(302 days)
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.
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.
This document describes the SpectraWAVE Imaging System, an intravascular imaging device combining Optical Coherence Tomography (OCT) and Near Infrared Spectroscopy (NIRS). It aims to demonstrate substantial equivalence to predicate devices, K192019 Dragonfly OpStar™ Imaging Catheter and K183599 Makoto Intravascular Imaging System™.
Here's an analysis of the acceptance criteria and the study that proves the device meets the acceptance criteria, based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not contain a specific table detailing quantitative acceptance criteria for device performance (e.g., accuracy, sensitivity, specificity for NIRS detection of lipid-core plaques) and corresponding reported performance values for each criterion. Instead, it broadly states that "All testing passed the acceptance criteria" for bench testing and that the animal study met acceptance criteria for acute performance and safety.
The Indications for Use (page 3) serve as a high-level set of intended performance characteristics for the NIRS capability:
- Detection of lipid core containing plaques of interest.
- Assessment of coronary artery lipid core burden.
- Identification of patients and plaques at increased risk of major adverse cardiac events.
However, specific numerical acceptance criteria for these indications (e.g., a minimum sensitivity or specificity for lipid core detection) are not provided in this document. The Device Comparison Tables (Table 1 and Table 2, pages 5-6) compare various technical specifications (e.g., catheter diameter, image collection time, rotational rate) to predicate devices, indicating that the SpectraWAVE device's specifications are "Substantially equivalent," which implies they meet comparable functional performance as the predicates.
For instance, a comparison point that serves as an implicit performance and acceptance criterion for the OCT portion is the "SpectraWAVE Imaging System allows imaging of vessels up to 5.2mm in diameter, which covers the expected range of left main coronary arteries" as stated in the "Discussion of Equivalence & Differences" column (page 6) when comparing to the primary predicate which is limited to 3.5mm. This implies the SpectraWAVE device meets or exceeds the imaging range of its predicate for OCT.
Similarly, under "NIRS Verification & Validation summarizes the NIRS performance of the SpectraWAVE system, with the predicate device as a reference" in Table 2, it indicates that the NIRS performance was evaluated against the predicate, implying an acceptance criterion of comparable performance. However, the specific quantitative comparison is not detailed here.
Given the absence of a detailed quantitative table in the provided text, a summary is provided below based on the implicit and some explicit performance claims.
| Acceptance Criteria (Inferred from Comparisons & Indications for Use) | Reported Device Performance (General Statements) |
|---|---|
| OCT Imaging: Imaging of coronary arteries, vessel diameter 2.0 to 5.2 mm. | "SpectraWAVE Imaging System allows imaging of vessels up to 5.2mm in diameter, which covers the expected range of left main coronary arteries." (page 6). Bench testing "successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria." (page 17) |
| NIRS Capability: Detection of lipid core containing plaques. | "NIRS Verification & Validation summarizes the NIRS performance of the SpectraWAVE system, with the predicate device as a reference." (page 1-2 of Table 2 discussion, page 7). Bench testing "successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria." (page 17). |
| NIRS Capability: Assessment of coronary artery lipid core burden. | "NIRS Verification & Validation summarizes the NIRS performance of the SpectraWAVE system, with the predicate device as a reference." (page 1-2 of Table 2 discussion, page 7). Bench testing "successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria." (page 17). |
| NIRS Capability: Identification of patients and plaques at increased risk of MACE. | "NIRS Verification & Validation summarizes the NIRS performance of the SpectraWAVE system, with the predicate device as a reference." (page 1-2 of Table 2 discussion, page 7). Bench testing "successfully completed, raising no new issues of safety or effectiveness. All testing passed the acceptance criteria." (page 17). |
| Catheter Safety & Performance: Acute performance and vascular injury in vivo. | Animal study: "the test device met the acceptance criteria for the study and should be considered to have acceptable acute performance and safety." (page 17) |
| General System Performance: Compliance with technical specifications and safety standards. | Bench testing: "demonstrates its system meets its performance specifications." "All testing passed the acceptance criteria." (page 17). Compliance with IEC 60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 62366-1, and IEC 60825-1 (EMC/Basic Electrical Safety, page 16). Software V&V met FDA regulations, standards, and guidance (page 16). Usability met ANSI/AAMI/IEC 62366-1 (page 17). Sterilization SAL 10^-6 (page 16). |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set Sample Size: The document does not specify exact sample sizes for test sets in a numerical sense (e.g., number of cases or images) for performance studies related to lipid core detection or OCT imaging metrics. It mentions "a series of bench tests" (page 17) and "a GLP animal study" (page 17).
