(82 days)
Diagnostic ultrasound imaging or fluid flow analysis of the human body as follows: Fetal, Abdominal, Pediatric, Small Organ (Thyroid, Breast and Testicles), Neonatal Cephalic, Adult Cephalic, Cardiac, Transesophageal, Peripheral Vascular.
ESAOTE's Mod.7200 is a compact ultrasound system used to perform non-invasive diagnostic general ultrasound studies. Its primary modes of operation are the following: B-Mode, M-Mode, Doppler and Color Flow Mapping. The MOD.7200 can be equipped with an LCD Color Display (Portable Configuration) or with a 15" Color Monitor and a cart (Mainframe Configuration). The full alphanumeric keyboard allows complete onscreen data entry of patient information and on-screen annotations. The MOD. 7200 uses annular phased array probes; its design provides a dynamically focused ultrasound beam. The MOD.7200 offers a vast selection of calculations and measurements which can be performed quickly and easily. The MOD. 7200 is designed for ease of use. The user interface allows the operator to perform an examination quickly and efficiently. Clearly labeled mode selection keys are easily accessed, and the system's "pop-up" menus allow the operator to change parameters with ease. The user may also access special function menus and perform calculations with a minimal number of key strokes. The MOD.7200 is equipped with a 3.5" floppy disk drive to simplify software modifications and provides fast, cost effective system upgrades. This drive can also be used for image storage. In addition, this system can be equipped with recording devices, including a S-VHS video recorder and a black-and-white or color page printer, which are controlled through the keyboard.
The provided document is a 510(k) premarket notification for the Biosound Esaote 7200 Ultrasound Imaging System, submitted in 1998. This type of submission focuses on demonstrating substantial equivalence to a predicate device already on the market, rather than on proving de novo safety and effectiveness through clinical trials with defined acceptance criteria and performance studies for an AI/ML device.
Therefore, the document does not contain the following information typically found in submissions for AI/ML devices:
- A table of acceptance criteria and reported device performance for an AI/ML algorithm.
- Sample sizes used for a test set or data provenance for AI/ML evaluation.
- Number of experts used to establish ground truth for a test set, or their qualifications.
- Adjudication method for a test set.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study results or effect sizes.
- Standalone performance for an AI algorithm.
- Type of ground truth used (e.g., expert consensus, pathology, outcomes data) in the context of an AI/ML performance study.
- Sample size for a training set.
- How ground truth for a training set was established.
Summary of the Document's Content Regarding Safety and Effectiveness:
The document establishes "substantial equivalence" of the 7200 Ultrasound Imaging System to a predicate device, the 7050 (AU3) Ultrasound Imaging System (K944287). This is the primary method described to demonstrate safety and effectiveness for conventional medical devices of this type at the time of submission.
Key points from the document:
- Predicate Device: 7050 (AU3) Ultrasound Imaging System (K944287).
- Demonstration of Safety and Effectiveness: The submission relies on establishing substantial equivalence to the legally marketed predicate device. This is achieved through a "Comparison Chart for Substantial Equivalence" (pages 1-2), which compares the technical characteristics and intended uses of the 7200 system with the 7050 system.
- Specific Comparisons: The comparison covers aspects like electrical safety (EN60601-1), ultrasound safety (Track 3 Acoustic Output Display), intended uses for various clinical applications (e.g., Cardiac, Vascular, Abdominal, Fetal), probe technology (Annular Array, Electronic Array, Doppler Probes), modes of operation (2D, M-Mode, PW, CW, CFM), imaging frequencies, display type, digital archival capabilities, VCR/page printer, and M&A capabilities.
- New vs. Previously Cleared Indications: The "Diagnostic Ultrasound Indications for Use Form" for the new 7200 system and its various transducers (pages 6-10) explicitly indicates which clinical applications are "N" (new indication) and which are "P" (previously cleared by FDA, meaning they are covered by the predicate device's clearance). The focus is on ensuring that the new device does not introduce new safety or effectiveness questions compared to the predicate for similar indications.
- Post-Clearance Requirement: The FDA letter (page 4) requires a post-clearance special report containing "acoustic output measurements based on production line devices." This ensures the device, once manufactured, continues to meet safety standards related to acoustic output. This is a safety check, not a performance study compared to a benchmark.
In conclusion, this document does not contain the information requested for AI/ML device acceptance criteria and performance studies because it relates to a conventional ultrasound imaging system from 1998, for which the regulatory pathway involved demonstrating substantial equivalence to a predicate device rather than a performance study specifically testing an AI/ML algorithm against defined metrics.
§ 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.