(25 days)
The Nic36 Amplifier is intended to be used by or under the direction of a physician for acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.
The Nic36 Amplifer is a fully programmable system which provides a total of 36 analog input channels each of which can be configured as monopolar or bipolar. The bioelectric signals are amplified and converted to digital form (analog to digital conversion). The amplifier receives its power from a dedicated AC/DC adapter which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Nic36 Amplifier is intended to be used to amplify and filter bioelectric signals captured via a lead or transdaor on the surface of the human body. It captures the data, converts it into a digital format and transmits it on to a host computer running appropriate software. Typical fields of application will be: Electroencephalograph (EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Nic36 Amplifier does not contain a Pulse Oximeter module.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Nic36 Amplifier system consists of three interconnected units: the amplifier box, the PCMCIA or BE Net interface and the AC/DC adapter; optionally the system may be completed by a led visual stimulator.
Here's an analysis of the provided text regarding the acceptance criteria and study information for the EB Neuro Nic36 Amplifier:
This 510(k) summary primarily focuses on establishing substantial equivalence to a predicate device (EB Neuro Mizar Amplifier K003154) rather than presenting a detailed independent study with specific acceptance criteria as you might find for a novel AI/software device. The information provided is characteristic of a Class II medical device where performance is compared against an already cleared predicate.
Therefore, many of your requested sections related to traditional study design, ground truth, and reader studies are not explicitly present or applicable in the provided text. I will fill in what can be inferred or explicitly stated.
Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly based on establishing substantial equivalence to the predicate device, the EB Neuro Mizar Amplifier (K003154). The Nic36 Amplifier's performance is considered acceptable if its technological characteristics and intended use are similar enough to the predicate such that it raises no new questions of safety and effectiveness.
| Item | Acceptance Criteria (Implied: Similar to Predicate) | Reported Device Performance (Nic36 Amplifier) |
|---|---|---|
| Intended Use | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations | Acquisition of EEG, polygraphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations |
| EEG/Polygraphic Channel | 32/40 (64/96/128 with expansion boards) | 36 monopolar fixed - (no expansion boards) |
| DC Channel | 32/40 | 4 |
| A/D Conversion | 16 bit Sigma-Delta A/D effectively transferred to host | 16 bit SAR effectively transferred to host |
| Sampling Rate | User selectable (128, 256, 512...up to 32 KHz/Channel) | User selectable (128, 256, 512...up to 8192 Hz/Channel) |
| CMRR | >100dB | >100dB |
| Noise | < 1.5 µVpp | <0.5 µVrms(AC) <7 µVrms(DC) |
| Power Supply | External IEC 601-1 mains adapter Internal batteries (optional) | External IEC 601-1 mains adapter |
| Internal Storage | N/A | N/A |
| Amplifier - PC Interface | PCMCIA or BE Net | PCMCIA (NicPCMCIA) or BE Net (NicNet) |
| Other Interfaces | 128x64 graph LCD display 5 push buttons | Power on LED / LED matrix Ohm Meter |
| Use standard sensors and electrodes | Yes | Yes |
| Dimension | 250 (L) x 170 (W) x 65 (h) (mm) | 203 (L) x 135 (W) x 38 (H) (mm) |
| Weight | 1.5 Kg | 0.55 Kg |
| Isolation | Fiber optic link Patient isolation BF type | Fiber optic link Patient isolation CF type |
| Safety Standards | IEC 601-1, IEC 601-1-2, IEC 601-2-26, IEC 601-1-4 | IEC 601-1, IEC 601-1-2, IEC 601-2-26, IEC 601-1-4 |
| System Components | Amplifier, Head box, AC/DC Adapter, PCMCIA or BE Net Interfaces/DC Input box (optional), LED Flash stimulator (optional) | Amplifier, AC/DC Adapter, PCMCIA (NicPCMCIA) or BE Net (NicNet) Interface/DC Input box (NicDCIN) (optional), LED Flash stimulator (NicLED Photic Stimulator) (optional) |
| Firmware | Resident and Runtime downloadable | Resident and Runtime downloadable |
| Patient Connection and Inputs | 32 monopolar – 32 plugs, 8 bipolar – 16 plugs, 1 Thermistor - 2 plugs, 2 Reference inputs – 2 plugs, 14 ISO GROUND inputs – 14 plugs | 36 monopolar inputs – 36 plugs, 2 Referemce inputs – 2 plug, 2 ISO GROUND inputs – 2 plug |
Study Details:
-
Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. This submission is a 510(k) for a physiological signal amplifier, comparing its technical specifications to a predicate device. It does not involve a "test set" of patient data in the way an AI/software device would. The evaluation is based on engineering specifications and adherence to safety standards.
