(72 days)
The Madsen Zodiac (Type 1096) is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes. (Prescription Use).
The MADSEN Zodiac Type 1096 device is designed to measure and evaluate the acoustic impedance/admittance of the human ear by means of acoustic probe signals at different frequencies and with temporal characteristics. MADSEN Zodiac is a compact device for immittance testing. You can operate Zodiac as a stand-alone unit using the built-in keypad and display, or, if you are using the OTOsuite Immittance software module, you can operate Zodiac using the PC's keyboard and mouse with the OTOsuite Immittance module acting as the display. MADSEN Zodiac supports the following probes:
- The hand-held Quick Check probe
- The two diagnostic probe types, Classic and Comfort
- A contralateral insert phone or TDH-39.
Supported tests: Depending on the configuration, Zodiac supports the following tests and functionalities:
- Tympanometry
- Reflex Screening
- Reflex Threshold
- Reflex Decay
- ETF-I (Eustachian Tube Function - Intact)
- ETF-P (Eustachian Tube Function -Perforated)
- Admittance Recording (multiple uses, e.g. patulous Eustachian Tube evaluation, acoustic reflexes with external stimulus)
- Manual Tympanometry
This is a MODIFIED version of our previous model, the predicate device.
The document describes a 510(k) premarket notification for the "Madsen Zodiac Model 1096" auditory impedance tester. The acceptance criteria and supporting study information are derived from the comparison to the predicate device (OTOflex 100 Type 1012) and the non-clinical testing performed.
Here's a breakdown of the requested information:
1. Table of Acceptance Criteria and Reported Device Performance:
The acceptance criteria are generally established by meeting the technical specifications of the predicate device and adhering to recognized standards. The "Reported Device Performance" column reflects the specifications of the Madsen Zodiac 1096.
| Characteristic | Acceptance Criteria (Predicate: OTOflex 100 Type 1012) | Reported Device Performance (Madsen Zodiac 1096) |
|---|---|---|
| Compliance Measuring System | ||
| Probe tones: 226 Hz | 85dB SPL ± 1.5 dB | 85 dB SPL ± 3 dB |
| Probe tones: 1000 Hz | 75dB SPL ± 1.5 dB | 69 dB SPL ± 3 dB (New 678 Hz and 800 Hz tones also specified) |
| THD (probe tones) | < 3% in 2 cc | < 1% in 2 cc |
| Frequency accuracy (probe tones) | ± 0.5% | ± 0.5% |
| Range (ml) | 0.1 ml to 8.0 ml ± 5% or 0.1 ml, whichever is greater | 0.2 ml to 5.0 ml ± 5% or 0.05 ml whichever is greater, 5 ml to 8.0 ml ± 15% |
| Acoustic reflex Contralateral Stimulation | ||
| Pure tones | 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz | 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz (3000 Hz not used) |
| Frequency accuracy (pure tones) | ± 0.5% | Same as predicate |
| Noise | White Noise according to IEC 61027 | Broad Band Noise according to IEC 60645-5 |
| Range (BBN, LPN, HPN) | BBN, LPN at 50 to 100 dB SPL ± 3 dB, HPN at 50 to 95 dB SPL ± 3 dB | BBN, LPN, HPN at 50 to 110 dB SPL ± 3 dB |
| THD (Contralateral) | < 3% in 2 cc (measured 5 dB below max output) | < 5% for levels below 110 dB HL, < 10% for levels above 110 dB HL |
| Acoustic reflex Ipsilateral Stimulation | ||
| Pure tones | 500 Hz, 1000 Hz, 2000 Hz, 3000 Hz, 4000 Hz | 500 Hz, 1000 Hz, 2000 Hz, 4000 Hz (3000 Hz not used) |
| Noise | White Noise according to IEC 61027 | Broad Band Noise according to IEC 60645-5 |
| Range (1000 Hz) | 1000 Hz at 50 to 120 dB HL ± 3 dB | 1000 Hz at 50 to 110 dB HL ± 3 dB |
| Range (2000 Hz) | 2000 Hz at 50 to 115 dB HL ± 3 dB | 2000 Hz at 50 to 110 dB HL ± 3 dB |
| Range (4000 Hz) | 4000 Hz at 50 to 110 dB HL ± 3 dB | 4000 Hz at 50 to 100 dB HL ± 3 dB |
| THD (Ipsilateral) | < 3% in 2 cc (measured 5 dB below max output) | < 5% for levels below 110 dB HL, < 10% for levels above 110 dB HL |
| Air Pressure System | ||
| Pressure sweep rate | 50, 100, 200, 400 daPa/s, A.F.A.P | 50, 100, 200, 400, 600 daPa/s |
| Pressure accuracy | ±10% or ±10 daPa, whichever is greatest | Same as predicate |
| Safety (hardware) | Separate safety +530 daPa and -730 daPa. ±70 daPa | Same as predicate |
| Safety (software) | Software safety +450 daPa and -650 daPa. ±70 daPa. | Same as predicate |
| General | ||
