(64 days)
No
The summary does not mention AI, ML, or any related terms, and the device description focuses on the hardware and imaging modalities without suggesting algorithmic interpretation beyond standard image processing.
No
The device is described as an "intravascular imaging device" intended for "examination" and "assessment" of coronary arteries and "identification of patients and plaques". Its function is to "detect lipid core-containing plaques" and "generate high resolution IVUS images that display structural details of the vessel and plaque," clearly indicating a diagnostic, rather than therapeutic, purpose.
Yes
The device is intended for the "near-infrared examination of coronary arteries," "detection of lipid-core-containing plaques," "assessment of coronary artery lipid core burden," and "identification of patients and plaques at increased risk of major adverse cardiac events," all of which are diagnostic functions. It also performs "intravascular ultrasound examination of coronary and peripheral intravascular pathology."
No
The device description explicitly states that the system is composed of three main hardware components: the Catheter, the Controller (Pullback and Rotation Device (PBR)), and the Console. These are physical components, not just software.
Based on the provided information, the Makoto Intravascular Imaging System™ is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Makoto System is an in vivo imaging device. It is inserted directly into the coronary and peripheral arteries to image the vessel walls and assess plaque composition and structure within the body.
- The intended use describes direct imaging of the arteries. The system is used for "near-infrared examination of coronary arteries" and "ultrasound examination of coronary and peripheral intravascular pathology." This is a direct imaging procedure, not the analysis of a biological sample.
- The device description confirms it's an imaging system. It describes a catheter, controller, and console that work together to produce images of the vessel.
Therefore, the Makoto Intravascular Imaging System™ falls under the category of an in vivo imaging device, not 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 and peripheral intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
Product codes
IYO, OGZ, OBJ
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Near-infrared spectroscopy (NIRS) and Intravascular Ultrasound (IVUS)
Anatomical Site
Coronary arteries, peripheral vasculature. Not for use in cerebral vessels.
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): No changes to patient contact materials or biocompatibility compared to predicate (K183599). Biocompatibility evaluation for the predicate TVC-C195-42 catheter applies, conducted for external communicating device in circulating blood, limited contact duration of
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.
0
Image /page/0/Picture/0 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, with the letters "FDA" in a blue square. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
December 7, 2021
Infraredx, Inc. Stephen Sum Sr. VP of Clinical. Regulatory & Research 28 Crosby Drive. Suite 100 Bedford, Massachusetts 01730
Re: K213303
Trade/Device Name: Makoto Intravascular Imaging System™, TVC-MC10/TVC-MC10i Dualpro IVUS + NIRS Imaging Catheter™, TVC-C195-42 Peripheral 014 Imaging Catheter, TVC-E195-42 Regulation Number: 21 CFR 892.1560 Regulation Name: Ultrasonic Pulsed Echo Imaging System Regulatory Class: Class II Product Code: IYO, OGZ, OBJ Dated: September 30, 2021 Received: October 4, 2021
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.
1
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely.
Aneesh Deoras Assistant Director Division of Cardiac Electrophysiology, Diagnostics and Monitoring Devices Office of Cardiovascular Devices Office of Product Evaluation and Ouality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K213303
Device Name
Makoto Intravascular Imaging System™, TVC-MC10/TVC-MC10i Dualpro IVUS + NIRS Imaging Catheter™, TVC-C195-42 Peripheral 014 Imaging Catheter, TVC-E195-42
Indications for Use (Describe)
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 and peripheral intravascular pathology.
a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The System is not indicated for use in the cerebral vessels.
| 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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3
Contents
| Traditional 510(k) Summary | |
|---|---|
| General Characteristics | |
| Catheter Characteristics | |
| Console & Controller Characteristics | |
| Performance Testing (Bench) | |
| Biocompatibility | |
| Sterilization and Shelf Life | |
| Performance Testing | |
| EMC and Electrical Safety Testing | |
| Performance Testing (Animal) | |
| Performance Testing (Clinical) | |
| Substantial Equivalence Rationale |
4
Traditional 510(k) Summary
| Submitted by: | Infraredx, Inc. |
|---|---|
| Contact Person: | Stephen Sum |
| Sr. VP of Clinical, Regulatory & Research | |
| Infraredx, Inc. | |
| 28 Crosby Drive, Suite 100 | |
| Bedford, MA 01730 | |
| Tel: 781.345.9651 Fax: 781.345.9551 | |
| Email: ssum@infraredx.com | |
| Date of Summary: | December 7, 2021 |
| 510(k) Number: | K213303 |
| Device Trade Name: | Makoto Intravascular Imaging System™, TVC-MC10/TVC- |
| MC10i | |
| Dualpro IVUS + NIRS Imaging Catheter™, TVC-C195-42 | |
| Peripheral 014 Imaging Catheter, TVC-E195-42 | |
| Common or Usual | |
| Name: | Ultrasonic Pulsed Echo Imaging System |
| Diagnostic Intravascular Catheter | |
| Classification: | 21 CFR 892.1560, 21 CFR 870.1200 |
| Class: | II |
| Product Code: | IYO, OGZ, OBJ |
| Predicate Device(s): | Makoto Intravascular Imaging System™, TVC-MC10/TVC- |
| MC10i | |
| Dualpro IVUS + NIRS Imaging Catheter™, TVC-C195-42 | |
| (K183599) | |
| 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. | |
| 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. |
5
-
- The System is intended for ultrasound examination of coronary and peripheral intravascular pathology.
