(28 days)
The OptiCross 35 15 MHz Peripheral Imaging Catheter is intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal interventional procedures.
OptiCross 35 15 MHz Peripheral Imaging Catheter (OptiCross 35) is designed for use with BSC's iLab™ Ultrasound Imaging System equipment and the motor drive unit, MDU5 PLUS™. When used together, the catheter, the motor drive unit, and iLab System equipment form a complete imaging system that allows for ultrasonic visualization of the peripheral vasculature.
OptiCross 35 consists of two main components: the telescoping section and the dual lumen sheath.
The telescoping section remains exterior to the patient's body during use and allows the imaging core to be advanced and retracted over 25cm of linear movement.
The dual lumen sheath has one lumen which surrounds the imaging core attached proximally to the hub, and the other lumen is for guidewire use.
The imaging core is composed of a high-torque, flexible, rotating drive cable with an outward-looking ultrasonic transducer at the distal tip. The proximal hub provides an electro-mechanical interface between the catheter and the motor drive unit. There are 25 radiopaque gold markers, approximately 1 cm apart, beginning at the distal end of the imaging core, which ends with a radiopaque housing that contains the transducer. Heparinized saline is flushed within the catheter prior to use to act as an acoustic medium.
The PZT transducer and the drive cable rotate independently from the sheath to provide 360° image resolution. The transducer converts electrical impulses sent by the motor drive into 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 live visualization of intravascular structures.
The provided document is a 510(k) premarket notification for the Boston Scientific OptiCross 35 15 MHz Peripheral Imaging Catheter. This document primarily focuses on demonstrating substantial equivalence to a predicate device through non-clinical performance data (bench testing, biological safety, electrical and mechanical safety, packaging validation), rather than presenting a study proving a device meets specific acceptance criteria for an AI or imaging diagnostic performance claim.
Therefore, many of the requested details about acceptance criteria, study design, ground truth establishment, expert involvement, and statistical analyses (like MRMC studies) are not applicable to this submission as they would typically be found in documentation for devices with more complex diagnostic algorithms or AI components.
However, I can extract the relevant information regarding the performance claims and the testing conducted:
1. A table of acceptance criteria and the reported device performance
The document does not present explicit "acceptance criteria" in a quantitative, diagnostic performance sense (e.g., sensitivity, specificity, accuracy for a clinical outcome). Instead, its acceptance is based on demonstrating substantial equivalence to a predicate device through a series of engineering and safety tests. The "performance criteria" listed are related to the physical and functional integrity of the catheter rather than diagnostic accuracy.
Here's a summary of the non-clinical performance data and what was evaluated:
| Acceptance Criteria (Evaluation Type) | Reported Device Performance Summary |
|---|---|
| Bench Testing | Evaluated physical integrity, functionality, and performance. - Deliverability - Guidewire and sheath compatibility - Image quality - Non-uniform rotational distortion - Measurement accuracy - General imaging capabilities - Dimensional requirements - Catheter tensile strengths - Freedom from leak - Visibility under fluoroscopy - Interface with ancillary devices - Environmental requirements - User interface requirements - Corrosion resistance - Particulates |
| Biological Safety Testing | Device is biocompatible for its intended use. - Compliance with ISO 10993-1 - Microbial assessments (bioburden, endotoxin) - Pyrogenicity and sterility assurance testing |
| Electrical and Mechanical Safety | - Acoustic Output: Below FDA Track 1 limits (tested per FDA Guidance, June 27, 2019). - Electromagnetic Compatibility (EMC): Compliance to IEC 60601-1-2 (4th Ed.) and IEC 60601-2-37 (Ed. 2.1). |
| Packaging Validation | Integrity of packaging configuration evaluated and maintained after electron beam sterilization, climatic conditioning, and distribution challenge conditioning (in accordance with ISO 11607-1 and ISO 11607-2). |
2. Sample sizes used for the test set and the data provenance
The document does not describe a "test set" in the context of a clinical performance study (e.g., patient data for diagnostic accuracy). The testing described is primarily bench-top and laboratory testing of the device itself.
- Sample Size for Bench Testing: Not explicitly stated but implied to be sufficient for engineering validation.
- Data Provenance: The studies are non-clinical, performed in a laboratory setting. No geographical origin of patient data or retrospective/prospective nature is applicable as no patient data was used for performance validation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth as typically defined for diagnostic AI/imaging devices (e.g., expert reads of images, pathology results) was not established because no clinical performance study involving human interpretation of images was conducted. The "ground truth" here is adherence to engineering specifications and safety standards.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable, as no human expert adjudication of diagnostic outputs occurred.
