Predicate Devices

SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060).

Reference Devices

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary explicitly states "Mentions AI, DNN, or ML: Not Found" and describes the device as a repackaging of previously cleared devices without mentioning any new AI/ML capabilities.

Therapeutic

No
The device is described as a diagnostic aid for auditory and hearing related disorders, not for treatment.

Diagnostic

Yes
The "Intended Use / Indications for Use" section explicitly states that the product is "intended to be used as a diagnostic aid in auditory and hearing related disorders."

SaMD (Software as a Medical Device)

No

The device description explicitly states that it is a "single integrated unit" combining previously cleared devices, including an "Opti-Amp DC-Powered," which is a hardware component. It also mentions physical contact with the patient via electrodes and sound delivery devices.

IVD (In Vitro Diagnostic)

Based on the provided information, this device is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostic devices are used to examine specimens derived from the human body, such as blood, urine, or tissue, to provide information for diagnosis, monitoring, or screening.
Device Function: The Smart USBLite device system records auditory evoked potentials and otoacoustic emissions. This involves measuring electrical signals and sound responses directly from the patient's body (scalp, ear).
Lack of Specimen Analysis: The description does not mention the analysis of any biological specimens. The device interacts directly with the patient's physiological responses.

Therefore, the Smart USBLite falls under the category of a medical device used for physiological measurement and diagnostic aid, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The Smart USBLite device is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages. This is the same intended use as that of the predicate devices.

The intended use of the Smart USBLite device system is for the recording of auditory evoked potential, otoacoustic emissions, & auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages.

Product codes (comma separated list FDA assigned to the subject device)

GWJ; EWO; GWO; GWL

Device Description

Smart USBLite is an auditory evoked potential and otoacoustic emission system that is capable of recording and measuring auditory evoked potential, otoacoustic emission, and auditory steady-state evoked potential data.
The Smart USBLite system combines the following FDA 510(k) previously cleared devices into a repackaged, smaller-sized, single integrated unit: SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060).

The feature modifications described in this Special 510(k) are to incorporate a repackaged variation of the listed predicate devices combined into a smaller-sized single integrated unit, the Smart USBLite. The Smart USBLite device is identical to the predicate device(s) in its intended use and methodologies, which have not changed as a result of modifications to the general specifications of the device. The Smart USBLite device can be used to perform all four different kinds of tests provided by the listed predicate devices, namely: auditory evoked potentials (AEP), auditory evoked potential screening, distortionproduct otoacoustic emissions (DPOAE), transient otoacoustic emissions (TrOAE), and auditory steadystate response (ASSR) testing.

The modifications associated with this new Smart USBLite device are mostly to the physical layout and aesthetics of the device hardware only, and do not change the software in any significant way. The new device utilizes hardware variations primarily to enhance size-reduction and portability, while still performing the same hardware functions in essentially the same ways as the predicate devices. The Smart USBLite uses the same five software packages used by the five individual predicate devices (i.e., SmartEP, SmartScreener, SmartOAE, SmartIrOAE, and SmartEP-ASSR software). The software has remained essentially the same for the new device, with small variations to accommodate differences in hardware. The same functionality and user interfaces have remained. Together, these minor hardware and software changes implement the same functionality and perform the same intended uses as the predicate devices in a single integrated unit.

The Smart USBLite hardware is very similar in electronics design to the predicate device hardware, except that the electronics hardware has been repackaged into a single, smaller, stand-alone box. Unlike the predicate devices, there is no separate pre-amplifier unit connected to the patient in the Smart USBLite system. Instead, all of the pre-amplifier electronics have been embedded inside of the SmartUSBLite receiver unit. The same patient isolation methods are used.

Besides packaging, the other minor modifications to the Smart USBLite over the previous devices are the number of input/output channels, gain, and filter specifications/characteristics.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

The patient's scalp and possibly other body sites with the contact objects being electrodes that are capable of measuring bio-potentials
The patient's ear with the contact object being a sound delivery device eartip, headphone, ear probe, or ear cups.

Indicated Patient Age Range

patients of all ages.

Intended User / Care Setting

The Smart USBLite is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate 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)

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.

SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060).

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.

K914876

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

Regulation Number and Section

§ 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).

