Lunderquist Extra Stiff Wire Guide

K220137 · William Cook Europe Aps · DQX · Feb 17, 2022 · Cardiovascular

Device Facts

• Record ID: K220137
• Device Name: Lunderquist Extra Stiff Wire Guide
• Applicant: William Cook Europe Aps
• Product Code: DQX · Cardiovascular
• Decision Date: Feb 17, 2022
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.

Device Story

Lunderquist Extra Stiff Wire Guides are PTFE-coated stainless steel wires used to facilitate vascular access and support delivery of interventional devices (sheaths, catheters, stents, endovascular grafts). Available in straight, curved, double-curved, and extended double-curved configurations; lengths 90-300 cm; flexible tips (4 cm or 7 cm) with gold coils for radiopacity in longer models. Operated by physicians in clinical/interventional settings. Device introduced into target vessel; acts as rail for subsequent device positioning. Benefits include anatomical access and procedural support. Submission clarifies intended use and updates labeling based on postmarket surveillance; no design or material changes.

Clinical Evidence

No clinical data. Bench testing not warranted as no changes were made to design, materials, manufacturing, or principles of operation; testing from predicate (K171513) remains applicable.

Technological Characteristics

PTFE-coated stainless steel wire guides; lengths 90-300 cm; flexible tips (4 cm or 7 cm) with gold coils for radiopacity. Configurations: straight, curved, double-curved, extended double-curved. Mechanical device; no energy source or software.

Indications for Use

Indicated for patients undergoing vascular diagnostic or interventional procedures requiring catheterization or device placement in major vessels (aorta, vena cava) and their access/adjacent vessels.

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

• Lunderquist® Extra Stiff Wire Guides (K171513)

Submission Summary (Full Text)

{0}------------------------------------------------

February 17, 2022

Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health and Human Services logo on the left and the FDA logo on the right. The FDA logo features the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue and "ADMINISTRATION" in a smaller font size below.

William Cook Europe ApS Jennifer Brown Director, Global Regulatory Science-Vascular/Regulatory Affairs Sandet 6 Bjaeverskov, 4632 Denmark

Re: K220137

Trade/Device Name: Lunderquist Extra Stiff Wire Guide Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: January 14, 2022 Received: January 18, 2022

#### Dear Jennifer Brown:

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

{1}------------------------------------------------

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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

for Lydia Glaw Assistant Director DHT2C: Division of Coronary and Peripheral Intervention Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health

Enclosure

{2}------------------------------------------------

# Indications for Use

510(k) Number (if known) K220137

Device Name Lunderquist Extra Stiff Wire Guides

#### Indications for Use (Describe)

The Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels .

| Type of Use (Select one or both, as applicable) | |
|----------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|
| <div> <span> X Prescription Use (Part 21 CFR 801 Subpart D) </span> </div> | <div> <span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> </div> |

#### CONTINUE ON A SEPARATE PAGE IF NEEDED.

This section applies only to requirements of the Paperwork Reduction Act of 1995.

#### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*

The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:

> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov

"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."

{3}------------------------------------------------

# 510(k) Summary K220137

| Date Prepared: | 14 January 2022 |
|----------------------------|---------------------------------------------|
| Submitted By: | William Cook Europe ApS |
| | Sandet 6 |
| | 4632 Bjaeverskov, Denmark |
| Contact: | Mie Dyrholm |
| Phone: | [phone] |
| Fax: | [phone] |
| Email: | [e-mail] |
| Device: | |
| Trade Name: | Lunderquist® Extra Stiff Wire Guides |
| Common Name: | Catheter Guide Wire / Wire, Guide, Catheter |
| Classification Name: | Catheter Guide Wire |
| Regulation / Product Code: | 21 CFR 870.1330 / DQX |
| Classification / Panel: | Class II / Cardiovascular |

### Intended Use:

The Lunderquist Extra Stiff Wire Guides are intended to facilitate catherization and/or placement of devices during vascular diagnostic procedures and vascular interventional procedures. The Lunderquist Extra Stiff Wire Guides are intended for use in the major vessels, the aorta and vena cava, including their access vessels and adjacent vessels.

{4}------------------------------------------------

### Predicate Devices:

The subject devices are substantially equivalent to the predicate devices, the Lunderquist® Extra Stiff Wire Guides (K171513, cleared 07 December 2017).

## Comparison to Predicate Device:

The subject Lunderquist® Extra Stiff Wire Guides are substantially equivalent to the predicate Lunderquist® Extra Stiff Wire Guides (K171513). The subject devicesare identical to the predicate devices in terms of principles of operation, design, materials of construction, manufacturing processes, sterilization process, and basic technological characteristics. The purpose of this submission is to clarify the intended use statement and update device labeling based on postmarket surveillance information.

#### Device Description:

Straight (TSMG-/-LES) and Curved (TSCMG-/-LES) Lunderquist® Extra Stiff Wire Guide. PTFE-coated stainless steel wire guides with lengths ranging from 90 cm to 300 cm and either a 4 cm or 7 cm flexible tip. For the 260 cm and 300 cm lengths, the flexible tip includes an inner gold coil for enhanced visibility. The J-curve radius for the curved wire guides is either 3 mm or 7 mm.

Double curved (TSCMG-/-LESDC) and extended double curved (TSCMG-/-E-LESDC) Lunderquist® Extra Stiff DC Wire Guide. PTFE-coated stainless steel wire guides with a 4 cm flexible tip that includes an inner gold coil for enhanced visibility. TSCMG-/-LESDC has a primary/secondary curve radius on 75/15 mm, and TSCMG-/-E-LESDC has an extended primary/secondary curve radius on 55/15 mm.

The Lunderquist® Extra Stiff Wire Guide is used both to assist in anatomical access for other devices (notincluded) and to support the delivery of medical devices. The wire guide is introduced into the target vessel; other devices, such as a sheath, catheter, stent, or endo vascular graft can then be passed over the wire guide to be positioned or manipulated within the vascular system.

The Lunderquist® Extra Stiff Wire Guides are available in different lengths, shapes, etc. to accommodate different anatomical applications.

{5}------------------------------------------------

### Performance Testing:

No changes to the design, materials, manufacturing, sterilization, or principles of operation have been introduced with the subject devices. Therefore, performance testing was not warranted, and testing provided for the predicate device (K171513) remains applicable.

## Conclusion:

The Lunderquist® Extra Stiff Wire Guides are substantially equivalentto the predicate devices, the Lunderquist® Extra Stiff Wire Guides (K171513). No changes have been made to the wire guides. The only changes being made are to the device IFU.