(300 days)
The Sphere-9Dx Diagnostic Catheter is indicated for electrophysiological mapping (recording and stimulation) of cardiac structures in the heart. This catheter is intended to obtain electrograms in the atrial regions of the heart. The catheter provides location information when used with a compatible Affera Mapping System.
The Sphere-9Dx Diagnostic catheter (AFR-00009) is a steerable irrigated multi-electrode catheter with a bidirectional deflecting tip intended for intracardiac mapping (stimulation and recording). The catheter includes an expandable lattice electrode array that fits a 2.7 mm (8 Fr) straight introducer sheath or a 2.8 mm (8.5 Fr) curved or deflectable sheath and expands to a 9.3 mm diameter in the cardiac chamber. The catheter is supplied with an insertion tool that must be used to aid in collapsing the expandable lattice electrode array for insertion into an introducer or guiding sheath. The expandable lattice electrode array contains 9 mini surface electrodes mounted on its surface with roughly 5 mm spacing to collect local electrograms and monitor local impedance. All mini surface electrodes may be used for recording or stimulation.
Here's an analysis of the acceptance criteria and study information for the Sphere-9Dx Diagnostic Catheter, based on the provided document:
This document is a 510(k) summary, which typically focuses on demonstrating substantial equivalence to a predicate device rather than providing a detailed report of a single, comprehensive study with specific performance metrics and AI efficacy. Therefore, a lot of the requested information (especially concerning AI-specific metrics, ground truth details for training, and MRMC studies) is not present in this type of regulatory submission.
1. Table of Acceptance Criteria and Reported Device Performance
The document states that "all acceptance criteria were met," but it does not provide a table with specific acceptance criteria values or detailed performance metrics. It lists categories of testing performed.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Design Verification Testing | "All acceptance criteria were met" |
| Design Validation | "All acceptance criteria were met" |
| Summative Usability Evaluation | "All acceptance criteria were met" |
| Pre-clinical Animal Testing | "All acceptance criteria were met" |
| Biocompatibility Testing | "All acceptance criteria were met" |
| Sterilization Validation and Adoption | "All acceptance criteria were met" |
| Packaging Validation | "All acceptance criteria were met" |
| Overall Safety and Effectiveness Claim | "No questions of safety or effectiveness are raised as a result of the testing, and the subject device is considered substantially equivalent to the predicate device based on the performance data collected. The subject and predicate devices share the same intended use and have similar underlying technological characteristics... Differences between the subject and predicate devices do not result in differences in overall device performance or fundamental scientific technology, and the subject device is considered substantially equivalent to the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes for the test sets within each testing category (Design Verification, Design Validation, Usability, etc.). It also does not explicitly state the data provenance (e.g., country of origin) or whether the data was retrospective or prospective. Pre-clinical animal testing suggests prospective animal data, but details are not provided.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not provided in the document. For a diagnostic catheter, "ground truth" would likely be established through clinical observation, correlation with other diagnostic modalities, or expert interpretation of electrograms. However, the details of how this was done for testing, including the number and qualifications of experts, are absent.
4. Adjudication Method for the Test Set
The document does not describe any specific adjudication methods (e.g., 2+1, 3+1) for establishing ground truth or resolving discrepancies in test results.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, and the effect size of how much human readers improve with AI vs without AI assistance
The document does not mention an MRMC study or any information related to AI assistance for human readers. This device is a diagnostic catheter for electrophysiological mapping, and the summary focuses on its hardware and basic functionality, not on software with AI capabilities that would directly assist human interpretation in a comparative effectiveness study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) study was done
This study is not described. The device, a diagnostic catheter, functions to obtain electrograms and location information when used with a compatible Affera Mapping System. It's not an AI algorithm performing diagnostic interpretation independently.
7. The Type of Ground Truth Used
The document does not explicitly state the type of ground truth used for each test. For a diagnostic catheter, ground truth for electrophysiological mapping would generally involve confirmed anatomical locations, known electrical activity patterns, or correlation with established clinical diagnostic methods, likely validated by expert consensus or established physiological principles, especially in pre-clinical studies.
8. The Sample Size for the Training Set
The document does not mention a training set. This is consistent with the device being a hardware catheter rather than a machine learning algorithm that requires a training phase.
9. How the Ground Truth for the Training Set was Established
Since no training set is mentioned, this information is not applicable and not provided.
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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the symbol of the Department of Health & Human Services on the left and the FDA acronym with the full name of the agency on the right. The FDA part is in blue, with the acronym in a solid blue square and the full name written in a smaller font next to it.
August 7, 2024
Medtronic, Inc. Matthew Lobeck Principal Regulatory Affairs Specialist 8200 Coral Sea Street NE Mounds View, Minnesota 55112
Re: K233433
Trade/Device Name: Sphere-9Dx Diagnostic Catheter (AFR-00009) Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: MTD Dated: October 12, 2023 Received: October 12, 2023
Dear Matthew Lobeck:
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"
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(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).
