(70 days)
Diagnostic Ultrasound System Indications for Use Form Device Name: CTS-415
Clinical Application: Fetal, Abdominal, Pediatric, Small Organ (specify), Cardiac, Peripheral Vascular
Mode of Operation: B, M, Combined (specify)
Small organs includes: thyroid, parathyroid, parotid, submaxillary gland testes and breast
Pediatric Comments: Pediatric Intended Uses include: Cardiology. Abdomen. Peripheral Vasa
Scanhead Indications for Use Form Device Name: Convex Array C3I40
Clinical Application: Fetal, Abdominal, Pediatric, Cardiac
Mode of Operation: B, M, Combined (specify)
Pediatric Comments: Pediatric Intended Uses include: Cardiology, Abdomen
Scanhead Indications for Use Form Device Name: Linear Array L7I50
Clinical Application: Pediatric, Small Organ (specify), Peripheral Vascular
Mode of Operation: B, M, Combined (specify)
Small organs includes: thyroid, parotid, submaxillary gland. testes and breast Pediatric Intended Uses include: Peripheral Vasa Pediatric Comments:
Model CTS-415 is a linear/convex electronic scanning ultrasonotomograph with a built-in digital scan converter (DSC) and main CPU module. The unit allows heart, abdominal organic and fetal tomographic images to be observable on a video monitor. The main unit is portable and is separable from other equipment to be carried for its use at another place as well as being usable in combination with a 9inch video monitor and a special photographic unit.
The provided 510(k) Premarket Notification for the CTS-415 with C3I40 and L7I50 Transducers focuses on demonstrating substantial equivalence to a predicate device (Hitachi Medical Corporation EUB-310, K862867). This type of submission relies on showing that the new device has similar technological characteristics and performs comparably to a device already cleared by the FDA, rather than proving novel effectiveness through clinical trials with specific acceptance criteria and outcome measurements.
Therefore, the document does not contain the detailed information requested about acceptance criteria, study design, sample sizes, expert ground truth establishment, or specific performance metrics in the way one would find for a de novo submission or a device claiming superiority.
Specifically, the document does not include:
- A table of specific acceptance criteria or reported device performance against such criteria.
- Information on a "test set" sample size, data provenance, number or qualifications of experts, or adjudication methods for ground truth because such a study design is not described.
- A multi-reader multi-case (MRMC) comparative effectiveness study or any effect size for human readers with/without AI assistance, as AI functionality is not mentioned for this device.
- A standalone (algorithm only) performance study.
- The type of ground truth used (e.g., pathology, outcomes data) for a study, as no such study is detailed.
- Sample size for a training set or how ground truth for a training set was established, as machine learning or AI models requiring such sets are not described.
Summary based on the provided document:
The device, "CTS-415 with C3I40 and L7I50 Transducers," is a Diagnostic Ultrasound System. Its acceptance for marketing by the FDA (K013327) is based on demonstrating substantial equivalence to the predicate device, Hitachi Medical Corporation EUB-310 (K862867).
The document lists the device's technological characteristics (e.g., scanning methods, display modes, frequency of probes, image adjustments, measuring functions) and its intended uses for various clinical applications (Fetal, Abdominal, Pediatric, Small Organ, Cardiac, Peripheral Vascular) in B and M modes, with the C3I40 and L7I50 transducers supporting specific subsets of these applications.
The "acceptance criteria" in this context are implicitly met by demonstrating that the device's technological characteristics and stated intended uses are substantially equivalent to a legally marketed predicate device. The FDA's letter explicitly states that the determination of substantial equivalence means the device can be marketed, subject to general controls and requirements for a post-clearance special report on acoustic output measurements. This process does not involve setting quantitative performance metrics like sensitivity, specificity, or accuracy against a pre-defined threshold in a clinical study as typically seen with de novo submissions for novel devices or AI/ML-enabled devices.
§ 892.1560 Ultrasonic pulsed echo imaging system.
(a)
Identification. An ultrasonic pulsed echo imaging system is a device intended to project a pulsed sound beam into body tissue to determine the depth or location of the tissue interfaces and to measure the duration of an acoustic pulse from the transmitter to the tissue interface and back to the receiver. This generic type of device may include signal analysis and display equipment, patient and equipment supports, component parts, and accessories.(b)
Classification. Class II (special controls). A biopsy needle guide kit intended for use with an ultrasonic pulsed echo imaging system only is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 892.9.