| Display | Graphic 128x128 dots | 7 inch, 15:9 WVGA, Resolution: 800 x 480 pixel |
| Standards Compliance | Safety: ANSI/AAMI ES 60601-1 (2005), CAN/CSA -C22.2 NO 60601.1 (2008) | Same as predicate, but in latest edition (EN 60601-1) |
| EMC: EN 60601-1-2, EN 300 328-2, EN 301 489-17 | Same as predicate, but in latest edition (EN 60601-1-2) | |
| Impedance/Admittance: EN 61027 Type 1, ANSI S3.39 Type 1 | Same as predicate, but in latest edition (EN 60645-5, ANSI S3.39) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document explicitly states: "Testing consisted of mainly non-clinical performance testing of the device against the applicable parameters specified in the following standards." This indicates that testing was primarily bench testing against technical specifications and standards, rather than a clinical study with a "test set" of patient data. Therefore, details regarding sample size, country of origin, or retrospective/prospective nature of a clinical test set are not applicable/provided.
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)
Given that the testing was non-clinical performance testing against standards and product specifications, there was no requirement for human experts to establish "ground truth" in the clinical sense for a test set. The ground truth was the established parameters within the cited industry standards (e.g., IEC 60601-1, EN 60645-5, ANSI S3.39) and the internal product specifications.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable, as there was no clinical test set requiring adjudication.
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 auditory impedance tester, which measures physical parameters of the ear. It does not involve AI for interpretation or human "readers" in the context of image analysis or similar tasks where MRMC studies are typically employed.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This refers to the performance of the device itself (algorithm only) without human intervention in operating the device or interpreting its direct output that is not supported by the device itself using its internal software. The submitted "non-clinical performance testing of the device against the applicable parameters specified in the following standards" (Section 7 and the comparison table) serves as this standalone performance evaluation. The device generates measurements and displays them, and its accuracy in doing so was assessed.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth for the non-clinical performance testing was based on:
- Established industry standards: such as IEC 60601-1, IEC 60601-1-2, EN/IEC 60645-5, and ANSI S3.39. These standards define the acceptable performance limits and measurement methodologies for auditory impedance testers.
- Manufacturer's own product specifications: The device was tested to assure compliance with the internal product specifications, which are detailed in the comparative table in Section 5.
8. The sample size for the training set
Not applicable. This device is a measurement instrument, not an AI/machine learning system that requires a "training set" in the conventional sense. Its functionality is based on established physical principles and calibrated measurements, not learned patterns from data.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract image of three human profiles facing to the right, stacked on top of each other. The profiles are stylized with flowing lines, giving the impression of movement or progress.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 1, 2016
Gn Otometrics Mr. Daniel Kamm Principal Engineer Kamm & Associates 8870 Ravello Ct. Naples, FL 34114
Re: K161707
Trade/Device Name: Madsen Zodiac Regulation Number: 21 CFR 874.1090 Regulation Name: Auditory Impedance Tester Regulatory Class: Class II Product Code: ETY Dated: August 4, 2016 Received: August 9, 2016
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
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with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801 and Part 809), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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/MedicalDevices/Safety/ReportaProblem/default.htm 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours.
