(309 days)
No
The summary describes a mapping catheter and its compatibility with navigation systems, but there is no mention of AI or ML being used for signal processing, analysis, or any other function.
No.
The device is used for recording and mapping electrical signals in the heart, and for cardiac stimulation during diagnostic electrophysiology studies. It is not described as providing treatment or therapy.
Yes
The device is described as "used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies" and "used to map the atrial regions of the heart," which are diagnostic activities.
No
The device description clearly states it is a catheter with a handle, shaft, and a magnetic sensor, indicating it is a physical hardware device, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is used for "recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies" and "to map the atrial regions of the heart." This describes a procedure performed within the body (in vivo) to gather electrical information and potentially stimulate the heart.
- Device Description: The description reinforces this by stating it's a "circular mapping catheter for performing electrophysiology mapping procedures and providing pacing signals to the heart."
- Lack of In Vitro Activity: There is no mention of the device being used to test samples of blood, tissue, or other bodily fluids outside of the body, which is the defining characteristic of an in vitro diagnostic device.
IVD devices are used to examine specimens obtained from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is used to directly interact with and gather information from the heart inside the patient.
N/A
Intended Use / Indications for Use
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled is a sensor-enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information.
The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is indicated for use as an adjunct to fluoroscopy.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
Advisor FL Circular Mapping Catheter, Sensor Enabled (Advisor FL, SE) is a circular mapping catheter for performing electrophysiology mapping procedures and providing pacing signals to the heart during electrophysiology procedures. The catheter handle and shaft design allows for improved maneuverability. A magnetic sensor in the distal shaft pocket provides compatibility with visualization and navigation systems. The catheter is compatible with SJM's EnSite™ Precision™ Cardiac Mapping system or MediGuide™ System (MG).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
atrial regions 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)
Bench and animal testing was performed to verify the device met the pre-determined acceptance criteria. The following tests were performed: Patient Leakage Dielectric Strength Defibrillation Protection Anchorage Flex Handle Push Radiopacity Biocompatibility Surface Corrosion Resistance Tensile Loop Characteristics Shaft Properties Functional Functional Simulated Use Electrical Properties Visualization and Navigation Sterilization/ Microbiology Packaging Shelf Life GLP Animal Safety.
The Advisor FL, SE has the same indications for use and technological characteristics as the predicate devices. Based on this and the data provided in this pre-market notification, the subject device and predicate device has been shown to be substantially equivalent.
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.
Inquiry AFocus II (K042775)
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.
MediGuide Enabled Livewire Steerable Electrophysiology Catheter (K101955)
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).
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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 13, 2016
St. Jude Medical Tamara Stanczak Principal Regulatory Affairs Specialist 5050 Nathan Lane Plymouth, Minnesota 55442
Re: K160335
Trade/Device Name: Advisor FL Circular Mapping Catheter, Sensor Enabled Advisor FL 15mm 12 Pole 333 Uni D Advisor FL 20mm 12 Pole 555 Uni D Advisor FL 15mm 12 Pole 333 Bi D Advisor FL 20mm 12 Pole 555 Bi D Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: September 26, 2016 Received: September 27, 2016
Dear Tamara Stanczak:
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.
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 vours.
Muda Jellman
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) K160335
Device Name
Advisor™ FL, Circular Mapping Catheter, Sensor EnabledTM
Indications for Use (Describe)
The Advisor™ FL Circular Mapping Catheter, Sensor Enabled steerable electrophysiology catheter used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies. The catheter can be used to map the atrial regions of the heart.
The catheter is used with the EnSite Precision™ System to combine and display magnetic processed patient positioning and navigation mapping information.
