(60 days)
No reference devices were used in this submission.
No
The device description focuses on the physical and electrical characteristics of a cable used for connecting a catheter to an EP recording system. There is no mention of any computational processing, algorithms, or learning capabilities. The performance studies are related to sterilization and physical integrity, not algorithmic performance.
No.
The cables are intended to be used with diagnostic catheters for intracardiac stimulation (pacing) and/or recording of electrical potentials during electrophysiology procedures. They provide an electrical connection but do not directly deliver therapy.
No
The device description clearly states that these are "Catheter Cables" which provide an electrical connection between a diagnostic catheter and an EP Recording System for intracardiac stimulation (pacing) and/or recording of electrical potentials. The diagnostic function is performed by the associated "BSC Cardiac Diagnostic Catheters" and the "Electrophysiology (EP) Recording System", which these cables connect to. Therefore, these cables are accessories to a diagnostic device, but are not diagnostic devices themselves.
No
The device description explicitly details physical hardware components (jacketed cables, connectors, pins, splitter yoke) and mentions sterilization and reprocessing, indicating it is a physical medical device, not software-only.
Based on the provided information, no, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the cables are used with cardiac diagnostic catheters during an electrophysiology procedure for intracardiac stimulation and/or recording of electrical potentials. This is a procedure performed on a living patient, not on a sample of biological material in vitro (outside the body).
- Device Description: The description details a cable that connects a catheter inserted into the heart to an EP recording system. This is a direct connection to the patient's internal electrical activity.
- Anatomical Site: The anatomical site is "intracardiac," which is inside the body.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
The device is a medical device used in vivo (within the body) to facilitate a diagnostic procedure performed directly on the patient.
N/A
Intended Use / Indications for Use
Blazer Dx-20 Catheter Cable:
The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Polaris X Catheter Cable:
The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Product codes (comma separated list FDA assigned to the subject device)
DRF
Device Description
Blazer™ Dx-20 Cable:
The subject Blazer Dx-20 Catheter cable (sold separately) is used with the Blazer Dx-20 Bidirectional Duodecapolar Catheter during an electrophysiology procedure. The Blazer Dx-20 Catheter Cable provides an electrical connection between the Blazer Dx-20 Diagnostic Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.
The main trunk consists of a jacketed 20-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 20 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Blazer Dx-20 cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using either EO or STERRAD™ sterilization methods. The Blazer Dx-20 cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.
Polaris X™ Cable:
The subject Polaris X Catheter Cable (sold separately) is used with the Polaris X Steerable Decapolar Mapping Catheters during an electrophysiology procedure. The Polaris X cable provides an electrical connection between the Polaris X Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.
The main trunk consists of a jacketed 10-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 10 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Polaris X cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using EO sterilization method. The Polaris X cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.
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
fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.
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)
Bioburden Testing:
Bioburden testing, per ISO 11737-1, Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products, was performed to confirm bioburden levels of the cables were not adversely affected.
Reusable Device Testing:
The subject Blazer Dx-20 and Polaris X cables underwent 10x manual cleaning and resterilization qualification. The cables were subjected to 2X EO sterilization in qualified EO cycles and then 10X manual cleaning and resterilization cycles using either EO or STERRAD methods, as described in the Blazer Dx-20 and Polaris X cable IFUs, to confirm the cable design meets its predetermined design input specifications.
Design Verification Testing:
Design verification testing was performed on a subset of product specifications to provide objective evidence that after 2X EO sterilization cycles, distribution challenge, climatic conditioning, and 10X manual cleaning and resterilization cycles, the Blazer Dx-20 and Polaris X cables meet the design input specifications in accordance with the applicable product specifications.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
No reference devices were used in this submission.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo is in blue and includes the letters "FDA" followed by the words "U.S. Food & Drug Administration".
April 25, 2023
Boston Scientific Corporation Stephanie Andre Principal Regulatory Affairs Specialist 4100 Hamline Ave North St. Paul, Minnesota 55112
Re: K230503
Trade/Device Name: Blazer™ Dx-20 Catheter Cable, Polaris X™ Catheter Cable Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter Or Electrode Recording Probe Regulatory Class: Class II Product Code: DRF Dated: February 23, 2023 Received: February 24, 2023
Dear Stephanie Andre:
We have reviewed vour 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,
Aneesh S. Deoras -S
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) K230503
Device Name
Blazer™ Dx-20 Catheter Cable Polaris XTM Catheter Cable
Indications for Use (Describe)
Blazer Dx-20 Catheter Cable:
The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Polaris X Catheter Cable:
The BSC Cables are intended to be used with the BSC Cardiac Diagnostic Catheters during an electrophysiology procedure for intracardiac stimulation (pacing) 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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510(k) Summary for Blazer Dx-20 Cable and Polaris X Cable K230503
I. Submitter
Boston Scientific Corporation Electrophysiology Division 4100 Hamline Ave North St. Paul, MN 55112
Contact: Stephanie Andre Principal Regulatory Affairs Associate Phone: 651-582-5544 E-mail: stephanie.andre@bsci.com
Date Prepared: February 23, 2023
II. Device
| Name of Device: | Blazer™ Dx-20 Catheter Cable |
|---|---|
| Polaris X™ Catheter Cable | |
| Common or Usual Name: | Blazer Dx-20 Cable |
| Polaris X Cable | |
| Classification Name: | Electrode recording catheter or electrode recording probe (21 CFR |
| 870.1220) | |
| Regulatory Class: | II |
| Product Code: | DRF |
III. Predicate Device
| Subject Device | Predicate Device | Predicate 510(k) |
|---|---|---|
| BlazerTM Dx-20 Catheter Cable | BlazerTM Dx-20 Catheter Cable | K081576 |
| Polaris XTM Catheter Cable | Electrophysiology Cable | K924163 |
The predicate cables have not been subject to a design-related recall.
