PERCU-PRO GUIDEWIRE

K094062 · Cardiosolutions, Inc. · DQX · Sep 27, 2010 · Cardiovascular

Device Facts

• Record ID: K094062
• Device Name: PERCU-PRO GUIDEWIRE
• Applicant: Cardiosolutions, Inc.
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 27, 2010
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The Percu-Pro™ Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.

Device Story

Percu-Pro™ GuideWire is a cardiovascular guidewire used to facilitate device placement during peripheral vascular procedures. Device consists of a stainless steel core wire with a PTFE-jacketed proximal end and a coil-covered, tapered ribbon tip finished with a silver-brazed ball tip. Used by clinicians in clinical settings to navigate vasculature. Single-use, sterile device.

Clinical Evidence

Bench testing only. Testing included biocompatibility, hemocompatibility, tensile strength, torque strength, resistance to fracture, torqueability, and tip flexibility.

Technological Characteristics

Stainless steel core wire; PTFE jacket; coil-covered distal end; silver-brazed ball tip. Single-use, sterile. No software or electronic components.

Indications for Use

Indicated for facilitating device placement during diagnostic and interventional peripheral vascular procedures. Contraindicated for coronary artery or neurovascular use.

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

• TechDevice Guidewire (K053251)
• TFX Guidewire (K963320)

Submission Summary (Full Text)

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K04662

## SEP 27 2010

## 510(k) Summary

As required by section 807.92

| Company Name | Cardiosolutions Inc. |
|---------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Address | 75 Mill St.<br>Stoughton, MA 02072<br>Phone: [phone]<br>Fax: [phone] |
| Contact Person | Michele Lucey |
| Date | September 23, 2010 |
| Trade Name | Percu-Pro™ GuideWire |
| Common Name | Cardiovascular Guidewire |
| Classification Name | Catheter Guidewire |
| Product Code | DQX |
| Regulation # | 21 CFR 870.1330 |
| Class | 2 |
| Panel | Circulatory System Devices Panel |
| Predicate Devices | TechDevice Guidewire (K053251)<br>TFX Guidewire (K963320) |
| Device Description | The Percu-Pro™ GuideWire is constructed of a stainless steel core wire The proximal<br>end of the core and is finished with a PTFE jacket. The coil covered distal end of the<br>core is tapered to a ribbon tip to increase flexibility and is finished with a silver brazed<br>ball tip. The guidewire is provided sterile and is a single use device. |
| Intended Use | The Percu-Pro™ GuideWire is intended to facilitate the placement of devices during<br>diagnostic and interventional vascular procedures in the peripheral vasculature. The<br>guidewire is not intended for use in coronary arteries or for neurovascular use. |
| Pre-Clinical Safety<br>and Performance<br>Testing | No performance standards have been established under Section 514 of the Food, Drug<br>and Cosmetic Act for these devices, However, pre-clinical safety and performance<br>testing was conducted in accordance with protocols based on the requirements of<br>industry standards and guidance documents. Preclinical testing conducted included<br>biocompatibility and hemocompatibility, tensile strength, torque strength, resistance to<br>fracture, torqueability, and tip flexibility. |
| Substantial<br>Equivalence | The Percu-Pro™ GuideWire is equivalent to the predicate devices in terms of intended<br>use, design, materials, technology, and performance. There are no differences<br>between devices which would raise new issues of safety or effectiveness. |

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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes representing the agency's mission to promote health, well-being, and human services. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter.

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

Cardiosolutions, Inc. c/o Ms. Michele Lucey Vice President, Regulatory Affairs & Quality Assurance 75 Mill Street Stoughton, MA 02072

SEP 2 7 - 2010

Re: K094062

Trade/Device Name: Percu-Pro™ GuideWire Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter Guide Wire Regulatory Class: Class II (two) Product Code: DOX Dated: September 6, 2010 Received: September 8, 2010

Dear Ms. Lucey:

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. Michele Lucey

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,

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

K 09 4062

SEP 2 7 2010

510(k) Number (if known):

Device Name: Percu-Pro™ Guidewire

Indications for Use:

The Percu-Pro™ Guidewire is intended to facilitate the placement of devices during diagnostic and interventional vascular procedures in the peripheral vasculature. The guidewire is not intended for use in coronary arteries or for neurovascular use.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

Over-The_Counter Use_ ________________________________________________________________________________________________________________________________________________________

(PLEASE DO NOTR WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

W.M.S.d

510(k) Number K054062