PREDICATE™ III GUIDEWIRE are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Device Description

The guidewire is made of an uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured over the core. The wire can have a distal coil or a full length coil that is made of Stainless Steel. The guidewire may contain proximal markers.

AI/ML Overview

The provided document describes a 510(k) premarket notification for the Predicate III Guidewire, a Class II medical device. This document focuses on demonstrating substantial equivalence to a predicate device rather than a standalone study proving novel performance against specific acceptance criteria. Therefore, most of the requested information about acceptance criteria, study design, expert involvement, and ground truth establishment, which are typical for studies evaluating diagnostic or AI-based devices, is not directly applicable or available in this submission.

However, I can extract information related to the device's qualification testing which serves to ensure it meets its design inputs and performs comparably to the predicate device.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met," and "The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary." However, it does not provide a specific table listing quantitative acceptance criteria and the corresponding reported performance values for the Predicate III Guidewire. Instead, it lists the types of tests performed to ensure compliance.

Acceptance Criteria (General Description)	Reported Device Performance (General Statement)
Visual/tactile, dimensional, and mechanical attributes	Complies with design input summary and established requirements. Test devices were manufactured and inspected according to these.
Compliance with design input summary (for specific tests below)	Demonstrates compliance with the design input summary and is at least as safe and effective as the current legally marketed device.
Biocompatibility (pre-defined acceptance criteria outlined in product Design Input Summary)	The addition of full-length coil does not affect biocompatibility, and the device is still in compliance with pre-defined acceptance criteria.

Specific Qualification Tests Performed (acting as evidence for meeting implied acceptance criteria):

Dimensional
Guidewire Pull Test
Camber Resistance
Visual Inspection
Wire Fracture Test
Corrosion
Wire Flex Test
ISO Strength of Union
Particulate Residue Test
Cytotoxicity (Biocompatibility)
Hemolysis (Biocompatibility)
Chemical Characterization (Biocompatibility)

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 exact sample sizes used for each of the bench tests or biocompatibility tests. It generally refers to "Test devices."
Data Provenance: Not applicable. The data is from in-house bench and lab testing of the manufactured guidewires by Lake Region Medical. The country of origin of the data is not explicitly stated but would presumably be the United States, given the company's location (Chaska, MN). The data is generated prospectively as part of product development and verification.

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. This is a medical device (guidewire) cleared based on substantial equivalence, not a diagnostic or AI device requiring expert-established ground truth from patient data. The "ground truth" for guidewire performance is established through engineering design specifications and material science.

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

Not applicable for this type of device submission. Adjudication methods are typically used in clinical studies or studies involving human interpretation (e.g., radiology reads).

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 not an AI-assisted device.

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

Not applicable. This is not an algorithm or software device. Bench testing constitutes a "standalone" evaluation of the physical device's characteristics against its design specifications.

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

The "ground truth" for this device is based on engineering design specifications, material properties, and established medical device performance standards (e.g., ISO standards for guidewires and biocompatibility). Compliance with these predefined technical and safety requirements serves as the "truth" that the device must meet.

8. The sample size for the training set:

Not applicable. This is not a machine learning or AI device that requires a training set.

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

Not applicable. This is not a machine learning or AI device.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of a human figure, represented by three overlapping profiles, suggesting a sense of community and support.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

November 25, 2014

Lake Region Medical Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Drive Chaska, MN 55318

Re: K142393

Trade/Device Name: Predicate III Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: Class II Product Code: DOX Dated: October 28, 2014 Received: October 30, 2014

Dear Mr. Pexa:

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 (reporting of medical

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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm. 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

Sincerely yours,

Melissa A. Torres -S

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

Enclosure

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Image /page/2/Picture/0 description: The image contains the logo for Lake Region Healthcare. The logo consists of a red abstract symbol on the left, followed by the words "Lake Region" in a bold, serif font. Below "Region" is the word "Medical" in a smaller font size.

INDICATIONS FOR USE STATEMENT

510(k) NUMBER (IF KNOWN): K142393

device name: PREDICATE™ III GUIDEWIRE

INDICATIONS FOR USE:

PREDICATE™ III GUIDEWIRE are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

PRESCRIPTION
USE

AND/OR

OVER-THE-COUNTER USE

(Part 21 CFR 801 Subpart D)

(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)

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e Region

PRODUCT: PREDICATE™ III GUIDEWIRE – Vascular Use JBMISSION DATE: August 260, 2014 SUBMISSION TYPE: SPECIAL 510(k)

510(k) SUMMARY

November 25, 2014

This summary is being included in the submission in lieu of a statement of availability.

