(57 days)
"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.
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.
The provided text describes the regulatory submission for the Tympany Otogram device and its comparison to predicate devices, focusing on substantial equivalence rather than a study proving the device meets specific acceptance criteria in a clinical performance sense.
Therefore, many of the requested elements (like sample size for test/training sets, number and qualifications of experts for ground truth, adjudication methods, MRMC studies, standalone performance, and type of ground truth) either do not apply directly to this type of submission or are not detailed in the provided information. This document is a 510(k) summary, which focuses on demonstrating equivalence to existing legally marketed devices based on technical characteristics and intended use, often supported by bench and user testing rather than extensive clinical trials with human subjects.
Here's an attempt to answer the questions based only on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The provided document does not explicitly state "acceptance criteria" in the format of specific quantitative thresholds to be met. Instead, it demonstrates "substantial equivalence" to predicate devices by comparing technical characteristics. The "reported device performance" is essentially the detailed technical specifications of the Otogram and its comparison to the predicate devices.
The table below reconstructs the comparison from the provided Substantial Equivalence Chart as effectively serving the role of demonstrating performance relative to established benchmarks (the predicate devices). The implied "acceptance criterion" for each characteristic is that the Otogram's performance/specification is comparable to or within acceptable ranges of the predicate devices.
| Characteristic | Acceptance Criterion (Predicate Devices) | Reported Device Performance (Tympany Otogram) |
|---|---|---|
| Probe tone: | ||
| Probe tone frequency | Madsen Zodiac 901: 226 Hz | 226 Hz, +/- 3% |
| Probe tone level | Madsen Zodiac 901: 85 dB SPL | 70 dB SPL, +/- 3 dB |
| Admittance measurement: | ||
| Total range | Madsen Zodiac 901: 0.1 ml to 8.0 ml | 0.2 ml to 6.0 ml |
| Reflex range | Madsen Zodiac 901: 0 ul to 375 ul | 0 ul to 375 ul |
| Calibration | Madsen Zodiac 901: 2 cc cavity | 0.5, 2, 5 cc cavity |
| Pressure system: | ||
| Pump system | Madsen Zodiac 901: Plunger type; stepper motor, digitally controlled | Peristaltic pump; stepper motor, digitally controlled |
| Pressure range - normal | Madsen Zodiac 901: +200 to -400 daPa | +200 to -400 daPa |
| Pressure range - extended | Madsen Zodiac 901: +400 to -600 daPa | NA |
| Accuracy | Madsen Zodiac 901: +/- 10% or +/- 10 daPa (whichever is greater) | +/- 15% or +/- 10 daPa (whichever is greater) |
| Pump speed | Madsen Zodiac 901: As fast as possible: 400 daPa/sec, 200 daPa/sec, 100 daPa/sec, 50 daPa/sec | 50 daPa/sec to 150 daPa/sec |
| Air release | Madsen Zodiac 901: Mechanical safety release valve set to +600 and -800 daPa. Manual & automatic air release | Mechanical safety release valve set to +600 and -800 daPa. Manual & automatic air release |
| Ipsi/contralateral stimuli: | ||
| Pure tone | Madsen Zodiac 901: 0.5, 1, 2, 4 kHz | 0.5, 1, 2, 4 kHz |
| Step size | Madsen Zodiac 901: 1, 2, 5, 10 dB | 1 to 10 dB |
| Attenuator range, ipsi lateral stimulus | Madsen Zodiac 901: 0.5, 1.0, 2.0, kHz 50-115 dB HL, 4.0 kHz 50-90 dB HL | 0.5, 1.0, 2.0, 4.0 kHz 80-105 dB HL |
| Attenuator range, contra lateral stimulus | Madsen Zodiac 901: 0.5, 1.0, 2.0, 4.0 kHz 50-100 dB HL, white noise | 0.5, 1.0, 2.0, 4.0 kHz 80-100 dB HL |
| Frequency accuracy | Madsen Zodiac 901: +/- 0.5% (also Bio-Logic AuDX: +/- 0.5%) | +/-0.5% |
| Distortion Product Otoacoustic Emissions: | ||
| F2 test frequency | Bio-Logic AuDX: 2.0, 3.0, 4.0, 5.0 kHz | 1.0, 1.5, 2.0, 3.0, 4.0 kHz |
| Stimulus level range | Bio-Logic AuDX: 55 dB SPL and 65 dB SPL | 45-70 dB SPL |
| Standard and safety characteristics: | ||
| Performance and calibration | IEC 1027, ANSI S3.39 (for Madsen Zodiac 901) | IEC 1027, ANSI S3.39 |
| Electrical safety | EN 60601-1, class I, type B (for Madsen Zodiac 901); EN 55011: 1991 Group 1 Class B (for Bio-Logic AuDX) | EN 60601-1, class I, type B |
The study proving the device meets these criteria is described as "bench, user, and laboratory testing" (Section 5. and 7.). These tests indicate that the new device is "as safe and effective as the predicate device," thus demonstrating substantial equivalence.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document mentions "bench, user, and laboratory testing" but does not quantify the sample size (e.g., number of devices tested, number of users, number of measurements).