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 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.
Aneesh S. Deoras -S
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics, and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality
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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
Sphere-9Dx Diagnostic Catheter (AFR-00009)
Indications for Use (Describe)
The Sphere-9Dx Diagnostic Catheter is indicated for electrophysiological mapping (recording and stimulation) of cardiac structures in the heart. This catheter is intended to obtain electrograms in the atrial recions of the heart. The catheter provides location when used with a compatible Affera Mapping System.
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
Date Summary Prepared:
Applicant:
| 8200 Coral Sea Street NEMounds View, MN U.S.A. 551121.800.328.2518Establishment Registration No. 3001504994 | |
|---|---|
| Official Correspondent: | Matthew LobeckPrincipal Regulatory Affairs SpecialistMedtronic8200 Coral Sea StreetMounds View, MN 55112Mobile: 612-202-5925Fax: 763.367.9903Email: matthew.lobeck@medtronic.com |
| Device Trade Name andModel: | Sphere-9Dx Diagnostic Catheter, AFR-00009 |
| Common Name: | Electrophysiology Catheter |
| Classification Name: | Electrode Recording Catheter |
| Classification & Panel: | Class II, 21 CFR 870.1220, Cardiovascular |
| Product Code: | MTD |
| Predicate Device: | PENTARAY Nav eco High Density Mapping Catheter(K201750) |
| Device Description: | The Sphere-9Dx Diagnostic catheter (AFR-00009) is asteerable irrigated multi-electrode catheter with abidirectional deflecting tip intended for intracardiac mapping(stimulation and recording). The catheter includes anexpandable lattice electrode array that fits a 2.7 mm (8 Fr)straight introducer sheath or a 2.8 mm (8.5 Fr) curved ordeflectable sheath and expands to a 9.3 mm diameter in thecardiac chamber. The catheter is supplied with an insertiontool that must be used to aid in collapsing the expandablelattice electrode array for insertion into an introducer or |
| contains 9 mini surface electrodes mounted on its surfacewith roughly 5 mm spacing to collect local electrograms andmonitor local impedance. All mini surface electrodes may beused for recording or stimulation. | |
| Intended Use: | The Sphere-9Dx Diagnostic Catheter is intended forintracardiac mapping (stimulation and recording). |
| Indications for Use: | The Sphere-9Dx Diagnostic Catheter is indicated forelectrophysiological mapping of cardiac structures in theheart (recording and stimulation). This catheter is intended toobtain electrograms in the atrial regions of the heart. Thecatheter provides location information when used with acompatible Affera Mapping System. |
| Comparison ofTechnologicalCharacteristics: | There are no significant differences in the fundamentalscientific technology between the predicate and subjectdevices. There Sphere-9Dx Diagnostic Catheter features thefollowing similarities with the predicate device:Same intended use Same fundamental scientific technology Deflectable, high-density mapping catheter Use of electrode arrays for intracardiacmapping (recording and stimulation) Utilization of magnetic sensor for navigationand tracking with a magnetic-based mappingsystem Similar catheter working lengths, allowing forplacement of the catheter tip in the intendedanatomical locations Both devices are designed to allow for catheterirrigation during use to prevent thrombus formation |
| The differences in technological characteristics involve thefollowing: | |
| Differences in tip design, number of electrodes, andelectrode spacing due to the unique proprietarydesign of each catheter. Deflection type: unidirectional, multiple models(predicate) vs bi-directional (subject) | |
| These changes do not constitute a difference in thefundamental scientific technology between the subject andpredicate devices. The physical and technologicalcharacteristics of the subject and predicate devices areconsidered substantially equivalent and do not raisequestions of safety or effectiveness. | |
| Safety and PerformanceData: | Performance testing applicable to the subject device wascompleted to ensure it performs as intended per the productspecifications and requirements, including specifications andrequirements related to use with a compatible Afferamapping system. The following testing has been completedin support of the Sphere-9Dx Diagnostic Catheter, and allacceptance criteria were met in accordance with appropriatestandards: |
| Design Verification Testing Design Validation Summative Usability Evaluation Pre-clinical Animal Testing Biocompatibility Testing Sterilization Validation and Adoption Packaging Validation | |
| No questions of safety or effectiveness are raised as a resultof the testing, and the subject device is consideredsubstantially equivalent to the predicate device based on theperformance data collected. | |
| Conclusion: | The subject and predicate devices share the same intendeduse and have similar underlying technological characteristics(i.e. deflectable, magnetic-based catheter intended for atrialand ventricular mapping and stimulation). Differencesbetween the subject and predicate devices do not result indifferences in overall device performance or fundamentalscientific technology, and the subject device is consideredsubstantially equivalent to the predicate device. |
guiding sheath. The expandable lattice electrode array
October 13, 2023
Medtronic, Inc.
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§ 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).