ROLL-X GUIDEWIRE

K082304 · St Jude Medical · DQX · Aug 27, 2008 · Cardiovascular

Device Facts

• Record ID: K082304
• Device Name: ROLL-X GUIDEWIRE
• Applicant: St Jude Medical
• Product Code: DQX · Cardiovascular
• Decision Date: Aug 27, 2008
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2
• Attributes: Therapeutic, 3rd-Party Reviewed

Intended Use

The Roll-X Guidewire is intended 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 stent devices during therapeutic intravascular procedures. The guidewire is not to be used in the cerebral blood vessels.

Device Story

Roll-X Guidewire is a steerable, radiopaque, stainless steel core wire with a coiled distal end; PTFE-coated core. Designed to facilitate placement of balloon dilatation catheters and compatible stents during PTCA/PTA procedures. Used by physicians in clinical settings; provides enhanced torque response and control during navigation of the vasculature. Device is provided sterile and non-pyrogenic. Benefits include improved maneuverability for catheter/stent delivery during therapeutic intravascular interventions.

Clinical Evidence

No clinical data. Evidence consists of non-clinical testing including in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life/package testing, and sterilization evaluation.

Technological Characteristics

Stainless steel core wire; coiled distal end; PTFE coating. Radiopaque distal tip. Steerable design. Provided sterile and non-pyrogenic.

Indications for Use

Indicated for patients undergoing percutaneous transluminal coronary angioplasty (PTCA), percutaneous transluminal angioplasty (PTA), or therapeutic intravascular procedures requiring stent placement. 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

• Asahi Prowater PTCA Coronary Guidewire (K052339)
• Hi-Torque Balanced Middleweight Universal (K013833)

Submission Summary (Full Text)

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082304

Image /page/0/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of squares on the left and the text "ST. JUDE MEDICAL" on the right. Below the text is the tagline "MORE CONTROL. LESS RISK."

AUG 2 7 2008

# 510(K) SUMMARY

#### 1. Administrative Information

| Name: | St. Jude Medical |
|-----------------|-------------------------------------------------------|
| Address: | 14901 DeVeau Place<br>Minnetonka, MN 55345 |
| Phone: | 763-383-2640 |
| Fax: | 763-383-2556 |
| Contact Person: | Jeff Sturm<br>Principal Regulatory Affairs Specialist |
| Date: | August 6, 2008 |

#### 2. DEVICE INFORMATION

Name of Device: Common Name: Classification Name: Product Code:

Roll-X™ Guidewire Coronary Guidewire Catheter Guide Wire (870.1330) DOX

# 3. Predicate Device Information

Asahi Prowater PTCA Coronary Guidewire (Abbott)- K052339 cleared Nov 2005 Hi-Torque Balanced Middleweight Universal (Abbott)- K013833 cleared Jan 2002

#### Device Description ব

Roll-X™ Guidewire is a steerable guide wire constructed of a stainless steel core wire and a colled wire design at the distal end. The core wire is PTFE coated. The Roll-X Guidewire has a unique distal end design to enhance torque response and control. The distal end of the guidewire is shapeable and is radiopaque. The guide wire is provided sterile and non-pyrogenic.

#### ട്. INTENDED USE

The Roll-X Guidewire is intended 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 stent devices during therapeutic intravascular procedures. The guidewire is not to be used in the cerebral blood vessels.

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Image /page/1/Picture/0 description: The image shows the logo for St. Jude Medical. The logo consists of a grid of nine squares, with the center 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."

### 6. TECHNOLOGICAL CHARACTERISTICS

Comparisons of the new and predicate devices show that the technological characteristics such as product performance, design and intended use are substantially equivalent to the currently marketed predicate devices.

## 7. SUMMARY OF NON-CLINICAL TESTING

Non-clinical testing of the Roll-X™ Guidewire includes in vitro bench testing, animal evaluation, biocompatibility testing, shelf-life and package testing and sterilization evaluation. Results of the testing demonstrate that the guidewire design meets product specifications and intended uses.

### 8. SUBSTANTIAL EQUIVALENCE CONCLUSION

The Roll-X™ Guidewire described in this 510(k) is substantially equivalent to the ASAHI Prowater PTCA Coronary Guidewire (K052339) and Hi-Torque Balanced Middleweight Universal Guidewire (K013833). The intended use, design, material types, technology, and performance of the Roll-X™ Guidewire is equivalent to the predicate devices. There are no differences between devices which would raise issues of safety or effectiveness.

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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services - USA. The seal is circular, with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. In the center of the seal is an abstract emblem that resembles an eagle or other bird-like figure. The emblem is stylized and composed of thick, curved lines.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

AUG 2 7 2008

St. Jude Medical c/o Mr. Jeff Sturm Principal Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345

Re: K082304

> Trade/Device Name: Roll-X™M Coronary Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II Product Code: DQX Dated: August 12, 2008 Received: August 13, 2008

Dear Mr. Sturm:

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 such 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 801); good manufacturing practice requirements as set forth in the quality

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Page 2 - Mr. Jeff Sturm

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. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at [phone]. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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/cdrh/industry/support/index.html.

Sincerely yours.

Duna R. Holmes

ABram 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):

Device Name: Roll-X™ Coronary Guidewire

Indications for Use:

Roll-X Coronary Guidewires are intended to facilitate the placement of balloon dilation catheters during percutaneous transluminal coronary angioplasty (PTCA) and percutaneous transluminal angioplasty (PTA). The wire is also intended to facilitate the placement of compatible stent devices during intended to faoilitate the procedures. The Guidewire is not to be used in the cerebral blood vessels.

Prescription Use X (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 IFNEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

suma R.vo. Annes

(Division Sign-Off) (Division Sign of Cardiovascular Devices

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510(k) Number_K082304