(28 days)
OptiCross™ 6 Coronary Imaging Catheter K153617
No
The description focuses on the physical components, mechanical operation, and basic signal processing for visualization. There is no mention of AI/ML algorithms for image analysis, interpretation, or other functions.
No
The device is described as an "ultrasound imaging catheter" intended for "ultrasound examination of coronary intravascular pathology only." Its primary function is diagnostic imaging, and it does not directly treat or prevent a disease or condition.
Yes
Explanation: The device is described as an "ultrasound examination" and "imaging catheter" for "ultrasonic examination of coronary intravascular pathology," which are all diagnostic functions. The "Intended Use / Indications for Use" section explicitly states "ultrasound examination of coronary intravascular pathology."
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 image processing is mentioned, the core of the device is a physical medical device.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD). Here's why:
- Intended Use: The intended use clearly states "ultrasound examination of coronary intravascular pathology only." This describes a diagnostic procedure performed in vivo (within the living body) using ultrasound imaging.
- Device Description: The description details a catheter designed to be inserted into the coronary arteries for imaging. This is consistent with an in vivo imaging device, not a device used to examine samples in vitro (outside the living body).
- Imaging Modality: The input imaging modality is Ultrasound, which is an in vivo imaging technique.
- Anatomical Site: The anatomical site is "Coronary intravascular," which is within the living body.
In Vitro Diagnostics (IVDs) are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not fit that description. It is an in vivo diagnostic imaging device.
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 (comma separated list FDA assigned to the subject device)
OBJ, ITX
Device Description
OptiCross™ X is a short-rail 40 MHz IVUS imaging catheter. It is compatible with a 0.014" guidewire, and at a minimum, a 5F guide catheter (≥ 0.058" ID).
OptiCross X 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 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) 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
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 (OptiCrossTM 6, K153617).
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 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), image artifact, 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. Biological Safety Testing: OptiCross™ X 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 results for OptiCross™ X are below the FDA Track 1 limits. Electromagnetic compatibility testing was also evaluated; demonstrating compliance to IEC 60601-1-2 (30 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™ 6 (K153617).
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.
OptiCross™ 6 Coronary Imaging Catheter K153617
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™ Coronary Imaging Catheter K123621
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 text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in all caps and is in a bold, serif font. The text is centered on the image and is the only element present.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
May 19, 2016
Boston Scientific Corporation Eric Elliott Principal Regulatory Affairs Specialist 47215 Lakeview Boulevard Fremont, California 94538
Re: K161125
Trade/Device Name: OptiCross™ X, 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: April 20, 2016 Received: April 21, 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) K161125
Device Name OptiCross™ X 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)
| Residential Use (Per CA SB2-330, Subject to Verification) |
|---|
| Senior Citizen Housing (Per SB2-330) |
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'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 | April 20, 2016 | | |
| Trade Name | OptiCross™ X
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™ 6 Coronary
Imaging Catheter | K153617 | 25-Feb-2016 |
| Reference
Device | OptiCross™ Coronary
Imaging Catheter | K123621 | 15-Apr-2013 |
| Description of
Device | OptiCross™ X is a short-rail 40 MHz IVUS imaging catheter.
It is compatible with a 0.014" guidewire, and at a minimum, a
5F guide catheter (≥ 0.058" ID).
OptiCross X 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 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) 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
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.
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| Device
Technoogy
Characteristics
and
Comparison to
Predicate
Device | OptiCrossTM X maintains the same fundamental scientific
technology and operating principles as the predicate
OptiCrossTM 6 (K153617). Furthermore, sheath/imaging
materials, device packaging, sterilization, ancillary capital
equipment, and indications for use remain unchanged. |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| With narrowed proximal sheath and imaging window profiles,
OptiCrossTM X offers physicians a smaller 5F compatible
alternative, while providing the same level of safety and
performance of OptiCrossTM 6 (6F compatible device). In
practice, OptiCrossTM X serves as the next iteration of BSC's
legacy 5F guide catheter compatible platform, OptiCrossTM
(K123621). | |
| Aside from the narrowed proximal sheath and imaging
window profile, the only remaining difference between
subject and predicate is the use of silicone for the anchor
seal O-ring (telescope assembly); the same material
employed by the legacy reference device OptiCrossTM
(K123621). With this one exception, all raw materials utilized
by OptiCrossTM X are identical to those of the predicate,
OptiCrossTM 6 (K153617). | |
| In support of a substantial equivalence determination, BSC
has compared and evaluated the 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
(OptiCrossTM 6, K153617). | |
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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 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), image artifact, 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. Biological Safety Testing: OptiCross™ X 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 results for OptiCross™ X are below the FDA Track 1 limits. Electromagnetic compatibility testing was also evaluated; demonstrating compliance to IEC 60601-1-2 (30 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™ 6 (K153617). 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 modifications
incorporated by OptiCross™ X 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™ X, is substantially equivalent
to the predicate device, OptiCross™ 6 (K153617); and that it
is at least as safe and effective for its intended use. |