ARCHER SUPER STIFF GUIDEWIRES

K101339 · Medtronic, Inc. · DQX · Aug 31, 2010 · Cardiovascular

Device Facts

• Record ID: K101339
• Device Name: ARCHER SUPER STIFF GUIDEWIRES
• Applicant: Medtronic, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 31, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

Device Story

The Archer Super Stiff Guidewire is a PTFE-coated stainless steel guidewire used by clinicians during diagnostic or interventional aortic procedures. It features a flexible tip section and an inner 8cm radiopaque spring to enhance visibility under imaging. Available in 200cm and 260cm lengths with single or double curve tip configurations, the device provides mechanical support for catheter placement and exchange. It is a sterile, single-use, disposable device. By reducing surface friction and providing distal flexibility, the guidewire assists the physician in navigating the vasculature, potentially improving procedural efficiency and patient outcomes during catheter-based interventions.

Clinical Evidence

No clinical data provided. Evidence consists of non-clinical in vitro bench testing and in-vivo pre-clinical animal studies. Bench testing included dimensional verification, tip stiffness, torsional integrity, tip strength, PTFE coating adhesion, and 3-point bend stiffness. Biocompatibility testing was performed per ISO 10993-1, including cytotoxicity, sensitization, intracutaneous reactivity, systemic toxicity, material-mediated pyrogenicity, hemolysis, complement activation, and thromboresistance. Shelf life testing was also conducted.

Technological Characteristics

PTFE-coated stainless steel corewire with distal spring construction (inner radiopaque spring and outer spring). Nominal 0.035" OD; 200 cm and 260 cm lengths. Single or double curve tip configurations. Sterilized via Ethylene Oxide. Biocompatibility per ISO 10993-1.

Indications for Use

Indicated for patients undergoing diagnostic or interventional procedures in the aorta requiring catheter placement or exchange where increased support, distal flexibility, and low surface friction are necessary.

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

• Cook Lunderquist Wire Guide (K061670)
• Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283)

Submission Summary (Full Text)

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K101339

| | | AUG 31 2010 |
|-------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------|
| 5. | 510K SUMMARY | |
| Submitter: | Medtronic Vascular<br>3576 Unocal Place<br>Santa Rosa, CA 95403<br>U.S.A. | |
| Contact Person: | Colleen Mullins<br>Sr. Regulatory Affairs Specialist<br>[phone] | |
| Date Prepared: | May 6th, 2010 | |
| Trade Name: | Archer Super Stiff Guidewires | |
| Common Name: | Guidewire | |
| Classification Name: | Wire, Guide, Cardiovascular | |
| Class: | 21 CFR 1330, Product Code DQX | |
| Product Code: | DQX | |
| Predicate Device(s): | Cook Lunderquist Wire Guide (K061670)<br>Boston Scientific Corporation Back-Up Meier Steerable<br>Guidewire (K020283) | |
| Device Description: | The Medtronic Archer Super Stiff Guidewire is a PTFE<br>coated stainless steel guidewire. The Archer Super Stiff<br>Guidewire is offered in 200cm and 260cm lengths and<br>incorporates a flexible tip section and inner 8cm radiopaque<br>spring for enhanced visibility. The Archer Super Stiff<br>guidewire is offered in single and double curve tip<br>configurations. The Archer Super Stiff guidewire is sterile,<br>non-pyrogenic, disposable and for single use only | |
| Statement of<br>Intended Use: | The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff<br>Guidewires are indicated to facilitate catheter placement<br>and exchange during diagnostic or interventional | |

Medtronic Vascular
Archer Super Stiff Guldewire

.

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procedures, where increased support, distal flexibility, and low surface friction of the guidewire is needed

### Summary of Technological Characteristics:

All configurations of the Archer Super Stiff Guidewire have the same distal spring construction with an inner radiopaque spring and an outer spring. The springs are attached to the corewire. The Archer Super Stiff Guidewires have a nominal 0.035'' OD and are available in 200 cm and 260 cm lengths with either a single or double curve tip configuration. The entire device is PTFE coated.

