(80 days)
The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss. The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to be able to understand the basic principles of the test method when explained by the operator.
The SA 201/202/203/204 audiometers are electroacoustic devices that produces controlled levels of test tones and signals. The SA201/202 are IEC 60645 Type 4 Pure Tone Audiometers and the SA203/204 Diagnostic Audiometers are IEC 60645 Type 3 Audiometers. The SA201/202 are manual pure tone air conduction, screening audiometers. SA202 has the additional capability to perform automatic pure tone audiometry. The SA203/204 are both automatic air and bone conduction audiometers with synchronized masking possibility in order to avoid overhearing to the not tested ear. The SA 204 has the additional capability of using speech-testing. Both can be operated manually if required. All models can be used for determination of hearing thresholds and assist to diagnose hearing loss. All models, 201/202/203/204 have a built-in microphone for easier communication with the test person. Furthermore they all have outputs for TDH39, Sennheiser HDA200 and EARtone 5A insert ear phones. SA203/204 have outputs for B71 Bone Conductor and Free-field system (optional).
The provided text describes the Entomed SA201/202 Screening Audiometer and SA203/204 Diagnostic Audiometer. It focuses on comparing these new devices to predicate devices (Interacoustic AD229b and GSI 61 Clinical Audiometer) to establish substantial equivalence, rather than detailing a specific study to prove the device meets acceptance criteria through performance metrics like sensitivity or specificity.
The acceptance criteria here are implicitly meeting or exceeding the performance characteristics outlined in various international standards for audiometers, as well as demonstrating substantial equivalence to predicate devices in terms of intended use, technological characteristics, and safety and effectiveness.
Here's an analysis based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily defined by adherence to international standards for audiometers and comparability to predicate devices. The "reported device performance" is essentially a statement of conformity to these standards and the detailed comparison to the predicates.
| Acceptance Criteria (Standards & Features) | Entomed SA201/202/203/204 Performance |
|---|---|
| International Standards Compliance | Meets or Exceeds: |
| IEC 60645-1 (1992) (Pure Tone Audiometers) | All models (SA201, SA202, SA203, SA204) comply. |
| IEC 60645-2 (1993) (Speech Audiometry) | SA204 complies; SA201, SA202, SA203 are NA (Not Applicable) as they don't perform speech audiometry. |
| ISO 389:1991 (Air Conduction Calibration) | All models comply. |
| ISO 389-2 (Insert Phone Calibration) | All models comply. |
| ISO 389-3 (Bone Vibrator Calibration) | SA203, SA204 comply; SA201, SA202 are NA (no bone conduction). |
| ISO 389-4 (Narrow Band Masking Noise Cal.) | SA203, SA204 comply; SA201, SA202 are NA (no narrow band masking). |
| ISO 389-7 (Free Field Audiometers Cal.) | SA203, SA204 comply; SA201, SA202 are NA (no free field). |
| IEC 60601-1 (1988) (General Safety) | All models comply. |
| IEC 60601-1-2 (2007) (EMC) | All models comply. |
| ISO 8253-1 (Pure Tone Air/Bone Audiometry) | All models comply (SA201/202 for air, SA203/204 for air and bone). |
| ISO 8253-2 (Sound Field Audiometry) | SA203, SA204 comply; SA201, SA202 are NA. |
| ISO 8253-3 (Speech Audiometry) | SA204 complies; SA201, SA202, SA203 are NA. |
| Predicate Device Comparability (General) | Deemed "substantially equivalent" to Interacoustic AD229b and GSI 61 Clinical Audiometer for indicated use and technical features. Differences are noted and justified as not raising new questions of safety or effectiveness. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not describe a clinical "test set" in the traditional sense of patient data for evaluating performance metrics like sensitivity or specificity. Instead, the "study" demonstrating performance is a technical comparison to legally marketed predicate devices and a declaration of conformity to established audiometry standards. There is no mention of patient data, sample sizes, or data provenance (country of origin, retrospective/prospective).
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not provided. The "ground truth" for this submission is adherence to established technical standards and the characteristics of existing predicate devices. No expert review of a clinical test set is described.
4. Adjudication Method for the Test Set
Not applicable, as no clinical test set requiring adjudication is described.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. The submission focuses on demonstrating substantial equivalence to predicate devices and adherence to international standards, not on statistical improvements in human reader performance with or without AI assistance. The device in question is an audiometer, a diagnostic instrument, not an AI-powered image analysis tool.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
Not applicable. The device is a physical audiometer, not an algorithm. Its performance is inherent in its electroacoustic output and functionality as per the relevant standards.
7. The Type of Ground Truth Used
The "ground truth" for this submission is multi-faceted:
- International Technical Standards: The IEC and ISO standards listed (e.g., IEC 60645-1, ISO 389) define accepted performance parameters for audiometers.
- Predicate Device Specifications: The technical specifications and intended uses of the Interacoustic AD229b and GSI 61 Clinical Audiometer serve as a benchmark for comparison. The conclusion of "substantial equivalence" relies on the new device performing similarly without raising new questions of safety or effectiveness.
