Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter

K211375 · Boston Scientific Corporation · DRF · Sep 10, 2021 · Cardiovascular

Device Facts

• Record ID: K211375
• Device Name: Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter
• Applicant: Boston Scientific Corporation
• Product Code: DRF · Cardiovascular
• Decision Date: Sep 10, 2021
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1220
• Device Class: Class 2

Intended Use

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

Device Story

Blazer Dx-20 is a sterile, single-use, bidirectional steerable diagnostic catheter; used in electrophysiology studies for intracardiac pacing and recording of electrical potentials. Device features 7F torqueable shaft with distal electrode rings; cylindrical handle includes steering knob for tip deflection and tension control knob for position locking. Physician operates device in clinical setting; catheter connects to external recording/mapping systems via cable. Input consists of cardiac electrical signals; output is electrical signal transmission to external systems for physician analysis. Device facilitates mapping and stimulation to diagnose cardiac arrhythmias; benefits patient by enabling precise electrophysiological assessment.

Clinical Evidence

Bench testing only. Biocompatibility testing performed per ISO 10993-1 (cytotoxicity, sensitization, reactivity, systemic toxicity, genotoxicity, thrombogenicity, hemolysis, platelet/leukocyte count, complement activation). Sterilization residuals verified per ISO 10993-7. Bacterial endotoxin and bioburden testing performed per ANSI/AAMI ST72 and ISO 11737-1. Mechanical design verification included reliability cycling for steering and introduction/withdrawal, and twisting tests.

Technological Characteristics

7F torqueable shaft; bidirectional curve configurations (Medium 25mm, Super Large 56mm); distal electrode rings for pacing/recording. Materials include adhesive components. Sterilization via Ethylene Oxide (ISO 10993-7). Compatible with standard electrophysiology recording/mapping systems via external cable. Mechanical steering mechanism with tension control.

Indications for Use

Indicated for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials in patients undergoing electrophysiological procedures.

Regulatory Classification

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.

Predicate Devices

• Blazer™ Dx-20 Bidirectional Steerable Diagnostic Catheter (K081576)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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: [phone] E-mail: [e-mail]

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 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

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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 /<br>Shaft Size | Number of<br>Electrodes | Useable Shaft<br>Length | Curve<br>Style | Electrode Spacing |
|------------------|--------------------------|-------------------------------------------------------|-------------------------|----------------|--------------------------------------------------|
| M004 20SL222 0 | 7F / 7F | 20 | 100 cm | Super<br>Large | 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/<br>2/8/2/8/2/8/2/8/2 mm |
| M004 20SL22025 0 | | | | | 2/20/2/2/2/2/2/2/2/2/<br>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/<br>2/10/2/10/2/10/2/10/2 mm | | | |
| M004 20M5405 0 | | 5/5/5/5/5/5/5/5/5/40/<br>5/5/5/5/5/5/5/5/5 mm | | | |
| M004 20M25505 0 | | 2/5/2/5/2/5/2/5/2/50/<br>5/5/5/5/5/5/5/5/5 mm | | | |
| M004 20M27028 0 | | 2/2/2/2/2/2/2/2/2/70/<br>2/8/2/8/2/8/2/8/2 mm | | | |
| M004 20M2840 0 | | | | | 2/8/2/8/2/8/2/8/2/40/<br>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.