Mandrel guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

Device Description

The Mandrel wire family is made of a coated (PTFE or Silicone) or uncoated Nitinol or Stainless Steel core wire that is tapered at the distal tip where a coil is secured to the distal end. The distal coil can be anywhere from 2cm to 30cm depending on specific design and can consist of Stainless Steel, Palladium, Platinum, or the proposed Tungsten materials. The guidewire may contain proximal core markers.

AI/ML Overview

The provided text describes a 510(k) submission for the Mandrel Guidewire with Tungsten, focusing on demonstrating substantial equivalence to previously cleared predicate devices. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance, human reader studies, or ground truth establishment for a diagnostic device.

The document primarily discusses bench testing for physical and material properties, and biocompatibility testing, to show that the modified device (with Tungsten) is as safe and effective as the predicate devices.

Therefore, many of the requested categories for AI/ML device evaluation are not applicable to this submission.

Here's a breakdown based on the information provided, highlighting the absence of AI/ML specific criteria:

Acceptance Criteria and Device Performance (Non-AI/ML Context)

Acceptance Criteria Category	Reported Device Performance (Non-AI/ML Context)
Visual Inspection	Test devices manufactured and inspected according to established requirements for visual/tactile attributes, demonstrating compliance with design input summary.
Dimensional Conformance	Test devices manufactured and inspected according to established requirements for dimensional attributes, demonstrating compliance with design input summary.
Radiopacity	Bench testing performed to show compliance with design input summary.
Lubricity	Bench testing performed to show compliance with design input summary.
J-Memory Test	Bench testing performed to show compliance with design input summary.
Body Stiffness	Bench testing performed to show compliance with design input summary.
Adhesion / Durability	Bench testing performed to show compliance with design input summary.
Guidewire Pull test	Bench testing performed to show compliance with design input summary.
Torque Strength	Bench testing performed to show compliance with design input summary.
Torque Control	Bench testing performed to show compliance with design input summary.
Linear Stiffness	Bench testing performed to show compliance with design input summary.
Lateral Stiffness	Bench testing performed to show compliance with design input summary.
Particulate Test	Bench testing performed to show compliance with design input summary.
ISO Strength of Union	Bench testing performed to show compliance with design input summary.
ISO Flex Test	Bench testing performed to show compliance with design input summary.
ISO Corrosion Resistance Test	Bench testing performed to show compliance with design input summary.
ISO Fracture Test	Bench testing performed to show compliance with design input summary.
Hydrodurability	Bench testing performed to show compliance with design input summary.
Biocompatibility (Cytotoxicity)	Biocompatibility testing per design input summary requirements showed the addition of Tungsten does not affect biocompatibility and is in compliance with pre-defined acceptance criteria.
Biocompatibility (Hemolysis)	Biocompatibility testing per design input summary requirements showed the addition of Tungsten does not affect biocompatibility and is in compliance with pre-defined acceptance criteria.

Study Details (Non-AI/ML Context)

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: Not explicitly stated as a number of devices. The document mentions "Test devices were manufactured and inspected according to established requirements."
Data Provenance: Not applicable in the context of clinical data. This refers to bench testing performed by Lake Region Medical.

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 as this is not a diagnostic device relying on expert interpretation for ground truth. Ground truth for physical properties (e.g., dimensions, strength) would be defined by engineering specifications and measurement standards.

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

Not applicable; no clinical adjudication process is described for this type of device and testing.

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/ML diagnostic device, and no MRMC study or human reader improvement is discussed.

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

Not applicable; this is not an AI/ML device.

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

For bench testing, the "ground truth" is based on established engineering specifications, published standards (e.g., ISO), and physical measurements. For biocompatibility, it's based on established biological safety evaluation criteria.

8. The sample size for the training set

Not applicable; this is not an AI/ML device, so there is no training set.

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

Not applicable; no training set described.

Summary

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Lake Region

SECTION 2.0 - 510(k) SUMMARY

September 24, 2014

This summary is being included in the Premarket Notification 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:	Mathew Pexa,
FDA REGISTRATION NUMBER: 2126666	Title:	Regulatory Specialist II

2.2 DEVICE TRADE NAME / PROPRIETARY NAME

Mandrel Guidewires or M-Wires

DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES 2.3

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.

IDENTIFICATION OF PREDICATE DEVICE(s) 2.5

K011084	Mandrel Guidewires (Lake Region Medical)
K022759	Mandrel Guidewires (Lake Region Medical)

Mandrel Guidewires (Lake Region Medical) K033758
K080144 Mandrel Guidewires (Lake Region Medical)

DEVICE DESCRIPTION 2.6

Lengths:	20cm to 500cm
Outside Diameter:	0.014" To 0.35"
Tips:	Straight or shaped with various flexibilities
Coil Length:	2cm to 30cm

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.

INTENDED USE STATEMENT 2.8

Mandrel 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.

2.9 CONTRAINDICATIONS

There are no contraindications listed.

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DEPARTMENT OF HEALTH & HUMAN SERVICES

Public Health Service

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

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

Re: K140485

Trade/Device Name: Mandrel Guidewire with Tungsten Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Regulatory Class: Class II Product Code: DQX Dated: February 11, 2014 Received: February 26, 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 four d 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 or any 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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Page 2 - Mathew Pexa

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

Sincerely yours,

Kenneth J. Cavanaugh -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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് Lal

PRODUCT: MANDREL GUIDEWIRE FAMILY w/ TUNGSTEN - Vascular Use SUBMISSION DATE: February 11, 2014 SUBMISSION TYPE: SPECIAL 510(k)

INDICATIONS FOR USE STATEMENT

510(k) NUMBER (IF KNOWN):

DEVICE NAME: Mandrel Guidewire

INDICATIONS FOR USE:

Mandrel guidewires are intended for use in angiographic procedures to introduce and position catheters and interventional devices within the coronary and peripheral vasculature.

PRESCRIPTION	X	AND/OR	OVER-THE-COUNTER
USE			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)

Bram D. Zuckerman -S 2014.03.27 16:48:58 -04'00'

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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 circular design 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. The logo is clean and professional, suggesting a healthcare organization.

TECHNOLOGICAL CHARACTERISTICS 2.10

The design specifications are substantially equivalent to the existing Mandrel Guidewires. Material used for the coil of the guidewire will include the addition material option of Tungsten.

2.11 QUALITY SYSTEM CONTROL

DESIGN CONTROLS

LRM is in conformance with the design control procedure requirements as specified in 21 CFR Part 820.33. 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:

Visual
Radiopacity
Lubricity
J-Memory Test
Body Stiffness
Adhesion / Durability
Guidewire Pull test
· Torque Strength • Torque Control
Dimensional • Linear Stiffness
Lateral Stiffness
Particulate Test
ISO Strength of Union
ISO Flex Test
ISO Corrosion Resistance Test
· ISO Fracture Test
· Hydrodurability
BIOCOMPATIBILITY TESTING

Biocompatibility testing per the design input summary requirements show the addition of Tungsten to the device does not affect the biocompatibility of 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

2.13 SUBSTANTIAL EQUIVALENCE DATA

The addition of Tungsten to 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.