LRM by LAKE REGION MFG., INC. | FDA 510(k) Summary

Steerable stainless steel core with radiopaque marker; a jacket, and polymer/hydrophilic coating is applied over the core/coil. The quidewires are bound by the following parameters: Outside Diameter: .016" - .045" Lengths: 20 cm -- 400 cm Tips: Straight, Shapable with standard and stiff tip flexibility

AI/ML Overview

Device Acceptance Criteria and Study Details:

This document describes the acceptance criteria and the study performed for a guidewire produced by Lake Region Manufacturing, Inc. (LRM). The study aims to demonstrate substantial equivalence of guidewires manufactured with a polymer/hydrophilic coating to existing predicate guidewires, specifically Terumo guidewires.

1. Table of Acceptance Criteria and Reported Device Performance:

The document broadly states that "All test results were within prescribed specification limits." While specific numerical acceptance criteria ranges are not provided, the reported performance indicates successful adherence to predefined standards for each test. For the biocompatibility tests, the results explicitly state whether the material passed or met the expectations for safety.

Test Performed	Acceptance Criteria (Implicit)	Reported Device Performance
Lubricity	Force required for insertion/withdrawal within a catheter lumen standardized to guidewire diameter must be within specifications.	All test results were within prescribed specification limits.
Coating Durability	Lubricity before and after multiple catheter insertions/withdrawals must be within specifications.	All test results were within prescribed specification limits.
Dimensional Measurement (OD)	Outside diameter at multiple body points (dry, 10 min soak, 40 min soak) must be within specifications.	All test results were within prescribed specification limits.
Distal Tip Flexibility	Flexibility of the distal tip must be within specifications.	All test results were within prescribed specification limits.
3-Point Bending Test	Guidewire body stiffness/flexibility must be within specifications.	All test results were within prescribed specification limits.
Rotational Control	Ability to place distal tip at desired location (360 degrees) when controlled from proximal end must be within specifications.	All test results were within prescribed specification limits.
Torsional Integrity	Torqueable strength of the guidewire must be within specifications.	All test results were within prescribed specification limits.
Radiopacity	Radiopacity of the distal tip must be equivalent to currently marketed hydrophilic guidewires.	All test results were within prescribed specification limits.
Tracking	Tractability of the guidewire must be within specifications.	All test results were within prescribed specification limits.
Pull Test	Strength of welded joint points must be within specifications.	All test results were within prescribed specification limits.
Biocompatibility Tests
Cytotoxicity	Pass assay (e.g., maximum Grade 2 cytotoxic response).	The samples evoked a mild cytotoxic response (Grade 2) when tested at a 48 hour exposure period. The test material passed the assay.
Hemolysis	No hemolysis should be produced.	The samples did not produce hemolysis.
Acute Systemic Toxicity	No signs or symptoms of systemic toxicity.	No signs or symptoms of Systemic Toxicity were observed for any of the samples.
Intracutaneous Test	Skin reactions should not be significant.	For all samples, skin reactions were not significant.
Implantation (7 Day)	Reaction not significant compared to negative control implant.	The reaction was not significant as compared to the negative control implant, for any of the samples.
Sensitization	Non-sensitizer.	The samples were deemed to be a non-sensitizer.
Pyrogen Test	No pyrogenic response.	The samples did not produce a pyrogenic response.

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

Test Set Sample Sizes:
- For each of the three product groups (.018" standard, .035" standard, and .038" stiff configurations), at least 200 samples were produced (600+ total samples).
- For each individual test, either 20 or 30 samples were selected.
- Additional sets of 20 or 30 samples were used for destructive tests.
Data Provenance: The data is prospective, as LRM manufactured "production samples" and "LRM samples" specifically for this comparative testing. The predicate Terumo product was "purchased by LRM, complete in packaging" for direct comparison. The country of origin for the data is implicitly the United States, as LRM is a U.S. company and the submission is to the FDA.

