(114 days)
Not Found
No
The document describes a system for hearing instrument testing and fitting that performs standard audiometry, real-ear measurements, and hearing aid testing based on established standards. There is no mention of AI or ML in the intended use, device description, or performance studies. The system appears to be based on traditional signal processing and measurement techniques.
No.
The device is intended for diagnostic testing (audiometry, real ear measurements) and technical inspection of hearing aids, not for providing therapy.
Yes
The Primus Fitting Unit (PFU) is explicitly stated as being "intended for hearing test" and "indicated for non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing." Audiometric testing is a diagnostic procedure to assess hearing. While it also states that it is "not indicated as a sole means of diagnostics," its use for audiometric testing qualifies it as a diagnostic device.
No
The device description explicitly states that the system includes hardware components for Audiometry (AUD), Real Ear Measurements (REM), and Hearing Instrument Testing (HIT), such as microphones, probes, couplers, and a power supply. While it is PC-operated with dedicated software, it is not solely software.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the Primus Fitting System is used for testing hearing instruments, performing audiometric tests on patients (air and bone conduction, speech), and conducting real-ear measurements. These activities involve interacting with the patient's auditory system and hearing aids, not analyzing biological samples.
- The device description focuses on acoustic measurements and signal processing. The components described (microphones, couplers, probes) are designed to measure sound and the response of hearing aids and the ear, not to analyze biological or chemical properties of a specimen.
- The intended use is related to hearing assessment and hearing aid fitting. The purpose is to evaluate hearing function and optimize hearing aid performance, which falls under the scope of audiology and hearing healthcare, not in vitro diagnostics.
Therefore, the Primus Hearing Instrument Test Unit and Primus Fitting Unit, as described, do not meet the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
Indications for use (PHITU):
The Primus Hearing Instrument Test Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician. Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing. The Primus Hearing Instrument Test Unit is intended to give an objective indication of the characteristics of a Hearing Aid, by visualizing a signal recorded in the test coupler with reference information such as target curves in order to make adjustments of the Hearing Instrument settings.
- The Primus Hearing Instrument Test Unit is indicated for technical quality inspection of hearing instruments with no clients involved.
Indications for use (PFU):
The Primus Fitting Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician. Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
- The Primus Fitting Unit is intended for hearing test.
- The Primus Fitting Unit with stated accessories is indicated for non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing in quiet office and sound treated environments.
- The Primus Fitting Unit is indicated for non-continuous real-ear measurements at the ear drum by means of noninvasive external ear canal insertion of a probe tube in quiet office environments.
- Finally the system can be used to present hearing instrument related sound examples through headsets or loudspeakers.
- The Primus Fitting Unit is Indicated for use with both pediatric and adult age groups.
- The Primus Fitting Unit is not indicated as a sole means of diagnostics.
Product codes (comma separated list FDA assigned to the subject device)
ETW, EWO
Device Description
The Primus Fitting System is a PC operated system that contains Primus Hearing Instrument Test unit (PHITU) for Hearing Instrument testing (HIT), Primus Fitting Unit (PFU) for Audiometry (AUD) and Real Ear measurement (REM). The Primus Fitting System is operated from a dedicated software application installed on a standard Windows operating system. The Primus Fitting system can either be sold individually (PHITU or PFU) or together (PHITU and PFU). The Primus software solution operates within the NOAH framework, as well as stand-alone. On-top diagrams and control panels make it easy to use simultaneously with the proprietary hearing instrument fitting systems of your choice. The stand-alone client data files hold all historical session information, and makes fittings away from the office very easy.
Audiometry (AUD)
Primus AUD is a PC based audiometry module providing a wide range of possibilities within pure tone audiometry, bone conduction audiometry and speech audiometry including inserts probe and industry standard headsets with an option of high frequency testing.
Real Ear Measurements (REM)
Primus REM offers classic Real Ear Measurements as well as comprehensive Speech Mapping measurements, where all measurements include high frequency testing. The measurements are supported by a large sound library including technical sounds, daily life sounds, speech signals and dialogue. The Primus REM module contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear. The classic Real Ear Measurements, which can be performed by Primus REM, include: Unaided, Occluded and Aided Response as well as Insertion Gain. Toggling between SPL and Gain shows the response measurements in gain view. The PFU hardware is powered by a USB connection from the PC and a medical grade power supply (for extended sound pressure) and can be placed at the most convenient working place.
