Nickel Titanium steerable core with a clear or colored, radiopaque jacket, with a polymer/ hydrophilic coating is applied over the core/jacket. The guidewires are bound by the following parameters: Outside Diameter: .018" - .038", Lengths: 150 cm - 260 cm, Tips: Straight or shaped with standard or long taper tip flexibility.

AI/ML Overview

The acceptance criteria for the Hydrophilic Coated Guidewire are based on a comparison to predicate Terumo guidewires across several performance metrics. The study aims to demonstrate substantial equivalence by ensuring the new guidewires meet the same design criteria and specifications as the predicate device.

1. Table of Acceptance Criteria and Reported Device Performance:

Test Performed	Acceptance Criteria	Reported Device Performance
Visual	Assess for visual appearance, such as tip integrity and jacket durability (cuts, splits, seams, etc., any indication that the tip has been compromised). The implication is that the device should appear undamaged and intact.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying satisfactory visual appearance.
Dimensional Measurement	Outside Diameter (dry, after 10-minute soak, and after 40-minute soak in normal saline) measured by laser micrometer at multiple body points. The implication is that the dimensions should be within specified ranges and comparable to the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying dimensional measurements were acceptable.
Lubricity	Measures the force required to insert and withdraw the guidewire within a catheter lumen standardized to each guidewire diameter. The implication is that the lubricity should be comparable to or better than the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying satisfactory lubricity.
Pull Test	Measures the strength of materials and joints in the guidewire. The implication is that the guidewire should withstand specified tensile forces without failure.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable material and joint strength.
3-Point Bending Test	Assess guidewire body stiffness/flexibility. The implication is that the stiffness/flexibility should be within specified ranges and comparable to the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable body stiffness/flexibility.
Coating Durability	Measures the lubricity before and after multiple catheter insertions and withdrawals. The implication is that the coating should maintain its lubricity after repeated use, comparable to the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying satisfactory coating durability.
Distal Tip (J) Memory	Assess the memory of the distal tip form of shaped product. The implication is that the shaped tip should retain its intended form after manipulation, comparable to the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable tip memory.
Kink Resistance	Measures the kink resistance properties of product made from kink resistance materials or products that are designed to have kink resistance properties. The implication is that the guidewire should resist kinking under specified conditions, comparable to the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable kink resistance.
Linear Stiffness	Measures the linear tip flexibility. The implication is that the tip flexibility should be within specified ranges and comparable to the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable linear tip flexibility.
Torque Control	Assess guidewire torque response and rotational 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. The implication is that the guidewire should provide precise and consistent torque control.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable torque control.
Torque Fatigue	Assess the torqueable strength of a guidewire. The implication is that the guidewire should withstand repeated torqueing without failure, comparable to the predicate device.	Not explicitly stated in quantitative terms. The summary states: "All test results were within prescribed specification limits," implying acceptable torqueable strength.
Acute Systemic Toxicity	No signs or symptoms of Systemic Toxicity were observed for any of the samples.	No signs or symptoms of Systemic Toxicity were observed for any of the samples.
Cytotoxicity (MEM)	The samples should not evoke a significant cytotoxic response. Specifically, the test material passed the assay for a mild cytotoxic response (Grade 1) at 48 hours.	The samples evoked a mild cytotoxic response (Grade 1), when tested at 48 hours. The test material passed the assay.
Hemolysis	The samples should not produce hemolysis.	The samples did not produce hemolysis.
Intracutaneous Test	Skin reactions should not be significant for all samples.	For all samples, skin reactions were not significant.
Pyrogen (Material Mediated)	The samples should not produce a pyrogenic response.	The samples did not produce a pyrogenic response.
Inhibition and Enhancement	No endotoxin detected at 0.03 eu/ml.	No endotoxin detected at 0.03 eu/ml.
Sensitization	The samples should not be a strong sensitizer, or should be deemed acceptable within a defined range.	The samples were deemed to be a weak sensitizer.
Thrombo In-Vitro (Plate Method)	The test article should be considered nonthrombogenic.	The test article was considered nonthrombogenic.