8. The Sample Size for the Training Set
Not applicable. This is not an AI/machine learning device that requires a training set of data.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as no training set is relevant to this device submission.
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OCT - 2 2009
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1092111
Summary of 510(k) owners administrative data
COMPANY NAME AND ADDRESS:
CONTACT PERSON:
EMAIL:
1
TELEPHONE NUMBER:
FAX:
TRADE NAME OF DEVICE:
COMMON NAME:
CLASSIFICATION:
PREDICATE DEVICE:
DATE SUMMARY PREPARED:
Entomed AB Bariumgatan 29 213 64 Malmö Sweden
Charlotte Mattisson
charlotte.mattisson@entomed.se
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46 (40) - 210090
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46 (40) - 210092
Entomed SA201/202 Screening Audiometer and Entomed SA203/204 Diagnostic Audiometer
Audiometer
Class II Medical Device, Reg no 874.1050, Product Code EWO
Interacoustic Diagnostic Audiometer AD229b and GSI 61 Clinical Audiometer
July 10 2009
{1}------------------------------------------------
2 Entomed AB
Entomed is a Swedish specialist company within the ENT (Ear-Nose-Throat) sector, founded 1986, with home production of audiometers, and an extensive agency business for Welch Allyn and diagnostical instruments from Grason-Stadler (GSI), Maico, and Oriola.
Up to year 2007 Entomed products were sold and distributed by GSI under the brand name GSI 66, GSI 67 and GSI 68. Since 2008 the products are sold directly from Entomed through a worldwide distributor network, under the brand names SA201TM SA202TM, SA 203TM and SA204TM
The SA20X series audiometer presented in this 510(k) submission is a new modernized generation of the well reputed product line. The new generation is digital and RoHS compatible.
3 Description of the device
The SA 201/202/203/204 audiometers are electroacoustic devices that produces controlled levels of test tones and signals.
The SA201/202 are IEC 60645 Type 4 Pure Tone Audiometers and the SA203/204 Diagnostic Audiometers are IEC 60645 Type 3 Audiometers.
The SA201/202 are manual pure tone air conduction, screening audiometers. SA202 has the additional capability to perform automatic pure tone audiometry.
The SA203/204 are both automatic air and bone conduction audiometers with synchronized masking possibility in order to avoid overhearing to the not tested ear. The SA 204 has the additional capability of using speech-testing. Both can be operated manually if required.
All models can be used for determination of hearing thresholds and assist to diagnose hearing loss.
All models, 201/202/203/204 have a built-in microphone for easier communication with the test person. Furthermore they all have outputs for TDH39, Sennheiser HDA200 and EARtone 5A insert ear phones. SA203/204 have outputs for B71 Bone Conductor and Free-field system (optional).
All models should be operated by people with education/training within the field of audiometry such as Audiologists. Hearing Aid dispensers, Health Care and School nurses with appropriate training in audiology and Ear Nose Throat specialists.
{2}------------------------------------------------
The performance characteristics for the SA 201/202/203/204 are such that they meet or exceed the following standards:
| Standard | Name | SA201 | SA202 | SA203 | SA204 |
|---|---|---|---|---|---|
| IEC 60645-1 (1992) | Audiometers Part1; Pure Tone Audiometers | x | x | x | x |
| IEC 60645-2(1993) | Audiometers Part 2; Equipment for Speech Audiometry | NA | NA | NA | x |
| ISO 389:1991 | Calibration of Air Conduction Audiometers | x | x | x | x |
| ISO 389-2 | Calibration of Insert Phones | x | x | x | x |
| ISO 389-3 | Calibration of Bone Vibrators | NA | NA | x | x |
| ISO 389-4 | Calibration of Narrow Band Masking Noise | NA | NA | x | x |
| ISO 389-7 | Calibration of Free Field Audiometers | NA | NA | x | x |
| IEC 60601-1 2nd edition 1988 | Medical Electrical Equipment Part1: General Requirements for Safety | x | x | x | x |
| IEC 60601-1-2 3rd edition 2007 | Medical Electrical Equipment Part1-2: General Requirements for Basic Safety and Essential Performance-Collateral Standard: Electromagnetic Compatibility - Requirements and Tests | x | x | x | x |
| ISO 8253-1 | Audiometric Test Methods Part1; Basic Pure Tone Air and Bone Conduction Threshold Audiometry | x | x | x | x |
| ISO 8253-2 | Audiometric Test Methods Part 2; Sound Field Audiometry with Pure Tone and Narrow Band Test Signals | NA | NA | x | x |
| ISO 8253-3 | Audiometric Test Methods Part 3 Speech Audiometry | NA | NA | NA | x |
.
NA = Not Applicable
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Indication for use. 4
The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss.
The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to understand the basic principles of the test method when explained by the operator.
