(72 days)
The Madsen Zodiac (Type 1096) is an auditory impedance tester 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. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes. (Prescription Use).
The MADSEN Zodiac Type 1096 device is designed to measure and evaluate the acoustic impedance/admittance of the human ear by means of acoustic probe signals at different frequencies and with temporal characteristics. MADSEN Zodiac is a compact device for immittance testing. You can operate Zodiac as a stand-alone unit using the built-in keypad and display, or, if you are using the OTOsuite Immittance software module, you can operate Zodiac using the PC's keyboard and mouse with the OTOsuite Immittance module acting as the display. MADSEN Zodiac supports the following probes:
- The hand-held Quick Check probe
- The two diagnostic probe types, Classic and Comfort
- A contralateral insert phone or TDH-39.
Supported tests: Depending on the configuration, Zodiac supports the following tests and functionalities:
- Tympanometry
- Reflex Screening
- Reflex Threshold
- Reflex Decay
- ETF-I (Eustachian Tube Function - Intact)
- ETF-P (Eustachian Tube Function -Perforated)
- Admittance Recording (multiple uses, e.g. patulous Eustachian Tube evaluation, acoustic reflexes with external stimulus)
- Manual Tympanometry
This is a MODIFIED version of our previous model, the predicate device.
The document describes a 510(k) premarket notification for the "Madsen Zodiac Model 1096" auditory impedance tester. The acceptance criteria and supporting study information are derived from the comparison to the predicate device (OTOflex 100 Type 1012) and the non-clinical testing performed.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally established by meeting the technical specifications of the predicate device and adhering to recognized standards. The "Reported Device Performance" column reflects the specifications of the Madsen Zodiac 1096.
| Characteristic | Acceptance Criteria (Predicate: OTOflex 100 Type 1012) | Reported Device Performance (Madsen Zodiac 1096) |
|---|---|---|
| Compliance Measuring System | ||
| Probe tones: 226 Hz | 85dB SPL ± 1.5 dB | 85 dB SPL ± 3 dB |
| Probe tones: 1000 Hz | 75dB SPL ± 1.5 dB | 69 dB SPL ± 3 dB (New 678 Hz and 800 Hz tones also specified) |
| THD (probe tones) |
§ 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.