SMART USBLITE, MODEL M011120
Device Facts
| Record ID | K061443 |
|---|---|
| Device Name | SMART USBLITE, MODEL M011120 |
| Applicant | Intelligent Hearing Systems |
| Product Code | GWJ · Neurology |
| Decision Date | Jun 23, 2006 |
| Decision | SESE |
| Submission Type | Special |
| Regulation | 21 CFR 882.1900 |
| Device Class | Class 2 |
| Attributes | Pediatric |
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.
Device Story
Smart USBLite is an integrated auditory evoked potential and otoacoustic emission system. It records physiological signals (AEP, OAE, ASSR) via electrodes and sound delivery transducers (ear probes/headphones). The device processes these inputs to measure response levels, latencies, and signal-to-noise ratios. It is used in clinical settings (hospitals, clinics, audiologist offices) by trained personnel. The system consolidates previously cleared IHS hardware into a single, portable unit with embedded pre-amplifier electronics. Output is displayed on a connected PC for clinician review to aid in diagnosing hearing disorders and estimating hearing thresholds. Benefits include improved portability and streamlined clinical workflow for auditory testing.
Clinical Evidence
Bench testing only. No clinical data provided. The device was evaluated for electromagnetic compatibility and electrical safety per EN60601-1, EN60601-1-2, EN55011, and EN61000 series standards.
Technological Characteristics
Portable auditory diagnostic system; integrates AEP, OAE, and ASSR testing. Materials: electrical components, circuit boards, transducers, electrodes, disposable ear tips. Sensing: bio-potential electrodes and acoustic probes. Energy: 5V DC external power supply. Connectivity: USB to PC. Isolation: 4000V DC, 10 MegaOhms. Software: same packages as predicates (SmartEP, SmartScreener, SmartOAE, SmartTrOAE, SmartEP-ASSR).
Indications for Use
Indicated for patients of all ages for recording and analysis of physiological data to diagnose auditory and hearing-related disorders, determine cochlear function, and estimate behavioral hearing thresholds.
Regulatory Classification
Identification
An evoked response auditory stimulator is a device that produces a sound stimulus for use in evoked response measurements or electroencephalogram activation.
Predicate Devices
- SmartEP (K904926)
- SmartScreener (K925648)
- SmartOAE (K964426)
- SmartTrOAE (K023859)
- SmartEP-ASSR (K031051)
- Opti-Amp DC-Powered (K052060)
Submission Summary (Full Text)
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# KO61443
1. 1. 2
# JUN 2 3 2006
:
# Special 510(k) Summary
:
| Prepared By: | Intelligent Hearing Systems<br>6860 SW 81st Street<br>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,<br>SmartOAE, SmartTrOAE, and SmartEP-ASSR) |
| Common Name: | Auditory Evoked Potential System & Otoacoustic Device |
| Classification Name: | Auditory Evoked Response Stimulator (per CFR 882.1900)<br>& Audiometer (per CFR 874.1050) |
| Predicate Device(s): | SmartEP (K904926), SmartScreener (K925648), SmartOAE<br>(K964426), SmartTrOAE (K023859), SmartEP-ASSR<br>(K031051), and Opti-Amp DC-Powered (K052060). |
| Device Description: | Smart USBLite is an auditory evoked potential and<br>otoacoustic emission system that is capable of recording<br>and measuring auditory evoked potential, otoacoustic<br>emission, and auditory steady-state evoked potential data. |
| | The Smart USBLite system combines the following FDA<br>510(k) previously cleared devices into a repackaged,<br>smaller-sized, single integrated unit: SmartEP (K904926),<br>SmartScreener (K925648), SmartOAE (K964426),<br>SmartTrOAE (K023859), SmartEP-ASSR (K031051), and<br>Opti-Amp DC-Powered (K052060). |
| Intended Use: | The Smart USBLite device is intended to be used as a<br>diagnostic aid in auditory and hearing related disorders, as<br>an objective measure of cochlear function, and as an<br>adjunctive tool in the estimation of behavioral hearing<br>thresholds on patients of all ages. This is the same<br>intended use as that of the predicate devices. |
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#### 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
- 2) 510(k) #K904926 SmartScreener Automated Auditory Evoked Potential Screening System
- 3) 510(k) #K964426 SmartOAE Distortion-Product Otoacoustic Emissions System
4) 510(k) #K023859 - SmartTrOAE Transient Otoacoustic Emissions System
- 5) 510(k) #K031051 SmartEP-ASSR Auditory Steady-State Response System
6) 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.
