(28 days)
Sonicath 9F, 12 MHZ (K902245)
No
The description focuses on the hardware components and basic signal processing for visualization, with no mention of AI or ML algorithms for image analysis, interpretation, or other functions.
No.
The device is used for ultrasonic visualization and imaging of intravascular structures, which is a diagnostic purpose, not a therapeutic one.
Yes
Explanation: The device is described as allowing for "ultrasonic visualization of peripheral intravascular structures" due to "Reflected ultrasound signals are converted back to electrical impulses...processed by the iLab equipment for live visualization of intravascular structures." This directly supports its function in examining and identifying medical conditions by creating images, which is characteristic of a diagnostic device. The "Intended Use" clearly states it is for patients with vascular occlusive disease for which intervention "is contemplated," implying a need for diagnosis or assessment for treatment.
No
The device description clearly details a physical catheter with a transducer, drive cable, and other hardware components, which is used in conjunction with external hardware (iLab equipment and MDU5 PLUS) to form an imaging system. It is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ultrasonic visualization of peripheral intravascular structures" in patients with vascular occlusive disease. This is a diagnostic procedure performed in vivo (within the living body) to visualize anatomical structures.
- Device Description: The device is a catheter that uses ultrasound to create images of blood vessels. This is a form of medical imaging, not a test performed on biological samples in vitro (outside the living body).
- IVD Definition: In Vitro Diagnostics are tests performed on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. This device does not perform such tests.
The device is an intravascular ultrasound (IVUS) catheter, which is a type of medical imaging device used for diagnostic purposes in vivo.
N/A
Intended Use / Indications for Use
The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for patients with vascular occlusive disease for which angioplasty, atherectomy, the placement of stents, or other intervention is contemplated.
Product codes (comma separated list FDA assigned to the subject device)
DXK, ITX
Device Description
Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for use with the Boston Scientific iLab™ equipment and 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 peripheral intravascular 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 the 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 is 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, a rotating drive cable, and a radiopaque tip. The hub assembly provides an electro-mechanical interface between the catheter and the motor drive unit. The drive cable houses the low frequency piezoelectric (PZT) transducer at the distal imaging window.
The PZT transducer and the drive cable rotate independently from the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive into 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 intravascular structures.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasonic
Anatomical Site
peripheral intravascular structures
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)
Non-clinical performance evaluations demonstrate the Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is substantially equivalent to, and at least as safe and effective as the Sonicath/Ultra ICE (K902245).
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, catheter fatigue, and bending stiffness.
Biological Safety Testing: Biocompatibility testing in accordance with ISO 10993-1, microbial assessments including bioburden and endotoxin, and pyrogenicity and sterility assurance testing show the device is biocompatible for its intended use.
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 - PI 9 MHz Peripheral Imaging Catheter are below the FDA Track 1 limits. Electromagnetic compatibility testing was also conducted demonstrating compliance to IEC 60601-1-2 (3rd 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 electron beam sterilization, climatic conditioning, and distribution challenge conditioning.
Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data.
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.
Sonicath 9F, 12 MHZ (K902245)
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.
Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (K160173)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
May 17, 2018
Boston Scientific Corporation Jennifer Foley Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311
Re: K181042
Trade/Device Name: Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter Regulation Number: 21 CFR 870.2330 Regulation Name: Echocardiograph Regulatory Class: Class II Product Code: DXK, ITX Dated: April 18, 2018 Received: April 19, 2018
Dear Jennifer Foley:
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 of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820);
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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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
M.A. Hillebrand
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) K181042
Device Name
Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter
Indications for Use (Describe)
The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for patients with vascular occlusive disease for which angioplasty, atherectomy, the placement of stents, or other intervention is contemplated.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D) |
|---|
| Over-The-Counter Use (21 CFR 801 Subpa |
|__ Over-The-Counter Use (21 CFR 801 Subpart C)
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SECTION 3. 510(k) Summary Per CFR 807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
Three Scimed Place
Maple Grove, MN 55311
USA |
|-------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and Information | Jennifer L. Foley, DVM
Regulatory Affairs Specialist
Tel: 763-955-8049
Fax: 763-494-2222
E-mail: jennifer.foley@bsci.com |
| Date Prepared | May 17, 2018 |
| Trade Name | Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter |
| Common Name | Intravascular Ultrasound Transducer |
| Classification
Name | Echocardiograph (DXK) is Class II per 21 CFR 870.2330
Diagnostic ultrasonic transducer (ITX) is Class II per 21 CFR 892.1570 |
| Predicate Device | Sonicath 9F, 12 MHZ (K902245) cleared October 9, 1990, amended
February 28, 1996 and marketed as Ultra ICE 9 MHz IntraCardiac Echo
Catheter. |
| Reference
Device | Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter (K160173), cleared
February 26, 2016 |
| Description of
Device | Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for use
with the Boston Scientific iLab™ equipment and 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 peripheral intravascular 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 the 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 is 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, a rotating drive |
| | cable, and a radiopaque tip. The hub assembly provides an electro- |
| | mechanical interface between the catheter and the motor drive unit. The
drive cable houses the low frequency piezoelectric (PZT) transducer at the
distal imaging window.
The PZT transducer and the drive cable rotate independently from the
sheath to provide 360° image resolution. The transducer converts electrical
impulses sent by the motor drive into 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 intravascular structures. |
| Intended Use | The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is intended for
intravascular ultrasonic visualization. |
| Indications for
Use | The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter is indicated for
patients with vascular occlusive disease for which angioplasty,
atherectomy, the placement of stents, or other intervention is contemplated. |
| Device
Technology
Characteristics
and Comparison
to Predicate
Device | The Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter maintains the
same fundamental scientific technology and operating principles as the
predicate Sonicath/Ultra ICE (K902245). The transducer, sheath design,
and indications for use remain unchanged. |
| | Modifications with respect to the predicate device include a new hub
interface for compatibility with the MDU5 PLUS™ motor drive unit as
similarly adopted by the Ultra ICE Plus 9 MHz IntraCardiac Echo Catheter
(K160173). |
| | Ultra ICE Plus - PI will be sterilized using electron beam (E-Beam)
irradiation. |
| | Non-clinical performance evaluations demonstrate the Ultra ICE Plus - PI
9 MHz Peripheral Imaging Catheter is substantially equivalent to, and at
least as safe and effective as the Sonicath/Ultra ICE (K902245). |
| Non-Clinical
Performance
Data | Determination of substantial equivalence is based on an assessment of
non-clinical performance 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,
catheter fatigue, and bending stiffness. |
| | Biological Safety Testing: |
| | Biocompatibility testing in accordance with ISO 10993-1, microbial
assessments including bioburden and endotoxin, and pyrogenicity and
sterility assurance testing show the device is biocompatible for its intended
use. |
| | 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 - PI 9 MHz Peripheral Imaging
Catheter are below the FDA Track 1 limits. Electromagnetic compatibility
testing was also conducted demonstrating compliance to IEC 60601-1-2
(3rd 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 electron beam sterilization, climatic conditioning, and
distribution challenge conditioning. |
| Clinical
Performance
Data | Not applicable; determination of substantial equivalence is based on an
assessment of non-clinical performance data. |
| Conclusion | With respect to the predicate, design modifications incorporated by Ultra
ICE Plus - PI 9 MHz Peripheral Imaging Catheter do not alter the
fundamental scientific technology or the indications for use. Based on the
Failure Mode Effects Analysis, comprehensive verification and validation
activities were successfully completed, generating no new issues of safety
or effectiveness. |
| | Non-clinical performance data supports a determination that the subject
device, Ultra ICE Plus - PI 9 MHz Peripheral Imaging Catheter, is
substantially equivalent to the predicate device, Sonicath/Ultra ICE
(K902245), and it is at least as safe and effective for its intended use. |
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