(114 days)
No
The summary describes standard ultrasound image processing and does not mention any AI or ML capabilities.
No
The device is described as a "diagnostic imaging tool" for "ultrasound examination of coronary intravascular pathology," which means it gathers information but does not actively treat or modify a disease or condition.
Yes
The "Device Description" explicitly states, "The HD-IVUS Ultrasound Imaging System is a minimally invasive intravascular ultrasound diagnostic imaging tool."
No
The device description explicitly lists multiple hardware components including a System Console, Roll Stand/mount, Patient Interface Module (PIM), and Power Supply, in addition to the software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "ultrasound examination of coronary intravascular pathology." This describes an imaging procedure performed in vivo (within the living body) to visualize structures and pathology.
- Device Description: The description clearly states it's a "minimally invasive intravascular ultrasound diagnostic imaging tool." It uses sound waves emitted and received by a catheter inside the body to create images.
- Mechanism: The device works by processing and displaying ultrasound data acquired directly from within the patient's coronary arteries. This is a direct imaging technique, not a test performed on a sample of biological material outside the body.
IVD devices, by definition, are used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This device does not fit that description.
N/A
Intended Use / Indications for Use
The HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
Product codes
IYO, QBJ
Device Description
The HD-IVUS Ultrasound Imaging System is a minimally invasive intravascular ultrasound diagnostic imaging tool when used in conjunction with an intravascular ultrasound catheter. The System is a medical device for use by or on the order of a physician. The HD-IVUS Ultrasound Imaging System is comprised of a System Console with a touch screen monitor, a Roll Stand, or bed-rail swing arm mount, a Patient Interface Module (PIM), a Power Supply, and an Intravascular Ultrasound Catheter (510(k) cleared and sold separately). The Catheter emits sound energy from a transducer at the distal tip of the catheter, which is guided into the coronary arteries of the heart. Sound waves that reflect from the inner vascular tissues are received by the transducer and sent to the System Console where a high resolution, cross-sectional image is displayed in real time. The technique provides for in-vivo visualization of the coronary artery lumen, coronary artery wall morphology, and devices (such as stents) at or near the surface of the coronary artery wall.
• System Console
The HD-IVUS system features a point-of-care system console that is mounted to a roll stand, or bed-rail swing arm mount. The System Console is the central component that is responsible for:
• managing the generation and display of IVUS images
• storing and exporting the image data
• providing the main user interface
• providing analysis tools (i.e., area measurements, linear measurements, and annotations)
The System Console receives, processes, displays, and records ultrasound image data from the transducer in the Kodama HD-IVUS catheter. The IVUS images are displayed on a high-resolution, 19-inch, flat panel, touch screen monitor. The monitor serves as the graphical user interface (GUI) for operating the system. All system information and controls are located on the touch screen monitor. The HD-IVUS system has internal storage for patient studies. Each study can contain data in the form of loops or stills. Study data is saved in DICOM format and can be exported to DVD, using the integrated DVD drive, or to a USB storage device, using one of the four USB ports.
• Roll Stand
The variable height roll stand supports the System Console and enables the console to be attached to a mobile stand that can be rolled up to the patient bed.
• Bed Rail Swing Arm
The bed rail swing arm mount supports the System Console and enables the console to be attached to a patient bed rail.
• Patient Interface Module (PIM)
The Patient Interface Module (PIM) provides the electromechanical interface between the catheter and the System Console. The PIM provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly.
The PIM also provides the electrical interface that transmits the signal from the integrated ultrasound generator to the catheter and receives the return signals. The PIM is placed into a sterile bag for normal use and can be situated near the patient in the sterile field. The PIM features an imaging on/off button and a recording on/off button. These controls enable the sterile operator to start or stop imaging and recording from within the sterile field. A LED light on the PIM indicates active recording.
Linear Translation System (LTS) (subject of this submission)
The Linear Translation System (LTS) is an accessory (companion product) to the HD-IVUS system and provides for linear translation (pullback) of the catheter imaging element under motorized (controlled speed) linear translation when used in conjunction with the PIM. The LTS is an optional accessory and not required for basic IVUS imaging.
Power Supply
The system includes a universal, medical grade external AC to DC power supply that enables direct connection to the hospital power source.