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#### 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 "
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### 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<br>SmartEP (K904926)<br>SmartScreener (K925648)<br>SmartOAE (K964426)<br>SmartTrOAE (K023859)<br>SmartEP-ASSR (K031051)<br>Opti-Amp DC Powered (K052060) | Device Under Current 510(k)<br>Review<br>Smart USBLite | |
|--------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------|--|
| Intended Use | SmartEP: Stimulate, record, &<br>process auditory evoked potentials<br><br>SmartScreener: Stimulate, record, &<br>process auditory evoked potentials<br>using simplified user interface, with<br>automated evoked response detection<br><br>SmartOAE: Elicitation and<br>measurement of distortion product<br>otoacoustic emissions<br><br>SmartTrOAE: Elicitation and<br>measurement of transient and<br>spontaneous otoacoustic emissions<br><br>SmartEP-ASSR: Stimulate, record, &<br>process auditory steady-state evoked<br>potentials. | Same | |
| Indications for Use | SmartEP, SmartScreener, & SmartEP-<br>ASSR: The recording & analysis of<br>physiological data necessary for the<br>diagnosis of auditory and hearing-<br>related disorders.<br><br>SmartOAE & SmartTrOAE:<br>Determination of cochlear function in<br>patients of all ages. | Same | |
| Target Population | All Ages | Same | |
| Design | External box housing circuitry<br>connected to personal computer via a<br>USB connection | Same | |
| | | | |
| Materials | Assorted electrical components,<br>circuit boards, sound transducers,<br>microphone, electrodes, and<br>disposable probe ear tips | Same | |
| Sterility | None required | Same | |
| Biocompatibility | Completely Biocompatible | Same | |
| Anatomical Site | Ear canal, arms, and head | Same | |
| Energy Delivery | Stimulation of the ear with sound<br>signals | Same | |
| Where Used | Clinical Setting | Same | |
| Safety | Meets EN 60601-1 | Same | |
| General | | | |
| Operating Temperature | 15°C to 40°C | Same | |
| Storage Temperature | 5°C to 50°C | Same | |
| Relative Humidity | 15% to 90% (at 40°C Non-<br>Condensing) | Same | |
| Atmospheric Pressure | None Specified | Same | |
| Mode of Operation | Continuous | Same | |
| Type of Protection | Class I (IEC 601) | Same | |
| Degree of Protection | Type B (IEC 601) | Same | |
| Protection Against<br>Fluids | IPX0 - Ordinary Equipment<br>(IEC 601) | Same | |
| Degree of Mobility | Portable Equipment | Same | |
| Vibration and Shock | N/A | Same | |
| Expected Lifetime | 10 Years from date of manufacture | Same | |
| Electrical Specifications | | | |
| Power Supply | Predicate Hardware Version # 1:<br>External medical grade power supply<br>3 Outputs: +15V (2.5A), -15V<br>(0.5A), and +5V (5A)<br>OR<br>Predicate Hardware Version # 2:<br>Internal medical grade power supply<br>3 Outputs: +15V (2A), -15V (0.7A)<br>and +5V (5A) | External medical grade power supply<br>1 Output: +5V (2A) | |
| Rated Input Current | Predicate Hardware Version # 1:<br>1.3 Amps<br>OR<br>Predicate Hardware Version # 2:<br>2.0 Amps | 0.5 Amps | |
| Rated Frequency | 50-60 Hz | Same | |
| Rated Input Voltage | 100-240 VoltsAC | Same | |
| Rated Max Input Power | 40 Watts | 10 Watts | |
| Fuse Type | Predicate Hardware Version # 1:<br>N/A (External Power Supply)<br>OR<br>Predicate Hardware Version # 2:<br>Time Lag Fuse (IEC 60127-2<br>compliant) | N/A (External Power Supply) | |
| Fuse Rating | Predicate Hardware Version # 1:<br>N/A (External Power Supply)<br>OR<br>Predicate Hardware Version # 2:<br>1.6 Amps, 250 VoltsAC | N/A (External Power Supply) | |
| Patient Isolation | 4000Vdc, 10 Mega Ohms | Same | |
| Data Acquisition | | | |
| A/D Resolution | 16 bit | Same | |
| Artifact Rejection | Programmable | Same | |
| Input Channels | SmartEP, SmartScreener, SmartEP-<br>ASSR:<br>1-4 Channels (Optically Isolated)<br>SmartOAE, SmartTrOAE:<br>1-2 Channels | Smart USBLite (EP, Screener,<br>ASSR):<br>1 Channel (Optically Isolated)<br>Smart USBLite (DPOAE, TrOAE):<br>1 Channel (Optically Isolated) | |
| Amplifiers/Filters | | | |
| Gain | SmartEP, SmartScreener, SmartEP-<br>ASSR:<br>Variable (30k-300k)<br>SmartOAE:<br>Fixed (100) | Smart USBLite (EP, Screener,<br>ASSR):<br>Fixed (100k)<br>Smart USBLite (DPOAE):<br>Same<br>Smart USBLite (TrOAE):<br>Same | |
