Predicate Devices

Reference Devices

Not Found

AI/ML (Artificial Intelligence / Machine Learning)

No
The summary describes standard EEG signal acquisition and processing for qEEG parameters, with no mention of AI/ML terms or capabilities.

Therapeutic

No
The device is used to measure and record electrical activity of the brain (EEG), monitor the state of the brain, and display EEG signals. This indicates a diagnostic or monitoring function, not a therapeutic one.

Diagnostic

Yes
The device is described as measuring and recording the electrical activity of a patient's brain, acquiring and displaying EEG signals, and calculating quantitative EEG parameters to monitor the state of the brain. This process involves collecting data to assess the condition or state of a patient, which aligns with the purpose of a diagnostic device.

SaMD (Software as a Medical Device)

No

The device description explicitly states that it "records, measures and displays Electroencephalographic (EEG) waveforms which are digitized and processed." This implies the presence of hardware components for signal acquisition (recording and measuring EEG) in addition to the software for processing and display. A software-only medical device would typically rely on data acquired by separate hardware.

IVD (In Vitro Diagnostic)

Based on the provided information, the ZOOM-100DC is not an IVD (In Vitro Diagnostic).

Here's why:

IVD Definition: In Vitro Diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
ZOOM-100DC Function: The ZOOM-100DC measures and records the electrical activity of the brain directly from the patient's scalp (Electroencephalogram - EEG). This is a non-invasive measurement of a physiological signal, not a test performed on a sample taken from the body.
Intended Use: The intended use clearly states it monitors the state of the brain by acquiring and displaying EEG signals and calculating qEEG parameters. This is a diagnostic tool for assessing brain function, not for analyzing a biological sample.

Therefore, the ZOOM-100DC falls under the category of a medical device used for physiological monitoring and diagnosis, but not an In Vitro Diagnostic device.

PCCP (Predetermined Change Control Plan) Authorized

N/A

Overview

Intended Use / Indications for Use

The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters.

Product codes

OLT, OMC

Device Description

The ZOOM-100DC records, measures and displays Electroencephalographic (EEG) waveforms which are digitized and processed.

Mentions image processing

Not Found

Mentions AI, DNN, or ML

Not Found

Input Imaging Modality

Not Found

Anatomical Site

brain / head

Indicated Patient Age Range

Not Found

Intended User / Care Setting

Hospitals and Clinics

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

The Conclusion section states: "The ZOOM-100DC, when compared to its predicate devices, has the same intended use and equivalent technological characteristics. Performance data demonstrate that the device performs equivalently to the predicate devices."

Key Metrics

Not Found

Predicate Device(s)

Nicólet Bravo Multi-Modality System (K991054), Cleveland Medical Crystal-EEG Model 10 (K970672), Brainz Instruments Ltd BRM3 Brain Monitor (K071449), Infinite Biomedical Technologies, LLC Model I-2000 Monitor (K072382)

Reference Device(s)

Not Found

Predetermined Change Control Plan (PCCP) - All Relevant Information

Not Found

Regulation Number and Section

§ 882.1400 Electroencephalograph.

(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).

Summary

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510(k) Summary

AUG 1 0 2009

The following information is provided as required by 21 CFR § 807.87 for BrainScope's 510(k) premarket notification. In response to the Safe Medical Devices Act of 1990, the following is a summary of the safety and effectiveness information upon which the substantial equivalence determination is based.

BRAINSCOPE COMPANY INC. Sponsor:

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

Proprietary Name:	ZOOM-100DC
Common Name:	Electroencephalograph
Regulatory Class:	Class II 21 CFR §882.1400
Product Codes:	OLT & OMC

Predicate Device(s): Nicólet Bravo Multi-Modality System (K991054), Cleveland Medical Crystal-EEG Model 10 (K970672), Brainz Instruments Ltd BRM3 Brain Monitor (K071449) and Infinite Biomedical Technologies, LLC Model I-2000 Monitor (K072382).

