What is the FDA product code for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

OGZ. It is classified under 21 CFR 870.1200 as a Class 2 device in the Cardiovascular panel.

What is the regulatory pathway for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

510(k) clearance (submission type: Traditional).

What are the predicate devices for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

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

Who can help prepare an FDA 510(k) submission like Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter

Q: Who is the manufacturer of Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter?

Infraredx, Inc. filed the 510(k) submission for Makoto Intravascular Imaging System, Dualpro IVUS + NIRS Imaging Catheter (K183599).

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

Intended 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)

Related Devices

K241576 — Makoto Intravascular Imaging System (VC-MC10 / TVC-MC10i); Dualpro IVUS+NIRS Imaging Catheter (TVC-C195-42); Peripheral 014 Imaging Catheter (TVC-E195-42 ) · Infraredx, Inc. · Feb 26, 2025
K213303 — Makoto Intravascular Imaging System, TVC-MC10/TVC-MC10i, Dualpro IVUS + NIRS Imaging Catheter ,TVC-C195-42, Peripheral 014 Imaging Catheter, TVC-E195-42 · Infraredx, Inc. · Dec 7, 2021
K163345 — TVC Imaging System, TVC Catheter · Infraredx, Inc. · Jun 21, 2017
K141682 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER · Infraredx, Inc. · Nov 24, 2014
K133897 — TVC IMAGING SYSTEM, TVC INSIGHT CATHETER · Infraredx, Inc. · Apr 23, 2014

Submission Summary (Full Text)

{0}------------------------------------------------ # Section 5: Traditional 510(k) Summary | Submitted by: | Infraredx, Inc. | |-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | Stephen Sum Sr. VP of Technology Innovation and Regulatory Affairs Infraredx, Inc. 34 Third Ave. Burlington, MA 01803 Tel: 781.345.9651 Fax: 781.345.9551 Email: ssum@infraredx.com | | Date of Summary: | November 20, 2018 | | Device Trade Name: | Makoto Intravascular Imaging System™, TVC-MC10 / TVC-MC10i Dualpro IVUS + NIRS Imaging Catheter™, TVC-C195-42 | | Common or Usual Name: | Ultrasonic Pulsed Echo Imaging System Diagnostic Intravascular Catheter | | Classification: | 21 CFR 892.1560, 21 CFR 870.1200 | | Class: Product Code: | II IYO, OGZ | | Predicate Device(s): | TVC Imaging System™, TVC-MC10/TVC-MC10i TVC Catheter™, TVC-C195-42 (K163345) | | Device Description: | 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 o 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. | | Indication 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. | | Technological Characteristics: | The Makoto Intravascular Imaging System™ is composed of three main components: the Catheter, the Controller (Pullback and Rotation Device (PBR)), and the Console. These three interconnected components work together to produce dual images of NIRS and IVUS in a single scan of the vessel. | {1}------------------------------------------------ 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 TVC-C195-42 and TVC- MC10, MC10i (K163345) | Proposed Device * TVC-C195-42 and TVC- MC10, MC10i | Comparison with Predicate Device | | Product Function | Near Infrared and Ultrasound Imaging System | Near Infrared and Ultrasound Imaging System | Same | | Intended Use | The TVC Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core- containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden. The System is intended for ultrasound examination of coronary intravascular pathology. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | The Makoto Intravascular Imaging System™ is intended for the near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography. The System is intended for the detection of lipid-core-containing plaques of interest. The System is intended for the assessment of coronary artery lipid core burden. 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. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. | Substantially Equivalent | | Where Used | Coronary | Coronary | Same | | System Components | NIR/IVUS Catheter Portable or Fixed Console (Laser, SBC, power supply) and Controller | NIR/IVUS Catheter Portable or Fixed Console (Laser, SBC, power supply) and Controller | Same | {2}------------------------------------------------ | Classification | Catheter – Product Code OGZ 21 CFR 870.1200 System Product Code IYO 21 CFR 892.1560 | Catheter – Product Code OGZ 21 CFR 870.1200 System Product Code IYO 21 CFR 892.1560 | Same | |----------------------------|----------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------|-----------------------------| | Clinical data in 510(k) | No | Yes | Substantially 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 TVC-C195-42 and TVC- MC10, MC10i (K163345) | Proposed Device TVC-C195-42 and TVC- MC10, MC10i | Comparison with 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 (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 sterile packaging | Intravascular NIR/IVUS catheter Priming accessory Controller sterile barrier | Intravascular NIR/IVUS catheter Priming accessory Controller sterile barrier | Same | | | Shelf Life | 6 months | 18 months | Substantially Equivalent | | | Transducer Center Frequency | 50MHz | 50MHz | Same | | | Controller and Console Characteristics: | | | | |-----------------------------------------|------------------------------------------------------------|--------------------------------------------------------|-------------------------------------| | Characteristic | Predicate TVC-C195-42 and TVC- MC10, MC10i (K163345) | Proposed Device TVC-C195-42 and TVC- MC10, MC10i | Comparison with Predicate Device | | Imaging Mode | Near Infrared light, Ultrasound | Near Infrared light, Ultrasound | Same | | Output | NIR light RF Ultrasound | NIR light RF Ultrasound | Same | {3}------------------------------------------------ | Hardware Components | CPU with 16GB RAM 1 Monitor and 1 Touchscreen Monitor Swept Source Laser | CPU with 16GB RAM 1 Monitor and 1 Touchscreen Monitor Swept Source Laser | Same | |-----------------------------------|-----------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|------| | Laser Type | Swept Source Semiconductor Laser | Swept Source Semiconductor Laser | Same | | Imaging element 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 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 {4}------------------------------------------------ | | predicate device (K163345) still applies. Note: EMC testing per IEC 60601- 1-2 was repeated after clearance of the predicate device specifically to satisfy Korean 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 on swine. There were no safety concerns in the swine coronary artery model after imaging with the TVC-C195-42 catheter. Assessment of the predicate where imaging was performed through an implanted stent to determine apposition 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 an indication stating "The System is intended for the identification of patients and plaques at increased risk of major adverse cardiac events" (see Substantial Equivalence Rationale below). The justification for this label expansion is based on the prospective, multi-center Lipid Rich Plaque (LRP) clinical study. | | | The overall study objective of the Lipid-Rich Plaque (LRP) Study was to 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 from new culprit lesions at both the patient level (vulnerable patients) and the segment level (vulnerable plaque). | | | 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. There were no statistically significant differences found due to age, race, ethnicity, or sex. | | Substantial Equivalence Rationale: | There are no proposed changes to the design, scientific principles of operation, principal technological characteristics, or safety of this product. The non-clinical and clinical testing performed on the proposed device indicates that it is safe and effective, and is substantially equivalent to the predicate device. | | | The proposal is to expand the indications for use of the device as indicated by the underscoring below: | | | 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. | {5}------------------------------------------------ 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. {6}------------------------------------------------ # 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) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {7}------------------------------------------------ Image /page/7/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: on the left, there is a seal with an abstract design, and on the right, there is the text "FDA U.S. FOOD & DRUG ADMINISTRATION" in blue. The text is arranged in three lines, with "FDA" being the largest and boldest, followed by "U.S. FOOD & DRUG" and then "ADMINISTRATION" in a smaller font size. # 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 {8}------------------------------------------------ 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