(25 days)
The Teratech Corporation Terason™ uSmart3200T is a general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body. Specific clinical applications and exam types include: Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular.
The Terason™ uSmarl3200T ultrasound system is equivalent to the previously cleared version of the t3200 and t3000 Ultrasound Systems described in the following 510(k) submissions (K110020 and K112953). This system contains a proprietary ultrasound engine for controlling the acoustic output of the transducer and processing the return echoes in real time. These data are then transferred to the tablet (previously laptop computer) over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image.
The Terason™ uSmart3200T ultrasound tablet weighs 4.9 pounds (2.21 Kg) and has an 11,5" backlit touch screen. The tablet dimensions (8,82"(H) x 12,64"(W) x 1,25"(D)) are chosen to allow portability. A Lithium-Polymer battery (integrated into the tablet) provides 2 hours of continuous ultrasound scanning. The tablet includes a docking station (for charging) that uses a medical-grade power supply. The ultrasound transducer connector is identical to that used in the Terason™ predicate device, the t3200. Optional accessories include a cart and printer.
The provided document is a 510(k) Summary for the Terason™ uSmart3200T Ultrasound System, detailing its substantial equivalence to previously cleared devices. It focuses on regulatory compliance, safety, and performance characteristics rather than clinical study results establishing diagnostic accuracy against a ground truth.
Therefore, the following information cannot be extracted from the provided text:
- A table of acceptance criteria and reported device performance (in terms of diagnostic accuracy metrics). The document refers to compliance with safety and performance standards (e.g., IEC 60601-1) but not clinical performance acceptance criteria like sensitivity, specificity, or AUC against a ground truth.
- Sample size used for the test set or its provenance.
- Number of experts used to establish ground truth or their qualifications.
- Adjudication method for the test set.
- Whether a multi-reader, multi-case (MRMC) comparative effectiveness study was done or its effect size.
- Whether a standalone (algorithm only) performance study was done.
- The type of ground truth used (expert consensus, pathology, outcomes data).
- Sample size for the training set.
- How the ground truth for the training set was established.
However, based on the document, I can provide the following relevant information regarding the device's acceptance criteria and the study that proves its compliance with regulatory standards:
The device's acceptance criteria are primarily defined by compliance with established international and national standards for medical electrical equipment, including safety, usability, electromagnetic compatibility, and acoustic output. The "study" proving the device meets these criteria consists of specific non-clinical tests and reports generated by accredited testing laboratories (Intertek).
1. A table of acceptance criteria and the reported device performance (focused on technical compliance):
| Acceptance Criteria Category | Specific Standard/Requirement | Reported Device Performance/Compliance |
|---|---|---|
| General Safety | IEC 60601-1 Medical Electrical Equipment Part 1: General Requirements for Safety | Intertek Test Record Number 100825075BOX-001 (indicates compliance) |
| Usability | IEC 62366, Medical Devices: Application of usability engineering to medical devices | Intertek Project: 100825075BOX-004 (indicates compliance) |
| IEC 60601-1-6, Medical Electrical Equipment Part 1-6: General requirements for safety- Collateral standard: Usability | Intertek Project: 100825075BOX-003 (indicates compliance) | |
| Electromagnetic Compatibility (EMC) | IEC 60601-1-2:2007, Medical Electrical Equipment - Part 1-2; General requirements for basic safety and essential performance - Collateral Standard: Electromagnetic compatibility - Requirements and tests | Intertek Test Record Number, 100933162BOX-017 (indicates compliance) |
| Specific Safety (Ultrasound) | IEC 60601-2-37 / EN60601-2-37 Medical Electrical Equipment Part 2: Particular requirements for the safety of ultrasonic medical diagnostic and monitoring equipment | Transducer Model 5C2A: Intertek Report 100825075BOX-006 (compliance) |
| Transducer Model 12L5A: Intertek Report 100825075BOX-007 (compliance) | ||
| Transducer Model 4V2A: Intertek Report 100825075BOX-005 (compliance) | ||
| Acoustic Output Display | NEMA UD 3 Acoustic Output Display | Terason uSmart3200T Ultrasound System User Guide (16-3301) (indicates adherence to display requirements) |
| Biocompatibility (Transducers) | ISO 10993 Part 5 and Part 10 | Biocompatibility reports for all transducers (indicates compliance) |
| Substantial Equivalence (General) | Comparison to predicate devices: Terason™ t3000 (K112953) and Terason™ t3200 (K110020) | The FDA's 510(k) clearance letter (K131209) states the device is "substantially equivalent" to predicate devices for the stated indications for use. |
| Indications for Use | General purpose ultrasound imaging and fluid flow analysis for specific clinical applications | The device supports Fetal, Abdominal, Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic; Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Peripheral Vascular. |
Important Note: This document describes a 510(k) submission, which primarily aims to demonstrate substantial equivalence to a previously cleared device. It does not typically involve new clinical efficacy studies with ground truth establishment in the way that, for example, a novel diagnostic AI algorithm would. The "performance" here refers to meeting established safety and performance standards for ultrasound devices, and demonstrating that changes from predicate devices (e.g., changing from laptop to tablet) do not raise new safety or effectiveness concerns.
§ 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.