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. 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 thumb-slide 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.

AI/ML Overview

The provided document is a 510(k) summary for the Polaris X™ Unidirectional Steerable Diagnostic Catheter. This document asserts substantial equivalence to a predicate device and includes performance data related to device safety and functionality, but it does not present a study with specific acceptance criteria and reported performance for diagnostic accuracy or effectiveness in a clinical context that would typically involve a test set, ground truth established by experts, or MRMC studies.

This type of submission focuses on demonstrating that a new device is as safe and effective as a legally marketed predicate device, especially when the technological characteristics are very similar. The performance data provided is primarily engineering, biological, and sterility testing to ensure the device performs as intended and is safe for use.

Therefore, many of the requested categories related to diagnostic performance studies (e.g., sample size for test set, number of experts for ground truth, MRMC study, standalone performance) are not applicable to the information presented in this 510(k) summary.

Here's a breakdown of the relevant information from the document:

1. A table of acceptance criteria and the reported device performance

The document lists various performance tests without explicitly stating numerical acceptance criteria or detailed quantitative results in a table format. Instead, it states that "The following performance data were provided in support of the substantial equivalence determination" and later concludes that "The performance data, including biocompatibility, sterilization and design verification testing supports that the subject catheter is as safe and effective as its predicate device."

Summary of Performance Data provided:

Test Category	Specific Tests Reported	Reported Performance (Qualitative)
Biocompatibility Testing	Cytotoxicity, Intracutaneous Reactivity, Pyrogen Testing, Genotoxicity (Mouse Lymphoma, Bacterial Reverse Mutation Study), Hemolysis (Direct Contact, Extract Method), Platelet and Leukocyte Count, Sensitization, Acute Systemic Toxicity, Thrombogenicity (Partial Thromboplastin Time), Complement Activation (SC5b-9)	Performed per GLP, ISO 10993-1:2018, and FDA Guidance. Implied to meet acceptable standards for externally communicating, limited contact, circulating blood contacting devices, supporting substantial equivalence and safety.
Sterilization Testing	Ethylene Oxide Residual Testing	Conducted to verify acceptable residual limits per ISO 10993-7. Implied to have met these limits.
Microbial Testing	Bacterial Endotoxin Testing	Performed per ANSI/AAMI ST72. Confirmed that endotoxin levels were not adversely affected. Implied to meet acceptable levels.
Microbial Testing	Bioburden Testing	Performed per ISO 11737-1. Confirmed that bioburden levels were not adversely affected. Implied to meet acceptable levels.
Design Verification	Reliability Cycle: Mechanical Integrity after Introduction / Withdrawal, Reliability Cycle: Mechanical Integrity after Steering Lifecycle, Twisting	Supports that the subject catheter is as safe and effective as its predicate device. This implies the device maintained mechanical integrity and functionality through these tests, satisfying product specifications (though the specific specifications are not detailed in this summary).

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Not applicable. The reported performance data are primarily laboratory and bench testing, not clinical studies involving "test sets" in the diagnostic sense, expert interpretation, or patient data. The "test sets" would refer to the samples or units of product subjected to the engineering, biological, and sterility tests. The document does not specify the number of units tested for each specific test.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)

Not applicable. This device is an electrode recording catheter, and the 510(k) pertains to its substantial equivalence based on safety and basic functional performance, not on direct diagnostic interpretation by experts.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This device is a steerable diagnostic catheter, not an AI or imaging diagnostic tool that would typically undergo an MRMC study.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is a physical medical device (catheter), not an algorithm or software.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Not applicable in the context of diagnostic "ground truth." The "ground truth" for the performance data presented would be the established scientific and engineering standards and specifications (e.g., ISO, ANSI/AAMI standards, internal product specifications).

8. The sample size for the training set

Not applicable. There is no mention of a "training set" as this is not an AI/machine learning device.

9. How the ground truth for the training set was established

Not applicable.

Summary

{0}------------------------------------------------

Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

September 14, 2021

Boston Scientific Corporation Donall Hosna Regulatory Affairs Senior Manager 4100 Hamline Ave North St. Paul, Minnesota 55112

Re: K211494

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: August 10, 2021 Received: August 11, 2021

Dear Donall Hosna:

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. 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 located 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.

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

{1}------------------------------------------------

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) for devices or postmarketing safety reporting (21 CFR 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 (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

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 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 Deoras Assistant Director (Acting) 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

{2}------------------------------------------------

Indications for Use

510(k) Number (if known) K211494

Device Name

Polaris XTM Unidirectional Steerable Diagnostic Catheter

Indications for Use (Describe)

The catheter is intended for temporary use in electrophysiological stimulation (pacing) and/or recording of electrical potentials.

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."

{3}------------------------------------------------

510(k) Summary

for

K211494, Polaris X Unidirectional Steerable Diagnostic Catheter

I. Submitter

Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112

Contact: Donall Hosna, MS Regulatory Affairs Senior Manager Phone: 651-582-6323 E-mail: donall.hosna@bsci.com

Date Prepared: August 9, 2021

II. Device

Name of Device: Polaris XTM 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

III. Predicate Device

Polaris XTM Unidirectional Steerable Diagnostic Catheter, K003452 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. Device Description

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

{4}------------------------------------------------

variety of electrode spacings, as detailed in Table 1. The distal electrode segment is capable of forming a 270° staK21ndard curve configuration.

UPN	TipLength	TipSize	ShaftSize	Number ofElectrodes	ElectrodeSpacing	UseableShaftLength	CurveStyle
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 thumb-slide 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.

V. Indications for Use

The catheter is intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.

VI. Comparison of Technological Characteristics with the Predicate Device

The Polaris X Unidirectional Steerable Diagnostic Catheter incorporates substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device. An adhesive material change is the primary technological difference between the subject and predicate devices.

Performance Data VII.

The following performance data were provided in support of the substantial equivalence determination:

Biocompatibility Testing

Biological testing was performed per Good Laboratory Practices (21 CFR. Part 58) with appropriate consideration of ISO 10993-1: 2018 Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a Risk Management Process and FDA Guidance Use of International Standard ISO 10993-1 (June 16, 2016) for devices categorized as externally communicating, limited contact, circulating blood contacting. The battery of testing included:

{5}------------------------------------------------

Cytotoxicity .
Intracutaneous Reactivity
Pyrogen Testing .
Genotoxicity, Mouse Lymphoma
Hemolysis, Direct Contact ●
. Platelet and Leukocyte Count
Sensitization .
. Acute Systemic Toxicity
Genotoxicity, Bacterial Reverse . Mutation Study
. Thrombogenicity, Partial Thromboplastin Time
Hemolysis, Extract Method ●
Complement Activation, SC5b-9 ●

Ethylene Oxide Residual Testing

Ethylene oxide residual testing was conducted to verify acceptable residual limits per ISO 10993-7, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.

Bacterial Endotoxin and Bioburden Testing

Bacterial endotoxin testing, per ANSI/AAMI ST72, Bacterial Endotoxins - Test Methods, Routine Monitoring, and Alternatives to Batch Testing, and bioburden testing, per ISO 11737-1, Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products, were performed to confirm endotoxin and bioburden levels of the catheter were not adversely affected.

Design Verification Testing

Product specifications tested were:

Reliability Cycle: Mechanical Integrity after Introduction / Withdrawal ●
Reliability Cycle: Mechanical Integrity after Steering Lifecycle ●
Twisting

VIII. 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. The performance data, including biocompatibility, sterilization and design verification testing supports that the subject catheter is as safe and effective as its predicate device.

Regulation Number and Section

§ 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).