(21 days)
Not Found
No
The summary describes a diagnostic catheter and a navigation system that superimposes the catheter tip position on real-time X-ray images. There is no mention of AI or ML in the intended use, device description, or performance studies. The technology described is focused on real-time tracking and visualization, not intelligent analysis or learning.
No.
The device is a diagnostic catheter used for evaluating cardiac arrhythmias and mapping electrophysiological activity, not for treating them.
Yes
The device is explicitly referred to as a "Diagnostic Catheter" and its stated "Intended Use" is for "evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites," which is a diagnostic purpose.
No
The device description clearly describes a physical catheter with electrodes and a passive sensor, which is a hardware component. While it interacts with software (MediGuide Technology), the device itself is not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are devices intended for use in the collection, preparation, and examination of specimens taken from the human body (such as blood, urine, or tissue) to provide information for the diagnosis, treatment, or prevention of disease.
- Device Function: The SJM Livewire™ Diagnostic Catheter is a medical device used within the body (in vivo) to evaluate cardiac arrhythmias. It works by being inserted into the heart and blood vessels to record electrical signals and, in the case of the MediGuide Enabled version, to be tracked in real-time using imaging technology.
- Lack of Specimen Analysis: The description does not mention the collection or analysis of any biological specimens from the patient. The device directly interacts with the patient's internal electrical activity and is guided by imaging.
Therefore, the SJM Livewire™ Diagnostic Catheter 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 with 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.
St. Jude Medical (SJM™) Livewire™ Steerable Electrophysiology Catheter can be used in the evaluation of a variety of cardiac arrhythmias from endocardial and intravascular sites.
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).
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
2D X-ray image
Anatomical Site
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)
Historical bench test data for buckle force was evaluated to set the proposed buckle force specifications.
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.
K101955, K102721, K022380, K913940
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 1, 2015
St. Jude Medical Harlan Jones Sr. Regulatory Affairs Specialist 14901 De Veau Place Minnetonka, Minnesota 55345-2126
Re: K150631
Trade/Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter Livewire Steerable 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: March 10, 2015 Received: March 11, 2015
Dear Harlan Jones:
We have reviewed your Section 510(k) premarket notification of intent to market the devices referenced above and have determined the devices are 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 devices, 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 devices are 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.
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
1
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 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,
Shawn W. Forrest -S
for
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
510(k) Number (if known): K150631
Device Name: St. Jude Medical MediGuide Enabled Livewire Steerable Electrophysiology Catheter
Indications for Use:
- The SJM™ Livewire™ Diagnostic Catheter, MediGuide Enabled™ can be used with ● 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 (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)
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INDICATIONS FOR USE
510(k) Number (if known): K150631
Device Name: Livewire™ Steerable Electrophysiology Catheter
Indications for Use:
St. Jude Medical (SJM™) 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)
Concurrence of CDRH, Office of Device Evaluation (ODE)
4
St. Jude Medical – 510(k) Summary
| 510(k) Summary | |
|---|---|
| 510(k) Number | K150631 |
| Submitter Information: | |
| Date Prepared: | 06 March 2015 |
| Submitter Name & | |
| Address: | St. Jude Medical - Atrial Fibrillation Division |
| 14901 DeVeau Place | |
| Minnetonka, MN 55345 | |
| Establishment Registration Number: 3005188751 | |
| Contact Person: | Harlan Jones |
| Senior Regulatory Affairs Specialist | |
| Phone (651) 756-3429 | |
| Fax (651) 756-3298 | |
| HJones02@sjm.com | |
| Device Information: | |
| Trade Name: | St. Jude Medical 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: | St. Jude Medical MediGuide Enabled Livewire Steerable |
| Electrophysiology Catheter (K101955) | |
| 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. The changes made to the buckle | |
| force requirement do not alter the fundamental design, packaging, | |
| biocompatibility, sterilization or labeling. | |
| Summary on Non- | |
| Clinical Testing | Historical bench test data for buckle force was evaluated to set the |
| proposed buckle force 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™ Electrophysiology Catheter (K102721, K022380, |
| K913940) | |
| 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 SJM 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. The changes made to the buckle force requirement | |
| do not alter the fundamental design, packaging, biocompatibility, | |
| sterilization or labeling. | |
| Summary on Non- | |
| Clinical Testing | Historical bench test data for buckle force was evaluated to set the |
| proposed buckle force 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. |
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