RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN

K120544 · St Jude Medical · DRF · Mar 19, 2012 · Cardiovascular

Device Facts

• Record ID: K120544
• Device Name: RESPONSE ELECTROPHYSIOLOGY CATHETERS WITH LUMEN
• Applicant: St Jude Medical
• Product Code: DRF · Cardiovascular
• Decision Date: Mar 19, 2012
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

Device Story

Response Electrophysiology Catheter with Lumen is a sterile, single-use diagnostic device featuring multiple electrodes and a fixed distal curve. It is designed for intracardiac electrogram (IECG) sensing. The catheter body consists of a continuous tube with a central lumen, allowing for fluid infusion via a 3-way valve. Used by clinicians in a clinical setting to evaluate cardiac arrhythmias from endocardial and intravascular sites. The device provides electrophysiological signals to the clinician, aiding in the diagnosis and mapping of arrhythmias. The modification involves a resin change, verified through biocompatibility testing.

Clinical Evidence

Bench testing only. Biocompatibility testing was performed in accordance with ISO 10993-1 to verify the safety of the modified resin material.

Technological Characteristics

Sterile, single-use diagnostic catheter; multiple electrodes; fixed distal curve; central lumen for fluid infusion; 3-way valve. Biocompatibility confirmed per ISO 10993-1.

Indications for Use

Indicated for evaluation of cardiac arrhythmias from endocardial and intravascular sites in patients requiring electrophysiological diagnostic procedures.

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

• Response™ Electrophysiology Catheter with Lumen (K914278)

Reference Devices

• Electrophysiology Catheters (K894500)

Submission Summary (Full Text)

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MAR 1 9 2012

| 510(k) Summary | |
|----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| 510(k) Number | |
| Date Prepared: | February 21, 2012 |
| Submitter Information: | |
| Submitter<br>Name/Address: | St. Jude Medical - Atrial Fibrillation Division<br>14901 DeVeau Place<br>Minnetonka, MN 55345<br>Establishment Registration Number: 3005188751 |
| Contact Person: | Marlene Peterson<br>Principal Regulatory Affairs Specialist<br>Phone [phone]<br>Fax [phone]<br>[e-mail] |
| Device Information: | |
| Trade Name: | Response™ Electrophysiology Catheter with Lumen |
| Common Name: | Electrode Recording Catheter |
| Classification Name: | Electrode Recording Catheter |
| Classification: | Class II, 21 CFR 870.1220, Product Code DRF. |
| Predicate Device(s): | Response™ Electrophysiology Catheter with Lumen<br>(K914278). |
| Device Description: | The Response™ Electrophysiology Catheter with Lumen is a<br>sterile, single use, electrophysiological diagnostic catheter with<br>multiple electrodes and a fixed distal curve for intracardiac<br>electrogram sensing (IECG). The body is a continuous tube with a<br>central lumen for fluid infusion through a 3-way valve. |
| Intended Use:<br>(Indications for Use) | St Jude Medical (SJM) Electrophysiology Catheters can be used in<br>evaluation of a variety of cardiac arrhythmias from endocardial and<br>intravascular sites. |
| Comparison to<br>Predicate Devices | The modified Response™ Electrophysiology Catheter with Lumen<br>has the same intended use and fundamental scientific technology as<br>the predicate device. The technological characteristics of the<br>modified Response™ Electrophysiology Catheter with Lumen are<br>substantially equivalent to the predicate devices including<br>packaging, biocompatibility, sterilization, and labeling. Through |
| | biocompatibility testing it was demonstrated that the resin<br>modification does not adversely affect the safety and effectiveness. |
| Summary on Non-<br>Clinical Testing | Bench testing was performed to verify the device modifications.<br>Results of testing demonstrate that the modified design meets<br>specifications as biocompatibility was confirmed in accordance<br>with ISO 10993-1. |
| Statement of<br>Equivalence | The modified St. Jude Medical Response™ Electrophysiology<br>Catheter with Lumen has the same indications for use and<br>technological characteristics as the predicate device. Based on this<br>and the data provided in this pre-market notification, St. Jude<br>Medical's modified Response™ Electrophysiology Catheter with<br>Lumen has been shown to be substantially equivalent to the<br>predicate. |

Response Electrophysiology Catheter
With Lumen
Special 510(k)

Confidential

St. Jude Medical

·

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Note; K914278 was originally submitted under the Daig Corporation which was subsequently obtained by St. Jude Medical. The predicate to K914278 was K894500 for Electrophysiology Catheters

Response Electrophysiology Catheter With Lumen Special 510(k)

Confidential

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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 its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the eagle. The logo is black and white.

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

MAR 1 9 2012

St. Jude Medical c/o Ms. Marlene Peterson Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345

Re: K120544

Trade/Device Name: St Jude Medical Response Electrophysiology Catheter with Lumen Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe. Regulatory Class: Class II (two) Product Code: DRF Dated: February 21, 2012 Received: February 23, 2012

Dear Ms. Peterson:

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. Marlene Peterson

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,

Kmphe

Bram Ø. 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

12 12 05 44 510(K) Number (if known):

Device Name: Response™ Electrophysiology Catheter with Lumen

Indications for Use:

St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.

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 OF NEEDED) .

Concurrence of CDRH, Office of Device Evaluation (ODE)

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