils, and internal handles. The coils cover the entire mandril and are secured using distal and proximal anchor points. The internal handle is permanently affixed to the proximal end of the wire guide and is designed to mate with the tip deflecting handle. The internal handle of the wire guide is not patient contacting.

The Reuter Tip Deflecting Wire Guide configuration with the TDW prefix is a disposable wire guide designed to be used with the Reusable Reuter Tip Deflecting Wire Guide handle which is not subject of this submission.

The Disposable Reuter Tip Deflecting Wire Guide configuration with the DTDW prefix is designed with a deflecting handle permanently affixed to the proximal end of the wire guide. The deflecting handle is manufactured from polycarbonate and stainless steel materials.

The purpose of the handle is to operate in a retracting motion thereby causing the tip of the connected wire guide to deflect to the specified radius.

The side-arm flushing adapter (Class II 510(k) exempt under product code DTL) is supplied with the Disposable Reuter Tip Deflecting Wire Guides as an accessory. The flushing adapter may be used to flush a catheter being used with the subject device during diagnostic and interventional procedures.

The subject device is a packaged, sterile device intended for single patient use.

AI/ML Overview

This document is a 510(k) summary for the Reuter Tip Deflecting Wire Guide, which is a medical device. The information provided primarily focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed study report of a new AI/software-based device. Therefore, many of the requested categories for AI/software studies are not applicable or cannot be extracted from this document.

Here's an analysis based on the provided text:

1. Table of acceptance criteria and the reported device performance

Test Performed	Acceptance Criteria	Reported Device Performance
Biocompatibility Testing (ISO 10993-1:2009)	Predetermined acceptance criteria	Met the predetermined acceptance criteria
Corrosion Testing (ISO 11070:2014 Annex B)	Predetermined acceptance criteria	Met the predetermined acceptance criteria
Flexing Test (ISO 11070:2014 Annex G)	Predetermined acceptance criteria	Met the predetermined acceptance criteria
Surface Examination (ISO 11070:2014 Section 8.5 & Annex G, approved protocol)	Predetermined acceptance criteria	Met the predetermined acceptance criteria
Fracture Testing (ISO 11070:2014 Annex F)	Predetermined acceptance criteria	Met the predetermined acceptance criteria
Tensile Testing of the Union of the Core Wire and Coil (ISO 11070:2014 Annex H)	Applicable values of ISO 11070:2014, Annex H	Met the predetermined acceptance criteria
Tensile Testing of the Union between Deflecting Handle and Wire Guide (ISO 11070:2017, Annex H)	Applicable values of ISO 11070:2017, Annex H	No explicit statement, but generally implies meeting criteria
Dimensional and Catheter Compatibility Testing (approved study protocol)	Predetermined acceptance criteria	Met the predetermined acceptance criteria
Radiopacity Testing (ASTM F640-12)	Predetermined acceptance criteria	Met the predetermined acceptance criteria

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

Sample Size: The document does not specify the sample size for each test. It mentions "The following tests were performed...", implying a certain number of units were tested for each criterion, but the exact count is not given.
Data Provenance: Not applicable. These are physical performance tests of a device, not data analysis tests. The testing would have been performed by Cook Incorporated or a contracted lab.

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)

Not applicable. The "ground truth" for these physical device tests is defined by the objective industry standards (ISO, ASTM) and the manufacturer's predetermined acceptance criteria for physical properties. No human experts are establishing "ground truth" in the context of diagnostic interpretation.

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

Not applicable. This is not an adjudication process for clinical or diagnostic data. The tests are objective measurements against defined standards.

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 document describes a physical medical device, not an AI software.

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

Not applicable. This document describes a physical medical device, not an algorithm.

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

Not applicable in the AI/software context. For this medical device, the "ground truth" or reference for evaluating performance is the adherence to established international standards (ISO, ASTM) and internal engineering specifications for physical and material properties.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model. There is no concept of a "training set."

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

Not applicable. This is a physical device, not an AI model.

Summary of the Study per the Document:

The document describes a series of performance tests conducted on the Reuter Tip Deflecting Wire Guide. These tests were designed to demonstrate that the modified device (with new lengths, diameter, and handle configuration) meets applicable design and performance requirements and supports a determination of substantial equivalence to its predicate device. The tests covered various aspects including:

Biocompatibility
Corrosion
Flexing
Surface Examination
Fracture
Tensile strength of the core wire and coil union
Tensile strength of the handle and wire guide union
Dimensional accuracy and catheter compatibility
Radiopacity

For all listed tests, the document explicitly states that the "predetermined acceptance criteria were met," indicating successful completion of the studies and compliance with the specified standards. The study's conclusions support that the modifications do not raise new questions of safety or effectiveness and that the device is substantially equivalent to the predicate.

