(28 days)
The Teratech Corporation Terason uSmart3300 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: Ophthalmic, Fetal, Abdominal, Intra-operative (Spec. and Neuro.), Pediatrics, Small Organ (Thyroid, Breast, Testes); Neonatal and Adult Cephalic, Trans-vaginal, Trans-esoph. (non-cardiac), Musculo-skeletal (Conventional and Superficial); Cardiac (Adult & Pediatric); Trans-esoph. (cardiac) Peripheral Vascular.
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 host single-board computer over a FireWire (aka IEEE 1394) connection for further processing and generation and display of the ultrasound image. The Terason™ uSmart3300 ultrasound weighs approximately 14.6 pounds and has a 15.6" backlit screen. The system dimensions (10"(H) x 14.5"(W) x 2.5"(D)) are chosen to allow the system to be hand carried. A Lithium-Polymer battery (integrated into the unit) provides 2 hours of continuous ultrasound scanning. The system includes a medical-grade power supply (for battery charging). The ultrasound transducer connector is identical to that used in the Terason™ uSmart3300 predicate device. Optional accessories include a cart and printer.
The provided text describes the Terason uSmart3300 Ultrasound System and its associated transducers, focusing on demonstrating substantial equivalence to predicate devices for FDA 510(k) clearance. The study primarily involves comparing the device's technical characteristics and safety performance against established standards and predicates, rather than a clinical efficacy study with human readers or specific performance metrics like sensitivity/specificity for a diagnostic task.
Here's an analysis of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
The acceptance criteria are implicitly defined by compliance with various medical device standards and demonstrating equivalence to predicate devices, particularly regarding safety and intended use. Performance is reported in terms of meeting these standards and having similar specifications to the predicates.
| Acceptance Criteria (Implicit) | Reported Device Performance and Compliance |
|---|---|
| Intended Use Equivalence: Device's intended uses are consistent with predicate devices. | The Terason uSmart3300's intended use ("general purpose Ultrasound System intended for use by a qualified physician for evaluation by ultrasound imaging or fluid flow analysis of the human body") is stated to be substantially equivalent to the predicate Terason uSmart3300 (K140773) and Sonosite Maxx (K071134). New indications for specific transducers (e.g., Ophthalmic for 15L4 and 12L5A) are compared to predicate devices with identical Ophthalmic indications (e.g., K071134 system and K082098 transducer). |
| Technological Characteristics Equivalence: Device's technical specifications are comparable to predicate devices. | System: The design and construction are identical to the predicate Terason uSmart3300 (K140773), using the same engine and custom beamformer chip for enhanced resolution. The ultrasound application software was modified to support new transducers and the new Ophthalmic indication. |
| Transducer 9MC3: Similar indications for use as predicate 8MC3 (K112953). Different frequency range but identical shape. Same manufacturer, acoustic array, and patient contact materials. Acoustic characteristics met safety guidelines of IEC60601-2-37. | |
| Transducer 8TE3: Identical indications for use to predicate Philips(Oldelft) S7-3t (K132304, K070792). Similar frequency range and probe shape. Same original manufacturer (Oldelft), acoustic array, and patient contact materials. No differences reported compared to predicate. | |
| Transducer PDOF: Identical indications for use to predicate Aloka ProSound-C3 UST-T109 (K110482). Identical frequency range and probe shape. Same original manufacturer (Sound Technology), acoustic array, and patient contact materials. | |
| Transducer 15L4: Similar Ophthalmic indication for use, frequency settings, and shape to predicate Sonosite Edge L25x (K082098). Different manufacturer (Vermon). Similar acoustic array and patient contact materials. Acoustic output safety guidelines were met, ensuring safety and equal effectiveness. | |
| Transducer 12L5A: Similar Ophthalmic indication for use, frequency settings, and shape to predicate Sonosite Edge L25x (K082098). Different manufacturer (Apex). Similar acoustic array and patient contact materials. Acoustic characteristics met safety guidelines of IEC60601-2-37, ensuring safety and effectiveness. | |
| Previously filed transducers: 4V2, 5C2A, 8EC4A, 8L2, 8V3A, 12L5A (non-ophthalmic), 15L4 (non-ophthalmic), 16HL7 are identical to those cleared under K140773. | |
| Acoustic Output Safety: Device adheres to acoustic output limits and standards. | Global Maximum Outputs (Worst Case Setting) reported for the system are: ISPTA.3: 652.9 mW/cm² (4V2A), TI Value: 5.64 (4V2A), MI: 1.78 (8EC4A), IPA.3@MI Max: 1029 W/cm² (15L4). These conform to NEMA UD 2-2004 and NEMA UD 3-2004. Acoustic testing was performed per IEC60601-2-37 standard for new transducers (9MC3, 8TE3, PDOF, 15L4 Ophthalmic, 12L5A Ophthalmic). |
| Electrical Safety and EMC: Device complies with relevant electrical safety and electromagnetic compatibility standards. | Compliance reports cited: IEC 60601-1, IEC60950-1, IEC 60601-2-37, IEC60601-1-2:2007. Specific Intertek and Oldelft reports are referenced for various transducers and system components. |
| Biocompatibility: Patient-contact materials are biocompatible. | Biocompatibility tests (ISO 10993 Part 5 and Part 10) were conducted for all transducers. Patient contact materials (e.g., Silicone ABS for 9MC3, Silicone for 8TE3, Epoxy Noryl for PDOF, Silicone ABS for 15L4 and 12L5A) are stated to be identical or similar to predicate devices and meet safety guidelines. |
| DICOM Compatibility: Device supports DICOM standards. | DICOM 3.0 Structured Reporting, Worklist - Image Viewer is supported, which is consistent with the predicate. |
| Quality Systems: Manufacturing processes adhere to recognized quality standards. | Stated that devices are manufactured using FDA GMPs and ISO-13485 quality systems. |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document primarily describes a technical and performance comparison against predicate devices and mandated standards, not a clinical study involving a "test set" of patient data for evaluating a diagnostic algorithm's performance. The "tests" mentioned are for technical and safety compliance (e.g., acoustic output, electrical safety, biocompatibility).
- Test Set Sample Size: Not applicable in the context of a clinical test set for AI/algorithm performance. The "tests" refer to engineering and regulatory compliance assessments.
- Data Provenance: Not applicable. The "data" comes from engineering measurements and compliance testing, not patient studies.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable. The submission focuses on device equivalence and safety/performance standards, not on evaluating the diagnostic accuracy of the device against expert-established ground truth in a clinical setting.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable, as there is no clinical test set requiring expert adjudication.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
This is not applicable. This document is for a medical ultrasound system (hardware and associated transducers), not an AI/algorithm-driven diagnostic aid. Therefore, no MRMC study or AI assistance evaluation would be conducted for this type of submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This submission is for an ultrasound imaging system, which is a diagnostic tool operated by a human, not a standalone algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
This is not applicable in the context of diagnostic accuracy. The "ground truth" here refers to the performance specifications and safety limits defined by recognized medical device standards (e.g., IEC, NEMA) and the established performance of predicate devices.
8. The sample size for the training set
This is not applicable. There is no mention of a training set as this is not an AI/machine learning device submission.
9. How the ground truth for the training set was established
This is not applicable. There is no training set for this device.
§ 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.