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

The document does not specify the number of experts or their qualifications used to establish ground truth for the functional performance tests (Lubricity, Rotational Control, etc.). These tests appear to be objective, quantitative measurements against predefined engineering specifications.
For biocompatibility tests, these are typically performed in specialized laboratories following established protocols, implying certified personnel, but specific expert qualifications are not detailed.

4. Adjudication Method for the Test Set:

The document does not describe an adjudication method for the test set results. The tests appear to be objective measurements compared against internal specifications or the performance of the predicate device. Therefore, it is likely that no formal adjudication was required beyond comparing the results to the established criteria.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not performed. This type of study is relevant for diagnostic imaging devices where human interpretation is involved. For a guidewire, the effectiveness is assessed through its physical and performance characteristics, not through human reader interpretation of output.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

Yes, the studies performed were standalone in the sense that they evaluated the device's inherent physical and functional properties directly. There is no "algorithm" or human-in-the-loop component to a guidewire's fundamental performance assessment in this context. The tests measure the device's characteristics directly.

7. Type of Ground Truth Used:

The ground truth used for the functional performance tests (Lubricity, Dimensional Measurement, etc.) is defined engineering specifications and comparative performance against a predicate device (Terumo guidewires). The goal was to show that the LRM device met its own specifications and was equivalent to the predicate.
For the biocompatibility tests, the ground truth is established by validated laboratory protocols and reference standards, following recommendations from the FDA's "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices."

8. Sample Size for the Training Set:

The concept of a "training set" is not applicable to this submission. The device is a physical medical instrument, not a machine learning algorithm. The manufacturing process itself could be considered "trained" through years of experience and quality controls, but there isn't a distinct "training set" of data in the AI/ML sense.

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

As the concept of a training set is not applicable, this question is not relevant to this device submission. The "ground truth" for the manufacturing process is established through documented quality systems, engineering change order reviews, material qualification, product qualification, and process qualification. These controls ensure consistency and adherence to design specifications over time.

Summary

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K960718

SECTION 2.0 - SUMMARY & CERTIFICATION

MAY 2 | 1996

2.1 General Information

2.1.1 Company Name, Address, and Telephone Number
Lake Region Manufacturing, Inc., (LRM) 340 Lake Hazeltine Drive Chaska, MN 55318

Telephone: (612) 448-5111 Fax: (612) 448-3441

2.1.2 Device Trade Name/Proprietary Name
LRM produces quidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large number of trade and proprietary names not including or associated with LRM. LRM has no proprietary names of its own to be included with this submission.
2.1.3 Device Common Names/Unusual Names, and Classification Names
These devices are commonly known as quides, guidewires, or spring guidewires.

The current classification names, and product codes are Angiographic Guidewire (74HAP), Catheter Guidewire (74DQX), and Radiological Catheter Guidewire (74JAJ)

2.1.4 LRM Establishment Registration Number: 2126666
2.1.5 Classification of Devices

The classification names listed above were originally classified as Class II devices by the Neurology (84HAD), Cardiovascular (74DQX), and Radiology (90JAJ) Review Panels respectively.

2.1.6 Applicability of Performance Standards
LRM has determined that no mandatory performance standards have been established for these devices under Section 514 of the Medical Device Amendments to Federal Food, Drug, and Cosmetic Act or by any subsequent regulatory action. LRM has also determined that there are no applicable voluntary standards.

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Labels, Labeling, and Advertising 2.2
LRM produces cardiovascular and vascular guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. Changes to the customer controlled labels, labeling, or promotional material are at their discretion, including the resolution of any resulting regulatory obligations.

A small fraction of the total production bears LRM controlled labels and labeling. Summary of Safety and Effectiveness

This summary is being included in the Premarket Notification submission in lieu of a statement of availability.

