(15 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal OB/GYN, Abdominal, Intraoperative (abdominal organs and vascular), Small Organs (breast, thyroid, testicle), Pediatric, Trans-vaginal, Peripheral Vessel, Cardiac, Musculo-skeletal (conventional), Neonatal Cephalic, Trans-Rectal.
C1 is a general purpose, highly portable, software-controlled. diagnostic ultrasound system. Its function is to acquire ultrasound data and display it on a monitor in 2D, M-mode, and Amplitude Doppler or in a combination of modes. C1 also gives the operator the ability to measure anatomical structures and offers analysis packages that provide information used for clinical diagnostic purposes. C1 has an output display with two basic indices, a mechanical index (MI) and a thermal index (TI). One index is automatically displayed. MI is displayed in B-mode. TI is displayed in all other modes. The C1 system is designed to accept a curved or linear transducer. All actions affecting the performance of the transducer are activated from the main system control panel. The C1 system is designed to accept transducers of the following types and frequency: frequency range: 2.0 - 7.0 MHz transducer types: Linear array Curved linear array. Specific operating conditions (frame rate, line density, center frequency, number of active elements etc.) are automatically optimized by the system software in response to user inputs such as depth, exam type, transducer, and optimize.
The SonoSite C1 Ultrasound System (K990806) is a diagnostic ultrasound system. This 510(k) summary focuses primarily on its substantial equivalence to predicate devices and adherence to safety standards rather than detailed performance studies with acceptance criteria.
Based on the provided document, here's an analysis of the acceptance criteria and study information:
1. Table of Acceptance Criteria and Reported Device Performance
The document does not explicitly define specific "acceptance criteria" in terms of clinical performance metrics (e.g., sensitivity, specificity, accuracy) for image quality or diagnostic capability. Instead, the acceptance criteria are implicitly defined by the device's conformance to established safety standards and its substantial equivalence to predicate devices. The reported device performance primarily relates to acoustic output limits.
| Acceptance Criteria Category | Specific Criteria | Reported Device Performance |
|---|---|---|
| Acoustic Output Limits | ISPTAd (Maximum) | 720 mW/cm² (Maximum) ^[3] |
| TIS/TIB/TIC (Range) | 0.1 - 4.0 (Range) ^[3] | |
| Mechanical Index (MI) (Maximum) | 1.9 (Maximum) ^[3] | |
| ISPPAd (Range) | 0 - 700 W/cm² (Range) ^[3] | |
| Electromechanical Safety | EN 60601-1 (IEC 601-1) | C1 has been designed to meet this standard ^[2] |
| UL 2601-1 | C1 has been designed to meet this standard ^[2] | |
| C22.2 No. 601.1 | C1 has been designed to meet this standard ^[2] | |
| CEI/IEC 1157:1992 | C1 has been designed to meet this standard ^[2] | |
| EN 60601-1-2 (IEC 601-1-2) | C1 has been designed to meet this standard ^[2] | |
| Biocompatibility | Transducer patient contact materials are biocompatible | Transducer patient contact materials are biocompatible ^[3] |
| Substantial Equivalence | Equivalence to ATL HDI® 5000, Medison SA88 Plus, and Cozumel ultrasound systems for described functions and intended uses | Device operates identically to predicate devices in modes (2D, M-mode, Amplitude Doppler) ^[3] |
2. Sample Size Used for the Test Set and Data Provenance
The provided 510(k) summary does not describe a clinical study with a "test set" in the sense of patient data used to evaluate device performance against specific clinical endpoints. The submission relies on substantial equivalence to previously cleared devices.
The "test set" in this context would primarily refer to technical verification tests for safety and performance (e.g., acoustic output measurements, electrical safety tests) rather than clinical image evaluations. There is no mention of a specific sample size for a clinical test set or data provenance (e.g., country of origin, retrospective/prospective). The FDA letter does, however, request a post-clearance special report containing acoustic output measurements based on production line devices, indicating ongoing technical verification.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications
This information is not provided because the document describes a substantial equivalence submission, which doesn't typically require a clinical study with a ground truth established by experts in the same way a de novo or PMA submission might. The evaluation relies on the known performance and safety of the predicate devices.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring expert adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, an MRMC comparative effectiveness study is not mentioned or implied in this 510(k) summary. The submission focuses on substantial equivalence of the device's technical specifications and intended uses rather than a comparative clinical performance study.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Yes, in the sense that the device's technical specifications and safety parameters (e.g., acoustic output) are evaluated regardless of human interaction for the purpose of regulatory clearance. However, this is for a diagnostic imaging device where a human operator (the sonographer/physician) is always "in the loop" for image acquisition, interpretation, and diagnosis. This is not an AI algorithm submission where "standalone performance" refers to the algorithm's diagnostic accuracy without human review.
7. The Type of Ground Truth Used
For the safety and performance claims made, the "ground truth" would be established by:
- Physical measurements against established standards: For acoustic output, electrical safety, and biocompatibility.
- Engineering specifications and design reviews: To ensure the device functions as described and is equivalent to predicates.
- Predicate device characteristics: The C1's performance is deemed acceptable because it is substantially equivalent to legally marketed predicate devices (ATL HDI® 5000, Medison SA88 Plus, Cozumel ultrasound system) ^[1,3]. The ground truth for its diagnostic capability is implicitly established by the historical performance and regulatory clearance of these predicates.
8. The Sample Size for the Training Set
Not applicable. The C1 Ultrasound system is a hardware and software device producing images and measurements, not an AI algorithm trained on a dataset.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" for this type of 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.