- a. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary and peripheral interventional procedures. The system is not indicated for use in the cerebral vessels.
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.
The proposed device has the same scientific principles of operation, principal technological characteristics, and safety profile as the currently marketed predicate device (K183599). Only minor design changes to the predicate device have been implemented. The tables below compare the general, catheter, controller, and console characteristics of the proposed and predicate devices.
Technological Characteristics:
6
| General Characteristics: | ||||
|---|---|---|---|---|
| Characteristic | PROPOSED DEVICE | |||
| Infraredx | ||||
| TVC-E195-42, TVC-C195-42 & | ||||
| TVC-MC10/ MC10i | PREDICATE DEVICE | |||
| Infraredx | ||||
| TVC-C195-42 & TVC-MC10/ MC10i | ||||
| (K183599) | REFERENCE | |||
| Philips Volcano | ||||
| Visions PV .014P RX | ||||
| Digital IVUS Catheter | ||||
| (K152829) | Comparison | |||
| with Predicate | ||||
| Device | ||||
| Product Function | Near Infrared and Ultrasound | |||
| Imaging System | Near Infrared and Ultrasound | |||
| Imaging System | Digital Intravascular | |||
| Ultrasound Catheter | Same | |||
| Intended Use | 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 | ||||
| and peripheral intravascular | ||||
| pathology. Intravascular ultrasound | ||||
| imaging is indicated in patients who | ||||
| are candidates for transluminal | ||||
| coronary and peripheral | ||||
| interventional procedures. It is not | ||||
| intended for use in cerebral vessels. | 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. | The Visions® PV.014P RX | |||
| Digital IVUS Catheter is | ||||
| designed for use in the | ||||
| evaluation of vascular | ||||
| morphology in blood | ||||
| vessels of the coronary | ||||
| and peripheral vasculature | ||||
| by providing a cross- | ||||
| sectional image of such | ||||
| vessels. This device is not | ||||
| currently indicated for use | ||||
| in the cerebral vessels. | ||||
| The Visions® PV.014P RX | ||||
| Digital IVUS Catheter is | ||||
| designed for use as an | ||||
| adjunct to conventional | ||||
| angiographic | ||||
| procedures to provide an | ||||
| image of the vessel lumen | ||||
| and wall structures. | Substantially | |||
| Equivalent | ||||
| Where Used | Coronary and Peripheral | Coronary | Peripheral | Substantially |
| Equivalent | ||||
| 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 | Diagnostic Intravascular | |||
| Catheter | ||||
| Diagnostic Ultrasound | ||||
| Transducer | Same | |||
| Classification | Catheter – | |||
| Product Code OGZ, OBJ | ||||
| 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 | Catheter – | |||
| Product Code OBJ | ||||
| 21 CFR 870.1200 | ||||
| Transducer | ||||
| Product Code ITX | ||||
| 21 CFR 892.1570 | Substantially | |||
| Equivalent |
7
| Catheter Characteristics: | ||||
|---|---|---|---|---|
| Characteristic | PROPOSED DEVICE | |||
| Infraredx | ||||
| TVC-E195-42, TVC-C195-42 & | ||||
| TVC-MC10/ MC10i | PREDICATE DEVICE | |||
| Infraredx | ||||
| TVC-C195-42 & TVC-MC10/ MC10i | ||||
| (K183599) | REFERENCE | |||
| Philips Volcano | ||||
| Visions PV .014P RX | ||||
| Digital IVUS Catheter | ||||
| (K152829) | Comparison | |||
| with Predicate | ||||
| Device | ||||
| Usable Length | 160 cm | 160 cm | 150 cm | Same |
| Sheath Distal Tip Profile | 2.4 F | 2.4 F | 1.5 F (0.019") | Same |
| Guidewire rail length | 1.2 cm | 1.2 cm | 24 cm | Same |
| Imaging window profile | 3.2 F | 3.2 F | 3.5 F | Same |
| Imaging core pullback | 15 cm | 15 cm | N/A | Same |
| Number of RO Marker | ||||
| Bands | 1 RO marker | |||
| (0.5cm from distal tip) | 1 RO marker | |||
| (0.5cm from distal tip) | 3 RO markers | Same | ||
| Max. guidewire OD | 0.014 in. | 0.014 in. | 0.014 in. | Same |
| Min. guide catheter ID | 6 F | 6 F | 5F | Same |
| Method of Sterilization | EtO | EtO | EtO | Same |
| Materials supplied in | ||||
| sterile packaging | Intravascular NIR/IVUS catheter | |||
| Priming accessory | ||||
| Controller sterile barrier | Intravascular NIR/IVUS catheter | |||
| Priming accessory | ||||
| Controller sterile barrier | Intravascular IVUS | |||
| catheter | ||||
| Priming accessory | Same |
8
| Shelf Life | 36 months | 18 months | [Unknown] | Substantially
Equivalent |
|--------------------------------|-----------------------------------------|-----------|-----------|-----------------------------|
| Transducer Center
Frequency | 50MHz | 50MHz | 20 MHz | Same |
| Catheter rotating hub
color | TVC-E195-42: Blue
TVC-C195-42: Green | Green | N/A | Substantially
Equivalent |
| Console & Controller Characteristics: | |||
|---|---|---|---|
| Characteristic | PROPOSED DEVICE | ||
| Infraredx | |||
| TVC-E195-42, TVC-C195-42 and TVC-MC10/ | |||
| MC10i | PREDICATE DEVICE | ||
| Infraredx | |||
| TVC-C195-42 and TVC-MC10/ MC10i | |||
| (K183599) | 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 | ||
| 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 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 RFID | Enabled for catheter type identification | Disabled | Substantially |
| Equivalent | |||
| Controller User Interface | LCD screen | LCD screen | Same |
| Graphical User Interface | NIRS-IVUS image for coronary scanning | ||
| (TVC-C195-42) | |||
| IVUS image only for peripheral scanning | |||
| (TVC-E195-42) | NIRS-IVUS image for coronary scanning | Substantially | |
| Equivalent |
9
Performance Testing (Bench):
Biocompatibility
There are no changes to the patient contact materials of the device compared to the predicate (K183599), 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.
