St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter

Q: Who is the manufacturer of St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter?

St Jude Medical filed the 510(k) submission for St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter (K151622).

Q: What is the FDA product code for St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter?

DRF. It is classified under 21 CFR 870.1220 as a Class 2 device in the Cardiovascular panel.

Q: What is the regulatory pathway for St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter?

510(k) clearance (submission type: Special).

Q: Who can help prepare an FDA 510(k) submission like St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

K151622 · St Jude Medical · DRF · Jul 15, 2015 · Cardiovascular

Device Facts

Record ID	K151622
Device Name	St.Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter and SJM Epicardial Catheter System, Supreme Electrophysiology Catheter
Applicant	St Jude Medical
Product Code	DRF · Cardiovascular
Decision Date	Jul 15, 2015
Decision	SESE
Submission Type	Special
Regulation	21 CFR 870.1220
Device Class	Class 2

Intended Use

The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with MediGuide™ Technology to enable real-time tip positioning and navigation. The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy.

Device Story

Electrophysiology catheters used for cardiac arrhythmia evaluation; endocardial/intravascular sites. MediGuide-enabled versions include passive sensor at tip for real-time 3D positioning/navigation; tracked by gMPS system; superimposed on 2D X-ray fluoroscopy. Catheters transmit electrical signals to ECG recorders or deliver pacing signals from external pacemakers. Used by physicians in clinical settings. New manufacturing process for outer insulation alters surface morphology; design verification confirms safety/effectiveness.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993; design verification testing performed per ISO 10555. Results confirmed that catheters with modified surface morphology met all product performance specifications and maintained acceptable biocompatibility profiles.

Technological Characteristics

Diagnostic electrophysiology catheters; polyurethane shaft/insulation; platinum electrodes. MediGuide-enabled models include passive sensor for electromagnetic tracking. Dimensions/form factors vary by model (steerable, fixed curve, lumen/no-lumen). Connectivity: passive sensor interfaces with gMPS system. Sterilization: not specified. Standards: ISO 10993 (biocompatibility), ISO 10555 (catheter performance).

Indications for Use

Indicated for patients requiring evaluation of cardiac arrhythmias via endocardial and intravascular sites. Compatible with MediGuide technology for real-time tip positioning and navigation as an adjunct to fluoroscopy.

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

MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K101955, K150631)
Livewire Steerable Electrophysiology Catheter (K913940, K022380, K102721, K150631)
Response Electrophysiology Catheter with Lumen (K914278, K942379, K120544)
Response Electrophysiology Catheter (K894500, K002976)
SJM Epicardial Catheter System (K081803)
Supreme Electrophysiology Catheter (K894500, K002976)

Related Devices

K150631 — St. Jude Medical MediGuide Enabled Livewire Steerable Electroohysiology Catheter, Livewire Electrophysiology Catheter · St Jude Medical · Apr 1, 2015
K101955 — ST JUDE MEDICAL MEDIGUIDE ENABLED LIVEWIRE STEERABLE ELECTROPHYSIOLOGY CATHETER, MODEL D402058 · St Jude Medical · Oct 15, 2010
K183547 — Marinr Steerable Intracardiac Electrode Catheter, StableMapr Steerable Intracardiac Electrode Catheter, Torqr Intracardiac Electrode Catheter, Soloist Intracardiac Electrode Catheter · Medtronic · Jul 30, 2019
K160335 — Advisor FL 15mm 12 Pole 333 Uni D, Advisor FL 20mm 12 Pole 555 Uni D, Advisor FL 15mm 12 Pole 333 Bi D, Advisor FL 20mm 12 Pole 555 Bi D · St Jude Medical · Dec 13, 2016
K252013 — EnSite X EP System · ABBOTT MEDICAL · Sep 25, 2025

Submission Summary (Full Text)

