(112 days)
Not Found
No
The summary describes a device for measuring otoacoustic emissions using signal analysis, with no mention of AI or ML terms, training/test sets, or performance metrics typically associated with AI/ML algorithms.
No
The device is described as an analyzer and screener, which are diagnostic functions, not therapeutic. It measures OAEs to assess cochlear function, it does not treat or alleviate a medical condition.
Yes
The device is described as an "Otoacoustic emission analyzer" that provides "robust indications of cochlear function," which implies it is used to assess the health or condition of the cochlea, a diagnostic purpose.
No
The device description explicitly states it is a "compact, self-contained, handheld Otoacoustic emission analyzer" with "integral, rechargeable batteries" and uses an "ear piece or 'probe'". This indicates it is a physical hardware device, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The Otoport measures otoacoustic emissions from the ear canal, which is a physiological measurement, not an analysis of a biological sample like blood, urine, or tissue.
- The intended use describes a physiological measurement. The device performs OAE measurements on ears via a probe fitted into the ear canal to assess cochlear function. This is a direct measurement of a bodily function.
Therefore, the Otoport falls under the category of a medical device that performs a physiological measurement, not an IVD.
N/A
Intended Use / Indications for Use
The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.
Product codes (comma separated list FDA assigned to the subject device)
EWO
Device Description
The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use.
The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise.
The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ears via an ear piece or "probe" fitted into the ear canal.
Indicated Patient Age Range
Newborn, child, adult
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
Section 5: 510(k) Summary
Otodynamics LTD 30-38 Beaconsfield Road AL10 8BB Hatfield Herts 108 GB Phone: 44 1707-267667 Fax: 44 1707-262327
NOV 1 3 2007
Contact: John Morgan
Summary Prepared: April 25, 2007
Trade Name : Otocheck
Common Name :
Classification Name : Audiometer
Predicate Device Identification:
CFR21: Product Code: EWO Device Class:II Legally Marketed Device: Otodynamics LTD ILO292DP Echoport & ILO2088 Echocheck Manufacturer: Otodynamics LTD K#: K983350 & K983352
Description:
The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use.
The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise.
The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.
1
Intended Use:
The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.
| | Otodynamics
ILO2088 Echocheck | Otodynamics ILO292
DP EchoportPlus | Otodynamics
Otoport |
|----------------------------------------------------|--------------------------------------------------------|----------------------------------------------------------------------------------|----------------------------------------------------------------------------------|
| 510(k) Number | K983352 | K983350 | This 510(k) |
| Target population | Newborn, child,
adult | Newborn, child, adult | Newborn, child,
adult |
| Intended use | Transient Evoked
otoacoustic
screening technique | Distortion Product and
Transient Evoked
otoacoustic screening
technique | Distortion Product
and Transient
Evoked otoacoustic
screening technique |
| Physiological
Measurement
Technique employed | Non-invasive | Non-invasive | Non-invasive |
Predicate Product Comparison Chart : .
2
| Signal output: | |||
|---|---|---|---|
| Frequency range: | |||
| TEOAE | 1,500 to 3,200Hz | 500 to 6,000Hz | 500 to 6,000Hz |
| DPOAE | N/A | 500 to 8,000Hz | 500 to 10,000Hz |
| Level range: TEOAE | 94 to 44dB SPL | 94 to 44dB SPL | 94 to 44dB SPL |
| DPOAE | N/A | 35 to 75dB SPL | 35 to 75dB SPL |
| Level increments: | |||
| TEOAE | 1.5dB steps +/-0.5 | 1.5dB steps +/-0.5 | 1dB steps +-0.5 |
| DPOAE | N/A | 1dB steps +/-0.5 | 1dB steps +/-0.5 |
| Signal to noise ratio | >85dB | >85dB | >85dB |
| Harmonic distortion: | |||
| TEOAE | N/A | N/A | N/A |
| DPOAE | N/A |