Device Description 2.4
2.3

Description of Guidewires Produced With Polymer/ 2.4.1 Hydrophilic Coating
Steerable stainless steel core with radiopaque marker; a jacket, and polymer/hydrophilic coating is applied over the core/coil. The quidewires are bound by the following parameters:

Outside Diameter: .016" - .045" 20 cm -- 400 cm Lengths: Straight, Shapable with standard Tips: and stiff tip flexibility

None of these guidew.res are for PTCA use. Note:

2.4.2 Engineering Specifications
The design specifications are the same for guidewires manufactured with or without the polymer/hydrophilic coating. The finished devices must meet the same design criteria. Section 2.5 contains comparative data to demonstrate equivalency.
2.5 Substantial Equivalence Data
2.5.1 Background Information

In order to demonstrate equivalence of guidewires manufactured with polymer/hydrophilic, LRM performed comparative testing between LRM polymer/hydrophilic guidewire and Terumo guidewires.

LRM chose a product mix of three groups of wires, based on the available Terumo products of .018" standard, .035" standard and .038" stiff configurations. LRM samples were manufactured following current manufacturing processes and procedures. Terumo product was purchased by LRM, complete in packaging. All samples were sterilized prior to testing.

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Comparative Test Data 2.5.2

Within each of the three groups, production samples
were made; at least two hundred (200+) samples of each size (600+ total samples) were produced per standard manufacturing procedures. For each test, there were either twenty (20) or thirty (30) samples selected. Some of the tests are destructive in nature which required the selection of additional sets of twenty (20) or thirty (30) samples to perform other tests.

The following product qualification tests were performed:

Measures the force required to insert Lubricity: 2.5.2.1 and withdraw the guidewire within a catheter lumen standardized to each guidewire diameter.
Coating Durability: Measures the lubricity before 2.5.2.2 and after multiple catheter insertions and withdrawals.
2.5.2.3 Dimensional Measurement - Outside Diameter, Dry and after 10 minutes soak and after 40 minute soak in normal saline : Micrometer measurement of the outside diameter of the guidewire at multiple body points.
Distal Tip Flexibility: Assess the flexibility of 2.5.2.4 the distal tip.
3-Point Bending Test: Assess guidewire body 2.5.2.5 stiffness/flexibility.
Rotational Control: Assess guidewire rotational 2.5.2.6 control to allow placement of the distal tip at a desired location in a 360 degree circle when controlled from the proximal end of the guidewire. Control may be clockwise or counter-clockwise.
2.5.2.7 Torsional Integrity: Assess the torqueable strength of a guidewire.
Assess the radiopacity of the distal 2.5.2.8 Radiopacity: tip, to establish equivalency to currently marketed hydrophilic guidewires.
2.5.2.9 Tracking: Assess the tractability of Lake Region's hydrophilic quidewire.
2.5.2.10 Measures the strength of welded joint Pull Test: points in the guidewire.
RESULTS : All test results were within prescribed specification limits.

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Qualification and Biocompatibility Test Data 2.6

Material/Product/Process Qualifications 2.6.1
LRM has formal quality systems in place to assure that each of the products manufactured with the polymer/hydrophilic coating remain equivalent to the predicate product, and that the changes will not have an adverse affect on the safe and effective use of the product. The quality systems include Engineering Change Order Review, Material Qualification, Product Qualification, and Process Qualification. These controls are applied to each product size/group.
2.6.2 Biocompatibility Testing
LRM has adapted the biocompatibility testing recommendations in the FDA's draft "Guidance for the Submission of Research and Marketing Applications for Interventional Cardiology Devices" dated May, 1993.

The following table lists the test that were performed and the test results.

TEST PERFORMED	TEST RESULTS
Cytotoxicity	The samples evoked a mildcytotoxic response (Grade 2)when tested at a 48 hourexposure period. The testmaterial passed the assay.
Hemolysis	The samples did not producehemolysis.
Acute Systemic Toxicity	No signs or symptoms ofSystemic Toxicity wereobserved for any of thesamples.
Intracutaneous Test	For all samples, skinreactions were notsignificant.
Implantation (7 Day)	The reaction was notsignificant as compared tothe negative controlimplant, for any of thesamples.
Sensitization	The samples were deemed to bea non-sensitizer.
Pyrogen Test	The samples did not produce apyrogenic response.

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.