Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

K183599 · Infraredx, Inc. · OGZ · Apr 12, 2019 · Cardiovascular

Device Facts

• Record ID: K183599
• Device Name: Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter
• Applicant: Infraredx, Inc.
• Product Code: OGZ · Cardiovascular
• Decision Date: Apr 12, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 870.1200
• Device Class: Class 2

Indications for Use

1. 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. 2. 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.

Device Story

Makoto Intravascular Imaging System performs dual-modality imaging using near-infrared spectroscopy (NIRS) and intravascular ultrasound (IVUS) to assess coronary artery vessel composition and structure. System inputs include NIRS light and RF ultrasound signals captured via a specialized catheter during a pullback scan. The system processes these inputs to generate a 'Chemogram' (mapping lipid core-containing plaques) and high-resolution IVUS images (transverse/longitudinal views). Used in clinical settings by physicians during invasive coronary angiography or interventional procedures. Output displayed on console monitors for real-time visualization of plaque burden and vessel pathology. Clinical utility includes identifying patients and plaques at increased risk of major adverse cardiac events, aiding clinical decision-making regarding coronary interventions. Benefits include improved assessment of vulnerable plaques and lipid core burden.

Clinical Evidence

Evidence based on the prospective, multi-center Lipid-Rich Plaque (LRP) clinical study. Study objective: determine relationship between NIRS-detected lipid-rich plaques (LRPs) at non-stenotic sites and prediction of subsequent coronary events at patient and segment levels. Results showed independent, statistically significant association between NIRS-identified coronary lipid cores and occurrence of patient/plaque level major adverse cardiovascular events. No significant differences found based on age, race, ethnicity, or sex.

Technological Characteristics

System comprises a NIR/IVUS catheter, controller (pullback/rotation device), and console (CPU, 16GB RAM, monitors, swept-source semiconductor laser). Imaging uses 50MHz transducer center frequency. Pullback speeds: 0.5, 1.0, 2.0 mm/s. Catheter features: 160cm length, 2.4F distal tip, 3.2F imaging window, 0.014" guidewire compatibility. Sterilization: EtO. Connectivity: Standalone console. Software: Rule-based/signal processing for NIRS/IVUS reconstruction.

Indications for Use

Indicated for patients undergoing invasive coronary angiography or transluminal coronary interventional procedures requiring near-infrared examination of coronary arteries for lipid-core-containing plaque detection/burden assessment and identification of patients/plaques at increased risk of major adverse cardiac events, or ultrasound examination of coronary intravascular pathology.

Regulatory Classification

Identification

An intravascular diagnostic catheter is a device used to record intracardiac pressures, to sample blood, and to introduce substances into the heart and vessels. Included in this generic device are right-heart catheters, left-heart catheters, and angiographic catheters, among others.

Predicate Devices

• TVC Imaging System™, TVC-MC10/TVC-MC10i (K163345)
• TVC Catheter™, TVC-C195-42 (K163345)

Submission Summary (Full Text)

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# Section 5: Traditional 510(k) Summary

