(107 days)
No
The summary describes image processing and analysis using NIRS and IVUS, but there is no mention of AI or ML algorithms being used for this analysis or for the prediction of adverse events. The prediction is based on the association found in the LRP study between NIRS-identified lipid cores and events.
No.
The device is for diagnostic imaging (identification of plaques, assessment of burden, and identification of at-risk patients/plaques) and does not treat or cure any condition.
Yes
The device is intended for the "near-infrared examination of coronary arteries," "detection of lipid-core-containing plaques of interest," "assessment of coronary artery lipid core burden," and "identification of patients and plaques at increased risk of major adverse cardiac events," and "ultrasound examination of coronary intravascular pathology." All of these are diagnostic purposes.
No
The device description explicitly states it is an "intravascular imaging device" that performs near-infrared spectroscopic analysis and generates IVUS images, indicating the presence of hardware components (catheter, imaging system) beyond just software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used outside of the body.
- Device Description: The Makoto Intravascular Imaging System™ is described as an intravascular imaging device. It uses near-infrared spectroscopy and intravascular ultrasound to examine coronary arteries inside the patient's body.
- Intended Use: The intended use clearly states the system is for the "near-infrared examination of coronary arteries in patients undergoing invasive coronary angiography" and "ultrasound examination of coronary intravascular pathology." These are procedures performed within the body.
Therefore, because the device operates and collects data directly within the patient's body rather than on samples taken from the body, it falls outside the definition of an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
- 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.
Product codes
IYO, OGZ
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 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near Infrared light, Ultrasound
Anatomical Site
coronary arteries
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Performance Testing (Bench):
Biocompatibility: No changes to patient contact materials; biocompatibility testing reported for predicate device (K163345) still applies. Evaluation was for external communicating device in circulating blood, for ≤ 24 hrs. Testing followed ISO 10993 and ASTM standards.
Sterilization and Shelf Life: No changes to device, packaging, or sterilization process requiring re-qualification. Sterilization testing reported for predicate device (K163345) still applies, met criteria defined in ISO 11135: 2014. Shelf life re-evaluated and augmented from 6 to 18 months; passed all catheter and accessory specifications.
Performance Testing: No changes significantly affecting safety or effectiveness compared to predicate (K163345). Verification and validation testing performed on catheter, console, controller, and software demonstrated system met all design specifications. Modifications documented and tested.
EMC and Electrical Safety Testing: No changes requiring re-evaluation of EMC and Electrical Safety. Testing for predicate device (K163345) still applies. EMC testing per IEC 60601-1-2 was repeated to satisfy Korean regulatory requirements.
Performance Testing (Animal): No changes requiring in vivo animal testing. Animal testing reported for predicate device (K163345) still applies. Assessment on swine showed no safety concerns in coronary artery model after imaging.
Performance Testing (Clinical):
Study Type: Prospective, multi-center Lipid Rich Plaque (LRP) clinical study.
Objective: To determine 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).
Key Results: Results satisfied the primary and key secondary endpoints, 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 due to age, race, ethnicity, or sex.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s):
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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. |
- 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) | |
|---|---|
| -------------------------------- | -- |
- 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)
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