HYDROPHILIC COATED GUIDEWIRE

• K Number: K133155
• Device Name: HYDROPHILIC COATED GUIDEWIRE
• Manufacturer: LAKE REGION MEDICAL
• Date Cleared: 2014-04-07 ( 172 days)
• Product Code: DQX
• Regulation Number: 870.1330
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K000011
• Predicate For: K170915

Intended Use

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

Device Description

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.

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.