(302 days)
Not Found
No
The summary describes image processing and software control but does not mention AI, ML, or related concepts like deep learning, neural networks, or training/test sets for such algorithms.
No
Explanation: The device is described as an "Imaging System" intended for "imaging of coronary arteries" and "detection of lipid core containing plaques." Its primary function is diagnostic, providing information about the patient's condition rather than directly treating it.
Yes
Explanation: The "Intended Use / Indications for Use" section explicitly states that the device is "intended for the detection of lipid core containing plaques of interest," "intended for the assessment of coronary artery lipid core burden," and "intended for the identification of patients and plaques at increased risk of major adverse cardiac events." These descriptions clearly indicate that the device is used to identify or assess a medical condition, which is the definition of a diagnostic device.
No
The device description explicitly lists multiple hardware components (Console, Catheter Interface Unit, Imaging Catheter) in addition to the software.
Based on the provided information, the SpectraWAVE Imaging System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states the system is for "imaging of coronary arteries" and "detection of lipid core containing plaques" and "assessment of coronary artery lipid core burden" within the body of a patient. This is an in vivo application, not in vitro (outside the body).
- Device Description: The device is a catheter-based system designed to be inserted into the coronary arteries. This is consistent with an in vivo imaging device.
- Input Imaging Modality: OCT and NIRS are imaging modalities used to visualize structures and composition within the body.
- Anatomical Site: The target anatomical site is the coronary arteries, which are internal to the body.
IVD devices are typically used to examine specimens (like blood, urine, tissue) that have been taken from the body. The SpectraWAVE system directly interacts with and images structures within the body.
N/A
Intended Use / Indications for Use
The SpectraWAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
Product codes
NQQ, ORD, OGZ, IYO
Device Description
The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.
The SpectraWAVE Imaging System consists of the following components:
- Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
- Software: A proprietary application software that orchestrates the control, . acquisition, processing, and display of the OCT-NIRS data.
- . Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
- . Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Optical Coherence Tomography (OCT), Near Infrared Spectroscopy (NIRS)
Anatomical Site
Coronary arteries, vessels 2.0 to 5.2 mm in diameter.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physicians and healthcare professionals, Cardiac catheterization laboratory
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
Design verification and validation of the SpectraWAVE Imaging System were performed in compliance with external standards and internal design control procedures comprised of Sterilization and shelf life, Biocompatibility, Software, EMC/Electrical Safety, bench testing, animal testing, and summative usability testing to confirm device performance. All testing passed the acceptance criteria.
- Sterilization and Shelf Life: Sterilization validation was performed to ensure a SAL of 10°, according to international sterilization standards. Visual Inspection, Leak, and Seal Strength testing were used to evaluate the integrity of the packaging configuration. Testing was conducted after sterilization, environmental conditioning including aging, and simulated shipping and distribution.
- Biocompatibility: The SpectraWAVE Imaging Catheter was subjected to a series of biocompatibility tests in accordance with FDA quidance, using International Standard ISO 10993-1. The studies performed on the SpectraWAVE Imaging Catheter were determined to support the biocompatibility of the device for use in its intended application.
- Software: SpectraWAVE Imaging System and Application Software were developed and tested in compliance with IEC 62304. Software verification and validation were conducted to FDA regulations, standards, and guidance document requirements. The results of this testing conclude the software has met these requirements.
- EMC/Basic Electrical Safety: The SpectraWAVE Imaging System has been tested and is in compliance with general safety requirements, IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, and IEC 60825-1.
- Bench testing: SpectraWAVE performed a series of bench tests to demonstrate its system meets its performance specifications using production-equivalent, finished, sterilized, and preconditioned product. Comprehensive verification and validation activities were successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria.
- Animal Testing: SpectraWAVE conducted a GLP animal study to evaluate acute performance and vascular injury following deployment of the SpectraWAVE Imaging Catheter in a porcine coronary artery model. Overall, the test device met the acceptance criteria for the study and should be considered to have acceptable acute performance and safety.
- Summative Usability Testing: Usability evaluation was conducted to establish that the SpectraWAVE Imaging System meets the needs of the intended users to perform OCT-NIRS imaging safely and effectively according to ANSI/AAMI/IEC 62366-1. The SpectraWAVE Imaging System has been found to be safe and effective for the intended users, uses, and use environments.
