(58 days)
Not Found
No
The summary describes image processing to construct an OCT image but does not mention AI, ML, or any related terms like deep learning or neural networks. The performance studies are bench tests, not clinical studies that would typically be used to validate an AI/ML algorithm.
No.
The device is for imaging and diagnostic purposes (imaging of coronary arteries to construct an OCT image), not for treatment or therapy.
Yes
The device is intended for "imaging of coronary arteries" and constructs an "Optical Coherence Tomography (OCT) image," which is used to visualize internal structures for medical assessment, indicating a diagnostic purpose.
No
The device description clearly details a physical catheter with an internal rotating fiber optic imaging core, external sheath, torque wire, and a Drive-motor and Optical Controller (DOC). While software is used for image processing, the device itself includes significant hardware components.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- Intended Use: The intended use is for "imaging of coronary arteries" in patients undergoing transluminal interventional procedures. This is an in vivo (within a living organism) imaging procedure, not an in vitro (outside of a living organism) diagnostic test performed on biological samples.
- Device Description: The device is an intravascular catheter that is inserted into the coronary arteries. It uses light to image the internal structure of the arteries. This is a direct interaction with the patient's anatomy.
- Lack of Biological Sample Analysis: IVDs typically involve the analysis of biological samples such as blood, urine, tissue, etc. This device does not collect or analyze any such samples.
- Imaging Modality: Optical Coherence Tomography (OCT) is an imaging technique used to visualize internal structures, not a method for analyzing biological samples.
Therefore, the Dragonfly OpStar Imaging Catheter with the OCT imaging system is an in vivo imaging device, not an IVD.
N/A
Intended Use / Indications for 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 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.
Product codes (comma separated list FDA assigned to the subject device)
DOO
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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT)
Anatomical Site
coronary arteries
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)
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.
No clinical testing is provided in this pre-market notification.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Dragonfly OpStarTM Imaging Catheter, AptiVueTM Software version E.5.1 (K192019)
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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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
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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) |
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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. |