5 Summary of Performance Comparison between SA 204 and Interacoustic AD 229b (predicate) and GSI 61 (predicate)
The predicates selected for the SE discussion in this 510(k) are the Interacoustic Diagnostic Audiometer AD229b and GSI 61 Clinical Audiometer. The technical features of the SA204 are very similar to the Interacoustic AD 229b. However, the technical design using two separate, identical channels differs between the SA204 and the Interacoustic AD 229. The SA204 has 2 identical channels. By adding another predicate to the SE discussion that also has 2 identical channels, the GSI 61, it is shown that the technical solution to use two identical channels is well known and accepted.
Similarities between the predicates are presented in Tables 1a-1d and differences between the predicates are presented in Tables 2a - 2d.
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| ComparisonParameter | SA204 | Interacoustic AD229b | GSI 61 |
|---|---|---|---|
| Intended use | "The Entomed SA201/202/203/204 series ofaudiometers are screening(201/202) and diagnostic(203/204) audiometers usedto determine hearingthresholds and assist todiagnose hearing lossThe audiometer can be usedon the majority of adultsand children (from 4 yearsof age and upwards). Thetest person has to be able tounderstand the basicprinciples of the test methodwhen explained by theoperator" | "The Interacoustic Model AD229Diagnostic Audiometer is indicatedfor use in conducting diagnostichearing evaluations and assistingin the diagnosis of possibleotologic disorders.Because of its master hearing aidcapability this device is alsoindicated for simulating a hearingaid during audiometric testing thusit may help in the selection andadjustment of a patient's hearingaid". (statement obtained from510(k) summary from 510(k)application K982249) | Determine hearing thresholds andassist to diagnose hearing loss. Itcan also be used in the selectionand adjustment of a patient'shearing aid. |
| AirConductionPure Tone -FrequencyRange andFormat | Range:125, 250, 500, 750, 1000,1500, 2000, 3000, 4000,6000, 8000 HzFormat:Steady,Pulsed (2.5 pulses/sec),Frequency Modulation(Warble: ± 5 % triangular10 Hz at 8 kHz, 8 Hz at 6kHz and 5 Hz at 125 Hz - 4kHz) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz.Format:Steady,Multiple Pulses (250-5000 msec.on/off),Frequency Modulation (Warble: ±5 % , 5Hz true sine wave) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz).Format:Steady,Pulsed (Tone pulsed 200 msec ON,200 msec OFF),Frequency Modulation (Tonemodulated ± 5 % of centrefrequency at a rate of 5 Hz) |
| BoneConduction -FrequencyRange | 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000,8000 Hz | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz |
| Narrow BandNoise Range | 125, 250, 500, 750, 1000,1500, 2000, 3000, 4000,6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| Speech NoiseRange | 125, 250, 500, 750, 1000,1500, 2000, 3000, 4000,6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| SynchronousMasking | Locks the noise attenuatorto the tone attenuator | Locks channel 2 attenuator tochannel 1 attenuator | Locks the noise attenuator to thetone attenuator |
| SpeechChannel L andR | Microphone: Input for livespeech testing andcommunicationsIN1 and IN2: Inputs forrecorded speech materialfrom external stereoCD/tape player | Microphone: Input for live speechtesting and communicationsChannel 1 and Channel 2: Inputsfor 2 channels for prerecordedmaterialSpeech Noise: Narrow Band noiseor White noise | Microphone: Input for live speechtesting and communicationsExternal A and External B:Accepts recorded speech materialfrom external stereo tape cassetteor CD playerSpeech Noise: White noise |
| Table 1a Similarities between SA204 and Interacoustic AD229b and GSI 61 | |||||||
|---|---|---|---|---|---|---|---|
| ------------------------------------------------------------------------- | -- | -- | -- | -- | -- | -- | -- |
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1
:
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| Speech Noise: White noisefiltered to a low and middlefrequency band, simulatingthe average spectrum ofconversational speech | |||
|---|---|---|---|
| CommunicationOperator/Testsubject | Talk Forward, Talk backand Monitor / Live Speechmonitor headset | Talk Forward, Talk back andMonitor / Live Speech monitorheadset | Talk Forward, Talk back andMonitor / Live Speech monitorheadset |
| Transducers | TDH39,EARTone 5A,Sennheiser HDA 200,Radioear B71 bone vibrator | TDH39,EARTone 5A,Sennheiser HDA 200,Radioear B71 bone vibrator | TDH50P,EARTone 3A,Single Insert Phone $(470 \Omega)$Sennheiser HDA 200,Radioear B71 bone vibrator |
| TonePresentation | ManualSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation |
| Patient signal | Test subject response switchpush button | Reed switch push button | Subject response hand switch |
