Madsen Zodiac

K161707 · Gn Otometrics · ETY · Sep 1, 2016 · Ear, Nose, Throat

Device Facts

• Record ID: K161707
• Device Name: Madsen Zodiac
• Applicant: Gn Otometrics
• Product Code: ETY · Ear, Nose, Throat
• Decision Date: Sep 1, 2016
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 874.1090
• Device Class: Class 2
• Attributes: Pediatric

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.

Device Story

Madsen Zodiac 1096 is an auditory impedance tester for middle ear evaluation. It delivers acoustic probe signals and air pressure stimuli (-600 to +400 daPa) to the external auditory canal. The device measures and graphs tympanic membrane mobility, acoustic reflex thresholds, reflex decay, and eustachian tube function. It operates as a standalone unit (via built-in keypad/display) or as a PC-based system using OTOsuite Immittance software. Used in hospitals, clinics, and hearing aid dispensing centers by audiologists and ENTs. Output includes graphical representations of admittance and numerical test results, which assist clinicians in diagnosing middle ear pathologies. Benefits include objective assessment of middle ear function and reflex pathways.

Clinical Evidence

No clinical data. Substantial equivalence is supported by bench testing, including compliance with ANSI/AAMI ES60601-1, IEC 60601-1-2, EN/IEC 60645-5, and ANSI S3.39. Biocompatibility was evaluated per ISO 10993. Software validation and risk analysis were performed.

Technological Characteristics

Auditory impedance tester; Type BF applied parts. Materials evaluated for biocompatibility (ISO 10993). Connectivity: USB 2.0, standalone or PC-based. Power: External supply (AFM60US24). Probe types: Quick Check, Classic, Comfort. Standards: EN 60601-1, EN 60645-5, ANSI S3.39. Software: C# based.

Indications for Use

Indicated for use by audiologists, ENTs, and healthcare professionals to test hearing in infants, children, and adults. Used to evaluate middle ear function, acoustic reflex thresholds, reflex decay, and eustachian tube function in patients with intact or perforated tympanic membranes.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• OTOflex 100 Type 1012 (K033645)

Submission Summary (Full Text)

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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 [phone] or [phone] 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 [phone] or [phone] 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) | |
|------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------|
| <div style="display:flex; align-items:center;"><span style="font-size:20px;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D)</div> | <div style="display:flex; align-items:center;"><span style="font-size:20px;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C)</div> |

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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 : [phone] Fax: [phone] 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 |

- 2. 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 |

- 3. 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.

