(15 days)
Diagnostic Ultrasound Imaging and Doppler Analysis of the human body as follows: Musculo-skeletal Conventional, Musculo-skeletal Superficial, Small Parts (small organ), Peripheral Vascular. Diagnostic Ultrasound System: Fetal, Abdominal, Pediatric, Small Parts I (small organ), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Transrectal, Transvaginal, Peripheral Vascular, Musculo-skeletal Conventional, Musculo-skeletal Superficial.
This premarket notification describes modifications to the ImagePoint M2410A system. It adds two new intended uses to the operating platform covering Musculo-Skeletal and Adult Cephalic (Transcranial Doppler) imaging. It adds harmonic imaging mode for the following applications: fetal, abdominal, pediatric, adult cephalic and cardiac. Hewlett-Packard considers Harmonic imaging to be a subset of 2D / B-mode imaging. This premarket notification also adds a transducer with new patient contact materials indicated for musculo-skeletal, vascular and small parts imaging. The classification names for these devices are: Diagnostic Oltrasound Transducer, Ultrasonic Pulsed Echo Imaging System and Ultrasonic Pulsed Doppler Imaging System. The modification involves expanded intended uses to the M2410A system, as well as, the addition of a new transducer with new patient contact materials, to be known as the HP 21376A Transducer. The ImagePoint system, with new platform modes, new indications for use, and new transcucer, functions in the same way as its predicate devices, the M2410A K954028), M2424A (K964309 and K980687) and the Acuson Aspen System, with L7 probe, (K973079) by allowing ultrasound imaging of the humar anatomy. The subject platform and transqucer have the same functionality and intended uses as their bredicates. The M2410A platform and HP 21376A transducer on the M2410A are similar to the predicate devices in all respects except the transducer has new patient contact materials. This 510(k) Notification includes biocompatibility test results that demonstrate biocompatibility of the new materia s.
This document describes the 510(k) summary for modifications to the ImagePoint M2410A ultrasound system and a new transducer, the HP 21376A. The modifications include expanded intended uses for the platform and the addition of a new transducer with new patient contact materials.
1. Acceptance Criteria and Reported Device Performance
The provided text does not contain any specific acceptance criteria or reported device performance metrics for the ImagePoint M2410A system or the HP 21376A transducer. The document focuses on demonstrating substantial equivalence to predicate devices and expanding the indications for use.
The tables in the document (Diagnostic Ultrasound Indications for Use Form) primarily listed the "Mode of Operation" for various "Clinical Application" categories. The 'N' in the tables indicates a "new indication" and 'P' indicates "previously cleared by FDA". There are no numerical performance values or targets.
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not contain information about a specific test set, its sample size, or data provenance (e.g., country of origin, retrospective or prospective data). The submission focuses on substantial equivalence based on the device's functionality and intended uses being similar to predicate devices. For biocompatibility, it states "biocompatibility test results that demonstrate biocompatibility of the new materials" were included, but details are absent here.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
The document does not mention any ground truth establishment by experts for a test set. This type of study detail is not typically found in a substantial equivalence claim for an ultrasound device based on expanded indications and new transducer materials.
4. Adjudication Method for the Test Set
As there is no mention of a test set or ground truth establishment, there is no adjudication method described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not describe a Multi-Reader Multi-Case (MRMC) comparative effectiveness study. There is no information on how human readers' performance might improve with or without AI assistance, as this submission predates widespread AI integration in medical imaging and focuses on fundamental device capabilities and safety/equivalence.
6. Standalone (Algorithm Only) Performance Study
The provided text does not include information about a standalone (algorithm only) performance study. The device described is a whole ultrasound imaging system and transducer.
7. Type of Ground Truth Used
Given the nature of the 510(k) submission (primarily focusing on expanded indications, new transducer materials, and substantial equivalence to predicate devices), there is no explicit mention of ground truth types (e.g., expert consensus, pathology, outcomes data) in the context of device performance evaluation. The "ground truth" in this context would likely be implicitly tied to the established safety and effectiveness of the predicate devices for similar applications.
8. Sample Size for the Training Set
The document does not mention a training set or its sample size. This type of information is relevant for AI/ML-based devices, which are not the focus of this 1999 ultrasound device submission.
9. How the Ground Truth for the Training Set Was Established
As there is no mention of a training set, there is no information on how its ground truth was established.
§ 892.1570 Diagnostic ultrasonic transducer.
(a)
Identification. A diagnostic ultrasonic transducer is a device made of a piezoelectric material that converts electrical signals into acoustic signals and acoustic signals into electrical signals and intended for use in diagnostic ultrasonic medical devices. Accessories of this generic type of device may include transmission media for acoustically coupling the transducer to the body surface, such as acoustic gel, paste, or a flexible fluid container.(b)
Classification. Class II.