Otowave 202 Portable Tympanometer

K150163 · Amplivox, Ltd. · NAS · Apr 23, 2015 · Ear, Nose, Throat

Device Facts

• Record ID: K150163
• Device Name: Otowave 202 Portable Tympanometer
• Applicant: Amplivox, Ltd.
• Product Code: NAS · Ear, Nose, Throat
• Decision Date: Apr 23, 2015
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 874.1090
• Device Class: Class 2
• Attributes: Pediatric

Indications for Use

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.

Device Story

Portable tympanometer for middle ear assessment; used in hospitals, ENT clinics, audiologist offices. Inputs: acoustic probe tone (226Hz) via ear canal probe; pressure variations. Operation: measures tympanic membrane admittance vs. pressure; performs ipsilateral/contralateral stapedial reflex tests. Outputs: tympanogram, reflex measurements, pass/fail results on LCD screen. Data management: internal database, PC download via USB, thermal printer output via IrDA. Benefits: enables objective detection of middle ear disorders; portable design facilitates use with neonates and general population. Operated by trained clinicians.

Clinical Evidence

No clinical data. Substantial equivalence established via bench performance testing, safety, EMC, and software validation.

Technological Characteristics

Handheld/desktop tympanometer; 226Hz probe tone; pressure range +200 to -400daPa. Materials: ISO 10993-1 compliant ear-tips. Power: AC adapter or 4x AA/NiMH batteries. Connectivity: USB (PC), IrDA (printer). Standards: IEC 60601-1:2005, EN 60601-1-2:2007, ANSI S3.39-1987/IEC 60645, EN60645-5 Type 2. Software: Firmware-based.

Indications for Use

Indicated for trained operators (audiologists, GPs, hearing aid dispensers, child health professionals) to detect possible middle ear otologic disorders in the general population.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• Amplivox Otowave 102 (K081841)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

April 23, 2015

Amplivox, Ltd. % Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. Naples, FL 34114

Re: K150163

Trade/Device Name: Otowave 202 Portable Tympanometer Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: NAS Dated: January 19, 2015 Received: January 26, 2015

Dear Mr. Kamm:

We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

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Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely yours,

# Eric A. Mann -S

for Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

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## Indications for Use

510(k) Number (if known) K150163

Device Name Amplivox Otowave 202

#### Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)

2 Prescription Use (Part 21 CFR 801 Subpart D)

Over-The-Counter Use (21 CFR 801 Subpart C)

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510(K) Summary, 510(k) K150163 Amplivox, Ltd. 6 Oasis Park Eynsham, Oxfordshire OX29 4TP, United Kingdom Tel: [phone] Fax: [phone] [e-mail] www.amplivox.ltd.uk Date prepared: April 7, 2015 Prepared by: Chris Roerig, Engineering Manager

- Identification of the Device: 1. Proprietary-Trade Name: Otowave 202 Classification Name/Product Code: Auditory impedance tester. Code: NAS Regulation: 874.1090 Auditory impedance tester Common/Usual Name: Tympanometer
#### 2. Equivalent legally marketed devices: Amplivox Otowave 102, K081841

- 3. Description of the Device: 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.
- 4. Indications for Use: 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 compliance of 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..
- 5. Safety and Effectiveness, comparison to predicate device. This device has the same indications for use as the predicate device K081841 and employs similar technology to accomplish the same tasks. A detailed comparison table is provided below.

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# 6. Substantial Equivalence Chart

