(29 days)
Not Found
No
The summary describes a diagnostic catheter system that uses real-time tracking and superimposition on X-ray images. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is based on passive sensor tracking and image overlay, not AI/ML algorithms for analysis or interpretation.
No.
The device descriptions and intended uses consistently state that the device is for "evaluation," "diagnosis," "mapping," and detecting "electrical signals," which are all diagnostic functions. While some models deliver "electrical signal from an external pacemaker to the heart for electrical pacing purposes," this is explicitly stated to be for "diagnosis" or "pacing purposes" rather than a therapeutic intervention to treat a disease.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device "can be used in the evaluation of a variety of cardiac arrhythmias." Similarly, the "Device Description" section repeatedly refers to it as an "electrophysiological diagnostic catheter" and mentions that electrodes "detect cardiac electrical signals that are transmitted to an electrocardiogram recorder for diagnosis." These statements clearly indicate the device's diagnostic purpose.
No
The device description clearly details multiple hardware components, including catheters with electrodes, a steerable introducer, a needle, and a system that tracks a passive sensor on the catheter tip using X-ray imaging. This is not a software-only device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states that this device is an electrophysiology catheter used for evaluating cardiac arrhythmias from within the body (endocardial and intravascular sites, and the epicardial surface). It detects electrical signals directly from the heart or delivers electrical signals to the heart.
- No Specimen Analysis: There is no mention of the device analyzing any specimens taken from the body. Its function is to interact directly with the heart's electrical activity.
Therefore, the device described falls under the category of an in vivo diagnostic or therapeutic device, not an in vitro diagnostic device.
N/A
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.
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.
The SJM™ Epicardial Catheter System is intended for electrophysiology studies involving the epicardial surface of the heart.
Product codes
DRF
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
endocardial and intravascular sites, inferior vena cava, superior vena cava, pulmonary veins and coronary sinus, epicardial surface of the heart.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
K101955, K150631, K913940, K022380, K102721, K150631, K914278, K942379, K120544, K894500, K002976, K081803
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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. |