The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart including those within transcatheter aortic valve procedures. This guidewire is not intended for use in the cerebrovasculature or coronary arteries.

Device Description

The 0.035" diameter, 260cm-300cm length guidewire is composed of two primary wire components: a core and a coil. Both components are made of stainless steel per ASTM A313. The core wire is a stainless steel wire which forms the inner body of the guidewire. The coil component is the guidewire's outer layer and is a stainless steel wire coated in Green Polytetrafluoroethylene (PTFE). The coil and core components are weld together on the distal and proximal ends, forming the guidewire. The distal end of the guidewire contains a double-curve.

AI/ML Overview

This document describes the qualification testing for a "Pre-Formed Guidewire" and compares it to a predicate device for a 510(k) submission.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The document lists "applicable bench tests performed at baseline and aging," and states that "Test pieces were tested and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes." It also states, "All test results support the claim of substantial equivalence." However, specific quantitative acceptance criteria (e.g., "tensile strength > X N") and the exact numerical results obtained for each test are not provided in this summary. The table below represents the categories of tests performed and the general statement of performance.

Acceptance Criteria Category	Reported Device Performance
Dimensional	Met established requirements
FDA Device Compatibility	Met established requirements
FDA Tensile Strength	Met established requirements
FDA Tip Flexibility	Met established requirements
FDA Coating Adherence/Integrity	Met established requirements
FDA Catheter Compatibility	Met established requirements
Packaging Study	Met established requirements
Particulate	Met established requirements
ISO Visual	Met established requirements
ISO Fracture	Met established requirements
ISO Flex	Met established requirements
ISO Corrosion Resistance	Met established requirements
ISO Strength of Union	Met established requirements
ISO Radiopacity	Met established requirements
Body Stiffness	Met established requirements
Biocompatibility (Cytotoxicity, Kligman Maximization, Irritation/Intracutaneous Reactivity, Complement Activation Assay, Rabbit Pyrogen, Hemolysis, Thrombogenicity, Lee and White Coagulation, Unactivated Thromboplastin Time Assay, Acute Systemic Toxicity Test, Partial Thromboplastin Time Assay, USP Physicochemical Test, Inhibition and Enhancement)	Found to be acceptable per ISO 10993 series
GLP Animal Study Performance	Substantially equivalent to the legally marketed device; acceptable performance and safety.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size for Test Set: Not explicitly stated for each bench test, biocompatibility test, or the animal study. The document mentions "Test pieces were tested," implying multiple samples, but gives no numbers.
Data Provenance: The document does not specify the country of origin for any data.
- Bench Testing: Performed by Lake Region Medical.
- Biocompatibility Testing: Performed by an unspecified lab.
- Animal Study: A GLP (Good Laboratory Practice) Animal Study was completed, implying it was conducted under controlled conditions, but the location is not mentioned.
Retrospective or Prospective: All testing appears to be prospective as it was specifically conducted to demonstrate equivalence for this 510(k) submission.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

This type of information is generally not applicable to a medical device 510(k) submission for a guidewire. The "ground truth" for guidewire performance is established through objective, quantifiable physical, chemical, and biological testing as performed in the bench and animal studies, not through expert consensus on qualitative observations.

4. Adjudication Method for the Test Set

Not applicable. As noted above, the "ground truth" is based on objective measurements and established standards, rather than subjective interpretation requiring adjudication among experts.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the Effect Size

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices where human readers interpret results, comparing their performance with and without AI assistance. This submission describes a physical medical device (guidewire) where performance is assessed through bench and animal testing.

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

Not applicable. This is not an AI (algorithm-only) device. The device itself is a physical guidewire. Human intervention is inherently part of its use (e.g., a physician manipulating the guidewire).

7. The Type of Ground Truth Used

The "ground truth" for the Pre-Formed Guidewire's performance and safety was established through a combination of:

Bench Testing: Objective measurements against established requirements for visual/tactile, dimensional, and mechanical attributes, often guided by standards like ISO 11070:1998 and FDA guidance.
Biocompatibility Testing: Compliance with ISO 10993 series standards, involving various biological assays directly measuring material interaction with biological systems.
GLP Animal Study: In-vivo evaluation of performance and safety, comparing the new device to a predicate device in a living system. This assesses real-world interaction and outcomes, often including histological and physiological assessments.

8. The Sample Size for the Training Set

Not applicable. This is a traditional 510(k) for a physical medical device, not an AI or machine learning algorithm. Therefore, there is no "training set" in the context of data for model development.

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/1 description: The image contains the logo for Lake Region Medical. The logo features a circular graphic to the left of the text "Lake Region". Below the word "Region" is the word "Medical" in a smaller font size. The logo is simple and professional.

PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)

SECTION 5.0: 510(k) SUMMARY

5.1	MANUFACTURER / REGISTRATION INFORMATION
Lake Region Medical340 Lake Hazeltine DriveChaska, MN 55318-1029 USAFDA REGISTRATION NUMBER: 2126666	Contact Person: Mathew PexaTitle: Regulatory Specialist IITelephone: 952-641-8511Fax: 952-448-3441

5.2 TRADE NAME (PROPRIETATY NAME)

Pre-Formed Guidewire

DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAME 5.3

CATHETER GUIDEWIRE (DQX)

CLASS OF DEVICE 5.4

This type of Guidewire was originally listed as a Class II device by the Cardiovascular (DQX) review panel.

