ROLL-X GUIDEWIRE

K100710 · St Jude Medical · DQX · Apr 28, 2010 · Cardiovascular

Device Facts

• Record ID: K100710
• Device Name: ROLL-X GUIDEWIRE
• Applicant: St Jude Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Apr 28, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: 3rd-Party Reviewed

Intended Use

Roll-X Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wires are also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures. The guidewires are not to be used in cerebral blood vessels.

Device Story

Roll-X Interventional Guidewires are steerable, 0.014" diameter devices used by clinicians during intravascular procedures to facilitate placement of balloon dilation catheters and other interventional devices. The device consists of a PTFE-coated stainless steel core wire with a shapeable, radiopaque distal coil spring. The distal end features a hydrophilic coating to aid navigation. The device is operated manually by a physician in a clinical setting (e.g., cath lab) to navigate the vasculature. The radiopaque tip allows for visualization under fluoroscopy, assisting the physician in guiding the wire to the target site. By providing torque response and control, the guidewire enables precise positioning of therapeutic devices, potentially improving procedural success and patient outcomes. The device is provided sterile and non-pyrogenic.

Clinical Evidence

Bench and animal testing only. Bench testing included tensile strength, torque strength, torqueability, tip flexibility, catheter compatibility, coating integrity, fracture resistance, corrosion resistance, radiopacity, and steering response. Biocompatibility testing included cytotoxicity, sensitization, irritation, acute systemic toxicity, hemolysis, PTT, complement activation, and in vivo thromboresistance. Animal studies assessed performance compared to currently marketed guidewires and evaluated the hydrophilic coating scheme. No human clinical trial data was required or provided.

Technological Characteristics

0.014" diameter steerable guidewire; stainless steel (SST) core wire; PTFE-coated proximal core; distal radiopaque coil; hydrophilic coating on distal end; shapeable tip; assembly via soldering, welding, and adhesives. Available in lengths of 180, 185, 190, and 300 cm. Sterilized via Ethylene Oxide (EO).

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA), or other therapeutic intravascular procedures requiring placement of compatible interventional devices. Contraindicated for use in cerebral blood 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

• Roll-X™ Guidewire (K082304)
• Asahi Prowater PTCA Coronary Guidewire (K052339)
• Hi-Torque Balance Middleweight Universal (K013833)
• Hi-Torque Balance Heavyweight Guidewire (K982083)

Submission Summary (Full Text)

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

1400710

Image /page/0/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of nine squares on the left, followed by the text "ST. JUDE MEDICAL" in a bold, sans-serif font. Below the company name is the phrase "MORE CONTROL. LESS RISK."

MORE CONTROL. LESS RISK.

# 510(K) SUMMARY

APR 2 8 2010

# 1. Administrative Information

| Name: | St. Jude Medical |
|-----------------|---------------------------------------------------------------|
| Address: | 14901 DeVeau Place<br>Minnetonka, MN 55345 |
| Phone: | 651-756-6522 |
| Fax: | 651-756-3049 |
| Contact Person: | Jennifer Zwiefelhofer<br>Senior Regulatory Affairs Specialist |
| Date: | February 19, 2009 |

# 2. Device Information

| Name of Device: | Roll-X™ Interventional Guidewire Portfolio |
|----------------------|--------------------------------------------|
| Common Name: | Guidewire |
| Classification Name: | Catheter Guidewire (870.1330) |
| Product Code: | DQX |

# 3. Predicate Device Information

Roll-X™ Guidewire (St. Jude Medical) - K082304 cleared Aug 2008 Asahi Prowater PTCA Coronary Guidewire (Abbott) - K052339 cleared Nov 2005 Hi-Torque Balance Middleweight Universal (Abbott) - K013833 cleared Jan 2002 Hi-Torque Balance Heavyweight Guidewire (Abbott) - K982083 cleared Sep 1998

## Device Description 4.

Roll-X™ Guidewires are steerable guidewires constructed of a stainless steel core wire with a coiled wire spring design at the distal end. The core wire is PTFE coated. Roll-X™ Guidewires have a unique distal end design to enhance torque response and control. The distal end of the guidewire is shapeable and is radiopague. The guidewires are provided sterile and non-pyrogenic.

> Page 1 of 3 Roll-X™ Interventional Guidewire Portfolio 510(k) Premarket Notification

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

Image /page/1/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a 3x3 grid of squares on the left, with one square rotated. To the right of the grid is the text "ST. Jude Medical" in a serif font. Below the text is the tagline "More control. Less risk."

