(107 days)
- The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden.
c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events. - The System is intended for ultrasound examination of coronary intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
The Makoto Intravascular Imaging System™ is an intravascular imaging device with the ability to simultaneously assess vessel composition and structure using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS). This dual-modality instrument performs near-infrared spectroscopic analysis of the vessel to detect lipid core-containing plaques of interest (LCP) displayed in a map called a Chemogram, and simultaneously generates high resolution IVUS images that display structural details of the vessel and plaque in transverse and longitudinal views.
The provided text discusses the Makoto Intravascular Imaging System™ (Dualpro IVUS + NIRS Imaging Catheter™). It's a 510(k) summary for a re-branded device that is substantially equivalent to a previously cleared predicate device (K163345), with an expanded indication for use.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:
Key Takeaway: The device's substantial equivalence and the expanded indication are primarily supported by existing data from the predicate device and a single prospective, multi-center clinical study (the Lipid-Rich Plaque (LRP) Study). The study's focus was on the NIRS component of the device and its ability to identify lipid-core-containing plaques associated with adverse cardiac events, rather than AI-driven performance. Therefore, many standard AI/ML study components (like expert ground truth for training/testing, adjudication methods for ground truth, MRMC studies, or standalone algorithm performance) are not directly addressed or applicable in the provided context as the device itself is not an AI/ML product. The "acceptance criteria" here relate to the clinical performance of the NIRS technology for its new indication.
1. Table of Acceptance Criteria and Reported Device Performance
The "acceptance criteria" for this submission are implicitly tied to demonstrating the clinical validity of the expanded indication for use, specifically "...the identification of patients and plaques at increased risk of major adverse cardiac events." The performance is measured by the study's ability to show a statistically significant association between NIRS-identified lipid cores and the occurrence of adverse cardiovascular events.
| Acceptance Criterion (Implicit for Expanded Indication) | Reported Device Performance (from LRP Study) |
|---|---|
| Demonstrate independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of patient-level major adverse cardiovascular events. | "The results satisfied the primary and key secondary endpoints of the LRP Study, demonstrating an independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of patient and plaque level major adverse cardiovascular events." |
| Demonstrate independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of plaque-level major adverse cardiovascular events. | "The results satisfied the primary and key secondary endpoints of the LRP Study, demonstrating an independent and statistically significant association between NIRS-identified coronary lipid cores and the occurrence of patient and plaque level major adverse cardiovascular events." |
| No statistically significant differences in findings due to age, race, ethnicity, or sex. | "There were no statistically significant differences found due to age, race, ethnicity, or sex." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The text states the study was a "prospective, multi-center Lipid Rich Plaque (LRP) clinical study." However, the exact sample size (number of patients or plaques) for this study is not specified in the provided text.
- Data Provenance: The study was "prospective" and "multi-center," indicating real-world data collection. The geographic origin (e.g., country) of the data is not specified.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications
This information is not applicable in the context of the provided text. The device itself (the Makoto Intravascular Imaging System) is an imaging system (NIRS + IVUS) that provides data and detects lipid cores. There is no mention of "AI" or "machine learning algorithm" within this summary that would require establishing ground truth via expert consensus for performance evaluation. The "ground truth" for the LRP study appears to be the occurrence of actual major adverse cardiovascular events in patients, not a subjective interpretation of images by experts.
4. Adjudication Method for the Test Set
Since the ground truth is based on the occurrence of clinical events, an "adjudication method" in the sense of resolving conflicting expert opinions on image interpretation is not applicable. Clinical events (e.g., major adverse cardiac events) are typically adjudicated by an independent clinical events committee in prospective trials, but the specifics of this adjudication are not detailed in the provided text.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size
An MRMC study is relevant for evaluating the impact of AI assistance on human reader performance. No MRMC comparative effectiveness study was mentioned or conducted as per the provided text because the device itself is not an AI/ML assistant to human readers. It's a diagnostic imaging tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is typically for AI/ML algorithms. The Makoto system is an imaging device that measures and displays information (NIRS chemogram). The "detection of lipid-core-containing plaques" is an output of the system's NIRS technology, not a result of a separate AI algorithm being evaluated for standalone performance. Therefore, a "standalone algorithm performance" evaluation as commonly understood for AI/ML is not applicable here. The LRP study assessed the clinical utility of the device's output (NIRS findings) in predicting events.