| | Amplivox Otowave 102, K081841 | Amplivox Otowave 202 K150163 |
|------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for<br>Use: | The Amplivox Otowave is designed for<br>use by trained operators in hospitals,<br>ENT clinics, and audiologist offices for<br>the detection of possible otologic<br>disorders associated with the functioning<br>of the middle ear. The instrument<br>performs two types of measurement:<br>Tympanometry is used to measure the<br>compliance of the tympanic membrane<br>and middle ear at a fixed frequency over<br>a range of pressures. Reflex tests are<br>used to measure stapedial reflexes. The<br>Otowave measures ipsilateral reflexes<br>and, when selected, reflex measurement<br>is automatically carried out after a<br>tympanogram is taken | The Amplivox Otowave 202 is designed for<br>use by trained operators (audiologists,<br>general practitioners, hearing aid<br>dispensers, and child health professionals) in<br>hospitals, ENT clinics, and audiologist offices<br>for the detection of possible otologic<br>disorders in the general population<br>associated with the functioning of the middle<br>ear. The instrument performs two types of<br>measurement: Tympanometry is used to<br>measure the compliance of the tympanic<br>membrane and middle ear at a fixed<br>frequency over a range of pressures. Reflex<br>tests are used to measure stapedial reflexes.<br>The Otowave measures ipsilateral reflexes<br>and, when selected, reflex measurement is<br>automatically carried out after a<br>tympanogram is taken. (SAME) |
| Configuration | Hand held battery operated | Hand held battery operated or AC line |
| Photo | Image: Amplivox Otowave 102 | Image: Amplivox Otowave 202 |
| TYMPANOMETRY<br>MEASUREMENTS | Probe tone: 226Hz +/- 2%, 85dB +/-2dB<br>Pressure range: +200daPa to -400daPa<br>+/-10daPa<br>Direction of sweep: positive to negative<br>Volumetric range: 0.2 to 5ml +/- 0.01ml<br>or 10% over range whichever is greater<br>Analysis performed: Compliance peak<br>level, compliance peak pressure level,<br>gradient and equivalent ear canal<br>volume. | Probe tone: 226Hz +/-2%; 85dB SPL +/-2dB<br>Pressure range: +200daPa to -400daPa +/- 10daPa or +/-10% (whichever is larger)<br>Direction of sweep: Positive to negative<br>Volumetric range: 0.2ml to 5ml +/-0.1ml or<br>+/-5% (whichever is larger)<br>Analysis performed: Compliance peak level,<br>compliance peak pressure level, gradient and<br>equivalent ear canal volume |
| | Amplivox Otowave 102, K081841 | Amplivox Otowave 202 K150163 |
| REFLEX<br>MEASUREMENTS | Otowave 102-1: 1KHz +/ 2%<br>Otowave 102-4: 500Hz, 1KHz, 2KHz &<br>4KHz +/- 2%<br>Reflex dB range: 85 to 100 dBHL<br>(programmable in 5 or 10 dB steps)<br>Reflex measurement range: 0.01ml to<br>0.5ml +/- 0.01ml<br>Analysis performed: Reflex maximum<br>amplitude and pass/fail at each test<br>level. | Reflex type: Ipsilateral, contralateral or both<br>Reflex frequencies: User defi ned – 500Hz,<br>1kHz, 2kHz and 4kHz (+/- 2%)<br>Refl ex levels 70dBHL to 100dBHL +/-2dB<br>(ipsilateral): (programmable in 5 or 10dB<br>steps)<br>Reflex levels 70dBHL to 110dBHL +/-2dB<br>(contralateral): (programmable in 5 or 10dB<br>steps)<br>Reflex detection 0.01ml to 0.5ml<br>threshold: (configurable in 0.01ml steps)<br>Analysis performed: Reflex maximum<br>amplitude and pass/fail at each test level |
| Printing | Designated printer: MCP8830 high speed<br>portable thermal printer<br>Data transfer: Infra-red IrDA 9600 Baud<br>Printing may also be completed via a PC<br>with the relevant applications | Two thermal printers (the Able AP1300 or<br>Sanibel MPT-II) are available as options for<br>use with the Otowave 202 both of which<br>communicate via an infra-red link (IrDA). |
| Weight | (Including batteries): 380g | 330g (without batteries);<br>430g (with batteries)<br>Probe – 110g (incl. connecting cable) |
| Size | 210 long x 80 wide x 40mm high<br>envelope. | 190 long x 85 wide x 40 high<br>(excluding connections)<br>Probe – 130 long x 25 (max) diameter |
| Power/Battery | Battery specification: 4x Alkaline AA or 4x<br>NiMH (>=2.3Ah) rechargeable | Mains – Amplivox mains adapter<br>(approved to medical safety standards)<br>Batteries – 4xAlkaline AA or 4xNiMH<br>(rechargeable >2.3Ah) |
| Display | LCD | LCD |
| Data<br>management | Internal database<br>30 patient records<br>Patient record identification<br>NOAH3 aud module<br>Amplivox impedance module<br>Data transfer: Infra-red IrDA 9600 Baud | Internal database:<br>20 patient records with patient record<br>identification<br>Electronic data NOAH aud module<br>storage (database Amplivox NOAH<br>impedance module<br>PC requirements: Transfer via USB cable/port |
| Safety/EMC<br>standards | Safety: EN60601-1: 1990<br>EMC: EN 60601-1-2: 1993 | Safety: IEC 60601-1:2005 (see below)<br>EMC: EN 60601-1-2:2007 |
| Impedance<br>Standard | EN60645-5:2005 Type 2 tympanometer | EN60645-5 Type 2 tympanometer |

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- 7. Summary of non-clinical testing: Material Evaluation to ISO 10993-1 was performed for the Otowave Tympanometer Ear-tips. (The material has not changed from our previous submission.) EMC testing was successfully performed according to EN 60601-1-2:2007. Safety testing was successfully performed according to IEC 60601-1:2005 + CORR. 1 (2006) + CORR. 2 (2007) Medical electrical equipment – Part 1: General Requirements for Basic Safety and

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Essential Performance ANSVAAMI ES60601-1 (2005 + C1:09 + A2:10) - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, includes Deviations for United States CAN/CSA-C22.2 No. 60601-1 (2008) - Medical Electrical Equipment - Part 1: General Requirements for Basic Safety and Essential Performance, includes National Differences for Canada, EN 60601-1: 2006 + CORR: 2010. 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. Software (i.e. firmware) validation: Performed per Amplivox 202 Tympanometer - Functional Specification / Test Plan. Risk analysis: Performed per Amplivox Otowave 202 Portable Tympanometer - Risk & Hazard Traceability Analysis plan.

- 8. Summary of clinical testing: Not applicable. Not required to establish substantial equivalence.
- Conclusion: After analyzing bench testing, safety, EMC, and software validation (with risk 9. analysis) testing we conclude that the Otowave 202 is as safe and effective as the predicate device, and has essentially the same technological characteristics, thus rendering it substantially equivalent to the predicate device.