| Submitted by: | Infraredx, Inc. |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | Stephen Sum<br>Sr. VP of Technology Innovation and Regulatory Affairs<br>Infraredx, Inc.<br>34 Third Ave.<br>Burlington, MA 01803<br>Tel: [phone] Fax: [phone]<br>Email: [e-mail] |
| Date of Summary: | November 20, 2018 |
| Device Trade Name: | Makoto Intravascular Imaging System™, TVC-MC10 / TVC-MC10i<br>Dualpro IVUS + NIRS Imaging Catheter™, TVC-C195-42 |
| Common or Usual Name: | Ultrasonic Pulsed Echo Imaging System<br>Diagnostic Intravascular Catheter |
| Classification: | 21 CFR 892.1560, 21 CFR 870.1200 |
| Class:<br>Product Code: | II<br>IYO, OGZ |
| Predicate Device(s): | TVC Imaging System™, TVC-MC10/TVC-MC10i<br>TVC Catheter™, TVC-C195-42 (K163345) |
| Device Description: | The Makoto Intravascular Imaging System™ is an intravascular imaging<br>device with the ability to simultaneously assess vessel composition and<br>structure using near-infrared spectroscopy (NIRS) and intravascular<br>ultrasound (IVUS). This dual-modality instrument performs near-infrared<br>spectroscopic analysis of the vessel to detect lipid core-containing plaques o<br>interest (LCP) displayed in a map called a Chemogram, and simultaneously<br>generates high resolution IVUS images that display structural details of the<br>vessel and plaque in transverse and longitudinal views. |
| Indication for Use: | 1. The Makoto Intravascular Imaging System™ is intended for the near-<br>infrared examination of coronary arteries in patients undergoing invasive<br>coronary angiography.<br>a. The System is intended for the detection of lipid-core-containing<br>plaques of interest.<br>b. The System is intended for the assessment of coronary artery lipid core<br>burden.<br>c. The System is intended for the identification of patients and plaques at<br>increased risk of major adverse cardiac events.<br>2. The System is intended for ultrasound examination of coronary<br>intravascular pathology.<br>a. Intravascular ultrasound imaging is indicated in patients who are<br>candidates for transluminal coronary interventional procedures. |
| Technological<br>Characteristics: | The Makoto Intravascular Imaging System™ is composed of three main<br>components: the Catheter, the Controller (Pullback and Rotation Device<br>(PBR)), and the Console. These three interconnected components work<br>together to produce dual images of NIRS and IVUS in a single scan of the<br>vessel. |

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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 | Predicate<br>TVC-C195-42 and TVC-<br>MC10, MC10i (K163345) | Proposed Device *<br>TVC-C195-42 and TVC-<br>MC10, MC10i | Comparison with<br>Predicate Device |
| Product Function | Near Infrared and Ultrasound<br>Imaging System | Near Infrared and Ultrasound<br>Imaging System | Same |
| Intended Use | The TVC Imaging System™ is<br>intended for the near-infrared<br>examination of coronary arteries<br>in patients undergoing invasive<br>coronary angiography. The<br>System is intended for the<br>detection of lipid-core-<br>containing plaques of interest.<br>The System is intended for the<br>assessment of coronary artery<br>lipid core burden.<br>The System is intended for<br>ultrasound examination of<br>coronary intravascular<br>pathology. Intravascular<br>ultrasound imaging is indicated<br>in patients who are candidates<br>for transluminal coronary<br>interventional procedures. | The Makoto Intravascular<br>Imaging System™ is intended<br>for the near-infrared examination<br>of coronary arteries in patients<br>undergoing invasive coronary<br>angiography. The System is<br>intended for the detection of<br>lipid-core-containing plaques of<br>interest. The System is intended<br>for the assessment of coronary<br>artery lipid core burden. The<br>System is intended for the<br>identification of patients and<br>plaques at increased risk of<br>major adverse cardiac events.<br>The System is intended for<br>ultrasound examination of<br>coronary intravascular<br>pathology. Intravascular<br>ultrasound imaging is indicated<br>in patients who are candidates<br>for transluminal coronary<br>interventional procedures. | Substantially<br>Equivalent |
| Where Used | Coronary | Coronary | Same |
| System<br>Components | NIR/IVUS Catheter<br>Portable or Fixed Console<br>(Laser, SBC, power supply) and<br>Controller | NIR/IVUS Catheter<br>Portable or Fixed Console<br>(Laser, SBC, power supply) and<br>Controller | Same |

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| Classification | Catheter –<br>Product Code OGZ<br>21 CFR 870.1200<br>System<br>Product Code IYO<br>21 CFR 892.1560 | Catheter –<br>Product Code OGZ<br>21 CFR 870.1200<br>System<br>Product Code IYO<br>21 CFR 892.1560 | Same |
|----------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------|
| Clinical data in<br>510(k) | No | Yes | Substantially<br>Equivalent |