| StoreFunction: | Internal Memory for ACL/R and BC L/R | Internal Memory for AC L/R andBC L/R and full speech curve | No internal memory for either ACL/R, BC L/R or speech curve |
| Test: AutoThreshold | Patient controlled HughsonWestlake procedureaccording to ISO 8253-1 | Patient controlled HughsonWestlake procedure according toISO 8253-1 or OSHA procedurewith automatic re-check (USedition only) | No auto threshold functionavailable |
| ComparisonParameter | SA203 | Interacoustic AD229b | GSI 61 |
| Intended use | "The Entomed SA201/202/203/204 series ofaudiometers are screening(201/202) and diagnostic(203/204) audiometers usedto determine hearingthresholds and assist todiagnose hearing lossThe audiometer can be usedon the majority of adultsand children (from 4 yearsof age and upwards). Thetest person has to be able tounderstand the basicprinciples of the test methodwhen explained by theoperator" | "The Interacoustic Model AD229Diagnostic Audiometer is indicatedfor use in conducting diagnostichearing evaluations and assistingin the diagnosis of possibleotologic disorders.Because of its master hearing aidcapability this device is alsoindicated for simulating a hearingaid during audiometric testing thusit may help in the selection andadjustment of a patient's hearingaid". | Determine hearing thresholds andassist to diagnose hearing loss. Itcan also be used in the selectionand adjustment of a patient'shearing aid. |
| AirConductionPure Tone -FrequencyRange andFormat | Range:125, 250, 500, 750, 1000,1500, 2000, 3000, 4000,6000, 8000 HzFormat:Steady,Pulsed (2.5 pulses/sec),Frequency Modulation(Warble: ± 5 % triangular10 Hz at 8 kHz, 8 Hz at 6kHz and 5 Hz at 125 Hz - 4kHz) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 HzFormat:Steady,Multiple Pulses (250-5000 msec.on/off ),Frequency Modulation (Warble: ±5 % , 5Hz true sine wave) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz).Format:Steady,Pulsed (Tone pulsed 200 msec ON,200 msec OFF),Frequency Modulation (Tonemodulated ± 5 % of centrefrequency at a rate of 5 Hz) |
| BoneConduction -FrequencyRange | 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000,8000 Hz | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz |
| Narrow BandNoise Range | 125, 250, 500, 750, 1000,1500, 2000, 3000, 4000,6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| Speech NoiseRange | Speech Noise not available | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| SynchronousMasking | Locks the noise attenuatorto the tone attenuator | Locks channel 2 attenuator tochannel 1 attenuator | Locks the noise attenuator to thetone attenuator |
| SpeechChannel L andR | Speech Channels L and Rare not available | Microphone: Input for live speechtesting and communicationsChannel 1 and Channel 2: Inputs | Microphone: Input for live speechtesting and communicationsExternal A and External B: |
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Table 1b. Similarities between SA203 and Interacoustic AD 229b and GSI 61
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| materialSpeech Noise: Narrow Band noiseor White noise | from external stereo tape cassetteor CD playerSpeech Noise: White noise | ||
|---|---|---|---|
| CommunicationOperator/Testsubject | Talk Forward | Talk Forward, Talk back andMonitor / Live Speech monitorheadset | Talk Forward, Talk back andMonitor / Live Speech monitorheadset |
| Transducers | TDH39,EARTone 5A,Sennheiser HDA 200,Radioear B71 bone vibrator | TDH39,EARTone 5A,Sennheiser HDA 200,Radioear B71 bone vibrator | TDH50P,EARTone 3A,Single Insert Phone (470 Ω )Sennheiser HDA 200,Radioear B71 bone vibrator |
| TonePresentation | ManualSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation |
| Patient signal | Test subject response switchpush button | Reed switch push button | Subject response hand switch |
| StoreFunction: | Internal Memory for ACL/R and BC L/R | Internal Memory for AC L/R andBC L/R and full speech curve | No internal memory for either ACL/R, BC L/R or speech curve |
| Test: AutoThreshold | Patient controlled HughsonWestlake procedureaccording to ISO 8253-1 | Patient controlled HughsonWestlake procedure according toISO 8253-1 or OSHA procedurewith automatic re-check (USedition only) | No auto threshold functionavailable |
| ComparisonParameter | SA202 | Interacoustic AD229b | GSI 61 |
