(57 days)
Not Found
No
The description focuses on standard audiometry functions and computer control via ASCII commands, with no mention of AI or ML terms or capabilities.
No
The device is an audiometric instrument used for measurement and diagnosis, not for treating a condition.
Yes
The device is intended for use by a qualified/trained audiologist for the measurement of acoustic impedance and performs comprehensive audiometry, tympanometry, acoustic reflex, and otoacoustic emissions, all of which are diagnostic functions.
No
The device description explicitly states that the Otogram is a "computer-controlled, audiometric instrument" and mentions a "standard RS-232 communication port" and "supplied PC," indicating the presence of hardware components beyond just software.
Based on the provided information, the "Otogram" device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices intended for use in vitro for the examination of specimens, including blood, tissue, and urine, derived from the human body, solely or principally for the purpose of providing information concerning a physiological or pathological state, or concerning a congenital abnormality.
- Otogram's Function: The Otogram performs audiometric tests (pure tone, speech, impedance, otoacoustic emissions) by interacting directly with the patient's ear system. It measures the ear's response to sound and pressure. This is a direct physiological measurement, not an examination of a specimen in vitro.
- Intended Use: The intended use describes the device as performing measurements on adult and pediatric subjects for acoustic impedance and other audiometric functions. This aligns with in-vivo testing, not in-vitro testing.
The device is clearly an audiometric instrument used for diagnosing hearing-related conditions through direct interaction with the patient's ear.
N/A
Intended Use / Indications for Use
"Otogram" can perform the functions of:
- Pure tone and speech audiometer.
- Impedance audiometer (tympanometry, acoustic reflex), and
- Distortion product otoacoustic emissions analyzer.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
Product codes (comma separated list FDA assigned to the subject device)
ETW; ETY
Device Description
The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, a Impedance Instrument, and a DPOAE Instrument. The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC. The device performs comprehensive audiometry; tympanometry, acoustic reflex; and otoacoustic emissions. Additional features include manual audiometer and NOAH v.3 compliant (hearing aid fitting software). Available in multiple languages, including English, Spanish, Russian, Mandarin, Vietnamese, and Korean.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
middle-ear and total ear system (implied)
Indicated Patient Age Range
"both adult and pediatric subjects"
Intended User / Care Setting
"qualified/trained audiologist"
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 laboratory testing indicates that the new device is as safe and effective as the predicate device.
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
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
EXHIBIT 2 Tympany Inc. 12807 Royal Drive, Suite 101 Stafford, TX 77477 Phone 281.313.5858 Fax 281.313.5844 Toll-Free 866.316.3606 Contact: Kenneth Barrow, Vice President Prepared July 2, 2004 510(k) Summary
-
- Identification of the Device: Proprietary-Trade Name: Otogram Classification Name: Audiometer 77 EWO. (Otoacoustic emission devices are not exempt) and 77 ETY, Admittance Meter (874.1090 Common/Usual Name: Audiometer, Impedance Audiometer, Otoacoustic Emissions Device
-
- Indications for Use (intended use) "Otogram" can perform the functions of:
-
- Pure tone and speech audiometer.
-
- Impedance audiometer (tympanometry, acoustic reflex), and
-
- Distortion product otoacoustic emissions analyzer.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
-
- Description of the Device: The Otogram is a computer-controlled, audiometric instrument combining the functions of an Audiometer, a Impedance Instrument, and a DPOAE Instrument. The device is controlled through the use of ASCII commands transmitted over a standard RS-232 communication port. Control software is installed on the supplied PC. The device performs comprehensive audiometry; tympanometry, acoustic reflex; and otoacoustic emissions. Additional features include manual audiometer and NOAH v.3 compliant (hearing aid fitting software). Available in multiple languages, including English, Spanish, Russian, Mandarin, Vietnamese, and Korean.
-
- Safety and Effectiveness, comparison to predicate device. The results of bench, user, and laboratory testing indicates that the new device is as safe and effective as the predicate device.
1
6. Substantial Equivalence Chart
| Characteristic | | Predicate
Impedance
Audiometer
Madsen Zodiac 901
K910247 | Predicate
Otoacoustic
Emissions
Bio-Logic AuDX
K974076 | Tympany Otogram
Combined Device
Impedance
Audiometer
Otoacoustic
Emissions |
|------------------------------------------------|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | | To diagnose hearing and
otologic disorders in the
middle-ear and total ear
system, using audiometry,
tympanometry, and acoustic
reflex. | To test cochlear function
and presence of otoacoustic
emissions. | To diagnose hearing and
otologic disorders in the
middle-ear and total ear
system, using audiometry,
tympanometry, and acoustic
reflex. To test cochlear
function and presence of
otoacoustic emissions |
| Technical | | | | |
| characteristics | | | | |
| Probe tone: | | | | |
| | Probe tone
frequency | 226 Hz | NA | 226 Hz, +/- 3% |
| | Probe tone level | 85 dB SPL | NA | 70 dB SPL, +/- 3 dB |
| Admittance
measurement: | | | | |
| | Total range | 0.1 ml to 8.0 ml | NA | 0.2 ml to 6.0 ml |
| | Reflex range | 0 ul to 375 ul | NA | 0 ul to 375 ul |
| | Calibration | 2 cc cavity | | 0.5, 2, 5 cc cavity |
| Pressure system: | | | | |
| | Pump system | Plunger type; stepper motor,
digitally controlled | NA | Peristaltic pump; stepper
motor, digitally controlled |
| | Pressure range -
normal | +200 to -400 daPa | NA | +200 to -400 daPa |
| | Pressure range -
extended | +400 to -600 daPa | NA | NA |
| | Accuracy | +/- 10% or +/- 10 daPa
(whichever is greater) | NA | +/- 15% or +/- 10 daPa
(whichever is greater) |
| | Pump speed | As fast as possible: | NA | 50 daPa/sec to 150
daPa/sec |
| | | 400 daPa/sec, 200
daPa/sec, 100 daPa/sec, 50
daPa/sec | NA | |
| | | Manuals speed control | NA | NA |
| | Air release | Mechanical safety release
valve set to +600 and -800
daPa | NA | Mechanical safety release
valve set to +600 and -800
daPa |
| | | Manual & automatic air
release | NA | Manual & automatic air
release |
| Ipsi/contralateral
stimuli | | | | |
| | Pure tone | 0.5, 1, 2, 4 kHz | NA | 0.5, 1, 2, 4 kHz |
| | Step size | 1, 2, 5, 10 dB | NA | 1 to 10 dB |
| | Attenuator range,
ipsi lateral
stimulus | 0.5, 1.0, 2.0, kHz 50-115 dB
HL, 4.0 kHz 50-90 dB HL | NA | 0.5, 1.0, 2.0, 4.0 kHz 80-105
dB HL |
| | Attenuator range,
contra lateral
stimulus | 0.5, 1.0, 2.0, 4.0 kHz 50-100
dB HL, white noise | NA | 0.5, 1.0, 2.0, 4.0 kHz 80-100
dB HL |
| | Frequency
accuracy | +/- 0.5% | +/- 0.5% | +/-0.5% |
| Distortion Product
Otoacoustic
Emissions | | | | |
| | Stimulus | | NA | 2 pure tone stimulus |
| Characteristic | | Predicate
Impedance
Audiometer
Madsen Zodiac 901
K910247 | Predicate
Otoacoustic
Emissions
Bio-Logic AuDX
K974076 | Tympany Otogram
Combined Device
Impedance
Audiometer
Otoacoustic
Emissions |
| | | | channels | channels |
| | F2 test frequency | NA | 2.0, 3.0, 4.0, 5.0 kHz | 1.0, 1.5, 2.0, 3.0, 4.0 kHz |
| | Stimulus level
range | NA | 55 dB SPL and 65 dB SPL | 45-70 dB SPL |
| Physical
characteristics: | | | | |
| | Computer
interface | RS 232C | RS 232C | Computer included, RS
232C |
| | Internal printer | Thermal 112 mm, 4.5" | Thermal 59 mm, 2 1/4" | Thermal 58 mm, 2 1/4" |
| | Printer interface | Parallel port | RS 232C thermal printer | Parallel port or USB |
| | Display | Graphic supertwist LCD
backlight, 256 lines x 128
dots | LCD 1" x 3" | Computer LCD 1024 x 768 |
| | | White text/graphics on blue
background | Black and white | Color, resistive touchscreen |
| | Control interface | Keyboard | Touchpad | Keyboard, touchscreen |
| | Size/weight -
metric | 370 x 385 x 120 mm (W x D
x H), 7.6kg | 98 x 41 x 197 mm (W x D x
H), 0.45 kg | 410 x 300 x 480 mm (W x D
x H), 20.4 kg |
| | Size/weight -
American | 14.8" x 15.4" x 4.8", 16.8 lbs | 3 7/8" x 1 5/8" x 7 3/4", 1 lbs | 16" x 19" x 12", 45 lbs |
| | Energy source | AC 50/60 Hz, 100-240 V | AC 50/60 Hz, 100-240 V | AC 50/60 Hz, 100-120 V |
| | Hardcopy output | Thermal paper or external
printer paper | External thermal printer | Thermal paper or external
printer paper |
| Standard and safety
characteristics | | | | |
| | Performance and
calibration | IEC 1027, ANSI S3.39 | NA | IEC 1027, ANSI S3.39 |
| | Electrical safety | EN 60601-1, class I, type B | EN 55011: 1991 Group 1
Class B | EN 60601-1, class I, type B |
2
7. Conclusion
After analyzing both bench and user testing data, it is the conclusion of Tympany Inc. that the Tympany OTOGRAM is safe and effective as the predicate device, has few technological differences, and has no new indications for use, thus rendering it substantially equivalent to the predicate device.
3
Image /page/3/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized graphic of three abstract human figures, represented by curved lines, facing to the right.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 3 2004
Tympany, Inc. c/o Daniel Kamm, P.E. Kamm & Associates P.O. Box 7007 Deerfield, IL 60015
Re: K041853
Trade/Device Name: Otogram, Audiometer, Impedance Audiometer, and Otoacoustics Emissions Device Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: ETY; ETW Dated: July 6, 2004
Received: July 9, 2004
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.
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 I hat 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.
4
Page 2 - Daniel Kamm, P.E.
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 Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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 (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
A kalgi korenthal
A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use
510(k) Number (if known):
Device Name: "Otogram" Combination -(Pure tone and speech audiometer, impedance audiometer, and distortion product otoacoustic emissions analyzer.)
Indications For Use:
"Otogram" can perform the functions of:
- Pure tone and speech audiometer, 1.
- Impedance audiometer (tympanometry, acoustic reflex), and 2.
- Distortion product otoacoustic emissions analyzer. 3.
The unit is intended for use by a qualified/trained audiologist on both adult and pediatric subjects for measurement of acoustic impedance.
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)
Prescription Use
(Per 21 CFR 801.109) TVC 8/30/04
TYC 8/30/04
Jivision of Onl Nose and Throat
510(k) Number K041853
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