(129 days)
No reference devices were used in this submission.
No
The device description focuses on the physical characteristics and functionality of a diagnostic catheter for electrophysiology studies. There is no mention of AI, ML, or any software-based analysis that would typically involve these technologies. The performance studies are related to safety and effectiveness compared to a predicate device, not algorithmic performance.
No.
A therapeutic device is used for treating or curing a disease or condition. This device is described as a "diagnostic catheter" intended for "intracardiac stimulation (pacing) and/or recording of electrical potentials" for "electrophysiology studies," which falls under diagnostic purposes, not therapeutic ones.
Yes
The 'Intended Use' section explicitly states the catheter is for "recording of electrical potentials," and the 'Device Description' refers to it as a "Diagnostic Catheter" and mentions its design to "carry electrical signals for...recording," which are functions of a diagnostic device.
No
The device description clearly details a physical catheter with a shaft, handle, steering knob, and electrode rings, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "intracardiac stimulation (pacing) and/or recording of electrical potentials" during electrophysiology studies. This is a procedure performed within the body to assess the heart's electrical activity.
- Device Description: The description details a catheter designed to be inserted into the heart to interact directly with the tissue for electrical stimulation and recording.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, urine, or tissue) outside of the body to provide diagnostic information. IVDs are specifically designed for testing samples in vitro.
Therefore, the Blazer Dx-20 Catheter is a medical device used for an in vivo (within the living body) procedure, not an in vitro diagnostic test.
N/A
Intended Use / Indications for Use
The Blazer Dx-20 Catheter is intended for temporary use in electrophysiology studies for intracardiac stimulation (nacing) and/or recording of electrical potentials.
Product codes
DRF
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
intracardiac
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key results: The performance data, including biocompatibility, sterilization, and design verification testing supports that the subject catheter is as safe and effective as its predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
No reference devices were used in this submission.
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).
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 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
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) 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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3
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 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
4
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 of
Electrodes | Useable Shaft
Length | Curve
Style | Electrode Spacing |
|------------------|--------------------------|-------------------------------------------------------|-------------------------|----------------|--------------------------------------------------|
| M004 20SL222 0 | 7F / 7F | 20 | 100 cm | Super
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/
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.
5
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
6
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.