Who is the manufacturer of ZOOM-100DC?

Brainscope Company, Inc. filed the 510(k) submission for ZOOM-100DC (K082886).

What is the FDA product code for ZOOM-100DC?

OLT. It is classified under 21 CFR 882.1400 as a Class 2 device in the Neurology panel.

What is the regulatory pathway for ZOOM-100DC?

510(k) clearance (submission type: Traditional).

Who can help prepare an FDA 510(k) submission like ZOOM-100DC?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

ZOOM-100DC

Q: What are the predicate devices for ZOOM-100DC?

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).

K082886 · Brainscope Company, Inc. · OLT · Aug 10, 2009 · Neurology

Device Facts

Record ID	K082886
Device Name	ZOOM-100DC
Applicant	Brainscope Company, Inc.
Product Code	OLT · Neurology
Decision Date	Aug 10, 2009
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 882.1400
Device Class	Class 2

Intended 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 Story

ZOOM-100DC is an electroencephalograph for hospitals and clinics. It acquires EEG signals via standard off-the-shelf electrodes placed on the patient's head. The device digitizes and processes these signals to display raw EEG waveforms and calculate quantitative EEG (qEEG) parameters. The system includes an external patient interface cable, audio cable, Compact Flash card for data storage, and a battery charger. It is operated by healthcare professionals to monitor brain state. The output, consisting of raw waveforms and derived qEEG metrics (absolute/relative power, mean frequency, coherence, asymmetry), assists clinicians in assessing brain electrical activity. The device is powered by a Li-Ion battery.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on technological comparison and bench testing demonstrating equivalent performance to predicate devices.

Technological Characteristics

Class II electroencephalograph (21 CFR 882.1400). Features 10/20 array with 8 single-ended channels. Bandwidth: 0.5-4000 Hz (raw), 0.5-45/50 Hz (processed). CMRR ≥ 100 dB; input impedance ≥ 10 Meg Ohms. Power: Li-Ion battery. Connectivity: Compact Flash card for data export. Software performs FFT-based qEEG analysis (absolute/relative power, mean frequency, coherence, asymmetry).

Indications for Use

Indicated for monitoring brain state via acquisition/display of EEG signals and calculation of standard qEEG parameters in patients requiring brain electrical activity measurement.

Regulatory Classification

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.

Predicate Devices

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)

Related Devices

K170363 — Ceribell Pocket EEG Device · Ceribell, Inc. · May 8, 2017
K242306 — SignalNED System (Model RE) · Forest Devices, Inc. · Sep 4, 2024
K201747 — 8-CH Electroencephalography Amplifier · Hipposcreen Neurotech Corp. · Dec 27, 2020
K030489 — BRM2 BRAIN MONITOR · Brainz Instruments , Ltd. · May 2, 2003
K112353 — GEODESIC EEG MOBILE 100 (GEM 100) · Electrical Geodesics, Inc. · Feb 17, 2012

Submission Summary (Full Text)

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows a handwritten alphanumeric string inside of a box. The string is "K082996". The characters are written in a simple, slightly irregular style, and the box is drawn with a single line. Image /page/0/Picture/1 description: The image shows the logo for Brainscope. Above the logo is the handwritten text "Page 1 of 4-". The logo is black and bolded. ### 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 {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the text "Page 2 of 4" written in cursive handwriting. Below this text is the word "BRAINSCOPE" in a bold, sans-serif font. The word is all capitalized and has a horizontal line above it. ### 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 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the text "Page 3 of 4" written in cursive handwriting. Below the page number is the logo for BrainScope. The BrainScope logo is in bold, black font. | 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 100 - 20kHz Available AEP | Unknown | Unknown | Unknown | | | | | | | | | | Processed EEG Bandwidth | 0.5 - 45 Hz 50Hz | 0.5 - 500 Hz | Unknown | Unknown | Unknown | | | | | | | | | | Automatic Artifacting | | Yes | | Unknown | | Unknown | | Unknown | | Unknown | | | | 1717 Rhode Island Avenue 9th Floor Washington, D.C. 20036 {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "Page 4 of 4" written in cursive. The number 4 is circled. The text indicates that this is the last page of a document. Image /page/3/Picture/1 description: The image shows the word "BRAINSCOPE" in a bold, sans-serif font. The word is all in uppercase letters and is black. There are horizontal lines above and below the word. The letters are closely spaced together, creating a solid block of text. | 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 2. 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 4. Coherence a. Monopolar Coherence b. Bipolar Coherence 5. 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 {4}------------------------------------------------ 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

ZOOM-100DC

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

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ZOOM-100DC

Device Facts

Intended Use

Device Story

Clinical Evidence

Technological Characteristics

Indications for Use

Regulatory Classification

Identification

Predicate Devices

Related Devices

Submission Summary (Full Text)

Panel 1

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