(29 days)
Not Found
No
The description focuses on the physical characteristics and functionality of a diagnostic catheter for electrophysiological studies, with no mention of AI or ML for data analysis, interpretation, or steering.
No
The device is indicated for diagnosis (diagnose cardiac arrhythmia) and not for treatment.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states, "The Blazer Dx-20 Catheter is indicated for use to diagnose cardiac arrhythmia."
No
The device description clearly details a physical catheter with electrodes, a steerable shaft, and a handle with knobs, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Function: The Blazer Dx-20 Catheter is a device that is inserted into the body (intracardiac) to directly interact with the heart's electrical system for diagnosis. It records electrical potentials and can be used for pacing.
- Intended Use: The intended use is to "diagnose cardiac arrhythmia" by being placed inside the heart. This is an in vivo (within the living body) diagnostic procedure, not an in vitro one.
The device description clearly indicates it's a catheter used for electrophysiological studies inside the heart, which is the opposite of an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The Blazer Dx-20 Catheter is indicated for use to diagnose cardiac arrhythmia.
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 tip and 19 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
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 this Special 510(k).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
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).
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Image /page/0/Picture/0 description: The image contains 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, followed by the words "U.S. FOOD & DRUG" in blue, and then the word "ADMINISTRATION" in a smaller font size, also in blue.
September 29, 2023
Boston Scientific Corporation Laura Wotta Regulatory Affairs Specialist 4100 Hamline Ave North St. Paul, Minnesota 55112-5798
Re: K232651
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 31, 2023 Received: August 31, 2023
Dear Laura Wotta:
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
1
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 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 (QS) 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 medical devices and radiation-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,
Marco Cannella -S
for
Aneesh Deoras Assistant Director 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) K232651
Device Name
BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
Indications for Use (Describe) The Blazer Dx-20 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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Image /page/3/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font and are blue. The word "Boston" is on the top line and the word "Scientific" is on the bottom line.
510(k) Summary for BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter
1. Submitter
Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112
Contact:
Laura Wotta Regulatory Affairs Specialist Phone: 651-581-2151 E-mail: laura.wotta@bsci.com
Date Prepared: August 31, 2023
2. Device
Trade Name: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter Common Name: Blazer Dx-20 Diagnostic Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220
3. Predicate Device
Trade Name: BLAZER™ Dx-20 Bidirectional Steerable Diagnostic Catheter Manufacturer: Boston Scientific Corporation Clearance Number: K211375 Common Name: Blazer Dx-20 Diagnostic Catheter Classification Name: Electrode Recording Catheter or Electrode Recording Probe Product Code: DRF Device Class and Panel: Class II, Cardiovascular Classification Regulation: 21 CFR Part 870.1220
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Image /page/4/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston" and "Scientific" are stacked on top of each other. The text is in a blue serif font.
4. 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 tip and 19 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.
| UPN | Tip Size /
Shaft Size | Number of
Electrodes | Useable Shaft
Length | Curve
Style | Electrode Spacing |
|----------------|--------------------------|-------------------------|-------------------------|----------------|-------------------------------------------------------|
| M00420SL2220 | 7F / 7F | 20 | 100 cm | Super
Large | 2/2/2 mm |
| M00420SL2520 | | | | | 2/5/2 mm |
| M00420SL2820 | | | | | 2/8/2 mm |
| M00420SL5550 | | | | | 5/5/5 mm |
| M00420SL21020 | | | | | 2/10/2 mm |
| M00420SL28600 | | | 100 cm | Super
Large | 2/8/2/8/2/8/2/8/2/60/
2/8/2/8/2/8/2/8/2 mm |
| M00420SL220250 | | | 100 cm | Super
Large | 2/20/2/2/2/2/2/2/2/2/
2/2/2/25/2/25/2/25/2 mm |
| M00420M2220 | | | 109 cm | Medium | 2/2/2 mm |
| M00420M2520 | | | | | 2/5/2 mm |
| M00420M210350 | 7F / 7F | 20 | | | 2/10/2/10/2/10/2/10/2/35/
2/10/2/10/2/10/2/10/2 mm |
| M00420M54050 | | | | | 5/5/5/5/5/5/5/5/5/40/
5/5/5/5/5/5/5/5/5 mm |
| M00420M255050 | | | | | 2/5/2/5/2/5/2/5/2/50/
5/5/5/5/5/5/5/5/5 mm |
| M00420M28400 | | | | | 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
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Image /page/5/Picture/0 description: The image shows the logo for Boston Scientific. The words "Boston Scientific" are written in a serif font. The color of the text is blue. The word "Boston" is on top of the word "Scientific".
5. Indications for Use/Intended Use
The Blazer Dx-20 Catheter is indicated for use to diagnose cardiac arrhythmia (Indications for Use).
The Blazer Dx-20 Catheter is intended for temporary use in electrophysiology 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).
6. Technological Characteristics
The Blazer Dx-20 catheter incorporates the 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 Blazer Dx-20 catheter do not impact the device's substantial equivalence to the previously cleared version of this device. The device is as safe, as effective, and performs as well as the predicate device. The indications for use, intended use, classification, product functions, materials, configuration, and sterility are substantially equivalent to the predicate device.
8. Performance Data
Not applicable for this Special 510(k).
8. Conclusion
The proposed Blazer Dx-20 catheter is equivalent in indications for use, intended use, classification, product functions, materials, configuration, and sterility to the predicate device, the Blazer Dx-20 catheter. Therefore, Boston Scientific believes the proposed Blazer Dx-20 catheter to be substantially equivalent to the predicate Blazer Dx-20 catheter.