CORE AND COIL ASSEMBLY GUIDEWIRE

• K Number: K971322
• Device Name: CORE AND COIL ASSEMBLY GUIDEWIRE
• Manufacturer: LAKE REGION MFG., INC.
• Date Cleared: 1998-07-22 ( 468 days)
• Product Code: DQX
• Regulation Number: 870.1330
• Type: Traditional
• Panel: CV
• Reference & Predicate Devices: K971322

Intended Use

For percutaneous entry of peripheral vessel using the Seldinger technique.

Device Description

NiTi core with stainless steel or platinum coil secured to the ground, flexible (distal) end of the core. The guidewires are bound by the following parameters: Outside Diameter: .014" - .045", Length: 20 cm - 500 cm, Tip: Straight, Shapable or Preshaped, Flexibility: Soft through Stiff, Coil Length: 2 cm - 30 cm. NOTE : None of these guidewires are for PTCA use.

AI/ML Overview

This document describes the regulatory submission for the Lake Region Manufacturing (LRM) Core and Coil Assembly (CCA) Guidewire. It presents information regarding the device's characteristics, safety, and effectiveness, primarily through comparative testing against a predicate device.

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Acceptance Criteria and Device Performance

The document does not explicitly state "acceptance criteria" in the format of pass/fail thresholds with specific numerical values for each test. Instead, it describes "prescribed specification limits" which the device met. The reported device performance is that all test results were within these prescribed specification limits.

Test Performed	Acceptance Criteria (Implicit)	Reported Device Performance
Visual	Products must meet visual aspects specifications.	All test results were within prescribed specification limits.
Dimensional Measurement (OD)	Micrometer measurements of OD must be within specifications.	All test results were within prescribed specification limits.
Distal Tip Flexibility	Flexibility of the distal tip must meet specifications.	All test results were within prescribed specification limits.
Kink Resistance	Core wire kink resistance must meet specifications.	All test results were within prescribed specification limits.
Torsional Integrity	Torsional strength must meet specifications.	All test results were within prescribed specification limits.
Pull Test	Strength of distal and proximal joints must meet specifications.	All test results were within prescribed specification limits.
3-Point Bending Test	Body stiffness/flexibility must meet specifications.	All test results were within prescribed specification limits.
Biocompatibility Tests
Cytotoxicity	No cytotoxic response.	No cytotoxic response (Grade 0).
Hemolysis	No hemolysis.	Produced no hemolysis.
Acute Systemic Toxicity	No signs/symptoms of systemic toxicity.	No signs or symptoms of systemic toxicity were observed.
Intracutaneous Test	Skin reactions not significant.	Skin reactions were not significant.
Implantation (7 Day)	Reaction not significant vs. negative control.	Reaction was not significant as compared to the negative control implant.
Sensitization	Non-sensitizer.	Deemed to be a non-sensitizer.
Pyrogen Test	No pyrogenic response.	Did not produce a pyrogenic response.

Study Details

1. Sample Size used for the test set and the data provenance:

   • Test Set Size: For each product qualification test, 30 samples were selected. Since there were three groups of LRM wires and two groups of Flexmedics product, and at least 200 samples of each size were produced (600+ total LRM samples), the 30 samples for each test were drawn from these larger production batches.
   • Data Provenance: The study was prospective as LRM samples were manufactured following current processes, and Flexmedics products were purchased (presumably new for the purpose of the study). The country of origin for the data is implicitly the United States, as LRM is based in Chaska, MN, and the submission is to the FDA.

2. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   • The document describes engineering and biocompatibility testing for a medical device. There is no mention of human "experts" establishing a "ground truth" in the context of clinical or diagnostic performance. Instead, the ground truth for the engineering tests would be established by validated test methods and established engineering specifications. For biocompatibility, the ground truth is determined by the specific laboratory assays and their established pass/fail criteria.

3. Adjudication method for the test set:

   • Not applicable. This is a technical performance and biocompatibility study, not a study involving human interpretation or adjudication of results in the traditional sense of clinical imaging or diagnostics.

4. 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:

   • No, an MRMC comparative effectiveness study was not done. This submission is for a guidewire, which is a physical medical device, not an AI or diagnostic system involving human readers.

5. If a standalone (i.e. algorithm only without human-in-the loop performance) was done:

   • Not applicable. This is a physical medical device.

6. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):

   • The "ground truth" for the engineering tests (e.g., dimensional, flexibility, kink resistance, torsional integrity, pull test, 3-point bending) is based on established engineering specifications and validated measurement techniques.
   • The "ground truth" for biocompatibility tests (e.g., cytotoxicity, hemolysis, systemic toxicity, intracutaneous, implantation, sensitization, pyrogen) is based on standardized laboratory assays and their predetermined pass/fail criteria, as recommended by FDA's General Program Memorandum #G95-1 and ISO-10993.

7. The sample size for the training set:

   • Not applicable. This document describes the manufacturing and testing of a physical medical device. There is no AI component or "training set" in the context of machine learning. The "training" for the device would be the manufacturing processes themselves.

8. How the ground truth for the training set was established:

   • Not applicable, as there is no "training set" in the context of AI/machine learning. The manufacturing processes and material specifications are the "ground truth" for the device's production.

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.