(112 days)
The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.
The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use. The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise. The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.
The provided text is a 510(k) summary for the Otodynamics Otoport, an Otoacoustic emission analyzer. This document focuses on demonstrating substantial equivalence to a predicate device and lacks specific information regarding acceptance criteria and the detailed study results that would typically be presented in a clinical trial report.
Therefore, many of the requested details about acceptance criteria, specific performance metrics, sample sizes for test and training sets, expert qualifications, and study methodologies are not available in the provided document.
Here's what can be extracted and what is missing:
Description of the Acceptance Criteria and Device Performance
The document does not explicitly state "acceptance criteria" in the traditional sense of numerical thresholds for a new study. Instead, it presents a comparison table showing the specifications of the new device (Otodynamics Otoport) against two predicate devices (Otodynamics ILO2088 Echocheck and Otodynamics ILO292 DP EchoportPlus). The implication is that the Otodynamics Otoport is acceptable because its specifications are comparable to or exceed those of the legally marketed predicate devices.
1. A table of acceptance criteria and the reported device performance
| Parameter | Acceptance Criteria (from Predicate Devices) | Reported Device Performance (Otodynamics Otoport) |
|---|---|---|
| Signal output: | ||
| Frequency range: TEOAE | 1,500 to 3,200Hz (ILO2088) / 500 to 6,000Hz (ILO292) | 500 to 6,000Hz |
| Frequency range: DPOAE | N/A (ILO2088) / 500 to 8,000Hz (ILO292) | 500 to 10,000Hz |
| Level range: TEOAE | 94 to 44dB SPL (Both Predicates) | 94 to 44dB SPL |
| Level range: DPOAE | N/A (ILO2088) / 35 to 75dB SPL (ILO292) | 35 to 75dB SPL |
| Level increments: TEOAE | 1.5dB steps +/-0.5 (Both Predicates) | 1dB steps +/-0.5 (Improved resolution compared to ILO2088) |
| Level increments: DPOAE | N/A (ILO2088) / 1dB steps +/-0.5 (ILO292) | 1dB steps +/-0.5 |
| Signal to noise ratio | >85dB (Both Predicates) | >85dB |
| Harmonic distortion: DPOAE | N/A (ILO2088) / <1% (ILO292) | <1% |
| Intermodulation distortion | N/A (ILO2088) / <-80dB (ILO292) | <-80dB |
| OAE Measurement system: | ||
| Frequency range: TEOAE | 1,500 to 3,200Hz (ILO2088) / 500 to 8,000Hz (ILO292) | 500 to 8,000Hz |
| Frequency range: DPOAE | N/A (ILO2088) / 500 to 10,000Hz (ILO292) | 500 to 10,000Hz |
| Amplitude range: TEOAE | -10 to +94dB SPL (Both Predicates) | -10 to +94dB SPL |
| Amplitude range: DPOAE | N/A (ILO2088) / -20 to +80dB SPL (ILO292) | -20 to +80dB SPL |
| Other parameters: | ||
| External input voltage | 100v AC (@ 60Hz for USA or 230v AC @ 50Hz (Both Predicates)) | 100v AC (@ 60Hz for USA or 230v AC @ 50Hz |
| Internal power source | 2.4v rechargeable battery (ILO2088) / 7.5v rechargeable battery (ILO292) | 3.6v rechargeable battery |
| Hard copy output | Dedicated battery portable printer (ILO2088) / Range of standard PC printers (ILO292) | Dedicated battery portable printer |
| Computer compatibility | PC Pentium III, 1 GHz, Windows 98 SE/ME/2000/XP, CD-ROM, RS232 (ILO2088) | PC Pentium III, 1 GHz, Windows 98 SE/ME/2000/XP, CD-ROM, USB port |
| DPOAE Resolution | N/A (ILO2088) / 1 point/octave to 8 points/octave (ILO292) | 1 point/octave to 8 points/octave |
| TEOAE Resolution | 100Hz (Both Predicates) | 100Hz |
| Latency artefact check | Yes (Both Predicates) | Yes |
| Real time data display | No (ILO2088) / Yes (ILO292) | Yes |
| Programmable test protocol | No (ILO2088) / Yes (ILO292) | Yes |
| Fully self documented file structure | Yes (Both Predicates) | Yes |
| Self-test | Yes (Both Predicates) | Yes |
| Probe identity check | No (ILO2088) / Yes (ILO292) | Yes |
| Built-in keypad | Yes (limited) (ILO2088) / Yes (ILO292) | Yes |
| Built-in LCD screen display | LEDs only (ILO2088) / Yes (ILO292) | Yes |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not provided. The document is a 510(k) summary focused on substantial equivalence through device specifications, not a clinical study report. There is no mention of a "test set" in the context of clinical performance evaluation with a specific sample size.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not provided. Since there's no described "test set" for performance evaluation, there's no mention of experts establishing ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not provided. Not applicable as there is no described test set or ground truth establishment process.
