(30 days)
Not Found
No
The description focuses on data acquisition, digitization, filtering, and transfer. There is no mention of AI or ML algorithms for analysis or interpretation of the data. The analysis is performed by the associated PC software, but the summary does not indicate that this software uses AI/ML.
No
The "Intended Use" section states the device is for "recording, displaying, analysis, printing and storage of human biological parameters... to assist in the diagnosis of various neurological disorders." It does not mention treating or preventing any conditions.
Yes
The "Intended Use / Indications for Use" section explicitly states that the Okti System is intended "to assist in the diagnosis of various neurological disorders."
No
The device description explicitly details hardware components such as a base unit, changeable modules, battery, network connections, digital and analogue electronic circuits, ADCs, FPGAs, a general-purpose processor, SD card, Ethernet, Wi-Fi, and Bluetooth interfaces. It is a physiological data acquisition device with physical components.
Based on the provided information, the Okti System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the Okti System is for "recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders." This involves collecting physiological signals directly from the patient's body.
- Device Description: The device description details the acquisition of electrical signals from electrodes placed on the patient (EEG, ECG, EMG, EOG).
- Lack of In Vitro Activity: IVD devices are designed to examine specimens derived from the human body (like blood, urine, tissue) outside of the body to provide information about a physiological state, health, or disease. The Okti System does not perform any analysis on such specimens. It directly measures physiological activity in vivo.
Therefore, the Okti System falls under the category of a physiological signal acquisition and analysis device, not an IVD.
N/A
Intended Use / Indications for Use
The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.
Product codes (comma separated list FDA assigned to the subject device)
GWQ
Device Description
The Okti is a physiological data acquisition device intended for conducting EEG studies. It is used in conjunction with a PC running Compumedics Profusion EEG software. Power is provided by either an internal Lithium-Ion battery or a POE 100BASE-TX network connection.
Physically, the Okti comprises a base unit housing the battery and digital electronic circuits. A changeable module connects to the base unit and houses the analogue circuity and electrode connectors providing options for 32, 64 or 128 referential, or single ended, channels primarily intended for EEG. Each module includes several differential inputs for electrode-based signals such as ECG, EMG or EOG. All these inputs are class CF for patient safety.
Patient physiological data is digitised using multiple 24-bit ADCs and filtered using fixed point FIR filters implemented internally to an FPGA located in the analogue module. The data is transferred to a general-purpose processor in the base unit over a synchronous serial link. From there the patient data may be saved to a device internal SD card or sent to a remote PC over an Ethernet or Wi-Fi LAN connection. A Bluetooth interface is also included for connection to external devices such as an oximeter.
The Okti system is available in Okti32, Okti64, or Okti128. These differ only in channel number with below characteristics.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Under the direction of a physician. In a hospital or other clinical environment.
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)
An extensive collection of tests have been conducted and successfully completed including:
- Electrical Safety Testing as per IEC 60601-1:2005. These ensure there is no potential for detrimental effects on patients, other persons, animals or the surroundings. They relate particularly to aspects concerning electrical safety such as means of operator protection, protection against electric shock and other hazards; as well as mechanical aspects such as construction and protection against spillage.
- Electromagnetic Compatibility Testing as per IEC 60601-1-2, and modification by the listed particular and collateral standards. These EMC tests were designed to verify that device emissions are in accordance with allowable limits, as well as device immunity against electrical and magnetic phenomena which may be expected to encounter in line with its intended use.
- Electroencephalograph safety and performance testing as per IEC 80601-2-26. Testing against the particular standard for electroencephalograph includes validation against multiple essential performance requirements such as accuracy of amplitude and rate of variation signal reproduction, input dynamic range and differential offset voltage, input noise, frequency response, and common mode rejection ratio.
- Bench testing against Okti functional requirements to ensure that performance meets hardware and software design specifications.
All tests passed with results equivalent to the Grael, and did not raise additional concerns of safety and effectiveness.
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.
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.
Not Found
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
§ 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).
0
February 9, 2023
Image /page/0/Picture/1 description: The image shows the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo is a blue square with the letters "FDA" in white. To the right of the square, the words "U.S. FOOD & DRUG ADMINISTRATION" are written in blue.
Compumedics Limited % Dave Yungvirt CEO Third Party Review Group, LLC 25 Independence Blvd Warren, New Jersey 07059
Re: K230073
Trade/Device Name: Okti Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: January 6, 2023 Received: January 10, 2023
Dear Dave Yungvirt:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Patrick Antkowiak -S
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known)
Device Name Okti
Indications for Use (Describe)
The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.
| Type of Use (Select one or both, as applicable) |
|---|
| X Prescription Use (Part 21 CFR 801 Subpart D) |
| Over-The-Counter Use (21 CFR 801 Subpart C) |
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Image /page/3/Picture/0 description: The image is a logo for Compumedics. The logo features a blue circle with a stylized "m" inside of it. To the right of the circle is the word "COMPUMEDICS" in blue, all caps. Below the company name is the tagline "Defining Life's Signals" in a smaller font.
510(k) Summary
Device Name: Okti
The following 510(k) summary is being submitted in accordance with 21 CFR 807.92.
