(43 days)
No
The description focuses on hardware and basic data communication, with no mention of AI or ML algorithms for data analysis or interpretation.
No.
The device is used to measure or determine cochlear function, which is a diagnostic purpose, not a therapeutic one.
Yes
The device's intended use is to "measure or determine cochlear function," which is a diagnostic purpose to assess a physiological function.
No
The device description clearly outlines physical hardware components including a printed circuit board, connectors, a pushbutton switch, and an LCD display, indicating it is not software-only.
Based on the provided text, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The intended use and device description clearly state that the Scout Sport Otoacoustic Emissions Test Instrument measures or determines cochlear function by measuring and recording otoacoustic emissions directly from the ear using an ear probe. It does not analyze blood, urine, tissue, or any other sample taken from the body.
- The device interacts directly with the patient. The description mentions an ear probe that connects to the patient's ear. IVDs typically do not have direct physical contact with the patient during the diagnostic process.
- The measurement is a physical response. Otoacoustic emissions are sounds produced by the inner ear in response to auditory stimuli. This is a physical measurement of a physiological function, not a chemical or biological analysis of a sample.
Therefore, the Scout Sport Otoacoustic Emissions Test Instrument is a diagnostic device, but it falls under a different regulatory category than In Vitro Diagnostics.
N/A
Intended Use / Indications for Use
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.
Product codes
Not Found
Device Description
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 basic functionality of the Scout system is virtually unchanged with the addition of the Sport device. DSP functions within the Sport are designed to duplicate as closely as possible the functions performed by the Ariel board. 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, such as "Low Battery", "Finished Calibrate", and "DPOAE Test in Progress".
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Cochlear function (ear)
Indicated Patient Age Range
Adults, children and infants.
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Extensive laboratory testing was performed on the Scout Sport OAE Test Instrument to verify proper operation over a wide range of environmental conditions. The following tests were completed: Temperature (Operating: 60 to 90 degrees F, Storage: 50 to 110 degrees F), Humidity (8% to 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), Magnetic Fields Emissions (RE101), Magnetic Field Immunity (RS101). The external charger is UL/CSA listed with current leakage of 100 microamps or less. The actual power delivered by the charger to the Sport device is a maximum of 12 volts DC with a maximum power less than 15 watts. To establish the safety and effectiveness of the software which controls the Scout Sport OAE Test Instrument, the system was validated in accordance with the IEEK Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards. The DSP program in the Scout Sport OAE Box, and changes to the standard Scout PC computer program necessary to accommodate the communication to and setup of the unit, were all developed and tested as specified in these procedures. The system was verified and validated; it was found to perform in accordance with specifications.
Key Metrics
Average noise floor is improved (lower noise) in Sport, over that of Scout.
Predicate Device(s)
Bio-logic Scout (formerly EMAV) OAE Instrumert (K944735)
Reference Device(s)
Etymotic Research CUBeDIS OAE product (K930553)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
Image /page/0/Picture/0 description: The image shows the date "MAY 29 1996". The month is "MAY", the day is "29", and the year is "1996". The text is in bold and black.
Image /page/0/Picture/1 description: The image shows a handwritten string of characters, "K961447". The characters are written in a bold, black font, and they appear to be slightly slanted. The string consists of one uppercase letter, followed by six digits.
Image /page/0/Picture/2 description: The image shows the logo for Bio-logic Systems Corp. The logo is in black and white. The word "Bio-logic" is in a bold, sans-serif font, and the words "SYSTEMS CORP" are in a smaller, sans-serif font below the first word.
One Bio-logic Plaza Mundelein, Illinois 60060-370C 1-800-323-8326 Fax: 847-949-8615
SECTION 2 : SUMMARY AND CERTIFICATION
510 (K) SUMMARY
SAFETY AND EFFECTIVENESS SUMMARY
Safety and effectiveness information concerning the Scout Sport OAE is summarized below
Because this is not a CLASS III device, the special certification defined for this section is not required.
(847) -949 -5200
| PREPARED BY: | Bio-logic Systems Corp
One Bio-logic Plaza
Mundelein, IL 60060 |
| -------------- | ---------------------------------------------------------------------- |
|---|
TELEPHONE :
CONTACT PERSON : Norman E. Brunner
DATE ON WHICH THE SUMMARY WAS PREPARED: April 15, 1996
NAME OF DEVICE:
Scout Spcrt_ - a Modification to the Scout (formerly EMAV) Otoacoustic Emissions (OAE) Test Instrument.
COMMON NAME : Otoacoustic Emissions Test Instrument
CLASSIFICATION NAME: Audiometer (per CFR 874.1050).
