(30 days)
No
The description focuses on the mechanical and ultrasonic components of the catheter and does not mention any AI or ML capabilities for image processing or analysis.
No.
The device is solely for ultrasound examination of coronary intravascular pathology, indicating it is a diagnostic tool, not a therapeutic one.
Yes
The "Intended Use / Indications for Use" states that the catheter is "intended for ultrasound examination of coronary intravascular pathology," which is a diagnostic purpose.
No
The device description clearly details physical hardware components including a catheter body, imaging core with a transducer, drive cable, and an electro-mechanical connector interface. It also mentions a connection to a Motordrive Unit (MDU5 PLUS™). This is not a software-only device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
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 imaging, not a test performed in vitro (outside the body) on biological samples.
- Device Description: The description details a catheter with an ultrasonic transducer designed to be inserted into the coronary arteries for imaging. This is consistent with an in vivo imaging device.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.), reagents, or any of the typical components or processes associated with in vitro diagnostics.
Therefore, this device is an in vivo imaging device, not an IVD.
N/A
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.
Product codes (comma separated list FDA assigned to the subject device)
OBJ, ITX
Device Description
OptiCross™ 6 HD (60 MHz Coronary Imaging Catheters) is a sterile, short rail imaging catheter.
It consists of two main assemblies:
- Imaging Core
- Catheter Body
The imaging core is composed of a hi-torque, flexible, rotating drive cable with a radial looking 60 MHz ultrasonic transducer at the distal tip. An electro-mechanical connector interface at the proximal end of the catheter makes the connection to the Motordrive Unit (MDU5 PLUS™). The MDU5 PLUS-catheter interface consists of an integrated mechanical drive socket and electrical connection.
The catheter body is comprised of three sections: - Distal Imaging Window Lumen
- Proximal Shaft Lumen
- Telescoping Section
The distal imaging window lumen and proximal shaft lumen sections comprise the "working length" of the catheter, and the telescoping section remains outside of the guiding catheter.
The catheter body has a distal imaging window lumen with proximal exit 1.6 cm from the distal end. A radiopaque (RO) marker is embedded in the catheter body at 0.5 cm from the distal tip. In addition, two insertion depth markers are located on the proximal shaft lumen at 90 cm and 100 cm from the distal tip to aid in estimating catheter position relative to the distal guide catheter tip. The proximal shaft lumen is attached to the telescoping section via a strain relief connection.
The telescoping shaft (section) allows the imaging core to be advanced and retracted for 15 cm of linear movement. The corresponding movement of the transducer occurs from the proximal end of the guidewire exit port to the proximal end of the distal imaging window lumen. The telescope section has proximal markers for lesion length assessment, consisting of a series of marks spaced 1 cm apart on the telescope body.
A flush port with a one-way check valve is used to flush the interior of the catheter body and maintain a flushed condition. The catheter must be flushed with heparinized saline prior to use, as this provides the acoustic coupling media required for ultrasonic imaging. The one-way check valve helps retain saline in the catheter during use.
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 data includes bench-top performance testing, packaging validation, biological safety, electromagnetic compatibility, acoustic output testing, and a GLP 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 design validation and business need evaluations claims associated with in-vivo image quality.
Biological Safety Testing:
OptiCross™ 6 HD catheter utilizes existing materials from the commercially available OptiCross™ family of catheters which have similar configurations and are manufactured under the same processing conditions. Hence the biocompatibility test data has been leveraged from the commercially available OptiCross™ 6 and OptiCross™ 18 Imaging Catheter to meet the requirements of ISO 10993-1.
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™ 6 HD are below the FDA Track 1 limits. Electromagnetic compatibility testing was also conducted; demonstrating compliance to IEC 60601-1-2 (3rd Edition).
Packaging Validation:
Packaging of OptiCross™ 6 HD catheters is equivalent to the packaging of other commercially available BSC IVUS catheters in the OptiCross™ product family. Thus, the OptiCross™ HD packaging will leverage the packaging DV results of the currently available OptiCross catheters to demonstrate it meets the required product specifications.
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, 40 MHz Coronary Imaging Catheter (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.
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.
K160514, K123621, K161125, K173284
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).
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Image /page/0/Picture/0 description: The image contains 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, with the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
January 17, 2018
Boston Scientific Corporation Mugdha Dongre Regulatory Affairs Specialist II 47215 Lakeview Boulevard Fremont, California 94538
Re: K173820
Trade/Device Name: OptiCross 6 HD, 60 MHz Coronary Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: December 15, 2017 Received: December 18, 2017
Dear Mugdha Dongre:
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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Page 2 - Mugdha Dongre
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 medical devices and radiation-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. Wilhelm
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) K173820
Device Name
OptiCross™ 6 HD, 60 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
| Submitter's Name and
Address | Boston Scientific Corporation
47215 Lakeview Boulevard
Fremont, CA 94538
USA | | |
|---------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------|---------------|
| Contact Name and
Information | Mugdha Dongre
Regulatory Affairs Specialist II
Tel: 510.624.1314
Fax: 510.440.7698
Email: Mugdha.Dongre@bsci.com | | |
| Date Prepared | December 15, 2017 | | |
| Trade Name | OptiCross™ 6 HD, 60MHz 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 Name | OptiCross™ 6 40 MHz
Coronary Imaging Catheter | K153617 | 25-Feb-2016 |
| Reference Devices | OptiCross™ 18, 30 MHz
Peripheral Imaging Catheter | K160514 | 22-June-2017 |
| | OptiCross™, 40 MHz Coronary
Imaging Catheter | K123621 | 15-April-2013 |
| | OptiCross™ X, 40 MHz
Coronary Imaging Catheter | K161125 | 19-May-2016 |
| | OptiCross™ HD, 60 MHz
Coronary Imaging Catheter | K173284 | 16-Nov-2017 |
| Device Description | OptiCross™ 6 HD (60 MHz Coronary Imaging Catheters) is a
sterile, short rail imaging catheter.
