(55 days)
The Advisor™ HD Grid X 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 AdvisorTM HD Grid X Mapping Catheter, Sensor EnabledTM, is a sterile, single use, 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 paddle magnetic sensors, two distal shaft ring electrodes, two shaft magnetic sensors, polymer braided shaft, handle, fluid lumen extension with a luer, and an electrical connector. The catheter also has an insertion tool intended to compress and guide the distal paddle into, and withdraw from, the hemostasis valve of an introducer sheath. The catheter is intended to be used with the EnSiteTM X EP System and other accessories, including the connecting cable and commercially available irrigation pumps.
This document is a 510(k) summary for the Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™. It states that the device is substantially equivalent to a predicate device and includes a summary of non-clinical testing.
Here's a breakdown of the requested information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria alongside specific quantitative device performance metrics. Instead, it states:
| Acceptance Criteria (General Statement) | Reported Device Performance (General Statement) |
|---|---|
| Bench design verification activities were performed and met their respective acceptance criteria. | Testing included dimensional, visual, mechanical integrity, simulated use, electrical, packaging, and shelf-life testing to assess substantial equivalence. Additionally, biocompatibility testing was conducted per the voluntary consensus standards under ISO 10993 and met all the biocompatibility endpoints for a medical device category for an external communicating medical device with limited (≤24 hour) circulating blood contact. |
2. Sample Size Used for the Test Set and Data Provenance
The document describes "bench design verification activities" and "biocompatibility testing." These are typically conducted in a lab environment using manufactured samples of the device.
- Sample Size for Test Set: Not explicitly stated in terms of number of devices or data points, but implies standard engineering and biocompatibility test sample sizes.
- Data Provenance: The tests are "bench design verification activities" and "biocompatibility testing." This typically refers to retrospective testing on manufactured devices, not prospective clinical studies with human or animal subjects. The origin is likely the manufacturer (Abbott Medical, Plymouth, MN, USA).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications
This information is not provided in the document. Bench and biocompatibility testing typically rely on standardized protocols and measurements, rather than expert consensus on "ground truth" in the way clinical studies might.
4. Adjudication Method for the Test Set
This information is not provided. Adjudication methods like 2+1 or 3+1 are relevant for clinical trials involving human interpretation of data, which is not the type of testing described here.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. The document explicitly states "Non-Clinical Testing Summary" and focuses on bench and biocompatibility tests. It does not mention any clinical studies, MRMC studies, or human reader performance.
6. Standalone (Algorithm Only) Performance Study
No. The device is a physical catheter, not an AI algorithm. Therefore, a standalone algorithm performance study is not applicable.
7. Type of Ground Truth Used (Expert Consensus, Pathology, Outcomes Data, etc.)
The ground truth for the non-clinical testing would be the physical and chemical specifications and performance standards outlined in the design and verification protocols for the device components and overall system, as well as the established safety criteria in ISO 10993 for biocompatibility. This is not "expert consensus," "pathology," or "outcomes data" in the clinical sense.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical instrument, not a machine learning model that requires a training set.
9. How the Ground Truth for the Training Set was Established
This information is not applicable, as there is no training set for this type of device.
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July 9, 2024
Abbott Medical Samantha Stretar Senior Regulatory Affairs Specialist 5050 Nathan Lane North Plymouth, Minnesota 55442
Re: K241372
Trade/Device Name: Advisor™ HD Grid X 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: July 2, 2024 Received: July 2, 2024
Dear Samantha Stretar:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 medical devices and radiation-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,
Marco Cannella -S for
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
Form Approved: OMB No. 0910-0120 Expiration Date: 07/31/2026 See PRA Statement below.
Submission Number (if known)
Device Name
Advisor™ HD Grid X Mapping Catheter, Sensor Enabled™
Indications for Use (Describe)
The Advisor™ HD Grid X 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.
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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K241372
510(K) SUMMARY
This 510(k) summary is prepared in accordance with the requirements of 21 CFR §807.92.
| 510(k) Information | |
|---|---|
| 510(k) Number | K241372 |
| 510(k) Type | Special 510(k) |
| Date Prepared | 14-May-2024 |
| Submitter Information | |
| Manufacturer Name andAddress | Abbott Medical5050 Nathan Lane NorthPlymouth, MN 55442USA |
| Phone Number | 651-756-5833 |
| Contact Person | Samantha StretarSenior Regulatory Affairs Specialist |
| Device Information | |
| Trade Name | AdvisorTM HD Grid X Mapping Catheter, Sensor EnabledTM |
| Common Name | Catheter, Intracardiac Mapping, High-Density Array |
| Class | II |
| Classification Name | 21 CFR 870.1220 Electrode recording catheter or electrode recording probe |
| Product Code | MTD - Catheter, Intracardiac Mapping, High-Density Array |
| Predicate Device | AdvisorTM HD Grid Mapping Catheter, Sensor EnabledTM (K172393, cleared 23-Apr-2018) |
| Reference Device | AdvisorTM HD Grid Mapping Catheter, Sensor EnabledTM (K202066, cleared 25-Nov-2020) |
| Device Description | The AdvisorTM HD Grid X Mapping Catheter, Sensor EnabledTM, is a sterile,single use, irrigated, high-density mapping catheter with a 7.5F shaft and an 8Fdistal shaft deflectable section. It is available in a D-F bi-directional curve modelthat is deflected using the actuator located on the catheter handle. The catheterworking length is 110 cm. The device consists of a paddle-shaped distal tip with16 electrodes, two paddle magnetic sensors, two distal shaft ring electrodes,two shaft magnetic sensors, polymer braided shaft, handle, fluid lumenextension with a luer, and an electrical connector. The catheter also has aninsertion tool intended to compress and guide the distal paddle into, andwithdraw from, the hemostasis valve of an introducer sheath.The catheter is intended to be used with the EnSiteTM X EP System and otheraccessories, including the connecting cable and commercially availableirrigation pumps. |
| 510(k) Information | |
| Indications for Use | The Advisor™ HD Grid X 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. |
| Predicate Comparison | |
| Comparison ofTechnologicalCharacteristics | The subject device has the same intended use, indications for use, andprinciples of operation as the predicate device. The subject device hassubstantially equivalent technological characteristics to the predicate device.Like the predicate, the subject device incorporates two magnetic sensors in the catheter shaft. The subject device also includes two magnetic sensors in the outer splines of the distal tip paddle assembly. Additional catheter components were modified from the predicate to accommodate the addition of the magnetic sensors within the paddle, improve manufacturability, and improve material stability for continuous improvement purposes. The predicate and subject device have the same working length, shaft French size, and electrode spacing. |
| Non-Clinical TestingSummary | Bench design verification activities were performed and met their respectiveacceptance criteria to ensure that the device in scope of this submission issubstantially equivalent to the predicate. Testing included dimensional, visual,mechanical integrity, simulated use, electrical, packaging, and shelf-life testingto assess substantial equivalence. Additionally, biocompatibility testing was conducted per the voluntary consensus standards under ISO 10993 and met all the biocompatibility endpoints for a medical device category for an external communicating medical device with limited (≤24 hour) circulating blood contact. |
| Statement of Equivalence | The subject device has the same intended use, indications for use, andprinciples of operation as the predicate device. The subject device has similartechnological characteristics to the predicate device and the completed benchdesign verification testing and biocompatibility testing provides objectiveevidence that the subject device is at least as safe and effective as thepredicate, and therefore, is substantially equivalent to the predicate. |
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K241372
§ 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).