Utilizing proprietary processes, these guides are constructed from a steerable, metallic core (Nitinol) with a radiopaque polymer (polyurethane) jacket and a hydrophilic coating is applied over the jacket. Guidewires are available up to 260cm length and in diameters from 0.018" to 0.038" depending on specific design requirements. Guidewires may have a straight or angled distal tip.

AI/ML Overview

This document summarizes the acceptance criteria and supporting studies for the Lake Region Medical Hydrophilic Coated Guidewires (K133155). The information primarily comes from the 510(k) Summary.

1. Table of Acceptance Criteria and Reported Device Performance

The provided document describes qualification testing to demonstrate equivalence to a predicate device, rather than explicit acceptance criteria with numerical targets and reported performance values. The tests performed are listed, implying that the device was found to be acceptable against established criteria for each test. Due to the lack of specific numerical acceptance criteria and performance data in the provided text, the table below lists the tests performed and notes that they were conducted to demonstrate equivalence and found acceptable.

Test Category	Test Name	Acceptance Criteria (Implicit)	Reported Device Performance
Bench Testing	Dimensional	Met established specific inspection criteria for visual/tactile, dimensional attributes.	Tested and found acceptable to demonstrate equivalence.
	FDA Device Compatibility	Met established specific inspection criteria. Test methods developed using FDA guidance.	Tested and found acceptable to demonstrate equivalence.
	FDA Tensile Strength	Met established specific inspection criteria. Test methods developed using FDA guidance.	Tested and found acceptable to demonstrate equivalence.
	FDA Tip Flexibility	Met established specific inspection criteria. Test methods developed using FDA guidance.	Tested and found acceptable to demonstrate equivalence.
	FDA Coating Adherence/Integrity	Met established specific inspection criteria. Test methods developed using FDA guidance.	Tested and found acceptable to demonstrate equivalence.
	FDA Catheter Compatibility	Met established specific inspection criteria. Test methods developed using FDA guidance.	Tested and found acceptable to demonstrate equivalence.
	FDA Torque Control	Met established specific inspection criteria. Test methods developed using FDA guidance.	Tested and found acceptable to demonstrate equivalence.
	FDA Combined Load	Met established specific inspection criteria. Test methods developed using FDA guidance.	Tested and found acceptable to demonstrate equivalence.
	Packaging Study	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Particulate	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Kink Resistance	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Linear Stiffness	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Lateral Stiffness	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	ISO Visual	Complied with ISO 11070:1998 and established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	ISO Fracture	Complied with ISO 11070:1998 and established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	ISO Flex	Complied with ISO 11070:1998 and established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	ISO Corrosion	Complied with ISO 11070:1998 and established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	ISO Strength of Union	Complied with ISO 11070:1998 and established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	ISO Radiopacity	Complied with ISO 11070:1998 and established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Body Stiffness	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Tip Integrity	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Jacket Durability	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Tip Puncture Resistance	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	Coating Performance Testing	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
	3 Point Bend	Met established specific inspection criteria.	Tested and found acceptable to demonstrate equivalence.
Biocompatibility	ISO Cytotoxicity	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Klingman Maximization Test	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Irritation / Intracutaneous Reactivity	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Systemic Toxicity	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Rabbit Pyrogen	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ASTM Hemolysis	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Complement Activation Assay	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Thrombogenicity	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Lee and White Coagulation	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Prothrombin Time Assay	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.
	ISO Unactivated Partial Thromboplastin Time Assay	Performed per ISO 10993 series and found acceptable.	Tested and found acceptable.

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

The document does not specify the sample sizes used for each individual bench or biocompatibility test. It states that "Test pieces were tested and inspected." This suggests a laboratory setting for testing physical and biocompatibility properties. The data provenance is presumed to be from internal lab testing conducted by Lake Region Medical ("Lake Region Medical performed testing"). The study is analogous to a pre-market, prospective validation of the device's physical and biological characteristics.

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

This information is not applicable to the type of testing described (bench and biocompatibility). The "ground truth" for these tests would be defined by the specified test methods (e.g., ISO standards, FDA guidance documents) and the scientific principles behind them, rather than expert consensus on clinical cases.

4. Adjudication Method for the Test Set

Not applicable. As described above, the testing involves objective measurement and analysis against predefined standards for physical and chemical properties, not subjective assessment requiring adjudication.

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 device is a guidewire, a physical medical instrument, not an AI-powered diagnostic or assistive tool. Therefore, MRMC studies comparing human reader performance with and without AI assistance are not relevant.

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

Not applicable. See point 5. This is a physical medical device, not an algorithm.

7. The Type of Ground Truth Used

The ground truth for the bench testing is based on:

Established specific inspection criteria for visual/tactile and dimensional attributes.
FDA Coronary and Cerebrovascular Guidance for certain test method development.
ISO 11070:1998 for guidewire test methods.

For biocompatibility testing, the ground truth is based on:

ISO 10993 series of standards.

These standards and guidance documents define the acceptable limits and methodologies for evaluating the device's physical and biological properties.

8. The Sample Size for the Training Set

Not applicable. This product is a physical medical device, not an AI model, so there is no training set mentioned or implied.

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

Not applicable. See point 8.

Summary

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Image /page/0/Picture/1 description: The image shows the logo for Lake Region Medical. The logo consists of a circular 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.