Intravascular Ultrasound Catheter (510(k) cleared under K113008 and sold separately)
The Kodama Intravascular Ultrasound Catheter is a minimally invasive intravascular ultrasound coronary imaging catheter. The catheter emits acoustic energy from a transducer at its distal tip, which is guided into the coronary arteries of the heart. Sound waves that are reflected from vascular tissues are received by the transducer and sent through the PIM to the system console. The catheter can be operated at two different frequencies, 40 MHz or 60 MHz, depending on user preference. An integrated telescope allows the imaging of multiple regions of interest in a single procedure by advancing or retracting the imaging assembly without moving the catheter sheath. (NOTE: Refer to the Directions for Use supplied with the Kodama Intravascular Ultrasound Catheter for additional information.)
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
coronary arteries of the heart, coronary artery
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician / hospital
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)
Summary of Non-clinical tests Conducted for Determination of Substantial Equivalence:
Performance Test Summary - New Device
Characteristic: Electromagnetic Compatibility, Standard/Test/FDA Guidance: Compliant with IEC 60601-1-2, Results Summary: Compliant with IEC 60601-1-2
Characteristic: Electrical Safety and Acoustic Safety, Standard/Test/FDA Guidance: Compliant with IEC 60601-1, IEC 60601-1-4, and IEC 60601-2-37, Results Summary: Compliant with IEC 60601-1, IEC 60601-1-4, and IEC 60601-2-37
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K12 2878 pg 1 of 6
JAN 1 1 2013
Special 510(k) (accessory to device) Silicon Valley Medical Instruments, Inc. 510(k) Summary
Image /page/0/Picture/3 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo is in black and white and features the letters "SVMI" in a stylized font. The words "Silicon Valley Medical Instruments Inc." are written in a smaller font below the letters.
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
A summary of 510(k) safety and effectiveness information in accordance with the requirements of 21 CFR 807.92
| Submitter Information | |
|---|---|
| Name: | Silicon Valley Medical Instruments, Inc. |
| Address | 47697 Westinghouse Drive, Suite 101, Fremont, CA 94539-7401 USA |
| Phone Number: | 510-897-4695 |
| Fax Number | 510-226-1230 |
| Establishment Registration | |
| Number | N/A – Not yet registered. |
| Contact Person | Richard E. Anderson; VP, RA/QA (richarda@svmii.com) |
| Date Prepared | 07 September 2012 |
| Name of Device | |
|---|---|
| Trade or Proprietary Name | HD-IVUS Ultrasound Imaging System |
| Common or Usual Name | System, Imaging, System, Imaging, Pulsed Echo, Ultrasonic (IYO) |
| Classification Name | Class II |
| Classification Panel | Cardiovascular |
| Regulation | 21 CFR 892.1560 (ΙΥΟ) |
| Product Code(s) | IYO |
| Legally Marketed Device(s) | |
| to which Equivalence is | |
| Claimed | Boston Scientific Corporation's iLab Ultrasound Imaging System |
| (Cleared 14Jul05 via K051679) | |
| Reason for Submission | New device |
| Device Description | The HD-IVUS Ultrasound Imaging System is a minimally invasive |
| intravascular ultrasound diagnostic imaging tool when used in | |
| conjunction with an intravascular ultrasound catheter. The System is a | |
| medical device for use by or on the order of a physician. The HD-IVUS | |
| Ultrasound Imaging System is comprised of a System Console with a | |
| touch screen monitor, a Roll Stand, or bed-rail swing arm mount, a | |
| Patient Interface Module (PIM), a Power Supply, and an Intravascular | |
| Ultrasound Catheter (510(k) cleared and sold separately). The Catheter | |
| emits sound energy from a transducer at the distal tip of the catheter, | |
| which is guided into the coronary arteries of the heart. Sound waves | |
| that reflect from the inner vascular tissues are received by the | |
| transducer and sent to the System Console where a high resolution, | |
| cross-sectional image is displayed in real time. The technique provides | |
| for in-vivo visualization of the coronary artery lumen, coronary artery | |
| wall morphology, and devices (such as stents) at or near the surface of | |
| the coronary artery wall. | |
| • System Console | |
| The HD-IVUS system features a point-of-care system console that is mounted to a roll stand, or bed-rail swing arm mount. The System Console is the central component that is responsible for: | |
| • managing the generation and display of IVUS images | |
| • storing and exporting the image data | |
| • providing the main user interface | |
| • providing analysis tools (i.e., area measurements, linear measurements, and annotations) | |
| The System Console receives, processes, displays, and records ultrasound image data from the transducer in the Kodama HD-IVUS catheter. The IVUS images are displayed on a high-resolution, 19-inch, flat panel, touch screen monitor. The monitor serves as the graphical user interface (GUI) for operating the system. All system information and controls are located on the touch screen monitor. The HD-IVUS system has internal storage for patient studies. Each study can contain data in the form of loops or stills. Study data is saved in DICOM format and can be exported to DVD, using the integrated DVD drive, or to a USB storage device, using one of the four USB ports. | |
| • Roll Stand | |
| The variable height roll stand supports the System Console and enables the console to be attached to a mobile stand that can be rolled up to the patient bed. | |
| • Bed Rail Swing Arm | |
| The bed rail swing arm mount supports the System Console and enables the console to be attached to a patient bed rail. | |
| • Patient Interface Module (PIM) | |
| The Patient Interface Module (PIM) provides the electromechanical interface between the catheter and the System Console. The PIM provides the mechanical interface to secure the catheter, as well as the mechanical energy to rotate the catheter's imaging assembly. |
1
K122878 pg 2016
Image /page/1/Picture/2 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo is composed of the letters SVMII in a stylized font. The words "Silicon Valley Medical Instruments Inc." are written below the letters in a smaller font.