| Intended use | "The Entomed SA201/202/203/204 series ofaudiometers are screening(201/202) and diagnostic(203/204) audiometers usedto determine hearingthresholds and assist todiagnose hearing lossThe audiometer can be usedon the majority of adultsand children (from 4 yearsof age and upwards). Thetest person has to be able tounderstand the basicprinciples of the test methodwhen explained by theoperator" | "The Interacoustic Model AD229Diagnostic Audiometer is indicatedfor use in conducting diagnostichearing evaluations and assistingin the diagnosis of possibleotologic disorders.Because of its master hearing aidcapability this device is alsoindicated for simulating a hearingaid during audiometric testing thusit may help in the selection andadjustment of a patient's hearingaid". | Determine hearing thresholds andassist to diagnose hearing loss. Itcan also be used in the selectionand adjustment of a patient'shearing aid. |
| AirConductionPure Tone -FrequencyRange andFormat | Range:125, 250, 500, 750, 1000,1500, 2000, 3000, 4000,6000, 8000 HzFormat:Steady,Pulsed (2.5 pulses/sec),Frequency Modulation(Warble: ± 5 % triangular10 Hz at 8 kHz, 8 Hz at 6kHz and 5 Hz at 125 Hz - 4kHz) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 HzFormat:Steady,Multiple Pulses (250-5000 msec.on/off ),Frequency Modulation (Warble: ±5 % , 5Hz true sine wave) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz).Format:Steady,Pulsed (Tone pulsed 200 msec ON,200 msec OFF),Frequency Modulation (Tonemodulated ± 5 % of centrefrequency at a rate of 5 Hz) |
| BoneConduction -FrequencyRange | Bone conduction notavailable | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz |
| Narrow BandNoise Range | Narrow Band Noise notavailable | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| Speech NoiseRange | Speech Noise not available | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| SynchronousMasking | Synchronous Masking notavailable | Locks channel 2 attenuator tochannel 1 attenuator | Locks the noise attenuator to thetone attenuator |
| SpeechChannel L andR | Speech Channel L and R notavailable | Microphone: Input for live speechtesting and communicationsChannel 1 and Channel 2: Inputsfor 2 channels for prerecorded | Microphone: Input for live speechtesting and communicationsExternal A and External B:Accepts recorded speech material |
| materialSpeech Noise: Narrow Band noiseor White noise | from external stereo tape cassetteor CD playerSpeech Noise: White noise | ||
| CommunicationOperator/Testsubject | Talk Forward | Talk Forward, Talk back andMonitor / Live Speech monitorheadset | Talk Forward, Talk back andMonitor / Live Speech monitorheadset |
| Transducers | TDH39,EARTone 5A,Sennheiser HDA 200 | TDH39,EARTone 5A,Sennheiser HDA 200,Radioear B71 bone vibrator | TDH50P,EARTone 3A,Single Insert Phone (470 Ω )Sennheiser HDA 200,Radioear B71 bone vibrator |
| TonePresentation | ManualSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation |
| Patient signal | Test subject response switchpush button | Reed switch push button | Subject response hand switch |
| StoreFunction: | Internal Memory for ACL/R | Internal Memory for AC L/R andBC L/R and full speech curve | No internal memory for either ACL/R, BC L/R or speech curve |
| Test: AutoThreshold | Patient controlled HughsonWestlake procedureaccording to ISO 8253-1 | Patient controlled HughsonWestlake procedure according toISO 8253-1 or OSHA procedurewith automatic re-check (US edition only) | No auto threshold functionavailable |
| ComparisonParameter | SA201 | Interacoustic AD229b | GSI 61 |
| Intended use | "The Entomed SA201/202/203/204 series ofaudiometers are screening(201/202) and diagnostic(203/204) audiometers usedto determine hearingthresholds and assist todiagnose hearing lossThe audiometer can be usedon the majority of adultsand children (from 4 yearsof age and upwards). Thetest person has to be able tounderstand the basicprinciples of the test methodwhen explained by theoperator" | "The Interacoustic Model AD229Diagnostic Audiometer is indicatedfor use in conducting diagnostichearing evaluations and assistingin the diagnosis of possibleotologic disorders.Because of its master hearing aidcapability this device is alsoindicated for simulating a hearingaid during audiometric testing thusit may help in the selection andadjustment of a patient's hearingaid". | Determine hearing thresholds andassist to diagnose hearing loss. Itcan also be used in the selectionand adjustment of a patient'shearing aid. |
| AirConductionPure Tone -FrequencyRange andFormat | Range:125, 250, 500, 750, 1000,1500, 2000, 3000, 4000,6000, 8000 HzFormat:Steady,Pulsed (2.5 pulses/sec),Frequency Modulation(Warble: ± 5 % triangular10 Hz at 8 kHz, 8 Hz at 6kHz and 5 Hz at 125 Hz - 4kHz) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 HzFormat:Steady,Multiple Pulses (250-5000 msec.on/off ),Frequency Modulation (Warble: ±5 % , 5Hz true sine wave) | Range:125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz).Format:Steady,Pulsed (Tone pulsed 200 msec ON,200 msec OFF),Frequency Modulation (Tonemodulated ± 5 % of centrefrequency at a rate of 5 Hz) |
| BoneConduction -FrequencyRange | Bone conduction notavailable | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz | 250, 500, 750, 1000, 1500, 2000,3000, 4000, 6000, 8000 Hz |