The proposed catheter (TVC-E195-42) is identical in design and materials to the predicate catheter (TVC-C195-42) with the exception of the color of the rotating hub (non-patient contact). Thus, the biocompatibility testing performed for the predicate device also applies to the proposed device.
Sterilization and Shelf Life
The predicate catheter (TVC-C195-42) is sterilized using ethylene oxide gas (EtO). The proposed catheter (TVC-E195-42) will be sterilized in the same manner.
The sterilization qualification for the predicate was last conducted in 2020 using the TVC-C195-42 catheter and packaging. Results reported met the criteria defined in ISO 11135: 2014. A successful requalification via document review was more recently performed in 2021.
The shelf life of the TVC-C195-42 catheter was re-evaluated to augment the shelf life from 18 to 36 months compared to the predicate (K183599) by accelerated aging per ASTM F1980. The TVC-C195-42 passed all catheter and accessory specifications to support a 36-month shelf life.
The proposed catheter (TVC-E195-42) is identical in design and materials to the predicate catheter (TVC-C195-42) with the exception of the color of the rotating hub. The packaging of the proposed catheter is also the same as that of the predicate except for the label content. Thus, the sterilization qualification and the shelf life validation performed for the predicate device also apply to the proposed device.
Performance Testing
There are no changes or modifications that significantly affect the safety or effectiveness of the system compared to the predicate (K183599). 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.
Minimal design changes are proposed to support the additional indication for IVUS imaging of the peripheral vasculature, namely:
10
| 1. | Distinguish coronary and peripheral catheters by hub color for easy visual identification. |
|---|---|
| 2. | Program radio-frequency identification (RFID) chip in catheter hub to identify catheter as either coronary or peripheral. |
| 3. | Activate RFID in controller to identify connected catheter as either coronary or peripheral. |
| 4. | Modify graphical user interface (GUI) so that only IVUS image is displayed when peripheral catheter is connected. |
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
The proposed device differs from the predicate device electrically in the implementation of radio-frequency identification (RFID) of the catheter connected to the system.
Electromagnetic compatibility (EMC) testing was conducted on the proposed device (TVC-MC10 System and TVC-E195-42 Catheter). Electrical Safety was not repeated on the proposed device as the changes (i.e., implementation of RFID) to the predicate had no impact on Electrical Safety.
The proposed device met all EMC requirements per IEC 60601-1-2:2014 (4th Ed).
| 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, which is identical in design (except for hub color) to the proposed TVC-E195-42 catheter. Additionally, an assessment of image quality and stent apposition were successfully performed. | |
| The proposed TVC-E195-42 catheter is identical in form, fit, and function to that of the predicate catheter TVC-C195-42 catheter. The above animal studies present a worst-case (coronary) model for the proposed TVC-E195-42 peripheral catheter in terms of safety and performance. Therefore, additional animal testing for the TVC-E195-42 catheter was not performed. | |
| Performance Testing (Clinical): | No prospective clinical trials were conducted in support of this Traditional 510(k). |
11
| Substantial
Equivalence
Rationale: | 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.
The System is intended for ultrasound examination of coronary and
peripheral intravascular pathology. |
|------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | a. Intravascular ultrasound imaging is indicated in patients who
are candidates for transluminal coronary and peripheral
interventional procedures. The System is not intended for
cerebral vessels. |
| | There are no proposed changes that significantly affect the safety or
effectiveness of the system compared to the predicate (K183599).
The proposed device has the same technological, engineering, and
performance specifications. The testing performed on the proposed
and predicate devices indicates that the proposed device is safe and
effective and is substantially equivalent to the predicate device. |