2
K122878 pg 30P6
:
Image /page/2/Picture/2 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo is composed of the letters "SVMII" in a stylized font. The words "Silicon Valley Medical Instruments Inc." are written below the letters in a smaller font.
The PIM also provides the electrical interface that transmits the signal from the integrated ultrasound generator to the catheter and receives the return signals. The PIM is placed into a sterile bag for normal use and can be situated near the patient in the sterile field. The PIM features an imaging on/off button and a recording on/off button. These controls enable the sterile operator to start or stop imaging and recording from within the sterile field. A LED light on the PIM indicates active recording.
Linear Translation System (LTS) (subject of this submission)
The Linear Translation System (LTS) is an accessory (companion product) to the HD-IVUS system and provides for linear translation (pullback) of the catheter imaging element under motorized (controlled speed) linear translation when used in conjunction with the PIM. The LTS is an optional accessory and not required for basic IVUS imaging.
Power Supply
The system includes a universal, medical grade external AC to DC power supply that enables direct connection to the hospital power source.
Intravascular Ultrasound Catheter (510(k) cleared under K113008 and sold separately)
The Kodama Intravascular Ultrasound Catheter is a minimally invasive intravascular ultrasound coronary imaging catheter. The catheter emits acoustic energy from a transducer at its distal tip, which is guided into the coronary arteries of the heart. Sound waves that are reflected from vascular tissues are received by the transducer and sent through the PIM to the system console. The catheter can be operated at two different frequencies, 40 MHz or 60 MHz, depending on user preference. An integrated telescope allows the imaging of multiple regions of interest in a single procedure by advancing or retracting the imaging assembly without moving the catheter sheath. (NOTE: Refer to the Directions for Use supplied with the Kodama Intravascular Ultrasound Catheter for additional information.)
| Intended Use of the Device | The HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. |
|---|---|
| ---------------------------- | ---------------------------------------------------------------------------------------------------------------------------------- |
3
K122878 pg 40R6
Image /page/3/Picture/2 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo is in black and white and features the letters "SVMI" in a stylized font. The words "Silicon Valley Medical Instruments Inc." are written in a smaller font below the letters.
| Indications for Use | The HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures. |
|---|---|
| --------------------- | -------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
4
K12 2878 pg 50P6
Image /page/4/Picture/2 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo consists of the letters 'SVMI' in a stylized font. The words 'Silicon Valley Medical Instruments Inc.' are written in a smaller font below the letters 'SVMI'.
