(346 days)
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No
The description explicitly states the modification is a change from analog to digital circuit technology and there are no mentions of AI, ML, or related concepts.
No
The device is described as an "ultrasound imaging system," which is used for diagnostic purposes by capturing images, not for therapy. The change is in the circuit technology from analog to digital for the "front end" of these imaging systems.
Yes
The device is described as an "ultrasound imaging system" which is used for diagnostic purposes. The change is a modification to the front-end circuit technology, not a change to its intended diagnostic use.
No
The device description explicitly states the modification is a change in circuit technology for the front end of ultrasound imaging systems, indicating a hardware change, not a software-only device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for HP ultrasound systems, which are imaging devices used to visualize internal structures of the body. IVDs are used to examine specimens (like blood, urine, or tissue) outside the body to diagnose or monitor conditions.
- Device Description: The description focuses on a change in the circuit technology of the ultrasound system's front end. This is related to the imaging process, not the analysis of biological samples.
- Input Imaging Modality: The input modality is Ultrasound, which is an imaging technique, not a method for analyzing biological specimens.
- Lack of IVD-related information: There is no mention of analyzing samples, reagents, or any other components typically associated with IVD devices.
Therefore, the information strongly indicates that this device is an ultrasound imaging system, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
This modification has no effect on intended use of the HP ultrasound systems.
Product codes
870.2100, 870.2120, 870.2330, 870.2880, 870.2890, 882.1240, 884.2225, 884.2960, 892.1550, 892.1560, 892.1570
Device Description
The modification addressed in this submission is a change from analog to digital circuit technology for the front end of the HP ultrasound imaging systems listed above.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Ultrasound
Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Software safety is verified by hazard analysis and software validation to ensure performance specifications are met. This validation, safety testing, and comparison to legally marketed devices demonstrate that the modified HP ultrasound imaging systems are substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
ATL HDI 3000 (K935009), Toshiba SSA-380A (K933743)
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
AUG - 8 1996
Attachment D: 510(k) SUMMARY of Safety and Effectiveness
Submitted by: Rob Butler (contact person), Regulatory Approvals Medical Products Group Hewlett-Packard Company 3000 Minuteman Road Andover, MA 01810 phone (508) 659-2785; fax (508) 687-8284
Summary prepared August 25, 1995.
H2410A
Device Name: This modification applies to three devices (Device Trade Names HP 11 10 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 1 Name) family and to the the Dhiling Co
Classification Name: FDA has classified Ultrasound Imaging Systems as Class II in 21 CFR.
870.2100 Cardiovascular Blood Flowmeter 870.2120 Extravascular Blood Flow Probe 870.2330 Echocardiograph 870.2880 Ultrasonic Transducer 870.2890 Vessel Occlusion Transducer 882.1240 Echoencephalograph 884.2225 Obstetric-gynecologic Ultrasonic Imager 884,2960 Obstetric Ultrasonic Transducer and Accessories 892.1550 Ultrasonic Pulsed Doppler Imaging System 892.1560 Ultrasonic Pulsed Echo Imaging System 892.1570 Diagnostic Ultrasonic Transducer
In this 510(k) submission, the legally marketed devices to which we claim equivalence are the ATL HDI 3000 (K935009) and the Toshiba SSA-380A (K933743) ultrasound imaging systems.
Device Description: The modification addressed in this submission is a change from analog to digital circuit technology for the front end of the HP ultrasound imaging systems listed above.
Intended Use: This modification has no effect on intended use of the HP ultrasound systems.
Technological Characteristics: The modified HP ultrasound imaging systems will use the same type of digital circuit technology for front end receive functions as the predicate devices.
The safety of this modification is shown by compliance to medical device safety standards (such as IEC 601 and UL 2601). Software safety is verified by hazard analysis and software validation to ensure performance specifications are met. This validation, safety testing, and comparison to legally marketed devices demonstrate that the modified HP ultrasound imaging systems are substantially equivalent to legally marketed predicate devices with regards to safety, effectiveness and intended use.
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