Device Description:

The ZOOM-100DC records, measures and displays Electroencephalographic (EEG) waveforms which are digitized and processed.

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

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Indications for Use:

The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters.

Device Comparison Table:

| | ZOOM-100DC | Bravo Multi-
Modality System
K991054 | Crystal-EEG Model
10 (K970672) | BRM3 Brain Monitor
(K071449) | Model I-2000
Monitor (K072382) |
|-----------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indication for
Use | The ZOOM-100DC
is used to measure
and record the
electrical activity of a
patient's brain. The
ZOOM-100DC is
intended to monitor
the state of the brain
by acquisition and
display of
electroencephalogram
(EEG) signals and by
the calculation of
standard quantitative
EEG (qEEG)
parameters. | The Bravo Multi-
Modality System is
intended to record and
display EEG, EP,
EMG and TCD data
in the clinic and
hospital (including
the hospital room,
operating room,
emergency room,
intensive care unit,
neuro intensive care
unit, critical care unit,
etc.), and to import
and display data from
third party monitoring
devices such as vital
signs monitors. It is
intended to aid the
diagnosis and
monitoring of
potential disorders of
the central and
peripheral nervous
system and muscles. | The Crystal-EEG
Model 10 is a mobile,
intermediate range,
wireless EEG system
intended to be used
for measuring and
transmitting
electroencephalogram
(EEG) signals. | A device used to
measure and record the
electrical activity of the
patient's brain obtained
by placing two or more
electrodes on the head.
The BRM3 Brain
Monitor is
intended for use to
monitor the state
of the brain by
acquisition of
electroencephalog
ram (EEG)
signals, in clinical
environments
such as the
intensive care
unit, and for
clinical research.
The BRM3 Brain
Monitor is
intended for use
only with neonatal
patients, defined
as from birth to 28
days post-
delivery, and
corresponding to a
post-conceptual
age of 24 to 46
weeks.
The BRM3 Brain
Monitor does not
provide any
diagnostic
conclusion about
the patient's
condition. | The 1-2000 Monitor
is intended to be used
for measuring and
recording the
electrical activity of a
patient's brain,
obtained by placing
electrodes on the
head.
The 1-2000 Monitor
is indicated for use in
monitoring the state
of the brain by
acquisition of
electroencephalogram
(EEG) signals, in
research and clinical
environments. |
| Modalities | EEG | EEG, Evoked
Potential EMG, CSA | EEG | EEG | EEG |
| Environment
of Use | Hospitals and Clinics | Hospitals and Clinics | Hospitals and Clinics | Hospitals and Clinics | Hospitals and Clinics |
| Power Source | Li Ion Battery | 120 Volt 60Hz AC | Unknown | Unknown | Unknown |

1717 Rhode Island Avenue 9t Floor Washington, D.C. 20036

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| Device Components | ZOOM-100DC
External Patient
Interface Cable
External Audio Cable
CF (Compact Flash)
Card
Battery Charger | PC running Microsoft
windows NT
Amplifier Unit
Patient Interface
Cables
Evoked Potential Unit
Evoked Potential
Patient interface
Cable | Unknown | Sensor Set (EEG skin
electrodes) or Sensor
Adaptor Set (electrode
adaptor)
Data Acquisition Unit
(EEG head stage)
Data Cable
Monitor
Power Supply Unit
and Roll-Pole. | tablet PC
battery powered
wireless headbox
headbox charger
power conditioner | | | | | | | | |
|-----------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------|---------|--|---------|--|---------|--|--|--|
| Electrode
Material | N/A | N/A | N/A | N/A | N/A | | | | | | | | |
| | Uses Standard off the
Shelf EEG electrodes | Uses Standard off the
Shelf EEG electrodes | Uses Standard off the
Shelf EEG electrodes | Uses Standard off the
Shelf EEG electrodes | Uses Standard off the
Shelf EEG electrodes | | | | | | | | |
| Screen
Display
Details | Displays:
Raw EEG Waveform | Displays:
Raw EEG Waveform
Raw averaged AEP
Waveform | Unknown | Displays:
Raw EEG Waveform
aEEG parameter
Signal Quality | Displays:
Raw EEG waveforms
EEG power
spectrum
95% Spectral Edge
Frequency | | | | | | | | |
| Hard copy of
Displayed
Data | Yes - through CF
(Compact Flash) card | Yes | Unknown | Unknown | Yes | | | | | | | | |
| Channels | 10/20 Array | 10/20 Array | 8 channels | 3 channels | 2 channels | | | | | | | | |
| | 8 single-ended
channels
corresponding to 8
electrodes placed
anywhere on the
head, including but
not limited to, all
locations defined by
the International
10/20 System. (5
differential channels
can be viewed
concurrently). | Up to 16 differential
channels | | | | | | | | | | | |
| Real Time
EEG Display | Yes | Yes | Yes | Yes | Yes | | | | | | | | |
| Real Time
EEG
Bandwidth | 0.5-4000 Hz
available | 0.5 - 500 Hz
Available EEG

