(63 days)
These catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The OptiCross and OptiCross 6 40 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.
OptiCross HD and OptiCross 6 HD 60 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.
All catheters consist 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 40 MHz or 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™) Instrument. 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
-
- Telescope 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 at 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.
The Coronary Imaging Catheter. 17.78 cm (7 in) extension tube. 3 cm³ (3 cc) and 10 cm³ (10 cc) syringes, and 4-way stopcock are provided in a single use sterilized package. The MDU5 PLUS Sterile Bag is provided in a separate sterile pouch within the finished carton along with the catheter package.
This document describes the FDA's 510(k) clearance for Boston Scientific's OptiCross™ Coronary Imaging Catheters, asserting their substantial equivalence to a predicate device. However, the document does not contain any information regarding acceptance criteria or a study that proves the device meets specific acceptance criteria.
The non-clinical performance data section explicitly states: "Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross™ Family Coronary Imaging Catheters."
Therefore, I cannot provide the requested information. The document focuses on demonstrating substantial equivalence through bench testing, rather than presenting a study with acceptance criteria, sample sizes, ground truth establishment, or multi-reader studies.
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January 14, 2022
Boston Scientific Corporation Cassie Clark Regulatory Affairs Specialist II 1 Scimed Place Maple Grove, Minnesota 55311
Re: K213593
Trade/Device Name: OptiCross™ Coronary Imaging Catheter, OptiCross™ 6 Coronary Imaging Catheter, OptiCross™ HD Coronary Imaging Catheter, and OptiCross™ 6 HD Coronary Imaging Catheter. Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: OBJ, ITX Dated: December 16, 2021 Received: December 17, 2021
Dear Cassie Clark:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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.
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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 and Part 809 ); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS)
regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
for Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Center for Devices and Radiological Health U.S. Food and Drug Administration
Enclosure
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Indications for Use
510(k) Number (if known) K213593
Device Name
OptiCross™Coronary Imaging Catheter, OptiCross™ 6 Coronary Imaging Catheter, OptiCross™ HD Coronary Imaging Catheter, and OptiCross™ 6 HD Coronary Imaging Catheter.
Indications for Use (Describe)
These catheters are intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
| Type of Use ( Select one or both, as applicable ) |
|---|
| ---------------------------------------------------------- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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K213593 510(k) Summary
per 21 CFR §807.92
| Sponsor | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA | ||
|---|---|---|---|
| Contact Name andInformation | Cassie ClarkOne Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-494-1425e-mail: Cassie.Clark@bsci.com | ||
| Prepared by | Cassie ClarkNovember 10, 2021 | ||
| Proprietary Name | OptiCross™ Coronary Imaging Catheter, OptiCross™ 6 CoronaryImaging Catheter, OptiCross™ HD Coronary Imaging Catheter,OptiCross™ 6 HD Coronary Imaging Catheter | ||
| Common Name | Diagnostic Intravascular Catheter, Ultrasound Transducer | ||
| Product Code | OBJ, ITX | ||
| Classification | Catheter, Ultrasound, Intravascular (OBJ) has been classified as ClassII per 21 CFR 870.1200Transducer Ultrasonic (ITX) has been classified as Class II per 21CFR 892.1570 | ||
| Predicate Device | OptiCross™ 6 HD CoronaryImaging Catheter | K173820 | January 17, 2018 |
| Other PredicateDevice | OptiCross™ HD CoronaryImaging Catheter | K173284 | November 16, 2017 |
| Reference Device | Atlantis SR Pro CoronaryImaging Catheter | K063312 | November 30, 2006 |
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Device Description
The OptiCross and OptiCross 6 40 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.
OptiCross HD and OptiCross 6 HD 60 MHz Coronary Imaging Catheters are sterile, short rail imaging catheters. Available in 5F and 6F sizes.
All catheters consist 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 40 MHz or 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™) Instrument. 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
-
- Telescope 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 at 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.
The Coronary Imaging Catheter. 17.78 cm (7 in) extension tube. 3 cm³ (3 cc) and 10 cm³ (10 cc) syringes, and 4-way stopcock are provided in a single use sterilized package. The MDU5 PLUS Sterile Bag is provided in a separate sterile pouch within the finished carton along with the catheter package.
Indications for Use / Intended 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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Comparison of Technological Characteristics
The OptiCross™, OptiCross™ 6, OptiCross™HD, and OptiCross™ 6 HD Coronary Imaging Catheters incorporate substantially equivalent design, materials, fundamental technology, interface with the IVUS imaging system, sterilization process, and intended use as those featured in the predicate; OptiCross™ 6 HD Coronary Imaging Catheter K173820. The OptiCross 6 Coronary Imaging Catheters utilize a 40 MHz transducer used for imaging. The OptiCross HD and OptiCross 6 HD catheters utilize a 60 MHz transducer used for higher definition imaging. All catheters interface with the same IVUS imaging system in the same way as the predicate.
Non-clinical Performance Data
Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing data.
Bench Testing
Bench testing was performed to evaluate physical integrity, functionality, and performance of the OptiCross™Family Coronary Imaging Catheters. Performance criteria includes imaging robustness requirements, catheter robustness requirements, dimensional requirements, and interface with compatible devices.
Clinical Testing
Performance testing from clinical studies is not required to demonstrate substantial equivalence of the OptiCross™ Family Coronary Imaging Catheters.
Conclusion
Based on the indications for use, technological characteristics, and performance testing, the OptiCross™ Family Coronary Imaging Catheters have been shown to be appropriate for their intended use and are considered to be substantially equivalent to the predicate device; OptiCross™ 6 HD Coronary Imaging Catheter K173820.
§ 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).