(74 days)
No
The device description and performance studies focus on the acoustic and electrical properties of the earphones, with no mention of AI or ML.
No
The device delivers auditory stimulus for testing and does not provide therapy or treatment.
No
The device is an accessory (earphones) that delivers auditory stimulus for diagnostic audiometers and evoked response systems, but it is not a diagnostic device itself. The earphones are the means for delivering the stimulus, not performing the diagnosis.
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 diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Function: The GN Otometrics Insert Earphones are described as transducers that deliver auditory stimulus to a patient's ears. They are used in conjunction with audiometers and auditory evoked response systems to assess hearing.
- Lack of Biological Sample Analysis: The device does not analyze any biological samples from the patient. It directly interacts with the patient's ears to deliver sound.
Therefore, the function and intended use of the GN Otometrics Insert Earphones clearly fall outside the scope of in vitro diagnostics.
N/A
Intended Use / Indications for Use
The GN Otometrics Insert Earphones are accessories to the GN Otometrics Audiometers and GN Otometrics Auditory Evoked Response systems. The GN Otometrics Insert Earphone 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 GN Otometrics Insert Earphones are transducers that convert electrical stimulus, provided by GN Otometrics Audiometers and GN Otometrics 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 Audiometer or Auditory Evoked Response Stimulator, by means of a connector. The other end of the cable is attached 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 a front acoustic transmission path and a back acoustic transmission path. The back acoustic transmission path consists of a series of tubes and cavities which are configured to create two resonant acoustic circuits. These resonant circuits are used to smooth the acoustic output at the eartip, by reducing the primary and secondary resonant peaks caused by the impedance mismatch at both ends of the front transmission path. The front acoustic transmission path consists of silicon tubing, tube nipple, and an eartip. The tube nipple provides acoustic and mechanical connection to the 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, Speaker, and back acoustic transmission path. Each Transducer case provides means of handling and labeling and means to secure the Electrical Transmission Path (cable).
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)
Substantial equivalence to the Etymotic Research ER-3 Insert Earphones (510(k) #K930003) was based on non-clinical performance testing of the acoustic and electrical parameters as specified in the ANSI/ASA S 3.6-2004, Specification for Audiometers.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Etymotic Research ER-3 Insert Earphones, 510(k) #K930003
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
510(k) Submission (21 CFR 807.90(e)) for GN Otometrics Insert Earphones
Section 5:
.
JUL 1 4 2008
510(k) Summary
| Date: | April 30, 2008 |
|---|---|
| Submitted By: | GN Otometrics |
| 125 E. Commerce Drive | |
| Schaumburg, IL 60173 | |
| USA | |
| Telephone: | |
| Fax: | 847-534-2150 #6932 |
| 847-534-2153 | |
| Contact Person: | Daniel Sansonetti |
| Manager of Research & Development | |
| dsansonetti@gnotometrics.com | |
| Name of Device: | OtoInsert |
| Common Name: | Insert Earphones for auditory stimulus delivery |
| Classification Name: | Accessories to devices with classification: |
| Audiometer (per 21 CFR section 874.1050) | |
| and | |
| 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 |
.
:
: 上一篇:
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1
Description of the Device:
The GN Otometrics Insert Earphones are transducers that convert electrical stimulus, provided by GN Otometrics Audiometers and GN Otometrics 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 Audiometer or Auditory Evoked Response Stimulator, by means of a connector. The other end of the cable is attached 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 a front acoustic transmission path and a back acoustic transmission path. The back acoustic transmission path consists of a series of tubes and cavities which are configured to create two resonant acoustic circuits. These resonant circuits are used to smooth the acoustic output at the eartip, by reducing the primary and secondary resonant peaks caused by the impedance mismatch at both ends of the front transmission path. The front acoustic transmission path consists of silicon tubing, tube nipple, and an eartip. The tube nipple provides acoustic and mechanical connection to the 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, Speaker, and back acoustic transmission path. Each Transducer case provides means of handling and labeling and means to secure the Electrical Transmission Path (cable).
