(87 days)
Not Found
No
The description focuses on the physical coupling mechanism and materials, with no mention of AI/ML terms or functionalities.
No.
The document states that the device is intended to support auditory evaluation studies and is used with devices like audiometers, which are diagnostic tools, not therapeutic devices.
No
The Smart Coupler is described as a "passive, ear-coupling, sound-delivery device accessory" and is "intended for short-term, non-invasive use to support auditory evaluation studies". It acts as an interface between the patient's ear and an auditory stimulator, but it does not itself perform diagnostics. It is used with diagnostic devices (like audiometers) but is not one itself.
No
The device description explicitly states it is a "passive, ear-coupling, sound-delivery device accessory" and a "non-invasive, cutaneous, passive, sound-delivery device accessory" that provides a physical interface. It also mentions biocompatible materials and adhesive hydrogel, indicating a physical hardware component.
Based on the provided information, the Smart Coupler is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Smart Coupler's Function: The Smart Coupler is a device accessory used to facilitate the delivery of sound for auditory evaluation studies. It is a physical interface that couples an auditory stimulator to the patient's ear.
- No Sample Analysis: The Smart Coupler does not analyze any biological samples from the patient. It is a passive device that aids in the physical connection for sound delivery.
The description clearly states its purpose is to support auditory evaluation studies by providing a coupling interface for sound delivery, not by analyzing biological samples.
N/A
Intended Use / Indications for Use
The Smart Coupler is intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. This is the same intended use as that of the predicate device.
The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.
The Smart Coupler is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medicalgrade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Product codes (comma separated list FDA assigned to the subject device)
GWJ
Device Description
The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Head and external ear.
Indicated Patient Age Range
patients of all ages.
Newborns and all ages (assumed).
Intended User / Care Setting
The Smart Coupler is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting.
Clinical setting.
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)
This submission includes the results of performance testing of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the testing.
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
§ 882.1900 Evoked response auditory stimulator.
(a)
Identification. An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.(b)
Classification. Class II (performance standards).
0
KO73384
510(k) Summary (per 21 CFR 807.92)
ಿದ್ದಾರೆ. ಇದರ ಪ್ರ
、
| Submitter: | Intelligent Hearing Systems
6860 SW 81st Street
Miami, FL 33143 |
|-------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact : | Edward Miskiel, Ph.D.
Telephone: (305) 668-6102
Facsimile: (305) 668-6103 |
| Date Summary Prepared: | November 29, 2007 |
| Device Identification:
Common Name:
Proprietary Name: | Acoustic Coupler
Smart Coupler |
| Predicate Device: | VIASYS Healthcare Comfort Cup & Ear Tip Accessories
(K031713) |
| Device Description: | The Smart Coupler is a non-invasive, cutaneous, passive, sound-delivery device accessory that provides a coupling interface between the patient's ear and the auditory stimulator used during audiometric testing. The device is a biocompatible, non-sterile, single patient use, disposable device.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medical-grade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient. |
| Intended Use: | The Smart Coupler is intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. This is the same intended use as that of the predicate device. |
| Parameter for
Comparison | Predicate Device | Similarity or Difference to
Predicate Device |
|-----------------------------|----------------------------------|-------------------------------------------------|
| Target Population | Newborns and all ages (assumed). | Same. |
| Where Used | Clinical setting. | Same. |
| Anatomical Sites | Head and external ear. | Same. |
| Sterility | Not supplied sterile. | Same. |
Comparison Summary of Technological Characteristics:
:
1
| Parameter for
Comparison | Predicate Device | Similarity or Difference to
Predicate Device |
|---------------------------------|----------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Biocompatibility | Unknown. | All material in contact with the
patient successfully passed the
biocompatibility testing criteria
specified in the ISO 10993 standard
for short-term skin contact
(cytotoxicity, skin irritation, & skin
sensitization). |
| Design | 2 models available:
• Circumaural
• Intra-aural | 3 models available:
• Circumaural
• Intra-aural
• Supra-aural |
| Materials | Foam, flexible elastomeric material,
and adhesive material to adhere to
skin surface. | Same (expect no foam). |
| Human Factors | Simple, easy-to-follow instructions. | Same. |
| Standards | None known. | Same. |
| Energy Used and/or
Delivered | Device is passive and does not
consume or produce any energy.
Only acoustic energy from a different
source is conveyed. | Same. |
| Chemical Safety | No chemicals are involved in the use
of this device. | Same. |
| Mechanical Safety | No mechanical parts. | Same. |
| Electrical Safety | Device is not electrical in nature. | Same. |
| Thermal Safety | Device is not thermal in nature. | Same. |
Substantial Equivalence:
This submission includes the results of performance testing of prototype devices to specifications. The results were as expected and no new issues of safety and effectiveness were raised as a result of the testing.
Conclusions:
Based on the information presented in this submission, the Smart Coupler device is as safe and effective as and is substantially equivalent to the identified predicate device.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three stripes forming its wing. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 8 2008
Intelligent Hearing Systems c/o Edward Miskiel, Ph.D. 6860 S.W. 81st Street Miami, FL 33143
Re: K073384
Trade/Device Name: Smart Coupler Regulation Number: 21 CFR 882.1900 Regulation Name: Evoked Response Auditory Stimulator Regulatory Class: Class II Product Code: GWJ Dated: February 14, 2008 Received: February 15, 2008
Dear Dr. Miskiel:
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.
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.
3
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 Center for Devices and Radiological Health's (CDRH's) Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding postmarket surveillance, please contact CDRH's Office of Surveillance and Biometric's (OSB's) Division of Postmarket Surveillance at 240-276-3474. For questions regarding the reporting of device adverse events (Medical Device Reporting (MDR)), please contact the Division of Surveillance Systems at 240-276-3464. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Maling B. Eglitis, ud
Malvina B. Eydelman, M. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
073384
Page 3 -
Indications for Use
510(k) Number (if known): K073384
Device Name: Smart Coupler
The Smart Coupler is a passive, ear-coupling, sound-delivery device accessory intended for short-term, non-invasive use to support auditory evaluation studies (including use with audiometers, auditory evoked potential and otoacoustic emissions devices) on patients of all ages. The Smart Coupler is a biocompatible, non-sterile, single patient use, disposable device.
The Smart Coupler is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's, or physician's office or other appropriate setting.
The anatomical sites of contact for the Smart Coupler are the external skin surrounding the ear (circumaural model), the external skin of the outer ear (supra-aural model), or the external skin of the ear canal (intra-aural model) with the contact object being a thin layer of medicalgrade, biocompatible adhesive hydrogel, used for adhering the Smart Coupler device to the patient.
Prescription Use (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel C Clapp
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises
510(k) Number KD73384
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