| Summary of the Technological Characteristics of the Device Compared to the Predicate Device | ||
|---|---|---|
| Characteristic | Predicate Device | |
| (SVMI's HD-IVUS Ultrasound | ||
| Imaging System - Cleared 17Dec11 | ||
| via K112997) | Additional Predicate | |
| (Boston Scientific Corporation's | ||
| iLab Ultrasound Imaging System - | ||
| Cleared 14Jul05 via K051679) | ||
| Signal Type | Echo | Doppler, Echo |
| Catheter Mechanical Drive | Patient Interface Module (PIM) | |
| (cleared with ultrasound system) | Motor Drive Unit (MDU) | |
| (cleared with ultrasound system) | ||
| Linear Translation System | ||
| (accessory to device(s)) | Subject of this submission - Linear | |
| Translation System that allows for | ||
| motorized (controlled speed) linear | ||
| pullback (translation) of the | ||
| catheter when used in conjunction | ||
| with the PIM (above) | Pullback Sled that allows for linear | |
| pullback (translation) of the | ||
| catheter when used in conjunction | ||
| with the MDU (above) | ||
| Signal Conductor | Coaxial wire traveling down | |
| catheter | Coaxial wire traveling down | |
| catheter | ||
| Signal Generator/ Receiver | ||
| Materials | PZT crystal transducer | PZT crystal transducer |
| Acoustic Output | Does not exceed Track 3 limits | Does not exceed Track 3 limits |
| Ultrasound Frequency | 40 MHz, 60 MHz ± 10% | 10-40 MHz ± 10% |
| Method of Use | Intravascular | Intravascular |
| User Interface | PC-based system with keyboard | |
| and touch screen and mouse | PC-based system with keyboard | |
| and touch screen and mouse | ||
| Software Interface | Custom GUI | Custom GUI |
| Intended Use | The HD-IVUS Ultrasound Imaging | |
| System (Console) is intended for | ||
| ultrasound examination of | ||
| coronary intravascular pathology | ||
| only. Intravascular ultrasound | ||
| imaging is indicated in patients | ||
| who are candidates for | ||
| transluminal coronary | ||
| interventional procedures. | The iLab Ultrasound Imaging | |
| System is intended for ultrasound | ||
| examinations of intravascular | ||
| pathology. Intravascular | ||
| ultrasound is indicated in patients | ||
| who are candidates for | ||
| transluminal interventional | ||
| procedures such as angioplasty | ||
| and atherectomy. |
5
K122878 pg 6aP6
Image /page/5/Picture/2 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo is in black and white and features the letters "SVMI" in a stylized font. The words "Silicon Valley Medical Instruments Inc." are written in a smaller font below the letters.
| Performance Data | ||
|---|---|---|
| Summary of Non-clinical tests Conducted for Determination of Substantial Equivalence | ||
| Performance Test Summary - New Device | ||
| Characteristic | Standard/Test/FDA Guidance | Results Summary |
| Electromagnetic | ||
| Compatibility | Compliant with IEC 60601-1-2 | Compliant with IEC 60601-1-2 |
| Electrical Safety and | ||
| Acoustic Safety | Compliant with IEC 60601-1, IEC | |
| 60601-1-4, and IEC 60601-2-37 | Compliant with IEC 60601-1, IEC | |
| 60601-1-4, and IEC 60601-2-37 |
. Conclusions Drawn from Design Verification/Validation and Non-clinical Data The HD-IVUS Ultrasound Imaging System (with Linear Translation System) is substantially equivalent in design and technology to the predicate device(s) with regard to intended use.
6
Image /page/6/Picture/0 description: The image shows the text "DEPARTMENT OF HEALTH & HUMAN SERVICES". The text is in black and is centered on the page. There is a line underneath the text. To the left of the text is a logo.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
JAN 1 1 2013
Silicon Valley Medical Instruments, Inc. (SVMI) c/o Richard E. Anderson 47697 Westinghouse Drive, Suite 101 Fremont, CA 94539-7401
Re: K122878
Trade Name: HD-IVUS Ultrasound Imaging System (with Linear Translation System) Regulation Number: 21 CFR 870.1200 Regulation Name: Diagnostic intravascular catheter Regulatory Class: Class II Product Code: QBJ Dated: December 10, 2013 Received: December 13, 2013
Dear Mr. Anderson:
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. 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
7
Page 2 – Mr. Richard Anderson
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 801); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours.
Owen P. Faris -S
Bram D. Zuckerman, M.D. for Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
8
K 122878 ps lofl
Special 510(k) (accessory to device) Silicon Valley Medical Instruments, Inc. Indications for Use
SVMI
Silicon Valley Medical Instruments Inc."
INDICATIONS FOR USE
510(k) Number (if known):
Device Name: HD-IVUS Ultrasound Imaging System (with Linear Translation System)
Indications for Use: Silicon Valley Medical Instrument's HD-IVUS Ultrasound Imaging System (Console) is intended for ultrasound examination of coronary intravascular pathology only. Intravascular ultrasound imaging is indicated in patients who are candidates for transluminal coronary interventional procedures.
___ AND/OR Over-The-Counter Use _ Prescription Use _____________________________________________________________________________________________________________________________________________________________
(Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Page 1 of 1
(Division Sign-Off)
Division of Cardiovascular Devices
510(k) Number K122878