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.

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.

AI/ML Overview

The submission describes the Auditdata Primus Fitting System, which consists of the Primus Hearing Instrument Test Unit (PHITU) and the Primus Fitting Unit (PFU). The device is intended for professionals to perform hearing instrument testing, audiometry, and real ear measurements.

Here's an analysis of the provided information regarding acceptance criteria and the study:

1. Table of Acceptance Criteria and Reported Device Performance:

The submission does not explicitly present a table of acceptance criteria with specific numerical targets and corresponding device performance metrics. Instead, it relies on demonstrating compliance with recognized industry standards. The reported "performance" is implicitly achieving compliance with these standards.

Acceptance Criteria (Implied)	Reported Device Performance
Compliance with EN/IEC 60601-1 (Medical Electrical Equipment - General Requirements for Safety)	Compliance achieved
Compliance with EN/IEC 60601-1-2 (Medical Electrical Equipment - Electromagnetic Compatibility)	Compliance achieved
Compliance with ANSI/S3.22 (Specification of Hearing Aid Characteristics)	Compliance achieved (through testing)
Compliance with IEC 60118-7 (Electroacoustics - Hearing aids - Measurement of performance characteristics)	Compliance achieved (through testing)
Compliance with EN60645-1/ANSI S3.6 Type 1 (Tone Audiometry)	Compliance achieved (through testing)
Compliance with EN60645-2/ANSI S3.6 Type A or A-E (Speech Audiometry)	Compliance achieved (through testing)
Compliance with EN 61669 (Equipment for the measurement of real-ear acoustical characteristics of hearing aids)	Compliance achieved (through testing)
Compliance with ANSI S3.46 (Methods of Measurement of Real-Ear Performance)	Compliance achieved (through testing)
Substantial Equivalence to Predicate Device (Aurical by GN Otometrics, K945199) based on design and performance	Demonstrated through side-by-side design comparison and non-clinical performance testing. Equivalent results were obtained when both devices were tested against the standards.

2. Sample Size Used for the Test Set and Data Provenance:

The submission explicitly states that "non-clinical performance testing" was conducted. However, it does not provide any details regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily device-centric, focusing on the functionality and measurement accuracy of the Primus Fitting System itself against established technical standards, rather than patient- or human-subject data.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications:

The document does not mention the involvement of experts to establish a "ground truth" for a test set in the context of diagnostic accuracy or clinical decision-making. The testing described focuses on the technical performance of the device against industry standards, where the "ground truth" is typically defined by the precise measurement requirements and specifications within those standards.

4. Adjudication Method for the Test Set:

Given that there is no mention of a human-interpreted test set or diagnostic accuracy evaluation, there is no information provided on an adjudication method.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:

A Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not conducted or described in this submission. The device is a measurement and testing system, not an AI diagnostic tool that assists human readers.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study:

The studies described are standalone performance evaluations of the device itself (PHITU and PFU). The tests assess the accuracy and compliance of the device's measurements and functionalities according to established technical standards (e.g., ANSI, IEC). The device operates as an instrument, and its performance is evaluated based on its ability to accurately perform those instrumental functions.

7. Type of Ground Truth Used:

The ground truth used for the testing is primarily the specifications and requirements defined within the referenced industry standards (e.g., ANSI S3.6, ANSI S3.22, ANSI S3.46, IEC 60118-7, EN 61669). The "ground truth" for this type of device, which measures acoustic properties and performs audiometry, is the accurate and precise adherence to these technical benchmarks. It does not involve expert consensus on medical conditions, pathology results, or clinical outcomes data in the typical sense of a diagnostic AI device.

8. Sample Size for the Training Set:

The submission does not mention a "training set" as the device is not described as utilizing machine learning or artificial intelligence in a way that would require a distinct training phase. Its operation is based on conventional electronic circuit design, digital signal processing, and software logic.

9. How the Ground Truth for the Training Set was Established:

Since there is no mention of a training set, there is no information on how ground truth for a training set was established.

Summary

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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

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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 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.

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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. .

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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 circuitboard design	Similar design

Industry standard Digital Signalprocessor	Similar design

Conventional molded plasticparts 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.

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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 forSafety.
EN/IEC 60601-1-2	Medical Electrical Equipment --Part 1: General Requirements forSafety; ElectromagneticCompatibility -- Requirements andTests
ANSI/ S3.22	Specification of Hearing AidCharacteristics
IEC 60118-7	Electroacoustics - Hearing aids -Part 7: Measurement of theperformance characteristics ofhearing aids for production,supply and delivery qualityassurance purposes
EN60645-1/ANSI S3.6 Type 1	Tone Audiometry
EN60645-2/ANSI S3.6 Type Aor A-E	Speech Audiometry
EN 61669	Equipment for the measurementof real-ear acousticalcharacteristics of hearing aids.
ANSI S3.46	Methods of Measurement ofReal-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

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Image /page/5/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three legs, enclosed in a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the upper portion of the circle.

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.

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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

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K113831

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 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

Regulation Number and Section

§ 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.