- 4. 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).
- 5. 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,<br>GN Otometrics A/S. | K161707 Madsen Zodiac 1096<br>GN Otometrics A/S |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The OTOflex 100 Type 1012 is an<br>auditory impedance tester that is<br>intended to change the air pressure in<br>the external auditory canal and measure<br>and graph the mobility characteristics of<br>the tympanic membrane to evaluate the<br>functional condition of the middle ear.<br>This device is also used to measure the<br>acoustic reflex threshold and decay<br>testing as well as eustachian tube<br>function testing for intact and<br>perforated tympanic membranes.<br>(Prescription Use). | The Madsen Zodiac (Type 1096) is an<br>auditory impedance tester that is<br>intended to change the air pressure in<br>the external auditory canal and measure<br>and graph the mobility characteristics of<br>the tympanic membrane to evaluate the<br>functional condition of the middle ear.<br>This device is also used to measure the<br>acoustic reflex threshold and decay<br>testing as well as eustachian tube<br>function testing for intact and<br>perforated tympanic membranes.<br>(Prescription Use). (SAME) |
| User population | Audiologists, ENTs and other health<br>care professionals in testing the<br>hearing of infants, children and<br>adults. | Same as predicate |
| Distribution | ENT Doctors, Audiologists and<br>professional Hearing Aid dispensers. | Same as predicate |
| Energy delivered | Acoustic stimuli:<br>Air pressure stimuli -600daPa to<br>+400daPa | Same as predicate |
| Characteristic | K033645, OTOflex 100 Type 1012,<br>GN Otometrics A/S. | K161707 Madsen Zodiac 1096<br>GN Otometrics A/S |
| Where used | Hospitals, private clinics and Hearing<br>Aid dispensers | Same as predicate |
| Instructions | The predicate devices functionality is<br>covered by a user's manual. | Same as predicate |
| Compliance<br>measuring system<br>Probe tones | 226 Hz at 85dB SPL $\pm$ 1.5 dB<br>1000Hz at 75dB SPL $\pm$ 1.5 dB<br>THD: < 3% in 2 cc<br>Frequency accuracy: $\pm$ 0.5%<br>Range: 0.1 ml to 8.0 ml $\pm$ 5% or 0.1 ml,<br>whichever is greater | 226 Hz at 85 dB SPL $\pm$ 3 dB<br>678 Hz at 72 dB SPL $\pm$ 3 dB<br>800 Hz at 70.5 dB SPL $\pm$ 3 dB<br>1000 Hz at 69 dB SPL $\pm$ 3 dB<br>THD: < 1% in 2 cc<br>Frequency accuracy: $\pm$ 0.5%<br>Range: 0.2 ml to 5.0 ml $\pm$ 5% or 0.05 ml<br>which ever is greater, 5 ml to 8.0 ml $\pm$<br>15% |
| Acoustic reflex<br>Contralateral<br>Stimulation | Pure tones: 500 Hz, 1000 Hz, 2000<br>Hz, 3000 Hz, 4000 Hz<br>Frequency accuracy: $\pm$ 0.5%<br>Noise White Noise according to IEC<br>61027<br>Low Pass 400 to 1600 Hz.<br>High Pass 1600 to 4000 Hz.<br>Roll off >12 dB/Octave.<br>Range at: BBN, LPN at 50 to 100 dB<br>SPL $\pm$ 3 dB, HPN at 50 to 95 dB SPL $\pm$ 3<br>dB<br>Step size dB 1, 2, 5, 10 dB<br><i>E-A-RTONE</i> ® 3A:<br>Range at: 500 Hz at 50 to 105 dB HL $\pm$<br>3 dB<br>1000 Hz at 50 to 120 dB HL $\pm$ 3 dB<br>2000 Hz at 50 to 115 dB HL $\pm$ 3 dB<br>3000 Hz at 50 to 105 dB HL $\pm$ 3 dB<br>4000 Hz at 50 to 110 dB HL $\pm$ 3 dB<br>THD: < 3% in 2 cc (measured 5 dB<br>below max output) | Same as predicate<br>Same as predicate<br>Broad Band Noise according to IEC<br>60645-5<br>Low Pass: TDH-39: 250 - 1600 Hz,<br>Insert: 400 - 1600 Hz.<br>High Pass: TDH-39: 1600 - 6000 Hz,<br>Insert: 1600 - 4000 Hz.<br>Same as predicate<br>Range: BBN, LPN, HPN at 50 to 110<br>dB SPL $\pm$ 3 dB<br>Same as predicate<br>Contralateral insert phone:<br>Range: 500 Hz at 50 to 115 dB HL $\pm$ 3<br>dB<br>Same as predicate<br>2000 Hz at 50 to 120 dB HL $\pm$ 3 dB<br>Frequency not used<br>4000 Hz at 50 to 120 dB HL $\pm$ 3 dB<br>THD: < 5% for levels below 110 dB HL,<br>< 10% for levels above 110 dB HL<br>Contralateral TDH-39 phone:<br>500 Hz at 50 to 115 dB HL $\pm$ 3 dB<br>1000 Hz at 50 to 120 dB HL $\pm$ 3 dB<br>2000 Hz at 50 to 115 dB HL $\pm$ 3 dB |
| Characteristic | K033645, OTOflex 100 Type 1012,<br>GN Otometrics A/S. | K161707 Madsen Zodiac 1096<br>GN 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 |
| Ipsilateral<br>Stimulation | Tone: 500 Hz, 1000 Hz, 2000 Hz, 3000<br>Hz, 4000 Hz | Tone: 500 Hz, 1000 Hz, 2000 Hz, 4000<br>Hz |
| | Frequency accuracy: ± 0.5% | Same as predicate |
| | Noise White Noise according to IEC<br>61027 | Broad Band Noise according to IEC<br>60645-5 |
| | 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 ±<br>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 dB<br>below max output) | THD: < 5% for levels below 110 dB HL,<br>< 10% for levels above 110 dB HL |
| Air pressure<br>system | Range: Normal +200 to -400 daPa/s.<br>Extended +400 to -600 daPa/s | Same as predicate |
| | Pressure sweep rate: 50, 100, 200,<br>400 daPa/s, A.F.A.P | Pressure sweep rate: 50, 100, 200,<br>400, 600 daPa/s |
| | Pressure accuracy: ±10% or ±10 daPa,<br>whichever is greatest | Same as predicate |
| | Pump measure direction: Positive to<br>negative or negative to positive | Same as predicate |
| | Safety: Separate safety +530 daPa<br>and -730 daPa. ±70 daPa | Same as predicate |
| | Software safety +450 daPa and -650<br>daPa. ±70 daPa. | Same as predicate |
| | | Manual control of pressure |
| Graph units | Unit of admittance graph Y-axis: ml,<br>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 WVGA<br>Resolution: 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)<br>Rel. humidity: 30 to 90 %, non-condensing<br>Warm-up time: < 2 min.<br>Air pressure: 600 hPa to 1060 hPa<br>Operation 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)<br>Rel. humidity: < 90 %, non-condensing<br>Air 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")<br>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")<br>PC-based version: 100 mm x 240 mm x 240 mm (3.9" x 9.4" x 9.4")<br>Quick Check probe: 28 mm x 22 mm x 100 mm (1.1" x 0.9" x 3.9")<br>Diagnostic probe: 10 mm x 10 mm x 25 mm (0.4" x 0.4" x 1.0")…