(95 days)
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
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 provided text is a 510(k) summary for the St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter. It describes the device, its intended use, and its equivalence to predicate devices. However, this document does not contain the detailed information necessary to answer all parts of your request regarding acceptance criteria and a specific study proving the device meets those criteria.
The 510(k) summary is a regulatory document asserting substantial equivalence to previously cleared devices, rather than a report detailing a clinical trial or performance study with acceptance criteria.
Therefore, I cannot populate the table or answer the specific questions about sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, or training set details as this information is not present in the provided text.
Based on the provided text, here's what can be inferred or explicitly stated:
1. Table of Acceptance Criteria and Reported Device Performance:
This information is NOT available in the provided 510(k) summary. The document asserts substantial equivalence to predicate devices based on design, technology, materials, and indications for use, without detailing specific performance metrics or acceptance criteria for a new study.
2. Sample size used for the test set and the data provenance:
This information is NOT available in the provided 510(k) summary. No specific test set or study data is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is NOT available in the provided 510(k) summary. No study involving expert-established ground truth is described.
4. Adjudication method for the test set:
This information is NOT available in the provided 510(k) summary. No study involving adjudication is described.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
This information is NOT available in the provided 510(k) summary. The document does not describe an AI-assisted device or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is NOT available in the provided 510(k) summary. The device is a physical catheter used in conjunction with a gMPS system under human guidance. There is no mention of a standalone algorithm performance evaluation.
7. The type of ground truth used:
This information is NOT available in the provided 510(k) summary. No explicit ground truth is mentioned as it primarily focuses on comparing the device to existing predicate devices rather than validating performance against a 'true' reference standard.
8. The sample size for the training set:
This information is NOT available in the provided 510(k) summary. There is no mention of a training set as the device is a medical instrument, not a machine learning algorithm requiring a training set.
9. How the ground truth for the training set was established:
This information is NOT available in the provided 510(k) summary. As mentioned, there is no training set described.
Summary of what the document does provide:
- Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter
- Intended Use: Used in the evaluation of cardiac arrhythmias from endocardial and intravascular sites. Used with a compatible gMPS system for real-time tip positioning and navigation, and as an adjunct to fluoroscopy.
- Basis for Clearance (510(k)): Substantial equivalence to predicate devices (St. Jude Medical Livewire Electrophysiology Catheter and MediGuide Guided Measurement Catheter (GMC)) based on similar technology, materials, design principles, dimensional characteristics, indications for use, and fundamental scientific technologies.
Therefore, to answer your questions fully, you would need different documentation, likely a dedicated clinical study report or a performance validation report, which is not part of this 510(k) summary.
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Section 5 – 510(k) Summary
| Submitter: | St. Jude Medical - Atrial Fibrillation Division14901 DeVeau PlaceMinnetonka, MN 55345Establishment Registration Number: 3005188751 |
|---|---|
| Contact Person: | Wendy PinorSr. Regulatory Affairs SpecialistPhone (651) 756-5223Fax (952) 930-9481 |
| Date Prepared: | July 9, 2010 |
| Trade Name: | St. Jude Medical MediGuide Enabled Livewire SteerableElectrophysiology Catheter |
| Classification: | Class II - 21 CFR 870.1220Electrode recording catheter or electrode recording probe |
| Product Code: | DRF |
| PredicateDevice(s): | The subject device is equivalent to the following St. JudeMedical devices:· St. Jude Medical Livewire Electrophysiology Catheter· MediGuide Guided Measurement Catheter (GMC) |
| DeviceDescription: | The MediGuide Enabled Livewire SteerableElectrophysiology Catheter is designed to allowelectrophysiological mapping at various endocardial andintravascular sites, including the inferior vena cava,superior vena cava, pulmonary veins and coronary sinus.The use of the MediGuide Enabled Livewire diagnosticmapping catheter in conjunction with the MediGuidegMPS system allows real-time tip positioning andnavigation during routine diagnostic evaluation.When connected to the ECG, the MediGuide EnabledLivewire Catheter will transmit routine electrical signalswhile the passive sensor at the tip of the catheter istracked by gMPS and is superimposed on any 2D X-rayimage in real time ("Live") fluoroscopy mode (the actual 3Dposition of the catheter tip is projected on the real time 2Dimage). |
| Intended Use: | The SJM MediGuide Enabled Catheter™ can be used inthe evaluation of a variety of cardiac arrhythmias fromendocardial and intravascular sites.The MediGuide Enabled Catheter™ is used with acompatible gMPS™ system to enable real-time tippositioning and navigation. |
| The MediGuide System is indicated for use as an adjunctto fluoroscopy | |
| Comparison toPredicate Devices | The MediGuide Enabled Livewire SteerableElectrophysiology Catheter uses similar technology,materials, and design principals as the predicated devices.The dimensional characteristics, indication for use and thefundamental scientific technologies of the predicatedevices are also substantially similar. |
| Conclusion: | St. Jude Medical considers the MediGuide EnabledLivewire Steerable Electrophysiology Catheter to beequivalent to or substantially similar to the predicatedevices listed above. This conclusion is based upon thedevices' similarities in design, technologicalcharacteristics, and principles of operation, materials, andindications 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.
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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
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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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§ 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).