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 Description

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.

AI/ML Overview

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.

Summary

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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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 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)

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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FOR FDA USE ONLY

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510(K) Summary, 510(k) K150163 Amplivox, Ltd. 6 Oasis Park Eynsham, Oxfordshire OX29 4TP, United Kingdom Tel: +44 (0)1865 880846 Fax: +44 (0)1865 880426 sales@amplivox.ltd.uk 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

1. 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.
1. 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..
1. 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 forUse:	The Amplivox Otowave is designed foruse by trained operators in hospitals,ENT clinics, and audiologist offices forthe detection of possible otologicdisorders associated with the functioningof the middle ear. The instrumentperforms two types of measurement:Tympanometry is used to measure thecompliance of the tympanic membraneand middle ear at a fixed frequency overa range of pressures. Reflex tests areused to measure stapedial reflexes. TheOtowave measures ipsilateral reflexesand, when selected, reflex measurementis automatically carried out after atympanogram is taken	The Amplivox Otowave 202 is designed foruse by trained operators (audiologists,general practitioners, hearing aiddispensers, and child health professionals) inhospitals, ENT clinics, and audiologist officesfor the detection of possible otologicdisorders in the general populationassociated with the functioning of the middleear. The instrument performs two types ofmeasurement: Tympanometry is used tomeasure the compliance of the tympanicmembrane and middle ear at a fixedfrequency over a range of pressures. Reflextests are used to measure stapedial reflexes.The Otowave measures ipsilateral reflexesand, when selected, reflex measurement isautomatically carried out after atympanogram is taken. (SAME)
Configuration	Hand held battery operated	Hand held battery operated or AC line
Photo	Image: Amplivox Otowave 102	Image: Amplivox Otowave 202
TYMPANOMETRYMEASUREMENTS	Probe tone: 226Hz +/- 2%, 85dB +/-2dBPressure range: +200daPa to -400daPa+/-10daPaDirection of sweep: positive to negativeVolumetric range: 0.2 to 5ml +/- 0.01mlor 10% over range whichever is greaterAnalysis performed: Compliance peaklevel, compliance peak pressure level,gradient and equivalent ear canalvolume.	Probe tone: 226Hz +/-2%; 85dB SPL +/-2dBPressure range: +200daPa to -400daPa +/- 10daPa or +/-10% (whichever is larger)Direction of sweep: Positive to negativeVolumetric range: 0.2ml to 5ml +/-0.1ml or+/-5% (whichever is larger)Analysis performed: Compliance peak level,compliance peak pressure level, gradient andequivalent ear canal volume
	Amplivox Otowave 102, K081841	Amplivox Otowave 202 K150163
REFLEXMEASUREMENTS	Otowave 102-1: 1KHz +/ 2%Otowave 102-4: 500Hz, 1KHz, 2KHz &4KHz +/- 2%Reflex dB range: 85 to 100 dBHL(programmable in 5 or 10 dB steps)Reflex measurement range: 0.01ml to0.5ml +/- 0.01mlAnalysis performed: Reflex maximumamplitude and pass/fail at each testlevel.	Reflex type: Ipsilateral, contralateral or bothReflex frequencies: User defi ned – 500Hz,1kHz, 2kHz and 4kHz (+/- 2%)Refl ex levels 70dBHL to 100dBHL +/-2dB(ipsilateral): (programmable in 5 or 10dBsteps)Reflex levels 70dBHL to 110dBHL +/-2dB(contralateral): (programmable in 5 or 10dBsteps)Reflex detection 0.01ml to 0.5mlthreshold: (configurable in 0.01ml steps)Analysis performed: Reflex maximumamplitude and pass/fail at each test level
Printing	Designated printer: MCP8830 high speedportable thermal printerData transfer: Infra-red IrDA 9600 BaudPrinting may also be completed via a PCwith the relevant applications	Two thermal printers (the Able AP1300 orSanibel MPT-II) are available as options foruse with the Otowave 202 both of whichcommunicate via an infra-red link (IrDA).
Weight	(Including batteries): 380g	330g (without batteries);430g (with batteries)Probe – 110g (incl. connecting cable)
Size	210 long x 80 wide x 40mm highenvelope.	190 long x 85 wide x 40 high(excluding connections)Probe – 130 long x 25 (max) diameter
Power/Battery	Battery specification: 4x Alkaline AA or 4xNiMH (>=2.3Ah) rechargeable	Mains – Amplivox mains adapter(approved to medical safety standards)Batteries – 4xAlkaline AA or 4xNiMH(rechargeable >2.3Ah)
Display	LCD	LCD
Datamanagement	Internal database30 patient recordsPatient record identificationNOAH3 aud moduleAmplivox impedance moduleData transfer: Infra-red IrDA 9600 Baud	Internal database:20 patient records with patient recordidentificationElectronic data NOAH aud modulestorage (database Amplivox NOAHimpedance modulePC requirements: Transfer via USB cable/port
Safety/EMCstandards	Safety: EN60601-1: 1990EMC: EN 60601-1-2: 1993	Safety: IEC 60601-1:2005 (see below)EMC: EN 60601-1-2:2007
ImpedanceStandard	EN60645-5:2005 Type 2 tympanometer	EN60645-5 Type 2 tympanometer

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1. 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.

1. 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.

Regulation Number and Section

§ 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.