(293 days)
No
The description focuses on basic image processing functionalities (defining ROI, quantifying brightness, tracking over time) and does not mention AI, ML, or related concepts.
No.
Explanation: The device is a software modification for ultrasound imaging systems that allows for image processing and quantification (e.g., brightness levels in a region of interest). It does not directly provide therapy; its function is diagnostic/imaging.
Yes
The device is a software modification to ultrasound imaging systems that provides capabilities to define a region of interest, quantify brightness levels, and track brightness levels over time. These functions are typically used to analyze medical images for diagnostic purposes. Additionally, one of its predicate devices is an "Image Processing System," which also suggests a diagnostic function.
No
The device is described as a software modification to existing hardware (Hewlett-Packard ultrasound imaging systems). While the submission is for the software modification, the device itself is the modified ultrasound system, which includes hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use statement explicitly states that the software modification "does not affect the intended use statements of the previously reviewed HP imaging platforms." These platforms are described as "ultrasound imaging systems," which are used for diagnostic imaging in vivo (within the living body), not in vitro (outside the body, typically on biological samples).
- Device Description: The description focuses on image processing capabilities (defining ROI, quantifying brightness, tracking brightness over time) on ultrasound images. This is consistent with an imaging device used for visualizing structures within the body.
- Input Imaging Modality: The input is Ultrasound, which is an in vivo imaging modality.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any other elements typically associated with in vitro diagnostics.
The software modification enhances the analysis of ultrasound images, which are generated from in vivo procedures. Therefore, it remains part of an in vivo diagnostic imaging system, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
This SW modification does not affect the intended use statements of the previously reviewed HP imaging platforms.
Product codes
DXK
Device Description
This 510(k) submittal is for a SW modification to Hewlett-Packard ultrasound imaging systems that have been previously reviewed by the FDA and found to be substantially equivalent. This SW modification provides the capability to: 1) define a region of interest (ROI) in an image; 2) quantify the average brightness level in the ROI: 3) track the brightness level versus time for the ROI. 2D images are created using different shades of grey. These shades of grey are assigned acoustic unit levels. The highest number (64,128,256) is given to the bright end of the scale. The lowest number (0,1) would be given to the dark or black end of the scale This SW feature looks at the grey levels stored in the digital . scan converter for a predefined region of interest selected by the operator. The average intensity or brightness for that region is then computed for one point in time. Successive calculations can be performed over time for the same region of interest using a time interval selected by the operator. There is no unique algorithm associated with the computation of the average brightness level from the data stored in the digital scan converter.
Mentions image processing
Yes
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Ultrasound
Anatomical Site
Not Found
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K 1 52 54
25540
MAR 1 1990
Attachment D to Cover Letter
Acoustic Densitometry 510 (k)
510(k) Summary of Safety and Effectiveness:21CFR 807.92
-
- Submitter's Name / Contact Person: Paul Schrader Address: 3000 Minuteman Road, Andover Ma. 01810 Telephone Number: 508-659-2404 Date summary was prepared: May 16, 1995
-
- Trade Name: Sonos Imaging System Common Name: Ultrasound Imaging System Classification Name: Echocardiograph 74DXK
3) Identification of Predicate Device
The predicate device for this submittal is made by Kontron Electronics and is called the Mipron Image Processing System.The 510(k)number for the Mipron system is K891689.
4) Description of the device and or modification being submitted for premarket approval.
This 510(k)submittal is for a SW modification to Hewlett-Packard ultrasound imaging systems that have been previously reviewed by the FDA and found to be substantially equivalent.
Functionality
This SW modification provides the capability to:
-
- define a region of interest (ROI) in an image;
-
- quantify the average brightness level in the ROI:
-
- track the brightness level versus time for the ROI.
Scientific concepts
2D images are created using different shades of grey.These shades of grey are assigned acoustic unit levels. The highest number (64,128,256) is given to the bright end of the scale. The lowest number (0,1) would be given to the dark or black end of the scale This SW feature looks at the grey levels stored in the digital . scan converter for a predefined region of interest selected by the operator. The average intensity or brightness for that region is then computed for one point in time. Successive calculations can be performed over time for the same region of interest using a time interval selected by the operator. There is no unique algorithm associated with the computation of the average brightness level from the data stored in the digital scan converter.
Significant characteristics of the device
This SW modification has only one characteristic that can be considered significant. It provides the user with a quantifiable assessment of image brightness. Image brightness assessment on earlier HP ultrasound systems was purely qualitative.
1
The most significant aspect of this SW modification is the minimal impact it will have on system safety.
1)It does not affect acoustic output levels
2)It does not affect the dimensions of the product
3)It does not affect the patient contact materials of the product
4)The brightness level is not used to make a diagnosis
- 6)It does not affect the primary electrical specifications (current draw, ratings, leakage current etc)of the host system.
5) Statement of Intended Use
This SW modification does not affect the intended use statements of the previously reviewed HP imaging platforms.The users guide will be modified to indicate that the brightness measurement is available along with the other measurement primatives and mathematical quantities calculated from primatives such as: frequency, length, time, area, circumference, slope, velocity etc.
| Feature | Predicate
Device | HP Acoustic
Densitometry |
|-----------------------------------------------------------------------|---------------------|-----------------------------|
| Used w/ real time video ultrasound
images | Yes | Yes |
| Used w/ ultrasound images played
back from VCR | Yes | Yes |
| Ability to measure image brightness | Yes | Yes |
| Range of grey scale quantification
(Grey Scale Acoustic Units: AU) | 0-255 | 0-63 |
| Ability to generate time vs
intensity graphs (see Appendix E) | Yes | Yes |
| # of images stored for time vs
intensity graph | 25 | 60 |
| Use of triggered images | Yes | Yes |
| Ability to post process image
brightness | Yes | Yes |
| Ability to define a region of
interest for brightness measurement | Yes | Yes |