| Lowpass Filter | SmartEP, SmartScreener:<br>Variable (30-5000 Hz) | Smart USBLite (EP, Screener):<br>Fixed (1500 Hz) | |
| | SmartOAE:<br>100 kHz | Smart USBLite (DPOAE):<br>Same | |
| | SmartTrOAE:<br>5000 Hz | Smart USBLite (TrOAE):<br>Same | |
| | SmartEP-ASSR:<br>Variable (30-5000 Hz) | Smart USBLite (ASSR):<br>Fixed (300 Hz) | |
| Highpass Filter | SmartEP, SmartScreener, SmartEP-ASSR:<br>Variable (1-500 Hz) | Smart USBLite (EP, Screener, ASSR):<br>Fixed (30 Hz) | |
| | SmartOAE:<br>200 Hz | Smart USBLite (DPOAE):<br>Same | |
| | SmartTrOAE:<br>450 Hz | Smart USBLite (TrOAE):<br>Same | |
| Filter Slope | SmartEP, SmartScreener, SmartEP-ASSR:<br>6 dB/octave | Smart USBLite (EP, Screener, ASSR):<br>12 dB/octave | |
| | SmartTrOAE:<br>24 dB/octave | Smart USBLite (TrOAE):<br>Same | |
| Notch Filter | 50/60Hz | Same | |
| Noise Level | SmartEP, SmartScreener, SmartEP-ASSR:<br>0.33 μV RMS (1-3000 Hz)<br>0.12 μVpp for 1024 averaged sweeps | Smart USBLite (EP, Screener, ASSR):<br>0.13 μV RMS (30-1500 Hz)<br>0.1 μVpp for 1024 averaged sweeps | |
| | SmartOAE, SmartTrOAE:<br>40 μV RMS | Smart USBLite (DPOAE, TrOAE):<br>Same | |
| Input Impedance | Opti-Amp DC Powered:<br>5 MegaOhms | Same | |
| CMR Ratio | Opti-Amp DC Powered:<br>117 dB at 60Hz,<br>110 dB at 1kHz | Same | |
| Auditory Stimuli | | | |
| Types | SmartEP, SmartScreener, SmartEP-<br>ASSR:<br>Clicks, Pure Tones, Multifrequency<br>Stimuli | Same | |
| | SmartOAE:<br>Multifrequency Tones | | |
| | SmartTrOAE:<br>Clicks, Tone Bursts | | |
| Duration | SmartEP, SmartScreener, SmartEP-<br>ASSR, SmartTrOAE:<br>25-5000 µsec | Same | |
| | SmartOAE:<br>Continuous | | |
| Envelopes | Linear, Blackman, Gaussian, Hanning,<br>Rectangular, Triangular, Trapezoidal,<br>Exact Blackman, Cosine, Cosine<br>Squared, Cosine Cubed | Same | |
| Intensity | SmartEP, SmartScreener:<br>0-125 dB SPL | | |
| | SmartOAE:<br>55-80 dB SPL<br>SmartTrOAE:<br>60-90 dB SPL | Same | |
| | SmartEP-ASSR:<br>0-80 dB SPL | | |
| Repetition Rate | SmartEP, SmartScreener, SmartEP-<br>ASSR:<br>1-100 Hz | | |
| | SmartOAE:<br>Continuous | Same | |
| | SmartTrOAE:<br>1-50 Hz | | |
| Test Frequencies | 500-16,000 Hz | Same | |
| Presentation | SmartEP, SmartScreener, SmartEP-<br>ASSR:<br>Monaural or Binaural | Same | |
| | SmartOAE, SmartTrOAE:<br>Monaural | | |
| | | | |
| Masking | White Noise Programmable | Same | |
| Transducers | Insert Earphones, Bone Vibrator,<br>Headphones, Sound Field, Ear Probe | Insert Earphones, Headphones, Ear<br>Probe | |
| Analysis & Measurement<br>Parameters | | | |
| Analysis Window | SmartEP, SmartEP-ASSR:<br>Variable (up to 2.5 msec) | Same | |
| | SmartScreener:<br>Fixed (25.6 msec) | | |
| | SmartOAE:<br>Fixed (102.4 msec)<br>SmartTrOAE:<br>Fixed (2.5-22.5 msec post-stimulus) | | |
| Artifact Rejection<br>Threshold | SmartEP, SmartScreener, SmartEP-<br>ASSR, SmartTrOAE:<br>User Selectable<br>SmartOAE:<br>Automated/Fixed | Same | |
| | | | |
| Measured Values | Response Level (dB SPL)<br>Noise Level (dB SPL)<br>Signal to Noise Ratio (dB SPL)<br>Response Latency (msec)<br>Frequency (Hz) | Same | |
| Computer Requirements | | | |
| Computer Type | Personal Computer | Same | |
| Operating System | Microsoft Windows 2000 or XP | Same | |
| Interface Connection | USB (Universal Serial Bus) | Same | |
Particular (1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . .
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Table 1: General, electrical, and performance specifications of predicate devices & current device under Special 510(k) review.
:
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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).
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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).
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#### 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.
、 ・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・・
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#### 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
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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.
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#### 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 Intern…