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
- Not applicable. This device is an Otoacoustic emission analyzer, not an AI-assisted diagnostic tool that would involve "human readers" or AI assistance in interpretation in the typical sense for an MRMC study. It measures physiological responses.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not explicitly stated in these terms. The "study" presented here is a comparison of technical specifications to predicate devices to establish substantial equivalence. The device itself operates independently to generate OAE measurements. Its performance is demonstrated by meeting the functional specifications comparable to the predicate devices.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not provided. For this type of device (a measurement tool), "ground truth" would typically refer to the accuracy of its physical measurements against a known standard (e.g., sound pressure level, frequency response against calibrated equipment). The document implies that the device's measurement capabilities are accurate and comparable to the predicate.
8. The sample size for the training set
- Not applicable. This device is hardware-based with signal processing, not a machine learning/AI model that requires a "training set" in the conventional sense.
9. How the ground truth for the training set was established
- Not applicable. As above, no training set is described.
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Section 5: 510(k) Summary
Otodynamics LTD 30-38 Beaconsfield Road AL10 8BB Hatfield Herts 108 GB Phone: 44 1707-267667 Fax: 44 1707-262327
NOV 1 3 2007
Contact: John Morgan
Summary Prepared: April 25, 2007
Trade Name : Otocheck
Common Name :
Classification Name : Audiometer
Predicate Device Identification:
CFR21: Product Code: EWO Device Class:II Legally Marketed Device: Otodynamics LTD ILO292DP Echoport & ILO2088 Echocheck Manufacturer: Otodynamics LTD K#: K983350 & K983352
Description:
The Otoport is a compact, sclf-contained, handheld Otoacoustic emission analyzer which has integral. rechargeable batteries for use.
The Otoport can screen for cochlear function using either Transicnt Evoked or Distortion Product Otacoustic Emissions (TE or DPOAEs). It uses state-of-the-art technology and high performance signal analysis to provide robust indications of cochlear function and high immunity to extraneous noise.
The Otoport has a high degree of connectivity, being capable of immediate connection to any IBM compatible PC via either USB port or Bluctooth wireless technology. The instrument will acccpt probes that are already in use with other products in the Otodynamics range of otoacoustic emission analyzer instruments. There is 100% compatibility between data recorded on the Otoport and data recorded on other Otodynamics OAE products.
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Intended Use:
The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.
| OtodynamicsILO2088 Echocheck | Otodynamics ILO292DP EchoportPlus | OtodynamicsOtoport | |
|---|---|---|---|
| 510(k) Number | K983352 | K983350 | This 510(k) |
| Target population | Newborn, child,adult | Newborn, child, adult | Newborn, child,adult |
| Intended use | Transient Evokedotoacousticscreening technique | Distortion Product andTransient Evokedotoacoustic screeningtechnique | Distortion Productand TransientEvoked otoacousticscreening technique |
| PhysiologicalMeasurementTechnique employed | Non-invasive | Non-invasive | Non-invasive |
Predicate Product Comparison Chart : .
