(29 days)
No reference devices were used in this submission.
No
The device description focuses on the physical components and mechanical steering mechanism of the catheter. There is no mention of AI, ML, or any computational analysis of the electrical potentials that would suggest the use of such technologies. The device is described as compatible with recording and mapping systems, implying it provides raw data for external analysis, not internal AI/ML processing.
No
The device is indicated for diagnosis and recording, not treatment.
Yes
The "Intended Use / Indications for Use" section explicitly states that the catheter is "indicated for use to diagnose cardiac arrhythmia."
No
The device description clearly outlines physical components like a catheter, electrodes, shaft, and handle, indicating it is a hardware device, not software-only.
Based on the provided information, the Polaris X catheter is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is to "diagnose cardiac arrhythmia" through "intracardiac stimulation (pacing) and/or recording of electrical potentials." This involves interacting directly with the patient's body to measure electrical activity within the heart.
- Device Description: The description details a catheter designed to be inserted into the body, with electrodes for direct contact with cardiac tissue.
- Lack of IVD Characteristics: IVDs are typically used to examine specimens (like blood, urine, tissue) outside of the body to provide information about a person's health. This device does not process or analyze biological specimens in this manner.
The Polaris X catheter is a diagnostic medical device used in vivo (within the living body) to gather electrical data from the heart.
N/A
Intended Use / Indications for Use
The Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
The Polaris X Unidirectional Steerable Diagnostic Catheter is a sterile, single use, unidirectional, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
The catheter consists of a distal electrode segment, a shaft and a handle. The distal electrode segment consists of 10 electrodes (decapolar); 1 tip electrode that is 2 mm in length and 9 ring electrodes in a variety of electrode spacings, as detailed in Table 1. The distal electrode segment is capable of forming a 270° standard curve configuration.
The shaft of the Polaris X catheter has a 6 French (F) outer diameter and a useable length of 105 cm. The proximal end of the shaft is connected to a handle, which contains a patented thumbslide steering control that actuates the curve.
This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Intracardiac
Indicated Patient Age Range
Adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients.
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)
Not applicable for Special 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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).
0
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October 27, 2023
Boston Scientific Corporation Amy Reilly Regulatory Affairs Specialist 4100 Hamline Avenue North St. Paul, Minnesota 55112-5798
Re: K233207
Trade/Device Name: Polaris X™ Unidirectional Steerable Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: September 28, 2023 Received: September 28, 2023
Dear Amy Reilly:
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"
1
(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
2
Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K233207
Device Name
Polaris XTM Unidirectional Steerable Diagnostic Catheter
Indications for Use (Describe) The Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
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510(k) Summary for Polaris X™ Unidirectional Steerable Diagnostic Catheter
1. Submitter
Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112
Contact: Amy Reilly Regulatory Affairs Specialist Phone: 651-582-4805 E-mail: amy.reilly(@bsci.com
Date Prepared: 28 September 2023
2. Device
Name of Device: Polaris X™ Unidirectional Steerable Diagnostic Catheter Common or Usual Name: Polaris X Diagnostic Catheter Classification Name: Electrode recording catheter or electrode recording probe (21 CFR 870.1220) Regulatory Class: II Product Code: DRF
3. Predicate Device
Polaris XTM Unidirectional Steerable Diagnostic Catheter, K211494 This predicate has not been subject to a design-related recall. No reference devices were used in this submission.
4. Device Description
The Polaris X Unidirectional Steerable Diagnostic Catheter is a sterile, single use, unidirectional, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
5
The catheter consists of a distal electrode segment, a shaft and a handle. The distal electrode segment consists of 10 electrodes (decapolar); 1 tip electrode that is 2 mm in length and 9 ring electrodes in a variety of electrode spacings, as detailed in Table 1. The distal electrode segment is capable of forming a 270° standard curve configuration.
| UPN | Tip
Length | Tip
Size | Shaft
Size | Number of
Electrodes | Electrode
Spacing | Useable
Shaft
Length | Curve
Style |
|--------------|---------------|-------------|---------------|-------------------------|----------------------|----------------------------|------------------|
| M004 7000D 0 | 2 mm | 6F | 6F | 10 | 2.5 mm | 105 cm | 270°
Standard |
| M004 7001D 0 | | | | | 5 mm | | |
| M004 7003D 0 | | | | | 2.5/5/2.5 mm | | |
| M004 7004D 0 | | | | | 2/8/2 mm | | |
| M004 7005D 0 | | | | | 2/10/2 mm | | |
Table 1: Polaris X Catheter UPNs and Technical Descriptions
The shaft of the Polaris X catheter has a 6 French (F) outer diameter and a useable length of 105 cm. The proximal end of the shaft is connected to a handle, which contains a patented thumbslide steering control that actuates the curve.
This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.
-
- Intended Use/Indications for Use
Intended Use: The Polaris X catheter is intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The device is intended for use in adult (not pediatric) patients, with the exclusion of pregnant and/or nursing patients.
- Intended Use/Indications for Use
Indications for Use: The Polaris X catheter is indicated for use to diagnose cardiac arrhythmia.
6. Comparison of Technological Characteristics with the Predicate Device
The Polaris X Unidirectional Steerable Diagnostic Catheter incorporates identical design, packaging, fundamental technology, manufacturing processes, and sterilization process as those featured in the predicate device. The updates to the intended use were for clarification purposes.
7. Substantial Equivalence
The proposed labeling modifications of the Polaris X catheter do not impact the device's substantial equivalence to the previously cleared version of this device is as safe, as effective and performs as well as the predicate device. The indications for use and
6
intended use, classification, product functions, materials, configuration, and sterility are substantially equivalent to the predicate device.
8. Performance Data
Not applicable for Special 510(k).
9. Conclusion
The subject Polaris X Unidirectional Steerable Diagnostic Catheter is substantially equivalent in indications for use, design, product function, materials, and sterility to the predicate Polaris X Unidirectional Steerable Diagnostic Catheter. Therefore, Boston Scientific believes the proposed Polaris X catheter is as safe and effective as its predicate device.