(30 days)
The Ultra ICE Plus rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
Ultra ICE Plus is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and latest motor drive unit, MDU5 PLUS™. When used together, the catheter, motor drive unit (MDU), and iLab equipment form a complete imaging system that allows for ultrasonic visualization of intracardiac structures. The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of three sections: the braided proximal shaft, single lumen mid-shaft, and the sonolucent distal tip. The catheter body comprises the usable length of the catheter (110 cm). The braided proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. The mid-shaft provides a flexible transition between the stiffer proximal shaft and the acoustically transparent distal tip. The distal tip serves as the imaging window and houses a septum situated between the inner lumen and the atraumatic rounded tip of the catheter. The self-sealing septum serves as the distal-flush entry point; as the catheter must be flushed with water prior to use. This provides the acoustic coupling media required for ultrasonic imaging. The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a low frequency piezoelectric (PZT) transducer at the distal imaging window. The hub assembly provides an electro-mechanical interface between the catheter and the motor drive unit. The drive cable and PZT transducer rotate independently of the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive in to transmittable acoustic energy. Reflected ultrasound signals are converted back to electrical impulses, returned to the motor drive unit, and are ultimately processed by the iLab equipment for live visualization of intracardiac structures.
This document is a 510(k) summary for the Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter. It focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data, rather than outlining a study to prove the device meets specific acceptance criteria for a new clinical claim. Therefore, much of the requested information regarding clinical studies and ground truth cannot be extracted directly from this document.
However, I can extract the acceptance criteria and the type of studies conducted for non-clinical performance, as well as what the document reports about the device's performance against these criteria.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Performance Criteria Evaluated (Implicit/Explicit from text) | Reported Device Performance |
|---|---|---|
| Bench Testing | Deliverability | Successfully met evaluation conditions |
| Guide catheter compatibility | Successfully met evaluation conditions | |
| Image quality | Successfully met evaluation conditions | |
| Non-uniform rotational distortion | Successfully met evaluation conditions | |
| Measurement accuracy | Successfully met evaluation conditions | |
| General imaging capabilities | Successfully met evaluation conditions | |
| Dimensional requirements | Successfully met evaluation conditions | |
| Visibility under fluoroscopy | Successfully met evaluation conditions | |
| Interface with ancillary devices | Successfully met evaluation conditions | |
| Environmental requirements | Successfully met evaluation conditions | |
| User interface requirements | Successfully met evaluation conditions | |
| Catheter fatigue and bending stiffness | Successfully met evaluation conditions | |
| Biological Safety | Biocompatibility (ISO 10993-1) | Successfully met evaluation conditions |
| Microbial assessments (bioburden, endotoxin, pyrogenicity) | Successfully met evaluation conditions | |
| Sterility assurance | Successfully met evaluation conditions | |
| Electrical & Mechanical Safety | Acoustic Output (FDA Guidance, below Track 1 limits) | Below FDA Track 1 limits |
| Electromagnetic compatibility (IEC 60601-1-2 (3rd Edition)) | Demonstrated compliance | |
| Packaging Validation | Integrity of packaging configuration (ISO 11607-1, ISO 11607-2) | Successfully met evaluation conditions |
Explanation of "Successfully met evaluation conditions": The document states for bench testing, biological safety, and packaging validation that "Non-clinical performance evaluations, as described above, indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device (Ultra ICE, K902245)." This implies that the device performed acceptably against the established criteria for each of these tests.
2. Sample size used for the test set and the data provenance:
- Test Set (Non-clinical): Specific sample sizes for each non-clinical test (e.g., number of catheters tested for fatigue, number of units for packaging validation) are not provided in this summary.
- Data Provenance: The studies were non-clinical bench, lab, and engineering tests conducted by the manufacturer (Boston Scientific Corporation). There is no mention of country of origin of data in terms of patient data, as no clinical studies were performed.
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):
- This information is not applicable as the studies described are non-clinical (bench testing, biocompatibility, electrical/mechanical safety, packaging validation). No human experts were used to establish ground truth in the context of diagnostic performance or clinical outcomes for these tests.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- This information is not applicable as the studies described are non-clinical tests. Adjudication methods are typically used in clinical studies.
