(16 days)
Not Found
No
The description focuses on automatic measurements and storage, which are standard features of medical devices and do not indicate the use of AI/ML. There is no mention of AI, ML, or related terms.
No.
The device is used for the detection of possible otologic disorders and performs diagnostic measurements, it does not provide therapy or treatment.
Yes
The device detects "possible otologic disorders associated with the functioning of the middle ear" by performing "Tympanometry" and "Reflex tests." These measurements are used to assess the "compliance of the tympanic membrane and middle ear" and "stapedial reflexes," which are diagnostic indicators.
No
The device description explicitly states it is a "hand held portable tympanometer" and describes physical features like memory storage and infrared links for printing and data transfer, indicating it is a hardware device with embedded software.
Based on the provided information, the Amplivox Otowave is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: IVD devices are used to examine specimens (like blood, urine, or tissue) taken from the human body to provide information about a person's health.
- Amplivox Otowave Function: The Amplivox Otowave directly measures the physical properties of the middle ear (tympanic membrane compliance, stapedial reflexes) using acoustic and pressure stimuli applied to the ear canal. It does not analyze biological specimens.
The device is a diagnostic tool, but it falls under the category of in vivo diagnostic devices as it interacts directly with the patient's body to obtain measurements.
N/A
Intended Use / 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.
Product codes (comma separated list FDA assigned to the subject device)
NAS, ETY
Device Description
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..
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear
Indicated Patient Age Range
Not Found
Intended User / Care Setting
trained operators in hospitals, ENT clinics, and audiologist offices
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The results of bench, user, and standards testing indicates that the new device is as safe and effective as the predicate devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
0
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
-
- 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) ..
-
- 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.
-
- 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..
-
- 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.
-
- Substantial Equivalence Chart (See next page)
1
K08184/
JUL 1 6 2008
| Item | K925585, GSI 38 AUTO
TYMP LUCAS GRASON-STADLER, INC. | K060885 the Maico
MI 44
Tympanometer. | Amplivox
Otowave 102 |
|-------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | (Not found in FDA database)
but inferred from
classification: 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. | The Maico
Diagnostics model
MI 44
tympanometer is
intended 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.
This is
accomplished by
measuring the
acoustic impedance
of the ear canal
under various
conditions. | 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. |
| User
Interface | LCD | LCD | LCD |
| Form
factor | Desktop
Image: [Desktop] | Desktop
Image: [Desktop] | Handheld
Image: [Handheld] |
| Power
source | 120 Vac | 100 - 240 V /
50/60 Hz | Battery Operated |
| Safety | Specification not found. | IEC 601-1 (EN
60601-1) | 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
2
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.
3
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
4
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
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