The catheter is used with the MediGuide™ Technology system to enable real-time positioning and navigation. The MediGuide™ Technology system is indicated for use as an adjunct to fluoroscopy.
| Type of Use (Select one or both, as applicable) |
|---|
| ------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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| 510(k) Summary | |
|---|---|
| 510(k) Number | K160335 |
| Submitter Information: | |
| Date Prepared: | December 13, 2016 |
| Submitter Name & Address: | St. Jude Medical |
| 5050 Nathan Lane | |
| Plymouth, MN 55442 | |
| Contact Person: | Tamara L Stanczak |
| Principal Regulatory Affairs Specialist | |
| Phone (651) 756-6656 | |
| Fax (651) 756-3301 | |
| Tstanczak@sjm.com | |
| Device Information: | |
| Trade Name: | Advisor™ FL, Circular Mapping Catheter, Sensor Enabled™ |
| Common Name: | Diagnostic Electrophysiology Catheter |
| Class: | II, 870.1220, Product Code DRF |
| Models | Advisor FL 15mm 12 Pole 333 Uni D |
| Advisor FL 20mm 12 Pole 555 Uni D | |
| Advisor FL 15mm 12 Pole 333 Bi D | |
| Advisor FL 20mm 12 Pole 555 Bi D | |
| Classification Name: | Electrode recording catheter or electrode recording probe |
| Primary Predicate Device: | Inquiry AFocus II (K042775) |
| Secondary Predicate | |
| Device: | MediGuide Enabled Livewire Steerable Electrophysiology Catheter |
| (K101955) | |
| Device Description: | Advisor FL Circular Mapping Catheter, Sensor Enabled (Advisor |
| FL, SE) is a circular mapping catheter for performing | |
| electrophysiology mapping procedures and providing pacing signals | |
| to the heart during electrophysiology procedures. The catheter | |
| handle and shaft design allows for improved maneuverability. A | |
| magnetic sensor in the distal shaft pocket provides compatibility | |
| with visualization and navigation systems. The catheter is | |
| compatible with SJM's EnSite™ Precision™ Cardiac Mapping | |
| system or MediGuide™ System (MG). | |
| Intended Use: | |
| (Indications for Use) | The Advisor™ FL Circular Mapping Catheter, Sensor Enabled™ is |
| a sensor-enabled steerable electrophysiology catheter used for | |
| recording intracardiac signals and cardiac stimulation during | |
| diagnostic electrophysiology studies. The catheter can be used to | |
| map the atrial regions of the heart. |
The catheter is used with the EnSite Precision™ System to
combine and display magnetic processed patient positioning and
navigation mapping information.
The catheter is used with the MediGuide™ Technology system to
enable real-time positioning and navigation. The MediGuide™
Technology system is indicated for use as an adjunct to
fluoroscopy. |
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Image /page/4/Picture/0 description: The image contains the logo for St. Jude Medical. The logo consists of a green square grid on the left and the text "ST. JUDE MEDICAL" on the right. The grid is made up of nine smaller squares, with one square slightly tilted.
| 510(k) Summary | |
|---|---|
| 510(k) Number | K160335 |
| Comparison to Predicate | |
| Devices | The Advisor FL, SE has the same intended use and fundamental |
| scientific technology as the predicate devices. The technological | |
| characteristics of the Advisor FL,SE are substantially equivalent to | |
| the predicate device including packaging, biocompatibility, | |
| sterilization, and labeling. Bench and animal testing demonstrated | |
| that the subject device is substantially equivalent to the predicate | |
| device. | |
| Summary on Non-Clinical | |
| Testing | Bench and animal testing was performed to verify the device met |
| the pre-determined acceptance criteria. The following tests were | |
| performed: | |
| Patient Leakage Dielectric Strength Defibrillation Protection Anchorage Flex Handle Push Radiopacity Biocompatibility Surface Corrosion Resistance Tensile Loop Characteristics Shaft Properties Functional Functional Simulated Use Electrical Properties Visualization and Navigation Sterilization/ Microbiology Packaging Shelf Life GLP Animal Safety | |
| Statement of Equivalence | The Advisor FL, SE has the same indications for use and |
| technological characteristics as the predicate devices. Based on | |
| this and the data provided in this pre-market notification, the subject | |
| device and predicate device has been shown to be substantially | |
| equivalent. |