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:
- No, an MRMC comparative effectiveness study was not stated as part of this submission. The submission explicitly states "Clinical Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data." This device is an imaging catheter itself, not an AI-assisted diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No, a standalone algorithm-only performance study was not stated as part of this submission. This device is an imaging catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the non-clinical tests, the "ground truth" was based on engineering specifications, regulatory standards (e.g., ISO, IEC, FDA guidance), and established scientific methods for evaluating device performance, safety, and compatibility. For example, acoustic output limits are defined by FDA guidance, and biocompatibility by ISO 10993-1.
8. The sample size for the training set:
- This information is not applicable. This is a submission for a medical device (catheter), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- This information is not applicable. This is a submission for a medical device (catheter), not an AI algorithm requiring a training set.
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Image /page/0/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES" in all caps. The text is in a bold, serif font. The words are arranged on a single line and centered.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 26, 2016
Boston Scientific Corporation Eric Elliott Principal Regulatory Specialist 47215 Lakeview Boulevard Fremont, California 94538
Re: K160173
Trade/Device Name: Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter Regulation Number: 21 CFR 870.2330 Regulation Name: Echocardiograph Regulatory Class: Class II Product Code: DXK, ITX Dated: January 22, 2016 Received: January 27, 2016
Dear Eric Elliott:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
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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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Mitchell Stein
for 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) K160173
Device Name Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter
Indications for Use (Describe)
The Ultra ICE Plus rounded tip catheter is indicated for enhanced ultrasonic visualization of intracardiac structures.
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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Section 7 510(k) Summary per 21 CFR 807.92
| Submitter'sName andAddress | Boston Scientific Corporation47215 Lakeview BoulevardFremont, CA 94538 |
|---|---|
| Contact Nameand Information | Eric ElliottPrincipal Regulatory Affairs Specialist510.624.1314Tel:Fax:510.440.7698E-mail: Eric.Elliott@bsci.com |
| Date Prepared | January 22, 2016 |
| Trade Name | Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter |
| Common Name | Echocardiograph, Ultrasound Transducer |
| ClassificationName | Ultrasound, Echocardiograph (DXK) has been classified asClass II per 21 CFR 870.2330 |
| Transducer Ultrasonic (ITX) has been classified as Class IIper 21 CFR 892.1570. | |
| PredicateDevice | Ultra ICE™ 9 MHz9-Oct-1990K902245IntraCardiac Echo Catheter |
| Description ofDevice | Ultra ICE Plus is intended for use with Boston Scientific's(BSC)'s iLab™ equipment and latest motor drive unit, MDU5PLUS™. When used together, the catheter, motor drive unit(MDU), and iLab equipment form a complete imaging systemthat allows for ultrasonic visualization of intracardiacstructures. |
| The catheter consists of two main components: the catheterbody and the imaging core. | |
| The catheter body consists of three sections: the braidedproximal shaft, single lumen mid-shaft, and the sonolucentdistal tip. The catheter body comprises the usable length ofthe catheter (110 cm). |
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| DeviceDescription,continued | The braided proximal shaft provides pushability to thecatheter and serves as a lumen to the imaging core. Themid-shaft provides a flexible transition between the stifferproximal shaft and the acoustically transparent distal tip.The distal tip serves as the imaging window and houses aseptum situated between the inner lumen and the atraumaticrounded tip of the catheter. The self-sealing septum servesas the distal-flush entry point; as the catheter must beflushed with water prior to use. This provides the acousticcoupling media required for ultrasonic imaging. |
|---|---|
| The imaging core consists of a proximal hub assembly and arotating drive cable that houses a low frequency piezoelectric(PZT) transducer at the distal imaging window. The hubassembly provides an electro-mechanical interface betweenthe catheter and the motor drive unit. | |
