(29 days)
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. ●
The Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
St Jude Medical (SJM) Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.
St Jude Medical (SJM) Electrophysiology Catheters can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
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).
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.
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.
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.
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.
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.
The provided text describes a 510(k) premarket notification for several electrophysiology catheters. This type of submission focuses on demonstrating substantial equivalence to a predicate device, rather than providing detailed clinical study results with acceptance criteria and performance metrics for AI-powered devices.
Therefore, the requested information regarding:
- A table of acceptance criteria and reported device performance
- Sample size and data provenance for a test set
- Number and qualifications of experts for ground truth
- Adjudication method
- MRMC comparative effectiveness study with effect size
- Standalone performance for an algorithm
- Type of ground truth used
- Sample size for training set
- How ground truth for the training set was established
cannot be extracted from this document because it is not relevant to a 510(k) submission for non-AI medical devices and this document does not describe any AI component.
The document details a comparison with predicate devices and focuses on non-clinical testing to demonstrate that a manufacturing process change (a new outer insulation manufacturing process resulting in a different surface morphology) does not adversely affect device safety and effectiveness.
Here's what can be extracted regarding the study that proves the device meets (safety and effectiveness) criteria, as presented in this 510(k) summary:
Study and Acceptance Criteria:
The "study" in this context refers to non-clinical testing performed to demonstrate that the modified devices are substantially equivalent to their predicates. The acceptance criteria are implicit in meeting the standards for biocompatibility and product performance.
1. Table of Acceptance Criteria and Reported Device Performance (as relevant to this submission):
| Acceptance Criteria (Implicit) | Reported Device Performance |
|---|---|
| Biocompatibility: Complies with ISO 10993 (to ensure the modified material does not cause adverse biological reactions). | "The catheters with the modified surface morphology of the proximal shaft demonstrated acceptable biocompatibility profile." |
| Product Performance/Safety & Effectiveness: Complies with ISO 10555 (specific to sterile, single-use intravascular catheters) and overall product specifications (to ensure functional integrity and performance are maintained despite the surface morphology change). | "DV testing was performed according to ISO 10555. The catheters with the modified surface morphology of the proximal shaft met product performance specifications." and "does not adversely affect the device safety and effectiveness." |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size for Test Set: Not explicitly stated as a number of devices, but it refers to the "catheters with the modified surface morphology of the proximal shaft" that underwent Biocompatibility and Design Verification (DV) testing. This typically involves a sufficient number of samples to statistically demonstrate compliance with the standards, but the exact count is not in this summary.
- Data Provenance: This is non-clinical lab test data, conducted internally or by contract labs following ISO standards. It is retrospective in the sense that the testing was completed prior to the submission. The country of origin of the data is not specified, but it would be where the manufacturing and testing facilities are located for St. Jude Medical (Minnetonka, MN, USA, as per the submitter information).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts:
- Not applicable. This is not a study requiring expert clinical assessment for ground truth. The "ground truth" here is compliance with established engineering and biological safety standards (ISO 10993 and ISO 10555).
4. Adjudication Method for the Test Set:
- Not applicable. This is not a comparative clinical study requiring expert adjudication. Acceptance is based on meeting predefined technical and biological endpoints in laboratory testing.
5. If a Multi-reader Multi-case (MRMC) Comparative Effectiveness Study Was Done:
- No. This is not an AI or imaging device, and no MRMC study was conducted or mentioned.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:
- No. This device is a physical electrophysiology catheter, not an algorithm, and does not operate in a "standalone" algorithmic capacity.
7. The Type of Ground Truth Used:
- For Biocompatibility: Compliance with ISO 10993 biological endpoints (e.g., cytotoxicity, irritation, sensitization).
- For Product Performance: Compliance with ISO 10555 mechanical and functional requirements, and internal product specifications (e.g., physical dimensions, electrical conductivity, steering mechanism integrity, fluid flow in the lumen for the Response with Lumen catheter).
8. The Sample Size for the Training Set:
- Not applicable. This is not a machine learning device; therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established:
- Not applicable (as there is no training set).
