(119 days)
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 or interpretation.
No
This device is for intravascular ultrasound examination and imaging, which are diagnostic procedures, not therapeutic interventions. The provided text explicitly states its use for "ultrasonic examination of peripheral intravascular pathology" and "Intrasound imaging."
Yes
The device, OptiCross™ 18, is an intravascular ultrasound imaging catheter explicitly stated as being used for "intravascular ultrasound examination" and to allow "ultrasonic examination of peripheral intravascular pathology." This explicitly indicates its role in obtaining information for diagnosis. Furthermore, the acoustic output testing refers to "Diagnostic Ultrasound Systems."
No
The device description clearly details a physical catheter with various components (catheter body, imaging core, transducer, etc.) and its interaction with hardware (motor drive unit, iLab equipment). While software is involved in processing the images, the device itself is a physical medical device.
Based on the provided information, the OptiCross™ 18 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states "intravascular ultrasound examination of peripheral vessels only." This describes a procedure performed within the body (in vivo) to visualize structures, not a test performed on samples outside the body (in vitro).
- Device Description: The description details a catheter designed to be inserted into blood vessels for imaging. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) outside of the body.
Therefore, the OptiCross™ 18 is an in vivo diagnostic imaging device, specifically an intravascular ultrasound (IVUS) catheter.
N/A
Intended Use / Indications for Use
OptiCross™ 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
Product codes (comma separated list FDA assigned to the subject device)
OBJ, ITX
Device Description
OptiCross™ 18 is a short-rail 30 MHz IVUS imaging catheter. It is compatible with a 0.018" guidewire, and at a minimum, a 6F guide catheter (≥ 0.068" ID).
OptiCross 18 is intended for use with Boston Scientific's (BSC)'s iLab™ equipment and BSC's 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 examination of peripheral intravascular pathology.
The catheter consists of two main components: the catheter body and the imaging core. The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal quidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter.
The distal quidewire lumen (1.6 cm in length) is used to track the catheter along the quidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter.
The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm).
The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging.
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 visualization.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Intravascular Ultrasound (IVUS)
Anatomical Site
Peripheral vessels
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 were conducted, including bench-top performance testing, packaging validation, biological safety, electromagnetic compatibility, acoustic output testing, and a pre-clinical animal study.
Bench Testing:
Evaluated physical integrity, functionality, and overall performance of the catheter. Performance criteria included deliverability, crossability, guide catheter compatibility, lubricity, retraction capability, image resolution, image penetration, non-uniform rotational distortion (NURD), measurement accuracy, pullback reliability, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness and simulated use structural integrity.
Pre-clinical Evaluation:
A study was performed to support acute performance and design validation claims associated with in-vivo image quality in the porcine model.
Biological Safety Testing:
Subjected to 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 OptiCross™ 18 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 subjected to electron beam sterilization, climatic conditioning, and distribution challenge conditioning.
Conclusion:
Non-clinical performance evaluations indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device (Atlantis™ 018).
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.
Atlantis™ 018 Peripheral Imaging Catheter K073623
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.
OptiCross™ 40 MHz Coronary Imaging Catheter K123621, Sonicath Ultra, 20 MHz Peripheral Imaging Catheter K060947
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
§ 870.1200 Diagnostic intravascular catheter.
(a)
Identification. An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/0 description: The image shows the logo for the United States Department of Health and Human Services. The logo features a stylized caduceus symbol, which is often associated with medicine and healthcare. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the symbol.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
June 22, 2016
Boston Scientific Corporation Eric Elliott Principal Regulatory Specialist 47215 Lakeview Blvd Fremont, California 94538
Re: K160514
Trade/Device Name: OptiCross 18: 30 MHz Peripheral Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: May 24, 2016 Received: Mav 24, 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 device
1
related adverse events) (21 CFR 803); 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.
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
2
Indications for Use
510(k) Number (if known)
Device Name OptiCross™ 18 30 MHz Peripheral Imaging Catheter
Indications for Use (Describe)
OptiCross™ 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) |
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3
Section 7 510(k) Summary per 21 CFR 807.92
| Submitter's
Name and
Address | Boston Scientific Corporation
47215 Lakeview Boulevard
Fremont, CA 94538 | | |
|------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|-------------|
| Contact Name
and Information | Eric Elliott
Principal Regulatory Affairs Specialist
Tel: 510.624.1314
Fax: 510.440.7698
E-mail: Eric.Elliott@bsci.com | | |
| Date Prepared | February 23, 2016 | | |
| Trade Name | OptiCross™ 18
30 MHz Peripheral Imaging Catheter | | |
| Common Name | Diagnostic Intravascular Catheter, Ultrasound Transducer | | |
| Classification
Name | Catheter, Ultrasound, Intravascular (OBJ) has been
classified as Class II per 21 CFR 870.1200
Transducer Ultrasonic (ITX) has been classified as Class II
per 21 CFR 892.1570. | | |
| Predicate
Device | Atlantis™ 018
Peripheral Imaging Catheter | K073623 | 13-Mar-2008 |
| Reference
Devices | OptiCross™ 40 MHz
Coronary Imaging Catheter | K123621 | 15-Apr-2013 |
| | Sonicath Ultra, 20 MHz
Peripheral Imaging Catheter | K060947 | 19-Apr-2006 |
| Description of
Device | OptiCross™ 18 is a short-rail 30 MHz IVUS imaging
catheter. It is compatible with a 0.018" guidewire, and at a
minimum, a 6F guide catheter (≥ 0.068" ID).
