(43 days)
The intended use of the Scout Sport Otoacoustic Emissions Test Instrument is to measure or determine cochlear function either by measuring and recording transient (click evoked) otoacoustic emissions or by measuring and recording distortion product otoacoustic emissions utilizing continuous pure tones. This intended use is identical to that of the predicate device.
The Scout Sport is a small device measuring 8.5"x4"x2.5" (LxWxD) and weighing 1.45 lbs (0.65 Kg), which is connected to a PC computer through a standard RS-232 serial data communications cable. -The Sport contains a single printed circuit board with all electronics necessary for a complete, self-contained auditory testing system. Control commands are sent to this unit from the computer, and data is returned to the computer from the Sport device. The new Scout Sport OAE device duplicates the functions of the Ariel DSP board hardware and software in a different hardware package. The Scout Sport is battery-powered, using rechargeable batteries and an external charger connected to the AC power. In addition to the charger connector, there are two other connectors on the box. One connector is a 6-pin mini-din which allows for serial communication to the computer. The other connector is a 7-pin mini-din which connects to the Etymotic ER-10C ear probe. There is a single momentary pushbutton switch on the unit, used to perform a RESTART function by the user. A 2-row x 16-character LCD display on the Sport is used to communicate various operational messages to the user.
The provided document describes the Bio-logic Scout Sport OAE, a medical device for measuring otoacoustic emissions (OAE). The document asserts that the Scout Sport performs equivalently to its predicate device, the Bio-logic Scout (formerly EMAV) OAE Instrument (K944735), with some improvements. The primary focus of the document is to demonstrate the safety and effectiveness of the Scout Sport, particularly its equivalence to the predicate device despite hardware configuration changes.
Here's an analysis of the acceptance criteria and the study that proves the device meets them, based solely on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't provide a formal table of quantitative acceptance criteria with specific thresholds for performance metrics. Instead, it focuses on demonstrating equivalence to the predicate device and highlights areas of improvement.
| Parameter for Comparison | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Intended Use | Identical to predicate device | No differences between Scout Sport and predicate. |
| Patient Population | Identical to predicate device | No differences between Scout Sport and predicate. |
| Hardware Configuration | Equivalent functionality, improved portability/compatibility | DSP board in separate enclosure, connected via serial cable. Allows use with virtually any computer, including notebooks. |
| Computer Control Software | Same test algorithms, adapted for new hardware | Only changes required to support new hardware; no differences in software test algorithms. |
| Ear Probe System | Identical to predicate device | Same Etymotic ER-10C probe used. Microphone preamplifier electronics moved into the Sport box. |
| Performance | At least equivalent to predicate, ideally improved | Average noise floor is improved (lower noise) in Sport, over that of Scout. Increased speed of testing. |
| Safety Characteristics | At least equivalent to predicate | No difference. No direct electrical connection to the patient. Maximum sound output is same as or less than Scout. |
| Environmental Conditions | Meet specified ranges for temperature, humidity, and flammability. Comply with EMC standards. | Temperature: Operating: 60-90°F, Storage: 50-110°F. Humidity: 8-80% (non-condensing). Flammability: UL94V-0. Electromagnetic Compatibility: Radiated Emissions CISPR 11 / EN55011, Electrostatic Discharge Immunity IEC 801-2, Radiated RF Immunity IEC 801-3. Battery/Charger Safety: UL/CSA listed external charger, current leakage |
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.