Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

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. The Mandrel guidewire family is bound by the following parameters: Lengths: 20cm to 500cm, Outside Diameter: 0.014" To 0.35", Tips: Straight or shaped with various flexibilities, Coil Length: 2cm to 30cm.

AI/ML Overview

This document describes a 510(k) submission for Mandrel Guidewires with the addition of Tungsten as a material option. The submission focuses on demonstrating substantial equivalence to previously marketed predicate devices.

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly present a table of acceptance criteria with corresponding performance metrics in a pass/fail format. Instead, it states that "all verification and validation activities resulted in the ability to demonstrate that the predetermined acceptance criteria were met" and that "the conclusions drawn from bench testing and biocompatibility testing demonstrate compliance with the design input summary."

The document lists the following tests performed to ensure compliance with the design input summary:

Acceptance Criteria (Test)	Reported Device Performance
Visual	Complies with design input summary
Radiopacity	Complies with design input summary
Lubricity	Complies with design input summary
J-Memory Test	Complies with design input summary
Body Stiffness	Complies with design input summary
Adhesion / Durability	Complies with design input summary
Guidewire Pull test	Complies with design input summary
Torque Strength	Complies with design input summary
Torque Control	Complies with design input summary
Dimensional	Complies with design input summary
Linear Stiffness	Complies with design input summary
Lateral Stiffness	Complies with design input summary
Particulate Test	Complies with design input summary
ISO Strength of Union	Complies with design input summary
ISO Flex Test	Complies with design input summary
ISO Corrosion Resistance Test	Complies with design input summary
ISO Fracture Test	Complies with design input summary
Hydrodurability	Complies with design input summary
Cytotoxicity (Biocompatibility)	Complies with pre-defined acceptance criteria
Hemolysis (Biocompatibility)	Complies with pre-defined acceptance criteria

Note: The specific numerical or descriptive acceptance criteria for each test are not provided in this summary, nor are the detailed results. The device performance is generally stated as "complies with design input summary" or "complies with pre-defined acceptance criteria."

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

The document states that "Test devices were manufactured and inspected according to established requirements." However, it does not provide the specific sample size used for the bench testing or biocompatibility testing. The data provenance is internal to Lake Region Medical through their "formal quality systems." There is no mention of country of origin for data or whether the study was retrospective or prospective in the standard sense (as this is a device modification submission, not a clinical trial). The data is generated from laboratory testing.

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

This type of information is not applicable to this device submission. The tests conducted are primarily physical, mechanical, and biological evaluations of the device itself, rather than diagnostic interpretations requiring expert consensus for ground truth. The "ground truth" for these tests would be the established engineering specifications and ISO standards.

4. Adjudication Method for the Test Set

This information is not applicable for the type of testing described (bench and biocompatibility). Adjudication methods like 2+1 or 3+1 are typically used for clinical studies involving human interpretation or subjective assessments.

5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done

No, an MRMC comparative effectiveness study was not done. This submission is for a material modification to a guidewire, and the testing focuses on the device's physical, mechanical, and biological properties, not its interpretive performance in a diagnostic context.

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

This question is not applicable. The device is a physical medical guidewire, not an algorithm or AI software. Therefore, there is no "standalone" algorithm performance to evaluate.

7. The Type of Ground Truth Used

The ground truth used for this submission is based on established engineering design input summaries, internal specifications, and relevant ISO standards for material properties, mechanical performance, and biocompatibility.

8. The Sample Size for the Training Set

This question is not applicable. There is no "training set" in the context of this device submission. The device is not an AI model requiring a dataset for training.

9. How the Ground Truth for the Training Set Was Established

This question is not applicable as there is no training set for this device.

Summary

{0}------------------------------------------------

Lake Region
Medical

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
2.3 DEVICE COMMON NAMES / USUAL NAMES / CLASSIFICATION NAMES
ENDOSCOPE AND ACCESSORIES (OCY); 21 CFR Part 876.1500
2.4 CLASS OF DEVICE
These devices are Class II.
2.5 IDENTIFICATION OF PREDICATE DEVICE(s)
K011084 Mandrel Guidewires (Lake Region Medical)
K080508 Mandrel Guidewires (Lake Region Medical)
2.6 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. The

Mandrel guidewire family is bound by the following parameters:
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.

2.8 INTENDED USE STATEMENT

Mandrel Guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

NOTE: This modification does not alter its intended use.

2.9 CONTRAINDICATIONS

There are no contraindications listed.

{1}------------------------------------------------

Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the caduceus symbol.

Public Health Service

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

April 8, 2014

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

K140482 Re:

Trade/Device Name: Mandrel Guidewire Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: OCY Dated: March 11, 2014 Received: March 12, 2014

Dear Mathew 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). and Cosmetic Hot (110. (110.) and the device, subject to the general controls provisions of the Act. The I ou may, dicrerere, manot of the Act include requirements for annual registration, listing of general connois provisions of rectice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability addition. " Ne 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 finay be subject to additions, 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.

{2}------------------------------------------------

Page 2 - Mathew Pexa

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

Sincerely yours,

Benjamin R Fisher -S

Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{3}------------------------------------------------

O I ake

PRODUCT: MANDREL GUIDEWIRE FAMILY w/ TUNGSTEN - Non-Vascular Use SUBMISSION DATE: February 12, 2014 SUBMISSION TYPE: SPECIAL 510(k)

INDICATIONS FOR USE STATEMENT

..............................................................................................................................................................................

510(k) NUMBER (IF KNOWN): K140482

DEVICE NAME: Mandrel Guidewire

INDICATIONS FOR USE:

Mandrel guidewires are intended to facilitate the introduction of other diagnostic and treatment devices used in gastroenterology and urology procedures.

------------------------------------------------------------------------------------------------------------------------------------------------------------------------------. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

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)

Benjamin R. Fisher -S
2014.04.08 08:53:29 -04'00'

PAGE 1 of

{4}------------------------------------------------

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

§ 876.1500 Endoscope and accessories.

(a)
Identification. An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.(b)
Classification —(1)Class II (special controls). The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.