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. No MRMC study was performed as this is not an AI-assisted diagnostic device, and its clearance is based on substantial equivalence to a predicate, not an improvement in human reader performance.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is not an algorithmic device in the sense of AI or automated measurement. Its function is to acquire intravascular ultrasound images for human interpretation. The "performance" measured here relates to the quality of the image acquisition and the physical properties of the catheter.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is adherence to established engineering, safety, and imaging quality standards for an ultrasound transducer, not clinical ground truth (e.g., disease presence). For example:
- Acoustic output "ground truth" is established by regulatory limits (FDA Track 1 limits).
- Biocompatibility "ground truth" is established by ISO 10993-1.
- Image quality, measurement accuracy, and other functional aspects are assessed against internal specifications determined by the manufacturer, likely based on industry standards and performance of the predicate device.
8. The sample size for the training set
Not applicable. This device does not have a "training set" as it is not an AI/machine learning device.
9. How the ground truth for the training set was established
Not applicable. This device does not have a "training set."
In summary: The provided document is a 510(k) summary for a medical device (an intravascular ultrasound catheter) based on substantial equivalence. It highlights non-clinical bench, safety, and integrity testing rather than a clinical performance study evaluating diagnostic accuracy or AI performance. Therefore, many of the questions related to AI-specific study designs, expert involvement, and ground truth establishment from clinical data are not addressed by this type of regulatory submission.
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April 17, 2020
Boston Scientific Corporation Jennifer Foley Regulatory Affairs Specialist 3 Scimed Place Maple Grove, Minnesota 55311
Re: K200733
Trade/Device Name: OptiCross 35 15 MHz Peripheral Imaging Catheter Regulation Number: 21 CFR 892.1570 Regulation Name: Diagnostic Ultrasonic Transducer Regulatory Class: Class II Product Code: ITX, OBJ Dated: March 19, 2020 Received: March 20, 2020
Dear Jennifer Foley:
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.
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
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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) 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 (OS) 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 mediation-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,
Mark Fellman Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K200733
Device Name
OptiCross 35 15 MHz Peripheral Imaging Catheter
Indications for Use (Describe)
The OptiCross 35 15 MHz Peripheral Imaging Catheter is intended for ultrasound examination of peripheral vascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal 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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Image /page/3/Picture/0 description: The image shows the logo for Boston Scientific. The logo is in blue and features the company name in a serif font. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The logo is simple and professional.
Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 (508) 683-4000
| Sponsor | Boston Scientific Corporation300 Boston Scientific WayMarlborough, Massachusetts 01752USA |
|---|---|
| Contact Nameand Information | Jennifer L. Foley, DVMThree Scimed PlaceMaple Grove, MN 55311-1566Phone: 763-955-8049Fax: 763-494-2222Email: Jennifer.Foley@bsci.com |
| Proprietary Name | OptiCross 35 15 MHz Peripheral Imaging Catheter |
| Common Name | Transducer, Ultrasonic, DiagnosticCatheter, Ultrasound Intravascular |
| Product Code | ITX, OBJ |
| Classification | 21 CFR 892.1570 – Transducer, Ultrasonic, Diagnostic21 CFR 870.1200 - Catheter, Ultrasound Intravascular |
| Predicate Device | Atlantis PV Imaging Catheter (K080272), cleared March 11, 2008 |
| Reference Device | OptiCross 18 30 MHz Peripheral Imaging Catheter (K160514), clearedJune 22, 2016 |
| DeviceDescription | OptiCross 35 15 MHz Peripheral Imaging Catheter (OptiCross 35) isdesigned for use with BSC's iLab™ Ultrasound Imaging Systemequipment and the motor drive unit, MDU5 PLUS™. When usedtogether, the catheter, the motor drive unit, and iLab Systemequipment form a complete imaging system that allows for ultrasonicvisualization of the peripheral vasculature.OptiCross 35 consists of two main components: the telescopingsection and the dual lumen sheath.The telescoping section remains exterior to the patient's body duringuse and allows the imaging core to be advanced and retracted over25cm of linear movement.The dual lumen sheath has one lumen which surrounds the imagingcore attached proximally to the hub, and the other lumen is forguidewire use.The imaging core is composed of a high-torque, flexible, rotating drivecable with an outward-looking ultrasonic transducer at the distal tip.The proximal hub provides an electro-mechanical interface betweenthe catheter and the motor drive unit. There are 25 radiopaque goldmarkers, approximately 1 cm apart, beginning at the distal end of theimaging core, which ends with a radiopaque housing that contains thetransducer. Heparinized saline is flushed within the catheter prior touse to act as an acoustic medium.The PZT transducer and the drive cable rotate independently from the |