- Clinical Testing: No clinical testing is provided in this pre-market notification.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left, there is a seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" arranged in a circular pattern. To the right of the seal, there is the FDA logo in blue, with the words "U.S. FOOD & DRUG" on top and "ADMINISTRATION" below. The logo is simple and professional, reflecting the FDA's role in regulating food and drugs.
February 28, 2023
SpectraWAVE, Inc. Farzad Parsaie VP, Quality Assurance & Regulatory Affairs 12 Oak Park Drive Bedford, Massachusetts 01730
Re: K221257
Trade/Device Name: SpectraWAVE Imaging System Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic pulsed echo imaging system Regulatory Class: Class II Product Code: NQQ, ORD, OGZ, IYO Dated: February 24, 2023 Received: February 24, 2023
Dear Farzad Parsaie:
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) K221257
Device Name
SpectraWAVE Imaging System
Indications for Use (Describe)
The Spectra WAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
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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3
Traditional 510(k) Summary
-
- Basic Information-Submitter:
| 510(k) Owner: | SpectraWAVE, Inc. |
|---|---|
| Address: | 12 Oak Park Drive |
| Bedford, MA 01730 | |
| (781) 701-8148 (main number) | |
| Official Contact: | Farzad Parsaie |
| VP, Quality Assurance & Regulatory Affairs | |
| (781) 701-8148 (main number) | |
| fparsaie@spectrawave.com | |
| Date Summary Prepared: | 28 February 2023 |
| 2. Device Name: | |
| Trade Name: | |
| Model Number: | |
| Common Name: | |
| Classification Name: | |
| Regulation Numbers: | SpectraWAVE Imaging System |
| System: 931; Catheter: 951 | |
| Optical Coherence Tomography Imaging System | |
| Ultrasonic pulsed echo imaging system | |
| Diagnostic intravascular catheter | |
| 21 CFR 892.1560, 21 CFR 870.1200 | |
| Product Code: | |
| Classification: | NQQ, ORD, OGZ, IYO |
| Class II |
-
- Predicate Devices:
2
- Predicate Devices:
-
K192019 Dragonfly OpStar™ Imaging Catheter, AptiVue™ Software version . E.5.1
-
. K183599 Infraredx, Inc. Makoto Intravascular Imaging System™, Dualpro™ IVUS+NIRS Imaging Catheter- secondary predicate
-
Device Description: 4.
The SpectraWAVE Imaging System is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure by combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS) in a single catheter-based system.
4
The SpectraWAVE Imaging System consists of the following components:
- Console: A mobile platform containing the optical and computing engine, physician and technologist touch displays, power distribution system, and input/output interface.
- Software: A proprietary application software that orchestrates the control, . acquisition, processing, and display of the OCT-NIRS data.
- . Catheter Interface Unit (CIU): A tethered CIU that controls the motion of the fiber optic imaging core within the Catheter sheath and connects the Catheter to the Console.
- . Imaging Catheter: A sterile, single patient use 2.5 French dual-modality imaging catheter containing a rotating fiber optic imaging core inside a protective sterile sheath.
-
- Indications for Use Statement:
The SpectraWAVE Imaging System is intended for the imaging of coronary arteries and is indicated in patients who are candidates for transluminal interventional procedures.
The SpectraWAVE Imaging Catheter is intended for use in vessels 2.0 to 5.2 mm in diameter.
The SpectraWAVE Imaging Catheter is not intended for use in a target vessel which has undergone a previous bypass procedure.
The NIRS capability of the SpectraWAVE Imaging System is intended for the detection of lipid core containing plaques of interest.
The NIRS capability of the SpectraWAVE Imaging System is intended for the assessment of coronary artery lipid core burden.
The NIRS capability of the SpectraWAVE Imaging System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
-
- Technological Characteristics:
The SpectraWAVE Imaging System is utilizing a primary and secondary predicate device as the product combines features of two predicate devices with the same intended use into a single new device. As shown in Tables 1 and 2 below, the SpectraWAVE Imaging System is substantially equivalent to the respective features of the two predicate devices because it has the same intended use, and the technological characteristics are similar and substantially equivalent to the cited predicates.
