CORE AND COIL ASSEMBLY GUIDEWIRE

K970994 · Lake Region Mfg., Inc. · EZB · Mar 25, 1997 · Gastroenterology, Urology

Device Facts

• Record ID: K970994
• Device Name: CORE AND COIL ASSEMBLY GUIDEWIRE
• Applicant: Lake Region Mfg., Inc.
• Product Code: EZB · Gastroenterology, Urology
• Decision Date: Mar 25, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5130
• Device Class: Class 1

Device Story

Guidewires consist of a NiTi core with a stainless steel or platinum coil at the distal end. Used as accessories for gastroenterology and urology catheters to facilitate placement. Operated by clinicians during procedures. Input is manual manipulation by the clinician; device provides structural support and guidance for catheter navigation. Benefits include improved access and navigation within the GI/urology tracts. Not for PTCA use.

Clinical Evidence

Bench testing only. No clinical data provided. Testing included 600+ samples across multiple sizes, evaluating visual, dimensional, mechanical (kink, torsion, pull, bending), and distal tip flexibility characteristics. Biocompatibility testing performed per ISO-10993, including cytotoxicity, hemolysis, acute systemic toxicity, intracutaneous, 7-day implantation, sensitization, and pyrogenicity tests; all results were negative/non-significant.

Technological Characteristics

Materials: NiTi core, stainless steel or platinum coil. Dimensions: 0.014"-0.045" OD, 20-500 cm length. Tip configurations: straight, shapable, or preshaped. Flexibility: soft to stiff. Sterilization: validated process for sterile-shipped units. No mandatory performance standards established.

Indications for Use

Indicated for use as a gastroenterology and urology catheter accessory. Not for PTCA use.

Regulatory Classification

Identification

A urological catheter and accessories is a flexible tubular device that is inserted through the urethra and used to pass fluids to or from the urinary tract. This generic type of device includes radiopaque urological catheters, ureteral catheters, urethral catheters, coudé catheters, balloon retention type catheters, straight catheters, upper urinary tract catheters, double lumen female urethrographic catheters, disposable ureteral catheters, male urethrographic catheters, and urological catheter accessories including ureteral catheter stylets, ureteral catheter adapters, ureteral catheter holders, ureteral catheter stylets, ureteral catheterization trays, and the gastro-urological irrigation tray (for urological use).

Predicate Devices

• Flexmedics guidewires

Submission Summary (Full Text)

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MAR 25 1997

# SECTION 2.0 - SUMMARY & CERTIFICATION

## 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: [phone] Fax: [phone]

### 2.1.2 Device Trade Name/Proprietary Name

LRM produces guidewires on an OEM basis for other manufactures, kit assemblers, and distributors. Consequently, there are a large number of trade and proprietary names not included 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 guides, guidewires, or spring guidewires.

The current classification name is Gastroenterology and Urology Catheter Accessory (78KOD)

### 2.1.4 LRM Establishment Registration Number: 2126666

### 2.1.5 Classification of Devices

The classification name listed above was originally classified as a Class II device by the Gastroenterology - Urology Review Panel (21CFR 876.5130).

### 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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## 2.2 Labels, Labeling, and Advertising

LRM produces gastroenterology and urology 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 portion of the total production bears LRM controlled labels and labeling.

## 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 CCA Guidewire products

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.

### 2.4.2 Engineering Specifications

The design specifications are the same for guidewires manufactured with or without a NiTi core or platinum coil. The finished devices must meet the same design criteria. Section 2.5 contains comparative data to demonstrate equivalency.

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## 2.5 Substantial Equivalence Data

### 2.5.1 Background Information

In order to demonstrate substantial equivalence of guidewires manufactured with a NiTi core and platinum coil, LRM performed comparative testing between LRM guidewires and Flexmedics guidewires.

LRM chose a product mix of three groups of LRM manufactured wires and two groups of Flexmedics product, based on the available Flexmedics products of .014" and .018" configurations. LRM samples were manufactured following current manufacturing processes and procedures. Flexmedics products were purchased by LRM, complete in packaging. All samples were sterilized prior to testing.

### 2.5.2 Comparative Test Data

Within each of the 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 30 samples selected. Some of the tests are destructive in nature which requires the selection of additional sets of 30 samples to perform other tests.

The following product qualification tests were performed:

- **2.5.2.1 Visual**: Assess the visual aspects of the product.
- **2.5.2.2 Dimensional Measurement - Outside Diameter**: Micrometer measurement of the outside diameter of the product at multiple body points.
- **2.5.2.3 Distal Tip Flexibility**: Assess the flexibility of the product’s distal tip.
- **2.5.2.4 Kink Resistance**: Assess the kink resistance of the core wire.
- **2.5.2.5 Torsional Integrity**: Assess the torsional strength of the product.
- **2.5.2.6 Pull Test**: Measures the strength of the distal and proximal joints of the product.
- **2.5.2.7 3-Point Bending Test**: Assess the product’s body stiffness/flexibility.

**RESULTS**: All test results were within prescribed specification limits.

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## 2.6 Qualification and Biocompatibility Test Data

### 2.6.1 Material/Product/Process Qualification

LRM has formal quality systems in place to assure that each of the products manufactured remain equivalent to the predicate product, and that the change 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 General Program Memorandum #G95-1, Subject: Use of International Standard ISO-10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", dated May 1, 1995.

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

| TEST PERFORMED | TEST RESULTS |
| --- | --- |
| Cytotoxicity | The sample evoked no cytotoxic response (Grade 0) |
| Hemolysis | The sample produced no hemolysis |
| Acute Systemic Toxicity | No signs or symptoms of systemic toxicity were observed |
| Intracutaneous Test | For all samples, the skin reactions were not significant. |
| Implantation (7 Day) | The reaction was not significant as compared to the negative control implant, for any of the samples. |
| Sensitization | The samples were deemed to be a non-sensitizer. |
| Pyrogen Test | The samples did not produce a pyrogenic response. |

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## 2.7 Packaging and Sterilization Information

LRM produce 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 CCA guidewire is placed in a dispenser and then into a Tyvek®/poly pouch. The packaged product may be packaged as five or ten pouches in a shelf carton, which are typical packaging configurations.

There will be no changes to the sterilization process for the portion of the packaged product shipped sterile to the 0customer. 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.