- Data Provenance:
- Bench Testing: In vitro, conducted internally by SpectraWAVE.
- Animal Testing: In vivo, conducted in a porcine coronary artery model, GLP (Good Laboratory Practice) study (page 17).
- Clinical Testing: "No clinical testing is provided in this pre-market notification." (page 17)
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts
This information is not provided in the document. Since no clinical testing was performed and detailed performance metrics for NIRS/OCT interpretation by experts are not discussed, there's no mention of experts establishing ground truth for a test set. Ground truth for the animal study would typically be established through pathological examination by veterinary pathologists, but details are not provided.
4. Adjudication Method for the Test Set
This information is not provided in the document. Without details on expert review or ground truth establishment by multiple parties, an adjudication method cannot be inferred.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study focusing on human readers' improvement with or without AI assistance was not explicitly described or provided in this pre-market notification. The document states, "No clinical testing is provided in this pre-market notification." (page 17).
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
The document broadly mentions "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." (page 16). While this confirms the software's functional correctness and validation, it does not specifically describe a standalone performance study of the algorithm's diagnostic capabilities (e.g., NIRS lipid core detection accuracy) without human intervention. The NIRS capability is intended for detection and assessment, implying an algorithmic component, but its standalone performance against a ground truth is not detailed in terms of metrics.
7. The Type of Ground Truth Used
- Bench Testing: Ground truth would be derived from known physical properties and measurements of phantoms or test objects.
- Animal Testing: Ground truth for acute performance and safety in the porcine model would typically involve direct observation, physiological measurements, and subsequent histopathological analysis of the vessel tissue. The document refers to "vascular injury" assessment, which implies pathological ground truth (page 17).
- NIRS Performance (implicit): The NIRS capabilities are compared against a predicate device, suggesting the predicate's established performance serves as a comparative reference, rather than explicitly an independent "ground truth" like pathology for novel claims. However, the predicate device (Makoto Intravascular Imaging System) itself utilizes NIRS for lipid core detection, which would have been validated against pathology in its original submission.
8. The Sample Size for the Training Set
This information is not provided. The document does not describe the development or training of any AI/ML models that would typically require a training set. Given that it's a 510(k) submission, the focus is on substantial equivalence rather than novel AI algorithm validation with separate training/test sets. Performance is demonstrated through equivalency to predicates and standard engineering verification and validation activities.
9. How the Ground Truth for the Training Set was Established
This information is not provided as no training set or AI/ML model training is described.
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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
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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) 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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Traditional 510(k) Summary
-
- Basic Information-Submitter:
| 510(k) Owner: | SpectraWAVE, Inc. |
|---|---|
| Address: | 12 Oak Park DriveBedford, MA 01730(781) 701-8148 (main number) |
| Official Contact: | Farzad ParsaieVP, 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 SystemSystem: 931; Catheter: 951Optical Coherence Tomography Imaging SystemUltrasonic pulsed echo imaging systemDiagnostic intravascular catheter21 CFR 892.1560, 21 CFR 870.1200 |
| Product Code:Classification: | NQQ, ORD, OGZ, IYOClass 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.
