(80 days)
No
The device is a passive, non-electrical accessory for delivering sound, with no mention of computational or analytical capabilities.
No.
The device is an accessory that delivers auditory stimuli for diagnostic screening, not for therapy or treatment.
No
The device is an accessory (earphone device) for delivering auditory stimuli from a screening and diagnostic system; it is not the diagnostic system itself.
No
The device is described as a physical, disposable foam and plastic device that delivers sound. It is not software.
Based on the provided information, the Bio-logic Ear Muffins® is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is used to examine specimens derived from the human body (like blood, urine, or tissue) to provide information for diagnosis, monitoring, or screening.
- Bio-logic Ear Muffins Function: The Bio-logic Ear Muffins® are described as a device for delivering auditory stimulus to the ear. They are an accessory to auditory evoked response systems. They do not analyze any biological specimens.
- Mechanism of Action: The device is a physical means of directing sound to the ear, not a tool for analyzing biological samples.
Therefore, the Bio-logic Ear Muffins® fall outside the definition of an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Bio-logic Ear Muffins® is a disposable earphone device intended to be used as an accessory to the Bio-logic ABaer / Navigator Pro auditory evoked response screening and diagnostic systems, and the Natus Medical Inc. ALGO series auditory evoked response screening systems. The Ear Muffins® device performs as the means for delivering the auditory stimulus from the auditory stimulator to the ear of the patient under test.
The Bio-logic Ear Muffins® device is especially indicated for use in the auditory evoked response screening of newborn infants, because the Ear Muffins® can be placed to cover the entire ear of the infant, so nothing has to be placed into the ear canal.
Product codes
HCC
Device Description
The Bio-logic Ear Muffins consist of a pair of single-use, disposable foam & plastic donut-shaped devices for delivering sound to the human ear. The Ear Muffin is specifically designed in size and shape to be used with infants. The Ear Muffin is one of the alternative sound delivery devices offered as accessory options to the ABaer and Navigator Pro product lines. The ABaer/Navigator Pro has received FDA Marketing Clearance via 510(k) #K994149. The Ear Muffins can also be used as a stand-alone device with the Natus Medical ALGO series of Newborn Hearing Screening systems, as demonstrated in the test results within this 510(k) notification.
Electrical safety is not an issue with the Ear Muffins, because the Ear Muffin is not electrical in nature, it is simply a different tubing system for sound delivery to the ear. The Ear Muffins connect to the output of Auditory Stimulator device (e.g., Natus ALGO), and provide an acoustic pathway to direct the auditory stimulus to the ear of the infant. The Muffins are applied to the baby's head to cover the ears, similar to the way a large set of headphones might cover the ears of an adult.
The Ear Muffin only makes very brief contact with the skin, and does not contact in vivo body tissues or fluids. The material used for the Ear Muffins has been found to be safe for this use by its manufacturer through appropriate biocompatibility testing.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Device is placed covering the ear of newborn infants.
Indicated Patient Age Range
Newborn & very young infants.
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
Non-clinical testing was performed to demonstrate the substantial equivalence of the Bio-logic Ear Muffins® to the Natus Medical Inc. Ear Couplers. This performance testing consisted of measuring the sound level within the ear canal of a large number of test subjects, using the Natus ALGO-2 device with (1) the Natus Ear Coupler and (2) the Bio-logic Ear Muffins®.
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 Bio-logic Ear Muffins® to the Natus Medical Inc. Ear Couplers. This performance testing consisted of measuring the sound level within the ear canal of a large number of test subjects, using the Natus ALGO-2 device with (1) the Natus Ear Coupler and (2) the Bio-logic Ear Muffins®. The average of all sound levels measured with (1) was within 1 dB SPL of the average of all sound levels measured with (2). Standard deviation for the results of tests (1) and (2) were approximately 1.4 dB SPL in both cases. Therefore, it is concluded that the performance of the Bio-logic Ear Muffins® is very similar to that of the Natus Medical Inc. Ear Coupler, and it is therefore substantially equivalent to this predicate device.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Average stimulus strength measured in ear canal is 79.28 dB SPL with standard deviation of 1.34 dB SPL.