Hearing Instrument Testing (HIT)
Primus HIT offers full featured technical measurements for testing and troubleshooting hearing instruments. The test can be run as an automatic test sequence in accordance with European and American standards. The Primus HIT unit module contains of 2 microphones (one for measuring and one for reference) and various couplers for hearing aid testing. The PHITU hardware is powered by a USB connection from the PC and can be placed at the most convenient working place.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Ear drum
Indicated Patient Age Range
pediatric and adult age groups.
Intended User / Care Setting
professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Care settings: extremely quiet environment, quiet office and sound treated environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
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)
Substantial equivalence to the Primus Fitting system is based a side-by-side design comparison (Aurical from GN Otometrics K945199) all verified by means of non-clinical performance testing of the Primus Fitting system as specified in ANSI S3.6, ANSI S3.22 and ANSI S3.46. The equivalent results from both the Primus fitting System and the Aurical System obtained when each device was tested to determine compliance with the standards clearly demonstrates the substantial equivalence between these two devices.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
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.
Not Found
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
§ 874.3310 Hearing aid calibrator and analysis system.
(a)
Identification. A hearing aid calibrator and analysis system is an electronic reference device intended to calibrate and assess the electroacoustic frequency and sound intensity characteristics emanating from a hearing aid, master hearing aid, group hearing aid or group auditory trainer. The device consists of an acoustic complex of known cavity volume, a sound level meter, a microphone, oscillators, frequency counters, microphone amplifiers, a distoration analyzer, a chart recorder, and a hearing aid test box.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 874.9.
0
K113831
APR 1 9 2012
Image /page/0/Picture/2 description: The image shows the logo for Auditdata. The logo consists of the word "auditdata" in a bold, sans-serif font, with a stylized sound wave graphic to the right. Below the logo is the tagline "Your Partner in Audiology Solutions" in a smaller font.
Chapter 5 510(k) Summary
510(k) Information
.
The following 510(k) summary has been prepared pursuant to requirements specified in 21 CFR 807.92(a)
Submitter/Owner
Auditdata A/S Banestroeget 13 DK-2630 Taastrup Denmark Phone: +45 70 20 31 24 Establishment Registration No: 3008386587 Contact: Dan Haugbøl QA & Regulatory Manager dan@auditdata.com
Summary date: March 08, 2012
Device Identification
Submission type: Traditional Reason for Submission: New Device Trade name: Primus Fitting System Common name: Primus Classification name: Hearing aid calibrator and analysis system Secondary class: Audiometer, 21 CFR 874.1050, EWO FDA: 21 CFR 874.3310 Device Product Code: ETW Classification Panel: Ear, Nose, and Throat Device Class: Class II
© Auditdata 2012
1
Image /page/1/Picture/0 description: The image shows the logo for Auditdata. The logo features the word "auditdata" in a bold, sans-serif font, with a stylized graphic of sound waves emanating from the right side of the word. Below the logo is the tagline "Your Partner in Audiology Solutions" in a smaller font.
Predicate Marked Device
Primus Fitting System has equivalence to:
Product Name: Aurical Manufacturer: GN Otometrics 510(k) Number: K945199
Device Description
The Primus Fitting System is a PC operated system that contains Primus Hearing Instrument Test unit (PHITU) for Hearing Instrument testing (HIT), Primus Fitting Unit (PFU) for Audiometry (AUD) and Real Ear measurement (REM). The Primus Fitting System is operated from a dedicated software application installed on a standard Windows operating system. The Primus Fitting system can either be sold individually (PHITU or PFU) or together (PHITU and PFU).
The Primus software solution operates within the NOAH framework, as well as stand-alone. On-top diagrams and control panels make it easy to use simultaneously with the proprietary hearing instrument fitting systems of your choice. The stand-alone client data files hold all historical session information, and makes fittings away from the office very easy.
Audiometry (AUD)
Primus AUD is a PC based audiometry module providing a wide range of possibilities within pure tone audiometry, bone conduction audiometry and speech audiometry including inserts probe and industry standard headsets with an option of high frequency testing.