Summary

0

KO61443

1. 2

JUN 2 3 2006

:

Special 510(k) Summary

:

| Prepared By: | Intelligent Hearing Systems
6860 SW 81st Street
Miami, FL 33143 |
|------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Telephone: | (305) 668-6102 |
| FAX: | (305) 668-6103 |
| Contact Person: | Edward Miskiel |
| Date Summary prepared: | May 23, 2006 |
| Name of the Device: | Smart USBLite (with options of SmartEP, SmartScreener,
SmartOAE, SmartTrOAE, and SmartEP-ASSR) |
| Common Name: | Auditory Evoked Potential System & Otoacoustic Device |
| Classification Name: | Auditory Evoked Response Stimulator (per CFR 882.1900)
& Audiometer (per CFR 874.1050) |
| Predicate Device(s): | SmartEP (K904926), SmartScreener (K925648), SmartOAE
(K964426), SmartTrOAE (K023859), SmartEP-ASSR
(K031051), and Opti-Amp DC-Powered (K052060). |
| Device Description: | Smart USBLite is an auditory evoked potential and
otoacoustic emission system that is capable of recording
and measuring auditory evoked potential, otoacoustic
emission, and auditory steady-state evoked potential data. |
| | The Smart USBLite system combines the following FDA
510(k) previously cleared devices into a repackaged,
smaller-sized, single integrated unit: SmartEP (K904926),
SmartScreener (K925648), SmartOAE (K964426),
SmartTrOAE (K023859), SmartEP-ASSR (K031051), and
Opti-Amp DC-Powered (K052060). |
| Intended Use: | The Smart USBLite device is intended to be used as a
diagnostic aid in auditory and hearing related disorders, as
an objective measure of cochlear function, and as an
adjunctive tool in the estimation of behavioral hearing
thresholds on patients of all ages. This is the same
intended use as that of the predicate devices. |

・・・・・・・・・

1

Technological Characteristics:

The Intelligent Hearing Systems (IHS) family of products is intended to be used for recording and analysis of human physiological data for the purpose of neurological diagnosis, screening, and treatment of sensory disorders. The Smart USBLite device referenced above is the latest in a series of systems of this type marketed by IHS. Other related devices comprising the IHS family of products include:

1. 510(k) #K904926 SmartEP Auditory Evoked Potential System
1. 510(k) #K904926 SmartScreener Automated Auditory Evoked Potential Screening System
1. 510(k) #K964426 SmartOAE Distortion-Product Otoacoustic Emissions System

510(k) #K023859 - SmartTrOAE Transient Otoacoustic Emissions System

1. 510(k) #K031051 SmartEP-ASSR Auditory Steady-State Response System

510(k) #K052060 - Opti-Amp DC-Powered Physiological Signal Amplifier System

The feature modifications described in this Special 510(k) are to incorporate a repackaged variation of the listed predicate devices combined into a smaller-sized single integrated unit, the Smart USBLite. The Smart USBLite device is identical to the predicate device(s) in its intended use and methodologies, which have not changed as a result of modifications to the general specifications of the device. The Smart USBLite device can be used to perform all four different kinds of tests provided by the listed predicate devices, namely: auditory evoked potentials (AEP), auditory evoked potential screening, distortionproduct otoacoustic emissions (DPOAE), transient otoacoustic emissions (TrOAE), and auditory steadystate response (ASSR) testing.

The modifications associated with this new Smart USBLite device are mostly to the physical layout and aesthetics of the device hardware only, and do not change the software in any significant way. The new device utilizes hardware variations primarily to enhance size-reduction and portability, while still performing the same hardware functions in essentially the same ways as the predicate devices. The Smart USBLite uses the same five software packages used by the five individual predicate devices (i.e., SmartEP, SmartScreener, SmartOAE, SmartIrOAE, and SmartEP-ASSR software). The software has remained essentially the same for the new device, with small variations to accommodate differences in hardware. The same functionality and user interfaces have remained. Together, these minor hardware and software changes implement the same functionality and perform the same intended uses as the predicate devices in a single integrated unit.

The Smart USBLite hardware is very similar in electronics design to the predicate device hardware, except that the electronics hardware has been repackaged into a single, smaller, stand-alone box. Unlike the predicate devices, there is no separate pre-amplifier unit connected to the patient in the Smart USBLite system. Instead, all of the pre-amplifier electronics have been embedded inside of the SmartUSBLite receiver unit. The same patient isolation methods are used.

Besides packaging, the other minor modifications to the Smart USBLite over the previous devices are the number of input/output channels, gain, and filter specifications/characteristics. A complete comparison between the Smart USBLite and the predicate devices is given in specifications Table 1.

Figures 1-2 give simplified block diagrams for the predicate devices system hardware and the new Smart USBLite system.