| Narrow BandNoise Range | Narrow Band Noise notavailable | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| Speech NoiseRange | Speech Noise not available | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000 Hz | 125, 250, 500, 750, 1000, 1500,2000, 3000, 4000, 6000, 8000,12000 Hz(High frequency as "Optionalaccessories" 8000 Hz to 20 000Hz) |
| SynchronousMasking | Synchronous Masking notavailable | Locks channel 2 attenuator tochannel 1 attenuator | Locks the noise attenuator to thetone attenuator |
| SpeechChannel L andR | Speech Channel L and R notavailable | Microphone: Input for live speechtesting and communicationsChannel 1 and Channel 2: Inputsfor 2 channels for prerecorded | Microphone: Input for live speechtesting and communicationsExternal A and External B:Accepts recorded speech material |
| materialSpeech Noise: Narrow Band noiseor White noise | from external stereo tape cassetteor CD playerSpeech Noise: White noise | ||
| CommunicationOperator/Testsubject | Talk Forward | Talk Forward, Talk back andMonitor / Live Speech monitorheadset | Talk Forward, Talk back andMonitor / Live Speech monitorheadset |
| Transducers | TDH39,EARTone 5A,Sennheiser HDA 200 | TDH39,EARTone 5A,Sennheiser HDA 200,Radioear B71 bone vibrator | TDH50P,EARTone 3A,Single Insert Phone (470 Ω )Sennheiser HDA 200,Radioear B71 bone vibrator |
| TonePresentation | ManualSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation | Manual or ReverseSingle PulseMultiple PulsesFrequency Modulation |
| Patient signal | Test subject response switchpush button | Reed switch push button | Subject response hand switch |
| StoreFunction: | Internal Memory for oneAC L/R audiogram | Internal Memory for AC L/R andBC L/R and full speech curve | No internal memory for eitherL/R, BC L/R or speech curve |
| Test: AutoThreshold | Auto threshold not available | Patient controlled HughsonWestlake procedure according toISO 8253-1 or OSHA procedurewith automatic re-check (USedition only) | No auto threshold functionavailable |
: :
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Table 1c. Similarities between SA202 and Interacoustic AD 229b and GSI 61
{9}------------------------------------------------
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:
and the comments of the comments of the comments of the comments of
{10}------------------------------------------------
.
Table 1d. Similarities between SA201 and Interacoustic AD 229b and GSI 61
{11}------------------------------------------------
and the comments of the comments of the comments of the comments of
:
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{12}------------------------------------------------
| Table 2a Differences between SA204 and Interacoustic AD229b and GSI 61 |
|---|
| Comparison Parameter | SA204 | Interacoustic AD229b | GSI 61 |
|---|---|---|---|
| Masking | White Noise and | White Noise available. | White Noise and Routing of |
| -White Noise | Routing of masking | Routing of masking not | Masking |
| -Routing of masking | not available | available | available |
| Frequency Selection | Any frequency can be | 125, 250, 750, 1500 Hz | No frequency can be deselected |
| deselected | or 8kHz can be | ||
| deselected | |||
| Tone Presentation | Not Available | Available | Available |
| -Reverse Tone | |||
| Routing possibilities | No routingpossibilities | No routing possibilities | Routing possibilities available |
| High Frequency | Not Available | Not Available | Available at 9, 10, 11.2, 12.5, 14,16, 18, 20 kHz |
| Digital Signal Generator | Yes | No | No |
| CF Card and Calibration Card | Yes | No | No |
| Display audiograms on Front | No | No | Yes |
| Display | |||
| Compatible Windows Software | AudiMax II | OtoAccess™ Databaseand diagnostic modulessoftwarePrintView,Interacoustics databaseand diagnostic modules,NOAH | Audi-Link Audiometer driver forNOAH |
| Internal Memory for full | Not Available | Available | Available |
| speech curve | |||
| Tests | SISI, ALT, ABLB, | SISI, ALT and High | SISI, ALT and High Frequency are |
| -SISI | Stenger, Stenger | Frequency are not | available. |
| -ALT | Speech and High | available. | ABLB, Stenger and Stenger |
| -ABLB | Frequency are not | ABLB, Stenger and | Speech are not available. |
| -Stenger | available | Stenger Speech are | |
| -Stenger Speech | available. | ||
| -High Frequency | |||
| 2 identical channels | Yes | No | Yes |
| Dimensions (LxWxH) | 37.6x26.4x7.3 cm | 36x26x10 cm | 50x39x32 cm |
| Weight | 1.25 kg | 1.8 kg | 8.7 kg |
| Power Supply | External, 100-240 V | External, 100-115 V or230 V | Internal Power Supply |
| Power Consumption | 15 W | 40 W | 90 W |
