(184 days)
Not Found
No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and the description of the modification focuses on "automatic determination" without mentioning learning or training.
No
The device is described as a software modification for an existing ultrasound platform (SD 800) that allows for automatic determination of flow angles for imaging. It is a diagnostic tool, not a therapeutic one.
Yes
The device aids in CVI imaging and Doppler, which are diagnostic ultrasound techniques used by sonographers to assess blood flow and tissue characteristics for medical diagnosis. The modification is to assist in automatically determining flow angles, which is a step in the diagnostic process.
No
The device is described as a "SW modification" to an existing "SD 800 platform," which is likely a hardware ultrasound system. The modification enhances a function of the existing hardware.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description states "No change from existing SD 800 platform reviewed during 510(k) 935923." While we don't have the details of K935923, the core function described is related to ultrasound imaging, specifically determining flow angles for Doppler and CVI imaging. This is a function of an imaging device, not a device used to examine specimens from the human body in vitro.
- Device Description: The description focuses on a "SW modification" that "allows for automatic determination of the flow angles used in Doppler and CVI imaging." This is a software feature for an ultrasound system.
- Input Imaging Modality: The input is "Ultrasound," which is an in vivo imaging technique, not an in vitro diagnostic method.
IVD devices are used to examine specimens (like blood, urine, tissue) from the human body to provide information for diagnosis, monitoring, or screening. This device's function is directly related to acquiring and processing ultrasound images of the body itself.
N/A
Intended Use / Indications for Use
No change from existing SD 800 platform reviewed during 510(k) 935923.
Product codes
90 IYN, 90 IYQ
Device Description
This SW modification allows for automatic determination of the flow angles used in Doppler and CVI imaging. The automatic flow angle is determined using an algorithm that is described in detail in Appendix C of the 510(k) report. Since the flow angle will be set automatically use of this SW modification will reduce the time a sonographer needs to set the angle. The sonographer still has the ability to overide the automatic placement if they do not like the automatic angle positioning.
Mentions image processing
Not Found
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
sonographer
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
Not Found
Key Metrics
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
MAR 1 9 1997
Attachment C
SD 800 SW Modification
510(k) Summary of Safety and Effectiveness: 21 CFR 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: August 26,1996
-
- Trade Name: SD 800 SonoDiagnost Ultrasound Imaging System Common Name : Ultrasound Imaging System Classification Pro Codes: 90 IYN & 90 IYQ
3) Identification of Predicate Device:
The predicate device for this submittal is existing SD 800 human interface controls which were reviewed by FDA on the SD 800 system that was submitted as part of K935923.
-
- Description of the device or modification being submitted for premarket approval.
Functionality: This SW modification allows for automatic determination of the flow angles used in Doppler and CVI imaging.
- Description of the device or modification being submitted for premarket approval.
Scientific Concepts: The automatic flow angle is determined using an algorithm that is described in detail in Appendix C of the 510(k) report.
Significant Characteristics of the Modification: Since the flow angle will be set automatically use of this SW modification will reduce the time a sonographer needs to set the angle. The sonographer still has the ability to overide the automatic placement if they do not like the automatic angle positioning.
-
- Statement of Intended Use: No change from existing SD 800 platform reviewed during 510(k) 935923.
-
- Predicate Device Comparison: The SD 800 already has the ability to manually position the flow angle cursor in the image. The new SW allows this position to automatically be determined by the system. Both sets of SW allow for final manual adjustment of the position.