Lunderquist® Fixed Core Wire Guide

K181353 · Cook Incorporated · DQX · Feb 15, 2019 · Cardiovascular

Device Facts

• Record ID: K181353
• Device Name: Lunderquist® Fixed Core Wire Guide
• Applicant: Cook Incorporated
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 15, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

Device Story

Lunderquist Fixed Core Wire Guide is a sterile, single-use catheter guide wire. Device consists of a mandril design with a distal spring coil and a proximal cannula. Used by physicians in clinical settings to facilitate the placement of diagnostic and interventional devices. The wire is 0.038 inch in diameter and 120 cm in length with a straight tip. It functions as a mechanical aid for navigation within the vasculature or other anatomical pathways during procedures. No electronic or software components are involved.

Clinical Evidence

Bench testing only. Testing included biocompatibility (ISO 10993-1), corrosion (ISO 11070), flexing, surface examination, fracture, tensile, tip flexibility (FDA 1995 guidance), radiopacity (ASTM F640-12), and dimensional/compatibility testing. All tests met predetermined acceptance criteria.

Technological Characteristics

Class II catheter guide wire. Features mandril design with distal spring coil and proximal cannula. Dimensions: 0.038 inch diameter, 120 cm length. Straight tip configuration. Materials tested per ISO 10993-1. Mechanical performance tested per ISO 11070 and FDA 1995 Coronary and Cerebrovascular Guidewire Guidance. Radiopacity tested per ASTM F640-12. Sterile, single-use device.

Indications for Use

Indicated for patients undergoing diagnostic and interventional procedures requiring device placement.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Mandril Wire Guides (K171997)

Reference Devices

• Fixed Core Wire Guides (K171764)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the Food and Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue.

February 15, 2019

Cook Incorporated Ms. Jennifer Allman, RAC Regulatory Affairs Project Manager 750 Daniels Way Bloomington, IN 47402

Re: K181353

Trade/Device Name: Lunderquist® Fixed Core Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 15, 2019 Received: January 15, 2019

Dear Ms. Allman:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Digitally signed by Lydia S. Glaw -S Lydia S. Glaw -S. Date: 2019.02.15 15:30:39 -05'00'

for Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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# Indications for Use

510(k) Number (if known) K181353

Device Name Lunderquist® Fixed Core Wire Guide

Indications for Use (Describe)

The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image features the logo for Cook Medical. The logo consists of the word "COOK" in a bold, sans-serif font, stacked above the word "MEDICAL" which is in a smaller, sans-serif font. The word "COOK" also has the registered trademark symbol to the right of it. The background is a solid red color, while the text is white.

K181353

#### 510(k) SUMMARY

## Lunderquist® Fixed Core Wire Guide 21 CFR §807.92 Date Prepared: May 21, 2018

### Submitted By:

| Applicant: | Cook Incorporated |
|-----------------------|---------------------------------------------------------------|
| Contact: | Jennifer L. Allman |
| Applicant Address: | Cook Incorporated<br>750 Daniels Way<br>Bloomington, IN 47404 |
| Contact Phone Number: | [phone] x104280 |
| Contact Fax Number: | [phone] |

#### Device Information:

| Trade Name: | Lunderquist® Fixed Core Wire Guide |
|----------------------|------------------------------------|
| Common Name: | Wire, Guide, Catheter |
| Classification Name: | Catheter guide wire |
| Regulation: | 21 CFR §870.1330 |
| Product Code: | DQX |

#### Predicate Device:

The predicate device is the Mandril Wire Guides (Cook, Inc., K171997) cleared for market on March 30, 2018.

#### Reference Device:

The reference device is the Fixed Core Wire Guides (Cook Inc., K171764) cleared for market on March 9, 2018.

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Image /page/4/Picture/2 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in large, white, sans-serif font on a red background. Below the word "COOK" is the word "MEDICAL" in a smaller, white, sans-serif font, also on a red background. The red background for "MEDICAL" is a rectangle that is slightly offset from the red background for "COOK".

## Device Description:

The Lunderquist® Fixed Core Wire Guide, subject of this submission, is a Class II device according to 21 CFR §870.1330; product code DQX (Wire, Guide, Catheter). The subject device consists of a mandril design with a distal spring coil anchored over the distal portion of the mandril and a cannula anchored over the proximal portion of the mandril. The Lunderquist Fixed Core Wire Guide is available with an outside diameter of 0.038 inch and a length of 120 centimeters (cm). The tip portion of the subject device is straight. The Lunderquist® Fixed Core Wire Guide is a packaged, sterile device intended for single patient use.

## Intended Use:

The Lunderquist Fixed Core Wire Guides are intended to facilitate placement of devices used during diagnostic and interventional procedures.

## Comparison of Technological Characteristics to Predicate:

The Lunderquist® Fixed Core Wire Guide, subject of this submission, is substantially equivalent to the predicate device, the Mandril Wire Guide (K171997), in that both devices have identical indications for use. The subject device is similar in technological characteristics (i.e., design and materials) to the predicate device with the addition of a 0.038 inch diameter configuration and a proximal cannula design.

### Performance Data:

The following tests were performed to demonstrate that the Lunderquist® Fixed Core Wire Guide met applicable design and performance requirements and support a determination of substantial equivalence.

- . Biocompatibility Testing - Tested in accordance with ISO 10993-1:2009. The predetermined acceptance criteria were met.
- . Corrosion Testing – Tested in accordance with Annex B of ISO 11070:2014. The predetermined acceptance criteria were met.
- . Flexing Test – Tested in accordance with the Annex G of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Surface Examination – Tested in accordance with BS EN ISO 11070:2014 Section 4.3. The pre-determined acceptance criteria were met.
- . Fracture Testing – Tested in accordance with Annex F of BS EN ISO 11070:2014. The pre-determined acceptance criteria were met.
- . Tensile Testing – Tested in accordance with the applicable values of BS EN ISO 11070:2014. Annex H. The pre-determined acceptance criteria were met.

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Image /page/5/Picture/1 description: The image shows the logo for Cook Medical. The logo consists of the word "COOK" in white, with a registered trademark symbol to the right of the word. Below the word "COOK" is the word "MEDICAL" in white, set against a red background. The background is a red rectangle.

- . Tip Flexibility Testing (Tip Deflection) – Tested in accordance with the FDA Coronary and Cerebrovascular Guidance (1995). The pre-determined acceptance criteria were met.
- . Radiopacity Testing - Tested in accordance with ASTM F640-12. The pre-determined acceptance criteria were met.
- Dimensional Measurement and Catheter Compatibility Testing Tested in accordance . with the FDA Coronary and Cerebrovascular Guidewire Guidance (1995) and with an approved study protocol. The pre-determined acceptance criteria were met.

### Conclusion:

The results of these tests support a conclusion that the Lunderquist® Fixed Core Wire Guide, subject of this submission, met the design input requirements based on the device's intended use and support the conclusion this device does not raise new questions of safety and/or effectiveness. The results of these tests support a determination of substantial equivalence to the predicate device, the Mandril Wire Guides (K171997).