(72 days)
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No
The document describes a standard auditory impedance tester and its functionalities. There is no mention of AI, ML, or any related concepts in the intended use, device description, or performance studies.
No
The device is described as an auditory impedance tester used to measure and evaluate the functional condition of the middle ear and acoustic reflexes. It is a diagnostic tool, not one that directly treats a medical condition.
Yes
The "Intended Use / Indications for Use" section explicitly states that the device is "to evaluate the functional condition of the middle ear" and "is also used to measure the acoustic reflex threshold and decay testing as well as eustachian tube function testing." These activities are all diagnostic in nature. Additionally, the "Device Description" mentions "diagnostic probe types."
No
The device description explicitly states it is a "compact device for immittance testing" and supports various hardware probes (Quick Check, Classic, Comfort, contralateral insert phone or TDH-39). While it can be operated with software, it is not solely software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device that interacts directly with the patient's ear to measure physical characteristics (air pressure changes, tympanic membrane mobility, acoustic reflexes, eustachian tube function). It is evaluating the functional condition of the middle ear.
- Device Description: The description details a device with probes that are inserted into the ear canal to perform measurements.
- Lack of In Vitro Activity: An IVD device is intended for use in vitro, meaning outside of the living body, to examine specimens derived from the human body (like blood, urine, tissue). This device does not process or analyze such specimens.
- Anatomical Site: The anatomical sites mentioned (external auditory canal, middle ear, tympanic membrane) are all within the living body.
The device is an auditory impedance tester, which is a type of medical device used for diagnostic purposes, but it operates in vivo (within the living body) rather than in vitro.
N/A
Intended Use / Indications for 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).
Product codes (comma separated list FDA assigned to the subject device)
ETY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
human ear, external auditory canal, tympanic membrane, middle ear
Indicated Patient Age Range
Audiologists, ENTs and other health care professionals in testing the hearing of infants, children and adults.
Intended User / Care Setting
User population: Audiologists, ENTs and other health care professionals in testing the hearing of infants, children and adults.
Distribution: ENT Doctors, Audiologists and professional Hearing Aid dispensers.
Where used: Hospitals, private clinics and Hearing Aid dispensers
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Non-clinical performance testing of the device against the applicable parameters specified in the following standards: ANSI/AAMI ES60601-1 (2005) + AMD 1 (2012), IEC 60601-1-2:2007, EN/IEC 60645-5 Types 1 and 2, ANSI S3.39 Types 1 and 2.
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.
Clinical testing was not required for a conclusion of substantial equivalence.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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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
1
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 1096
GN Otometrics A/S |
|-------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use: | The OTOflex 100 Type 1012 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) 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). (SAME) |
| User population | Audiologists, ENTs and other health
care professionals in testing the
hearing of infants, children and
adults. | Same as predicate |
| Distribution | ENT Doctors, Audiologists and
professional 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 1096
GN Otometrics A/S |
| Where used | Hospitals, private clinics and Hearing
Aid dispensers | Same as predicate |
| Instructions | The predicate devices functionality is
covered by a user's manual. | Same as predicate |
| Compliance
measuring system
Probe tones | 226 Hz at 85dB SPL $\pm$ 1.5 dB
1000Hz at 75dB SPL $\pm$ 1.5 dB
THD: 12 dB/Octave.
Range at: BBN, LPN at 50 to 100 dB
SPL $\pm$ 3 dB, HPN at 50 to 95 dB SPL $\pm$ 3
dB
Step size dB 1, 2, 5, 10 dB
E-A-RTONE ® 3A:
Range at: 500 Hz at 50 to 105 dB HL $\pm$
3 dB
1000 Hz at 50 to 120 dB HL $\pm$ 3 dB
2000 Hz at 50 to 115 dB HL $\pm$ 3 dB
3000 Hz at 50 to 105 dB HL $\pm$ 3 dB
4000 Hz at 50 to 110 dB HL $\pm$ 3 dB
THD: 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: