The Bio-logic Insert Earphones are accessories to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response systems. The Bio-logic Insert Earphones devices perform as the means for delivering auditory stimulus to the ears of the patient under test. The interface to the ears of the patient is provided by means of disposable foam eartips, designed to fit infants, children, and adults.

Device Description

The Bio-logic Insert Earphones are transducers that convert electrical stimulus, provided by the Bio-logic ABaer / Navigator Pro Auditory Evoked Response Stimulators, into acoustic stimulus, which is then coupled to the patient's ears. They are comprised of five sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Speaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.

AI/ML Overview

The provided text describes the Bio-logic Insert Earphones and compares them to a predicate device, the Etymotic Research ER-3 Insert Earphones. The study presented is a non-clinical performance test to demonstrate substantial equivalence, rather than a clinical study evaluating diagnostic performance. Therefore, many of the requested elements are not applicable in this context.

Here's an analysis based on the available information:

1. Table of Acceptance Criteria and Reported Device Performance

For non-clinical performance, the acceptance criterion implicitly is "substantial equivalence" to the predicate device in key output parameters, particularly sound level and frequency bandwidth.

Parameter for Comparison	Acceptance Criteria (Predicate: Etymotic Research ER-3)	Reported Bio-logic Insert Earphone Performance	Reported Bio-logic Broadband Insert Earphone Performance	Met Criteria?
1 kHz Sensitivity (re IEC 711 Coupler @ 1.0 Vrms AC Drive)	114 dB SPL	111 dB SPL	85 dB SPL	Yes (with calibration for standard, designed lower for broadband)
Frequency Bandwidth (± 5 dB) (re IEC 711 Coupler)	100 Hz – 4,000 Hz	100 Hz – 4,000 Hz	100 Hz – 10,000 Hz	Yes (same for standard, broader by design for broadband)
Intended Use	Auditory Evoked Response	Same	Same	Yes
Target Population	Infants, Children, and Adults	Same	Same	Yes
Human Factors	Simple, easy-to-follow instructions	Same	Same	Yes
Design	Transducer and circuit mounted in a case, cable connection, silicon sound tube and foam eartip	Similar physical design with different cable type and slightly different acoustics	Similar physical design with different cable type, transducer type, acoustics and filter to produce a broader band frequency response at a lower output	Yes
Energy Used and/or Delivered	Device is passive and consumes less than 0.5 Wpeak. Electrical energy converted to acoustic energy.	Same	Same	Yes
Standards Met	Associated with stimulation device	Same	Same	Yes
Bio-compatibility	All material passed bio-compatibility testing	Same	Same	Yes
Sterility	Not supplied sterile	Same	Same	Yes
Compatibility with Environment	No environmental issues	Same	Same	Yes
Chemical Safety	No chemicals involved in the use of this device.	Same	Same	Yes
Thermal Safety	Device does not contain any thermal producing components.	Same	Same	Yes
Mechanical Safety	Device does not contain any moving components.	Same	Same	Yes
Electrical Safety	Patient is isolated from device via silicon sound tube and foam eartip.	Same	Same	Yes

Note regarding "Met Criteria?": For the standard Bio-logic Insert Earphone, the differences in sensitivity were calibrated to achieve similar frequency response. For the Broadband Insert Earphone, the differences were by design to achieve a wider bandwidth. Both outcomes were deemed substantially equivalent based on the provided discussion.

2. Sample size used for the test set and the data provenance

Sample Size: Not applicable. This was a non-clinical laboratory test, not a study involving human subjects or collected data from a "test set" in the typical sense of a clinical trial. The "test set" comprised the Bio-logic Insert Earphone, the Bio-logic Broadband Insert Earphone, and the predicate Etymotic Research ER-3 Insert Earphones.
Data Provenance: Not applicable. The data was generated in a controlled laboratory setting (described as measuring sound level within a Bruel & Kjaer Type 711 Occluded Ear simulator). It is not retrospective or prospective clinical data from a specific country.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

Not applicable. Ground truth, in the sense of expert consensus on clinical findings, is not relevant for this non-clinical engineering performance study. The "ground truth" here is the physical acoustic output measurements, which are objectively measurable by standard laboratory equipment.

4. Adjudication method for the test set

Not applicable. There was no need for human adjudication of test results, as the measurements were objective physical quantities.