Real Ear Measurements (REM)
Primus REM offers classic Real Ear Measurements as well as comprehensive Speech Mapping measurements, where all measurements include high frequency testing. The measurements are supported by a large sound library including technical sounds, daily life sounds, speech signals and dialogue. The Primus REM module contains 2 probes (one for each ear) each with 2 microphones used for measuring the sound level outside and inside the ear.
The classic Real Ear Measurements, which can be performed by Primus REM, include: Unaided, Occluded and Aided Response as well as Insertion Gain. Toggling between SPL and Gain shows the response measurements in gain view.
The PFU hardware is powered by a USB connection from the PC and a medical grade power supply (for extended sound pressure) and can be placed at the most convenient working place.
Hearing Instrument Testing (HIT)
Primus HIT offers full featured technical measurements for testing and troubleshooting hearing instruments. The test can be run as an automatic test sequence in accordance with European and American standards. The Primus HIT unit module contains of 2 microphones (one for measuring and one for reference) and various couplers for hearing aid testing.
The PHITU hardware is powered by a USB connection from the PC and can be placed at the most convenient working place.
2
Image /page/2/Picture/0 description: The image shows the logo for Auditdata. The logo consists of the word "auditdata" in a bold, sans-serif font, with a stylized sound wave graphic to the right of the word. Below the logo is the tagline "Your Partner in Audiology Solutions".
PHITU Indication for Use/Intended use
Indications for use (PHITU):
The Primus Hearing Instrument Test Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician. Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
The Primus Hearing Instrument Test Unit is intended to give an objective indication of the characteristics of a Hearing Aid, by visualizing a signal recorded in the test coupler with reference information such as target curves in order to make adjustments of the Hearing Instrument settings.
- The Primus Hearing Instrument Test Unit is indicated for technical quality inspection of . hearing instruments with no clients involved.
Indications for use (PFU):
The Primus Fitting Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
- . The Primus Fitting Unit is intended for hearing test.
- The Primus Fitting Unit with stated accessories is indicated for non-continuous, . noninvasive air and optionally bone conduction and speech audiometric testing in quiet ·office and sound treated environments.
- . The Primus Fitting Unit is indicated for non-continuous real-ear measurements at the ear drum by means of noninvasive external ear canal insertion of a probe tube in quiet office environments.
- . Finally the system can be used to present hearing instrument related sound examples through headsets or loudspeakers.
- . The Primus Fitting Unit is Indicated for use with both pediatric and adult age groups.
- The Primus Fitting Unit is not indicated as a sole means of diagnostics. .
3
Image /page/3/Picture/0 description: The image shows the word "auditdata" in a bold, sans-serif font. To the right of the word, there is a stylized graphic that resembles radio waves or sound waves emanating from a point. The overall impression is that of a company logo or brand name.
Your Partner in Audiology Solutions
Technological Characteristics
The PHITU and PFU unit uses the same overall technology as the predicate devices:
| PFU/PHITU | Predicate devices |
|---|---|
| Conventional electronic circuit | |
| board design | Similar design |
| Industry standard Digital Signal | |
| processor | Similar design |
| Conventional molded plastic | |
| parts design | Similar design |
| Conventional sheet metal design | Similar design |
| Industry standard headset | Same |
| Mains operated energy source | Same |
Comparison to Predicate Device
Fitting systems like the Primus Fitting System have been produced for decades. The system most similar to the Primus Fitting System in terms of technical design and features is the Aurical from GN Otometrics.
From a measurement perspective, the two systems utilize very similar signal processing and electrical design within the device, and both are controlled and operated by software running on the PC.
The primary difference between the two devices is associated with the mechanical design, where Aurical is a combined AUD/REM/HIT unit and Primus Fitting System have independent HIT and REM/AUD unit operated by software running on the PC.
Substantial Equivalence Performance testing
Substantial equivalence to the Primus Fitting system is based a side-by-side design comparison (Aurical from GN Otometrics K945199) all verified by means of non-clinical performance testing of the Primus Fitting system as specified in ANSI S3.6, ANSI S3.22 and ANSI S3.46 This is further supported by the design implementations obtained as a result being compliant to
the standards listed below.