{0}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 15, 2015 St. Jude Medical Maria Obreztchikova Sr. Regulatory Affairs Specialist One St. Jude Medical Drive St. Paul, MN 55117 Re: K151622 Trade/Device Name: MediGuide Enabled Livewire Steerable Electrophysiology Catheter, Livewire Steerable Electrophysiology Catheter, Response Electrophysiology Catheter with Lumen, Response Electrophysiology Catheter, SJM Epicardial Catheter System. Supreme Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: June 15, 2015 Received: June 16, 2015 Dear Maria Obreztchikova: 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading. 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. Image /page/0/Picture/11 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features the department's name encircling a stylized symbol. The symbol consists of three abstract human profiles facing right, with flowing lines beneath them. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA". {1}------------------------------------------------ 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 of medical devicerelated 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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours, forBram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ 510(k) Number (if known): Device Name: MediGuide Enabled Livewire Steerable Electrophysiology Catheter Indications for Use: - The SJMTM Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the ● evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. - The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is compatible with ● MediGuide™ Technology to enable real-time tip positioning and navigation. - The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy. ● 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 IF NEEDED) {3}------------------------------------------------ 510(k) Number (if known): _ _ _ _ _ _ _ _ _ K151622 Device Name: Livewire™ Steerable Electrophysiology Catheter Indications for Use: The Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. Prescription Use (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 IF NEEDED) {4}------------------------------------------------ 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 _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED) {5}------------------------------------------------ 510(k) Number (if known): _ Device Name: Response™ Electrophysiology Catheter 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 _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED) {6}------------------------------------------------ 510(k) Number (if known): _ Device Name: SJMTM Epicardial Catheter System Indications for Use: St Jude Medical (SJM) Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart. Prescription Use _____________________________________________________________________________________________________________________________________________________________ (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 IF NEEDED) {7}------------------------------------------------ 510(k) Number (if known): _ Device Name: Supreme™ Electrophysiology Catheter 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 (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 IF NEEDED) {8}------------------------------------------------ | 510(k) Summary | | |----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | 510(k) Number | K151622 | | Submitter Information: | | | Date Prepared: | 15 June 2015 | | Submitter Name & Address: | St. Jude Medical 14901 DeVeau Place Minnetonka, MN 55345 Establishment Registration Number: 3005188751 | | Contact Person: | Maria Obreztchikova Senior Regulatory Affairs Specialist Phone (651) 756-4424 Fax (651) 756-3298 mobreztchikova@sjm.com | | Device Information: | | | Trade Name: | MediGuide Enabled Livewire Steerable Electrophysiology Catheter | | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K101955, K150631) | | Device Description: | The MediGuide Enabled Livewire Steerable Electrophysiology Catheter is designed to allow electrophysiological mapping at various endocardial and intravascular sites including the inferior vena cava, superior vena cava, pulmonary veins and coronary sinus. The use of the MediGuide Enabled Livewire diagnostic mapping catheter in conjunction with the MediGuide gMPS system allows real-time tip positioning and navigation during routine diagnostic evaluation. When connected to the ECG, the MediGuide Enabled Livewire Catheter will transmit routine electrical signals while the passive sensor at the tip of the catheter is tracked by gMPS and is superimposed on any 2D X-ray image in real time (“Live”) fluoroscopy mode (the actual 3D position of the catheter tip is projected on the real time 2D image). | | Intended Use: (Indications for Use) | • The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. • The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is | | compatible with MediGuide™ Technology to enable real-time tip positioning and navigation. | | | • The MediGuide™ Technology is indicated for use as an adjunct to fluoroscopy. | | | Comparison to Predicate Devices | The MediGuide Enabled Livewire Steerable Electrophysiology Catheter that is the subject of this application remains substantially equivalent to the predicate device. There have been no changes to the device materials, packaging, sterilization or labeling. The proposed catheter includes a new outer insulation manufacturing process that