Submission Details
Fax number:
Applicant Information:
| Submitter: | Compumedics Limited |
|---|---|
| Address: | 30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia |
| Phone number: | +61 (0) 3 8420 7300 |
| Fax number: | +61 (0) 3 8420 7399 |
| Contact person: | Michael Frischman |
| Address: | 30-40 Flockhart Street, Abbotsford 3067, Victoria, Australia |
| Phone number: | +61 (0) 3 8420 7362 |
Email: michael.frischman@compumedics.com.au Submission Prepared: 02/11/2022
Subject Device Information:
| Trade name: | Okti |
|---|---|
| Common name: | Okti |
| Primary Product code: | GWQ |
| Classification Names: | Full-Montage Standard Electroencephalograph |
| Panel: | Neurology |
| Device class: | II |
| Regulation numbers: | 21 CFR 882.1400 |
- 61 (0) 3 8420 7399
Predicate Device Information
| Trade Name: | Grael System |
|---|---|
| Model: | Grael EEG |
| Manufacturer: | Compumedics Limited |
| 510(k) number: | K093223 |
| 510(k) Decision Date: | 15th January 2010 |
| Classification: | Full-Montage Standard Electroencephalograph, Ventilatory Effort Recorder |
| Product code: | GWQ, MNR |
| Device class: | II |
| Regulation numbers: | 21 CFR 882.1400 |
Intended Use / Indications For Use
The Okti System is intended for use in the recording, displaying, analysis, printing and storage of human biological parameters such as heart and muscle activity, eye movement, breathing and body movements to assist in the diagnosis of various neurological disorders. The Okti is designed for use in a hospital or other clinical environment. The Okti is only to be used under the direction of a physician.
4
Image /page/4/Picture/0 description: The image shows the logo for Compumedics. The logo features a blue circle with a stylized "m" inside, followed by the word "COMPUMEDICS" in blue, sans-serif font. Below the company name is the tagline "Defining Life's Signals".
Device Description
The Okti is a physiological data acquisition device intended for conducting EEG studies. It is used in conjunction with a PC running Compumedics Profusion EEG software. Power is provided by either an internal Lithium-Ion battery or a POE 100BASE-TX network connection.
Physically, the Okti comprises a base unit housing the battery and digital electronic circuits. A changeable module connects to the base unit and houses the analogue circuity and electrode connectors providing options for 32, 64 or 128 referential, or single ended, channels primarily intended for EEG. Each module includes several differential inputs for electrode-based signals such as ECG, EMG or EOG. All these inputs are class CF for patient safety.
Patient physiological data is digitised using multiple 24-bit ADCs and filtered using fixed point FIR filters implemented internally to an FPGA located in the analogue module. The data is transferred to a generalpurpose processor in the base unit over a synchronous serial link. From there the patient data may be saved to a device internal SD card or sent to a remote PC over an Ethernet or Wi-Fi LAN connection. A Bluetooth interface is also included for connection to external devices such as an oximeter.
The Okti system is available in Okti32, Okti64, or Okti128. These differ only in channel number with below characteristics.
| Model | Inputs |
|---|---|
| Okti32 | 32, DC-coupled, fully isolated, referential (monopolar); 8 user-defined, DC-coupled, fully isolated, bipolar inputs |
| Okti64 | 64, DC-coupled, fully isolated, referential (monopolar); 4 user-defined, DC-coupled, fully isolated, bipolar inputs |
| Okti128 | 128, DC-coupled, fully isolated, referential (monopolar); 8 user-defined, DC-coupled, fully isolated, bipolar inputs |
Comparison to Predicate Device
The Okti's predicate device is the Grael (K093223) comprises two primary models: the Grael, is a full channel device suitable for conducting either PSG or EEG studies; and the Grael EEG, a reduced channel device suitable for EEG studies only.
The Grael EEG is optimized for neurological studies, and does not contain inputs used for respiratory monitoring during PSG which are not necessary for neurological studies. The Grael EEG model is the predicate device and claims relating to PSG are not being made for the Okti.
| Characteristic | Okti | Grael EEG |
|---|---|---|
| Usage | ||
| 510(k) Number | - | K093223 |
| Classification | 882.1400 | 882.1400 |
| Product Code | GWQ | GWQ |
| Class | II | II |
| Intended Use | EEG studies to assist in the | |
| diagnosis of various | ||
| neurological disorders | EEG studies to assist in the | |
| diagnosis of various | ||
| neurological disorders | ||
| Type of Use | Prescription Only | Prescription Only |
| Use Environment | Hospital / Clinical use only | Hospital / Clinical use only |
| Temperature | -10°C to 50°C storage/non- | |
| operating | ||
| 0°C to 40°C operating | -10°C to 50°C storage/non- | |
| operating | ||
| 0°C to 40°C operating | ||
| Relative Humidity | 20 to 90% relative humidity | |
| non-condensing | 20 to 90% relative humidity | |
| non-condensing | ||
| Altitude | 300 charge/discharge cycle at 23°C, 11.25 volts) or Power Over Ethernet (either mid-span injector or PoE switch, per IEEE 802.3af standard) | |
| Operating Voltage | 48 Volts | 48 Volts |
| Power Consumption | 100 MΩ all channels | > 100 MΩ channels 1-32 |
20 MΩ channels 33-40 |
| Bias Current | Typically 1nA | Typically 1nA |
| Input Noise | 100dB | > 100dB |
| Crosstalk |