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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".
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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
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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)
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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 Medical14901 DeVeau PlaceMinnetonka, MN 55345Establishment Registration Number: 3005188751 |
| Contact Person: | Maria ObreztchikovaSenior Regulatory Affairs SpecialistPhone (651) 756-4424Fax (651) 756-3298mobreztchikova@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 ElectrophysiologyCatheter is designed to allow electrophysiological mapping atvarious endocardial and intravascular sites including the inferiorvena cava, superior vena cava, pulmonary veins and coronary sinus.The use of the MediGuide Enabled Livewire diagnostic mappingcatheter in conjunction with the MediGuide gMPS system allowsreal-time tip positioning and navigation during routine diagnosticevaluation.When connected to the ECG, the MediGuide Enabled LivewireCatheter will transmit routine electrical signals while the passivesensor at the tip of the catheter is tracked by gMPS and issuperimposed on any 2D X-ray image in real time (“Live”)fluoroscopy mode (the actual 3D position of the catheter tip isprojected on the real time 2D image). |
| Intended Use:(Indications for Use) | • The SJM™ Livewire™ Diagnostic Catheter, MediGuideEnabled™ can be used in the evaluation of a variety of cardiacarrhythmias from endocardial and intravascular sites.• The Livewire™ Diagnostic Catheter, MediGuide Enabled™ is |
| compatible with MediGuide™ Technology to enable real-timetip positioning and navigation. | |
| • The MediGuide™ Technology is indicated for use as an adjunctto fluoroscopy. | |
| Comparison toPredicate Devices | The MediGuide Enabled Livewire Steerable ElectrophysiologyCatheter that is the subject of this application remains substantiallyequivalent to the predicate device. There have been no changes tothe device materials, packaging, sterilization or labeling. Theproposed catheter includes a new outer insulation manufacturingprocess that results in a different surface morphology than thepredicate catheter. The biocompatibility and design verification(DV) testing demonstrated that the surface morphology modificationto the outer layer of the catheter proximal shaft does not adverselyaffect 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 proximalshaft demonstrated acceptable biocompatibility profile.DV testing was performed according to ISO 10555. The catheterswith the modified surface morphology of the proximal shaft metproduct performance specifications. |
| Statement ofEquivalence | The MediGuide Enabled Livewire Steerable ElectrophysiologyCatheter that is the subject of this application has the sameindications for use and technological characteristics as the predicatedevice. Based on this and the data provided in this pre-marketnotification, the subject device remains substantially equivalent tothe 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 aflexible electrode catheter constructed of a polyurethaneinsulation/shaft and incorporates platinum electrodes. The active tipmay be manipulated by a remote means located at the proximal endof the catheter. |
| Intended Use:(Indications for Use) | The Livewire™ Steerable Electrophysiology Catheter can be used inthe evaluation of a variety of cardiac arrhythmias from endocardialand intravascular sites. |
| Comparison toPredicate Devices | The Livewire Steerable Electrophysiology Catheter that is thesubject of this application remains substantially equivalent to thepredicate device. There have been no changes to the devicematerials, packaging, sterilization or labeling. The proposed catheterincludes a new outer insulation manufacturing process that results ina different surface morphology than the predicate catheter. Thebiocompatibility and design verification (DV) testing demonstratedthat the surface morphology modification to the outer layer of thecatheter proximal shaft does not adversely affect the device safetyand effectiveness. |
| Summary on Non-Clinical Testing | Biocompatibility testing was performed according to ISO 10993.The catheters with the modified surface morphology of the proximalshaft demonstrated acceptable biocompatibility profile.DV testing was performed according to ISO 10555. The catheterswith the modified surface morphology of the proximal shaft metproduct performance specifications. |
| Statement ofEquivalence | The Livewire Steerable Electrophysiology Catheter that is thesubject of this application has the same indications for use andtechnological characteristics as the predicate device. Based on thisand the data provided in this pre-market notification, the subjectdevice 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 fixeddistal curve and multiple electrodes. The electrodes detect cardiacelectrical signals that are transmitted to an electrocardiogramrecorder for diagnosis or deliver the electrical signal from anexternal pacemaker to the heart for electrical pacing purposes. Thecatheter body is a continuous tube with a central lumen for fluidinfusion through a 3-way valve. |