results in a different surface morphology than the predicate catheter. The biocompatibility and design verification (DV) testing demonstrated that the surface morphology modification to the outer layer of the catheter proximal shaft does not adversely affect the device safety and effectiveness. | | Summary on Non- Clinical Testing | Biocompatibility testing was performed according to ISO 10993. The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile. DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications. | | Statement of Equivalence | The MediGuide Enabled Livewire Steerable Electrophysiology Catheter that is the subject of this application has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device remains substantially equivalent to the predicate device. | | Device Information: | | | Trade Name: | Livewire™ Steerable Electrophysiology Catheter | | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | Livewire™ Steerable Electrophysiology Catheter (K913940, K022380, K102721, K150631) | | Device Description: | The SJM Livewire™ Steerable Electrophysiology Catheter is a flexible electrode catheter constructed of a polyurethane insulation/shaft and incorporates platinum electrodes. The active tip may be manipulated by a remote means located at the proximal end of the catheter. | | Intended Use: (Indications for Use) | The Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. | | Comparison to Predicate Devices | The Livewire Steerable Electrophysiology Catheter that is the subject of this application remains substantially equivalent to the predicate device. There have been no changes to the device materials, packaging, sterilization or labeling. The proposed catheter includes a new outer insulation manufacturing process that results in a different surface morphology than the predicate catheter. The biocompatibility and design verification (DV) testing demonstrated that the surface morphology modification to the outer layer of the catheter proximal shaft does not adversely affect the device safety and effectiveness. | | Summary on Non- Clinical Testing | Biocompatibility testing was performed according to ISO 10993. The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile. DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications. | | Statement of Equivalence | The Livewire Steerable Electrophysiology Catheter that is the subject of this application has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device remains substantially equivalent to the predicate device. | | Device Information: | | | Trade Name: | Response™ Electrophysiology Catheter with Lumen | | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | Response™ Electrophysiology Catheter with Lumen (K914278, K942379, K120544) | | Device Description: | The Response™ Electrophysiology Catheter with Lumen is a sterile, single use, electrophysiological diagnostic catheter with a fixed distal curve and multiple electrodes. The electrodes detect cardiac electrical signals that are transmitted to an electrocardiogram recorder for diagnosis or deliver the electrical signal from an external pacemaker to the heart for electrical pacing purposes. The catheter body is a continuous tube with a central lumen for fluid infusion through a 3-way valve. | | Intended Use: (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. | | Comparison to Predicate Devices | The Response™ Electrophysiology Catheter with Lumen that is the subject of this application remains substantially equivalent to the | | | predicate device. There have been no changes to the device materials, packaging, sterilization or labeling. The proposed catheter includes a new outer insulation manufacturing process that results in a different surface morphology than the predicate catheter. The biocompatibility and design verification (DV) testing demonstrated that the surface morphology modification to the outer layer of the catheter proximal shaft does not adversely affect the device safety and effectiveness. | | Summary on Non- Clinical Testing | Biocompatibility testing was performed according to ISO 10993. The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile. DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications. | | Statement of Equivalence | The Response™ Electrophysiology Catheter with Lumen that is the subject of this application has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device remains substantially equivalent to the predicate device. | | Device Information: | | | Trade Name: | Response ™ Electrophysiology Catheter | | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | Response™ Electrophysiology Catheter (K894500, K002976) | | Device Description: | The Response™ Electrophysiology Catheter is a sterile, single use, electrophysiological diagnostic catheter. The catheter has fixed distal curve available in various styles, no lumen, and varying electrode numbers and spacing. The electrodes detect cardiac electrical signals that are transmitted to an electrocardiogram recorder for diagnosis or deliver the electrical signal from an external pacemaker to the heart for electrical pacing purposes. | | Intended Use: (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. | | Comparison to Predicate Devices | The Response™ Electrophysiology Catheter that is the subject of this application remains substantially equivalent to the predicate device. There have been no changes to the device materials, packaging, sterilization or