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

Sample Size: For each test type, either fifteen (15) or ten (10) test samples were selected. Some destructive tests required additional sets of fifteen (15) or ten (10) samples. Within each of the three groups of guidewires (based on Terumo products of .018", .035", and .038" standard configurations), production samples were made representing the minimum (smallest size), maximum (largest size), and mode (most common size).
Data Provenance:
- Country of Origin: Not explicitly stated, but LRM (Lake Region Manufacturing, Inc.) is based in Chaska, MN, USA. Terumo is a Japanese company, but the document states "Terumo product was purchased by LRM, complete in packaging," suggesting the predicate devices were commercially available products.
- Retrospective or Prospective: The testing was prospective, as "LRM samples were produced following current manufacturing processes and procedures," and "All samples were sterilized prior to testing." This indicates newly manufactured devices were subjected to the specified tests.

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

Not applicable. This device is a guidewire, and the "ground truth" for performance is established through objective, quantitative engineering and biocompatibility tests rather than expert interpretation of medical images or clinical outcomes. The tests evaluate physical properties and biological reactions against predefined specifications.

4. Adjudication Method for the Test Set:

Not applicable. Adjudication methods like 2+1 or 3+1 typically apply to studies where human reviewers interpret data (e.g., medical images) and their disagreements need resolution. For objective engineering and biocompatibility tests, the pass/fail criteria are instrumental, and the results are directly measured or observed.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and the Effect Size of How Much Human Readers Improve with AI vs. Without AI Assistance:

Not applicable. This is not an AI-powered device, nor is it a diagnostic device that involves human readers interpreting medical cases. The study focuses on hardware performance and biocompatibility.

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

Not applicable. This is not an algorithm or AI device. The tests performed are standalone evaluations of the guidewire's physical and biological properties.

7. The Type of Ground Truth Used:

The ground truth is established through:

Engineering Specifications/Design Criteria: For all performance tests (e.g., visual, dimensional, lubricity, strength, stiffness, durability, memory, kink resistance, torque control, fatigue). The "prescribed specification limits" serve as the ground truth against which the device performance is measured.
Predicate Device Performance: The primary method for establishing substantial equivalence for the performance tests was comparative testing against Terumo guidewires, implying that the performance of the Terumo guidewires (which are legally marketed) served as a benchmark for acceptability.
Biocompatibility Standards/Guidelines: For biocompatibility tests, the ground truth is established by recognized standards like ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing," and the FDA's General Program Memorandum #G95-1, which define acceptable biological responses (e.g., no systemic toxicity, mild cytotoxicity acceptable, no hemolysis, non-significant skin reactions, etc.).

8. The Sample Size for the Training Set:

Not applicable. This is a medical device (guidewire), not a machine learning model. Therefore, there is no "training set" in the context of AI/ML.

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

Not applicable, as there is no training set for this device.

Summary

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JUL 10 1998

510(K)

K981326

SECTION 2.0 - SUMMARY & CERTIFICATION

General Information 2.1
Company Name, Address, and Telephone Number 2.1.1

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 guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. Consequently there are a large mumber 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/Usual Names, and Classification Names
These devices are commonly known as guides, 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.
2.2 Labels, Labeling, and Advertising
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.

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JUL 1 0 1998

ﻘﺮ

2.3 Summary of Safety and Effectiveness
This summary is being included in the Premarket Notification submission in lieu of a statement of availability.
2.4 Device Description
2.4.1 Description of Guidewire

Nickel Titanium steerable core with a clear or colored, radiopaque jacket, with a polymer/ hydrophilic coating is applied over the core/jacket. The guidewires are bound by the following parameters:

Outside Diameter:	.018" - .038"
Lengths:	150 cm - 260 cm
Tips:	Straight or shaped with standard or long taper tip flexibility

Note: None of these guidewires are for PTCA use.

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 hydrophilic guidewires and Terumo guidewires.

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

2.5.2 Comparative Test Data

Within each of the three groups, production samples were made representing the minimum (smallest size), maximum (largest size) and mode (most common size). For each test series, samples were produced per standard manufacturing procedures. For each test type, either fifteen (15) or ten (10) test samples were selected. Some of the tests are destructive in nature which required the selection of additional sets of fifteen (15) or ten (10) samples to perform other tests.