Eric A. Mann -S
for 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
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Indications for Use
510(k) Number (if known) K161707
Device Name Madsen Zodiac Model 1096 (SA or PC)
Indications for Use (Describe)
The Madsen Zodiac (Type 1096) is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) | ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(K) Summary, 510(k) K161707 Submitter: GN Otometrics A/S Hoerskaetten 9 Taastrup, DENMARK DK-2630 Registration number: 9612197 Tel : +45 45 75 55 55 Fax: +45 45 75 55 59 Contact: Asif Muhammad, Global Director RA/QA Date Prepared: June 16, 2016
| 1. | Identification of the Device: | 510(k) Number K161707 |
|---|---|---|
| Proprietary-Trade Name: | Madsen Zodiac 1096 (SA or PC) | |
| Common Name: | Tester, Auditory Impedance | |
| Classification Name: | Auditory impedance tester. | |
| Product Code: | ETY | |
| Regulation Number | 874.1090 |
-
- Equivalent legally marketed device: 510(K) Number. K033645
| Proprietary-Trade Name: | OTOflex 100 Type 1012, GN Otometrics A/S. |
|---|---|
| Common Name: | Tester, Auditory Impedance |
| Classification Name: | Auditory impedance tester. |
| Product Code: | ETY |
| Regulation Number | 874.1090 |
-
- Description of the Device: The MADSEN Zodiac Type 1096 device is designed to measure and evaluate the acoustic impedance/admittance of the human ear by means of acoustic probe signals at different frequencies and with temporal characteristics. MADSEN Zodiac is a compact device for immittance testing. You can operate Zodiac as a stand-alone unit using the built-in keypad and display, or, if you are using the OTOsuite Immittance software module, you can operate Zodiac using the PC's keyboard and mouse with the OTOsuite Immittance module acting as the display. MADSEN Zodiac supports the following probes:
- The hand-held Quick Check probe
- The two diagnostic probe types, Classic and Comfort
- A contralateral insert phone or TDH-39.
Supported tests: Depending on the configuration, Zodiac supports the following tests and functionalities:
- Tympanometry
- · Reflex Screening
- Reflex Threshold
- · Reflex Decay
• ETF-I (Eustachian Tube Function - Intact) • ETF-P (Eustachian Tube Function -Perforated)
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- Admittance Recording (multiple uses, e.g. patulous Eustachian Tube evaluation, acoustic reflexes with external stimulus)
- Manual Tympanometry
This is a MODIFIED version of our previous model, the predicate device.
-
- Indications for Use (intended use): The Madsen Zodiac (Type 1096) is an auditory impedance tester that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. This device is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing for intact and perforated tympanic membranes. (Prescription Use).
-
- Technological Characteristics. This device has the same indications for use as the predicate device and employs similar technology to accomplish the same tasks. Modifications to the cleared device are not substantial and do not change the operating principles of the device. The intended use and fundamental technological characteristics remain the same as the predicate device and modifications do not affect the safety or effectiveness of the device.
| Characteristic | K033645, OTOflex 100 Type 1012,GN Otometrics A/S. | K161707 Madsen Zodiac 1096GN Otometrics A/S |
|---|---|---|