7. The Type of Ground Truth Used
The primary ground truth for the expanded indication based on the LRP study was outcomes data, specifically the "occurrence of patient and plaque level major adverse cardiovascular events." The NIRS detection of lipid-rich plaques served as the predictor, and the clinical events were the outcome used as ground truth to validate the prediction.
8. The Sample Size for the Training Set
This information is not applicable. The device's NIRS technology is based on spectroscopy and its physical principles, not a machine learning model that requires a "training set" in the conventional AI/ML sense. The LRP study focused on validating the clinical utility of the device's output, not on training an underlying algorithm.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no "training set" in the context of an AI/ML algorithm for this device.
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Section 5: Traditional 510(k) Summary
| Submitted by: | Infraredx, Inc. |
|---|---|
| Contact Person: | Stephen SumSr. VP of Technology Innovation and Regulatory AffairsInfraredx, Inc.34 Third Ave.Burlington, MA 01803Tel: 781.345.9651 Fax: 781.345.9551Email: ssum@infraredx.com |
| Date of Summary: | November 20, 2018 |
| Device Trade Name: | Makoto Intravascular Imaging System™, TVC-MC10 / TVC-MC10iDualpro IVUS + NIRS Imaging Catheter™, TVC-C195-42 |
| Common or Usual Name: | Ultrasonic Pulsed Echo Imaging SystemDiagnostic Intravascular Catheter |
| Classification: | 21 CFR 892.1560, 21 CFR 870.1200 |
| Class:Product Code: | IIIYO, OGZ |
| Predicate Device(s): | TVC Imaging System™, TVC-MC10/TVC-MC10iTVC Catheter™, TVC-C195-42 (K163345) |
| Device Description: | The Makoto Intravascular Imaging System™ is an intravascular imagingdevice with the ability to simultaneously assess vessel composition andstructure using near-infrared spectroscopy (NIRS) and intravascularultrasound (IVUS). This dual-modality instrument performs near-infraredspectroscopic analysis of the vessel to detect lipid core-containing plaques ointerest (LCP) displayed in a map called a Chemogram, and simultaneouslygenerates high resolution IVUS images that display structural details of thevessel and plaque in transverse and longitudinal views. |
| Indication for Use: | 1. The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasivecoronary angiography.a. The System is intended for the detection of lipid-core-containingplaques of interest.b. The System is intended for the assessment of coronary artery lipid coreburden.c. The System is intended for the identification of patients and plaques atincreased risk of major adverse cardiac events.2. The System is intended for ultrasound examination of coronaryintravascular pathology.a. Intravascular ultrasound imaging is indicated in patients who arecandidates for transluminal coronary interventional procedures. |
| TechnologicalCharacteristics: | The Makoto Intravascular Imaging System™ is composed of three maincomponents: the Catheter, the Controller (Pullback and Rotation Device(PBR)), and the Console. These three interconnected components worktogether to produce dual images of NIRS and IVUS in a single scan of thevessel. |
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The proposed device has the same technological characteristics, design and configuration as the currently marketed predicate device (K163345). The tables below compare the general, catheter, controller, and console characteristics of the proposed and predicate devices.
| General Characteristics: | |||
|---|---|---|---|
| Characteristic | PredicateTVC-C195-42 and TVC-MC10, MC10i (K163345) | Proposed Device *TVC-C195-42 and TVC-MC10, MC10i | Comparison withPredicate Device |
| Product Function | Near Infrared and UltrasoundImaging System | Near Infrared and UltrasoundImaging System | Same |
| Intended Use | The TVC Imaging System™ isintended for the near-infraredexamination of coronary arteriesin patients undergoing invasivecoronary angiography. TheSystem is intended for thedetection of lipid-core-containing plaques of interest.The System is intended for theassessment of coronary arterylipid core burden.The System is intended forultrasound examination ofcoronary intravascularpathology. Intravascularultrasound imaging is indicatedin patients who are candidatesfor transluminal coronaryinterventional procedures. | The Makoto IntravascularImaging System™ is intendedfor the near-infrared examinationof coronary arteries in patientsundergoing invasive coronaryangiography. The System isintended for the detection oflipid-core-containing plaques ofinterest. The System is intendedfor the assessment of coronaryartery lipid core burden. TheSystem is intended for theidentification of patients andplaques at increased risk ofmajor adverse cardiac events.The System is intended forultrasound examination ofcoronary intravascularpathology. Intravascularultrasound imaging is indicatedin patients who are candidatesfor transluminal coronaryinterventional procedures. | SubstantiallyEquivalent |
| Where Used | Coronary | Coronary | Same |
| SystemComponents | NIR/IVUS CatheterPortable or Fixed Console(Laser, SBC, power supply) andController | NIR/IVUS CatheterPortable or Fixed Console(Laser, SBC, power supply) andController | Same |
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| Classification | Catheter –Product Code OGZ21 CFR 870.1200SystemProduct Code IYO21 CFR 892.1560 | Catheter –Product Code OGZ21 CFR 870.1200SystemProduct Code IYO21 CFR 892.1560 | Same |
|---|---|---|---|
| Clinical data in510(k) | No | Yes | SubstantiallyEquivalent |
- The TVC Imaging System and the TVC Catheter (K163345) were re-branded in September, 2017 to the Makoto Intravascular Imaging System and the Dualpro IVUS + NIRS Imaging Catheter. The original model numbers, TVC-MC10/TVC-MC10i and TVC-C195-42, remained the same under the new brand.