PRODUCT: Hydrophilic Coated Guidewires SUBMISSION DATE: September 30, 2013 SUBMISSION TYPE: Traditional 510(k)

K133155, 510(k) Summary Page 1 of 3

SECTION 1.0: 510(k) SUMMARY

1.1 MANUFACTURER / REGISTRATION INFORMATION

Lake Region Medical	Contact Person:	Tracy Meyer
340 Lake Hazeltine Drive	Title:	Regulatory Specialist
Chaska, MN 55318-1029 USA	Telephone:	952-641-8510
FDA REGISTRATION NUMBER: 2126666	Fax:	952-448-3441

1.2 TRADE NAME (PROPRIETATY NAME)

Hydrophilic Coated Guidewires

1.3 DEVICE COMMON NAMES/USUAL NAMES/CLASSIFICATION NAMES

These devices are commonly known as guidewires, or spring guidewires. The current classification names and product codes are Wire, Guide, Catheter (DQX).

CLASS OF DEVICE 1.4

The classification names listed above were originally classified as Class II devices by the Cardiovascular (74DQX) Review Panel.

IDENTIFICATION OF PREDICATE DEVICE(s) 1.5

510(k)NUMBER	MANUFACTURER	DEVICE NAME
K000011	Lake Region Medical	Hydrophilic Coated Guidewire

PROPOSED DEVICE DESCRIPTION 1.6

OUTSIDE DIAMETER: 0.018"-0.038"

LENGTHS: 80cm - 260cm TIP SHAPE: Straight or Angled

1.7 COMPLIANCE WITH APPLICABLE STANDARDS

The proposed Hydrophilic Coated Guidewires is in compliance with ISO 10993, ISO 11070, ISO 15223, EN 980, ISO 594.

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Image /page/1/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a circular symbol to the left of the words "Lake Region" in a bold, sans-serif font. Below "Region" is the word "Medical" in a smaller font size.

PRODUCT: Hydrophilic Coated Guidewires SUBMISSION DATE: September 30, 2013 SUBMISSION TYPE: Traditional 510(k)

SECTION 1.0: 510(k) SUMMARY

INTENDED USE STATEMENT 1.8

To facilitate the placement of devices during diagnostic and interventional procedures.

1.9 CONTRAINDICATIONS

None Known

1.10 COMPARISON

The proposed Hydrophilic Coated Guidewire is substantially equivalent to the predicate Hydrophilic Coated Guidewire with 510(k) number K000011.

QUALIFICATION TESTING 1.11

The conclusions drawn from non-clinical and biocompatibility testing demonstrate the device is substantially equivalent to the claimed predicate device.

BENCH TESTING

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

. Dimensional
FDA Device Compatibility .
FDA Tensile Strength ●
FDA Tip Flexibility .
FDA Coating Adherence/Integrity 0
FDA Catheter Compatibility .
FDA Torque Control .
. FDA Combined Load
. Packaging Study
Particulate .
Kink Resistance .
Linear Stiffness .
Lateral Stiffness .
ISO Visual ●
ISO Fracture
ISO Flex .
ISO Corrosion .
ISO Strength of Union .
. ISO Radiopacity
Body Stiffness .
Tip Integrity .
Jacket Durability .
Tip Puncture Resistance .
Coating Performance Testing .
3 Point Bend .

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Image /page/2/Picture/0 description: The image shows the logo for Lake Region Medical. The logo consists of a circular graphic on the left, followed by the words "Lake Region" in a bold, serif font. The word "Medical" is written in a smaller font below "Region."

PRODUCT: Hydrophilic Coated Guidewires SUBMISSION DATE: September 30, 2013 SUBMISSION TYPE: Special 510(k)

K133155, 510(k) Summary Page 3 of 3

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1 , 1 1 QUALIFICATION TESTING Continued

BIOCOMPATIBILITY TESTING

Biocompatibility testing per ISO 10993 series has been performed on the proposed Hydrophilic Guidewires and has been found to be acceptable:

ISO Cytotoxicity .
. ISO Klingman Maximization Test
ISO Irritation / Intracutaneous Reactivity .
ISO Systemic Toxicity .
. ISO Rabbit Pyrogen
. ASTM Hemolysis
ISO Complement Activation Assay
ISO Thrombogenicity
ISO Lee and White Coagulation �
ISO Prothrombin Time Assay ◆
ISO Unactivated Partial Thromboplastin Time . Assay

1.12 SUBSTANTIAL EQUIVALENCE DATA

The proposed Hydrophilic Coated Guidewire has the same intended use as predicate Hydrophilic Coated Guidewires legally marketed by Lake Region Medical and cleared by 510(k) K000011.

The proposed Hydrophilic Coated Guidewires have the same physical characteristics as the predicate device with the exception of the change to the hydrophilic coating. All required tests 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 consists of a stylized eagle with three stripes extending from its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

Public Health Service

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

April 7, 2014

Lake Region Medical % Tracy Meyer, Regulatory Specialist 340 Lake Hazeltine Drive Chaska, MN 55318-1029

Re: K133155

Trade/Device Name: Hydrophilic Coated Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Guidewire Catheter Regulatory Class: Class II Product Code: DQX Dated: March 5, 2014 Received: March 6, 2014

Dear Tracy Meyer,

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.

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Page 2 - Tracy Meyer

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 devicerelated 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/Resourcesfor You/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 vours.

Image /page/4/Picture/5 description: The image shows the name "Bram D. Zuckerman" in bold, black font. Below the name is the letter "S" in a similar font. To the right of the name and the letter is the acronym "FDA" in a stylized, outlined font.

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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C Lak

PRODUCT: Hydrophilic Coated Guidewires SU8MISSION DATE: September 30, 2013 SUBMISSION TYPE: Traditional 510(k)

INDICATIONS FOR USE

510(k) NUMBER (IF KNOWN): K133155

DEVICE NAME: Hydrophilic Coated Guidewire

INDICATIONS FOR USE:

To facilitate the placement of devices during diagnostic and interventional procedures.

PRESCRIPTION × USE

OVER-THE-.4ND/OR

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

Tanya X. Shortus

Kenya Brothers -S 2014.04.07 17:30:11 -04'00'

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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.