Who is the manufacturer of Opticross 35 15 MHz Peripheral Imaging Catheter?

Boston Scientific Corporation filed the 510(k) submission for Opticross 35 15 MHz Peripheral Imaging Catheter (K200733).

What is the FDA product code for Opticross 35 15 MHz Peripheral Imaging Catheter?

ITX. It is classified under 21 CFR 892.1570 as a Class 2 device in the Radiology panel.

What is the regulatory pathway for Opticross 35 15 MHz Peripheral Imaging Catheter?

510(k) clearance (submission type: Special).

Who can help prepare an FDA 510(k) submission like Opticross 35 15 MHz Peripheral Imaging Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Opticross 35 15 MHz Peripheral Imaging Catheter

Q: What are the predicate devices for Opticross 35 15 MHz Peripheral Imaging Catheter?

Atlantis PV Imaging Catheter (K080272).

K200733 · Boston Scientific Corporation · ITX · Apr 17, 2020 · Radiology

Device Facts

Record ID	K200733
Device Name	Opticross 35 15 MHz Peripheral Imaging Catheter
Applicant	Boston Scientific Corporation
Product Code	ITX · Radiology
Decision Date	Apr 17, 2020
Decision	SESE
Submission Type	Special
Regulation	21 CFR 892.1570
Device Class	Class 2

Intended 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.

Device Story

The OptiCross 35 is an intravascular ultrasound (IVUS) imaging catheter used with the iLab Ultrasound Imaging System and MDU5 PLUS motor drive unit. It features a dual-lumen sheath and a telescoping section for 25cm of linear movement. The imaging core contains a rotating drive cable with a 15 MHz PZT transducer at the distal tip. During use, the catheter is flushed with heparinized saline as an acoustic medium. The transducer converts electrical impulses from the motor drive into acoustic energy and receives reflected signals, which are processed by the iLab system for 360° live visualization of peripheral vasculature. Used in clinical settings by physicians, the device aids in the assessment of vascular pathology during interventional procedures. It includes 25 radiopaque markers for positioning. The system provides real-time imaging to guide clinical decision-making and improve procedural outcomes.

Clinical Evidence

No clinical data was required or provided. Substantial equivalence was demonstrated through non-clinical bench testing, including physical integrity, functionality, deliverability, image quality, measurement accuracy, biocompatibility, electromagnetic compatibility (IEC 60601-1-2, IEC 60601-2-37), and packaging validation (ISO 11607).

Technological Characteristics

15 MHz PZT transducer; rotary driveshaft mechanism; dual-lumen sheath; 0.035" guidewire compatibility; 105 cm working length; 25 radiopaque gold markers; electron beam sterilization; biocompatibility per ISO 10993-1; acoustic output below FDA Track 1 limits; compliant with IEC 60601-1-2 and IEC 60601-2-37.

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring ultrasound examination of peripheral vascular pathology.

Regulatory Classification

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.

Predicate Devices

Atlantis PV Imaging Catheter (K080272)

Reference Devices

OptiCross 18 30 MHz Peripheral Imaging Catheter (K160514)

Related Devices

K160514 — OptiCross 18, 30 MHz Peripheral Imaging Catheter · Boston Scientific Corporation · Jun 22, 2016
K222568 — OptiCross 18 Peripheral Imaging Catheter · Boston Scientific Corporation · Sep 23, 2022
K123621 — OPTICROSS 40 MHZ CORONARY IMAGING CATHETER · Boston Scientific Corp · Apr 15, 2013
K161125 — OptiCross X, 40 MHz Coronary Imaging Catheter · Boston Scientific Corporation · May 19, 2016
K153617 — OptiCross 6, 40 MHz Coronary Imaging Catheter (US Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (EU Distribution), OptiCross 6, 40 MHz Coronary Imaging Catheter (Intercontinental Distribution) · Boston Scientific Corporation · Feb 25, 2016

Submission Summary (Full Text)

{0}------------------------------------------------ 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, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue. 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 {2}------------------------------------------------ # 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) | <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> <line stroke="black" stroke-width="2" x1="2" x2="13" y1="2" y2="13"></line> <line stroke="black" stroke-width="2" x1="13" x2="2" y1="2" y2="13"></line> </svg> Prescription Use (Part 21 CFR 801 Subpart D) | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | <svg height="15" width="15"> <rect fill="none" height="15" stroke="black" stroke-width="1" width="15" x="0" y="0"></rect> </svg> Over-The-Counter Use (21 CFR 801 Subpart C) | #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ 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 www.bostonscientific.com | 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. | {4}------------------------------------------------ | 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 | {5}------------------------------------------------ | 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. {6}------------------------------------------------ | 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. |