| Catheter Characteristics: | ||||
|---|---|---|---|---|
| Characteristic | PredicateTVC-C195-42 and TVC-MC10, MC10i (K163345) | Proposed DeviceTVC-C195-42 and TVC-MC10, MC10i | Comparison withPredicate Device | |
| Usable Length | 160 cm | 160 cm | Same | |
| Sheath Distal Tip Profile | 2.4 F | 2.4 F | Same | |
| Guidewire rail length | 1.2 cm | 1.2 cm | 1.2 cm | Same |
| Imaging window profile | 3.2 F | 3.2 F | Same | |
| Imaging core pullback | 15 cm | 15 cm | Same | |
| Number of RO Marker Bands | 1 RO marker(0.5cm from distal tip) | 1 RO marker(0.5cm from distal tip) | Same | |
| Maximum guidewire OD | 0.014 in. | 0.014 in. | Same | |
| Minimum guide catheter I.D. | 6 F | 6 F | Same | |
| Method of Sterilization | EtO | EtO | Same | |
| Packaging | Card/pouch | Card/pouch | Same | |
| Materials supplied in sterilepackaging | Intravascular NIR/IVUScatheterPriming accessoryController sterile barrier | Intravascular NIR/IVUScatheterPriming accessoryController sterile barrier | Same | |
| Shelf Life | 6 months | 18 months | SubstantiallyEquivalent | |
| Transducer CenterFrequency | 50MHz | 50MHz | Same |
| Controller and Console Characteristics: | |||
|---|---|---|---|
| Characteristic | PredicateTVC-C195-42 and TVC-MC10, MC10i (K163345) | Proposed DeviceTVC-C195-42 and TVC-MC10, MC10i | Comparison withPredicate Device |
| Imaging Mode | Near Infrared light, Ultrasound | Near Infrared light, Ultrasound | Same |
| Output | NIR lightRF Ultrasound | NIR lightRF Ultrasound | Same |
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| HardwareComponents | CPU with 16GB RAM1 Monitor and 1 TouchscreenMonitorSwept Source Laser | CPU with 16GB RAM1 Monitor and 1 TouchscreenMonitorSwept Source Laser | Same |
|---|---|---|---|
| Laser Type | Swept Source SemiconductorLaser | Swept Source SemiconductorLaser | Same |
| Imaging elementpullback speed | 0.5, 1.0, and 2.0 mm/s | 0.5, 1.0, and 2.0 mm/s | Same |
| Pullback Distance | 150mm | 150mm | Same |
| Controller Housing | Handle | Handle | Same |
| Controller UserInterface | LCD screen | LCD screen | Same |
Performance Testing (Bench):
Biocompatibility
There are no changes to the patient contact materials of the device compared to the predicate (K163345), and therefore no changes to its biocompatibility. The biocompatibility testing reported for the predicate device still applies.
The biocompatibility evaluation of the predicate TVC-C195-42 catheter was conducted for an external communicating device in circulating blood, with a limited contact duration of ≤ 24 hrs. The series of testing was conducted utilizing Good Laboratory Practice (GLP) following ISO 10993 and ASTM standards.
Sterilization and Shelf Life
There are no changes to the device, its packaging, or the sterilization process requiring sterilization re-qualification. The sterilization testing reported for the predicate device (K163345) still applies.
The sterilization qualification for the predicate was conducted using the TVC-C195-42 catheter and packaging. Results reported met the criteria defined in ISO 11135: 2014.
The shelf life of the TVC-C195-42 catheter was re-evaluated to augment the shelf life from 6 to 18 months compared to the predicate (K163345). The TVC-C195-42 passed all catheter and accessory specifications to support an 18-month shelf life.