2.1	MANUFACTURER / REGISTRATION INFORMATION
	Lake Region Medical	Telephone:	952-448-5111
	340 Lake Hazeltine Dr.	Fax:	952-448-3441
	Chaska, Mn 55318	Contact Person:	Sze Yuen Tan
	FDA REGISTRATION NUMBER: 2126666	Title:	Regulatory Intern
2.2	DEVICE TRADE NAME / PROPRIETARY NAME

PREDICATE™ III GUIDEWIRE

2.3 DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES CATHETER GUIDEWIRE (DQX)

2.4 CLASS OF DEVICE

These devices are commonly known as guides, guidewires, or spring guidewires. The current classification name and product code is Catheter Guidewire (DQX) and is considered a Class II device per 21 CFR Part 870.1330.

2.5 IDENTIFICATION OF PREDICATE DEVICE(s)

K140485 Mandrel Guidewires (Lake Region Medical)

2.6 DEVICE DESCRIPTION

Core Material	Stainless Steel or Nitinol
Coil Material	Stainless Steel
Coil Length	Full length
Joining Agents	Weld
Tip Type	Straight, Shaped
Tip Flexibilities	Various
Overall Lengths	30cm to 500cm
Outside Diameters	0.018" to 0.038"
Sterilization Method	ETO

2.7 COMPLIANCE WITH APPLICABLE STANDARDS

LRM has determined that no mandatory standards, performance standards, or special controls have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic or by any subsequent regulatory action. However, the following standards are referenced within this filing: ISO 10993, ISO 11070, ISO 11135, ISO 11138.

2.8 INTENDED USE STATEMENT

PREDICATE™ III GUIDEWIRES are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

NOTE: This modification does not alter its intended use.

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Image /page/4/Picture/0 description: The image shows the logo for Lake Region Healthcare. The logo consists of a red abstract symbol on the left, followed by the words "Lake Region" in a bold, sans-serif font. Below "Region" is the word "Medical" in a smaller font. The logo is clean and professional, suggesting a healthcare organization.

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PRODUCT: PREDICATE™ III GUIDEWIRE – Vascular Use BMISSION DATE: August 260, 2014 SUBMISSION TYPE: SPECIAL 510(k)

2.9 CONTRAINDICATIONS

There are no contraindications listed.

2.10 TECHNOLOGICAL CHARACTERISTICS

The design specifications are substantially equivalent to the existing Mandrel Guidewires.

QUALITY SYSTEM CONTROL

DESIGN CONTROLS

LRM is in conformance with the design control procedure requirements as specified in 21 CFR Part 820.30. Risk analysis was completed by means of a Failure Mode and Effects Analysis and all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met.

MATERIALS / SUPPLIER / PRODUCT / PROCESS CONTROLS

LRM has formal quality systems in placed to assure that each product manufactured remains equivalent to the predicate products, and that the changes will not have an adverse effect on safety or effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Supplier Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size / group.

2.12 QUALIFICATION TESTING

The conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary which shows the device is at least as safe and effective as the current legally marketed device.

BENCH TESTING

In order to demonstrate equivalence of the guidewire, Lake Region Medical performed bench testing to establish requirements. Test devices were manufactured and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. The devices were then subjected to the following test methods to show the devices comply with the design input summary:

Dimensional
Guidewire Pull Test
Camber Resistance
Visual Inspection
Wire Fracture Test ●
· Corrosion
Wire Flex Test
ISO Strength of Union
Particulate Residue Test
BIOCOMPATIBILITY TESTING

Biocompatibility testing per the design input summary requirements show the addition of full length coil to the device does not affect the biocompatibility of the device and the device is still in compliance with pre-defined acceptance criteria outlined in the product Design Input Summary. A biocompatibility risk assessment determined the following biocompatibility tests are required:

Cytotoxicity
Hemolysis
Chemical Characterization

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Image /page/5/Picture/0 description: The image shows the logo for Lake Region Healthcare. The logo consists of a red abstract symbol on the left, followed by the words "Lake Region" in a bold, sans-serif font. Below "Region" is the word "Medical" in a smaller font size.

2.13 CHANGES FROM PREDICATE DEVICE

Include a Stainless Steel Coil only option as opposed to Stainless Steel, Platinum/Tungsten, -Palladium, and Tungsten
-Weld as a joining option as opposed to options for Braze, Solder, Epoxy and Weld
-Full length coil as opposed to 2cm to 30cm distal tip coil
-Min. Diameter goes to 0.018" as opposed to 0.014"
-Max. Diameter goes to 0.035" as opposed to 0.038"
-No coating options as opposed to PTFE coating

2.14 SUBSTANTIAL EQUIVALENCE DATA

The changes included in this 510(k) for the Mandrel guidewire family does not change the indications for use of the Mandrel guidewires and is not a change to the fundamental scientific technology. The information summarized above shows the device will perform as well as the previously marketed device.

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.