(28 days)
OptiCross 18 30 MHz Peripheral Imaging Catheter (K160514)
No
The description focuses on the hardware components and basic signal processing for visualization, with no mention of AI/ML for image analysis, interpretation, or other functions.
No.
The device is solely for diagnostic purposes (ultrasound examination of peripheral vascular pathology and visualization of intravascular structures), not for treating any condition.
Yes
The device is described as an "ultrasound examination of peripheral vascular pathology" and "ultrasonic visualization of the peripheral vasculature." Its purpose is to provide "live visualization of intravascular structures," which are all diagnostic functions.
No
The device description clearly details a physical catheter with a transducer, drive cable, and other hardware components, which are integral to its function. While it interacts with a system that processes signals (which likely includes software), the device itself is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "ultrasound examination of peripheral vascular pathology only." This is an in vivo imaging procedure, meaning it is performed within the living body.
- Device Description: The description details a catheter with an ultrasonic transducer that is inserted into the peripheral vasculature to visualize structures inside the body.
- Mechanism of Action: The device uses ultrasound to create images of internal structures. This is a form of medical imaging, not a test performed on biological samples outside the body.
IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
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.
Product codes
ITX, OBJ
Device Description
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
peripheral vascular
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 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.
Clinical Testing:
Performance testing from clinical studies is not required to demonstrate substantial equivalence of OptiCross 35 15 MHz Peripheral Imaging Catheter.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Atlantis PV Imaging Catheter (K080272)
Reference Device(s)
OptiCross 18 30 MHz Peripheral Imaging Catheter (K160514)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
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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
1
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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Boston Scientific Corporation 300 Boston Scientific Way Marlborough, MA 01752 (508) 683-4000
| Sponsor | Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, Massachusetts 01752
USA |
|-------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Name
and Information | Jennifer L. Foley, DVM
Three Scimed Place
Maple Grove, MN 55311-1566
Phone: 763-955-8049
Fax: 763-494-2222
Email: Jennifer.Foley@bsci.com |
| Proprietary Name | OptiCross 35 15 MHz Peripheral Imaging Catheter |
| Common Name | Transducer, Ultrasonic, Diagnostic
Catheter, Ultrasound Intravascular |
| Product Code | ITX, OBJ |
| Classification | 21 CFR 892.1570 – Transducer, Ultrasonic, Diagnostic
21 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), cleared
June 22, 2016 |
| Device
Description | 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. |
| Indications for
Use/ Intended
Use | OptiCross 35 15 MHz Peripheral Imaging Catheter is intended for
ultrasound examination of peripheral vascular pathology only.
Intravascular ultrasound imaging is indicated for patients who are
candidates for transluminal interventional procedures. |
| Device
Technology
Characteristics
and Comparison
to Predicate
Device | OptiCross 35 15 MHz Peripheral Imaging Catheter incorporates the
following changes from the predicate Atlantis PV Imaging Catheter
(K080272): an updated hub that aligns with other marketed OptiCross
catheters; modified telescope markers; additional radiopaque markers
along the distal portion of the catheter; a longer, smoother taper to the
distal catheter tip; addition of a strain relief to prevent kinking; addition
of equivalent materials within the sheath and drive cable due to vendor
obsolescence; and updated packaging appropriate for the newly
designed device. |
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| Characteristic | Predicate
Atlantis PV (K080272) | Proposed
OptiCross 35 (OC35) |
|----------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | The Atlantis PV 15 MHz Peripheral
Imaging Catheter is intended for
intravascular ultrasonic visualization. | The OptiCross 35 15 MHz Peripheral
Imaging Catheter is intended for
intravascular ultrasonic visualization. |
| Indications for Use | The Atlantis PV Peripheral Imaging
Catheter is intended for ultrasound
examination of peripheral pathology
only. Intravascular ultrasound imaging is
indicated in patients who are candidates
for transluminal interventional procedures. | The OptiCross 35 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. |
| Catheter Design | Sheath, Imaging Core with Telescope
Section | Sheath, Imaging Core with Telescope
Section |
| SAL | 10-6 | 10-6 |
| Packaging | Carrier tube assembly contained within a
thermoformed tray and a poly-Tyvek
pouch, stored in a shelf carton | Carrier tube assembly contained within a
thermoformed tray and a poly-Tyvek
pouch, 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 | | |
| Guidewire
Compatibility | 0.035" (0.89mm) | 0.035" (0.89mm) |
| Sheath
Compatibility | ≥ 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 additional
radiopaque markers, 1 cm apart |
|-------------------------------|--------------------------------------------------------------|------------------------------------------------------------------------------|
| Dual Lumen Sheath
OD (max) | 0.111" | 0.108" |
| Biocompatibility | Meets all the requirements in accordance
with ISO 10993-1 | Meets all the requirements in accordance
with 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 |
| Transducer
Frequency | 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. |