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Not Applicable. No ground truth in the context of expert medical interpretation for patient data is established or required for this type of device submission. The device's performance is measured against technical specifications and regulatory standards.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. See above.
-
If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No. This is not an AI/software device designed to assist human readers, so an MRMC study is not relevant or included.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. The Nic36 Amplifier is a hardware device for signal acquisition and amplification; it is not an algorithm, and thus standalone performance for an algorithm is not relevant.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Not Applicable. For this submission, the "ground truth" or standard for comparison is the technical specifications and regulatory compliance of the predicate device (Mizar Amplifier K003154) and relevant international safety standards (IEC 601-1, IEC 601-1-2, IEC 601-2-26, IEC 601-1-4). The device's own performance is measured against these technical benchmarks, not clinical outcomes or expert consensus on patient data.
-
The sample size for the training set:
- Not Applicable. This is a hardware device, not a machine learning algorithm, so there is no training set.
-
How the ground truth for the training set was established:
- Not Applicable. This is a hardware device, not a machine learning algorithm, so there is no training set or ground truth for one.
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510(k) Summary EB Neuro. S.p.A. Nic36 Amplitier
JUN - 1 2004
510(k) Summary
The following 510(k) summary has been prepared pursuant to requirements specified in 21CFR 807.92(a).
807.92(a)(1)
Submitter Information
Carri Graham, Official Corresondent The Anson Group 7992 Castleway Drive Indianapolis, Indiana 46250
(317) 849-1916 Phone: (317) 577-9070 Facsimile:
Carri Graham Contact Person:
May 5, 2004 Date:
807.92(a)(2)
| Trade Name: | Nic36 Amplifier | |
|---|---|---|
| Common Name: | Physiological Signal Amplifier | |
| Classification Name(s): | Physiological Signal Amplifier | |
| Classification Number: | 84GWL | |
| 807.92(a)(3) | ||
| Predicate Device(s) | ||
| EB Neuro, S.p.A. | Mizar Amplifier | K003154 |
Additional Substantial Equivalence Information is provided in the following Technological Characteristics Table.
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510(k) Summary EB Neuro. S.p.A. Nic36 Amplifier
807.92 (a)(4)
Device Description
The Nic36 Amplifer is a fully programmable system which provides a total of 36 analog The NiCSO Aniphier is a fully programmation of amplified and converted to digital form mput challiers cach of witch can '00 bonnigation's its power from a dedicated ACDC
(analog to digital conversion). The amplifier receives its power from a dedicated AC/DC (affalog to digital conversion). The amirements, which feeds a +15VDC. Internally, the +15VDC is further isolated by a dedicated DC/DC CF type converter.
The Nic36 Amplifier is intended to be used to amplify and filter bioelectric signals The NICJO Ampillier is Intended to the surface of the human body. It captures the data, capidled via a lead of thansdaor on assess it on to a host computer running appropriate converts it into a urgital fields of application will be: Electroencephalograph ampirication Soltware. Typted Ticlas or upportunians
(EEG), Evoked Potentials (EP), Electromyography (EMG), Polysomnography (Sleep Analysis) and General Polygraphy.
The Nic36 Amplifier does not contain a Pulse Oximeter module.
The host computer must use one of the following Operating Systems: Microsoft Windows 98, Microsoft Windows NT or Microsoft Windows XP.
The Nic36 Amplifier system consists of three interconnected units: the amplifier box, the The Nicholo Ampiriter System ocubists be AC/DC adapter; optionally the system may be completed by a led visual stimulator.
807.92(a)(5)
Intended Use(s)
The Nic36 Amplifier is intended to be used by or under the direction of a physician for The Nicov Timplifier to graphy and polysomnography signals and transmission of these signals to a PC during recording of neurophysiology examinations.
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510(k) Summary
EB Neuro, S.p.A.
