The Blazer Dx-20 Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.

Device Description

The Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is a sterile, single use, steerable, diagnostic catheter intended for temporary use in electrophysiological studies for intracardiac stimulation (pacing) and/or recording of electrical potentials. The catheter is provided in two different bidirectional curve configurations, Medium (25 mm diameter) and Super Large (56 mm diameter), to assist the physician in reaching the desired anatomical location. The distal electrode segment of the catheter contains an electrode rings which are designed to carry electrical signals for endocardial stimulation (pacing) and/or recording. The electrode rings are placed on the distal segment of the catheter in various electrode spacing configurations, as described in Table 1. A 7F torqueable shaft connects the distal electrode segment to an ergonomically designed cylindrical handle. The catheter handle contains both a steering knob and tension control knob. The degree of tip deflection of the catheter is controlled by the steering knob. The adjustable tension control knob can be tightened to hold the tip in the desired position. 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 text describes the Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter and its submission for 510(k) clearance. The focus of the submission is to demonstrate substantial equivalence to a predicate device, primarily by showing that an adhesive material change does not negatively impact the device's safety and effectiveness.

Here’s an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list quantitative acceptance criteria in a clear, tabular format for device performance metrics like sensitivity, specificity, or accuracy, which would be common for diagnostic AI/software devices. Instead, the "acceptance criteria" are implied by the types of tests performed to demonstrate safety and effectiveness for a physical medical device (catheter), particularly in comparison to its predicate.

Acceptance Criteria (Implied)	Reported Device Performance
Biocompatibility: Meet biological safety standards	Passed a battery of tests per ISO 10993-1 and FDA Guidance (Cytotoxicity, Sensitization, Intracutaneous Reactivity, Acute Systemic Toxicity, Pyrogen Testing, Genotoxicity (Bacterial Reverse Mutation, Mouse Lymphoma), Thrombogenicity, Hemolysis (Direct Contact & Extract), Platelet/Leukocyte Count, Complement Activation).
Ethylene Oxide Residuals: Remain within acceptable limits	Passed testing per ISO 10993-7.
Bacterial Endotoxin & Bioburden: Maintain safe levels	Passed testing per ANSI/AAMI ST72 (Bacterial Endotoxins) and ISO 11737-1 (Bioburden).
Mechanical Reliability (Introduction/Withdrawal): Maintain integrity	Passed "Reliability Cycle: Mechanical Integrity after Introduction / Withdrawal" test.
Mechanical Reliability (Steering Lifecycle): Maintain integrity	Passed "Reliability Cycle: Mechanical Integrity after Steering Lifecycle" test.
Mechanical Reliability (Twisting): Maintain integrity	Passed "Twisting" test.
Overall Equivalence: As safe and effective as predicate	"The performance data, including biocompatibility, sterilization, and design verification testing supports that the subject catheter is as safe and effective as its predicate device."

2. Sample Size Used for the Test Set and Data Provenance

The document does not specify a "test set" in the context of patient data or clinical trials, as this is a physical device clearance (catheter) rather than an AI/software diagnostic. The performance data refers to bench testing and biological evaluations on device components or whole devices. Therefore, common sample size definitions for clinical studies don't apply directly here. The provenance of the data is from internal testing conducted by Boston Scientific Corporation. The studies are not described as retrospective or prospective clinical studies, but rather laboratory and engineering verification tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not applicable to the provided document. The ground truth for this medical device submission involves established standards for biocompatibility (e.g., ISO 10993 series), sterilization (e.g., ISO 10993-7), and engineering specifications. These standards define the "ground truth" against which the device's physical and biological properties are measured, rather than expert consensus on medical images or diagnoses.

4. Adjudication Method for the Test Set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical trials or studies where human expert disagreement needs to be resolved for ground truth establishment. For physical device testing, adherence to a particular standard or engineering specification determines acceptance.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study is relevant for diagnostic imaging devices or AI tools that assist human readers in making diagnoses. The Blazer™ Dx-20 is a physical diagnostic catheter.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done

No, this question does not apply. The device is a physical catheter, not an algorithm. Therefore, there is no "standalone performance" of an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on established international standards and regulatory guidelines for medical device safety and performance. This includes:

ISO 10993-1, 10993-7
FDA Guidance for ISO 10993-1
ANSI/AAMI ST72
ISO 11737-1
Good Laboratory Practices (21 CFR Part 58)
Internal engineering specifications for mechanical properties (reliability cycles, twisting).