| Intended Use:(Indications for Use) | St Jude Medical (SJM) Electrophysiology Catheters can be used inthe evaluation of a variety of cardiac arrhythmias from endocardialand intravascular sites. |
| Comparison toPredicate Devices | The Response™ Electrophysiology Catheter with Lumen that is thesubject of this application remains substantially equivalent to the |
| predicate device. There have been no changes to the devicematerials, packaging, sterilization or labeling. The proposed catheterincludes a new outer insulation manufacturing process that results ina different surface morphology than the predicate catheter. Thebiocompatibility and design verification (DV) testing demonstratedthat the surface morphology modification to the outer layer of thecatheter proximal shaft does not adversely affect the device safetyand effectiveness. | |
| Summary on Non-Clinical Testing | Biocompatibility testing was performed according to ISO 10993.The catheters with the modified surface morphology of the proximalshaft demonstrated acceptable biocompatibility profile.DV testing was performed according to ISO 10555. The catheterswith the modified surface morphology of the proximal shaft metproduct performance specifications. |
| Statement ofEquivalence | The Response™ Electrophysiology Catheter with Lumen that is thesubject of this application has the same indications for use andtechnological characteristics as the predicate device. Based on thisand the data provided in this pre-market notification, the subjectdevice 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 fixeddistal curve available in various styles, no lumen, and varyingelectrode numbers and spacing. The electrodes detect cardiacelectrical signals that are transmitted to an electrocardiogramrecorder for diagnosis or deliver the electrical signal from anexternal pacemaker to the heart for electrical pacing purposes. |
| Intended Use:(Indications for Use) | St Jude Medical (SJM) Electrophysiology Catheters can be used inthe evaluation of a variety of cardiac arrhythmias from endocardialand intravascular sites. |
| Comparison toPredicate Devices | The Response™ Electrophysiology Catheter that is the subject ofthis application remains substantially equivalent to the predicatedevice. There have been no changes to the device materials,packaging, sterilization or labeling. The proposed catheter includes anew outer insulation manufacturing process that results in a differentsurface morphology than the predicate catheter The |
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{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 toPredicate 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 proximalshaft demonstrated acceptable biocompatibility profile.DV testing was performed according to ISO 10555. The catheterswith the modified surface morphology of the proximal shaft metproduct performance specifications.labeling. The proposed catheter includes a new outer insulationmanufacturing process that results in a different surface morphologythan the predicate catheter. The biocompatibility and designverification (DV) testing demonstrated that the surface morphologymodification to the Response catheter outer shaft does not adverselyaffect the device safety and effectiveness. |
|---|---|
| Statement ofEquivalence | The SJM™ Epicardial Catheter System that is the subject of thisapplication has the same indications for use and technologicalcharacteristics as the predicate device. Based on this and the dataprovided in this pre-market notification, the subject device remainssubstantially 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 fixeddistal curve available in various styles, no lumen, and varyingelectrode numbers and spacing. The electrodes detect cardiacelectrical signals that are transmitted to an electrocardiogramrecorder for diagnosis or deliver the electrical signal from anexternal pacemaker to the heart for electrical pacing purposes. |
| Intended Use:(Indications for Use) | St Jude Medical (SJM) Electrophysiology Catheters can be used inthe evaluation of a variety of cardiac arrhythmias from endocardialand intravascular sites. |
| Comparison toPredicate Devices | The Supreme™ Electrophysiology Catheter that is the subject of thisapplication 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 outerinsulation manufacturing process that results in a different surfacemorphology than the predicate catheter. The biocompatibility anddesign verification (DV) testing demonstrated that the surfacemorphology 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. |
§ 870.1220 Electrode recording catheter or electrode recording probe.
(a)
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.(b)
Classification. Class II (performance standards).