| Intended Use: | The OTOflex 100 Type 1012 is anauditory impedance tester that isintended to change the air pressure inthe external auditory canal and measureand graph the mobility characteristics ofthe tympanic membrane to evaluate thefunctional condition of the middle ear.This device is also used to measure theacoustic reflex threshold and decaytesting as well as eustachian tubefunction testing for intact andperforated tympanic membranes.(Prescription Use). | The Madsen Zodiac (Type 1096) is anauditory impedance tester that isintended to change the air pressure inthe external auditory canal and measureand graph the mobility characteristics ofthe tympanic membrane to evaluate thefunctional condition of the middle ear.This device is also used to measure theacoustic reflex threshold and decaytesting as well as eustachian tubefunction testing for intact andperforated tympanic membranes.(Prescription Use). (SAME) |
| User population | Audiologists, ENTs and other healthcare professionals in testing thehearing of infants, children andadults. | Same as predicate |
| Distribution | ENT Doctors, Audiologists andprofessional Hearing Aid dispensers. | Same as predicate |
| Energy delivered | Acoustic stimuli:Air pressure stimuli -600daPa to+400daPa | Same as predicate |
| Characteristic | K033645, OTOflex 100 Type 1012,GN Otometrics A/S. | K161707 Madsen Zodiac 1096GN Otometrics A/S |
| Where used | Hospitals, private clinics and HearingAid dispensers | Same as predicate |
| Instructions | The predicate devices functionality iscovered by a user's manual. | Same as predicate |
| Compliancemeasuring systemProbe tones | 226 Hz at 85dB SPL $\pm$ 1.5 dB1000Hz at 75dB SPL $\pm$ 1.5 dBTHD: < 3% in 2 ccFrequency accuracy: $\pm$ 0.5%Range: 0.1 ml to 8.0 ml $\pm$ 5% or 0.1 ml,whichever is greater | 226 Hz at 85 dB SPL $\pm$ 3 dB678 Hz at 72 dB SPL $\pm$ 3 dB800 Hz at 70.5 dB SPL $\pm$ 3 dB1000 Hz at 69 dB SPL $\pm$ 3 dBTHD: < 1% in 2 ccFrequency accuracy: $\pm$ 0.5%Range: 0.2 ml to 5.0 ml $\pm$ 5% or 0.05 mlwhich ever is greater, 5 ml to 8.0 ml $\pm$15% |
| Acoustic reflexContralateralStimulation | Pure tones: 500 Hz, 1000 Hz, 2000Hz, 3000 Hz, 4000 HzFrequency accuracy: $\pm$ 0.5%Noise White Noise according to IEC61027Low Pass 400 to 1600 Hz.High Pass 1600 to 4000 Hz.Roll off >12 dB/Octave.Range at: BBN, LPN at 50 to 100 dBSPL $\pm$ 3 dB, HPN at 50 to 95 dB SPL $\pm$ 3dBStep size dB 1, 2, 5, 10 dBE-A-RTONE ® 3A:Range at: 500 Hz at 50 to 105 dB HL $\pm$3 dB1000 Hz at 50 to 120 dB HL $\pm$ 3 dB2000 Hz at 50 to 115 dB HL $\pm$ 3 dB3000 Hz at 50 to 105 dB HL $\pm$ 3 dB4000 Hz at 50 to 110 dB HL $\pm$ 3 dBTHD: < 3% in 2 cc (measured 5 dBbelow max output) | Same as predicateSame as predicateBroad Band Noise according to IEC60645-5Low Pass: TDH-39: 250 - 1600 Hz,Insert: 400 - 1600 Hz.High Pass: TDH-39: 1600 - 6000 Hz,Insert: 1600 - 4000 Hz.Same as predicateRange: BBN, LPN, HPN at 50 to 110dB SPL $\pm$ 3 dBSame as predicateContralateral insert phone:Range: 500 Hz at 50 to 115 dB HL $\pm$ 3dBSame as predicate2000 Hz at 50 to 120 dB HL $\pm$ 3 dBFrequency not used4000 Hz at 50 to 120 dB HL $\pm$ 3 dBTHD: < 5% for levels below 110 dB HL,< 10% for levels above 110 dB HLContralateral TDH-39 phone:500 Hz at 50 to 115 dB HL $\pm$ 3 dB1000 Hz at 50 to 120 dB HL $\pm$ 3 dB2000 Hz at 50 to 115 dB HL $\pm$ 3 dB |
| Characteristic | K033645, OTOflex 100 Type 1012,GN Otometrics A/S. | K161707 Madsen Zodiac 1096GN Otometrics A/S |
| 4000 Hz at 50 to 115 dB HL ± 3 dB | ||
| < 2.5 % for levels below 110 dB HL | ||
| < 5 % for levels above 110 dB HL | ||
| IpsilateralStimulation | Tone: 500 Hz, 1000 Hz, 2000 Hz, 3000Hz, 4000 Hz | Tone: 500 Hz, 1000 Hz, 2000 Hz, 4000Hz |
| Frequency accuracy: ± 0.5% | Same as predicate | |
| Noise White Noise according to IEC61027 | Broad Band Noise according to IEC60645-5 | |
| Low Pass 400 to 1600 Hz | Same as predicate | |
| High Pass 1600 to 4000 Hz | Same as predicate | |
| Roll off >12 dB/Octave | Same as predicate | |
| Step size dB: 1, 2, 5, 10 dB | Same as predicate | |
| Range at: 500 Hz at 50 to 105 dB HL ±3 dB | Same as predicate | |
| 1000 Hz at 50 to 120 dB HL ± 3 dB | 1000 Hz at 50 to 110 dB HL ± 3 dB | |
| 2000 Hz at 50 to 115 dB HL ± 3 dB | 2000 Hz at 50 to 110 dB HL ± 3 dB | |
