(87 days)
The Amplivox Otowave 202 is designed for use by trained operators (audiologists, general practitioners, hearing aid dispensers, and child health professionals) in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders in the general population associated with the functioning of the middle ear. The instrument performs two types of measurement: Tympanometry is used to measure the tympanic membrane and middle ear at a fixed frequency over a range of pressures. Reflex tests are used to measure stapedial reflexes. The Otowave measures ipsilateral reflexes and, when selected, reflex measurement is automatically carried out after a tympanogram is taken.
The Otowave 202 relies heavily on long-established practice in the clinical area of middle-ear measurements, and implements tympanometer functionality in a small desk-top device that may be powered from the mains (via a d.c. adapter) or by internal batteries. Stimuli are applied to the patient by means of a probe mounted on a flexible connecting lead for ease of use (especially with neonates) and additional contralateral stimuli are available if required via a separate plug-in transducer. Operation is via an intuitive menu-driven user interface, with test data displayed on the integral screen and capable of download to a PC via a USB connection and to a printer via an infrared communications (IrDA) interface. Tympanometers work by measuring the admittance of the tympanic membrane while the pressure in the ear canal is varied. The admittance is at a maximum when the air pressure across the tympanic membrane is balanced.
The provided document is a 510(k) premarket notification for the Amplivox Otowave 202 Portable Tympanometer. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than undergoing a new clinical trial for efficacy. Therefore, much of the information typically found in an acceptance criteria study (e.g., sample sizes for test sets, expert-established ground truth, MRMC studies) is not applicable or not explicitly provided in the context of this regulatory submission.
Here's a breakdown based on the information available:
Acceptance Criteria and Reported Device Performance
The document presents a comparison of the Amplivox Otowave 202 to its predicate device, the Amplivox Otowave 102 (K081841). The "acceptance criteria" are implied by the specifications of the predicate device and the new device's ability to meet or exceed those specifications, as well as adherence to relevant industry standards.
Table of Acceptance Criteria and Reported Device Performance (as derived from the comparison table and testing summaries):
| Feature/Acceptance Criterion | Predicate Device (Otowave 102, K081841) Performance | Proposed Device (Otowave 202, K150163) Performance | Comments / Compliance |
|---|---|---|---|
| Indications for Use | Same as Otowave 202 | Detection of possible otologic disorders associated with the functioning of the middle ear. | Substantially Equivalent. |
| Tympanometry Probe Tone | 226Hz +/- 2%, 85dB +/-2dB | 226Hz +/-2%; 85dB SPL +/-2dB | Meets/Equivalent. |
| Tympanometry Pressure Range | +200daPa to -400daPa +/-10daPa | +200daPa to -400daPa +/- 10daPa or +/-10% (whichever is larger) | Meets/Equivalent. |
| Tympanometry Direction of Sweep | Positive to negative | Positive to negative | Meets/Equivalent. |
| Tympanometry Volumetric Range | 0.2 to 5ml +/- 0.01ml or 10% over range whichever is greater | 0.2ml to 5ml +/-0.1ml or +/-5% (whichever is larger) | Meets/Equivalent (with slightly different tolerance reporting). |
| Tympanometry Analysis Performed | Compliance peak level, compliance peak pressure level, gradient and equivalent ear canal volume. | Compliance peak level, compliance peak pressure level, gradient and equivalent ear canal volume | Meets/Equivalent. |
| Reflex Frequencies | Otowave 102-1: 1KHz +/- 2%; Otowave 102-4: 500Hz, 1KHz, 2KHz & 4KHz +/- 2% | User defined – 500Hz, 1kHz, 2kHz and 4kHz (+/- 2%) | Broader/Improved functionality. |
| Ipsilateral Reflex Levels | 85 to 100 dBHL (programmable in 5 or 10 dB steps) | 70dBHL to 100dBHL +/-2dB (programmable in 5 or 10dB steps) | Broader range, Meets/Equivalent. |
| Contralateral Reflex Levels | Not explicitly listed as a standard feature, but the Otowave 102 does offer contralateral stimuli if required. | 70dBHL to 110dBHL +/-2dB (programmable in 5 or 10dB steps) | Improved (more specified). |
| Reflex Measurement/Detection Range | 0.01ml to 0.5ml +/- 0.01ml | 0.01ml to 0.5ml (configurable in 0.01ml steps) | Meets/Equivalent. |
| Reflex Analysis Performed | Reflex maximum amplitude and pass/fail at each test level. | Reflex maximum amplitude and pass/fail at each test level. | Meets/Equivalent. |
| Material Evaluation (Ear-tips) | Compliant with ISO 10993-1 | Compliant with ISO 10993-1 | No change from previous submission. |
| EMC Standard Compliance | EN 60601-1-2: 1993 | EN 60601-1-2:2007 | Meets/Improved to newer standard. |
| Safety Standard Compliance | EN60601-1: 1990 | IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007); ANSVAAMI ES60601-1 (2005 + C1:09 + A2:10); CAN/CSA-C22.2 No. 60601-1 (2008) | Meets/Improved to newer standards and international variations. |
| Impedance Standard Compliance | EN60645-5:2005 Type 2 tympanometer | EN60645-5 Type 2 tympanometer | Meets/Equivalent. |
| Bench Performance (against ANSI S3.39-1987/IEC60645) | Implied compliance through predicate comparison | Satisfies requirements of ANSI S3.39-1987/IEC60645 | Explicitly stated as meeting standard. |
| Software (Firmware) Validation | Implied | Performed per Functional Specification / Test Plan | Explicitly stated as performed. |
| Risk Analysis | Implied | Performed per Risk & Hazard Traceability Analysis plan | Explicitly stated as performed. |
Study Details (Based on available information)
2. Sample size used for the test set and the data provenance:
- Sample Size: Not applicable. This submission relies on substantial equivalence through bench testing and adherence to standards, not human subject testing for performance.
- Data Provenance: Not applicable for performance testing in humans. Bench testing was performed on the device itself.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Number of Experts: Not applicable. Ground truth for device performance was established against engineering specifications and international standards, not clinical expert consensus on patient data.
- Qualifications of Experts: Not applicable in the context of human data. The "experts" would be the engineers and regulatory specialists ensuring compliance with the technical standards and testing protocols.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Adjudication Method: Not applicable. This is not a study involving human evaluations or interpretations requiring adjudication.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- MRMC Study: No. This device is not an AI-powered diagnostic tool requiring human reader studies. It's a medical measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Standalone Performance: Yes, in the sense that the device's technical specifications and performance against physical standards (e.g., probe tone accuracy, pressure range) were tested without human interpretation of clinical outcomes. The document states: "Bench performance testing: Measurements were carried out with an Otowave 202 tympanometer to confirm that it satisfies the requirements of ANSI S3.39-1987/IEC60645."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc):
- Type of Ground Truth: The ground truth for this device's performance is established by engineering/technical standards and specifications (e.g., IEC 60601-1, EN 60601-1-2, EN60645-5, ANSI S3.39-1987) for medical electrical equipment, EMC, and tympanometers, as well as the specifications of the predicate device.
8. The sample size for the training set:
- Sample Size for Training Set: Not applicable. This device does not employ machine learning or AI models that require a training set of data.
9. How the ground truth for the training set was established:
- Ground Truth for Training Set: Not applicable, as there is no training set for this type of device.
§ 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.