Performance Testing
There are no changes or modifications that significantly affect the safety or effectiveness of the system compared to the predicate (K163345). The proposed device has the same technological, engineering, and performance specifications. Only minor modifications have been made to the device since the market clearance of the predicate.
Verification and validation testing of the predicate was performed on the catheter, console, controller, and software to demonstrate that the system met all design specifications. All modifications were documented, reviewed, and approved per the Quality System Regulation. Where appropriate, modifications were tested according to verification and validation protocols and results recorded and documented per the Quality Management System.
EMC and Electrical Safety Testing
There are no changes to the device requiring re-evaluation of EMC and Electrical Safety. The EMC and Electrical Safety testing reported for the
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| predicate device (K163345) still applies. Note: EMC testing per IEC 60601-1-2 was repeated after clearance of the predicate device specifically to satisfyKorean regulatory requirements (i.e. testing at 220VAC/60Hz, CB scheme). | |
|---|---|
| Performance Testing(Animal): | There are no changes to the device requiring in vivo animal testing.The animal testing reported for the predicate device (K163345) still applies. |
| The in vivo animal assessment of the predicate device was conducted onswine. There were no safety concerns in the swine coronary artery modelafter imaging with the TVC-C195-42 catheter. Assessment of the predicatewhere imaging was performed through an implanted stent to determineapposition and malapposition of the stent met the objectives of the study. | |
| Performance Testing(Clinical): | The proposed change is an expansion of the intended use to include anindication stating "The System is intended for the identification ofpatients and plaques at increased risk of major adverse cardiac events"(see Substantial Equivalence Rationale below). The justification forthis label expansion is based on the prospective, multi-center LipidRich Plaque (LRP) clinical study. |
| The overall study objective of the Lipid-Rich Plaque (LRP) Study wasto determine in patients undergoing multi-vessel NIRS-IVUS imaging,the relationship between LRPs detected by intracoronary NIRS at non-stenotic sites and the prediction of subsequent coronary events fromnew culprit lesions at both the patient level (vulnerable patients) andthe segment level (vulnerable plaque). | |
| The results satisfied the primary and key secondary endpoints of theLRP Study, demonstrating an independent and statistically significantassociation between NIRS-identified coronary lipid cores and theoccurrence of patient and plaque level major adverse cardiovascularevents. There were no statistically significant differences found due toage, race, ethnicity, or sex. | |
| Substantial EquivalenceRationale: | There are no proposed changes to the design, scientific principles ofoperation, principal technological characteristics, or safety of this product.The non-clinical and clinical testing performed on the proposed deviceindicates that it is safe and effective, and is substantially equivalent to thepredicate device. |
| The proposal is to expand the indications for use of the device as indicated bythe underscoring below: | |
| The Makoto Intravascular Imaging System is intended for the near-infraredexamination of coronary arteries in patients undergoing invasive coronaryangiography. | |
| a.The System is intended for the detection of lipid-core-containingplaques of interest. | |
| b.The System is intended for the assessment of coronary artery lipid coreburden. | |
| c.The System is intended for the identification of patients and plaques atincreased risk of major adverse cardiac events. |
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The System is intended for ultrasound examination of coronary intravascular pathology.
- Intravascular ultrasound imaging is indicated in patients who are a. candidates for transluminal coronary interventional procedures.
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Indications for Use
510(k) Number (if known) K183599
Device Name
Makoto Intravascular Imaging System™ Dualpro™ IVUS+NIRS Imaging Catheter
| Indications for Use (Describe) | |
|---|---|
| -------------------------------- | -- |
- The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography.
a. The System is intended for the detection of lipid-core-containing plaques of interest.
b. The System is intended for the assessment of coronary artery lipid core burden.
c. The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events.
- The System is intended for ultrasound examination of coronary intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
| 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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April 12, 2019
Infraredx, Inc. Stephen Sum Sr. VP of Technology Innovation and Regulatory Affairs 34 Third Avenue Burlington, Massachusetts 01803
Re: K183599
Trade/Device Name: Makoto Intravascular Imaging System, TVC-MC10/ TVC-MC10i Dualpro IVUS + NIRS Imaging Catheter, TVC-C195-42 Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic Intravascular Catheter Regulatory Class: Class II Product Code: OGZ, IYO Dated: March 11, 2019 Received: March 12, 2019
Dear Stephen Sum:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Bram D. Zuckerman, M.D. Director Division of Cardiovascular Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
§ 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).