2

Safety and Effectiveness:

The Smart USBLite utilizes many of the same design principles, circuit designs, and operating principles as are used in the predicate devices. All of the modifications of the Smart USBLite device were designed in accordance with procedures that meet FDA QSR Design Control and ISO-13485:2003 specifications.

The Smart USBLite device will be evaluated and certified for both electromagnetic compatibility and electrical safety prior to release, by a certified National Recognized Test Laboratory (NRTL),

Washington Laboratories, Ltd. 7560 Lindbergh Dr. Gaithersburg, Maryland 20879,

which will conduct the appropriate EMI/EMC testing for medical equipment, to elements of the requirements of:

. EN60601-1:1990: "Medical Electrical Equipment, Part I : General Requirements for Safety."
EN60601-1-2:2001: "Medical Electrical Equipment, Part 1: General Requirements for Safety.2.Collateral . Standard: Electromagnetic Compatibility – Requirements and Tests"
. EN55011:1998: "Industrial, Scientific, & Medical (ISM) Radio-Frequency Equipment – Radio Disturbances Characteristics - Limits & Methods of Measurements"
EN61000-3-2:1995: "Electromagnetic Compatibility (EMC) Part 3-2:Limits for Harmonic Current . Emissions "
EN61000-3-3:1995: "Electromagnetic Compatibility (EMC) Part 3-3: Limits of Voltage Fluctuations and . Flicker in Low-Voltage Supply Systems for Equipment with Rated Current up to 16 A "

3

Substantial Equivalence Based on Assessment of Performance Data:

The Smart USBLite is substantially equivalent to the predicate SmartEP, SmartOAE, SmartTrOAE, SmartEP-ASSR, and Opti-Amp DC-Powered devices marketed by Intelligent Hearing Systems with FDA 510(k) clearance numbers K904926, K925648, K964426, K023859, K031051, and K052060 (respectively). The intended use of the device has not changed as a result of modifications to the general or electrical specifications of the device(s) listed below.

SPECIFICATIONS

| Parameter | Predicate Devices
SmartEP (K904926)
SmartScreener (K925648)
SmartOAE (K964426)
SmartTrOAE (K023859)
SmartEP-ASSR (K031051)
Opti-Amp DC Powered (K052060) | Device Under Current 510(k)
Review
Smart USBLite | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | SmartEP: Stimulate, record, &
process auditory evoked potentials

SmartScreener: Stimulate, record, &
process auditory evoked potentials
using simplified user interface, with
automated evoked response detection

SmartOAE: Elicitation and
measurement of distortion product
otoacoustic emissions

SmartTrOAE: Elicitation and
measurement of transient and
spontaneous otoacoustic emissions

SmartEP-ASSR: Stimulate, record, &
process auditory steady-state evoked
potentials. | Same | |
| Indications for Use | SmartEP, SmartScreener, & SmartEP-
ASSR: The recording & analysis of
physiological data necessary for the
diagnosis of auditory and hearing-
related disorders.

Particular (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

4

. . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .

5

... and those state and the state and the second and the

.

:: :

6

and the consideration in the successful control consistence in the consistent of

:

7

15 4-8 dose of the control control control controlled in

:

8

Table 1: General, electrical, and performance specifications of predicate devices & current device under Special 510(k) review.

:

9

Image /page/9/Figure/0 description: This image is a block diagram of predicate device hardware. The diagram includes components such as electrodes, an ear probe, earphones/headphones, and a pre-amplifier labeled as (Opti-Amp DC-Powered). The pre-amplifier has an isolation of 400 Volts DC and 10 MegaOhms, and it connects to a desktop or laptop computer via a fiber optic cable and a predicate hardware receiver unit. The power supply is medical grade and operates at 120/240 Volts, providing +/-15 Volts DC and +5 Volts DC.

Figure 1: Block diagram of the predicate devices hardware system. This system uses an Opti-Amp pre-amplifier unit (refer to FDA 510(k) numbers K914876 and K052060) connected to the patient, which is powered by one of two schemes: 1) Two AA batteries housed internally (K914876), or 2) +15Volts taken from the hardware receiver unit and regulated using a high voltage isolation DC-DC converter (K052060).

.

10

Image /page/10/Figure/0 description: This image is a block diagram of the Smart USBLite Hardware unit. The diagram shows the different components of the system, including the ear probe, electrodes, desktop or laptop computer, power supply, and earphones or headphones. The Smart USBLite Hardware unit has an isolation of 400 Volts DC, 10 MegaOhms and requires +5 VoltsDC.

