RADIA STEERABLE DIAGNOSTIC CATHETER

K091370 · C.R. Bard, Inc. · DRF · Jun 5, 2009 · Cardiovascular

Device Facts

• Record ID: K091370
• Device Name: RADIA STEERABLE DIAGNOSTIC CATHETER
• Applicant: C.R. Bard, Inc.
• Product Code: DRF · Cardiovascular
• Decision Date: Jun 5, 2009
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

Device Story

Radia™ Steerable Diagnostic Catheter is a steerable atrial mapping EP catheter; features up to 20 platinum electrodes on a polymer shaft; includes internal steering wires controlled by a rotary-style handle for tip deflection. Used by physicians in clinical settings for temporary intracardiac sensing, recording, stimulation, and pacing during arrhythmia evaluation. Device inputs are electrical signals from the heart; outputs are electrical signals transmitted to external recording/pacing equipment. Physician observes signals on external monitors to guide clinical decision-making regarding arrhythmia diagnosis and management. Benefits include precise catheter positioning for improved diagnostic mapping.

Clinical Evidence

Bench testing only. No clinical data provided.

Technological Characteristics

Polymer shaft; platinum electrodes; rotary-style handle for tip deflection; internal steering wires. Mechanical device; no software or electronic processing components.

Indications for Use

Indicated for patients undergoing evaluation of cardiac arrhythmias requiring temporary intracardiac sensing, recording, stimulation, and pacing. Contraindicated in conditions where catheter manipulation is unsafe (e.g., intracardiac mural thrombus). Transseptal approach contraindicated in patients with left atrial thrombus, myxoma, or interatrial baffle patch. Retrograde transaortic approach contraindicated in patients with aortic valve replacement.

Regulatory Classification

Identification

An electrode recording catheter or an electrode recording probe is a device used to detect an intracardiac electrocardiogram, or to detect cardiac output or left-to-right heart shunts. The device may be unipolar or multipolar for electrocardiogram detection, or may be a platinum-tipped catheter which senses the presence of a special indicator for cardiac output or left-to-right heart shunt determinations.

Predicate Devices

• Orbiter ST Diagnostic Electrode Catheter (K992373)
• EP•XT Steerable Electrode Catheter (K921872A)

Submission Summary (Full Text)

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# 8. 510(k) Summary

# K091370 510(k) SUMMARY

JUN - 5 2009

This 510(k) Summary is provided per the requirements of section 807.92(c).

| 510(k) Number: | TBD |
|---------------------|----------------------------------------------------------------------------------------------------------------------------------------|
| Owner Name: | Bard Electrophysiology Division of C. R. Bard, Inc. |
| Address: | 55 Technology Drive<br>Lowell, MA 01851 |
| Contact Person: | Julie Broderick<br>Director, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>Email address: [e-mail] |
| Alternate Contact: | Ana Randall<br>Manager, Regulatory Affairs<br>Tel: [phone]<br>Fax: [phone]<br>Email address: [e-mail] |
| Date Prepared: | May 1, 2009 |
| Device Trade Name: | Radia™ Steerable Diagnostic Catheter |
| Device Common Name: | Diagnostic electrode catheter |
| Class: | Class II. 21 CFR 870.1220. Product Code DRE |

#### Predicate Device(s):

- Orbiter ST Diagnostic Electrode Catheter (K992373) .
- EP•XT Steerable Electrode Catheter (previously known as Bard Steerable Catheter) . (K921872A)

#### Device Description:

The Radia™ Steerable Diagnostic Catheter is a steerable atrial mapping EP catheter with up to 20 electrodes. The device consists of a polymer shaft with platinum electrodes and internal steering wires mounted on a rotary-style handle for deflection of the catheter tip.

Page 1 of 2

Special 510(k) Submission fo Bard Radia™ Steerable Diagnostic Catheter

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## Indication for Use:

Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

## Comparison to Predicate Devices:

The Radia™ Steerable Diagnostic Catheter has the same intended use and fundamental scientific technology as the predicate devices. All technological characteristics of the Radia™ Steerable Diagnostic Catheter are substantially equivalent to the predicate devices including packaging, biocompatibility, sterilization, and labeling. Where minor technological and material differences exist between the proposed device and the predicate devices, performance testing demonstrated that these differences do not adversely affect the safety and effectiveness of the proposed device.

#### Summary of Non-Clinical Testing:

Bench testing of the Radia™ Steerable Diagnostic Catheter was performed to support substantial equivalence. Results of testing demonstrate that the Radia™ Steerable Diagnostic Catheter design meets product specifications and intended uses.

#### Statement of Equivalence:

The Radia™ Steerable Diagnostic Catheter has the same indications for use and technological characteristics as the predicate devices. Based on this and the design and engineering data provided in the pre-market notification, Radia™ Steerable Diagnostic Catheter has been shown to be substantially equivalent.

Page 2 of 2

Special 510(k) Submiss Bard Radia™ Steerable Diagnostic Car

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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 consists of a stylized eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular fashion around the eagle. The eagle is depicted in black, and the text is also in black.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

# JUN - 5 2009

C.R. Bard, Inc. Bard Electrophysiology c/o Ms. Julie Broderick, RAC Director, Regulatory Affairs 55 Technology Drive Lowell, MA 01851

Re: K091370

Trade/Device Name: RadiaTM Steerable Diagnostic Catheters Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe Regulatory Class: Class II (Two) Product Code: DRF

Dated: May 7, 2009 Received: May 8, 2009

#### Dear Ms. Broderick:

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. Ilsting 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. Julie Broderick, RAC

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/cdrh/mdr/ 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/cdrh/industry/support/index.html.

Sincerely vours.

smuch R. behmes

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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7. Statement of Indications for Use 91370 ndications for Use

#### 510(k) Number (if known):

Device Name: Radia™ Steerable Diagnostic Catheter

Indications for Use:

Bard Electrophysiology's steerable diagnostic electrode catheters are intended for temporary intracardiac sensing, recording, stimulation and temporary pacing during the evaluation of cardiac arrhythmias.

#### Contraindications:

The catheter should not be used in conditions where manipulation of the catheter would be unsafe (e.g., intracardiac mural thrombus).

The transseptal approach is contraindicated in patients with left atrial thrombus or myxoma, or interatrial baffle patch. The retrograde transaortic approach is contraindicated in patients with aortic valve replacement

Prescription Use × (Part 21 CFR 801 Subpart D)

AND/OR

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

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

Victor H. Von Brzackermay

Division Slar-Off Division of Cardiovascular Devic

510(k) Number K091370