#### 5. · Intended Use

Roll-X Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wires are also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures. The guidewires are not to be used in cerebral blood vessels.

# Technological Characteristics 6.

The Roll-X Guidewires as compared to the Roll-X. Asahi Prowater, Hi-Torque BMW and Hi-Torque BHW guidewires are substantially equivalent in many ways, including intended use, design, material types, and technology as outlined below.

Intended Use:

- Roll-X, Prowater, BMW and BHW guidewires have the same intended ● indication which is to facilitate the placement of balloon dilatation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures.
Product Design, Material Types and Technology:

- Sized 0.014" .
- Available in similar lengths (180, 185 or 190cm and 300 cm) ●
- Contain a SST core wire .
- � Contain a distal radiopaque coil
- Have flexible tip designs that can be shaped by the user .
- Are joined by a combination of solders, welds, and/or adhesives �
- Proximal SST cores wires are PTFE coated �
- Contain a hydrophilic coating on the distal end

## Summary of Non-clinical Testing 7.

Performance testing of the Roll-X Guidewires consists of bench and animal testing. Results of the testing demonstrate that the quidewire design meets product specifications and intended uses. A summary of the bench and performance testing conducted is listed below:

> Page 2 of 3 · Roll-X™ Interventional Guidewire Portfolio 510(k) Premarket Notification

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

| Item | Tests | |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------|
| Device performance | • Tensile Strength<br>• Torque Strength<br>• Torqueability<br>• Tip Flexibility<br>• Catheter Compatibility<br>• Coating<br>Adherence/Integrity | • Flexing Test<br>• Fracture Test<br>• Corrosion Resistance<br>• Radiopacity<br>• Steering Response<br>• Tip Load Test |
| Biocompatibility | • Cytotoxicity<br>• Sensitization<br>• Irritation<br>• Acute Systemic Toxicity<br>• Hemolysis<br>• Partial Thromboplastin Time<br>• Complement Activation<br>• In vivo Thromboresistance | |
| Sterilization/Microbiology | • Ethylene Oxide Sterilization Evaluation<br>• Bioburden<br>• EO residuals<br>• Endotoxin | |
| Packaging | • Pouch Peel Test<br>• Visual Inspection<br>• Pouch Seal Integrity | |
| Shelf Life | • Same as device performance and packaging | |
| Animal Testing | • Study #1 – assess performance as compared to<br>currently marketed guidewire<br>• Study #2 – development of hydrophilic coating<br>scheme | |

Darfarmanca Tactina Cummo

# Substantial Equivalence Conclusion 8.

The Roll-X™ Guidewires described in this 510(k) are substantially equivalent to the St. Jude Medical Roll-X™ Guidewire (K082304), the Abbott Vascular ASAHI Prowater Coronary Guidewire (K052339), the Abbot Vascular (previously Guidant Vascular Intervention) Hi-Torque Balance Middleweight™ Universal Guidewire (K013833) and the Abbot Vascular (previously Guidant Vascular Intervention) Hi-Torque® Balance Heavy Weight Guidewire (K982083). The intended use, design, material types, technology, and performance of the Roll-X™ Guidewires are equivalent to the predicate devices. There are no differences between devices which would raise issues of safety or effectiveness.

> Page 3 of 3 Roll-XTM Interventional Guidewire Portfolio 510(k) Premarket Notification

. ই

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

Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with outstretched wings.

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room W-O66-0609 Silver Spring, MD 20993-0002

St. Jude Medical c/o Mr. Mark Job Responsible Third Party Official Regulatory Technologies Services LLC 1394 25th Street NW Buffalo, MN 55313

APR 2 8 2010

Re: K100710

Trade/Device Name: Roll-XTM Interventional Guidewire Portfolio Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guidewire Regulatory Class: Class II (two) Product Code: DQX Dated: March 11, 2010 Received: March 12, 2010

Dear Mr. Job:

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. Insting 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.

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

Page 2 - Mr. Mark Job

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 (OS) 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/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 vours.

Duna R. V. Aunes

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

Enclosure

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

# Indications for Use

510(k) Number (if known): |८ | DO 7 | 0

Device Name: Roll-X™ Interventional Guidewire Portfolio

Indications For Use:

Roll-X Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wires are also intended to facilitate the placement of compatible interventional devices during therapeutic intravascular procedures. The guidewires are not to be used in cerebral blood vessels.

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

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

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

Concurrence of CDRH, Office of Device Evaluation (ODE)

Dunna (Division Slan-Off) Division of Cardiovascular Devices

Page 1 of 1

510(k) Number_K100710