| sheath to provide 360° image resolution. The transducer convertselectrical impulses sent by the motor drive into transmittable acousticenergy. Reflected ultrasound signals are converted back to electricalimpulses, returned to the motor drive unit, and are ultimatelyprocessed by the iLab equipment for live visualization of intravascularstructures. | |
| Indications forUse/ IntendedUse | OptiCross 35 15 MHz Peripheral Imaging Catheter is intended forultrasound examination of peripheral vascular pathology only.Intravascular ultrasound imaging is indicated for patients who arecandidates for transluminal interventional procedures. |
| DeviceTechnologyCharacteristicsand Comparisonto PredicateDevice | OptiCross 35 15 MHz Peripheral Imaging Catheter incorporates thefollowing changes from the predicate Atlantis PV Imaging Catheter(K080272): an updated hub that aligns with other marketed OptiCrosscatheters; modified telescope markers; additional radiopaque markersalong the distal portion of the catheter; a longer, smoother taper to thedistal catheter tip; addition of a strain relief to prevent kinking; additionof equivalent materials within the sheath and drive cable due to vendorobsolescence; and updated packaging appropriate for the newlydesigned device. |
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| Characteristic | PredicateAtlantis PV (K080272) | ProposedOptiCross 35 (OC35) |
|---|---|---|
| Intended Use | The Atlantis PV 15 MHz PeripheralImaging Catheter is intended forintravascular ultrasonic visualization. | The OptiCross 35 15 MHz PeripheralImaging Catheter is intended forintravascular ultrasonic visualization. |
| Indications for Use | The Atlantis PV Peripheral ImagingCatheter is intended for ultrasoundexamination of peripheral pathologyonly. Intravascular ultrasound imaging isindicated in patients who are candidatesfor transluminal interventional procedures. | The OptiCross 35 Peripheral ImagingCatheter is intended for ultrasoundexamination of peripheral vascularpathology only. Intravascular ultrasoundimaging is indicated in patients who arecandidates for transluminal interventionalprocedures. |
| Catheter Design | Sheath, Imaging Core with TelescopeSection | Sheath, Imaging Core with TelescopeSection |
| SAL | 10-6 | 10-6 |
| Packaging | Carrier tube assembly contained within athermoformed tray and a poly-Tyvekpouch, stored in a shelf carton | Carrier tube assembly contained within athermoformed tray and a poly-Tyvekpouch, stored in a shelf carton |
| Accessories | 3cc and 10cc syringes, 4-way stopcock,extension set | 3cc and 10cc syringes, 4-way stopcock,extension set |
| Single-Use | Yes | Yes |
| Specifications | ||
| GuidewireCompatibility | 0.035" (0.89mm) | 0.035" (0.89mm) |
| SheathCompatibility | ≥ 8.5 F | ≥ 8 F |
| Working Length | 95 cm | 105 cm |
| Sheath Design | Dual Lumen | Dual Lumen |
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| Distal Markers | Radiopaque catheter tip | Radiopaque catheter tip plus 25 additionalradiopaque markers, 1 cm apart |
|---|---|---|
| Dual Lumen SheathOD (max) | 0.111" | 0.108" |
| Biocompatibility | Meets all the requirements in accordancewith ISO 10993-1 | Meets all the requirements in accordancewith ISO 10993-1 |
| Scanning Method | Rotary Driveshaft | Rotary Driveshaft |
| Mode of Operation | B-Mode, Autoscanning | B-Mode, Autoscanning |
| Image Rate | 30 Hz Maximum | 30 Hz Maximum |
| Sector Angle | 360 Degrees | 360 Degrees |
| TransducerFrequency | 15 MHz | 15 MHz |
| Acoustic Output | Below FDA Track 1 limits | Below FDA Track 1 limits |
Non-Clinical Performance Data
Determination of substantial equivalence is based on an assessment of non-clinical performance bench testing, including 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, quidewire and sheath compatibility, image quality, non-uniform rotational distortion, measurement accuracy, general imaging capabilities, dimensional requirements, catheter tensile strengths, freedom from leak, visibility under fluoroscopy, interface with ancillary devices, environmental requirements, user interface requirements, corrosion resistance and particulates.
Biological Safety Testing:
Biocompatibility testing in accordance with ISO 10993-1, microbial assessments including bioburden and endotoxin, and pyrogenicity and sterility assurance testing show the device is biocompatible for its intended use.
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 (June 27, 2019). Acoustic Output test results for the OptiCross 35 15 MHz Peripheral Imaging Catheter are below the FDA Track 1 limits. Electromagnetic compatibility testing was also conducted demonstrating compliance to IEC 60601-1-2 (4th Edition) and IEC 60601-2-37 (Edition 2.1).
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 electron beam sterilization, climatic conditioning, and distribution challenge conditioning.
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| Clinical Testing | Performance testing from clinical studies is not required to demonstrate substantial equivalence of OptiCross 35 15 MHz Peripheral Imaging Catheter. |
|---|---|
| Conclusion | Based on the indications for use, technological characteristics, and performance testing, OptiCross 35 15 MHz Peripheral Imaging Catheter has been shown to be appropriate for its intended use and is considered to be substantially equivalent to Atlantis PV Imaging Catheter, K080272. |
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.