(64 days)
The VuPad ultrasound system is a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic application, intended to both visualize the interior of the eye by means of ultrasound and to make measurements inside the eye, including the measurement of axial length for determination of IOL Power.
The VuPad is a portable ultrasound biometric ruler intended for use in ophthalmic applications. The system allows for the measurement of several key ocular features including axial length (AXL), anterior chamber depth, and lens thickness while also aiding in the calculation of associated IOL power for implanted lenses. The device is used by coupling the probe / transducer to the eye either through direct contact or immersion methods. Available modes are biometric A-scan, and UBM (high frequency B-scan). The A-scan mode of the system features a live A-scan trace with storage for up to five scans. There are five (auto/ manual) examination modes that use three different tissue velocities to calculate individual intraocular distances within the eye (ACD, Lens, and Vitreous). Other features include: post examination review of scans & measurement; five IOL formulas (six refractive and three post refractive) for lens power calculations; an immersion scanning capability for zero corneal compression of the eye while scanning and storage for up to five different user profiles. The B-Scan mode produces a live, two-dimensional image to facilitate the identification and measurement of ocular pathologies in the posterior-chamber of the eye, particularly when view of the chamber is obscured, such as is the case with cataracts. The VuPad is a stand-alone system that runs on a Windows 8 platform and may be networked (by the user) for interface with electronic medical records systems, printing, and other purposes. The system consists of the VuPad console, ultrasound probe(s) and transducer(s), and foot pedal.
The provided text describes the Sonomed VuPad (K140199) as a multi-purpose computer-based ultrasonic diagnostic system for ophthalmic applications, used for visualizing the interior of the eye and making measurements, including axial length for IOL power determination. The submission compares the device to two predicate devices: the E-Z Scan 5500+ A-Scan / B-Scan System (K040668) and the VuMax System (K060626).
However, the provided documentation primarily focuses on establishing substantial equivalence to predicate devices based on similarities in intended use, technology, method of operation, and various functional parameters. It does not contain a dedicated study section with acceptance criteria and a detailed report of device performance against those criteria in a clinical or analytical study context.
The only direct performance metric mentioned for the device itself is "A-Scan Measurement Accuracy: ±0.1 mm (clinical) ±0.02 mm (theoretical)." This is listed in the comparison tables as a similarity to the EZScan AB5500+. The document states that "Electrical, mechanical, environments safety and performance testing according to standard IEC 60601-1, IEC 60601-2-37, and EN/IEC 60601-1-2(2001) are currently pending," implying that detailed performance studies to explicitly "prove the device meets the acceptance criteria" were not yet fully completed or included in the summary at the time of submission.
Therefore, many of the requested details about a study evaluating the device against acceptance criteria cannot be extracted from this document, as such a study is not explicitly described.
Here's the information that can be extracted:
1. Table of Acceptance Criteria and Reported Device Performance
Based on the "Similarities" table, the clinical measurement accuracy from the predicate device is implicitly adopted as an expected performance level for the VuPad's A-Scan.
| Acceptance Criteria (Implied from Predicate - EZScan AB5500+) | Reported Device Performance (VuPad) |
|---|---|
| A-Scan Measurement Clinical Accuracy: ±0.1 mm | A-Scan Measurement Clinical Accuracy: ±0.1 mm |
| A-Scan Measurement Theoretical Accuracy: ±0.023 mm | A-Scan Measurement Theoretical Accuracy: ±0.02 mm |
| A-Scan Measurement Range: 18 - 40 mm | A-Scan Measurement Range: 18 - 40 mm |
| A-Scan Transducer Frequency: 10 MHz | A-Scan Transducer Frequency: 10 MHz |
| B-Scan Lines per Scan: 128 or 256 (VuMax: 256) | B-Scan Lines per Scan: 256 |
| B-Scan Axial Accuracy (Theoretical): 10 MHz: 0.2088 mm (EZScan) | B-Scan Axial Accuracy (Theoretical): 12.5 MHz: 0.2034 mm; 35 or 50 MHz: 0.0146mm |
| Acoustic Output: ISPTA.3 |
§ 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.