(258 days)
The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrode electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular regions of the heart.
The Advisor HD Grid Mapping Catheter, Sensor Enabled, is a sterile, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite Velocity and EnSite Precision Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps.
The provided text describes the St. Jude Medical Advisor HD Grid Mapping Catheter, Sensor Enabled. It mentions several types of testing conducted to demonstrate substantial equivalence to predicate devices, including bench, in vivo, and biocompatibility testing. However, the document does NOT contain a study that establishes acceptance criteria and provides specific device performance data in the format requested.
The document lists various performance characteristics that were tested (e.g., irrigation pressure, electrical resistance, magnetic resistance, and compliance to various ISO and ANSI/AAMI/IEC standards), as well as a "GLP safety study" and an "Accuracy study" as part of in vivo testing. It states that "The resulting evidence obtained from the design verification and validation testing did not raise new questions of safety and effectiveness, and demonstrates that the subject device is as safe and effective as the predicate devices."
However, it does not provide the acceptance criteria for these tests, nor does it present the reported device performance against those criteria in a quantitative manner. Therefore, I cannot complete the table or answer most of the specific questions about the study design, sample sizes, ground truth establishment, or expert involvement, as this information is not present in the provided text.
Based on the provided text, I can only state that an "Accuracy study" was performed as an in vivo test, but no details about its methodology, results, or how it proved the device met specific acceptance criteria are given.
The information regarding acceptance criteria and a study proving their fulfillment is absent from the provided FDA 510(k) clearance letter and associated indications for use and device description.
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April 23, 2018
St. Jude Medical, Inc. Jennifer Ruether Regulatory Affairs Manager 5050 Nathan Lane North Plymouth, Minnesota 55442
Re: K172393
Trade/Device Name: Advisor HD Grid 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: MTD Dated: March 14, 2018 Received: March 16, 2018
Dear Jennifer Ruether:
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 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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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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.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Wilhelmsen
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)
Device Name
Advisor HD Grid Mapping Catheter, Sensor Enabled
Indications for Use (Describe)
The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated for multiple electrophysiological mapping of cardiac structures in the heart, i.e., recording or stimulation only. This catheter is intended to obtain electrograms in the atrial and ventricular 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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Image /page/3/Picture/1 description: The image shows the St. Jude Medical logo. The logo consists of a green square grid with one square rotated, followed by the text "ST. JUDE MEDICAL" in black. Below the logo, the text "St. Jude Medical is now Abbott." is written in blue.
Abbott Laboratories St. Jude Medical 5050 Nathan Lane North Plymouth, MN 55442 USA 651 756 5400 Main 651 756 5355 Fax
510(k) Number K172393
Submitter Information
| Date Prepared | April 13, 2018 |
|---|---|
| Submitter Name &Address | St. Jude Medical5050 Nathan Lane NorthPlymouth, MN 55442Phone: 651 756 5400Fax: 651 756 5355 |
| Contact Person | Jennifer RuetherRegulatory Affairs Manager |
Device Identification
| Trade Name | Advisor™ HD Mapping Catheter, Sensor Enabled™ |
|---|---|
| Common Name | Catheter, Intracardiac Mapping, High-Density Array |
| Classification | 21 CFR 870.1220; Electrode recording catheter or electrode recording probe;Procode MTD; Class II |
| Predicate Device | Primary: PentaRay NAV High Density Mapping Catheter, Biosense Webster;K120425 |
| Secondary: Advisor FL Circular Mapping Catheter, Sensor Enabled, St. JudeMedical; K160335 | |
| Reference Application | EnSite™ Velocity™ Cardiac Mapping System v5.2 & EnSite Precision™Cardiac Mapping System v2.2 (currently under review with FDA in aconcomitant 510(k) submission) |
| Indications for Use | The Advisor HD Grid Mapping Catheter, Sensor Enabled, is indicated formultiple electrode electrophysiological mapping of cardiac structures in theheart, i.e., recording or stimulation only. This catheter is intended to obtainelectrograms in the atrial and ventricular regions of the heart. |
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Image /page/4/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square made up of smaller squares, with one square tilted. To the right of the square is the text "ST. JUDE MEDICAL" in a bold, sans-serif font. Below the company name is the text "St. Jude Medical is now Abbott" in a smaller, blue font.
