(69 days)
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.
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.
The provided text describes a 510(k) premarket notification for the OptiCross™ 6 40 MHz Coronary Imaging Catheter. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than proving novel effectiveness through extensive clinical trials. Therefore, much of the requested information regarding clinical studies, human readers, and detailed ground truth for AI algorithms is not applicable to this document.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly provide a table of acceptance criteria with specific numerical targets (e.g., "measurement accuracy > 95%") alongside reported performance values. Instead, it lists the types of tests performed and states that the device met the requirements, indicating successful performance in each area.
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Bench-top Performance | Physical integrity, functionality, and performance met standards | Demonstrated 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 | Compliant with ISO 10993-1, microbial assessments met standards | Successfully passed biocompatibility, bioburden, endotoxin, pyrogenicity, and sterility assurance assessments. |
| Electrical and Mechanical Safety | Acoustic output below FDA Track 1 limits; compliant with IEC 60601-1-2 (3rd Edition) | Acoustic output test results are below FDA Track 1 limits. Electromagnetic compatibility testing demonstrated compliance to IEC 60601-1-2 (3rd Edition). |
| Packaging Validation | Met standards of ISO 11607-1 and ISO 11607-2 | Integrity of packaging configuration evaluated and met standards after sterilization, climatic conditioning, and distribution challenge. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in terms of number of devices or data points. Bench testing involves a representative number of devices to assess performance.
- Data Provenance: Not applicable in the context of clinical data for an AI device. The data for bench and safety testing would be generated in a lab setting by the manufacturer (Boston Scientific Corporation). All testing is non-clinical.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. This is not an AI-enabled device requiring expert ground truth for image interpretation. The testing focuses on the physical and functional performance of the catheter.
4. Adjudication method for the test set
Not applicable. This is not an AI-enabled device.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI-enabled device and no MRMC study was conducted. The determination of substantial equivalence is based on non-clinical performance data.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a medical device (intravascular imaging catheter), not an AI algorithm.
7. The type of ground truth used
For bench testing, the "ground truth" is the established engineering specifications, performance standards, and regulatory requirements (e.g., dimensional tolerances, image quality parameters, safety limits). For biological safety, it's compliance with ISO standards and successful completion of specific biological assessments.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established
Not applicable.
Summary of the Study that Proves the Device Meets Acceptance Criteria:
The study described is a non-clinical performance evaluation to demonstrate substantial equivalence to a predicate device (OptiCross™ K123621). This means the focus is on proving that the new device, OptiCross™ 6, is as safe and effective as a previously cleared device, not necessarily on proving novel clinical efficacy.
The study included:
- Bench Testing: Extensive tests to evaluate the physical integrity, functionality, and performance of the catheter across various aspects such as deliverability, image resolution, measurement accuracy, and structural integrity.
- Biological Safety Testing: Assessments for biocompatibility (in accordance with ISO 10993-1), bioburden, endotoxin, pyrogenicity, and sterility assurance.
- Electrical and Mechanical Safety Testing: Evaluation of acoustic output against FDA guidance and electromagnetic compatibility testing to ensure compliance with IEC 60601-1-2.
- Packaging Validation: Testing the integrity of the packaging configutation according to ISO 11607-1 and ISO 11607-2.
The document explicitly states: "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)." It also notes "Clinical Performance Data: Not applicable; determination of substantial equivalence is based on an assessment of non-clinical performance data."
The "acceptance criteria" were implied by the successful completion and compliance with the various tests and standards mentioned (e.g., "Acoustic Output test results for the OptiCross™ 6 are below the FDA Track 1 limits," and "demonstrating compliance to IEC 60601-1-2"). The report concludes that based on these non-clinical data, the device meets the safety and effectiveness requirements for substantial equivalence.
