(78 days)
Not Found
No
The device description and performance testing focus on the physical and acoustic properties of the earphones, with no mention of AI or ML.
No
This device is an accessory to an Auditory Evoked Response system, used for delivering auditory stimuli for diagnostic testing, not for therapeutic purposes.
No
The device is an accessory (earphones) that delivers auditory stimulus for diagnostic systems. It does not perform diagnostic functions itself.
No
The device description explicitly states it is comprised of physical components like an electrical transmission path, electrical filter, speaker, acoustic transmission path, and transducer case, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Device Function: The Bio-logic Insert Earphones are described as accessories that deliver auditory stimulus to a patient's ears. They are transducers that convert electrical signals into acoustic signals.
- Intended Use: The intended use is to provide auditory stimulus for Auditory Evoked Response systems. This is a physiological measurement, not an analysis of a biological specimen.
- No Specimen Analysis: The description does not mention the collection or analysis of any biological specimens.
The device is a medical device used for delivering a stimulus to a patient's body, which falls under a different category of medical devices than IVDs.
N/A
Intended Use / Indications for Use
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.
Product codes
EWO
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.
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
ears
Indicated Patient Age Range
Infants, children, and adults.
Intended User / Care Setting
Not Found
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)
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.
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.
Etymotic Research ER-3 Insert Earphones, 510(k) #K930003
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
§ 874.1050 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.
0
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 Plaza
Mundelein, 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 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.
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:
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.
2
| Parameter for
Comparison | Etymotic
Research ER-3
Insert Earphones
(510(k) #K930003) | Bio-logic
Insert Earphone | Bio-logic
Broadband Insert
Earphone |
|---------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Intended Use | Auditory Evoked
Response | Same | Same |
| Target Population | Infants, Children,
and Adults | Same | Same |
| Human Factors | Simple, easy-to-
follow instructions
are provided. | Same | Same |
| Design | Transducer and
circuit mounted in a
case. Connected to
the test device via a
cable, and
connected to the
patient via 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. |
| 1 kHz Sensitivity
(re IEC 711
Coupler @ 1.0
Vrms AC Drive) | 114 dB SPL | 111 dB SPL | 85 dB SPL |
| Frequency
Bandwidth (± 5
dB)(re IEC 711
Coupler) | 100 Hz – 4,000 Hz | Same | 100 Hz – 10,000
Hz |
| Energy Used and
or Delivered | Device is passive
and consumes less
than 0.5 Wpeak.
This electrical
energy is converted
into acoustic
energy and
delivered to the
patient's ear. | Same | Same |
| Standards Met | Associated with
stimulation device | Same | Same |
| Bio-compatibility | All material passed
bio-compatibity
testing | Same | Same |
| Sterility | Not supplied sterile | Same | Same |
| Parameter for
Comparison | Etymotic
Research ER-3
Insert Earphones
(510(k) #K930003) | Bio-logic
Insert Earphone | Bio-logic
Broadband Insert
Earphone |
| Compatibility
with Environment | No environmental
issues | Same | Same |
| Chemical Safety | No chemicals
involved in the use
of this device. | Same | Same |
| Thermal Safety | Device does not
contain any thermal
producing
components. | Same | Same |
| Mechanical Safety | Device does not
contain any moving
components. | Same | Same |
| Electrical Safety | Patient is isolated
from device via
silicon sound tube
and 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:
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.
(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 | | |