Figure 2: Block diagram of the Smart USBLite system. The pre-amplifier electronics are embedded inside the receiver unit so there is no separate pre-amplifier unit. The patient cables are connected directly to the Smart USBLite box. The patient is afforded protection by using a high voltage isolation DC-DC converter (rated up to 4000 volts DC, 10 Mega Ohms), as in K052060. The Smart USBLite system derives its power from a +5V, 2A external medical grade power supply, which meets the appropriate safety requirements (IEC60601-1, UL2601-1, CSA601.1, EN60601-1, and EN60950).

のことになる。

.........

. .

11

Product Labeling

There have been no changes in intended use, advertisements, and directions for use due to the type of modifications to the original SmartEP, SmartScreener, SmartOAE, SmartTrOAE, and SmartEP-ASSR devices marketed by Intelligent Hearing Systems with FDA 510(k) clearance numbers K904926, K925648, K964426, K023859, and K031051 (respectively). The only changes in product labeling between the predicate device(s) and the device under current Special 510(k) review are in the electrical rating label, which includes a change in the reference model number (M011120) and the power specifications. Both changes have resulted from the modifications mentioned in this Special 510(k). The electrical rating label for the Smart USBLite box is shown in the figure below.

Image /page/11/Figure/2 description: The image shows a product label with various details. It includes the brand name "INTELLIGENT HEARING SYSTEMS" and the product name "Smart USB Lite". The label also contains manufacturing information, such as the year "2006", a reference number "M011120", and a serial number "1-1.0". Additionally, it specifies the power requirements as "+5V DC, 2A, 10W".

Figure 3: Electrical rating label for the Smart USBLite box.

、・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・

12

Declaration of Conformity:

As required by our risk analysis, all verification and validation activities have been performed for the Smart USBLite device by designated individuals at Intelligent Hearing Systems. The results have demonstrated that all predetermined acceptance criteria have been met, in accordance with our ISO-13485 quality system. All records, including Device Master Records and Design History Files, are available for review upon request.

・・・・ 1936年 - 1915-2019 - 1947-1944 - 1987 - 1947 - 1997 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 1992 - 19

... .. .. ..

Edward Miskiel, Ph.D. President & CEO

5/23/06

Date

13

Image /page/13/Picture/1 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is an abstract image of an eagle with three heads.

Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850

SEP - 6 2006

Intelligent Hearing Systems c/o Mr. Edward Miskiel 6860 S. W. 81st St. Miami, FL 33143

Re: K061443

Trade/Device Name: Smart USBLite (with SmartEP, SmartScreener, SmartOAE, SmartTrOAE, & SmartEP-ASSR) Regulation Number: 21CFR 874.1050 Regulation Name: Audiometer Regulatory Class: II Product Code: GWJ; EWO; GWO; GWL Dated: May 23, 2006: Received: May 24, 2006

Dear Mr. Miskiel:

This letter corrects our substantially equivalent letter of June 23, 2006.

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 (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 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.

14

Page 2 - Mr. Edward Miskiel

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/cdrh/industry/support/index.html.

Sincerely yours,

M.B. Eghelmsi 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

15

510(k) Number (if known): KD61443

Device Name: Smart USBLite (with options of SmartScreener, SmartOAE, SmartTrOAE, & SmartEP-ASSR)

Indications for Use:

The intended use of the Smart USBLite device system is for the recording of auditory evoked potential, otoacoustic emissions, & auditory steady-state evoked potential data. The product is intended to be used as a diagnostic aid in auditory and hearing related disorders, as an objective measure of cochlear function, and as an adjunctive tool in the estimation of behavioral hearing thresholds on patients of all ages.

The Smart USBLite system combines the following FDA 510(k) previously cleared devices into a repackaged, smaller-sized, single, integrated unit: SmartEP (K904926), SmartScreener (K925648), SmartOAE (K964426), SmartTrOAE (K023859), SmartEP-ASSR (K031051), and Opti-Amp DC-Powered (K052060).

The Smart USBLite is intended to be used by trained personnel in a hospital, nursery, clinic, audiologist's office or other appropriate setting.

The anatomical sites of contact are:

(1) The patient's scalp and possibly other body sites with the contact objects being electrodes that are capable of measuring bio-potentials
(2) The patient's ear with the contact object being a sound delivery device eartip, headphone, ear probe, or ear cups.

Prescription Use (Per 21 CFR 801.109)

Over-the-Counter Use _

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

OR

Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Ophthalmic Ear,
Nose and Throat Devises

510(k) Number	K061443
---------------	---------

Prescription Use
(Per 21 CFR 801.109)