Nic36 Amplifier
807.92(a)(6)
Technological Characteristics
| Item | EB NeuroMIZAR AmplifierK003154 | EB NeuroNic36 AmplifierThis Submission |
|---|---|---|
| Intended Use | Acquisition of EEG, polygraphyand polysomnography signals andtransmission of these signals to aPC during recording ofneurophysiology examinations | Acquisition of EEG, polygraphyand polysomnography signals andtransmission of these signals to aPC during recording ofneurophysiology examinations |
| EEG/Polygraphic channel | 32/40(64/96/128 with expansionboards) | 36 monopolar fixed - (noexpansion boards) |
| DC channel | 32/40 | 4 |
| A/D conversion | 16 bit Sigma-Delta A/Deffectively transferred to host | 16 bit SAR effectively transferredto host |
| Sampling rate | User selectable (128, 256, 512...up to 32 KHz/Channel | User selectable (128, 256, 512...up to 8192 Hz/Channel) |
| CMRR | >100dB | >100dB |
| Noise | < 1.5 µVpp | <0.5 µVrms(AC) <7 µVrms(DC) |
| Power Supply | External IEC 601-1 mains adapterInternal batteries (optional) | External IEC 601-1 mains adapter |
| Internal Storage | N/A | N/A |
| Amplifier - PC Interface | PCMCIA or BE Net | PCMCIA (NicPCMCIA) or BE Net(NicNet) |
| Other Interfaces | 128x64 graph LCD display 5push buttons | Power on LED / LED matrix OhmMeter |
| Use standard sensors andelectrodes | Yes (electrodes and sensors arenot included with the Amplifer) | Yes (electrodes and sensors are notincluded with the Amplifier) |
| Dimension | 250 (L) x 170 (W) x 65 (h)(mm) | 203 (L) x 135 (W) x 38 (H) (mm) |
| Weight | 1.5 Kg | 0.55 Kg |
| Isolation | Fiber optic linkPatient isolation BF type | Fiber optic linkPatient isolation CF type |
| Safety Standards | ||
| IEC 601-1IEC 601-1-2IEC 601-2-26IEC 601-1-4 | IEC 601-1IEC 601-1-2IEC 601-2-26IEC 601-1-4 | |
| System Components | Amplifier.Head boxAC/DC AdapterPCMCIA or BE Net Interfaces/DC Input box (optional)LED Flash stimulator (optional) | AmplifierAC/DC AdapterPCMCIA (NicPCMCIA) or BE Net(NicNet) Interface/DC Input box (NicDCIN)(optional)LED Flash stimulator (NicLEDPhotic Stimulator) (optional) |
| Firmware | Resident and Runtimedownloadable | Resident and Runtimedownloadable |
| Patient connection andinputs | 32 monopolar – 32 plugs8 bipolar – 16 plugs1 Thermistor - 2 plugs2 Reference inputs – 2 plugs14 ISO GROUND inputs – 14plugs | 36 monopolar inputs – 36 plugs2 Referemce inputs – 2 plug2 ISO GROUND inputs – 2 plug |
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Image /page/4/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling a stylized caduceus or a representation of the human form, composed of three interconnected figures.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 1 2004
EB Neuro, S.P.A. c/o Ms. Carrie Graham The Anson Group, LLC 7992 Castleway Group Indianapolis, Indiana 46250
Re: K041198 Trade/Device Name: Nic36 Amplifier Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWL Dated: May 5, 2004 Received: May 7, 2004
Dear Ms. Graham:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your becamed the device is substantially equivalent (for the indications felerenced above and nave acterimes ally marketed predicate devices marketed in interstate for use stated in the encrosure) to regary the enactment date of the Medical Device Amendments, or to commerce provided in accordance with the provisions of the Federal Food, Drug, devices mat have been require approval of a premarket approval application (PMA). alle Cosmetic Ac. (Act) that to not required to the general controls provisions of the Act. The 1 ou may, mercrore, manel act include requirements for annual registration, listing of general controll provided on the 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 If your device is classified (soc above) also Existing major regulations affecting your device can
may be subject to such additional controls. Existing major regulation FD a may be subject to back as a sublema, Title 21, Parts 800 to 898. In addition, FDA may be found in the Our cements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean r lease be advised that I Dri of ibeautes or our device complies with other requirements of the Act that I Dri has made a avoid regulations administered by other Federal agencies. You must of any I colcal statutes and regaranents, including, but not limited to: registration and listing (21 Comply with an the Fier 31equirements,01); good manufacturing practice requirements as set CFR Part 807); mooning (21 CFR Part 820); and if applicable, the electronic form in the qualify by solling (Sections 531-542 of the Act); 21 CFR 1000-1050.
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Page 2 - Ms. Carrie Graham
This letter will allow you to begin marketing your device as described in your Section 510(k) I ins letter with anow you to ogen mailions of substantial equivalence of your device to a legally prematication. "The Privation of thing of cation 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 If you desire specific advice for your act (301) 594-4659. Also, please note the regulation entitled, Comacs the Office of Commarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small other general informational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Miriam C. Provost
Celia M. Witten, Ph.D., M.D. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
Ko41198 510(k) Number (if known):
Nic36 Amplifier Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The Nic36 Amplifier is intended to be used by or under the direction of a physician for The Nicco Ampillier is michied to be acourby signals and transmission of these acquisition of EEG, polygraphy and polysiology examinations.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _ (21 CFR 807 Subpart C)
(Please Do NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K041198
§ 882.1835 Physiological signal amplifier.
(a)
Identification. A physiological signal amplifier is a general purpose device used to electrically amplify signals derived from various physiological sources (e.g., the electroencephalogram).(b)
Classification. Class II (performance standards).