(90 days)
Not Found
No
The device description details a deterministic algorithm based on measuring the Spectral Gradient angle of the ear drum's resonance curve, not AI/ML. There are no mentions of AI, ML, training data, or complex learning algorithms.
No
Explanation: The device is intended to assist parents in determining when to seek medical attention for detecting middle ear fluid, not for direct treatment or therapy.
Yes
The device detects the presence of middle ear fluid, which is a medical condition (otitis media with effusion), and is intended to assist in determining when to seek medical attention, fulfilling the definition of a diagnostic device.
No
The device description explicitly states it is an "instrument" with a "built-in microphone" and measures the response of the ear drum to a "sound stimulus," indicating it is a hardware device that uses acoustic reflectometry.
Based on the provided information, the EarCheck device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs analyze samples taken from the human body. The EarCheck device works by sending sound waves into the ear and analyzing the reflected sound waves. It does not analyze a biological sample like blood, urine, or tissue.
- The device description focuses on the physical response of the eardrum. It measures the mechanical resonance characteristics of the eardrum to detect the presence of fluid. This is a physical measurement, not a biochemical or biological analysis of a sample.
Therefore, the EarCheck device falls under the category of a medical device that interacts with the body directly, rather than an IVD that analyzes samples from the body.
N/A
Intended Use / Indications for Use
EarCheck is an advanced medical instrument which accurately detects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.
Product codes
ETY
Device Description
EarCheck determines the condition of the middle ear by measuring the response of the ear drum to a sound stimulus. Using a built-in microphone, EarCheck registers the intensity of different frequencies of reflected sound waves to detect the absence or presence of fluid in the middle ear.
The instrument analyzes the mechanical resonance characteristic of the ear drum, indicating the condition of the ear by measuring the Spectral Gradient angle of the ear drum's resonance curve. In a normal ear, the ear drum has full freedom of motion, producing a shallow wide Spectral Gradient angle. When fluid is present, the motion of the ear drum is restricted and a narrower Spectral Gradient angle results. The determination of the absence or presence of middle ear fluid is displayed in one of five levels on the instrument.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle ear / ear drum
Indicated Patient Age Range
children from 6 months to young adult
Intended User / Care Setting
parents and other caregivers / home
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
The EarCheck was tested in both ears of over 500 study subjects in the Validation Study. In summary, the Validation Study demonstrated that the EarCheck can appropriately provide information that indicates a subject's risk of having middle ear effusion (MEE). The Validation Study also demonstrated that the EarCheck was substantially equivalent to the predicate device - the EarCheck Pro - in its performance.
Clinical studies demonstrated statistically significant diagnostic concordance between the EarCheck and the EarCheck Pro.
Furthermore, the Validation Study demonstrated that the diagnostic performance of the EarCheck is consistent with its labeling.
Clinical studies demonstrated that the EarCheck is able to generate reproducible readings on the same ears.
Finally, the Validation Study demonstrated that the EarCheck did not exhibit any actual or potential safety hazards in the testing of both ears, twice in over 500 patients.
Other studies demonstrated that: consumers can take accurate readings, interpret the readings, and take appropriate action; the EarCheck can be appropriately used in the home to monitor middle ear health; the EarCheck performance is comparable to that of the EarCheck Pro and the tympanometer in the presence of earwax; and the EarCheck's human factors design and instructions for use are appropriate.
Key Metrics
Not Found
Predicate Device(s)
MDI EarCheck Pro (K970685)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
510(k) Summary (as per 21CFR807.92)
August 13, 1997
Submitter and Contact Person:
AUG 1 8 1997
Sandra Kimball Vice President, Medical and Regulatory Affairs MDI Instruments, Inc. 200 Unicorn Park Drive Woburn, MA 01801 617-935-0150 617-935-8139 fax
Trade Name:
EarCheck
Common Name:
Acoustic Reflectometer
Classification Name:
Auditory Impedance Tester (as per 21CFR874.1090)
Predicate Devices:
MDI EarCheck Pro (K970685)
Description of Device:
EarCheck determines the condition of the middle ear by measuring the response of the ear drum to a sound stimulus. Using a built-in microphone, EarCheck registers the intensity of different frequencies of reflected sound waves to detect the absence or presence of fluid in the middle ear.
The instrument analyzes the mechanical resonance characteristic of the ear drum, indicating the condition of the ear by measuring the Spectral Gradient angle of the ear drum's resonance curve. In a normal ear, the ear drum has full freedom of motion, producing a shallow wide Spectral Gradient angle. When fluid is present, the motion of the ear drum is restricted and a narrower Spectral Gradient angle results. The determination of the absence or presence of middle ear fluid is displayed in one of five levels on the instrument.
1
Indications for Use:
EarCheck is an advanced medical instrument which accurately detects the presence of middle ear fluid (i.e., otitis media with effusion) that may be associated with acute ear infection. The device is intended to assist parents in determining when to seek medical attention. The instrument is designed for use in the home by parents and other caregivers on children from 6 months to young adult.
Summary of Clinical Performance Data:
The EarCheck was tested in both ears of over 500 study subjects in the Validation Study. In summary, the Validation Study demonstrated that the EarCheck can appropriately provide information that indicates a subject's risk of having middle ear effusion (MEE). The Validation Study also demonstrated that the EarCheck was substantially equivalent to the predicate device - the EarCheck Pro - in its performance.
Clinical studies demonstrated statistically significant diagnostic concordance between the EarCheck and the EarCheck Pro.
Furthermore, the Validation Study demonstrated that the diagnostic performance of the EarCheck is consistent with its labeling.
Clinical studies demonstrated that the EarCheck is able to generate reproducible readings on the same ears.
Finally, the Validation Study demonstrated that the EarCheck did not exhibit any actual or potential safety hazards in the testing of both ears, twice in over 500 patients.
Other studies demonstrated that: consumers can take accurate readings, interpret the readings, and take appropriate action; the EarCheck can be appropriately used in the home to monitor middle ear health; the EarCheck performance is comparable to that of the EarCheck Pro and the tympanometer in the presence of earwax; and the EarCheck's human factors design and instructions for use are appropriate.
Technical Specifications:
| Dimensions: | 7.0 in, H x 2.75 in, W x 2.5 in, D
(169 mm x 87 mm x 87 mm) |
|---------------------|----------------------------------------------------------------|
| Weight: | 6.2 oz (174 g) (With Batteries) |
| Measuring Range: | 1.8 kHz to 4.4 kHz |
| Sound Volume: | 80 dB SPL (+ 6 dB) |
| Sound Duration: | 0.2 second sweep |
| Display: | LCD Display |
| Display Hold Time: | 10 sec. |
| Power: | Two AA Alkaline Batteries |
| Battery Symbol: | Low Battery. |
| Battery Life: | Approximately 1000 readings in 4 months |
| High Noise Level: | Error Indicator. |
| Ambient Temperature | |
| Operating Range: | +50°F to +95°F (15°C to 35°C). |
2
| • Relative Humidity
Operating Range: |