* 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 | Predicate<br>TVC-C195-42 and TVC-<br>MC10, MC10i (K163345) | Proposed Device<br>TVC-C195-42 and TVC-<br>MC10, MC10i | Comparison with<br>Predicate 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<br>(0.5cm from distal tip) | 1 RO marker<br>(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 sterile<br>packaging | Intravascular NIR/IVUS<br>catheter<br>Priming accessory<br>Controller sterile barrier | Intravascular NIR/IVUS<br>catheter<br>Priming accessory<br>Controller sterile barrier | Same | |
| Shelf Life | 6 months | 18 months | Substantially<br>Equivalent | |
| Transducer Center<br>Frequency | 50MHz | 50MHz | Same | |

| Controller and Console Characteristics: | | | |
|-----------------------------------------|------------------------------------------------------------|--------------------------------------------------------|-------------------------------------|
| Characteristic | Predicate<br>TVC-C195-42 and TVC-<br>MC10, MC10i (K163345) | Proposed Device<br>TVC-C195-42 and TVC-<br>MC10, MC10i | Comparison with<br>Predicate Device |
| Imaging Mode | Near Infrared light, Ultrasound | Near Infrared light, Ultrasound | Same |
| Output | NIR light<br>RF Ultrasound | NIR light<br>RF Ultrasound | Same |

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| Hardware<br>Components | CPU with 16GB RAM<br>1 Monitor and 1 Touchscreen<br>Monitor<br>Swept Source Laser | CPU with 16GB RAM<br>1 Monitor and 1 Touchscreen<br>Monitor<br>Swept Source Laser | Same |
|-----------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------|
| Laser Type | Swept Source Semiconductor<br>Laser | Swept Source Semiconductor<br>Laser | Same |
| Imaging element<br>pullback 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 User<br>Interface | 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-<br>1-2 was repeated after clearance of the predicate device specifically to satisfy<br>Korean regulatory requirements (i.e. testing at 220VAC/60Hz, CB scheme). |
|---------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Performance Testing<br>(Animal): | There are no changes to the device requiring in vivo animal testing.<br>The animal testing reported for the predicate device (K163345) still applies. |
| | The in vivo animal assessment of the predicate device was conducted on<br>swine. There were no safety concerns in the swine coronary artery model<br>after imaging with the TVC-C195-42 catheter. Assessment of the predicate<br>where imaging was performed through an implanted stent to determine<br>apposition and malapposition of the stent met the objectives of the study. |
| Performance Testing<br>(Clinical): | The proposed change is an expansion of the intended use to include an<br>indication stating "The System is intended for the identification of<br>patients and plaques at increased risk of major adverse cardiac events"<br>(see Substantial Equivalence Rationale below). The justification for<br>this label expansion is based on the prospective, multi-center Lipid<br>Rich Plaque (LRP) clinical study. |
| | The overall study objective of the Lipid-Rich Plaque (LRP) Study was<br>to determine in patients undergoing multi-vessel NIRS-IVUS imaging,<br>the relationship between LRPs detected by intracoronary NIRS at non-<br>stenotic sites and the prediction of subsequent coronary events from<br>new culprit lesions at both the patient level (vulnerable patients) and<br>the segment level (vulnerable plaque). |
| | The results satisfied the primary and key secondary endpoints of the<br>LRP Study, demonstrating an independent and statistically significant<br>association between NIRS-identified coronary lipid cores and the<br>occurrence of patient and plaque level major adverse cardiovascular<br>events. There were no statistically significant differences found due to<br>age, race, ethnicity, or sex. |
| Substantial Equivalence<br>Rationale: | There are no proposed changes to the design, scientific principles of<br>operation, principal technological characteristics, or safety of this product.<br>The non-clinical and clinical testing performed on the proposed device<br>indicates that it is safe and effective, and is substantially equivalent to the<br>predicate device. |
| | The proposal is to expand the indications for use of the device as indicated by<br>the underscoring below: |
| | The Makoto Intravascular Imaging System is intended for the near-infrared<br>examination of coronary arteries in patients undergoing invasive coronary<br>angiography. |
| | a.<br>The System is intended for the detection of lipid-core-containing<br>plaques of interest. |
| | b.<br>The System is intended for the assessment of coronary artery lipid core<br>burden. |
| | c.<br>The System is intended for the identification of patients and plaques at<br>increased 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) | |
|--------------------------------|--|
|--------------------------------|--|

1. 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.

2. 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 ([e-mail]) or phone [phone] 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