PREDICATE DEVICE: Bio-logic Scout (formerly EMAV) OAE Instrumert (K944735)
1
Scout Sport - Modification to Scout Otoacoustic Emissions (OAE) Test Instrument
DESCRIPTION OF THE 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 first Bio-logic product for Otoaccustic Emissions (OAE) testing is the Scout predicate device referenced above. In this system, the hardware and software to perform the CAE test is contained on a computer-installed DSP board made by Ariel Corporation. The DSP software program on the Ariel board is included in the Etymotic Research CUBeDIS OAE product (K930553), which was the predicate device for the Scout 510(k) application. The Ariel board (with DSP software) and ER-10C ear probe is purchased as a kit from Etymotic Research and used as the basis for the Scout product. The Scout PC computer software provides additional features and enhancements over the CUBeDIS product, as described in the Scout 510(k) application.
The new Scout Sport OAE device duplicates the functions of the Ariel DSP board hardware and software in a different hardware package. Because of the size of the Ariel board, and due to the fact that it has to be installed inside a PC computer, the need for a full-length, unobstructed slot in the computer limits the PC's that can accommodate the Scout system. Additionally, it precludes the use of a notebook computer unless a docking station is used to house the DSP board. The new Sport device allows virtually any computer to be used for OAE testing, even notebooks. It also provides simplified cabling arrangements and enhanced portability, which makes it practical to reliably move the test instrument from place to place within the hospital .
The basic functionality of the Scout system is virtually unchanged with the addition of the Sport device. DSP functions within the Sport are designed to duplicate as closely as possible the functions performed by the Ariel board. Extensive testing has been performed to demonstrate this equivalence. In all areas significant to the performance and quality of the OAE testing, these test results show significant correlation to Scout performance, with lower noise levels and increased speed of testing. The Scout PC computer software programs were changed in areas necessary to accommodate the new Sport hardware. I/O port addresses, memory page requirements, and various hardware-related system calls were changed because of the movement of the hardware from the computer internal bus to the serial port.
The Scout Sport is battery-powered, using rechargeable batteries and an external charger connected to the AC power. În 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. This is necessary because the unit is batterypowered and will automatically shut down when not in use. A 2-row x 16-character LCD display on the Sport is used to communicate various operational messages to the user, such as "Low Battery", "Finished Calibrate", and "DPOAE Test in Progress".
2
Section 2 - Page 3 Scout Sport - Modification to Scout Otoacoustic Emissions (OAE) Test Instrument
The intended use of the Scout Sport Otoacoustic INTENDED USE: 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.
PATIENT POPULATION: Adults, children and infants.
SAFETY AND EFFECTIVENESS:
Extensive laboratory testing was performed on the Scout Sport OAE Test Instrument to verify proper operation over a wide range of environmental conditions. The following tests were completed according to the corresponding standards or specifications:
| Temperature: | a.) Operating: | 60 to 90 degrees F |
|---|---|---|
| b.) Storage: | 50 to 110 degrees F | |
| Humidity: | 8% to 80% (non-condensing) |
Flammability: UL94V-0
Electromagnetic Compatibility: Radiated Emissions CISPR 11 / EN55011 Electrostatic Discharge Immunity: IEC 801-2 IEC 801-3 Radiated RF Immunity: Magnetic Fields Emissions: RE101 Magnetic Field Immunity: RS101
The Sport is battery-powered, using recharqeable batteries with an external charger connected to the AC power line. This external charger is UL/CSA listed with current leakage of 100 microamps are less. The actual power delivered by the charger to the Sport device is a maximum of 12 volts DC with a maximum power less than 15 watts.
To establish the safety and effectiveness of the software which controls the Scout Sport OAE Test Instrument, the system was validated in accordance with the IEEK Standards for Software Engineering, as well as Bio-logic internal software development policies and procedures modeled after the IEEE Standards. " The DSP program in the Scout Sport OAE Box, and changes to the standard Scout PC computer program necessary to accommodate the communication to and setup of the unit, were all developed and tested as specified in these procedures. The system, for which this application is submitted, was verified and validated; it was found to perform in accordance with specifications.
3
Scout Sport - Modification to Scout Section 2 - Page 4 Otoacoustic Emissions (OAE) Test Instrument
The following comparison is provided as a summary of technological characteristics relative to the predicate device Scout (formerly EMAV). This is to demonstrate that the Scout Sport has no significant differences which would adversely affect product safety and effectiveness.
| Parameter for comparison. | Similarity or Difference. |
|---|---|
| Intended Use | No differences. |
| Population | No differences. |
| Hardware Configuration | Original Scout used DSP board inside |
| computer, Sport uses DSP board housed | |
| in separate enclosure connected to | |
| computer via serial communications | |
| cable . | |
| Computer Control Software | Only differences are changes to Scout |
| software required to support the new | |
| hardware configuration. No | |
| differences in software test | |
| algorithms. | |
| Ear Probe System | No differences. Both systems use |
| Etymotic ER-10C probe. Same | |
| microphone preamplifier electronics | |
| housed in separate box for Scout | |
| system is included within Sport box. | |
| Performance | Average noise floor is improved |
| (lower noise) in Sport, over that of | |
| Scout | |
| Safety Characteristics | No difference. There is no direct |
| electrical connection to the patient | |
| in either case. Maximum sound output | |
| of Sport is same as or less than | |
| Scout |