5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

Not applicable. This was not a comparative effectiveness study involving human readers or AI.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This device is an earphone, not an algorithm, and does not involve AI or human-in-the-loop performance in the sense of diagnostic interpretation.

7. The type of ground truth used

The "ground truth" relevant to this submission is the objective physical measurement of acoustic output (sound level, frequency response) as measured by a Bruel & Kjaer Type 711 Occluded Ear simulator.

8. The sample size for the training set

Not applicable. This is a physical device, not an AI model requiring a training set.

9. How the ground truth for the training set was established

Not applicable. As above, this is a physical device.

Summary

{0}------------------------------------------------

K031352

Image /page/0/Picture/2 description: The image shows a logo for Bio-Logic Systems Corp. The logo consists of a black square with a white circle partially overlapping the lower-left corner. The text "Bio-Logic" is written in white letters below the circle, with the word "SYSTEMS CORP" in smaller letters underneath. The registered trademark symbol is located to the right of the word "logic".

One Bio-logic Plaza Mundelein, IL 60060-3700 1-800-323-8326 Fax: 847-949-8615 www.bio-logic.com

Section 10:

Premarket Notification 510(k) Summary

Date of which the Summary was Prepared:

April 25, 2003

Submitted By:	Bio-logic Systems Corp.One Bio-logic PlazaMundelein, IL 60060
---------------	-----------------------------------------------------------------------

Telephone:	847-949-5200 ext. 359
Fax:	847-949-8615
Email:	egundersen@blsc.com
Contact Person:	Erik Gundersen
Name of Device:	Bio-logic Insert Earphones
Common Name:	Earphones for Evoked Response auditory stimulus delivery
Classification Name:	Accessories to devices with classification:Stimulator, Auditory, Evoked Response,(per 21 CFR section 882.1900)
Predicate Device:	Etymotic Research ER-3 Insert Earphones, 510(k)#K930003

{1}------------------------------------------------

Description of the Device:

The Electrical Transmission Path consists of a shielded cable. The cable is connected to the Bio-logic ABaer / Navigator Pro Auditory Evoked Response Stimulators, by means of a 6-pin Mini DIN. The other end of the cable is connected to the left and right Electrical Filter Sections.

Each Electrical Filter section (left and right) consists of a passive analog filter to provide electrical pre-emphasis response shaping to the stimulus prior to reaching the Speakers.

Each Speaker (left and right) converts the electrical stimulus into an acoustic stimulus. The acoustic stimulus is delivered to the patient's ear by means of the Acoustic Transmission Path.

Each Acoustic Transmission Path (left and right) consists of silicon tubing and a tube nipple. The tube nipple provides acoustic and mechanical connection to a disposable eartip. The disposable eartips interface to the patient's ear and deliver the acoustic stimulus.

Each Transducer Case (left and right) houses an Electrical Filter and Speaker and provides means of handling and labeling.

Intended Use of the Device:

{2}------------------------------------------------

Parameter forComparison	EtymoticResearch ER-3Insert Earphones(510(k) #K930003)	Bio-logicInsert Earphone	Bio-logicBroadband InsertEarphone
Intended Use	Auditory EvokedResponse	Same	Same
Target Population	Infants, Children,and Adults	Same	Same
Human Factors	Simple, easy-to-follow instructionsare provided.	Same	Same
Design	Transducer andcircuit mounted in acase. Connected tothe test device via acable, andconnected to thepatient via siliconsound tube andfoam eartip.	Similar physicaldesign withdifferent cable typeand slightlydifferent acoustics.	Similar physicaldesign withdifferent cable type,transducer type,acoustics and filterto produce abroader bandfrequency responseat a lower output.
1 kHz Sensitivity(re IEC 711Coupler @ 1.0Vrms AC Drive)	114 dB SPL	111 dB SPL	85 dB SPL
FrequencyBandwidth (± 5dB)(re IEC 711Coupler)	100 Hz – 4,000 Hz	Same	100 Hz – 10,000Hz
Energy Used andor Delivered	Device is passiveand consumes lessthan 0.5 Wpeak.This electricalenergy is convertedinto acousticenergy anddelivered to thepatient's ear.	Same	Same
Standards Met	Associated withstimulation device	Same	Same
Bio-compatibility	All material passedbio-compatibitytesting	Same	Same
Sterility	Not supplied sterile	Same	Same
Parameter forComparison	EtymoticResearch ER-3Insert Earphones(510(k) #K930003)	Bio-logicInsert Earphone	Bio-logicBroadband InsertEarphone
Compatibilitywith Environment	No environmentalissues	Same	Same
Chemical Safety	No chemicalsinvolved in the useof this device.	Same	Same
Thermal Safety	Device does notcontain any thermalproducingcomponents.	Same	Same
Mechanical Safety	Device does notcontain any movingcomponents.	Same	Same
Electrical Safety	Patient is isolatedfrom device viasilicon sound tubeand foam eartip.	Same	Same

