(178 days)
Not Found
No
The summary describes a standard intravascular ultrasound (IVUS) system with image acquisition, storage, and basic measurement capabilities. There is no mention of AI, ML, or advanced image processing techniques that would suggest the use of these technologies. The performance studies focus on electrical safety, acoustic output, and software development according to older guidance documents, not AI/ML validation.
No
The device is described as an Intravascular Ultrasound (IVUS) system intended for diagnostic imaging to detect abnormalities and perform measurements, not for therapeutic intervention.
Yes
Explanation: The "Intended Use/Indications for Use" section states that the device can "detect abnormalities" and the "Summary of Performance Studies" mentions "diagnostic ultrasound medical devices" in relation to acoustic output measurements. This directly indicates its diagnostic purpose.
No
The device description explicitly details hardware components such as a scanner unit, card rack, video switch board, cables, connectors, and common components like a keyboard, display, power supply, and internal computer, indicating it is a hardware-based system with integrated software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states that the device is for intravascular applications to obtain, store, and retrieve 2D images and perform measurements and analysis on these images. This is a diagnostic imaging device used in vivo (within the body).
- Device Description: The description details an ultrasound system with an intravascular component. Ultrasound is an imaging modality, not a method for analyzing biological samples in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, tissue, etc.) or performing tests on these samples outside of the body. IVDs are designed to examine specimens obtained from the human body to provide information for diagnosis, monitoring, or screening.
Therefore, this device falls under the category of a diagnostic imaging device, specifically an intravascular ultrasound (IVUS) system, rather than an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on these.
The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device.
As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices.
The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to:
- · Produce 2D images that can be used to detect abnormalities.
- · Store images in the CFM system or via the CFM system to other storage media.
Images can be retrieved from the CFM system or storage media for measurement and analysis.
Indications for use:
Intra cardiac
Coronary vessel
Peripheral vessel
Product codes
Not Found
Device Description
The IVUS consists of a basic scanner unit integrated into the CFM 775/800 ultrasound system. The basic scanner unit consists of a card rack mounted into the CFM 775/800; a video switch board mounted into the CFM 775/800 card rack; cables for interconnections; a connector for the motor drive and components that are common with the CFM 775/800. These common components include the keyboard and display, connectors for ECG and AUX, power supply, and internal computer (EchoPac) for video grabbing and archival (CFM 800 only), and peripherals such as a VCR printer. The system is used with specified off-the-shelf motor pod and ultrasound catheters not manufactured by Vingmed Sound A/S.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
ultrasound
Anatomical Site
Intra cardiac, Coronary vessel, Peripheral vessel
Indicated Patient Age Range
Not Found
Intended User / Care Setting
duly licensed physician who has received appropriate training
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)
Nonclinical tests:
The product has been designed for electrical patient safety by complying with IEC 601-1 and EN 60601-1-2, EN 55011 and IEC 801-2/-3-/-4/-5 for EMC protections. Other tests performed have included measurements of acoustic output in accordance with the FDA guidance document of December 1985 for measuring and reporting acoustic output of diagnostic ultrasound medical devices. The software is developed in accordance with a software development plan and the software level of concern, as described in the document "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) review" dated August 29,1991, is moderate.
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.
CVIS Insight III. K921750
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
Not Found
§ 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
510(k) Summary PER 21 CFR 807.92
Submitted by: 1:
Vingmed Sound A/S
P.O. Box 141.
JAN - 2 1997
N-3191 Horten, Norway
Contact person: Einar Korn Heide Aas, Director, Regulatory Affairs
Summary prepared: 19. June 1996
Device Name: 2:
Intra Vascular Ultrasound System (IVUS) option for Vingmed Sound Color Flow Mapping System
-
Predicate Device: 3:
CVIS Insight III. K921750 -
Device Description: 4:
The IVUS consists of a basic scanner unit integrated into the CFM 775/800 ultrasound system. The basic scanner unit consists of a card rack mounted into the CFM 775/800; a video switch board mounted into the CFM 775/800 card rack; cables for interconnections; a connector for the motor drive and components that are common with the CFM 775/800. These common components include the keyboard and display, connectors for ECG and AUX, power supply, and internal computer (EchoPac) for video grabbing and archival (CFM 800 only), and peripherals such as a VCR printer. The system is used with specified off-the-shelf motor pod and ultrasound catheters not manufactured by Vingmed Sound A/S. -
Intended Use: న్:
The IVUS option for the CFM product family is intended for intravascular applications at all system control settings. When used with a Vingmed Color Flow Mapping (CFM) imaging system the device can be used to obtain, store and retrieve 2D images and perform measurements and analysis on these.