- Technological Characteristics:
5
| Table 1: Primary Predicate Device Comparison | |||
|---|---|---|---|
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of |
| Equivalence & | |||
| Differences | |||
| Model | SpectraWAVE Imaging System | OPTIS Imaging System | |
| Dragonfly OpStar™ Imaging Catheter | |||
| 510(k) Number | This submission | K192019 | NA |
| Product Code | NQQ - System, imaging, optical coherence | ||
| tomography | |||
| ORD - Optical Coherence Tomography, | |||
| Intravascular Catheter | NQQ - System, imaging, optical coherence | ||
| tomography | |||
| DQO - Catheter, Intravascular, Diagnostic | Same for NQQ code | ||
| Substantially | |||
| equivalent for ORD | |||
| vs DQO codes. | |||
| While the predicates | |||
| used DQO as an | |||
| additional code, the | |||
| ORD code is more | |||
| exact for both the | |||
| proposed and | |||
| predicate devices. | |||
| Intended Use | The SpectraWAVE Imaging System and the | ||
| SpectraWAVE Imaging Catheter are intended | |||
| for the imaging of coronary arteries. | The OPTIS Imaging System with Dragonfly | ||
| OpStar Imaging Catheter is intended for the | |||
| imaging of coronary arteries. | Same | ||
| Intended | |||
| Users | Physicians and healthcare professionals | Physicians and healthcare professionals | Same |
| Operational | |||
| Environment | Cardiac catheterization laboratory | Cardiac catheterization laboratory | Same |
| Indications | |||
| For Use | The SpectraWAVE 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 with | ||
| 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 | Substantially | ||
| equivalent for the | |||
| OCT portion of the | |||
| device. | |||
| The scan range of | |||
| the SpectraWAVE | |||
| Table 1: Primary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of |
| Equivalence & | |||
| Differences | |||
| Model | SpectraWAVE Imaging System | OPTIS Imaging System | |
| Dragonfly OpStar™ Imaging Catheter | |||
| The SpectraWAVE Imaging Catheter is | |||
| intended for use in vessels 2.0 to 5.2 mm in | |||
| diameter. |
The SpectraWAVE Imaging Catheter is not
intended for use in a target vessel which has
undergone a previous bypass procedure.
The NIRS capability of the SpectraWAVE
Imaging System is intended for the detection of
lipid core containing plaques of interest.
The NIRS capability of the SpectraWAVE
Imaging System is intended for the
assessment of coronary artery lipid core
burden.
The NIRS capability of the SpectraWAVE
Imaging System is intended for the
identification of patients and plaques at
increased risk of major adverse cardiac events. | 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.
The AptiVue™ E-series software is intended
for use only with compatible OPTIS™ imaging
systems. The OPTIS imaging system with a
compatible Dragonfly™ imaging catheter is
intended for the imaging of coronary arteries
and is indicated in patients who are candidates
for transluminal interventional procedures. The
compatible Dragonfly™ imaging catheters are
intended for use in vessels 2.0 to 3.5 mm in
diameter. The compatible Dragonfly™ imaging
catheters are not intended for use in the left
main coronary artery or in a target vessel
which has undergone a previous bypass
procedure.
The OPTIS imaging system is intended for use
in the catheterization and related
cardiovascular specialty laboratories and will
further compute and display various
physiological parameters based on the output
from one or more electrodes, transducers, or
measuring devices. The physician may use the
acquired physiological parameters, along with | Imaging System
allows imaging of
vessels up to 5.2mm
in diameter, which
covers the expected
range of left main
coronary arteries. |
| Table 1: Primary Predicate Device Comparison | | | |
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of
Equivalence &
Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System
Dragonfly OpStar™ Imaging Catheter | |
| System
Components | Imaging System reusable electrical mechanical
unit
Intravascular imaging catheter
Disposable accessories | Imaging System reusable electrical mechanical
unit
Intravascular imaging catheter
Disposable accessories | Substantially
Equivalent |
| Primary
Functions | Delivers energy (infrared light) to the tissue.
Measures the depth and pattern of reflections
from the tissue from the return near infrared
light to create high resolution, real time images.
Stores images for evaluation and review. | Delivers energy (infrared light) to the tissue.
Measures the depth and pattern of reflections
from the tissue from the return near infrared
light to create high resolution, real time images.
