(300 days)
Not Found
No
The summary describes a diagnostic catheter for electrophysiological mapping and mentions its use with a compatible mapping system, but there is no mention of AI or ML in the device description, intended use, or performance studies.
No
The device is described as a "Diagnostic Catheter" indicated for "electrophysiological mapping (recording and stimulation)" to "obtain electrograms". Its function is to collect diagnostic information rather than to treat a condition.
Yes
The "Intended Use / Indications for Use" section explicitly states "The Sphere-9Dx Diagnostic Catheter is indicated for electrophysiological mapping (recording and stimulation) of cardiac structures in the heart" and "This catheter is intended to obtain electrograms in the atrial regions of the heart." The name of the device itself also includes "Diagnostic Catheter".
No
The device description clearly details a physical catheter with electrodes, an expandable lattice array, and an insertion tool, indicating it is a hardware device, not software-only.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "electrophysiological mapping (recording and stimulation) of cardiac structures in the heart." This involves directly interacting with the patient's body to measure electrical activity.
- Device Description: The device is a catheter designed for insertion into the heart. It collects electrograms and monitors local impedance within the body.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device operates inside the body.
Therefore, the Sphere-9Dx Diagnostic Catheter is an in vivo diagnostic device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
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.
Product codes
MTD
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cardiac structures in the heart, 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
Performance testing applicable to the subject device was completed to ensure it performs as intended per the product specifications and requirements, including specifications and requirements related to use with a compatible Affera mapping system. The following testing has been completed in support of the Sphere-9Dx Diagnostic Catheter, and all acceptance criteria were met in accordance with appropriate standards:
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 result of the testing, and the subject device is considered substantially equivalent to the predicate device based on the performance data collected.
Key Metrics
Not Found
Predicate Device(s)
PENTARAY Nav eco High Density Mapping Catheter (K201750)
Reference Device(s)
Not Found
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). 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
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510(k) Summary
Date Summary Prepared:
Applicant:
| | 8200 Coral Sea Street NE
Mounds View, MN U.S.A. 55112
1.800.328.2518
Establishment Registration No. 3001504994 |
|----------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Official Correspondent: | Matthew Lobeck
Principal Regulatory Affairs Specialist
Medtronic
8200 Coral Sea Street
Mounds View, MN 55112
Mobile: 612-202-5925
Fax: 763.367.9903
Email: matthew.lobeck@medtronic.com |
| Device Trade Name and
Model: | 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 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 |
| | 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. |
| Intended Use: | The Sphere-9Dx Diagnostic Catheter is intended for
intracardiac mapping (stimulation and recording). |
| Indications for Use: | The Sphere-9Dx Diagnostic Catheter is indicated for
electrophysiological mapping of cardiac structures in the
heart (recording and stimulation). 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. |
| Comparison of
Technological
Characteristics: | There are no significant differences in the fundamental
scientific technology between the predicate and subject
devices. There Sphere-9Dx Diagnostic Catheter features the
following similarities with the predicate device:
Same intended use Same fundamental scientific technology Deflectable, high-density mapping catheter Use of electrode arrays for intracardiac
mapping (recording and stimulation) Utilization of magnetic sensor for navigation
and tracking with a magnetic-based mapping
system Similar catheter working lengths, allowing for
placement of the catheter tip in the intended
anatomical locations Both devices are designed to allow for catheter
irrigation during use to prevent thrombus formation |
| | The differences in technological characteristics involve the
following: |
| | Differences in tip design, number of electrodes, and
electrode spacing due to the unique proprietary
design of each catheter. Deflection type: unidirectional, multiple models
(predicate) vs bi-directional (subject) |
| | These changes do not constitute a difference in the
fundamental scientific technology between the subject and
predicate devices. The physical and technological
characteristics of the subject and predicate devices are
considered substantially equivalent and do not raise
questions of safety or effectiveness. |
| Safety and Performance
Data: | Performance testing applicable to the subject device was
completed to ensure it performs as intended per the product
specifications and requirements, including specifications and
requirements related to use with a compatible Affera
mapping system. The following testing has been completed
in support of the Sphere-9Dx Diagnostic Catheter, and all
acceptance criteria were met in accordance with appropriate
standards: |
| | 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 result
of the testing, and the subject device is considered
substantially equivalent to the predicate device based on the
performance data collected. |
| Conclusion: | The subject and predicate devices share the same intended
use and have similar underlying technological characteristics
(i.e. deflectable, magnetic-based catheter intended for atrial
and ventricular mapping and stimulation). 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. |
guiding sheath. The expandable lattice electrode array
October 13, 2023
Medtronic, Inc.
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