| Attenuator Controls | 1 HL rotary controlfor test signalintensity and 1 HLrotary control for | 1 HL rotary control forchannel 1 and 1 HLrotary control forchannel 2 | - 2 independent HL rotary controlsfor test signal and maskingintensity-push buttons that allows intensity |
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| Comparison Parameter | SA203 | Interacoustic AD229b | GSI 61 |
|---|---|---|---|
| Masking | White Noise and | White Noise available. | White Noise and Routing of |
| -White Noise | Routing of masking | Routing of masking not | Masking |
| -Routing of masking | not available | available | available |
| Frequency Selection | Any frequency can bedeselected | 125, 250, 750, 1500 Hzor 8kHz can bedeselected | No frequency can be deselected |
| Tone Presentation | Not Available | Available | Available |
| -Reverse Tone | |||
| Routing possibilities | No routingpossibilities | No routing possibilities | Routing possibilities available |
| High Frequency | Not Available | Not Available | Available at 9, 10, 11.2, 12.5, 14,16, 18, 20 kHz |
| Digital Signal Generator | Yes | No | No |
| CF Card and Calibration Card | Yes | No | No |
| Display audiograms on FrontDisplay | No | No | Yes |
| Compatible Windows Software | AudiMax II | OtoAccess™ Databaseand diagnostic modulessoftwarePrintView,Interacoustics databaseand diagnostic modules,NOAH | Audi-Link Audiometer driver forNOAH |
| Internal Memory for fullspeech curve | Not Available | Available | Available |
| Tests | SISI, ALT, ABLB,Stenger, StengerSpeech and HighFrequency are notavailable | SISI, ALT and HighFrequency are notavailable.ABLB, Stenger andStenger Speech areavailable. | SISI, ALT and High Frequency areavailable.ABLB, Stenger and StengerSpeech are not available. |
| -SISI | |||
| -ALT | |||
| -ABLB | |||
| -Stenger | |||
| -Stenger Speech | |||
| -High Frequency | |||
| 2 identical channels | Yes | No | Yes |
| Dimensions (LxWxH) | 37.6x26.4x7.3 cm | 36x26x10 cm | 50x39x32 cm |
| Weight | 1.15 kg | 1.8 kg | 8.7 kg |
| Power Supply | External, 100-240 V | External, 100-115 V or230 V | Internal Power Supply |
| Power Consumption | 15 W | 40 W | 90 W |
| Attenuator Controls | 1 HL rotary controlfor test signalintensity and 1 HLrotary control formasking intensity | 1 HL rotary control forchannel 1 and 1 HLrotary control forchannel 2 | - 2 independent HL rotary controlsfor test signal and maskingintensity-push buttons that allows intensitystep size of 1, 2 or 5 dB |
,
·
Table 2b Differences between SA203 and Interacoustic AD229b and GSI 61
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| Comparison Parameter | SA202 | Interacoustic AD229b | GSI 61 |
|---|---|---|---|
| Masking | White Noise and | White Noise available. | White Noise and Routing of |
| -White Noise | Routing of masking | Routing of masking not | Masking |
| -Routing of masking | not available | available | available |
| Frequency Selection | Any frequency can be | 125, 250, 750, 1500 Hz | No frequency can be deselected |
| deselected | or 8kHz can be | ||
| deselected | |||
| Tone Presentation | Not Available | Available | Available |
| -Reverse Tone | |||
| Routing possibilities | No routingpossibilities | No routing possibilities | Routing possibilities available |
| High Frequency | Not Available | Not Available | Available at 9, 10, 11.2, 12.5, 14, |
| 16, 18, 20 kHz | |||
| Digital Signal Generator | Yes | No | No |
| CF Card and Calibration Card | Yes | No | No |
| Display audiograms on Front | No | No | Yes |
| Display | |||
| Compatible Windows Software | AudiMax II | OtoAccessTM Database | Audi-Link Audiometer driver for |
| and diagnostic modules | NOAH | ||
| software | |||
| PrintView, | |||
| Interacoustics database | |||
| and diagnostic modules, | |||
| NOAH | |||
| Internal Memory for full | Not Available | Available | Available |
| speech curve | |||
| Tests | SISI, ALT, ABLB, | SISI, ALT and High | SISI, ALT and High Frequency are |
| -SISI | Stenger, Stenger | Frequency are not | available. |
| -ALT | Speech and High | available. | ABLB, Stenger and Stenger |
| -ABLB-Stenger | Frequency are not | ABLB, Stenger and | Speech are not available. |
| -Stenger Speech | available | Stenger Speech are | |
| -High Frequency | available. | ||
| 2 identical channels | Yes | No | Yes |
| Dimensions (LxWxH) | 37.6x26.4x7.3 cm | 36x26x10 cm | 50x39x32 cm |
| Weight | 1.15 kg | 1.8 kg | 8.7 kg |
| Power Supply | External, 100-240 V | External, 100-115 V or | Internal Power Supply |
| 230 V | |||
| Power Consumption | 15 W | 40 W | 90 W |
| Attenuator Controls | 1 HL rotary control | 1 HL rotary control for | - 2 independent HL rotary controls |
| for test signal | channel 1 and 1 HL | for test signal and masking | |
| intensity and 1 HL | rotary control for | intensity | |
| rotary control for | channel 2 | -push buttons that allows intensity | |
| masking intensity | step size of 1, 2 or 5 dB |
.