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.5050 Biofeedback device.
(a)
Identification. A biofeedback device is an instrument that provides a visual or auditory signal corresponding to the status of one or more of a patient's physiological parameters (e.g., brain alpha wave activity, muscle activity, skin temperature, etc.) so that the patient can control voluntarily these physiological parameters.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter when it is a prescription battery powered device that is indicated for relaxation training and muscle reeducation and prescription use, subject to § 882.9.
0
OCT 1 5 2001
Image /page/0/Picture/1 description: The image shows a handwritten alphanumeric string. The string is "KO12384". The characters are written in a cursive style with a slight slant.
One Bio-logic Plaza Mundelein, Illinois 60060-3700 1-800-323-8326 Fax: 847-949-8615 Biogre
SECTION 10 BIO-LOGIC EAR MUFFINS ® 510(k)
PREMARKET NOTIFICATION 510(k) SUMMARY
PREPARED BY:
Bio-logic Systems Corp One Bio-logic Plaza Mundelein, IL 60060
TELEPHONE: FAX: Email:
(847)-949-5200 ext. 224 (847)-949-8615 normb@blsc.com
Norman E. Brunner CONTACT PERSON:
DATE ON WHICH THE SUMMARY WAS PREPARED: July 20, 2001
NAME OF DEVICE: Bio-logic Ear Muffins®
Earphones for Evoked Response auditory stimulus delivery. COMMON NAME:
CLASSIFICATION NAME: Accessory to primary device, classification: Stimulator, Auditory, Evoked Response, (per 21 CFR section 882.1900).
PREDICATE DEVICE: Natus Medical Inc. Ear Coupler Earphones, part of ALGO Disposable Kit used with ALGO-2 Newborn Hearing Screener, 510(k) #K936039.
Page 10
1
DESCRIPTION OF THE DEVICE:
The Bio-logic Ear Muffins consist of a pair of single-use, disposable foam & plastic donutshaped devices for delivering sound to the human ear. The Ear Muffin is specifically designed in size and shape to be used with infants. The Ear Muffin is one of the alternative sound delivery devices offered as accessory options to the ABaer and Navigator Pro product lines. The ABaer/Navigator Pro has received FDA Marketing Clearance via 510(k) #K994149. The Ear Muffins can also be used as a stand-alone device with the Natus Medical ALGO series of Newborn Hearing Screening systems, as demonstrated in the test results within this 510(k) notification.
Electrical safety is not an issue with the Ear Muffins, because the Ear Muffin is not electrical in nature, it is simply a different tubing system for sound delivery to the ear. The Ear Muffins connect to the output of Auditory Stimulator device (e.g., Natus ALGO), and provide an acoustic pathway to direct the auditory stimulus to the ear of the infant. The Muffins are applied to the baby's head to cover the ears, similar to the way a large set of headphones might cover the ears of an adult.
The Ear Muffin only makes very brief contact with the skin, and does not contact in vivo body tissues or fluids. The material used for the Ear Muffins has been found to be safe for this use by its manufacturer through appropriate biocompatibility testing.
INTENDED USE OF THE DEVICE:
The Bio-logic Ear Muffins® is a disposable earphone device intended to be used as an accessory to the Bio-logic ABaer / Navigator Pro auditory evoked response screening and diagnostic systems, and the Natus Medical Inc. ALGO series auditory evoked response screening systems. The Ear Muffins® device performs as the means for delivering the auditory stimulus from the auditory stimulator to the ear of the patient under test.
The Bio-logic Ear Muffins® device is especially indicated for use in the auditory evoked response screening of newborn infants, because the Ear Muffins® can be placed to cover the entire ear of the infant, so nothing has to be placed into the ear canal.
2
COMPARISON SUMMARY OF TECHNOLOGICAL CHARACTERISTICS:
| PARAMETER FOR
COMPARISON | Bio-logic Systems Corp.