labeling. The proposed catheter includes a new outer insulation manufacturing process that results in a different surface morphology than the predicate catheter The | {9}------------------------------------------------ {10}------------------------------------------------ {11}------------------------------------------------ {12}------------------------------------------------ | Summary on Non-Clinical Testing | biocompatibility and design verification (DV) testing demonstrated that the surface morphology modification to the catheter outer shaft does not adversely affect the device safety and effectiveness. Biocompatibility testing was performed according to ISO 10993. The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile. DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications. | |----------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Statement of Equivalence | The Response™ Electrophysiology Catheter with Lumen that is the subject of this application has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device remains substantially equivalent to the predicate device. | | Device Information: | | | Trade Name: | SJM™ Epicardial Catheter System | | Common Name: | Epicardial Catheter System | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | SJM™ Epicardial Catheter System (K081803) Response™ Electrophysiology Catheter (K894500) | | Device Description: | The SJM™ Epicardial Catheter System consists of the following SJM components: • 17 Gauge Tuohy Needle, 11.4 cm • Response™ Electrophysiology Catheter, 6F • Agilis™ NxT Steerable Introducer, 40 cm (includes steerable sheath, dilator, and guidewire) The Response™ Electrophysiology Catheter, 6F, is designed to provide pacing and recording capabilities during electrophysiology studies involving the epicardial surface of the heart. The distal tip of the catheter contains four platinum electrodes. It is curved to facilitate greater reach when advanced out of the steerable introducer. | | Intended Use: (Indications for Use) | The SJM™ Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart. | | Comparison to Predicate Devices | The Epicardial Catheter System that is the subject of this application remains substantially equivalent to the predicate device. There have been no changes to the device materials, packaging, sterilization or | {13}------------------------------------------------ | Summary on Non-Clinical Testing | Biocompatibility testing was performed according to ISO 10993. The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile. DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications. labeling. The proposed catheter includes a new outer insulation manufacturing process that results in a different surface morphology than the predicate catheter. The biocompatibility and design verification (DV) testing demonstrated that the surface morphology modification to the Response catheter outer shaft does not adversely affect the device safety and effectiveness. | |----------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Statement of Equivalence | The SJM™ Epicardial Catheter System that is the subject of this application has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device remains substantially equivalent to the predicate device. | | Device Information | | | Trade Name: | Supreme™ Electrophysiology Catheter | | Common Name: | Diagnostic Electrophysiology Catheter | | Classification Name: | Electrode recording catheter or electrode recording probe | | Class: | Class II, 21 CFR 870.1220, Product Code DRF | | Predicate Device: | Supreme™ Electrophysiology Catheter (K894500, K002976) | | Device Description: | The Supreme™ Electrophysiology Catheter is a sterile, single use, electrophysiological diagnostic catheter. The catheter has fixed distal curve available in various styles, no lumen, and varying electrode numbers and spacing. The electrodes detect cardiac electrical signals that are transmitted to an electrocardiogram recorder for diagnosis or deliver the electrical signal from an external pacemaker to the heart for electrical pacing purposes. | | Intended Use: (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. | | Comparison to Predicate Devices | The Supreme™ Electrophysiology Catheter that is the subject of this application remains substantially equivalent to the predicate device. There have been no changes to the device materials, packaging, sterilization or labeling. The proposed catheter includes a new outer insulation manufacturing process that results in a different surface morphology than the predicate catheter. The biocompatibility and design verification (DV) testing demonstrated that the surface morphology modification to the catheter outer shaft does not | {14}------------------------------------------------ | Summary on Non-Clinical Testing | Biocompatibility testing was performed according to ISO 10993. The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile. DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications. adversely affect the device safety and effectiveness. | |---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Statement of Equivalence | The Supreme™ Electrophysiology Catheter that is the subject of this application has the same indications for use and technological characteristics as the predicate device. Based on this and the data provided in this pre-market notification, the subject device remains substantially equivalent to the predicate device. |