Abbott Laboratories St. Jude Medical 5050 Nathan Lane North Plymouth, MN 55442 USA 651 756 5400 Main 651 756 5355 Fax
The Advisor HD Grid Mapping Catheter, Sensor Enabled, is a sterile, singleuse, irrigated, high-density mapping catheter with a 7.5F shaft and an 8F distal shaft deflectable section. It is available in a D-F bi-directional curve model that is deflected using the actuator located on the catheter handle. The catheter working length is 110 cm. The device consists of a paddle-shaped distal tip with 16 electrodes, two distal shaft ring electrodes, two magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical Device Description connector. The catheter also has an introducer tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is compatible with the EnSite Velocity and EnSite Precision Cardiac Mapping Systems and other accessories, including the connecting cable and commercially available irrigation pumps. The Advisor HD Grid Mapping Catheter, Sensor Enabled, is similar to the predicate devices in design and performance. All catheters use multiple electrodes to facilitate electrophysiological mapping and are available in similar dimensions and curve shapes; additionally, all incorporate magnetic sensors to accommodate use with the respective compatible mapping systems. Like the PentaRay catheter, the subject device incorporates a fluid lumen for irrigation of Technological the distal tip and is indicated for use in the atria and ventricles; the catheters Characteristics differ in terms of distal tip shape, and compatible mapping systems. The Advisor HD Grid and the Advisor FL catheters share the same shaft and handle design, and are compatible with the same mapping system; due to the difference in distal tip designs, the subject device differs from the Advisor FL catheter in irrigation and indications for use. Technological differences between the subject and predicate devices in indications for use, irrigation, and system-level accuracy resulted in the same questions of safety and effectiveness. The Advisor HD Grid Mapping Catheter, Sensor Enabled, is substantially equivalent to the predicate devices based on comparisons of the device functionality, technological characteristics, and intended use. The identified differences between the technological characteristics have been evaluated through the following bench, in vivo, and biocompatibility testing: Substantial . Physical and Dimensional Characteristics: Outer dimension Equivalence and O Summary of Studies Electrode spacing O Paddle length O Paddle alignment O Deflection curve shape, angle, and planarity O
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Image /page/5/Picture/1 description: The image shows the logo for St. Jude Medical. The logo consists of a green square made up of smaller squares, with one square tilted. To the right of the square is the text "ST. JUDE MEDICAL" in a bold, sans-serif font. Below the logo is the text "St. Jude Medical is now Abbott" in a smaller, blue font.
Abbott Laboratories
St. Jude Medical 5050 Nathan Lane North Plymouth, MN 55442 USA Main 651 756 5400 651 756 5355 Fax
- . Handling Characteristics:
- Actuation force/torque O
- O Freedom from play
- Manual/adjustable lock O
- Torque response O
- O Column strength
- O Paddle stiffness
- Durability Characteristics:
- O Torque and tensile strength (after conditioning)
- . Performance Characteristics:
- Irrigation pressure, leakage, flow rate, luer compliance to ISO O 594-2
- Electrical resistance, isolation, fluid ingress O
- Magnetic resistance, isolation, signal characteristics, O compatibility with EnSite systems
- Compliance to ANSI/AAMI/IEC 60601: ●
- Patient leakage ೧
- Dielectric strength O
- Defibrillation protection O
- Anchorage flex O
- O Handle push
- Compliance to ISO 10555-1:
- Radiopacity O
- Surface/visual inspection O
- Corrosion resistance O
- 0 Tensile strength
- Compliance to ISO 1099993: ●
- Cytotoxicity O
- Sensitization O
- Irritation O
- Acute Systemic Toxicity O
- Pyrogenicity O
- Hemocompatibility O
- o Thrombogenicity
- In vivo studies: ●
- GLP safety study O
- Accuracy study O
All thrombogenicity testing was conducted using heparin to maintain an ACT value higher than 300; therefore, Advisor HD Grid requires use of anticoagulation for both right and left side procedures, and is labeled accordingly. The resulting evidence obtained from the design verification and validation testing did not raise new questions of safety and effectiveness, and demonstrates that the subject device is as safe and effective as the predicate devices.
Substantial Equivalence and Summary of Studies
§ 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).