(243 days)
The Blazer Dx-20 is a diagnostic catheter indicated for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
The Boston Scientific Corporation Blazer Dx-20 is a sterile, single use steerable diagnostic electrophysiology catheter used to record intracardiac electrical potentials. The Blazer Dx-20 Catheter is also used to deliver pacing stimuli from an external source. The Blazer Dx-20 Catheter is a bi-directionally steerable diagnostic catheter built on a modified SteeroCath Dx shaft platform with a molded handle. It has one tip electrode and up to 19 ring electrodes for a total of 20. The ring spacing configurations vary with each model. The catheter shaft of the Blazer Dx-20 is equivalent to the SteeroCath Dx Catheter, which is designed to allow for a standard curve of the catheter distal section. The catheter shaft has a soft distal section in order to minimize trauma and risk of perforation. The Blazer Dx-20 Catheters use a thumb-actuated bidirectional steering mechanism. contained within an ergonomically shaped cylindrical handle that is also utilized by the currently marketed SteeroCath Dx Diagnostic catheters. A thumb-level motion of the piston actuates the steering of the distal tip. The catheter is placed into the heart and is guided to location by steering the distal tip area of the catheter. Tip and ring electrodes come into contact with the endocardium where electrical contact is made and pacing and recording of electrograms becomes possible. No new technology or circuitry is associated with the transmission of electrical signals to or from the endocardium - the Blazer Dx-20 Catheter relies on platinum-iridium alloy, ring electrodes whose circuitry is identical to standard electrode and pacing catheters. Additionally, the electrical connections made (catheter to EP recorder) are similar to those for commercially available electrode recording and pacing v catheters.
The provided text describes a medical device submission (510(k)) for the Blazer Dx-20 Steerable Diagnostic Catheter. This is a submission for a physical medical device, not a software-based AI/ML device.
Therefore, most of the requested information (acceptance criteria, device performance tables, sample sizes for test/training sets, expert ground truth, adjudication methods, MRMC studies, standalone performance, and ground truth types) is not applicable in the context of this document. The submission focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Here's a summary based on the provided text, highlighting what is and isn't applicable:
1. Table of acceptance criteria and reported device performance:
This information is not applicable as the submission is for a physical medical device, not an AI/ML system. The document states:
"Specifically, non-clinical tests adopted by and conducted for the Blazer Dx-20 Catheter included biocompatibility, sterility, packaging, physical integrity, and electrical integrity testing that all passed and have shown substantial equivalence to the predicate device, the SteeroCath Diagnostic Catheter."
The "acceptance criteria" are implied to be that these non-clinical tests "passed," demonstrating substantial equivalence, but specific quantitative criteria and performance metrics are not given in this summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
Not applicable. No test set of data (in the context of an AI/ML algorithm) was used. The evaluation was based on non-clinical engineering and biological safety tests of the physical device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
Not applicable. No "ground truth" in the context of expert consensus on data was established. The evaluation was based on non-clinical engineering and biological safety tests.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable. No adjudication method for a data test set was used. The evaluation was based on non-clinical engineering and biological safety tests.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
Not applicable. This relates to AI/ML software performance. The submission is for a physical diagnostic catheter, and no MRMC study, or human-in-the-loop AI assistance, was conducted or described.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This relates to AI/ML software performance. The submission is for a physical medical device, and no standalone algorithm performance was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
Not applicable. No "ground truth" (in the context of AI/ML data) was used. The device's safety and effectiveness were evaluated via non-clinical tests (biocompatibility, sterility, packaging, physical integrity, and electrical integrity) to demonstrate substantial equivalence to a predicate device.
8. The sample size for the training set:
Not applicable. No training set was used. This is a physical medical device, not an AI/ML algorithm.
9. How the ground truth for the training set was established:
Not applicable. No training set or ground truth for it was established. This is a physical medical device.
