(49 days)
No
The summary describes a physical catheter with integrated sensors for mapping cardiac signals. There is no mention of AI, ML, or any software-based analysis beyond basic signal recording and mapping within the associated system.
No
The device is used for recording and mapping intracardiac signals, primarily for diagnostic purposes in electrophysiology studies, not for treating a condition.
Yes
The "Intended Use / Indications for Use" section states: "The catheter is used for recording intracardiac signals and cardiac stimulation during diagnostic electrophysiology studies." This explicitly indicates its use in diagnostic procedures.
No
The device description clearly states it is a physical catheter with integrated sensors and electrodes, which are hardware components. It is intended to be used with a cardiac mapping system, but the device itself is not software-only.
Based on the provided information, the Advisor VL Circular Mapping Catheter, Sensor Enabled is not an IVD (In Vitro Diagnostic) device.
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 involves direct interaction with the patient's body (in vivo) to gather electrical signals from the heart.
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, outside of the body (in vitro) to detect diseases, conditions, or infections.
- Device Description: The description details a catheter designed to be inserted into the heart, which is an in vivo procedure, not an in vitro test.
Therefore, the Advisor VL Circular Mapping Catheter, Sensor Enabled is an in vivo diagnostic and therapeutic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The Advisor VL Circular Mapping Catheter, Sensor Enabled is a steerable electrophysiology catheter with integrated sensors. The catheter is 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.
Product codes
DRF
Device Description
Advisor VL Circular Mapping Catheter, Sensor Enabled (Advisor VL) is a variable radius, circular mapping catheter. It has an adjustable 4 French (F) distal loop size with a diameter ranging from 15mm – 25mm with models containing both ten (10) equidistant or twenty (20) paired platinum-iridium electrodes. The catheter has integrated sensors with two impedance-based navigational electrodes and two magnetic sensors located at the distal end of the shaft. The catheter is intended to be used with the EnSiteTM PrecisionTM Cardiac Mapping System.
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
• Human Factors
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Advisor FL, Circular Mapping Catheter, Sensor Enabled (K160335)
Reference Device(s)
Reflexion Spiral Variable Radius Catheter (K072012)
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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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
September 17, 2019
Abbott Medical Tamara Stanczak Regulatory Affairs Project Manager 5050 Nathan Lane North Plymouth, Minnesota 55442
Re: K192037
Trade/Device Name: Advisor VL Circular Mapping Catheter, Sensor Enabled Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: July 29, 2019 Received: July 30, 2019
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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 with all the Act's
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requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Mark Fellman Assistant Director DHT2A: Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices OHT2: Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known)
Device Name
Advisor™ VL Circular Mapping Catheter, Sensor EnabledTM
Indications for Use (Describe)
The Advisor VL Circular Mapping Catheter, Sensor Enabled is a steerable electrophysiology catheter with integrated sensors. The catheter is 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ 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 | K192037 |
| Submitter Information: | |
| Date Prepared: | July 29, 2019 |
| Submitter Name & Address | Abbott Medical |
| 5050 Nathan Lane North | |
| Plymouth, MN 55442 | |
| Contact Person | Tamara L Stanczak |
| Regulatory Affairs Project Manager | |
| Phone: 651-756-6656 | |
| Email: tamara.stanczak@abbott.com | |
| Device Information: | |
| Trade Name: | AdvisorTM VL Circular Mapping Catheter, |
| Sensor EnabledTM | |
| Common Name: | Diagnostic Electrophysiology Catheter |
| Class: | Class II, 21CFR870.1220 |
| Product Code: | DRF |
| Classification Name: | Catheter, Electrode Recording, or Probe, |
| Electrode Recording | |
| Predicate Device: | Advisor FL, Circular Mapping Catheter, |
| Sensor Enabled (K160335) | |
| Reference Device: | Reflexion Spiral Variable Radius Catheter |
| (K072012) | |
| Device Description: | Advisor VL Circular Mapping Catheter, |
| Sensor Enabled (Advisor VL) is a variable | |
| radius, circular mapping catheter. It has an | |
| adjustable 4 French (F) distal loop size with a | |
| diameter ranging from 15mm – 25mm with | |
| models containing both ten (10) equidistant or | |
| twenty (20) paired platinum-iridium | |
| electrodes. The catheter has integrated sensors | |
| with two impedance-based navigational | |
| electrodes and two magnetic sensors located | |
| at the distal end of the shaft. The catheter is | |
| intended to be used with the EnSiteTM | |
| PrecisionTM Cardiac Mapping System. | |
| Intended Use: | |
| (Indications for Use) | Advisor VL catheter is a steerable |
| electrophysiology catheter with integrated | |
| sensors. The catheter is 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. | |
| Comparison to Predicate Devices | The Advisor VL is substantially equivalent to |
| the predicate devices based on comparisons of | |
| the device functionality, technological | |
| 510(k) Summary | |
| 510(k) Number | K192037 |
| characteristics, and intended use. The | |
| differences in loop diameter and number of | |
| electrodes between Advisor VL and Advisor | |
| FL have been evaluated through bench, in | |
| vivo, and biocompatibility testing. Bench and | |
| animal testing demonstrated that the subject | |
| device is substantially equivalent to the | |
| predicate device. Results from bench, in vivo, | |
| and biocompatibility testing did not result in | |
| new questions with regard to safety and | |
| effectiveness of the device. | |
| Summary on Non-Clinical Tests | 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 | |
| • Human Factors | |
| Statement of Equivalence | The Advisor VL 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 and predicate device has been | |
| shown to be substantially equivalent. |
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