Ear Muffins® | Similarity or
difference to Predicate
Device |
|---------------------------------|-----------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------|
| Indications for Use | Auditory Evoked Response
screening for infants. | Same. |
| Target Population | Newborn & very young infants. | Same. |
| Design | Lightweight foam & plastic donut-
shape covered earphones with
plastic tubing connecting to
stimulator | Slight differences in
size, shape and
thickness of materials. |
| Materials | Disposable foam & plastic. | Very similar. |
| Performance | Average stimulus strength measured
in ear canal is 79.28 dB SPL with
standard deviation of 1.34 dB SPL. | Same to within less than
1 dB SPL. |
| Sterility | Not supplied sterile. | Same. |
| Biocompatibility | All materials successfully passed
biocompatibility testing. | Same. |
| Mechanical Safety | No mechanical parts. | Same. |
| Chemical Safety | No chemicals involved in the use of
this device. | Same. |
| Anatomical Sites | Device is placed covering the ear of
newborn infants. | Same. |
| Human Factors | Simple, easy-to-follow instructions
are provided. | Same. |
| Energy Used and/or
Delivered | Device is passive and consumes no
energy. Only Auditory energy is
delivered as noted above. | Same. |
| Standards Met | Associated with stimulation device. | Same. |
| Electrical Safety | Device not electrical in nature. | Same. |
| Thermal Safety | Device not thermal in nature. | Same |
DISCUSSION AND ASSESSMENT OF NON-CLINICAL PERFORMANCE DATA:
Non-clinical testing was performed to demonstrate the substantial equivalence of the Bio-logic Ear Muffins® to the Natus Medical Inc. Ear Couplers. This performance testing consisted of measuring the sound level within the ear canal of a large number of test subjects, using the Natus ALGO-2 device with (1) the Natus Ear Coupler and (2) the Bio-logic Ear Muffins®. The average of all sound levels measured with (1) was within 1 dB SPL of the average of all sound levels measured with (2). Standard deviation for the results of tests (1) and (2) were approximately 1.4 dB SPL in both cases. Therefore, it is concluded that the performance of the Bio-logic Ear Muffins® is very similar to that of the Natus Medical Inc. Ear Coupler, and it is therefore substantially equivalent to this predicate device.
3
Image /page/3/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized eagle or bird symbol, composed of three curved lines, representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
OCT 1 5 2001
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Norman E. Brunner Vice President of Research and Development Bio-Logic Systems Corporation One Bio-logic Plaza Mundelein, Illinois 60060
Re: K012384
Trade/Device Name: Bio-logic Ear Muffins Regulation Number: 882.5050 Regulation Name: Biofeedback device Regulatory Class: II Product Code: HCC Dated: July 26, 2001 Received: July 27, 2001
Dear Mr. Brunner:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo nave roviewed your becamed the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use sured in the encreated of 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). and Oosmeter For (110) that the device, subject to the general controls provisions of the Act. The I ou may, dicrore, marks of the Act include requirements for annual registration, listing 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 If your device 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 r toase be actived that I Dr bristian that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must or any I 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.
4
Page 2 - Mr. Norman E. Brunner
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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained 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,
Susan Walker, MD
Image /page/4/Picture/5 description: The image shows a freehand drawing of a curved line. The line starts at the bottom left, curves upwards into a loop, and then extends to the right. The drawing is simple and abstract, resembling a stylized symbol or signature.
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Not Assigned
........
Device Name: Bio-logic Ear Muffins®
Indications For Use:
The Bio-logic Ear Muffins® is a disposable earphone device intended to be used as an accessory to the Bio-logic ABaer / Navigator Pro auditory evoked response screening and diagnostic systems, and the Natus Medical Inc. ALGO series auditory evoked response screening systems. The Ear Muffins® device performs as the means for delivering the auditory stimulus from the auditory stimulator to the ear of the patient under test.
The Bio-logic Ear Muffins® device is especially indicated for use in the auditory evoked response screening of newborn infants, because the Ear Muffins® can be placed to cover the entire ear of the infant, so nothing has to be placed into the ear canal.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Su-WL
(Division Sim-Off) Division of General, Restorative and Neurological Devices
510(k) Number_140123 €4
Prescription Use
(Per 21 CFR 801.109) ✓
OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)