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FEB -3 2009
510(K) SUBMISSION
Blazer Dx-20 Steerable Diagnostic Catheter
5.0 510(k) Summary
Modified Device Information
Table 1: Modified Device Information
| Category: | Comments: |
|---|---|
| Sponsor: | Boston Scientific Corporation150 Baytech DriveSan Jose, CA 95134 |
| Correspondent: | Ronald C. Allen, Ph.D.Director, Regulatory Affairs150 Baytech DriveSan Jose, CA 95134 |
| Contact Information: | Email: allenr@bsci.comPhone: (408) 935-6310Fax: (408) 957-6202 |
| Device Common Name: | Electrode recording and pacing catheter; steerable catheter |
| Device Proprietary Name: | Blazer Dx-20 Diagnostic Catheter |
| Device Classification Number: | 21 CFR §870.1220 |
| Device Classification | Class II |
Predicate Device Information
Table 2: Predicate Device Information
| Category: | Comments: |
|---|---|
| Predicate Device: | SteeroCath Dx Diagnostic Catheter (K940168/K913375) |
| Predicate Device Manufacturer: | Boston Scientific Corporation |
| Predicate Device Common Name: | Electrode recording and pacing catheter; steerablecatheter |
| Predicate Device ClassificationNumber: | 21 CFR §870.1220 |
| Predicate Device Classification: | Class II |
Date Summary Was Prepared
June 4, 2008
Boston Scientific Corporation 510(k) Submission
CONFIDENTIAL
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Description of the Device
The Boston Scientific Corporation Blazer Dx-20 is a sterile, single use steerable diagnostic electrophysiology catheter used to record intracardiac electrical potentials. The Blazer Dx-20 Catheter is also used to deliver pacing stimuli from an external source. The Blazer Dx-20 Catheter is a bi-directionally steerable diagnostic catheter built on a modified SteeroCath Dx shaft platform with a molded handle. It has one tip electrode and up to 19 ring electrodes for a total of 20. The ring spacing configurations vary with each model.
The catheter shaft of the Blazer Dx-20 is equivalent to the SteeroCath Dx Catheter, which is designed to allow for a standard curve of the catheter distal section. The catheter shaft has a soft distal section in order to minimize trauma and risk of perforation.
The Blazer Dx-20 Catheters use a thumb-actuated bidirectional steering mechanism. contained within an ergonomically shaped cylindrical handle that is also utilized by the currently marketed SteeroCath Dx Diagnostic catheters. A thumb-level motion of the piston actuates the steering of the distal tip. The catheter is placed into the heart and is guided to location by steering the distal tip area of the catheter. Tip and ring electrodes come into contact with the endocardium where electrical contact is made and pacing and recording of electrograms becomes possible. No new technology or circuitry is associated with the transmission of electrical signals to or from the endocardium - the Blazer Dx-20 Catheter relies on platinum-iridium alloy, ring electrodes whose circuitry is identical to standard electrode and pacing catheters. Additionally, the electrical connections made (catheter to EP recorder) are similar to those for commercially available electrode recording and pacing v catheters.
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.
Boston Scientific Corporation 510(k) Submission
CONFIDENTIAL
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510(K) SUBMISSION
Blazer Dx-20 Steerable Diagnostic Catheter
Comparison to Predicate Device
Table 3: Comparison to Predicate Device
| Predicate Device | Subject Device | |
|---|---|---|
| Manufacturer | Boston Scientific Corporation | Same |
| Device | Electrode Recording Catheter;Steerable Catheter | Same |
| 510(k) Reference | K940168K913375 | Current Submission |
| Regulatory Class | II | Same |
| DeviceClassification | 21 CFR §870.1220 | Same |
| Intended Use | Record electrical potentials andpacing from intracardiac locations | Same |
| Single Use? | Yes | Same |
| EO Sterilized? | Yes | Same |
Summary of the Non-clinical Data
Specifically, non-clinical tests adopted by and conducted for the Blazer Dx-20 Catheter included biocompatibility, sterility, packaging, physical integrity, and electrical integrity testing that all passed and have shown substantial equivalence to the predicate device, the SteeroCath Diagnostic Catheter.
Abstract of the Clinical Data
As the non-clinical tests demonstrated the safety and effectiveness of the device, no clinical studies were conducted for the Blazer Dx-20 Catheter.
Boston Scientific Corporation 510(k) Submission
CONFIDENTIAL
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Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB -3 2009
Boston Scientific Corporation c/o Ms. April Malmborg Principal Regulatory Affairs Specialist 150 Baytech Drive San Jose, CA 95134
Re: K081576
Trade/Device Name: Blazer Dx-20 Diagnostic Catheter Regulation Number: 21 CFR 870.1220 Regulation Name: Electrode Recording Catheter or Electrode Recording Probe Regulatory Class: Class II (two) Product Code: DRF Dated: December 19, 2008 Received: December 22, 2008
Dear Ms. Malmborg:
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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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
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Page 2 - Ms. April Malmborg
or any Federal 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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0120. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometrics' (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
R. be himes
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K081576
Device Name:
Blazer Dx-20 Diagnostic Catheter
Indications For Use:
The Blazer Dx-20 is a diagnostic catheter indicated for temporary use in electrophysiology studies for intracardiac stimulation (pacing) and/or recording of electrical potentials.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
une 2. J. James
Division Sign Off
(Division Sign-Off) Division of Cardiovascular Devices 510(k) Number K081576
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રેણ
§ 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).