Who is the manufacturer of Dragonfly OpStar Imaging Catheter?

ABBOTT MEDICAL filed the 510(k) submission for Dragonfly OpStar Imaging Catheter (K230411).

What is the FDA product code for Dragonfly OpStar Imaging Catheter?

DQO. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Dragonfly OpStar Imaging Catheter?

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

What are the predicate devices for Dragonfly OpStar Imaging Catheter?

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019).

Who can help prepare an FDA 510(k) submission like Dragonfly OpStar 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.

Dragonfly OpStar Imaging Catheter

K230411 · ABBOTT MEDICAL · DQO · Apr 14, 2023 · Cardiovascular

Device Facts

Record ID	K230411
Device Name	Dragonfly OpStar Imaging Catheter
Applicant	ABBOTT MEDICAL
Product Code	DQO · Cardiovascular
Decision Date	Apr 14, 2023
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 870.1200
Device Class	Class 2

Intended Use

The Dragonfly OpStar™ Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragong Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure.

Device Story

Sterile, single-use intravascular catheter; external sheath facilitates placement; internal rotating fiber optic imaging core emits near-infrared light; receives reflected light; stainless-steel torque wire visible under fluoroscopy; pulled back through window tube by Drive-motor and Optical Controller (DOC); emitted/reflected light processed by OPTIS System software to construct OCT images; used in clinical interventional settings by physicians; provides real-time visualization of coronary artery structures; aids clinical decision-making during interventional procedures; patient benefit includes high-resolution imaging of coronary anatomy.

Clinical Evidence

No clinical testing provided. Bench testing only; design verification and validation tests confirmed device meets user needs and product specifications.

Technological Characteristics

Sterile, single-use intravascular catheter. Components: external sheath, internal rotating fiber optic imaging core, stainless-steel torque wire. Principle: Optical Coherence Tomography (OCT) using near-infrared light. Dimensions: compatible with 2.0-3.5 mm vessels. Connectivity: interfaces with Drive-motor and Optical Controller (DOC) and OPTIS System software.

Indications for Use

Indicated for patients who are candidates for transluminal interventional procedures requiring coronary artery imaging. Vessel diameter 2.0-3.5 mm. Contraindicated for left main coronary artery or vessels with previous bypass procedures.

Regulatory Classification

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.

Predicate Devices

Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version E.5.1 (K192019)

Related Devices

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K242098 — Cornaris Intravascular Imaging System (P80-E); Cornaris Intravascular Imaging System (Mobile-E); LumenCross Imaging Catheter (F2) · Shenzhen Vivolight Medical Device & Technology Co., Ltd. · Apr 11, 2025
K242966 — Gentuity® HF-OCT Imaging System with Vis-Rx Prime® Micro-Imaging Catheter · Gentuity, LLC · Jan 31, 2025
K093857 — C7 XR IMAGING SYSTEM WITH C7 DRAGONFLY IMAGING CATHETER AND DISPOSABLE ACCESSORIES · Lightlab Imaging, Inc. · Apr 30, 2010

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows 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 14, 2023 Abbott Medical Mingzi Deng Associate Director, Regulatory Affairs 4 Robbins Road Westford, Massachusetts 01886 Re: K230411 Trade/Device Name: Dragonfly OpStar™ Imaging Catheter Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: DOO Dated: February 14, 2023 Received: February 15, 2023 Dear Mingzi Deng: 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 {1}------------------------------------------------ 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 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, Aneesh S. Deoras -S Aneesh Deoras 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) K230411 Device Name Dragonfly OpStar™ Imaging Catheter #### Indications for Use (Describe) The Dragonfly OpStar™ Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragong Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. | 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) | ## 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}------------------------------------------------ # 510(K) SUMMARY | 510(k) SUMMARY | | |------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | | 510(k) Summary Per 21 CFR §807.92 | | 510(k) Number | K230411 | | Date Prepared | February 14, 2023 | | Submitter Name & Address | Abbott Medical 4 Robbins Road Westford, MA, 01886 | | Contact Person | Derek Pike 978-577-3595 | | Alternative Contact Person | Mingzi Deng 781-640-4474 | | Proprietary / Trade Name | Dragonfly OpStarTM Imaging Catheter | | Common / Usual Name | Diagnostic Imaging Catheter | | Product Classification | Product Code: DQO | | Product Regulation Number | 21 CFR 870.1200 | | Predicate Device | Dragonfly OpStarTM Imaging Catheter, AptiVueTM Software version E.5.1 (K192019), cleared 11 November 2019 | | Device Description | The Dragonfly OpStar Imaging Catheter is a sterile, single-use intravascular catheter consisting of a catheter body external sheath and an internal rotating fiber optic imaging core. The external sheath serves two primary functions: 1) to facilitate placement of the device into the coronary artery and 2) to cover and protect the internal rotating fiber optic imaging core. The inner rotating fiber optic imaging core emits near infrared light to tissues and receives reflected light. It is driven by a stainless-steel torque wire visible under fluoroscopy and pulled back through the window tube of the external sheath by the Drive-motor and Optical Controller (DOC). The emitted and returned reflected light are combined and processed by the OPTIS System software to construct an Optical Coherence Tomography (OCT) image. The patient is never exposed to moving parts as the external sheath completely covers the rotating imaging core. | | Indications for Use / Intended Use | The Dragonfly OpStarTM Imaging Catheter with the OCT imaging system is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. | {4}------------------------------------------------ | Comparison of Subject to Predicate Device | The Dragonfly OpStar Imaging Catheter is substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of intended use, indications for use, operational characteristics, fundamental design, and technological characteristics. There are no technological differences between the predicate device and new device. | | | |-------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------| | | | Feature | Predicate Device: Dragonfly OpStar Imaging Catheter (K192019) | | | Intended Use | The Dragonfly OpStar Imaging Catheter with the OCT imaging system is intended for the visualization and imaging of coronary arteries during an interventional procedure. | Same | | | Indications for Use | Intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures. The Dragonfly OpStar Imaging Catheter is intended for use in vessels 2.0 to 3.5 mm in diameter. The Dragonfly OpStar Imaging Catheter is not intended for use in the left main coronary artery or in a target vessel which has undergone a previous bypass procedure. | Same | | Summary on Non-Clinical Testing | Design verification and validation bench tests were performed on the Dragonfly OpStar Imaging Catheter in compliance with internal design control procedures. The results demonstrate that the Dragonfly OpStar Imaging Catheter meets the user needs and product specifications and is appropriate for its intended use and does not raise any new issues of safety and effectiveness. | | | | Summary of Clinical Testing | No clinical testing is provided in this pre-market notification. | | | | Statement of Equivalence | The Dragonfly OpStar Imaging Catheter is substantially equivalent to the predicate Dragonfly OpStar Imaging Catheter (K192019) in terms of intended use, indications for use, operational characteristics, fundamental design, and technological characteristics. | | |