| 3000 Hz at 50 to 105 dB HL ± 3 dB | Frequency not used | |
| 4000 Hz at 50 to 110 dB HL ± 3 dB | 4000 Hz at 50 to 100 dB HL ± 3 dB | |
| THD: < 3% in 2 cc (measured 5 dBbelow max output) | THD: < 5% for levels below 110 dB HL,< 10% for levels above 110 dB HL | |
| Air pressuresystem | Range: Normal +200 to -400 daPa/s.Extended +400 to -600 daPa/s | Same as predicate |
| Pressure sweep rate: 50, 100, 200,400 daPa/s, A.F.A.P | Pressure sweep rate: 50, 100, 200,400, 600 daPa/s | |
| Pressure accuracy: ±10% or ±10 daPa,whichever is greatest | Same as predicate | |
| Pump measure direction: Positive tonegative or negative to positive | Same as predicate | |
| Safety: Separate safety +530 daPaand -730 daPa. ±70 daPa | Same as predicate | |
| Software safety +450 daPa and -650daPa. ±70 daPa. | Same as predicate | |
| Manual control of pressure | ||
| Graph units | Unit of admittance graph Y-axis: ml,cc, mmho, µl | Same as predicate |
| Unit of graph X-axis: daPa, sec | Same as predicate | |
| Device display | Graphic 128x128 dots | Display: 7 inch, 15:9 WVGAResolution: 800 x 480 pixel |
| Light indication on probes | ||
| Light indications | ||
| Interface | Wireless Bluetooth data transfer to | |
| Characteristic | K033645, OTOflex 100 Type 1012, GN Otometrics A/S. | K161707 Madsen Zodiac 1096 GN Otometrics A/S |
| PC | Compatible: USB 2.0 | |
| Operating environment | Temperature: +15°C to +35°C (59°F to +95°F)Rel. humidity: 30 to 90 %, non-condensingWarm-up time: < 2 min.Air pressure: 600 hPa to 1060 hPaOperation at temperatures below -20°C or above +60°C may cause permanent damage. | Same as predicate |
| Storing and handling | Temperature: -20°C to +60°C (-4°F to +140°F)Rel. humidity: < 90 %, non-condensingAir pressure: 500 hPa to 1060 hPa | Same as predicate |
| Dimensions (HxWxD) | MADSEN OTOflex 100 (HxWxD): 20 cm x 4.9 cm x 7.8 cm (7.9" x 1.9" x 3.0")Charger unit (HxWxD): 18 cm x 4.9 cm x 7.8 cm (6.9" x 1.9" x 3.0") | Stand-alone version: 190 mm x 248 mm x 261 mm (7.5" x 9.8" x 10.3")PC-based version: 100 mm x 240 mm x 240 mm (3.9" x 9.4" x 9.4")Quick Check probe: 28 mm x 22 mm x 100 mm (1.1" x 0.9" x 3.9")Diagnostic probe: 10 mm x 10 mm x 25 mm (0.4" x 0.4" x 1.0") |
| Weight | MADSEN OTOflex 100: 0.6 kg/1.3 lbCharger unit: 0.23 kg/0.5 lb | Stand-alone version: 2.65 kg/5.85 lbPC-based version: 1.65 kg/3.64 lb |
| Power supply | Battery types: Rechargeable (Ni-MH type) AA (R6) 1.2V, 4 pcs.Battery supply voltage: Nom. 5 V, max. 6.4 V, min. 4.0 V (instrument power-off voltage)Charger unitType identification: Charger unit is type 1012 Charger from GN Otometrics A/SPower: 100 - 240 VAC ±10%, 50/60 HzPower consumption < 10 VA | External power supply XP Power, type AFM60US24Output: 24 V, 2.5 AN/AN/AInput: 100-240 V AC, 50-60 Hz, 1.5 APower consumption < 60 VA |
| Miscellaneous | 2cc coupler.Clock and calendar. | Same as predicateSame as predicatePrinter: Built-in printer. Prints 600 dot |
| Characteristic | K033645, OTOflex 100 Type 1012,GN Otometrics A/S. | K161707 Madsen Zodiac 1096GN Otometrics A/Sline/s on 112 mm paper width |
| Programminglanguage | C++ | C# |
| Calibration | Equipment should be calibratedregularly according to EN 61027 andANSI S3.39 | Same as predicate |
| Standards | Safety: ANSI/AAMI ES 60601-1 (2005),CAN/CSA -C22.2 NO 60601.1 (2008)MADSEN OTOflex 100: IEC 60601-1,Class II, Internal Powered, Type BF,IPX0Charger unit: EN 60601-1, Class II,IPX0EMC: EN 60601-1-2, EN 300 328-2, EN301 489-17Impedance/Admittance: EN 61027Type 1, ANSI S3.39 Type 1 | Same as predicate, but in latesteditionMADSEN Zodiac: EN 60601-1, Class II,externally powered, Type BF, IPXOPower supply: Class I externallypowered supplySame as predicate, but in latesteditionSame as predicate, but in latestedition |
| Command wheel | X | X |
| Tactile buttons | X | X |
