(69 days)
No
The summary describes a standard intravascular ultrasound catheter and imaging system, focusing on hardware components and basic signal processing for visualization. There is no mention of AI, ML, or advanced image analysis techniques that would typically indicate the use of such technologies.
No
This device is an imaging catheter used for diagnostic purposes (ultrasound examination of coronary intravascular pathology), not for treatment or therapy.
Yes
The device is intended for "ultrasound examination of coronary intravascular pathology only," and its "Intended Use / Indications for Use" states that "Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures." This clearly indicates its use in identifying or characterizing disease or injury.
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 signals, the device itself is a physical medical device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ultrasound examination of coronary intravascular pathology only." This describes an in vivo imaging procedure performed directly on a patient, not a test performed on a sample of biological material outside the body.
- Device Description: The description details a catheter designed to be inserted into the coronary arteries for ultrasound imaging. This is consistent with an in vivo medical device.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, tissue, etc.) in vitro.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is an imaging tool used within the body.
N/A
Intended Use / Indications for Use
This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Product codes
OBJ, ITX
Device Description
OptiCross™ 6 is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 6F guide catheter (>= 0.064" ID).
OptiCross 6 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 coronary 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 guidewire lumen. The proximal shaft, distal shaft, and distal guidewire lumen comprise the usable length of the catheter (135 cm). The proximal telescoping section remains outside of the guide catheter. The distal guidewire lumen (1.6 cm) is used to track the catheter along the guidewire 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 one-way 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Coronary intravascular
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, as described below, indicate that the subject device is substantially equivalent to, and at least as safe and effective as the predicate device (OptiCross).
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, crossability, guide catheter compatibility, lubricity, retraction capability, image resolution, image penetration, non-uniform rotational distortion, image artifact, measurement accuracy, pullback reliability, general imaging capabilities, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness and simulated use structural integrity.
Biological Safety Testing: OptiCross™ 6 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 OptiCross™ 6 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
OptiCross™ 40 MHz Coronary Imaging Catheter K123621
Reference Device(s)
iCross™ IVUS Catheter K111043, NC Emerge™ PTCA Catheter K141236
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 U.S. Department of Health & Human Services. The logo features the department's name in a circular arrangement around a stylized symbol. The symbol is a depiction of a caduceus, which is a traditional symbol of medicine, with a modern and abstract design.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
February 25, 2016
Boston Scientific Corporation Eric Elliott Principal Regulatory Specialist 47215 Lakeview Blvd Fremont, California 94538
Re: K153617
Trade/Device Name: Opticross 6: 40 MHz Coronary Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, 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
1
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 vours.
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)
K153617
Device Name OptiCross™ 6 40 MHz Coronary Imaging Catheter
Indications for Use (Describe)
This catheter is intended for ultrasound examination of coronary intravascular pathology only. Intrasound imaging is indicated in patients who are candidates for transluminal coronary 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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510(k) Summary per 21 CFR 807.92 Section 3
| 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 | December 18, 2015 | | |
| Trade Name | OptiCross™ 6
40 MHz Coronary 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 | OptiCross™ 40 MHz Coronary
Imaging Catheter | K123621 | 15-Apr-2013 |
| Reference
Devices | iCross™ IVUS Catheter
NC Emerge™ PTCA Catheter | K111043
K141236 | 08-Aug-2011
07-Aug-2014 |
| Description of
Device | OptiCross™ 6 is a short-rail 40 MHz IVUS imaging catheter.
It is compatible with a 0.014" guidewire, and at a minimum, a
6F guide catheter (≥ 0.064" ID).
OptiCross 6 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
coronary 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 guidewire
lumen. The proximal shaft, distal shaft, and distal guidewire
lumen comprise the usable length of the catheter (135 cm).
The proximal telescoping section remains outside of the guide
catheter.
The distal guidewire lumen (1.6 cm) is used to track the |
|----------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | catheter along the guidewire 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 one-
way 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 | This catheter is intended for ultrasound examination of
coronary intravascular pathology only. Intravascular
ultrasound imaging is indicated in patients who are
candidates for transluminal coronary interventional
procedures. |
| Device
Technology
Characteristics
and
Comparison to
Predicate
Device | OptiCross™ 6 maintains the same fundamental scientific
technology and operating principles as the predicate
OptiCross™ (K123621). Furthermore, the imaging
components, packaging, sterilization, ancillary capital
equipment, and indications for use remain unchanged. |
| | With increased proximal sheath and imaging window profiles,
OptiCross 6 offers physicians a larger alternative to OptiCross
while providing the same level of safety and performance. In
practice, OptiCross 6 serves as the replacement for BSC's
legacy 6F guide catheter compatible platform, iCross
(K111043). |
| | Additional design modifications with respect to the predicate
device include a narrowed distal tip profile and utilization of
BSC's latest hydrophilic coating, ZGlide™. Material changes
have also been made to the rotator retainer, anchor seal O-
ring, female telescope tube, and catheter sheath. |
| | 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
(OptiCross). |
5
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 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, crossability, guide catheter compatibility, lubricity, retraction capability, image resolution, image penetration, non-uniform rotational distortion, image artifact, measurement accuracy, pullback reliability, general imaging capabilities, dimensional requirements, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, catheter robustness and simulated use structural integrity.
Biological Safety Testing:
OptiCross™ 6 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 OptiCross™ 6 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, OptiCross™ (K123621).
Clinical Performance Data
Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data.
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