The Amplatz Support Wire Guide with Apex Curve is used to facilitate the placement of devices during diagnostic and interventional procedures. The Amplatz Support Wire Guide with Apex Curve is intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those used within trans-catheter aortic valve procedures.

Device Description

The Amplatz Support Wire Guide with Apex Curve, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device utilizes a fixed core design. The Amplatz Support Wire Guide with Apex Curve is available with an outside diameter of 0.035 inches, a length of 260 centimeters, a curved tip, and an exterior coating. The Amplatz Support Wire Guide with Apex Curve is a packaged, sterile device intended for single patient use.

AI/ML Overview

The provided text is a 510(k) summary for the "Amplatz Support Wire Guide with Apex Curve." It details the device's characteristics, intended use, and the testing performed to demonstrate its substantial equivalence to a predicate device. However, this document does not describe a study involving an AI/Machine Learning device or a performance study with human readers.

The studies mentioned are engineering and bench tests, along with an animal model evaluation, to demonstrate the physical and functional performance of a medical guidewire. They are not clinical studies designed to assess the performance of an AI algorithm in assisting human readers or as a standalone diagnostic tool.

Therefore, I cannot provide the requested information about acceptance criteria for an AI device, sample sizes for test sets involving human readers, expert ground truth establishment, MRMC studies, or training set details as these kinds of studies were not conducted or reported in this document for K171445.

Here's a breakdown of what can be extracted or inferred from the text regarding the device's acceptance criteria and the studies that met them, even though it's not an AI device:

1. A table of Acceptance Criteria and Reported Device Performance

The document states that for each test, "The predetermined acceptance criteria were met." It does not provide the specific numerical acceptance criteria or the numerical performance results. It only affirms that the criteria were satisfied.

Acceptance Criteria Category (Test Type)	Reported Device Performance
Biocompatibility Testing	Met predetermined acceptance criteria (in accordance with ISO 10993-1:2009).
Corrosion Testing	Met predetermined acceptance criteria (in accordance with Annex B of ISO 11070:2014).
Flexing Test	Met predetermined acceptance criteria (in accordance with Annex G of ISO 11070:2014).
Fracture Testing	Met predetermined acceptance criteria (in accordance with Annex F of ISO 11070:2014).
Radiopacity Testing	Met predetermined acceptance criteria (in accordance with ASTM F640-12).
Tip Flexibility Testing	Performed for characterization purposes (in accordance with FDA Coronary and Cerebrovascular Guidewire Guidance). No specific acceptance criteria mentioned as it was for characterization.
Tensile Testing of the Union of the Core Wire and Coil of the Guide Wire	Met predetermined acceptance criteria (in accordance with applicable values of ISO 11070:2014, Annex H).
Performance Testing of Aged Devices	Met predetermined acceptance criteria (in accordance with ISO 11070:2014, Section 4.3 and Annex G).
Acute Performance Evaluation (Animal Model)	All test articles evaluated met the predetermined acceptance criteria for all performance parameters.

Regarding the requested information that cannot be provided for this device:

Sample sizes used for the test set and the data provenance: Not applicable in the context of an AI device. For the physical tests, sample sizes would be according to ISO standards or internal protocols, but not specified here. The animal model study would have a sample size of animals, but this is not disclosed.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for these tests is based on physical measurements and functional evaluations against engineering specifications.
Adjudication method (e.g., 2+1, 3+1, none) for the test set: Not applicable.
If a multi-reader multi-case (MRMC) comparative effectiveness study was done: No, this was not an AI device requiring such a study.
If a standalone (i.e., algorithm only without human-in-the-loop performance) was done: No, this was not an AI device.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Ground truth for the reported tests would be based on established engineering specifications, material properties, and functional performance metrics (e.g., force required to fracture, flexibility measurements, corrosion resistance). For the animal study, it would be based on observed device performance within the animal model against predefined success criteria.
The sample size for the training set: Not applicable, as this is not an AI device.
How the ground truth for the training set was established: Not applicable, as this is not an AI device.

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). On the left is the Department of Health & Human Services logo. 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.

January 10, 2018

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

Re: K171445

Trade/Device Name: Amplatz Support Wire Guide with Apex Curve Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: December 7, 2017 Received: December 8, 2017

Dear Ms. 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. 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 (QS) regulation (21 CFR Part 820);

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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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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,

Nicole G. Ibrahim -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) K171445

Device Name

Amplatz Support Wire Guide with Apex Curve

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)	□

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COOK INCORP

510(k) SUMMARY

Amplatz Support Wire Guide with Apex Curve 21 CFR §807.92 Date Prepared: December 7, 2017

Submitted By:

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

Device Information:

Trade Name:	Amplatz Support Wire Guide with Apex Curve
Common Name:	Wire, Guide, Catheter
Classification Name:	Catheter guide wire
Regulation:	21 CFR §870.1330
Product Code:	DQX

Predicate Devices:

The predicate device is the S-Wire Guidewire System cleared for market under K153397, on August 18, 2016.

Device Description:

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centimeters, a curved tip, and an exterior coating. The Amplatz Support Wire Guide with Apex Curve is a packaged, sterile device intended for single patient use.

Intended Use:

Comparison to Predicate:

The Amplatz Support Wire Guide with Apex Curve, subject of this submission, and the predicate device, the S-Wire Guidewire System, are substantially equivalent in that these devices have identical indications for use. The subject device and the predicate device are both available in a 0.035 inch diameter, a 260 centimeter length, and a curved distal tip. The subject device is manufactured with a PTFE coating and the predicate device is manufactured with a PTFE coating on the shaft and silicone coating on the distal coil. The subject device is similar in design, technological characteristics, and materials to the S-Wire Guidewire System (K153397).

Technological Characteristics:

The following tests were performed to demonstrate that the Amplatz Support Wire Guide with Apex Curve 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.
I Fracture Testing - Tested in accordance with Annex F of ISO 11070:2014. 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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Tip Flexibility Testing Testing in accordance with FDA Coronary and 트 Cerebrovascular Guidewire Guidance. Testing was performed for characterization purposes.
. 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.
. Performance Testing of Aged Devices – Testing in accordance with ISO 11070:2014, Section 4.3 and Annex G. The predetermined acceptance criteria were met.
Acute Performance Evaluation Evaluation of device performance in an animal . model under conditions intended to simulate clinical use. All of the test articles evaluated met the predetermined acceptance criteria for all of the performance parameters.

Conclusion:

The results of these tests support a conclusion that the Amplatz Support Wire Guide with Apex Curve met the design input requirements based on the intended use and support the conclusion this device does not raise new issues of safety or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the S-Wire Guidewire System (K153397).

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.