| The drive cable and PZT transducer rotate independently ofthe sheath to provide 360° image resolution. The transducerconverts electrical impulses sent by the motor drive in totransmittable acoustic energy. Reflected ultrasound signalsare converted back to electrical impulses, returned to themotor drive unit, and are ultimately processed by the iLabequipment for live visualization of intracardiac structures. | |
| IntendedUse/Indicationsfor Use | The Ultra ICE™ Plus rounded tip catheter is indicated forenhanced ultrasonic visualization of intracardiac structures. |
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Device The Ultra ICE™ Plus 9 MHz IntraCardiac Echo Catheter Technoogy maintains the same fundamental scientific technology and Characteristics operating principles as the predicate Ultra ICE™ (K902245). and Furthermore, the transducer, sheath design, and indications Comparison to for use remain unchanged. Predicate Modifications with respect to the predicate device include a Device new hub interface for compatibility with the MDU5 PLUS™ motor drive unit, potting adhesives aligned with current manufacturing processes, and replacement of a now obsolete resin (non-patient contacting component) that serves as strain relief between the distal housing and coax cable. In practice, Ultra ICE™ Plus is the drop-in replacement for BSC's mature Ultra ICE™ platform, but with the latest hub technology and compatibility with the MDU5 PLUS motor drive unit; as similarly adopted by the now prevalent OptiCross™ Coronary Imaging Catheter (K123621). Finally, Ultra ICE™ Plus will be sterilized using electron beam (E-Beam) irradiation, not gamma as utilized by the predicate. In support of a substantial equivalence determination, BSC has compared and evaluated the material and design differences between the subject and predicate device. Non-clinical performance evaluations, as described below, indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device (Ultra ICE, K902245).
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Non-Clinical Determination of substantial equivalence is based on an Performance assessment of non-clinical performance data. Data Non-clinical data includes bench-top performance evaluations, packaging validation, biological safety, electromagnetic compatibility, and acoustic output testing. Bench Testing: Bench testing was performed to evaluate physical integrity, functionality, and performance of the catheter. Performance criteria includes deliverability, guide catheter compatibility, image quality, non-uniform rotational distortion, measurement accuracy, general imaging capabilities, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, and catheter fatique and bending stiffness when prepped and used per the DFU. Biological Safety Testing: Ultra ICE™ Plus was subjected to a series of biocompatibility tests in accordance with ISO 10993-1, microbial assessments including bioburden and endotoxin. pyrogenicity, and sterility assurance. Electrical and Mechanical Safety: Acoustic Output was evaluated in accordance with FDA Guidance, Information for Manufacturers Seeking Marketing Clearance of Diagnostic Ultrasound Systems and Transducers (September 9, 2008). Acoustic Output test results for the Ultra ICE™ Plus are below the FDA Track 1 limits. Electromagnetic compatibility testing was also conducted; demonstrating compliance to IEC 60601-1-2 (3'd Edition). Packaging Validation: The integrity of the packaging configuration was evaluated in accordance with ISO 11607-1 and ISO 11607-2. Testing was conducted on fully packaged units after subjected to electron beam sterilization, climatic conditioning, and distribution challenge conditioning. Conclusion: Non-clinical performance evaluations, as described above, indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device, Ultra ICE™ (K902245). Clinical Not applicable; determination of substantial equivalence is Performance based on an assessment of non-clinical performance data. Data
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| Conclusion | With respect to the predicate, design modificationsincorporated by Ultra ICE™ Plus do not alter thefundamental scientific technology or the indications for use.Based on Failure Mode Effects Analysis (FMEA),comprehensive verification and validation activities weresuccessfully completed; raising no new issues of safety oreffectiveness.Non-clinical performance data supports a determination thatthe subject device, Ultra ICE™ Plus, is substantiallyequivalent to the predicate device, Ultra ICE™ (K902245);and that it is at least as safe and effective for its intendeduse. |
|---|---|
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§ 870.2330 Echocardiograph.
(a)
Identification. An echocardiograph is a device that uses ultrasonic energy to create images of cardiovascular structures. It includes phased arrays and two-dimensional scanners.(b)
Classification. Class II (performance standards).