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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:
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| Table 1: Primary Predicate Device Comparison | |||
|---|---|---|---|
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly OpStar™ Imaging Catheter | |
| 510(k) Number | This submission | K192019 | NA |
| Product Code | NQQ - System, imaging, optical coherencetomographyORD - Optical Coherence Tomography,Intravascular Catheter | NQQ - System, imaging, optical coherencetomographyDQO - Catheter, Intravascular, Diagnostic | Same for NQQ codeSubstantiallyequivalent for ORDvs DQO codes.While the predicatesused DQO as anadditional code, theORD code is moreexact for both theproposed andpredicate devices. |
| Intended Use | The SpectraWAVE Imaging System and theSpectraWAVE Imaging Catheter are intendedfor the imaging of coronary arteries. | The OPTIS Imaging System with DragonflyOpStar Imaging Catheter is intended for theimaging of coronary arteries. | Same |
| IntendedUsers | Physicians and healthcare professionals | Physicians and healthcare professionals | Same |
| OperationalEnvironment | Cardiac catheterization laboratory | Cardiac catheterization laboratory | Same |
| IndicationsFor Use | The SpectraWAVE Imaging System is intendedfor the imaging of coronary arteries and isindicated in patients who are candidates fortransluminal interventional procedures. | The Dragonfly OpStar™ imaging catheter withOCT imaging system is intended for theimaging of coronary arteries and is indicated inpatients who are candidates for transluminalinterventional procedures. The DragonflyOpStar Imaging Catheter is intended for use in | Substantiallyequivalent for theOCT portion of thedevice.The scan range ofthe SpectraWAVE |
| Table 1: Primary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly OpStar™ Imaging Catheter | |
| The SpectraWAVE Imaging Catheter isintended for use in vessels 2.0 to 5.2 mm indiameter.The SpectraWAVE Imaging Catheter is notintended for use in a target vessel which hasundergone a previous bypass procedure.The NIRS capability of the SpectraWAVEImaging System is intended for the detection oflipid core containing plaques of interest.The NIRS capability of the SpectraWAVEImaging System is intended for theassessment of coronary artery lipid coreburden.The NIRS capability of the SpectraWAVEImaging System is intended for theidentification of patients and plaques atincreased risk of major adverse cardiac events. | vessels 2.0 to 3.5 mm in diameter. TheDragonfly OpStar Imaging Catheter is notintended for use in the left main coronary arteryor in a target vessel which has undergone aprevious bypass procedure.The AptiVue™ E-series software is intendedfor use only with compatible OPTIS™ imagingsystems. The OPTIS imaging system with acompatible Dragonfly™ imaging catheter isintended for the imaging of coronary arteriesand is indicated in patients who are candidatesfor transluminal interventional procedures. Thecompatible Dragonfly™ imaging catheters areintended for use in vessels 2.0 to 3.5 mm indiameter. The compatible Dragonfly™ imagingcatheters are not intended for use in the leftmain coronary artery or in a target vesselwhich has undergone a previous bypassprocedure.The OPTIS imaging system is intended for usein the catheterization and relatedcardiovascular specialty laboratories and willfurther compute and display variousphysiological parameters based on the outputfrom one or more electrodes, transducers, ormeasuring devices. The physician may use theacquired physiological parameters, along with | Imaging Systemallows imaging ofvessels up to 5.2mmin diameter, whichcovers the expectedrange of left maincoronary arteries. | |
| Table 1: Primary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly OpStar™ Imaging Catheter | |
| SystemComponents | Imaging System reusable electrical mechanicalunitIntravascular imaging catheterDisposable accessories | Imaging System reusable electrical mechanicalunitIntravascular imaging catheterDisposable accessories | SubstantiallyEquivalent |
| PrimaryFunctions | Delivers energy (infrared light) to the tissue.Measures the depth and pattern of reflectionsfrom the tissue from the return near infraredlight 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 reflectionsfrom the tissue from the return near infraredlight to create high resolution, real time images.Stores images for evaluation and review. | Same |
| ImageCreation,Display andStorage | Process reflected optical signals to constructimages.Display images.Store images. | Process reflected optical signals to constructimages.Display images.Store images. | Same |
| MeasureVessel CrossSectional Area | Calculate and report vessel cross sectionalarea | Calculate and report vessel cross sectionalarea | Same |
| MeasureVessel LinearDimensions | Calculate and display vessel diameter at userspecified locations within the displayed image | Calculate and display vessel diameter at userspecified locations within the displayed image | Same |
