(69 days)
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.
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
The provided document describes the ER35 ERO-SCAN Pro Hearing Test System, a device intended to measure otoacoustic emissions and tympanic membrane performance. The submission is a Traditional 510(k) Premarket Notification.
Here's an analysis of the provided information regarding acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance
The document primarily focuses on establishing substantial equivalence to predicate devices and adherence to performance standards rather than defining specific acceptance criteria for a new clinical study. The "performance" discussed is related to compliance with existing standards.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Compliance with ANSI S3.39-1987 (Aural Impedance and Admittance) | The ER35 is in compliance with this standard. |
| Compliance with IEC 60645-5 (Aural Acoustic Impedance / Admittance) | The ER35 is in compliance with this standard. |
| Compliance with ANSI S3.6-2004 (Audiometers) | The ER35 is in compliance with this standard. |
| Substantial Equivalence to Predicate Devices | The ER35 utilizes the same technology and has the same intended use as the cited predicate devices (ERO-SCAN OAE Test System K980533, K010165; Interacoustics AT235 Impedance Audiometer K994254). All device parameters and materials are stated to be the same, with some reduced parameter ranges on the ER35. |
| Intended Use Match | The ER35 is intended to be a test instrument that measures otoacoustic emissions and tympanic membrane performance (tympanometry), matching the intended use of predicate devices. |
| Indications for Use Match | The ER35 is indicated for testing cochlear and middle ear function in infants, children, and adults by measuring OAEs and tympanometry. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any specific sample sizes for a test set or clinical study. The submission relies on demonstrating substantial equivalence to existing devices and compliance with recognized performance standards. Therefore, information on data provenance (country of origin, retrospective/prospective) for a test set is also not provided.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the document does not describe a clinical study that required expert-established ground truth. The device performance is assessed against recognized standards and equivalence to predicate devices, not through a new ground truth determination of a specific condition.
4. Adjudication Method for the Test Set
This information is not applicable as the document does not describe a clinical study requiring an adjudication method.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
The document does not mention a multi-reader multi-case (MRMC) comparative effectiveness study. This type of study would typically assess the improvement of human readers with AI assistance, which is not relevant to this device's function or the nature of its 510(k) submission.
6. Standalone Performance Study
The document does not describe a standalone (algorithm only without human-in-the-loop performance) study. The ER35 is described as a "microprocessor-controlled instrument" designed for screening, implying it performs measurements rather than an "algorithm only" function in the AI sense. Its performance is linked to its compliance with established standards for such instruments.
7. Type of Ground Truth Used
The concept of "ground truth" (expert consensus, pathology, outcomes data) as typically understood for diagnostic algorithms is not directly applicable to this 510(k) submission. The "truth" or "performance" is benchmarked against established performance standards for audiometers and immittance meters (ANSI S3.39-1987, IEC 60645-5, ANSI S3.6-2004) and the demonstrated performance and technical specifications of legally marketed predicate devices.
8. Sample Size for the Training Set
The document does not mention a training set sample size. This is expected for a device like the ER35, which is an instrument measuring physiological responses, rather than an AI/Machine Learning model that requires a training set.
9. How Ground Truth for the Training Set Was Established
This information is not applicable as there is no mention of a training set or an AI/Machine Learning model that would require a ground truth for training.
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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 LaneElk Grove Village, IL 60007 |
| Contact Person: | Steve IsebergManager of Instrumentation ProductsEtymotic Research, Inc.Tel: (847) 228-0006Fax: (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 874.1050Class 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 instrumentdesigned to screen otoacoustic emissions and tympanicmembrane performance (tympanometry). Test informationis stored in memory, displayed on a graphic LCD, and canbe printed by a dot matrix printer or stored on a computer.The product is manufactured and delivered completely |
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| assembled to the retailer using materials and techniqueswidely used by manufacturers of hearing devices | |
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| Intended Use: | The ER35 is intended to be a test instrument that measuresotoacoustic emissions and tympanic membraneperformance (tympanometry). |
| Indications for Use: | The ER35 ERO-SCAN Pro Hearing Test System (ER35) isindicated for testing of cochlear and middle ear function ininfants, children, and adults by measuring otoacousticemissions (OAEs) and tympanometry. |
| Comparison to Predicate Device: | |
| All device parameters and patient contacting materials arethe same for both the product which is the subject of this510(k) and the predicate devices. In a few areas, the ER35has reduced parameter ranges than the predicate devices. | |
| Conclusion: | The ER35 utilizes the same technology and has the sameintended use as the cited predicate devices, and is thereforesubstantially equivalent (21 CFR 807.92(a)(3)). |
| Performance Standards: | The ER35 is in compliance with the following performanceand safety standards: Specifications for Instruments toMeasure Aural Impedance and Admittance (Aural AcousticImmittance) (ANSI S3.39-1987), American NationalStandards Institute, New York, 1996.; Instruments for theMeasurement of Aural Acoustic Impedance / Admittance(IEC 60645-5), International Electrotechnical Commission,Geneva, 2004; and Specification for Audiometers(Dental/ENT) (ANSI S3.6-2004), American NationalStandards Institute, New York, 2004. |
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
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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.
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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
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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)
§ 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.