CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE

K120298 · St. Jude Medical, Cardiac Rhythm Management Divisi · DQX · May 8, 2012 · Cardiovascular

Device Facts

• Record ID: K120298
• Device Name: CPS EXCEL MEDIGUIDE ENABLED GUIDEWIRE
• Applicant: St. Jude Medical, Cardiac Rhythm Management Divisi
• Product Code: DQX · Cardiovascular
• Decision Date: May 8, 2012
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1330
• Device Class: Class 2

Intended Use

The St. Jude Medical™ CPS Excel™ MediGuide Enabled™ guidewire is intended for use with the MediGuide system to enable real-time tip positioning and navigation within the coronary and peripheral vasculature. The MediGuide system is intended for use as an adjunct to fluoroscopy

Device Story

CPS Excel MediGuide Enabled Guidewire is a hydrophilic-coated guidewire containing an integrated magnetic sensor. Used with the MediGuide System, it enables real-time visualization of the guidewire tip position within coronary and peripheral vasculature. The device functions as an adjunct to fluoroscopy, assisting physicians during interventional procedures such as left heart lead implantation. By providing real-time navigation data, the system allows for precise positioning, potentially reducing fluoroscopy time and radiation exposure for the patient.

Clinical Evidence

No clinical data provided; substantial equivalence is based on design, technological characteristics, and performance testing.

Technological Characteristics

Hydrophilic-coated guidewire with integrated magnetic sensor for electromagnetic tracking. Compatible with the MediGuide System. Class II device (21 CFR 870.1330).

Indications for Use

Indicated for real-time tip positioning and navigation within coronary and peripheral vasculature, including facilitating left heart lead implantation, as an adjunct to fluoroscopy.

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

• St Jude Medical CPS Courier Guidewire (K073082)
• MediGuide Guided Measurement Catheter (GMC) (K091781)

Submission Summary (Full Text)

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长120298
中小2 Pago 15

MAY - 8 2012

## Section 5- 510(k) Summary

| Submitter : | St Jude Medical, CRMD<br>15900 Valley View Court<br>Sylmar, CA 91324<br>Establishment Registration Number: 2017865 |
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| Contact Person : | Colleen Canan<br>Staff Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone] |
| Date Prepared : | January 27, 2012 |
| Trade Name : | CPS Excel ^TM MediGuide Enabled ^TM Guidewire and accessories |
| Classification : | Class II-21 CFR 870.1330<br>Catheter, Guidewire |
| Product Code : | DQX |
| Predicate Device: | The subject device is equivalent to the following St Jude Medical and<br>MediGuide Devices |
| | St Jude Medical CPS Courier ^TM Guidewire (K073082) cleared on January<br>9, 2008 |
| | MediGuide Guided Measurement Catheter (GMC) (K091781) cleared on<br>October 16, 2009 |
| Device Description : | The St. Jude Medical CPS Excel ^TM , MediGuide Enabled ^TM guidewire is a<br>MediGuide enabled guidewire with a hydrophilic coating. The CPS<br>Excel, MediGuide Enabled guidewire contains a magnetic sensor allowing<br>it to be visualized using the MediGuide system |
| Intended Use: | The St. Jude Medical ^TM CPS Excel ^TM MediGuide Enabled ^TM guidewire is<br>intended for use with the MediGuide system to enable real-time tip<br>positioning and navigation within the coronary and peripheral vasculature.<br>The MediGuide system is intended for use as an adjunct to fluoroscopy |
| Comparison to<br>Predicate Devices | The St Jude Medical CPS Excel MediGuide Enabled guidewire has a<br>similar intended use and the same fundamental scientific technology as the |

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predicate devices. All technological characteristics of CPS Excel MediGuide Enabled guidewire kit are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Where differences exist between the subject device and the predicate devices performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the subject device.

Conclusion : St Jude Medical considers the CPS Excel MediGuide Enabled guidewire kit to be equivalent to the predicate devices listed above. This conclusion is based upon the device similarities in design, technological characteristics, principles of operation, materials and indications for use.

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## DEPARTMENT OF HEALTH & HUMAN SERVICES

Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle with three stripes forming its body and tail. The eagle is positioned within a circle that contains the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" in a circular arrangement around the bird.

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

JUN 13 2012

St. Jude Medical c/o Ms. Colleen Canan Staff Regulatory Submission Specialist 15900 Valley View Court Sylmar, CA 91342

> K120298 CPS Excel™ MediGuide Enabled™ Guidewire and accessories Regulation Number: 21 CFR 870.1330 Regulation Name: Catheter guide wire Regulatory Class: II (two) Product Code: 74 DQX Dated (Date on orig SE ltr): April 6, 2012 Received (Date on orig SE Itr): April 10, 2012

Dear Ms. Canan:

Re:

This letter corrects our substantially equivalent letter of May 8, 2012.

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 (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 Canan

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/CDRH0ffices/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/ReportalProblem/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,

Bram D. Zuckerman, M.D.

Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

CPS Excel™ MediGuide Enabled™ Guidewire Device Name: Models DS2M027, DS2M028, DS2M029

Indications for Use:

The St. Jude Medical CPS Excel™ MediGuide Enabled™Guidewire is intended for use with the MediGuide™ System to enable real-time tip positioning and navigation within the coronary and peripheral vasculature (such as to facilitate left heart lead implantation). The MediGuide system is intended for use as an adjunct to fluoroscopy.

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Concurrence of CDRH, Office of Device Evaluation (ODE)

| Prescription Use<br>(Part 21 CFR 801 Subpart D) | |
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AND/OR

| Over-The-Counter Use<br>(21 CFR 801 Subpart C) | |
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| (Division Sign-Off) | |
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| Division of Cardiovascular Devices | |
| 510(k) Number | K120298 |