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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
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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'sName andAddress | Boston Scientific Corporation47215 Lakeview BoulevardFremont, CA 94538 | ||
|---|---|---|---|
| Contact Nameand Information | Eric ElliottPrincipal Regulatory Affairs SpecialistTel: 510.624.1314Fax: 510.440.7698E-mail: Eric.Elliott@bsci.com | ||
| Date Prepared | December 18, 2015 | ||
| Trade Name | OptiCross™ 640 MHz Coronary Imaging Catheter | ||
| Common Name | Diagnostic Intravascular Catheter, Ultrasound Transducer | ||
| ClassificationName | Catheter, Ultrasound, Intravascular (OBJ) has been classifiedas Class II per 21 CFR 870.1200Transducer Ultrasonic (ITX) has been classified as Class IIper 21 CFR 892.1570. | ||
| PredicateDevice | OptiCross™ 40 MHz CoronaryImaging Catheter | K123621 | 15-Apr-2013 |
| ReferenceDevices | iCross™ IVUS CatheterNC Emerge™ PTCA Catheter | K111043K141236 | 08-Aug-201107-Aug-2014 |
| Description ofDevice | OptiCross™ 6 is a short-rail 40 MHz IVUS imaging catheter.It is compatible with a 0.014" guidewire, and at a minimum, a6F 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, motordrive unit (MDU), and iLab equipment form a completeimaging system that allows for ultrasonic examination ofcoronary intravascular pathology.The catheter consists of two main components: the catheterbody and the imaging core. |
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| DeviceDescription,continued | The catheter body consists of four sections: the telescopeassembly, proximal shaft, distal shaft, and the distal guidewirelumen. The proximal shaft, distal shaft, and distal guidewirelumen comprise the usable length of the catheter (135 cm).The proximal telescoping section remains outside of the guidecatheter.The distal guidewire lumen (1.6 cm) is used to track the |
|---|---|
| catheter along the guidewire and incorporates a radiopaquemarker band (0.5 cm from the distal tip). The distal shaftserves as a flexible and acoustically transparent imagingwindow. The proximal shaft provides pushability to thecatheter and serves as a lumen to the imaging core. Twoinsertion markers are located on the proximal shaft (90 and100 cm from the distal tip). These markers facilitateestimation of catheter position relative to the distal tip of theguide catheter. | |
| The telescope assembly allows the imaging core to beadvanced and retracted up to 15 cm. The correspondingmovement of the transducer occurs within the imagingwindow from 2 to 17 cm from the distal tip of the catheter.The telescoping shaft includes 16 incremental markers (1 cmapart) for lesion length assessment; the 5-cm, 10-cm, and 15-cm markers are distinct. The outer surface of the catheterbody also employs a hydrophilic coating to enhance lubricityand promote deliverability (distal 23 cm). | |
| The imaging core consists of a proximal hub assembly and arotating drive cable that houses a piezoelectric (PZT)transducer at the distal imaging window. The hub assembly(1) provides an electro-mechanical interface between thecatheter and the motor drive unit and (2) incorporates a one-way check valve that is used to flush the interior of thecatheter body. The catheter must be flushed with heparinizedsaline prior to use, as this provides the acoustic couplingmedia required for ultrasonic imaging. | |
| The drive cable and PZT transducer rotate independently ofthe sheath to provide 360° image resolution. The transducerconverts electrical impulses sent by the motor drive in totransmittable acoustic energy. Reflected ultrasound signalsare converted back to electrical impulses, returned to themotor drive unit, and are ultimately processed by the iLabequipment for visualization. | |
| IntendedUse/Indicationsfor Use | This catheter is intended for ultrasound examination ofcoronary intravascular pathology only. Intravascularultrasound imaging is indicated in patients who arecandidates for transluminal coronary interventionalprocedures. |
| DeviceTechnologyCharacteristicsandComparison toPredicateDevice | OptiCross™ 6 maintains the same fundamental scientifictechnology and operating principles as the predicateOptiCross™ (K123621). Furthermore, the imagingcomponents, packaging, sterilization, ancillary capitalequipment, and indications for use remain unchanged. |
| With increased proximal sheath and imaging window profiles,OptiCross 6 offers physicians a larger alternative to OptiCrosswhile providing the same level of safety and performance. Inpractice, OptiCross 6 serves as the replacement for BSC'slegacy 6F guide catheter compatible platform, iCross(K111043). | |
| Additional design modifications with respect to the predicatedevice include a narrowed distal tip profile and utilization ofBSC's latest hydrophilic coating, ZGlide™. Material changeshave also been made to the rotator retainer, anchor seal O-ring, female telescope tube, and catheter sheath. | |
| In support of a substantial equivalence determination, BSChas compared and evaluated the material and designdifferences 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). |
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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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Conclusion With respect to the predicate, design modifications incorporated by OptiCross™ 6 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, is substantially equivalent to the predicate device, OptiCross™ (K123621); and that it is at least as safe and effective for its intended use.
§ 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).