| CalculateVesselPhysicalParameters | Calculate and display mathematicalcomparisons of image data such as %reduction from average, length of narrowing. | Calculate and display mathematicalcomparisons of image data such as %reduction from average, length of narrowing. | Same |
| Table 1: Primary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly OpStar™ Imaging Catheter | |
| ProceduralSteps | System set-up, patient data entry, catheterpreparation insertion of catheter into the arteryunder fluoroscopic guidance, properpositioning of the catheter distal to the targetvessel, image acquisition and evaluation of theacquired images. | System set-up, patient data entry, catheterpreparation and flushing, insertion of catheterinto the artery under fluoroscopic guidance,proper positioning of the catheter distal to thetarget vessel, image acquisition and evaluationof the acquired images. | SubstantiallyEquivalent |
| Use of Results | Physicians evaluate the images in combinationwith other tests and evaluations to assess thepatient's coronary arteries. | Physicians evaluate the images in combinationwith other tests and evaluations to assess thepatient's coronary arteries. | Same |
| Imaging Catheter | |||
| PrimaryFunctions | To position the catheter into the vessel to beimaged.To deliver near infrared light to tissues.To collect reflections. | To position the catheter into the vessel to beimaged.To deliver near infrared light to tissues.To collect reflections. | Same |
| DesignFeatures | Rapid exchange, mono-rail tip design with twosub-assemblies (catheter sheath and imagingcore). | Rapid exchange, mono-rail tip design with twosub-assemblies (catheter sheath and imagingcore). | Same |
| Sterile | Yes | Yes | Same |
| Single Use | Yes | Yes | Same |
| Guide WireCompatibility | Compatible with 0.014" guide wires | Compatible with 0.014" guide wires | Same |
| Dimensions,Catheter | 2.5 Fr diameter window141 cm insertable length | ≤ 3.0 Fr diameter window135 cm (min) insertable length | Substantiallyequivalent.Performance testdata, including |
| Table 1: Primary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion of Equivalence & Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly 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 ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly OpStar™ Imaging Catheter | |
| LongitudinalMovement | Imaging core moves longitudinally inside asheath within the vessel to obtain imagesacross the length of the target vessel(pullback). | Imaging core moves longitudinally inside asheath within the vessel to obtain imagesacross the length of the target vessel(pullback). | Same |
| Reusable Electrical Mechanical Unit | |||
| EnergySource | Near infrared light | Near infrared light | Same |
| Weight | 200 lbs (approximate) | < 209 lbs (approximate) | Substantiallyequivalent |
| OperatingConditions | 10 - 32°C5 - 80% RH, non-condensing | 10 - 32°C30 - 80% Relative Humidity | Substantiallyequivalent |
| Imaging and Pullback Specifications | |||
| CatheterRotationalRate | 200 per second | 180 per second | Substantiallyequivalent |
| Frame Rate | 200 per second | 180 per second | Substantiallyequivalent |
| AutomatedPullback | Yes | Yes | Same |
| Image Length | 50 mm / 110 mm | 54 mm / 75 mm | Substantiallyequivalent |
| ImageCollectionTime | Approximately 2 seconds | Approximately 2-4 seconds | Substantiallyequivalent |
| Table 1: Primary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly OpStar™ Imaging Catheter | |
| CatheterPreparation | No flush | Contrast flush | Substantiallyequivalent. The OCTpredicate requiresflushing the catheterwith contrast;however, theSpectraWAVEImaging Catheterdoes not require acontrast flush. |
| MinimumGuideCatheter | ≥ 6 Fr | ≥ 6 Fr | Same |
| CatheterConfiguration | Single optical imaging catheter, mechanicallyrotated | Single optical imaging element, mechanicallyrotated | Same |
| Proximal EndConfiguration | Single connector, mechanical snap in motordrive unit | Single connector, mechanical snap in motordrive unit | Same |
| User Interface and Displays | |||
| Sterile BarrierInterface | Catheter Interface Unit encapsulated in singleuse disposable bag | Motor Drive Unit encapsulated in single usedisposable bag | Same |
| Configuration | Mobile cart with braking system | Mobile cart with braking system | Same |
| User Input | Touch screen | Keyboard and mouse | Substantiallyequivalent |
| Data Storage | Native format | DICOM and native format | Substantiallyequivalent |
| Table 1: Primary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | Abbott Medical | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | OPTIS Imaging SystemDragonfly OpStar™ Imaging Catheter | |
| Monitors | Two high resolution touch-screen monitors | Two high resolution monitors | Substantiallyequivalent |
| SoftwareProgram | Windows-based | Windows-based | Same |
| Displays | Cross-sectional image (frame)Longitudinal view | Cross-sectional image (frame)Longitudinal view | Same |