5.5 IDENTIFICATION OF PREDICATE DEVICE(s) ====================================================================================================================================
	510(k) NUMBER MANUFACTURER	DEVICE NAME
K930622	Boston Scientific	Amplatz SuperStiff Guidewire

5.6 DEVICE DESCRIPTION

OUTSIDE DIAMETER:	0.035"
LENGTHS:	260cm - 300cm
TIP SHAPE:	Double-curve
TIP SIZES:	Small - Large

COMPLIANCE WITH APPLICABLE STANDARDS 5.7

The guidewire is in compliance with ISO 10993-1, ISO 10993-4, ISO 10993-7, ISO 10993-7, ISO 10993-10, ISO 10993-11, ISO 10993-12, ISO 15223-1, EN 980, ISO 11135-1, and ISO 11070.

AUG 2 3 2013

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C Lake Regio

PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)

K130798 Page 2 of 3

SECTION 5.0: 510(k) SUMMARY

5.8 INTENDED USE STATEMENT

The Pre-Formed guidewires are intended to facilitate the introduction and placement of interventional devices within the chambers of the heart, including those used within transcatheter aortic valve procedures.

5.8 CONTRAINDICATIONS

This wire is not intended for use in the cerebrovasculature or coronary arteries.

59 COMPARISON

Comparison bench and animal tests were completed on the Boston Scientific Amplatz SuperStiff guidewire with 510(k) number K930622 to determine substantial equivalence.

5.10 OUALIFICATION TESTING

The conclusions drawn from bench testing, biocompatibility, and a GLP animal study demonstrate the device is as safe, as effective and performs at least as safely and effectively as the legally marketed device.

BENCH TESTING

In order to demonstrate equivalence of the guidewire, Lake Region Medical performed testing to establish requirements. Test pieces were tested and inspected according to established requirements for visual/tactile, dimensional and mechanical attributes. Test methods were developed using FDA Coronary and Cerebrovascular Guidewire guidance and ISO 11070:1998. The following table lists the applicable bench tests performed at baseline and aging include:

Dimensional .
. FDA Device Compatibility
FDA Tensile Strength .
. FDA Tip Flexibility
. FDA Coating Adherence/Integrity
FDA Catheter Compatibility .
. Packaging Study
Particulate .
. ISO Visual
. ISO Fracture
ISO Flex .
. ISO Corrosion Resistance
ISO Strength of Union .
. ISO Radiopacity
Body Stiffness

BIOCOMPATIBILITY TESTING

Biocompatibility testing per ISO 10993 series has been performed on the Pre-Formed guidewires and has been found to be acceptable.

Cytotoxicity .
. Kligman Maximization Test
Irritation / Intracutaneous Reactivity .
Complement Activation Assay
Rabbit Pyrogen 0
Hemolysis
Thrombogenicity
. Lee and White Coagulation
. Unactivated Thromboplastin Time Assay
Acute Systemic Toxicity Test .
Partial Thromboplastin Time Assay .
USP Physicochemical Test .
. Inhibition and Enhancement

ANIMAL STUDIES

A GLP Animal Study was completed to evaluate customer feedback, performance and safety of the Guidewire compared to the currently marketed device. The studies show the guidewires are substantially equivalent to the legally marketed device.

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Lake Reg

PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)

SUBSTANTIAL EQUIVALENCE DATA 5.11

The Pre-Formed guidewires are substantially equivalent to the Amplatz SuperStiff Guidewire manufactured by Boston Scientific cleared under 510(k) number K930622.

The guidewire has similar technological characteristics to the predicate device. The technological differences between the proposed device and the predicate device are:

Larger Proximal Core Diameter .
-Longer Distal Grind
. Lack of intermediate joint
-Stainless steel weld (as opposed to Solder)
Double Curve on distal tip -
-Lack of moveable core

The data generated by accepted test methods and comparisons to the predicate device show that the Pre-Formed guidewire is substantially equivalent to the predicate device and the technological differences listed above do not pose any new issues of safety or effectiveness.

The Pre-Formed guidewires are substantially equivalent to the Amplatz SuperStiff Guidewire cleared under 510(k) K930622. All test results support the claim of substantial equivalence.

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Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle.

Public Health Service

Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002

August 23, 2013

Lake Region Medical C/O Mr. Mathew Pexa Regulatory Specialist II 340 Lake Hazeltine Drive Chaska, MN 55318-1029

Rc: K130798

Trade/Device Name: Pre-Formed Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II Product Code: DQX Dated: August 14, 2013 Received: August 14, 2013

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 docs 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 (sec above) into cither 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 device-rclated adverse events) (21 CFR 803); good manufacturing practice requirements us set

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Page 2 - Mr. Mathew Pexa

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 Small Manufacturers, International and Consumer Assistance at its tollfree number (800) 638-2041 or (301) 796-7100 or at its Internet address

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

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 (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,

M.A. Hillen

for

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

Enclosure

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C Lake R

PRODUCT: PRE-FORMED GUIDEWIRE SUBMISSION DATE: March 21, 2013 SUBMISSION TYPE: TRADITIONAL 510(k)

INDICATIONS FOR USE

510(k) NUMBER (IF KNOWN): K130798

DEVICE NAME: PRE-FORMED GUIDEWIRES

INDICATIONS FOR USE:

This guidewire is not intended for use in the cerebrovasculature or coronary arteries.

PRESCRIPTION X

USE

AND/OR

OVER-THE-COUNTER USE (21 CFR 807 Subpart C)

(Part 21 CFR 801 Subpart D)

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED) Concurrence of CDRH, Office of Device Evaluation (ODE)

PAGE 1 of

M.A. Zillmann

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.