These standards represent the accepted scientific and regulatory consensus on what constitutes a safe and effective medical device in terms of biocompatibility, sterilization, and mechanical integrity.

8. The Sample Size for the Training Set

This information is not applicable to this submission. "Training set" refers to data used to train machine learning models. The Blazer™ Dx-20 is a physical medical device, not an AI/ML algorithm.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable for the reason stated in point 8.

Summary

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September 10, 2021

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

Re: K211375

Trade/Device Name: Blazer™ Dx-20 Bidirectional 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

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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

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Indications for Use

510(k) Number (if known) K211375

Device Name

Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter

Indications for Use (Describe)

The Blazer Dx-20 Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (nacing) and/or recording of electrical potentials.

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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K211375

510(k) Summary for Blazer Dx-20 Bidirectional 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: May 03, 2021

II. Device

Name of Device: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter Common or Usual Name: Blazer Dx-20 Diagnostic Catheter Classification Name: Electrode recording catheter or electrode recording probe (21 CFR 870.1220) Regulatory Class: II Product Code: DRF

Predicate Device III.

Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter, K081576 This predicate has not been subject to a design-related recall.

No reference devices were used in this submission.

IV. Device Description

The distal electrode segment of the catheter contains an electrode rings which are designed to carry electrical signals for endocardial stimulation (pacing) and/or recording. The electrode rings are placed on the distal segment of the catheter in various electrode spacing configurations, as

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K211375

described in Table 1. A 7F torqueable shaft connects the distal electrode segment to an ergonomically designed cylindrical handle.

The catheter handle contains both a steering knob and tension control knob. The degree of tip deflection of the catheter is controlled by the steering knob. The adjustable tension control knob can be tightened to hold the tip in the desired position

This catheter is compatible with most commercially available recording and mapping systems and connects to these systems via a cable, which is available separately.

UPN	Tip Size /Shaft Size	Number ofElectrodes	Useable ShaftLength	CurveStyle	Electrode Spacing
M004 20SL222 0	7F / 7F	20	100 cm	SuperLarge	2/2/2 mm
M004 20SL252 0					2/5/2 mm
M004 20SL282 0					2/8/2 mm
M004 20SL555 0					5/5/5 mm
M004 20SL2102 0					2/10/2 mm
M004 20SL2860 0					2/8/2/8/2/8/2/8/2/60/2/8/2/8/2/8/2/8/2 mm
M004 20SL22025 0					2/20/2/2/2/2/2/2/2/2/2/2/2/25/2/25/2/25/2 mm
M004 20M222 0			109 cm	Medium	2/2/2 mm
M004 20M252 0		2/5/2 mm
M004 20M21035 0		2/10/2/10/2/10/2/10/2/35/2/10/2/10/2/10/2/10/2 mm
M004 20M5405 0		5/5/5/5/5/5/5/5/5/40/5/5/5/5/5/5/5/5/5 mm
M004 20M25505 0		2/5/2/5/2/5/2/5/2/50/5/5/5/5/5/5/5/5/5 mm
M004 20M27028 0		2/2/2/2/2/2/2/2/2/70/2/8/2/8/2/8/2/8/2 mm
M004 20M2840 0					2/8/2/8/2/8/2/8/2/40/2/8/2/8/2/8/2/8/2 mm

Table 1: Blazer Dx-20 Catheter UPNs and Technical Descriptions

V. Indications for Use

The Blazer Dx-20 Bidirectional Steerable Diagnostic 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 Blazer Dx-20 Bidirectional 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.

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K211375

VII. Performance Data

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:

• Cytotoxicity	• Sensitization
• Intracutaneous Reactivity	• Acute Systemic Toxicity
• Pyrogen Testing	• Genotoxicity, Bacterial Reverse Mutation Study
• Genotoxicity, Mouse Lymphoma	• Thrombogenicity, Partial Thromboplastin Time
• Hemolysis, Direct Contact	• Hemolysis, Extract Method
• Platelet and Leukocyte Count	• 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

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VIII. Conclusion

The subject Blazer Dx-20 Bidirectional Steerable Diagnostic Catheter is substantially equivalent in indications for use, design, product function, materials, and sterility to the predicate Blazer Dx-20 Bidirectional 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).