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The following product qualification tests were performed:

Visual: Assess the product for visual appearance, such as tip integrity and jacket 2.5.2.1 durability (cuts, splits, seams, etc., any indication that the tip has been compromised).
Dimensional Measurement Qutside Diameter, Dry and after 10 minute soak 2.5.2.2 and after 40 minute soak in normal saline : Laser micrometer measurement of the outside diameter of the guidewire at multiple body points.
Lubricity: Measures the force required to insert and withdraw the guidewire 2.5.2.3 within a catheter lumen standardized to each guidewire diameter.
Pull Test: Measures the strength of materials and joints in the guidewire. 2.5.2.4
2.5.2.5 3-Point Bending Test: Assess guidewire body stiffness/flexibility.
Coating Durability: Measures the lubricity before and after multiple catheter 2.5.2.6 insertions and withdrawals.
Distal Tip(J) Memory: Assess the memory of the distal tip form of shaped 2.5.2.7 product.
2.5.2.8 Kink Resistance: Measures the kink resistance properties of product made from kink resistance materials or products that are designed to have kink resistance properties.
2.5.2.9 Linear Stiffness: Measures the linear tip flexibility.
Torque Control: Assess guidewire torque response and rotational control to allow 2.5.2.10 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.
2.5.2.11 Torque Fatigue: Assess the torqueable strength of a guidewire.

RESULTS: All test results were within prescribed specification limits.

2.6 Qualification and Biocompatibility Test Data
2.6.1 Material/Product/Process Oualifications

LRM has formal quality systems in place to assure that each product 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.

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2.6.2 Biocompatibility Testing

LRM has adapted the biocompatibility testing recommendations in the FDA's General Program Memorandum #G95-1 Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", dated May 1, 1995.

TEST PERFORMED	TEST RESULTS
Acute Systemic Toxicity	No signs or symptoms of Systemic Toxicitywere observed for any of the samples.
Cytotoxicity (MEM)	The samples evoked a mild cytotoxic response(Grade 1), when tested at 48 hours. The testmaterial passed the assay.
Hemolysis	The samples did not produce hemolysis.
Intracutaneous Test	For all samples, skin reactions were notsignificant.
Pyrogen (Material Mediated)	The samples did not produce a pyrogenicresponse.
Inhibition and Enhancement	No endotoxin detected at 0.03 eu/ml
Sensitization	The samples were deemed to be a weaksensitizer.
Thrombo In-Vitro (Plate Method)	The test article was considerednonthrombogenic

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

2.7 Packaging and Sterilization Information

LRM produces guidewires on an OEM basis for other manufacturers, kit assemblers, and distributors. There is no direct distribution by LRM. A small portion of the production is private label, single packaged to customer specifications, a fraction of that product is provided sterile to the customer.

The single packaged polymer/hydrophilic coated guidewires s placed in a dispenser and then into a Tyvek/poly pouch, along with a tray containing a torque device. The product may be packaged as five (5) pouches in a shelf carton five(5) pack, which is a typical packaging configuration.

There will be no changes to the sterilization process for the portion of packaged product shipped sterile to the customer. For the product that is shipped bulk, the packaging design and sterilization process parameters are the customer's responsibility. LRM will not recommend that its customers modify their packaging or sterilization procedures as a result of this submission.

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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing right, with three curved lines above them, resembling a stylized representation of a human form.

JUL 1 0 1998

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

Ms. Kim E. Aves Regulatory Compliance Manager Lake Region Manufacturing, Inc. 340 Lake Hazeltine Drive Chaska, MN 55318

K981326 Re : Hydrophilic Coated Guidewire Regulatory Class: DOX Product Code: II Dated: April 10, 1998 April 13, 1998 Received:

Dear Ms. Aves:

We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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). 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.

If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. this response to your premarket notification Please note: submission does not affect any obliqation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.

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Page 2 - Ms. Kim E. Aves

This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4648. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 Other general information on your responsibilities CFR 807.97). under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597, or at its internet address "http://www.fda.qov/cdrh/dsma/dsmamain.html".

Sincerely yours,

Thomas J. Callahon

Thomas J. Callahan, Ph.D. Director Division of Cardiovascular, Respiratory, and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health

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510(k) Number (if known): Unknown

Hydrophilic Coated Guidewire Device Name:

Indications for Use:

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

NOTE: These guidewires are not intended for PTCA use.

TaA

(Divisior Sion-Off) Division - Rig reascular, Respirator ano Neuroropos, occides 510(k) Number .

(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ Prescription Use _ X OR (Per 21 CFR 801.109) PREMARKET NOTIFICATION

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.