4
Image /page/4/Picture/0 description: The image shows the logo for Auditdata. The logo consists of the word "auditdata" in a bold, sans-serif font, with a stylized sound wave graphic to the right. Below the logo is the tagline "Your Partner in Audiology Solutions" in a smaller, sans-serif font.
Conclusion about Safety and Effectiveness
Evaluating the results of testing to the following key standards has allowed us to make conclusions about the safety and effectiveness of the Primus Fitting System.
| Standard | Description |
|---|---|
| EN/IEC 60601-1 | Medical Electrical Equipment -- |
| Part 1: General Requirements for | |
| Safety. | |
| EN/IEC 60601-1-2 | Medical Electrical Equipment -- |
| Part 1: General Requirements for | |
| Safety; Electromagnetic | |
| Compatibility -- Requirements and | |
| Tests | |
| ANSI/ S3.22 | Specification of Hearing Aid |
| Characteristics | |
| IEC 60118-7 | Electroacoustics - Hearing aids - |
| Part 7: Measurement of the | |
| performance characteristics of | |
| hearing aids for production, | |
| supply and delivery quality | |
| assurance purposes | |
| EN60645-1/ANSI S3.6 Type 1 | Tone Audiometry |
| EN60645-2/ANSI S3.6 Type A | |
| or A-E | Speech Audiometry |
| EN 61669 | Equipment for the measurement |
| of real-ear acoustical | |
| characteristics of hearing aids. | |
| ANSI S3.46 | Methods of Measurement of |
| Real-Ear Performance |
|
The equivalent results from both the Primus fitting System and the Aurical System obtained when each device was tested to determine compliance with the standards clearly demonstrates the substantial equivalence between these two devices.
Based on the results of testing to the applicable requirements of the aforementioned standards and achieving compliance to them, we hereby conclude that Primus Fitting System is both safe and effective.
5-5
5
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Auditdata A/S c/o Mr. Dan Haugbol Banestroeget 13 DK-2630 Taastrup Denmark
APR 1 9 2012
Re: K113831
Trade/Device Name: Primus Fitting System Regulation Number: 21 CFR 874.3310 Regulation Name: Hearing aid calibrator and analysis system Regulatory Class: II Product Code: ETW, EWO Dated: March 8, 2012 Received: March 14, 2012
Dear Mr. Haugbol:
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.
6
Page 2 - Mr. Dan Haugbol
Please be advised that FDA's issuance of a substantial equivalence determination does not mean I loast ve devisou that I Driver and that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must of any I odolar statuation and regenanents, 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 forth in the quality systems (QS) regulation (2) 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/CDRH/CDRHOffices/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/MedicalDevices/Safety/ReportalProblem/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 Small Manufacturers, International and Consumer Assistance 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,
Eda K. VMD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
7
Indications for Use Statement
510(k) Number: K113831 Device Name: Primus Fitting System
Primus Hearing Instrument Test Unit (PHITU)
The Primus Hearing Instrument Test Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
The Primus Hearing Instrument Test Unit is intended to give an objective indication of the characteristics of a Hearing Aid, by visualizing a signal recorded in the test coupler with reference information such as target curves in order to make adjustments of the Hearing Instrument settings.
- The Primus Hearing Instrument Test Unit is indicated for technical quality inspection of hearing instruments with no clients involved.
Primus Fitting Unit (PFU):
The Primus Fitting Unit is intended for use by professionals such as an audiologist, hearing healthcare specialist, or trained technician.
Audiometric testing should take place in an extremely quiet environment and care should be taken to ensure optimal test conditions and safety of the client during testing.
· The Primus Fitting Unit is intended for hearing test.
- · The Primus Fitting Unit with stated accessories is indicated for non-continuous, noninvasive air and optionally bone conduction and speech audiometric testing in quiet office and sound treated environments.
- The Primus Fitting Unit is indicated for non-continuous real-ear measurements at the ear drum by means of noninvasive external ear canal insertion of a probe tube in quiet office environments.
- Finally the system can be used to present hearing instrument related sound examples through headsets or loudspeakers.
- The Primus Fitting Unit is indicated for use with both pediatric and adult age groups.
- · The Primus Fitting Unit is not indicated as a sole means of diagnostics.
Prescription Use × AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (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 (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
chgs
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number.
KIJ3831