- Data Provenance: Not specified. It's internal company testing ("Tympany Inc."). There is no indication of country of origin or whether the testing was retrospective or prospective in detail, although "user testing" implies prospective interaction with the device.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable/Not specified. This is a technical medical device, and the "ground truth" for its performance is typically established by comparing its physical outputs (e.g., sound frequencies, pressure measurements) against calibrated standards and predicate devices, rather than expert consensus on a diagnosis for a test set. The submission focuses on technical performance and safety.
4. Adjudication method for the test set
Not applicable/Not specified. Adjudication methods like 2+1 or 3+1 are typically used in studies where human readers evaluate cases and their agreement needs to be resolved. This document describes bench and user testing of a medical device's technical specifications and safety, not an evaluation of diagnostic accuracy by human readers.
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
No. This type of study (MRMC, AI assistance) is not mentioned and is typically associated with diagnostic algorithms or imaging interpretation, which is not the primary focus of this device's regulatory submission. The Otogram is a measurement device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable for this device in the context of "algorithm only." The performance of the device itself (its hardware and embedded software) was tested, implying a "standalone" evaluation of its technical capabilities against its specifications and predicate devices. However, this is not in the context of an "AI algorithm." The device's operation is "computer-controlled" (Section 4), but the submission focuses on its measurement functions, not on a standalone diagnostic algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for the device's technical performance would be established by calibrated standards and the specifications of predicate devices. For example, to verify "Probe tone frequency: 226 Hz, +/- 3%", the device's output would be measured against a known, highly accurate frequency standard. For safety, compliance with standards like EN 60601-1 is the ground truth. There's no mention of patient-specific "outcomes data" or "pathology" as ground truth for this type of device submission.
8. The sample size for the training set
Not applicable. The device described (Otogram) is an audiometer, impedance instrument, and DPOAE instrument. It is a measurement device, not an AI/machine learning model that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
Not applicable (as established in point 8).
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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.
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6. Substantial Equivalence Chart
| Characteristic | PredicateImpedanceAudiometerMadsen Zodiac 901K910247 | PredicateOtoacousticEmissionsBio-Logic AuDXK974076 | Tympany OtogramCombined DeviceImpedanceAudiometerOtoacousticEmissions | |
|---|---|---|---|---|
| Intended Use: | To diagnose hearing andotologic disorders in themiddle-ear and total earsystem, using audiometry,tympanometry, and acousticreflex. | To test cochlear functionand presence of otoacousticemissions. | To diagnose hearing andotologic disorders in themiddle-ear and total earsystem, using audiometry,tympanometry, and acousticreflex. To test cochlearfunction and presence ofotoacoustic emissions | |
| Technical | ||||
| characteristics | ||||
| Probe tone: | ||||
| Probe tonefrequency | 226 Hz | NA | 226 Hz, +/- 3% | |
| Probe tone level | 85 dB SPL | NA | 70 dB SPL, +/- 3 dB | |
| Admittancemeasurement: | ||||
| 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; steppermotor, 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 150daPa/sec | |
| 400 daPa/sec, 200daPa/sec, 100 daPa/sec, 50daPa/sec | NA | |||
| Manuals speed control | NA | NA | ||
| Air release | Mechanical safety releasevalve set to +600 and -800daPa | NA | Mechanical safety releasevalve set to +600 and -800daPa | |
| Manual & automatic airrelease | NA | Manual & automatic airrelease | ||
| Ipsi/contralateralstimuli | ||||
| 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 lateralstimulus | 0.5, 1.0, 2.0, kHz 50-115 dBHL, 4.0 kHz 50-90 dB HL | NA | 0.5, 1.0, 2.0, 4.0 kHz 80-105dB HL | |
| Attenuator range,contra lateralstimulus | 0.5, 1.0, 2.0, 4.0 kHz 50-100dB HL, white noise | NA | 0.5, 1.0, 2.0, 4.0 kHz 80-100dB HL | |
| Frequencyaccuracy | +/- 0.5% | +/- 0.5% | +/-0.5% | |
| Distortion ProductOtoacousticEmissions | ||||
| Stimulus | NA | 2 pure tone stimulus | ||
| Characteristic | PredicateImpedanceAudiometerMadsen Zodiac 901K910247 | PredicateOtoacousticEmissionsBio-Logic AuDXK974076 | Tympany OtogramCombined DeviceImpedanceAudiometerOtoacousticEmissions | |
| 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 levelrange | NA | 55 dB SPL and 65 dB SPL | 45-70 dB SPL | |
| Physicalcharacteristics: | ||||
| Computerinterface | RS 232C | RS 232C | Computer included, RS232C | |
| 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 LCDbacklight, 256 lines x 128dots | LCD 1" x 3" | Computer LCD 1024 x 768 | |
| White text/graphics on bluebackground | Black and white | Color, resistive touchscreen | ||
| Control interface | Keyboard | Touchpad | Keyboard, touchscreen | |
| Size/weight -metric | 370 x 385 x 120 mm (W x Dx H), 7.6kg | 98 x 41 x 197 mm (W x D xH), 0.45 kg | 410 x 300 x 480 mm (W x Dx 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 externalprinter paper | External thermal printer | Thermal paper or externalprinter paper | |
| Standard and safetycharacteristics | ||||
| Performance andcalibration | IEC 1027, ANSI S3.39 | NA | IEC 1027, ANSI S3.39 | |
| Electrical safety | EN 60601-1, class I, type B | EN 55011: 1991 Group 1Class B | EN 60601-1, class I, type B |
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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.
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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.
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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
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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
Page 1 of 1
§ 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.