Comparison Summary of Technological Characteristics:

{3}------------------------------------------------

Discussion and Assessment of Non-Clinical Performance Data:

Non-clinical testing was performed to demonstrate the substantial equivalence of the Biologic Insert Earphones to the Etymotic Research ER-3 Insert Earphones. This performance testing consisted of measuring the sound level within a Bruel & Kjaer Type 711 Occluded Ear simulator using a Bio-logic Navigator Pro Auditory Evoked Response Stimulator with the Etymotic Research ER-3 Insert Earphone, the Bio-logic Insert Earphone, and the Bio-logic Broadband Insert Earphone.

The test results show that the sound level output of the Bio-logic Insert Earphone is an average of 3 dB lower than the Etymotic ER-3 Insert Earphone. This difference in output is calibrated by increasing the drive signal by +3 dB. After the calibration, the resulting frequency response is nearly

The test results show that the sound level output of the Bio-logic Broadband Insert Earphone is an average of 29 dB lower than the Etymotic ER-3 Insert Earphone. This difference is due to the fact that Bio-logic Broadband Insert Earphone was designed to have a much smoother, wider bandwidth frequency response. The Bio-logic Broadband Insert Earphones are a special version of the Bio-logic Insert Earphones and are utilized ONLY for applications where wider bandwidth is required.

Therefore, it is concluded that the performance of the Bio-logic Insert Earphones is very similar to that of the Etymotic ER-3 Insert Earphone (510(k) #K930003), and they are therefore substantially equivalent to this predicate device.

{4}------------------------------------------------

Image /page/4/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" written around it. Inside the circle is a stylized symbol that resembles an eagle or bird with three stripes extending from its back.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

JUL 16 2003

Bio-Logic Systems Corporation c/o Erik C. Gundersen Design Engineer IV One Bio-logic Plaza Mundelein, IL 60060

Re: K031352

Trade/Device Name: Bio-logic Insert Earphones Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: April 25, 2003 Received: April 30, 2003

Dear Mr. Gundersen:

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. Iisting of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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 with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); 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.

{5}------------------------------------------------

Page 2 – Erik C. Gundersen

This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (301) 594-4613. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html

Sincerely yours,

A Kalpi Rosenthal

A. Ralph Rosenthal, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

{6}------------------------------------------------

Section 8:

Statement for Indications for Use

510(k) Number (if known):_K (03/352

Device Name: Bio-logic Insert Earphones

Indication For Use:

(Please Do Not Write Below This Line - Continue on Another Page if Needed) ----------------------------------------------------------------------------------------------------------------------------------

Concurrence of CDRH, Office of Device Evaluation (ODE)

Prescription Use(Per 21 CFR 801.109)	✓	OR	Over-The-Counter Use
------------------------------------------	--------------------------------------------	----	----------------------	--

Prescription Use(Per 21 CFR 801.109)	✓	(Division Sign-Off) Division of Ophthalmic Ear, Nose and Throat Devises	(Optional Format 1-2-96)
510(k) Number	K031352

Regulation Number and Section

§ 874.1050 Audiometer.

(a)
Identification. An audiometer or automated audiometer is an electroacoustic device that produces controlled levels of test tones and signals intended for use in conducting diagnostic hearing evaluations and assisting in the diagnosis of possible otologic disorders.(b)
Classification. Class II. Except for the otoacoustic emission device, the device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter, if it is in compliance with American National Standard Institute S3.6-1996, “Specification for Audiometers,” and subject to the limitations in § 874.9.