The Archer Super Stiff Guidewire has similar materials of construction to the predicate devices. It also has the same technological characteristics as the predicate devices as shown in the table below.

| Characteristic | Archer<br>Endovascular<br>Guidewire<br>(This 510k) | Cook<br>Lunderquist<br>Wire Guides<br>(K061670) | BSX Back-up<br>Meier<br>Guidewire<br>(K020283) |
|-------------------------|----------------------------------------------------|-------------------------------------------------|------------------------------------------------|
| Diameter | 0.035" | 0.035" | 0.035" |
| Length | 200 cm<br>260 cm | 260 cm<br>300 cm | 185-300 cm |
| Tip<br>Configuration | Single J or Double<br>J curve | Straight, Single J<br>or double J | Straight, Angled |
| Sterilization<br>Method | Ethylene Oxide | Ethylene Oxide | Ethylene Oxide |

#### Summary of Non-Clinical data:

Non-clinical verification and validation of the Archer Super Stiff Guidewire consists of the following in vitro bench tests that were performed on the Archer Super Stiff Guidewire.

| In vitro Bench Tests |
|----------------------|
|----------------------|

| Dimensions-OD-Tip Joint |
|------------------------------|
| Dimensions-OD-Proximal Joint |
| Dimensions-OD-Distal Spring |
| Dimensions-OD-Corewire |
| Dimensions-Overall Length |
| Dimensions-Tip Width |
| Dimensions-Out of Plane |
| Dimensions-Radiopaque Length |

Medtronic Vascular Archer Super Stiff Guidewire

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## Medtronic

| In vitro Bench Tests |
|-----------------------------------------------|
| Tip Stiffness |
| Tip Integrity-Torsional |
| Tip Integrity-Strength |
| PTFE Coating Adhesion-Corewire<br>and springs |
| 3 Point Bend Stiffness-Proximal |

Biocompatibility testing was also performed per the requirements of ISO 10993-1 on the Archer Super Stiff Guidewire as listed below:

| Biocompatibility Tests |
|-----------------------------------------|
| ISO Cytotoxicity Study |
| ISO Maximization Sensitization<br>Study |
| ISO Intracutaneous Study |
| ISO/USP Systemic Toxicity<br>Study |
| USP Material Mediated Pyrogen<br>Study |
| ASTM Hemolysis Study |
| Compliment Activation (C3a &<br>SC5b-9) |
| in Vivo Thromboresistance<br>Study |

In addition shelf life testing (product and packaging) and in-vivo pre-clinical (Animal Study) testing was performed on the Archer Super Stiff guidewire.

The Non-Clinical test results verify that the Archer Super Stiff Guidewire is substantially equivalent to the predicate devices and is adequate for its intended use

### Conclusion from Data:

The Archer Super Stiff Guidewire is substantially equivalent in intended use, materials, technological characteristics and performance of the predicates wires, the Cook Lunderquist Wire Guide (K061670) and Boston Scientific Corporation Back-Up Meier Steerable Guidewire (K020283).

Medtronic Vascular Archer Super Stiff Guidewire

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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized graphic of an eagle or bird-like figure with outstretched wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular pattern around the graphic.

### DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Medtronic Vascular c/o Ms. Colleen Mullins Senior Regulatory Affairs Specialist 37 A Cherry Hill Drive Danver, MA 01923

## AUG 3 1 2010

Re: K101339

Trade/Device Name: Medtronic Archer Super Stiff Guidewires Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: July 20, 2010 Received: July 21, 2010

Dear Ms. Mullins:

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. 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 (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.

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#### Page 2 - Ms. Colleen Mullins

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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number [phone] or [phone] or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely yours,
W. Wood.

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): K 101339

Device Name: Medtronic Archer Super Stiff Guidewires

Indications for Use:

The Medtronic Archer 0.035 inch (0.89 mm) Super Stiff Guidewires are intended to facilitate catheter placement and exchange during diagnostic or interventional procedures in the aorta, where increased support, distal flexibility, and low surface friction of the guidewire is needed.

Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR

Over-The-Counter Use (21 CFR 807 Subpart C)

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

| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|--------------------------------------------------------|--|
| K101339 | |
| (Division Sign-Off) | |
| Division of Cardiovascular Devices | |

510(k) Number_