CONDUCTOR CORONARY GUIDEWIRE

K090193 · Concert Medical, LLC · DQX · Sep 25, 2009 · Cardiovascular

Device Facts

• Record ID: K090193
• Device Name: CONDUCTOR CORONARY GUIDEWIRE
• Applicant: Concert Medical, LLC
• Product Code: DQX · Cardiovascular
• Decision Date: Sep 25, 2009
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.

Device Story

Flexible coronary guidewire; available with silicone or hydrophilic coating. Used to guide placement of catheters within coronary arteries during PTCA or other vascular interventional procedures. Operated by physicians in clinical settings. Device facilitates navigation of vasculature; provides trackability for catheter delivery. Benefits patient by enabling access to coronary lesions for therapeutic or diagnostic intervention.

Clinical Evidence

Bench testing only. Testing performed in accordance with FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance. Biocompatibility testing conducted per ISO 10993-1. FMEA used to evaluate risks.

Technological Characteristics

Flexible wire construction; silicone or hydrophilic coating. Patient-contacting materials tested for biocompatibility per ISO 10993-1. Mechanical performance assessed per FDA 1995 guidance.

Indications for Use

Indicated for use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries for patients undergoing PTCA or other therapeutic or diagnostic procedures.

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

• Galeo Hydro Guidewire (K001736)
• Galeo Guidewire (K982272)

Submission Summary (Full Text)

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Concert Medical, LLC January 20, 2009

510(k) Premarket Notification (Traditional) Conductor Coronary Guidewire

# Section 5 - 510(k) Summary

## General Information

Owner's Name: Address:

Telephone Number: Fax Number: Contact Person:

Concert Medical, LLC SEP 2 5 2009 77 Accord Park Drive Norwell, MA 02061 [phone] [phone] Nancy Martin, VP of Operations & Regulatory Affairs

Subject Device Name: Trade Name: Common/Usual Name: Classification Name:

Conductor Coronary Guidewire Conductor Coronary Guidewire Coronary Guidewire DQX - Wire, Guide, Catheter 21 CFR 870.1330; Class II

Predicate Device Name; Trade Name: Common/Usual Name: Classification Name:

Premarket Notification:

Galeo Guidewire Galeo Guidewire Coronary Guidewire DQX - Wire, Guide, Catheter 21 CFR 870.1330; Class II K001736 (Galeo Hydro Guidewire), SE date August 2, 2000 K982272 (Galeo Guidewire), SE date January 8, 1999

### Device Description

The Concert Medical Conductor coronary guidewire consists of a flexible wire that is available with silicone or hydrophilic coating. The wire is intended to guide the placement of intravasculable will with compatible lumens during PTCA or other therapeutic or diagnostic procedures.

#### Indications for Use

For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.

#### Performance Testing

Performance data demonstrated that the Concert Medical Conductor guidewire is substantially equivalent to the predicate device and/or met pre-determined acceptance criteria. The risks associated with use of the new device were found acceptable when evaluated by FMEA.

Bench tests performed in accordance with FDA's January 1995 Coronary and Cerebrovascular Guidewire Guidance included assessments of performance data. Biocompatibility testing was performed on the patient-contacting materials present in the Conductor guidewire in accordance with ISO 10993-1.

#### Conclusion

The Concert Medical Conductor coronary guidewire meets all the pre-determined acceptance criteria of the testing performed to confirm safety and effectiveness; the Conductor guidewire is substantially equivalent to the predicate device.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

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Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-0609 Silver Spring, MD 20993-0002

Concert Medical, LLC C/O Pamela Papineau, RAC Delphi Medical Device Consulting, Inc. 5 Whitcomb Avenue Ayer, MA 01432

SEP 2 5 2009

Re: K090193

Trade/Device Name: Conductor Coronary Guidewire Regulation Number: 21 CFR 870.1330 Regulation Name: Wire, Guide, Catheter Regulatory Class: Class II Product Code: DQX Dated: September 14, 2009 Received: September 16, 2009

Dear Ms. Papineau:

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.

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

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Page 2 - Ms. Pamela Papineau

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/ResourcesforYou/Industry/default.htm.

Sincerely yours,

Duna R. Palmer

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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Concert Medical, LLC January 20, 2009

### Section 4 - Indications for Use Statement

510(k) Number (if known):

K090193

Device Name:

Conductor Coronary Guidewire

Indications for Use:

For use in vascular interventional procedures to facilitate placement of catheters within the coronary arteries.

Prescription Use X (Per 21 CFR 801 Subpart D) OR

Over-the -Counter Use (Per 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)

vina D. Jackson

(Division Sign-Off) Division Ci Cardiovascular Devices

510(k) Number_K090193