Summary

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December 20, 2018

Cook Incorporated Jennifer Allman Regulatory Affairs Specialist 750 Daniels Way Bloomington, Indiana 47402

Re: K180830

Trade/Device Name: Reuter Tip Deflecting Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: November 20, 2018 Received: November 21, 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. 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.

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

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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.htm); good manufacturing practice requirements as set forth in the quality systems (OS) 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 (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 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,

Michael John -S 2018.12.20 14:57:13 -05'00' 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) K180830

Device Name

Reuter Tip Deflecting Wire Guides

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

Reuter Tip Deflecting Wire Guide 21 CFR §807.92 Date Prepared: March 30, 2018

Submitted By:

Applicant:	Cook Incorporated
Contact:	Jennifer L. Allman
Applicant Address:	Cook Incorporated750 Daniels WayBloomington, IN 47404
Contact Phone Number:	(812) 335-3575 x104280
Contact Fax Number:	(812) 332-0281

Device Information:

Trade Name:	Reuter Tip Deflecting Wire Guides
Common Name:	Wire, Guide, Catheter
Classification Name:	Catheter guide wire
Regulation:	21 CFR §870.1330
Product Code:	DQX
Device Classification/Panel:	Class II, Cardiovascular

Primary Predicate Device:

The predicate device is the Reuter Tip Deflecting Wire Guide (Cook Inc., D012681) granted pre-amendment status on April 28, 2014.

Reference Devices:

K171764, Fixed Core Wire Guides

K140485, Mandrel Guidewires or M-Wires

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Device Description:

The purpose of the handle is to operate in a retracting motion thereby causing the tip of the connected wire guide to deflect to the specified radius.

The subject device is a packaged, sterile device intended for single patient use.

Indication for Use:

Disposable Reuter Tip Deflecting Wire Guides are intended for use in curving or deflecting catheter tips for pulmonary angiography, selective angiography, translumbar aortography, bronchography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

Reuter Tip Deflecting Wire Guides are intended for use with the Reuter Tip Deflecting Handle assembly for curving or deflecting catheter tips for pulmonary angiography,

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selective angiography, translumbar aortography, bronchography, repositioning of central venous catheter tips and other vascular and non-vascular applications.

Comparison to Predicates:

The Reuter Tip Deflecting Wire Guide, subject of this submission, has been modified from the predicate Reuter Tip Deflecting Wire Guide (D012681), with the reuseable handle to include wire guide lengths of 110 and 145 centimeters, an additional diameter of 0.025 inches, a disposable handle configuration, and specific curve configurations of 5 and 10 millimeters.

Technological Characteristics:

The following tests were performed to demonstrate that the Reuter Tip Deflecting Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence.

. Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The predetermined acceptance criteria were met.
Corrosion Testing - Tested in accordance with Annex B of ISO 11070:2014. The predetermined acceptance criteria were met.
. Flexing Test - Tested in accordance with the Annex G of ISO 11070:2014. The predetermined acceptance criteria were met.
. Surface Examination - Testing in accordance with Section 8.5 and Annex G of ISO 11070:2014, and an approved study protocol. The predetermined acceptance criteria were met.
Fracture Testing - Tested in accordance with Annex F of ISO 11070:2014. The predetermined acceptance criteria were met.
. Tensile Testing of the Union of the Core Wire and Coil of the Guide Wire -Tested in accordance with the applicable values of ISO 11070:2014, Annex H. The predetermined acceptance criteria were met.
I Tensile Testing of the Union between the Deflecting Handle and the Wire Guide - Tested in accordance with the applicable values of ISO 11070:2017, Annex H.
. Dimensional and Catheter Compatibility Testing - Testing in accordance with an approved study protocol. The predetermined acceptance criteria were met.
. Radiopacity Testing - Testing in accordance with ASTM F640-12. The predetermined acceptance criteria were met.

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Conclusion:

The results of these tests support a conclusion that the Reuter Tip Deflecting Wire Guides met the design input requirements based on the intended use and support the conclusion that the modifications do not raise new questions of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Reuter Tip Deflecting Wire Guide (D012681).

Regulation Number and Section

§ 870.1330 Catheter guide wire.

(a)
Identification. A catheter guide wire is a coiled wire that is designed to fit inside a percutaneous catheter for the purpose of directing the catheter through a blood vessel.(b)
Classification. Class II (special controls). The device, when it is a torque device that is manually operated, non-patient contacting, and intended to manipulate non-cerebral vascular guide wires, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.