No reference devices were used in this submission.
IV. Device Description
Blazer™ Dx-20 Cable:
The subject Blazer Dx-20 Catheter cable (sold separately) is used with the Blazer Dx-20 Bidirectional Duodecapolar Catheter during an electrophysiology procedure. The Blazer Dx-20
4
Catheter Cable provides an electrical connection between the Blazer Dx-20 Diagnostic Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.
The main trunk consists of a jacketed 20-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 20 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Blazer Dx-20 cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using either EO or STERRAD™ sterilization methods. The Blazer Dx-20 cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.
Polaris X™ Cable:
The subject Polaris X Catheter Cable (sold separately) is used with the Polaris X Steerable Decapolar Mapping Catheters during an electrophysiology procedure. The Polaris X cable provides an electrical connection between the Polaris X Catheter and the Electrophysiology (EP) Recording System. The cable has one connector that directly connects to the diagnostic catheter and multiple connection points that connect to an EP Recording System.
The main trunk consists of a jacketed 10-conductor cable that is split into individual leads by means of an over-molded splitter yoke. The proximal end of the cable has 10 universal 2 mm shrouded male pins that are typical to electrophysiology recording and stimulation systems. The Polaris X cable is provided sterile using an EO sterilization process. The cable is reusable and can be reprocessed (i.e. re-sterilized) up to 10 times using EO sterilization method. The Polaris X cable is to be used in a fully-equipped electrophysiology lab by physicians thoroughly trained in invasive cardiac mapping and ablation procedures.
UPN and Technical Description
Each cable has a single configuration. The UPN and general technical specifications of the Blazer Dx-20 and Polaris X cables are provided in Table 1.
| UPN | Product Description | Length | Number of Contacts | Reprocessing Method | Jacket Color |
|---|---|---|---|---|---|
| M00420S0 | Blazer Dx-20 | ||||
| Catheter Cable | 5 ft | 20 | EO | ||
| STERRAD | Grey | ||||
| M0045454S0 | Polaris X | ||||
| Catheter Cable | 5 ft | 10 | EO | Black |
Table 1: Electrophysiology Cable Descriptions and UPNs
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V. Intended Use
The BSC cables are intended to be used with the BSC cardiac diagnostic catheters during an electrophysiology procedure for intracardiac stimulation (pacing) and/or recording of electrical potentials.
VI. Comparison of Technological Characteristics with the Predicate Device
The Blazer Dx-20 Cable and Polaris X Cable incorporate substantially equivalent design, packaging, fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate devices. The non-patient contacting material changes are the primary technological differences between the subject and predicate devices.
Performance Data VII.
The following performance data were provided in support of the substantial equivalence determination:
Bioburden Testing
Bioburden testing, per ISO 11737-1, Microbiological Methods - Part 1: Determination of a Population of Microorganisms on Products, was performed to confirm bioburden levels of the cables were not adversely affected.
Reusable Device Testing
The subject Blazer Dx-20 and Polaris X cables underwent 10x manual cleaning and resterilization qualification. The cables were subjected to 2X EO sterilization in qualified EO cycles and then 10X manual cleaning and resterilization cycles using either EO or STERRAD methods, as described in the Blazer Dx-20 and Polaris X cable IFUs, to confirm the cable design meets its predetermined design input specifications.
Design Verification Testing
Design verification testing was performed on a subset of product specifications to provide objective evidence that after 2X EO sterilization cycles, distribution challenge, climatic conditioning, and 10X manual cleaning and resterilization cycles, the Blazer Dx-20 and Polaris X cables meet the design input specifications in accordance with the applicable product specifications.
6
VIII. Conclusion
The subject Blazer Dx-20 Catheter Cable and Polaris X Catheter Cable are substantially equivalent in indications for use, design, product function, materials, and sterility to the predicate Blazer Dx-20 Catheter Cable and predicate Electrophysiology Cable, respectively. The performance data, including sterilization, and design verification testing supports that the subject catheters are substantially equivalent to their respective predicate devices.