(71 days)
Not Found
No
The summary describes standard ultrasound image processing and does not mention AI, ML, or related concepts.
No.
The device is described as an "ultrasound diagnostic imaging tool" used for visualization, not for treatment or therapy.
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, 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 is a diagnostic imaging procedure performed in vivo (within the living body) using ultrasound technology.
- Device Description: The description clearly states it's a "minimally invasive intravascular ultrasound diagnostic imaging tool" that provides "in-vivo visualization."
- Mechanism: The system uses a catheter with a transducer inserted into the coronary arteries to emit and receive sound waves, creating images of the internal structures. This is a direct imaging technique performed on the patient.
- Lack of In Vitro Activity: There is no mention of the device being used to examine specimens (like blood, tissue, or urine) outside of the body, which is the defining characteristic of an in vitro diagnostic device.
IVD devices are specifically designed to examine specimens in vitro to provide information for diagnosis, monitoring, or screening. This device operates directly on the patient's internal anatomy.
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 (comma separated list FDA assigned to the subject device)
IYN; IYO
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, 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. 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, 19inch, 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 25 studies. Each study can have up to eight loops, with a maximum of 9000 frames per loop. 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 two 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.
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 signal. When placed in a sterile bag, the PIM can be situated near the patient in the sterile field. The PIM features an imaging on/off button and a recording on/off button, which enable the physician to start or stop imaging and recording from within the sterile field. An orange LED light on the PIM indicates active recording.
Power Supply: The system includes a universal, medical grade, external power supply that enables direct connection to the hospital power source.
Intravascular Ultrasound Catheter (510(k) cleared 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.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Coronary intravascular
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Physician
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.
Electromagnetic Compatibility: 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.
Conclusions Drawn from Design Verification/Validation and Non-clinical Data: The HD-IVUS Ultrasound Imaging System is substantially equivalent in design and technology to the predicate device(s) with regard to intended use.
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): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 892.1550 Ultrasonic pulsed doppler imaging system.
(a)
Identification. An ultrasonic pulsed doppler imaging system is a device that combines the features of continuous wave doppler-effect technology with pulsed-echo effect technology and is intended to determine stationary body tissue characteristics, such as depth or location of tissue interfaces or dynamic tissue characteristics such as velocity of blood or tissue motion. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II.
0
KI12997
DEC 1 7 2011
Traditional 510(k) (new device) Silicon Valley Medical Instruments, Inc. 510(k) Summary CONFIDENTIAL
Image /page/0/Picture/3 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo consists of the letters SVMII in a bold, sans-serif font. The words "Silicon Valley Medical Instruments Inc." are printed 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 | 7 October 2011 |
| Name of Device | |
|---|---|
| Trade or Proprietary Name | HD-IVUS Ultrasound Imaging System |
| Common or Usual Name | System, Imaging, Pulsed Doppler, Ultrasonic (IYN); System, Imaging, Pulsed Echo, Ultrasonic (IYO) |
| Classification Name | Class II |
| Classification Panel | Cardiovascular |
| Regulation | 21 CFR 892.1550 (IYN); 21 CFR 892.1560 (IYO) |
| Product Code(s) | IYN; 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, 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 |
1
Traditional 510(k) (new device) Silicon Valley Medical Instruments, Inc. 510(k) Summary CONFIDENTIAL
Image /page/1/Picture/1 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo consists of the letters "SVMI" in a bold, sans-serif font. The words "Silicon Valley Medical Instruments Inc." are printed in a smaller font below the letters. The letters and words are all in black.
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. 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, 19inch, 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 25 studies. Each study can have up to eight loops, with a maximum of 9000 frames per loop. 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 two 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. 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
2
Traditional 510(k) (new device) Silicon Valley Medical Instruments, Inc. 510(k) Summary CONFIDENTIAL
·
Image /page/2/Picture/1 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo consists of the letters SVMII in a bold, sans-serif font. The words "Silicon Valley Medical Instruments Inc." are written in a smaller font below the letters SVMII. The letters are in black, and the background is white.
i
| | signal from the integrated ultrasound generator to the catheter and
receives the return signal. When placed in a sterile bag, the PIM
can be situated near the patient in the sterile field. The PIM
features an imaging on/off button and a recording on/off button,
which enable the physician to start or stop imaging and recording
from within the sterile field. An orange LED light on the PIM
indicates active recording. |
|----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Power Supply |
| | The system includes a universal, medical grade, external power
supply that enables direct connection to the hospital power source. |
| | Intravascular Ultrasound Catheter (510(k) cleared 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. |
| 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. |
| Summary of the Technological Characteristics of the Device Compared to the Predicate Device | ||
|---|---|---|
| Characteristic | Predicate | New Device |
| (Boston Scientific Corporation's | ||
| iLab Ultrasound Imaging System | ||
| – Cleared 14Jul05 via K051679) | (SVMI's HD-IVUS Ultrasound | |
| Imaging System) |
·
3
Traditional 510(k) (new device) Silicon Valley Medical Instruments, Inc. 510(k) Summary CONFIDENTIAL
Image /page/3/Picture/1 description: The image shows the logo for Silicon Valley Medical Instruments Inc. The logo consists of the letters SVM in a bold, sans-serif font. The words "Silicon Valley Medical Instruments Inc." are printed in a smaller font below the letters.