It consists of two main assemblies:
- Imaging Core
- Catheter Body
The imaging core is composed of a hi-torque, flexible, rotating
drive cable with a radial looking 60 MHz ultrasonic transducer at
the distal tip. An electro-mechanical connector interface at the
proximal end of the catheter makes the connection to the
Motordrive Unit (MDU5 PLUS™). The MDU5 PLUS-catheter
interface consists of an integrated mechanical drive socket and
electrical connection.
The catheter body is comprised of three sections: | | |
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| 1. Distal Imaging Window Lumen | |
|---|---|
| 2. Proximal Shaft Lumen | |
| 3. Telescoping Section | |
| The distal imaging window lumen and proximal shaft lumen | |
| sections comprise the "working length" of the catheter, and the | |
| telescoping section remains outside of the guiding catheter. | |
| The catheter body has a distal imaging window lumen with | |
| proximal exit 1.6 cm from the distal end. A radiopaque (RO) | |
| marker is embedded in the catheter body at 0.5 cm from the distal | |
| tip. In addition, two insertion depth markers are located on the | |
| proximal shaft lumen at 90 cm and 100 cm from the distal tip to aid | |
| in estimating catheter position relative to the distal guide catheter | |
| tip. The proximal shaft lumen is attached to the telescoping section | |
| via a strain relief connection. | |
| The telescoping shaft (section) allows the imaging core to be | |
| advanced and retracted for 15 cm of linear movement. | |
| The corresponding movement of the transducer occurs from the | |
| proximal end of the guidewire exit port to the proximal end of the | |
| distal imaging window lumen. The telescope section has proximal | |
| markers for lesion length assessment, consisting of a series of | |
| marks spaced 1 cm apart on the telescope body. | |
| A flush port with a one-way check valve is used to flush the interior | |
| of the catheter body and maintain a flushed condition. The catheter | |
| must be flushed with heparinized saline prior to use, as this | |
| provides the acoustic coupling media required for ultrasonic | |
| imaging. The one-way check valve helps retain saline in the | |
| catheter during use. | |
| 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 | The OptiCross™ 6 HD, catheter is a 60 MHz ultrasound coronary |
| imaging catheter intended to operate with a BSC IVUS system for | |
| diagnostic imaging. It will be used with a minimum 6F (>0.064" | |
| ID) guide catheter / introducer sheath and a 0.014" guidewire. |
The OptiCross™ 6 HD Coronary Imaging Catheter incorporates a
transducer with new design features intended to utilize a 60MHz
frequency to enhance image resolution while maintaining similar
depth of penetration as well as similar performance characteristics
as that of its predicate OptiCross™ 6 40Mhz Coronary Imaging
Catheter.
Modifications with respect to the predicate device include: |
| | A new transducer (new design with new materials) PCA board populated with two zero Ohm resistors to generate DC coupling. 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™ 6, 40 MHz
Coronary Imaging Catheter (K153617). |
| 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 GLP 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 design validation and
business need evaluations claims associated with in-vivo image
quality. |
| | Biological Safety Testing:
OptiCross™ 6 HD catheter utilizes existing materials from the
commercially available OptiCross™ family of catheters which have
similar configurations and are manufactured under the same
processing conditions. Hence the biocompatibility test data has
been leveraged from the commercially available OptiCross™ 6 and
OptiCross™ 18 Imaging Catheter to meet the requirements of ISO
10993-1. |
| | 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™ 6 HD are below the FDA Track 1 limits.
Electromagnetic compatibility testing was also conducted;
demonstrating compliance to IEC 60601-1-2 (3rd Edition). |
| | Packaging Validation: |
| | Packaging of OptiCross™ 6 HD catheters is equivalent to the
packaging of other commercially available BSC IVUS catheters in
the OptiCross™ product family. Thus, the OptiCross™ HD
packaging will leverage the packaging DV results of the currently
available OptiCross catheters to demonstrate it meets the required
product specifications. |
| | 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, 40 MHz Coronary Imaging Catheter (K153617). |
| 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™ 6 HD 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™ 6 HD, is substantially equivalent to the
predicate device, OptiCross™ 6, 40 MHz Coronary Imaging
Catheter (K153617); and that it is at least as safe and effective for
its intended use |
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