:
:
Table 2c Differences between SA202 and Interacoustic AD229b and GSI 61
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| Comparison Parameter | SA201 | Interacoustic AD229b | GSI 61 |
|---|---|---|---|
| Masking | White Noise and | White Noise available. | White Noise and Routing of |
| -White Noise | Routing of masking | Routing of masking not | Masking |
| -Routing of masking | not available | available | available |
| Frequency Selection | Any frequency can be | 125, 250, 750, 1500 Hzor 8kHz can be | No frequency can be deselected |
| deselected | deselected | ||
| Tone Presentation | Not Available | Available | Available |
| -Reverse Tone | |||
| Routing possibilities | No routingpossibilities | No routing possibilities | Routing possibilities available |
| High Frequency | Not Available | Not Available | Available at 9, 10, 11.2, 12.5, 14,16, 18, 20 kHz |
| Digital Signal Generator | Yes | No | No |
| CF Card and Calibration Card | Yes | No | No |
| Display audiograms on FrontDisplay | No | No | Yes |
| Compatible Windows Software | AudiMax II | OtoAccess™ Databaseand diagnostic modulessoftwarePrintView,Interacoustics databaseand diagnostic modules,NOAH | Audi-Link Audiometer driver forNOAH |
| Internal Memory for fullspeech curve | Not Available | Available | Available |
| Tests | SISI, ALT, ABLB,Stenger, StengerSpeech and HighFrequency are notavailable | SISI, ALT and HighFrequency are notavailable.ABLB, Stenger andStenger Speech areavailable. | SISI, ALT and High Frequency areavailable.ABLB, Stenger and StengerSpeech are not available. |
| -SISI | |||
| -ALT | |||
| -ABLB | |||
| -Stenger | |||
| -Stenger Speech | |||
| -High Frequency | |||
| 2 identical channels | Yes | No | Yes |
| Dimensions (LxWxH) | 37.6x26.4x7.3 cm | 36x26x10 cm | 50x39x32 cm |
| Weight | 1.15 kg | 1.8 kg | 8.7 kg |
| Power Supply | External, 100-240 V | External, 100-115 V or230 V | Internal Power Supply |
| Power Consumption | 15 W | 40 W | 90 W |
| Attenuator Controls | 1 HL rotary controlfor test signalintensity and I HLrotary control formasking intensity | 1 HL rotary control forchannel 1 and 1 HLrotary control forchannel 2 | - 2 independent HL rotary controlsfor test signal and maskingintensity-push buttons that allows intensitystep size of 1, 2 or 5 dB |
:
Table 2d Differences between SA201 and Interacoustic AD229b and GSI 61
;
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Technical Design Differences between the SA204 and Predicates
6.1 Digital Signal Processor
6
The tone generator within the SA204 is a Digital Signal Processor. This might be different to the GSI 61 and the AD229b. Most audiometers operate by using an analog tone generator.
This may be a new way to produce a tone, at a certain frequency, within the field of audiometry. However the digital technique has been used within other competence areas for several years hence it is well-known and accepted (for example within computers, mp3-players, video-game consoles). Generating the frequency digitally is a modern way to produce a signal. The frequencies and SPL levels produced are such that they meet the demands of those described in the standard IEC 60645-1 and 60645-2.
6.2 CF Card and Calibration Card
The SA 201/202/203/204 uses a concept where part of the software necessary for operating the audiometer and calibrating the audiometer is stored on separate memory cards that can be attached and removed from the main board. These cards are here referred to as the Calibration CF Card and the CF Card. CF stands for Compact Flash. The CF Card contains the CPU and memory.
Traditionally EPROM has been used for control and storage of software version, set-up data, calibration data etc. Technically it is much more difficult to manipulate software on a CF Card than on an EPROM and hence the risks for unauthorized changes decreases when using the CF Cards.
Furthermore, by using one CF Card for calibration and another for operation of the audiometer, and restricting the access to the Calibration CF Card, the risk for calibration data being faulty/changed/altered is minimized.
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Image /page/17/Picture/0 description: The image shows the logo for the Department of Health & Human Services - USA. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around the perimeter. Inside the circle is an abstract image of an eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Entomed AB c/o Charlotte Mattisson, Ph.D. Quality Assurance and Regulatory Affairs Bariumgatan 29 SE-213 64 Malmö Sweden
OCT - 2 2009
Re: K092111
Trade/Device Name: Entomed SA201/202 Screening Audiometer and SA203/204 Diagnostic Audiometer
Regulation Number: 21 CFR 874.1050
Regulation Name: Audiometer Regulatory Class: II Product Code: EWO Dated: July 10, 2009 Received: July 14, 2009
Dear Dr. Mattisson:
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 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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set
{18}------------------------------------------------
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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH0ffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Malvina B. Eydelman, M. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indication for Use
510(k) Number (if known):
Device Name:
Entomed SA201/202 Screening Audiometer and SA203/204 Diagnostic Audiometer
Indication For Use:
The Entomed SA 201/202/203/204 series of audiometers are screening and diagnostic audiometers used to determine hearing thresholds and assist to diagnose hearing loss.
The audiometer can be used on the majority of adults and children (from 4 years of age and upwards). The test person has to be able to understand the basic principles of the test method when explained by the operator.
Prescription Use AND/OR Over-The Counter Use X (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation
Shullon hey
(Division Sign-Off)
Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number
× Prescription Use (Per 21 CFR 801.109)
§ 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.