Intended Use of the Device:
The GN Otometrics Insert Earphones are accessories to the GN Otometrics Audiometers and GN Otometrics Auditory Evoked Response systems. The GN Otometrics Insert Earphone 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
510(k) Submission (21 CFR 807.90(e)) for GN Otometrics Insert Earphones
Comparison to Predicate Device:
The GN Otometrics Insert Earphones were designed to be a direct replacement to the Etymotic Research ER-3 Insert Earphones (510(k) #K930003). The GN Ottometrics Insert Earphones share the same technological characteristics as the Etymotic Research ER-3 Insert Earphones (510(k) #K930003). Both insert earphones are comprised of the same sections: 1.) Electrical Transmission Path, 2.) Electrical Filter, 3.) Spcaker, 4.) Acoustic Transmission Path, and 5.) Transducer Case.
The Electrical Transmission Path in both the GN Otometrics and Etymotic Insert Earphones are comprised of a cable with a connector on each end. The only differences are cable manufacturer, cable color, durometer, nominal dimensions, and connector type.
The Electrical Filter sections of both the GN Otometrics and Etymotic Insert Earphones are identical with respect to component values and configuration. The only difference is component manufacturers.
The Speaker in both the GN Otometrics and Etymotic Insert Earphones are from the same manufacturer and are the same model number.
The Acoustic Transmission Path in both the GN Otometrics and Etymotic Insert Earphones are identical with respect to nominal dimensions and configuration. Both the GN Otometrics and Etymotic Insert Earphones have a front and back acoustic transmission path. The only difference in the back transmission path is the material and construction method. The Etymotic Insert Earphones use PVC tubing to create the acoustic resonant circuits, while the GN Otometrics uses stainless steel tubes inseted into a rubber molded part. The end result of both construction methods is the same. The front transmission path is identical with respect to materials, dimensions, and counting means to the patient. Both the GN Otometrics and Etymotic Insert Earphones use the same disposable eartips from the same manufacturer.
The Transducer Case in both the GN Otometrics and Etymotic Insert Earphones are similar with exception to shape and color.
The intended use of both the GN Otometrics and Etymotic Insert Earphones is the same. Both the GN Otometrics and Etymotic Insert Earphones are intended to been a transducers to convert electrical stimulus, delivered by an Audiometer or Evoked Potential stimulator, into acoustic stimulus, which is then delivered to the patient's ear by means of a disposable Eartip.
Substantial Equivalence Performance Metrics:
Substantial equivalence to the Etymotic Research ER-3 Insert Earphones (510(k) #K930003) was based on non-clinical performance testing of the acoustic and electrical parameters as specified in the ANSI/ASA S 3.6-2004, Specification for Audiometers.
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes forming its wing, symbolizing the department's mission to protect and promote the health and well-being of Americans. 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
UUL 1 4 2008
GN Otometrics c/o Daniel Sansonetti Manager of Research & Development 125 E. Commerce Drive Schaumburg, IL 60173
Re: K081234
Trade/Device Name: GN Otometrics Insert Earphones Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO Dated: June 27, 2008 Received: June 27, 2008
Dear Mr. Sansonetti:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced aboye 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.
4
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,
M. B. Egerkins, mD
Malvina B. Eydelman, M.D. Director Division of Ophthalmic and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Submission (21 CFR 807.90(e)) for GN Otometrics Insert Earphones
Section 4:
Indications for Use
510(k) Number (if known): 1/208 /234
Device Name: GN Otometrics Insert Earphones
Indications for Use:
The GN Otometrics Insert Earphones are accessories to the GN Otometrics Audiometers and Chartr EP Auditory Evoked Response systems. The GN Otometrics 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.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Laura Sohn
n of Ophthalmic Far and Throat Devises
510(k) Number K081234