The Approach Hydro ST Wire Guide is manufactured using a stainless steel wire with a PTFE coating and a stainless steel and platinum distal tip. The wire guide has a hydrophilic coating. The maximum outside diameter is 0.0142 inches and will be available in 135, 190 and 300 centimeter lengths. It will be supplied sterile, intended for one-time use.

AI/ML Overview

Here's an analysis of the provided text regarding the acceptance criteria and study for the Approach Hydro ST Wire Guide, structured to answer your questions:

The provided text outlines the declaration of substantial equivalence for the "Approach Hydro ST Wire Guide" based on various tests. However, it does not explicitly state specific numerical acceptance criteria for each test. Instead, it states that "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."

Therefore, for aspects requiring quantitative acceptance criteria or detailed study specifics beyond what's directly stated, I must indicate that the information is "Not provided in the document."

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

Test	Acceptance Criteria	Reported Device Performance
Tensile Test	Not provided (Assumed to meet industry standards for wire guide tensile strength)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Tip Stiffness	Not provided (Assumed to meet industry standards for wire guide tip stiffness)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Fracture Test	Not provided (Assumed to meet industry standards for wire guide fracture resistance)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Flexing Test	Not provided (Assumed to meet industry standards for wire guide flexibility and fatigue resistance)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Torque Strength Test	Not provided (Assumed to meet industry standards for wire guide torque strength)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Torque Response Test	Not provided (Assumed to meet industry standards for wire guide torque response)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Lubricity Test	Not provided (Assumed to meet industry standards for wire guide lubricity)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Corrosion Resistance Test	Not provided (Assumed to meet industry standards for wire guide corrosion resistance)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Biocompatibility Testing	Not provided (Assumed to meet ISO 10993 standards for medical devices)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Bioburden Testing	Not provided (Assumed to meet industry standards for bioburden levels for sterile devices)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
Endotoxin Testing	Not provided (Assumed to meet industry standards for endotoxin levels for sterile devices)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."
EtO Residual Testing	Not provided (Assumed to meet industry standards for ethylene oxide residuals for sterile devices)	"The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide."

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 for test set: Not provided in the document.
Data provenance: Not provided in the document. These are product performance tests, likely conducted in a controlled laboratory setting (e.g., Cook Incorporated's facilities) rather than clinical data from a specific country. They are inherently prospective in the sense that they are tests performed on newly manufactured devices.

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

Number of experts: Not applicable. The "ground truth" for engineering performance tests like tensile strength, flexibility, etc., is established by validated testing methodologies and instrumentation, not expert consensus in the medical sense.
Qualifications of experts: Not applicable.

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

Adjudication method: Not applicable. These are objective engineering tests; results are determined by measurement and adherence to pre-defined test protocols, not by human adjudication of qualitative data.

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

MRMC study: No. This document describes the testing of a physical medical device (wire guide), not an AI-powered diagnostic or assistive tool.
Effect size: Not applicable.

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

Standalone performance: Not applicable. This document is about a physical medical device, not an algorithm.

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

Type of ground truth: The "ground truth" for these tests are the established engineering specifications, material properties, and performance standards relevant to wire guides for facilitating catheter delivery into the peripheral vasculature. These standards would be derived from industry guidelines, regulatory requirements (e.g., FDA guidance documents, ISO standards), and internal company performance benchmarks for the device's intended use.

8. The sample size for the training set

Sample size for training set: Not applicable. This refers to the testing of a physical device, not an AI model requiring a training set.

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

How ground truth for training set was established: Not applicable.

Summary

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Image /page/0/Picture/0 description: The image shows a handwritten number, which appears to be a serial number or code. The number is "091385". The handwriting is cursive and slightly slanted, with varying stroke thicknesses.

510(k) Summary

Submitted By:

Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402

AUG 0 7 2009

Device:

Trade Name: · Proposed Classification:

Approach Hydro ST Wire Guide Wire, Guide, Catheter 21 CFR §870.1330

Indications for Use:

The Approach Hydro ST Wire Guide is indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Predicate Devices:

The Approach Hydro ST Wire Guide is identical in terms of intended use and similar in terms of materials of construction and technological characteristics to predicate devices reviewed as devices for facilitating delivery of percutaneous catheters into the peripheral vasculature.

Device Description:

Substantial Equivalence:

The Approach Hydro ST Wire Guide is similar to many devices in commercial p distribution for facilitating delivery of percutaneous catheters into the peripheral vasculature. The identical indications for use, principles of operations, similar materials of construction and technological characteristics of the wire guide support a determination of substantial equivalence.

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Test Data:

The Approach Hydro ST Wire Guide was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:

Tensile Test 1.
Tip Stiffness 2.
Fracture Test 3.
1. Flexing Test
న. Torque Strength Test
Torque Response Test 6.
1. Lubricity Test
1. Corrosion Resistance Test
Biocompatibility Testing 9.
1. Bioburden Testing
Endotoxin Testing 11.
1. EtO Residual Testing

The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a wire guide.

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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and body. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the eagle.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-0609 Silver Spring, MD 20993-0002

AUG 0 7 2009

Cook Incorporated % Ms. Karen Bradburn, RAC Senior Regulatory Affairs Specialist 750 Daniels Way P.O. Box 489 Bloomington, Indiana 47402-0489

Re: K091385

Trade/Device Name: Approach Hydro ST Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: II Product Code: DQX Dated: July 7, 2009 Received: July 8, 2009

Dear Ms. Bradburn:

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.

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.

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Page 2-Ms. Karen Bradburn

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 device-related 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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

uma R. bichner

Image /page/3/Picture/9 description: The image shows a black and white drawing of a symbol. The symbol appears to be a stylized letter, possibly a cursive 'S' or a similar character. The lines are thick and somewhat uneven, giving the symbol a hand-drawn appearance.

Bram Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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Ko91385 510(k) Number (if known):

Device Name: Approach Hydro ST Wire Guide

Indications for Use:

Indicated for use in facilitating delivery of percutaneous catheters into the peripheral vasculature.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the-Counter Use (21 CFR 807 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE) Druma R. Jo Mars ﻟﻠ (Division Sign-Off)

Division of Cardiovascular Devices

510(k) Number Ko 9138

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.