| Signal Type | Doppler, Echo | Doppler, Echo |
|---|---|---|
| Catheter Mechanical Drive | Patient Interface Module (PIM) | |
| (cleared with ultrasound system) | Motor Drive Unit (MDU) | |
| (cleared with ultrasound system) | ||
| 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. |
| 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 | IEC 60601-1-2. | Compliant with IEC 60601-1-2. |
| Electrical Safety and | ||
| Acoustic Safety | 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 is substantially equivalent in design and technology to the predicate device(s) with regard to intended use.
4
Image /page/4/Picture/0 description: The image shows the logo of the Department of Health & Human Services USA. The logo consists of a circular seal on the left, containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the seal is a stylized emblem resembling an abstract human figure. To the right of the seal, the word "DEPARTMENT" is printed in bold, large font.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room - WO66-G609 Silver Spring, MD 20993-0002
Mr. Richard E. Anderson VP, RA/QA Silicon Valley Medical Instruments, Inc. 47697 Westinghouse Drive, Suite 101 FREMONT CA 94539-7401
DEC 1 7 2011
Re: K112997
Trade/Device Name: HD-IVUS Ultrasound Imaging System Regulation Number: 21 CFR 892.1550 Regulation Name: Ultrasonic pulsed doppler imaging system Regulatory Class: II Product Code: IYN and IYO Dated: October 7, 2011 Received: October 7, 2011
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.
If your device is classified (see above) into class II (Special Controls), it may be subject to such additional controls. Existing major regulations affecting your device can be found in Title 21, Code of Federal Regulations (CFR), Parts 800 to 895. 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 Parts 801 and 809); medical device reporting (reporting of
5
medical device-related adverse events) (21 CFR 803); and good manufacturing practice medical device returns as set forth in the quality systems (QS) regulation (21 CFR Part 820). This letter requirements as set form in the quality -device as described in your Section 510(k) premarket will anow you to begin marketing your intial equivalence of your device to a legally marketed noticate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Parts 801 and If you desire spositional weeks your viro Diagnostic Device Evaluation and Safety at (301) 796-5450. 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 under the MDK regulation (21 Of RT Pur 005), product of and the 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 Tou may other butter generarers, 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/cdrh/industry/support/index.html.
Sincerely Yours,
Mary Pastel
Mary S. Pastel, Sc.D. Director Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety Center for Devices and Radiological Health
Enclosure
6
Indications for Use
510(k) Number: K112997
Device Name: SVMI's HD-IVUS Ultrasound Imaging 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.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of In Vitro Diagnostic Devices (OIVD)
Aruld D'Aun
(Division Sign-Off) Division of Radiological Devices Office of In Vitro Diagnostic Device Evaluation and Safety
510(k) Number: K112997
Page 1 of 1
7
Appendix G: Example Diagnostic Ultrasound Indications For Use Format
SVMI HD-IVUS Console System: SVMI Kodama Catheter Transducer:
Intended Use: Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows:
| Clinical Application | Mode of Operation | |||||||
|---|---|---|---|---|---|---|---|---|
| General | ||||||||
| (Track 1 Only) | Specific | |||||||
| (Tracks 1 & 3) | B | M | PWD | CWD | Color | |||
| Doppler | Combined | |||||||
| (Specify) | Other* | |||||||
| (Specify) | ||||||||
| Ophthalmic | Ophthalmic | |||||||
| Fetal | ||||||||
| Imaging | ||||||||
| & Other | Fetal | |||||||
| Abdominal | ||||||||
| Intra-operative (Specify) | ||||||||
| Intra-operative (Neuro) | ||||||||
| Laparoscopic | ||||||||
| Pediatric | ||||||||
| Small Organ (Specify) | ||||||||
| Neonatal Cephalic | ||||||||
| Adult Cephalic | ||||||||
| Trans-rectal | ||||||||
| Trans-vaginal | ||||||||
| Trans-urethral | ||||||||
| Trans-esoph. (non-Card.) | ||||||||
| Musculo-skeletal | ||||||||
| (Conventional) | ||||||||
| Musculo-skeletal | ||||||||
| (Superficial) | ||||||||
| Intravascular | ||||||||
| Other (Specify) | ||||||||
| Cardiac | Cardiac Adult | |||||||
| Cardiac Pediatric | ||||||||
| Intravascular (Cardiac) | P | |||||||
| Trans-esoph. (Cardiac) | ||||||||
| Intra-cardiac | ||||||||
| Other (Specify) | ||||||||
| Peripheral | ||||||||
| Vessel | Peripheral vessel | |||||||
| Other (Specify) |
N = new indication; P = previously cleared by FDA; E = added under this appendix
- Examples of other modes of operation may include: A-mode, Amplitude Doppler, 3-D Imaging, Harmonic Imaging, Tissue Motion Doppler, and Color Velocity Imaging