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

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| Amplifier
Common
Mode
Rejection
Ratio

(CMRR)	≥ 100 dB	≥ 110 dB	Unknown	Unknown	Unknown
Amplifier
Input
Impedance	≥ 10 Meg Ohms	> 100 Meg Ohms	Unknown	Unknown	Unknown
Electrode
Impedance
Test	Yes	Yes	Unknown	Unknown	Yes
EEG Derived
Measures	Yes- Derived from
FFT*	Yes- Derived from
FFT*	N/A	N/A	N/A
	1. Absolute Power
a. Monopolar Power
b. Bipolar Power

Relative Power
a. Relative
Monopolar Power
b. Relative Bipolar
Power

3.Mean frequency
variables (univariate
and multivariate)
a. Monopolar Mean
Frequency
b. Bipolar Mean
Frequency

Coherence
a. Monopolar
Coherence
b. Bipolar
Coherence
Asymmetry
a. Monopolar
Asymmetry | | | | |

See comparison of measures in section 12.3.

Conclusion

The ZOOM-100DC, when compared to its predicate devices, has the same intended use and equivalent technological characteristics. Performance data demonstrate that the device performs equivalently to the predicate devices. The ZOOM-100DC is substantially equivalent.

1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036

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Image /page/4/Picture/0 description: The image shows a logo for the Department of Health & Human Services - USA. The logo consists of two parts: a circular text element and a symbolic graphic. The text element reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged in a circular fashion. To the right of the text is a symbol that resembles an abstract eagle or bird in flight, composed of three stylized lines.

DEPARTMENT OF HEALTH & HUMAN SERVICES

Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002

Brainscope Company Inc. % Mr. Michael E. Singer 1717 Rhode Island Avenue, 9th Floor Washington, District of Columbia 20036

2009

Re: K082886

Trade/Device Name: ZOOM-100DC Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLT, OMC Dated: July 24, 2009 Received: July 28, 2009

Dear Mr. Singer:

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 application (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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.

5

Page 2 - Mr. Michael E. Singer

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to

http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

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/MedicalDevices/ResourcesforYou/Industry/default.htm.

Mark N. Melkerson Director Division of Surgical, Orthopedic,

Sincerely vours.

and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

6

Indications for Use Statement

K082886 510(k) Number:

Device Name: ZOOM-100DC

Indications for Use:

The ZOOM-100DC is used to measure and record the electrical activity of a patient's brain. The ZOOM-100DC is intended to monitor the state of the brain by acquisition and display of electroencephalogram (EEG) signals and by the calculation of standard quantitative EEG (qEEG) parameters.

Prescription Use _____________________________________________________________________________________________________________________________________________________________

AND/OR

、

Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________

(Part 21 CFR 801 Subpart D)

(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)

signature

(Division Sign-Off) (Division Sign-On)
Division of Surgical, Orthopedic, and Restorative Devices

510(k) Number K082886