The IVUS option is intended for use by duly licensed physician who has received appropriate training in proper operation of the device.
As with any procedure of this sort, the physician conducting the examination must exercise sound medical judgment in the selection of patients for this product, and be skilled in interpreting the echocardiographic data obtained from intra-vascular ultrasound devices.
The IVUS option is intended to be used with a Vingmed Color Flow Mapping (CFM) imaging system to apply ultrasound energy from an intra-vascular catheter to:
- · Produce 2D images that can be used to detect abnormalities.
- · Store images in the CFM system or via the CFM system to other storage media.
Images can be retrieved from the CFM system or storage media for measurement and analysis.
1
Comparison With Predicate Device 6:
The folowing table depicts the similarities and differences between the Vingmed Sound IVUS System and the CVIS Insight III.
| New device | Predicate device | |
|---|---|---|
| 510(k) number | IVUS | CVIS Insight III |
| K921750 | ||
| Indications for use | Intra cardiac | Intra cardiac |
| Coronary vessel | Coronary vessel | |
| Peripheral vessel | Peripheral vessel | |
| General device description | Embedded processor for system | |
| control | Embedded processor for system | |
| control | ||
| Operator interface with imaging | ||
| controls, alphanumeric | ||
| keyboard, trackball, TGC | ||
| controls, software menu | ||
| controls | Operator interface with | |
| alphanumeric keyboard, remote | ||
| control, trackball, software | ||
| menu controls | ||
| B&W - or colour monitor | B&W monitor | |
| Picture-in-picture (angio and | ||
| ultrasound on one screen) | Picture-in-picture (angio and | |
| ultrasound on one screen) | ||
| Two traces | Two traces | |
| Imaging modes | B-mode | B-mode |
| 360 degree image format | 360 degree image format | |
| Catheters | Single element rotating | |
| transducer | Single element rotating | |
| transducer | ||
| Single element fixed transducer | ||
| with rotating mirror | Single element fixed transducer | |
| with rotating mirror | ||
| Measurements | General (distance, area and % | |
| stenosis) | General (distance, area and % stenosis) | |
| Acoustic output and device | ||
| settings used | Track 1 | Track 1 |
| Image archiving and | ||
| communications | EchoPAC, magneto-optical | |
| disc, video | Video, digital raw-data transfer, | |
| research option (RF output) | ||
| General safety and effectiveness | Conforms to IEC601-1, | |
| EN60601-1-2 | - |
| Table 1: General system comparison table | ||||||
|---|---|---|---|---|---|---|
| -- | -- | -- | -- | -- | ------------------------------------------ | -- |
7: Nonclinical tests:
ﺴﯿﺴﻪ
The product has been designed for electrical patient safety by complying with IEC 601-1 and EN 60601-1-2, EN 55011 and IEC 801-2/-3-/-4/-5 for EMC protections. Other tests performed have included measurements of acoustic output in accordance with the FDA
2
MINGMED SOUND
guidance document of December 1985 for measuring and reporting acoustic output of diagnostic ultrasound medical devices. The software is developed in accordance with a software development plan and the software level of concern, as described in the document "Reviewers Guidance for Computer Controlled Medical Devices Undergoing 510(k) review" dated August 29,1991, is moderate.
8: Conclusion:
Based on the analysis of the comparison matrix described in 6 above and the results of the nonclinical testing described in 7 above, Vingmed Sound A/S has concluded that the Intra Vascular Ultrasound System (IVUS) option for Vingmed Sound Color Flow Mapping System is safe, effective, ad performs as well as or better than the legally marketed device in 3 above.