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| Signal output: | |||
|---|---|---|---|
| Frequency range:TEOAE | 1,500 to 3,200Hz | 500 to 6,000Hz | 500 to 6,000Hz |
| DPOAE | N/A | 500 to 8,000Hz | 500 to 10,000Hz |
| Level range: TEOAE | 94 to 44dB SPL | 94 to 44dB SPL | 94 to 44dB SPL |
| DPOAE | N/A | 35 to 75dB SPL | 35 to 75dB SPL |
| Level increments:TEOAE | 1.5dB steps +/-0.5 | 1.5dB steps +/-0.5 | 1dB steps +-0.5 |
| DPOAE | N/A | 1dB steps +/-0.5 | 1dB steps +/-0.5 |
| Signal to noise ratio | >85dB | >85dB | >85dB |
| Harmonic distortion:TEOAE | N/A | N/A | N/A |
| DPOAE | N/A | <1% | <1% |
| Intermodulationdistortion | N/A | <-80dB | <-80dB |
| OAE Measurement system: | |||
| Frequency range:TEOAE | 1,500 to 3,200Hz | 500 to 8,000Hz | 500 to 8,000Hz |
| DPOAE | N/A | 500 to 10,000Hz | 500 to 10,000Hz |
| Amplitude range:TEOAE | -10 to +94dB SPL | -10 to +94dB SPL | -10 to +94dB SPL |
| DPOAE | N/A | -20 to +80dB SPL | -20 to +80dB SPL |
| Other parameters: | |||
| External inputvoltage: | Via charger adaptor:100v AC (@ 60Hzfor USA or 230v AC@ 50Hz | 100v AC (@ 60Hz forUSA or 230v AC @50Hz | Via charger adaptor100v AC (@ 60Hzfor USA or 230vAC @ 50Hz |
..............................................................................................................................................................................
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| Internal powersource: | 2.4v rechargeablebattery | 7.5v rechargeablebattery | 3.6v rechargeablebattery |
|---|---|---|---|
| Hard copy output: | Dedicated batteryportable printer | Range of standard PCprinters | Dedicated batteryportable printer |
| Computercompatibility | PC Pentium III, 1GHz. Windows 98SE/ME/2000/XP,CD-ROM drive.RS232communications port | Recommendedminimum system:Laptop PC, VGA orbetter 486 33MHz4MB RAM for DOSusage. Pentium laptopPC 8MB RAM forWindows 95 usage | PC Pentium III, 1GHz, Windows 98SE/ME/2000/XP.CD-ROM drive.USB port. |
| DPOAE Resolution: | N/A | 1 point/octave to8 points/octave | 1 point/octave to8 points/octave |
| TEOAE Resolution: | 100Hz | 100Hz | 100Hz |
| Latency artefactcheck: | Yes | Yes | Yes |
| Real time datadisplay: | No | Yes | Yes |
| Programmable testprotocol | No | Yes | Yes |
| Fully selfdocumented filestructure: | Yes | Yes | Yes |
| Self-test: | Yes | Yes | Yes |
| Probe identitycheck: | No | Yes | Yes |
| Built-in keypad: | Yes (limited) | Yes | Yes |
| Built-in LCD screendisplay: | LEDs only | Yes | Yes |
..
Kolzzo33
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Image /page/4/Picture/1 description: The image shows the logo for the Department of Health & Human Services - USA. The logo consists of a stylized eagle or bird symbol made up of three curved lines. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Otodynamics Ltd. c/o E. J. Smith Smith Associates, Inc. 1676 Village Green, Suite A Crofton, Maryland 21114
NOV 1 3 2007
Re: K072033
Trade/Device Name: Otodynamics Otoport Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: October 15, 2007 Received: October 15, 2007
Dear Mr. Smith:
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 the reporting 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. Egolins, 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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Indications for Use
510(k) Number (if known): _ KoJ2033
Device Name: Otodynamics Otoport
Indications for Use:
The Otoport can perform Transient Evoked (TE) and Distortion Product (DP) Oto-Acoustic Emission (OAE) measurements on ears via an ear piece or "probe" fitted into the ear canal.
Prescription Use V (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 OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Quthen
(Division Sign-Off)
Division of Ophthalmic Ear, Nose and Throat Devises
510(k) Number K072033
Page I of
X
ription Use
Prescription Use
1 Prescription Use -------------------------------------------------------------------------------------------------------------------------------------------------------------
§ 874.1050 Audiometer.
(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.