Stores images for evaluation and review. | Same |
| Image
Creation,
Display and
Storage | Process reflected optical signals to construct
images.
Display images.
Store images. | Process reflected optical signals to construct
images.
Display images.
Store images. | Same |
| Measure
Vessel Cross
Sectional Area | Calculate and report vessel cross sectional
area | Calculate and report vessel cross sectional
area | Same |
| Measure
Vessel Linear
Dimensions | Calculate and display vessel diameter at user
specified locations within the displayed image | Calculate and display vessel diameter at user
specified locations within the displayed image | Same |
| Calculate
Vessel
Physical
Parameters | Calculate and display mathematical
comparisons of image data such as %
reduction from average, length of narrowing. | Calculate and display mathematical
comparisons of image data such as %
reduction from average, length of narrowing. | Same |
| Table 1: Primary Predicate Device Comparison | | | |
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of
Equivalence &
Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System
Dragonfly OpStar™ Imaging Catheter | |
| Procedural
Steps | System set-up, patient data entry, catheter
preparation insertion of catheter into the artery
under fluoroscopic guidance, proper
positioning of the catheter distal to the target
vessel, image acquisition and evaluation of the
acquired images. | System set-up, patient data entry, catheter
preparation and flushing, insertion of catheter
into the artery under fluoroscopic guidance,
proper positioning of the catheter distal to the
target vessel, image acquisition and evaluation
of the acquired images. | Substantially
Equivalent |
| Use of Results | Physicians evaluate the images in combination
with other tests and evaluations to assess the
patient's coronary arteries. | Physicians evaluate the images in combination
with other tests and evaluations to assess the
patient's coronary arteries. | Same |
| Imaging Catheter | | | |
| Primary
Functions | To position the catheter into the vessel to be
imaged.
To deliver near infrared light to tissues.
To collect reflections. | To position the catheter into the vessel to be
imaged.
To deliver near infrared light to tissues.
To collect reflections. | Same |
| Design
Features | Rapid exchange, mono-rail tip design with two
sub-assemblies (catheter sheath and imaging
core). | Rapid exchange, mono-rail tip design with two
sub-assemblies (catheter sheath and imaging
core). | Same |
| Sterile | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Guide Wire
Compatibility | Compatible with 0.014" guide wires | Compatible with 0.014" guide wires | Same |
| Dimensions,
Catheter | 2.5 Fr diameter window
141 cm insertable length | ≤ 3.0 Fr diameter window
135 cm (min) insertable length | Substantially
equivalent.
Performance test
data, including |
| Table 1: Primary Predicate Device Comparison | | | |
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of Equivalence & Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System
Dragonfly OpStar™ Imaging Catheter | bench, in-vitro and in-vivo testing, demonstrates that the images and measurements provided by the SpectraWAVE Imaging System are substantially equivalent to the Abbott OPTIS Imaging System and Dragonfly OpStar Imaging Catheter. |
| Tip Design | Distal tip delivers near infrared light onto the tissue and collects reflections | Distal tip delivers near infrared light onto the tissue and collects reflections | Same |
| Body Contact | Direct blood contact | Direct blood contact | Same |
| Biocompatibility | Per ISO 10993-1 | Per ISO 10993-1 | Same |
| Insertion | Inserted into an artery under fluoroscopic guidance.
Catheter positioned distal to the target region in the vessel to be imaged. | Inserted into an artery under fluoroscopic guidance.
Catheter positioned distal to the target region in the vessel to be imaged. | Same |
| Rotational Movement | Imaging core rotates inside a sheath within the vessel to obtain full 360 degrees to deliver light to create a cross-sectional image. | Imaging core rotates inside the sheath within the vessel to obtain full 360 degrees to deliver light to create a cross-sectional image. | Same |
| Table 1: Primary Predicate Device Comparison | | | |
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of
Equivalence &
Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging System
Dragonfly OpStar™ Imaging Catheter | |
| Longitudinal
Movement | Imaging core moves longitudinally inside a
sheath within the vessel to obtain images
across the length of the target vessel
(pullback). | Imaging core moves longitudinally inside a
sheath within the vessel to obtain images
across the length of the target vessel
(pullback). | Same |
| | Reusable Electrical Mechanical Unit | | |
| Energy
Source | Near infrared light | Near infrared light | Same |
| Weight | 200 lbs (approximate) |