(95 days)
Not Found
Not Found
No
The description focuses on real-time tracking and navigation using a passive sensor and a gMPS system superimposed on 2D X-ray images. There is no mention of AI or ML algorithms for image analysis, prediction, or decision support.
No.
The device is described as a diagnostic mapping catheter used for evaluation and real-time tip positioning and navigation, not for therapeutic interventions.
Yes
The "Intended Use / Indications for Use" section states: "The SJM MediGuide Enabled Livewire™ steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites." and "The MediGuide Enabled Livewire™ Steerable Electrophysiology Catheter is used with a compatible gMPS™ system to enable real-time tip positioning and navigation." The "Device Description" also refers to it as a "diagnostic mapping catheter" and states its use in "electrophysiological mapping" and "diagnostic evaluation".
No
The device description clearly describes a physical catheter with a passive sensor, which is a hardware component, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The SJM MediGuide Enabled Livewire™ steerable Electrophysiology Catheter is a device used within the body (endocardial and intravascular sites) to evaluate cardiac arrhythmias and provide real-time tip positioning and navigation during electrophysiological mapping. It directly interacts with the patient's internal anatomy and electrical signals.
- Lack of Specimen Analysis: The description does not mention the analysis of any specimens taken from the body. The device is used for direct measurement and navigation within the patient.
Therefore, the device's function and intended use fall outside the scope of In Vitro Diagnostics. It is an invasive medical device used for diagnostic and procedural guidance purposes.
N/A
Intended Use / Indications for Use
The SJM MediGuide Enabled Catheter™ can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites. The MediGuide Enabled Catheter™ is used with a compatible gMPS™ system to enable real-time tip positioning and navigation. The MediGuide System is indicated for use as an adjunct to fluoroscopy.
The SJM MediGuide Enabled Livewire™ steerable Electrophysiology Catheter 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 used with a compatible gMPS™ system to enable real-time tip positioning and navigation. The MediGuide System is indicated for use as an adjunct to fluoroscopy
Product codes (comma separated list FDA assigned to the subject device)
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).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D X-ray image (fluoroscopy)
Anatomical Site
Various endocardial and intravascular sites, including the inferior vena cava, superior vena cava, pulmonary veins and coronary sinus
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Section 5 – 510(k) Summary
| Submitter: | St. Jude Medical - Atrial Fibrillation Division
14901 DeVeau Place
Minnetonka, MN 55345
Establishment Registration Number: 3005188751 |
|------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Wendy Pinor
Sr. Regulatory Affairs Specialist
Phone (651) 756-5223
Fax (952) 930-9481 |
| Date Prepared: | July 9, 2010 |
| Trade Name: | St. Jude Medical MediGuide Enabled Livewire Steerable
Electrophysiology Catheter |
| Classification: | Class II - 21 CFR 870.1220
Electrode recording catheter or electrode recording probe |
| Product Code: | DRF |
| Predicate
Device(s): | The subject device is equivalent to the following St. Jude
Medical devices:
· St. Jude Medical Livewire Electrophysiology Catheter
· MediGuide Guided Measurement Catheter (GMC) |
| 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: | The SJM MediGuide Enabled Catheter™ can be used in
the evaluation of a variety of cardiac arrhythmias from
endocardial and intravascular sites.
The MediGuide Enabled Catheter™ is used with a
compatible gMPS™ system to enable real-time tip
positioning and navigation. |
| | The MediGuide System is indicated for use as an adjunct
to fluoroscopy |
| Comparison to
Predicate Devices | The MediGuide Enabled Livewire Steerable
Electrophysiology Catheter uses similar technology,
materials, and design principals as the predicated devices.
The dimensional characteristics, indication for use and the
fundamental scientific technologies of the predicate
devices are also substantially similar. |
| Conclusion: | St. Jude Medical considers the MediGuide Enabled
Livewire Steerable Electrophysiology Catheter to be
equivalent to or substantially similar to the predicate
devices listed above. This conclusion is based upon the
devices' similarities in design, technological
characteristics, and principles of operation, materials, and
indications for use. |
ude Medical St. Jude Medical
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized emblem resembling an eagle or bird-like figure with three curved lines representing its wings or feathers.
15 2010
OCT
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
St. Jude Medical c/o Ms. Wendy Pinor Sr. Regulatory Affairs Specialist 14901 DeVeau Place Minnetonka, MN 55345
Re: K101955
Trade/Device Name: St Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode recording catheter or electrode recording probe. Regulatory Class: Class II (two) Product Code: DRF Dated: September 16, 2010 Received: September 17, 2010
Dear Ms. Pinor:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food. Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
3
Page 2 - Ms. Wendy Pinor
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Indications for Use
OCT 1 5 2010
510(k) Number (if known): K101955
Device Name:
St Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter
Indications for Use:
The SJM MediGuide Enabled Livewire™ steerable Electrophysiology Catheter 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 used with a compatible gMPS™ system to enable real-time tip positioning and navigation.
The MediGuide System is indicated for use as an adjunct to fluoroscopy
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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| (Division Sign-Off) | |
|---|---|
| Division of Cardiovascular Devices | |
| 510(k) Number | K101955 |
St. Jude Medical
Page 15of 129 PreMarket Notification for the MediGuide Enabled Livewire Steerable Electrophysiology Catheter
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