(69 days)
Not Found
No
The document describes a microprocessor-controlled instrument for measuring otoacoustic emissions and tympanometry, with no mention of AI, ML, or related concepts in the device description, intended use, or other sections.
No.
The ER35 is described as a "test instrument" and a "screening" device that "measures otoacoustic emissions and tympanic membrane performance (tympanometry)". Its purpose is to assess cochlear and middle ear function, which falls under diagnostic or screening categories rather than direct therapeutic intervention.
Yes
The device is intended for "testing of cochlear and middle ear function" and measures "otoacoustic emissions" and "tympanic membrane performance," which are used to evaluate the function of these parts of the ear, indicating a diagnostic purpose.
No
The device description explicitly states it is a "microprocessor-controlled instrument" and is "manufactured and delivered completely assembled," indicating it is a hardware device with embedded software, not a standalone software-only device.
Based on the provided information, the ER35 is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body, such as blood, urine, or tissue, to provide information about a person's health.
- ER35 Function: The ER35 directly measures physiological responses within the ear (otoacoustic emissions and tympanic membrane performance). It does not analyze samples taken from the body.
The ER35 is a diagnostic device used for assessing hearing function, but it falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
The ER35 is intended to be a test instrument that measures otoacoustic emissions and tympanic membrane performance (tympanometry).
The ER35 ERO-SCAN Pro Hearing Test System (ER35) is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) and tympanometry.
Product codes (comma separated list FDA assigned to the subject device)
EWO, ETY
Device Description
The ER35 is a microprocessor-controlled instrument designed to screen otoacoustic emissions and tympanic membrane performance (tympanometry). Test information is stored in memory, displayed on a graphic LCD, and can be printed by a dot matrix printer or stored on a computer. The product is manufactured and delivered completely assembled to the retailer using materials and techniques widely used by manufacturers of hearing devices
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
cochlear and middle ear
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)
Not Found
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
§ 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
K070880
Traditional 510(k) Premarket Notification ER35 ERO-SCAN Pro Hearing Test System
JUN - 7 2007
3.0 510(K) SUMMARY
| Submission Date: | March 30, 2000 |
|---|---|
| ------------------ | ---------------- |
Submitter Information:
:
| Company Name: | Etymotic Research, Inc. |
|---|---|
| Company Address: | Etymotic Research, Inc. |
| 61 Martin Lane | |
| Elk Grove Village, IL 60007 | |
| Contact Person: | Steve Iseberg |
| Manager of Instrumentation Products | |
| Etymotic Research, Inc. | |
| Tel: (847) 228-0006 | |
| Fax: (847) 228-6836 |
Device Information:
| Trade Name: | ER35 ERO-SCAN Pro Hearing Test System |
|---|---|
| Common Name: | ER35 ERO-SCAN Pro (ER35) |
| Classification Name: | Audiometer and Auditory Impedance Tester |
| Device Class: | Class II, 510(k) exempt, 21 CFR 874.1050 |
| Class II, 21 CFR 874.1090 | |
| Predicate Devices: | ERO-SCAN OAE Test System (K980533, K010165) |
| Etymotic Research, Inc. | |
| Class II, 510(k) exempt | |
| Interacoustics AT235 Impedance Audiometer (K994254) | |
| International Distributors of Electronics for Medicine, Inc. | |
| (IDEM) | |
| Class II | |
| Device Description: | The ER35 is a microprocessor-controlled instrument |
| designed to screen otoacoustic emissions and tympanic | |
| membrane performance (tympanometry). Test information | |
| is stored in memory, displayed on a graphic LCD, and can | |
| be printed by a dot matrix printer or stored on a computer. | |
| The product is manufactured and delivered completely |
・
1
:
:
: :
:
:
:
·
| assembled to the retailer using materials and techniques
| widely used by manufacturers of hearing devices | |
|---|---|
| Intended Use: | The ER35 is intended to be a test instrument that measures |
| otoacoustic emissions and tympanic membrane | |
| performance (tympanometry). | |
| Indications for Use: | The ER35 ERO-SCAN Pro Hearing Test System (ER35) is |
| indicated for testing of cochlear and middle ear function in | |
| infants, children, and adults by measuring otoacoustic | |
| emissions (OAEs) and tympanometry. | |
| Comparison to Predicate Device: | |
| All device parameters and patient contacting materials are | |
| the same for both the product which is the subject of this | |
| 510(k) and the predicate devices. In a few areas, the ER35 | |
| has reduced parameter ranges than the predicate devices. | |
| Conclusion: | The ER35 utilizes the same technology and has the same |
| intended use as the cited predicate devices, and is therefore | |
| substantially equivalent (21 CFR 807.92(a)(3)). | |
| Performance Standards: | The ER35 is in compliance with the following performance |
| and safety standards: Specifications for Instruments to | |
| Measure Aural Impedance and Admittance (Aural Acoustic | |
| Immittance) (ANSI S3.39-1987), American National | |
| Standards Institute, New York, 1996.; Instruments for the | |
| Measurement of Aural Acoustic Impedance / Admittance | |
| (IEC 60645-5), International Electrotechnical Commission, | |
| Geneva, 2004; and Specification for Audiometers | |
| (Dental/ENT) (ANSI S3.6-2004), American National | |
| Standards Institute, New York, 2004. |
:
:
:
.
2
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/12 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus, which is a symbol often associated with healthcare. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged around the caduceus in a circular fashion.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Etymotic Research, Inc. c/o Campbell L. Tuskey Becker & Associates Consulting, Inc. 2001 Pennsylvania Avenue NW, Suite 950 Washington, DC 20006
JUN -7 2007
Re: K070880
Trade/Device Name: ER35 ERO-SCAN Pro Hearing Test System Regulation Number: 21 CFR 874.1050 Regulation Name: Audiometer Regulatory Class: Class II Product Code: EWO, ETY Dated: May 18, 2007 Received: May 21, 2007
Dear Ms. Tuskey:
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 for association 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). and Coometre Fros ( 100 ) 100 ) 100 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
Page 2- Ms. Campbell L. Tuskey
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 (240) 276-0115. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrl/industry/support/index.html.
Sincerely yours,
MB Egelman SiMD
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
4
Traditional 510(k) Premarket Notification ER35 ERO-SCAN Pro Hearing Test System Etymotic Research, Inc. Page 5
STATEMENT OF INDICATIONS FOR USE 2.0
510(k) Number (if known): K 070880
Device Name:
ER35 ERO-SCAN Pro Hearing Test System
Indications for Use:
The ER35 ERO-SCAN Pro Hearing Test System (ER35) is indicated for testing of cochlear and middle ear function in infants, children, and adults by measuring otoacoustic emissions (OAEs) and tympanometry.
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)
Page 1 of 1
Prescription Use
(Per 21 CFR 801.109)