(16 days)
The Amplivox Otowave is designed for use by trained operators in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders 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.
This is a hand held portable tympanometer. It features: Automatic measurement of ear canal volume, tympanic compliance peak, placement . of the peak and the gradient. . Automatic detection of stapedial reflexes. . Up to 30, dual-ear patient tests can be stored in non-volatile memory. 9 . Configurable settings for user preferences, held in non-volatile memory. . Printout via an infrared link to a thermal printer. . Transfer to Windows XP via an infrared IrDA link for storage and display using . NOAH..
The Amplivox Otowave 102 Hand Held Portable Tympanometer (K081841) was cleared based on substantial equivalence to predicate devices, rather than meeting specific performance acceptance criteria from a clinical study. The provided document does not contain an acceptance criteria table or a detailed study demonstrating device performance against such criteria.
Instead, the submission focuses on the device's intended use, description, and comparison to legally marketed predicate devices (K925585, GSI 38 AUTO TYMP LUCAS GRASON-STADLER, INC. and K060885 the Maico MI 44 Tympanometer) to establish substantial equivalence.
Here's a breakdown of the requested information based on the provided text:
1. A table of acceptance criteria and the reported device performance
This information is not provided in the given document. The submission states: "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." However, it does not detail specific acceptance criteria or quantitative performance metrics from these tests.
2. Sample sized used for the test set and the data provenance
This information is not provided in the given document. The document mentions "bench, user, and standards testing" but does not specify sample sizes or data provenance (e.g., country of origin, retrospective/prospective nature).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not provided in the given document. The clearance relies on substantial equivalence, not on the establishment of ground truth by experts for a specific test set.
4. Adjudication method for the test set
This information is not provided in the given document.
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
A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not mentioned or indicated in the provided document. The device is a diagnostic instrument, not an AI-assisted diagnostic tool for human readers; therefore, this type of study would not be applicable or expected in this context.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
The device is a standalone tympanometer. Its performance would inherently be "algorithm only" as it provides automated measurements. However, no specific study detailing its standalone performance with quantitative results is provided. The comparison is made against predicate devices, implying similar performance characteristics.
7. The type of ground truth used
This information is not explicitly stated in the provided document. Given that the device performs measurements for the "detection of possible otologic disorders," the implied 'ground truth' in a clinical setting would likely be established through clinical diagnosis by medical professionals (e.g., ENT specialists, audiologists) or potentially through pathology/imaging in more severe cases. However, no specific ground truth method for the pre-market testing is described.
8. The sample size for the training set
This information is not provided in the given document. The device is a traditional medical instrument, not an AI/machine learning system, so the concept of a "training set" in that context does not apply.
9. How the ground truth for the training set was established
This information is not provided in the given document, as it is not an AI/machine learning device requiring a training set with established ground truth.
Summary of what is available from the document regarding acceptance criteria and study:
The submission for the Amplivox Otowave 102 Hand Held Portable Tympanometer (K081841) focuses on demonstrating substantial equivalence to existing predicate devices (K925585, GSI 38 AUTO TYMP LUCAS GRASON-STADLER, INC. and K060885 the Maico MI 44 Tympanometer).
The evidence for this substantial equivalence is primarily based on:
- Intended Use Compatibility: The intended use of the Otowave 102 is highly similar to that of the predicate devices.
- Technological Characteristics: The device performs similar measurements (Tympanometry and Reflex tests) as the predicate devices. Differences noted are primarily in form factor (handheld vs. desktop) and power source (battery-operated vs. AC).
- Safety and Effectiveness Claims: The document states, "The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices." However, no detailed reports, specific results, or quantitative acceptance criteria from these tests are provided. The "standards testing" refers to adherence to safety standards like UL and IEC 60601-1, which would involve meeting predefined benchmarks for electrical and mechanical safety.
In essence, the "acceptance criteria" here are implicitly met by demonstrating that the new device is comparable in function, safety, and effectiveness to devices already cleared for market. The study, if one could call it that, is a comparative assessment against predicate devices supported by general "bench, user, and standards testing" without specific details on methodologies or results in the provided document.
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1/16/08
510(k) Summary K08
Amplivox Ltd 29-30 Station Approach, Kidlington Oxford, OXON OX5 1JD UNITED KINGDOM Tel: +44 (0)1865 842411 Fax: +44 (0)1865 841853 www.amplivox.ltd.uk Contact: Chris Roerig Date Prepared: May 16, 2008
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- Identification of the Device: Proprietary-Trade Name: Amplivox Otowave 102 Hand Held Portable Tympanometer. Classification Name: Tympanometer Product Codes Tympanometer: NAS (new product code, no 510(k)s under this code) Audiometer: EWO or Tester, auditory impedance ETY Common/Usual Name: Tympanometer.