OptiCross 18 is intended for use with Boston Scientific's
(BSC)'s iLab™ equipment and BSC's 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 examination of
peripheral intravascular pathology.
The catheter consists of two main components: the catheter
body and the imaging core. | | |
4
Device Description, continued
The catheter body consists of four sections: the telescope assembly, proximal shaft, distal shaft, and the distal quidewire lumen. The proximal shaft, distal shaft, and distal quidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter.
The distal quidewire lumen (1.6 cm in length) is used to track the catheter along the quidewire and incorporates a radiopaque marker band (0.5 cm from the distal tip). The distal shaft serves as a flexible and acoustically transparent imaging window. The proximal shaft provides pushability to the catheter and serves as a lumen to the imaging core. Two insertion markers are located on the proximal shaft (90 and 100 cm from the distal tip). These markers facilitate estimation of catheter position relative to the distal tip of the guide catheter.
The telescope assembly allows the imaging core to be advanced and retracted up to 15 cm. The corresponding movement of the transducer occurs within the imaging window from 2 to 17 cm from the distal tip of the catheter. The telescoping shaft includes 16 incremental markers (1 cm apart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheter body also employs a hydrophilic coating to enhance lubricity and promote deliverability (distal 23 cm).
The imaging core consists of a proximal hub assembly and a rotating drive cable that houses a piezoelectric (PZT) transducer at the distal imaging window. The hub assembly (1) provides an electro-mechanical interface between the catheter and the motor drive unit and (2) incorporates a oneway check valve that is used to flush the interior of the catheter body. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging.
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 visualization.
| Intended |
|---|
| Use/Indications |
| for Use |
OptiCross 18 is intended for intravascular ultrasound examination of peripheral vessels only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
5
| Device
Technoogy
Characteristics
and
Comparison to
Predicate
Device | OptiCross™ 18 maintains the same indications for use,
fundamental scientific technology, and operating principles
as those of the predicate device (Atlantis™ 018, K073623). |
|---------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | OptiCross 18 serves as the replacement for BSC's legacy
peripheral imaging catheter, Atlantis 018, but with the latest
proximal hub interface (and with it compatibility with the
MDU5 PLUS Motor Drive Unit) – as already utilized by BSC's
OptiCross™ (K123621) and OptiCross™ 6 (K153617)
Coronary Imaging Catheters. Likewise, other modifications
to Atlantis 018 include utilization of BSC's latest sheath and
telescope designs presently employed by OptiCross™ 6. |
| | In addition to adopting the latest hub, telescope, and sheath
designs as described above; OptiCross 18 utilizes a lower
frequency (30 MHz) transducer intended to enhance depth of
penetration relative to the predicate, Atlantis 018 (40 MHz).
Finally, OptiCross™ 18 will be sterilized via electron beam
(E-Beam) irradiation; not gamma, a practice now consistent
for all BSC Imaging Catheters. |
| | 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
(Atlantis 018). |
6
| 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 testing,
packaging validation, biological safety, electromagnetic
compatibility, acoustic output testing, and a pre-clinical
animal study to validate imaging performance in the porcine
model. |
| | Bench Testing:
Bench testing was performed to evaluate physical integrity,
functionality, and overall performance of the catheter.
Performance criteria includes deliverability, crossability,
guide catheter compatibility, lubricity, retraction capability,
image resolution, image penetration, non-uniform rotational
distortion (NURD), measurement accuracy, pullback
reliability, dimensional requirements, visibility under
fluoroscopy, interface with ancillary devices, environmental
requirements, user interface requirements, catheter
robustness and simulated use structural integrity. |
| | Pre-clinical Evaluation:
The purpose of this study was to support acute performance
and design validation claims associated with in-vivo image
quality. |
| | Biological Safety Testing:
OptiCross™ 18 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 OptiCross™ 18 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 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, | |
Atlantis™ 018 (K073623).
7
| 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 OptiCross™ 018 do not alter the
fundamental scientific technology or the indications for use.
Based on Failure Mode Effects Analysis (FMEA),
comprehensive verification and validation activities were
successfully completed; raising no new issues of safety or
effectiveness.
Non-clinical performance data supports a determination that
the subject device, OptiCross™ 18, is substantially
equivalent to the predicate device, Atlantis™ 018 (K073623);
and that it is at least as safe and effective for its intended
use. |