| UserConvenienceFeatures | Computer aided measurement tools, such asborder contours.Computation of cross-sectional area andpercent stenosis. | Image notation.Computer aided measurement tools, such asborder contours.Computation of cross-sectional area andpercent stenosis. | Substantiallyequivalent. |
| Table 2: Secondary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | InfraReDx, Inc. | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | Makoto Intravascular Imaging System™Dualpro™ IVUS+NIRS Imaging Catheter | |
| 510(k) Number | This submission | K183599 | NA |
| ProductFunction | Near Infrared Imaging System | Near Infrared and Ultrasound Imaging System | Substantially equivalentfor NIRS portion of thesystem |
| Product Code | OGZ - CatheterIYO - System | OGZ - CatheterIYO - System | Substantially equivalentThe SpectraWAVEImaging System is acombined system. Seeprimary predicate. |
| Indications ForUse | The SpectraWAVE Imaging System isintended for the imaging of coronaryarteries and is indicated in patients whoare candidates for transluminalinterventional procedures.The SpectraWAVE Imaging Catheter isintended for use in vessels 2.0 to 5.2 mmin diameter.The SpectraWAVE Imaging Catheter isnot intended for use in a target vesselwhich has undergone a previous bypassprocedure.The NIRS capability of the SpectraWAVEImaging System is intended for thedetection of lipid-core containing plaquesof interest.The NIRS capability of the SpectraWAVEImaging System is intended for the | 1. The Makoto Intravascular ImagingSystem™ is intended for the near-infraredexamination of coronary arteries in patientsundergoing invasive coronary angiography.a. The System is intended for the detection oflipid-core-containing plaques of interest.b. The System is intended for the assessmentof coronary artery lipid core burden.c. The System is intended for the identificationof patients and plaques at increased risk ofmajor adverse cardiac events.2. The System is intended for ultrasoundexamination of coronary intravascularpathology.a. Intravascular ultrasound imaging isindicated in patients who are candidates fortransluminal coronary interventionalprocedures. | Substantially equivalentto the NIRS portion ofthe SprectraWAVEImaging System. |
| Table 2: Secondary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | InfraReDx, Inc. | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | Makoto Intravascular Imaging System™Dualpro™ IVUS+NIRS Imaging Catheter | |
| assessment of coronary artery lipid coreburden.The NIRS capability of the SpectraWAVEImaging System is intended for theidentification of patients and plaques atincreased risk of major adverse cardiacevents. | |||
| SystemComponents | NIR CatheterPortable Console(Laser, computer, power supply) andController | NIR/IVUS CatheterPortable or Fixed Console(Laser, SBC, power supply) and Controller | Substantially equivalent |
| Imaging Mode | Near Infrared Light | Near Infrared light, Ultrasound | Substantially equivalentto the NIRS portion ofpredicate |
| Output | NIR Light | NIR lightRF Ultrasound | Substantially equivalentto the NIRS portion ofpredicate |
| Laser Type | Swept source semiconductor laser | Swept source semiconductor laser | Same |
| Image ElementPullback Speed | 60 mm/s | 0.5, 1.0, and 2.0 mm/s | Substantially equivalent.Ability of system toperform pullback andacquire data at specifiedspeed is demonstratedthrough systemverification. With respectto post-processing,NIRS Verification & |
| Table 2: Secondary Predicate Device Comparison | |||
| Manufacturer | SpectraWAVE, Inc. | InfraReDx, Inc. | Discussion ofEquivalence &Differences |
| Model | SpectraWAVE Imaging System | Makoto Intravascular Imaging System™Dualpro™ IVUS+NIRS Imaging Catheter | Validation summarizesthe NIRS performance ofthe SpectraWAVEsystem, with thepredicate device as areference. |
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- Performance Testing:
- 7.1 Summary of Performance Testing:
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.
- 7.2 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.
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7.3 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. -
7.4 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: 7.5
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. -
7.6 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.
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7.7 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.
- 7.8 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.
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7.9 Clinical Testing:
No clinical testing is provided in this pre-market notification. -
- Conclusion and Statement of Equivalence:
The information presented in this 510(k) submission demonstrates that the SpectraWAVE Imaging System is as safe and effective as the predicate device and is therefore considered substantially equivalent to the predicate devices.
- Conclusion and Statement of Equivalence:
§ 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.