| Hybrid (PCcontrolled andstandalone) | X | X |
| Built-in 2cc testcavity | X | X |
| Replaceable testcavity | n/a | X |
| Diagnostic probe | X | X |
| DedicatedScreening probe | n/a | X |
| Two probesconnected at once | n/a | X |
| Light indicationson probe(s) | n/a | X |
| Control buttonson probe(s) | n/a | X |
| Contra phone | Insert type: YesSupra-aural type: No | Insert type: YesSupra-aural type: Optional |
| PC Connection | X | X |
| PC ConnectionType | BlueTooth | USB |
| Controllable by PC | X | X |
| Internal Printer | NO | Yes |
6. Substantial Equivalence Chart
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Image /page/9/Picture/0 description: This image shows two different devices from GN Otometrics A/S. The first device is the K033645, OTOflex 100 Type 1012, which is a blue handheld device with a screen and several buttons. The second device is the K161707 Madsen Zodiac 1096, which has two versions: Stand Alone and PC Based.
-
- Description of Non-clinical Testing: Testing consisted of mainly non-clinical performance testing of the device against the applicable parameters specified in the following standards:
| Standards No. | Standards Organization | Standards Title | Version | |
|---|---|---|---|---|
| 1 | ANSI/AAMIES60601-1 (2005) +AMD 1 (2012) | ANSI/AAMI | Medical Electrical Equipment -- Part 1: GeneralRequirements for Basic Safety and Essential Performance | 2012 |
| 2 | IEC 60601-1-2:2007 | EN/IEC | Medical Electrical Equipment - Part 1-2: Collateral StandardElectromagnetic Compatibility Requirements and Tests | 2007 |
| 3 | EN/IEC 60645-5Types 1 and 2, | EN (Same asIEC) | Electroacoustics - Audiometric equipment - Part 5:Instruments for the measurement of aural acousticimpedance/admittance | 2005 |
| 4 | ANSI S3.39 Types 1and 2. | ANSI | American National Standard Specifications for Instrumentsto Measure Aural Acoustic Impedance and Admittance(Aural Acoustic Immittance) | 1987(R2012) |
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Additionally, biocompatibility of patient contact materials was evaluated according to ISO 10993 for irritation, sensitization, and cytotoxicity. Software validation and risk analysis was successfully conducted, and performance testing was done to assure compliance with our own product specifications. The specifications are detailed in the comparison table, above.
-
- Description of Clinical Testing: Clinical testing was not required for a conclusion of substantial equivalence.
Conclusion: After analyzing bench testing, safety, EMC, applicable standards, and software validation testing we conclude that the Madsen Zodiac 1096 is as safe and effective as the predicate device, and has essentially the same indications for use, thus rendering it substantially equivalent to the predicate device.
- Description of Clinical Testing: Clinical testing was not required for a conclusion of substantial equivalence.
§ 874.1090 Auditory impedance tester.
(a)
Identification. An auditory impedance tester is a device that is intended to change the air pressure in the external auditory canal and measure and graph the mobility characteristics of the tympanic membrane to evaluate the functional condition of the middle ear. The device is used to determine abnormalities in the mobility of the tympanic membrane due to stiffness, flaccidity, or the presence of fluid in the middle ear cavity. The device is also used to measure the acoustic reflex threshold from contractions of the stapedial muscle, to monitor healing of tympanic membrane grafts or stapedectomies, or to monitor followup treatment for inflammation of the middle ear.(b)
Classification. Class II (special controls). The device, when it is a tympanometer or auditory impedance tester that complies with FDA-recognized consensus standard ANSI S3.39, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.