- Equivalent legally marketed devices: K925585, GSI 38 AUTO TYMP LUCAS GRASON-2. STADLER, INC. and K060885 the Maico MI 44 Tympanometer. (Plus numerous others) ..
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- Indications for Use (intended use) The Amplivox Otowave is designed for use by trained operators in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders 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.
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- Description of the Device: This is a hand held portable tympanometer. It features:
- Automatic measurement of ear canal volume, tympanic compliance peak, placement . of the peak and the gradient.
- . Automatic detection of stapedial reflexes.
- Up to 30, dual-ear patient tests can be stored in non-volatile memory. 9
- Configurable settings for user preferences, held in non-volatile memory. .
- Printout via an infrared link to a thermal printer. .
- Transfer to Windows XP via an infrared IrDA link for storage and display using . NOAH..
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- Safety and Effectiveness, comparison to predicate device. The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
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- Substantial Equivalence Chart (See next page)
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K08184/
JUL 1 6 2008
| Item | K925585, GSI 38 AUTOTYMP LUCAS GRASON-STADLER, INC. | K060885 the MaicoMI 44Tympanometer. | AmplivoxOtowave 102 |
|---|---|---|---|
| Intended Use: | (Not found in FDA database)but inferred fromclassification: a device that isintended to change the airpressure in the externalauditory canal and measureand graph the mobilitycharacteristics of thetympanic membrane toevaluate the functionalcondition of the middle ear.The device is used todetermine abnormalities inthe mobility of the tympanicmembrane due to stiffness,flaccidity, or the presence offluid in the middle ear cavity.The device is also used tomeasure the acoustic reflexthreshold from contractions ofthe stapedial muscle, tomonitor healing of tympanicmembrane grafts orstapedectomies, or to monitorfollowup treatment forinflammation of the middleear. | The MaicoDiagnostics modelMI 44tympanometer isintended for use bytrained operators inhospitals, ENTclinics andaudiologist officesfor the detection ofpossible otologicdisorders associatedwith the functioningof the middle ear.This isaccomplished bymeasuring theacoustic impedanceof the ear canalunder variousconditions. | The Amplivox Otowave isdesigned for use by trainedoperators in hospitals, ENTclinics, and audiologistoffices for the detection ofpossible otologic disordersassociated with thefunctioning of the middleear. The instrumentperforms two types ofmeasurement:Tympanometry is used tomeasure the compliance ofthe tympanic membrane andmiddle ear at a fixedfrequency over a range ofpressures. Reflex tests areused to measure stapedialreflexes. The Otowavemeasures ipsilateral reflexesand, when selected, reflexmeasurement isautomatically carried outafter a tympanogram istaken. |
| UserInterface | LCD | LCD | LCD |
| Formfactor | DesktopImage: [Desktop] | DesktopImage: [Desktop] | HandheldImage: [Handheld] |
| Powersource | 120 Vac | 100 - 240 V /50/60 Hz | Battery Operated |
| Safety | Specification not found. | IEC 601-1 (EN60601-1) | UL and IEC 60601-1 |
- 7 . Conclusion After analyzing bench, user, and standards testing data, it is the conclusion of Amplivox Ltd. that the Otowave 102 Tympanometer is safe and effective as the predicate devices, has few technological differences, and have no new indications for use, thus rendering them substantially equivalent to the predicate devices
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with a double helix intertwined around a staff. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 1 6 2008
Amplivox Ltd. c/o James W. Monroe Intertek Testing Services NA, Inc. 2307 E. Aurora Rd., Unit B7 Twinsburg, OH 44087
Re: K081841
Trade/Device Name: Amplivox Otowave 102 Hand Held Portable Tympanometer Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: June 27, 2008 Received: June 30, 2008
Dear Mr. Monroe:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
M. B. Egelston, mD
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
Enclosure
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08/84/
Indications for Use
510(k) Number (if known): __
Device Name: Amplivox Otowave 102 Hand Held Portable Tympanometer.
Indications For Use:
The Amplivox Otowave is designed for use by trained operators in hospitals, ENT clinics, and audiologist offices for the detection of possible otologic disorders 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..
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number
Page 1 of 1
§ 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.