(238 days)
No
The document explicitly states "The device does not contain software" and there are no mentions of AI, DNN, or ML in the provided text. The device is described as an electrode positioning system and the performance study compares it to a predicate device based on spectral shape and frequency, not AI/ML performance metrics.
No
The device is described as an EEG electrode positioning system used to acquire electrophysiological EEG signals. Its purpose is to facilitate the collection of diagnostic data, not to provide therapy.
Yes
The device is used to acquire electrophysiological EEG signals, which are then read through an EEG data collection device, indicating its role in obtaining data for diagnostic purposes (EEG is a diagnostic tool).
No
The device description explicitly states, "The device does not contain software". It is a hardware-based EEG electrode positioning system.
Based on the provided information, the WAVi Headset is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD Definition: An IVD device is a medical device used to perform tests on samples such as blood, urine, or tissue to detect diseases, conditions, or infections. These tests are performed outside of the body (in vitro).
- WAVi Headset Function: The WAVi Headset is an EEG electrode positioning system. It is used to acquire electrophysiological signals directly from the patient's scalp (in vivo). It facilitates the placement of electrodes for an EEG data collection device, which then measures the electrical activity of the brain.
- Lack of Sample Testing: The description clearly states that the device acquires signals from an individual and does not mention any testing of biological samples.
Therefore, the WAVi Headset falls under the category of a medical device used for physiological signal acquisition, not an IVD device.
N/A
Intended Use / Indications for Use
The WAV Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
Product codes
GXY
Device Description
The WAVI™ Headset is an EEG electrode positioning system used to quickly place the electrodes in a uniform and consistent manner in accordance with the international standard Ten-Twenty System (10-20) to acquire electrophysiological EEG signals from an individual to a suitable EEG data collection device.
The device consists of the WAVi™ Headset, WAVi™ eSoc™ Single Use and Tin Electrode Contacts; the head set comes in five models/sizes (XS, S, M, L, XL). This device is portable, nonsterile, non-invasive, non-radiation emitting, point-of-care use device for use in healthcare facilities and hospitals.
Device characteristics include the eSoc™ Single Use Electrode Contacts which are soaked in 0.9% Normal Saline which is unique as it serves as the electro-conductive material and patient contact allowing the brain's electrical signals to be read through an EEG data collection device. Typical set-up and procedure time is less than twenty minutes.
The device does not contain software, biologics, drugs, coatings or any claim of sterility.
The WAVI™ Headset, eSoc™ Single Use and Ear Electrode Contacts are made from wellestablished medical grade materials; the Headset is made from a proprietary EVA material with tin plated ring electrode ports for placement of the Nylon 101 WAVi™ eSoc™ Single Use Electrode Contacts, and two ear electrodes are also made from Tin. A wire harness is embedded between two layers of EVA and is attached to each electrode port. The wire harness exits the headset to a 32-pin connector port.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
On the head
Patient's skin (scalp)
Indicated Patient Age Range
Adults and Children
Intended User / Care Setting
routine clinical and research settings
healthcare facilities and hospitals.
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
The WAVi™ Headset and the Electro-Cap™ were also compared side-by-side on three test subjects using a Lexicor Neurosearch-24 Brain mapper (K915820); the spectral shape and maximum frequency of the corresponding WAVi Headset and Electro-Cap spectrums at each of the 10/20 EEG locations were consistently similar within each subject.
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The WAVi™ Headset and the Electro-Cap™ System were compared for sizing, electrode placement and labeling, and was found to be substantially equivalent.
The WAVi™ Headset and the Electro-Cap™ were also compared side-by-side on three test subjects using a Lexicor Neurosearch-24 Brain mapper (K915820); the spectral shape and maximum frequency of the corresponding WAVi Headset and Electro-Cap spectrums at each of the 10/20 EEG locations were consistently similar within each subject.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1320 Cutaneous electrode.
(a)
Identification. A cutaneous electrode is an electrode that is applied directly to a patient's skin either to record physiological signals (e.g., the electroencephalogram) or to apply electrical stimulation.(b)
Classification. Class II (performance standards).
0
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the circumference. Inside the circle is a stylized image of three human profiles facing right, stacked on top of each other, creating a flowing, abstract design.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 28, 2017
WAVi, Co. David Jones FDA Consultant 3535 S Irving St. Englewood, Colorado 80110
Re: K162460
Trade/Device Name: WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode Contacts Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 22, 2017 Received: March 31, 2017
Dear Mr. Jones:
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. 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in
1
the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
for
Sincerely.
Michael J. Hoffmann -S
Carlos L. Peña, PhD, MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162460
Device Name
WAVi™ Headset and WAVi™ eSocTM Single Use Electrode Contacts
Indications for Use (Describe)
The WAV Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
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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3
510(k) SUMMARY
| Submitted by: | WAVi Co.
3535 S. Irving Street
Englewood, CO 80110
804-909-2389 | |
|----------------------|---------------------------------------------------------------------------------------------------------|-------------------|
| Contact Person: | David Jones
281-989-8515 | |
| Date Prepared: | April 28, 2017 | |
| Proprietary Name: | WAVi™ Headset and WAVi™ eSoc™ Single Use Electrode
Contacts | |
| Model Numbers: | WH-100: XS Headset
WH-200: S Headset
WH-300: M Headset
WH-400: L Headset
WH-500: XL Headset | |
| Common Name: | EEG 10-20 Electrode Headset and Electrodes | |
| Classification: | Class II: | 21 CFR § 882.1320 |
| Classification Name: | Cutaneous Electrode – GXY | |
| Predicate Devices: | Electro-Cap™ System (K112319)
Electro-Cap™ Intl., Inc.
1011 West Lexington Rd.
Eaton, OH 45320 | |
Device Description:
The WAVI™ Headset is an EEG electrode positioning system used to quickly place the electrodes in a uniform and consistent manner in accordance with the international standard Ten-Twenty System (10-20) to acquire electrophysiological EEG signals from an individual to a suitable EEG data collection device.
The device consists of the WAVi™ Headset, WAVi™ eSoc™ Single Use and Tin Electrode Contacts; the head set comes in five models/sizes (XS, S, M, L, XL). This device is portable, nonsterile, non-invasive, non-radiation emitting, point-of-care use device for use in healthcare facilities and hospitals.
Device characteristics include the eSoc™ Single Use Electrode Contacts which are soaked in 0.9% Normal Saline which is unique as it serves as the electro-conductive material and patient contact allowing the brain's electrical signals to be read through an EEG data collection device. Typical set-up and procedure time is less than twenty minutes.
The device does not contain software, biologics, drugs, coatings or any claim of sterility.
4
The WAVI™ Headset, eSoc™ Single Use and Ear Electrode Contacts are made from wellestablished medical grade materials; the Headset is made from a proprietary EVA material with tin plated ring electrode ports for placement of the Nylon 101 WAVi™ eSoc™ Single Use Electrode Contacts, and two ear electrodes are also made from Tin. A wire harness is embedded between two layers of EVA and is attached to each electrode port. The wire harness exits the headset to a 32-pin connector port.
Intended Use:
The WAVi Headset is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
Technological Characteristics
| Manufacturer | WAVi Co. | Electro-Cap |
|---|---|---|
| Trade Name | WAVi Headset | Electro-Cap System (K780045) |
| Indication for Use | The WAVi Headset is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. | The Electro-Cap is intended for use in routine clinical settings where rapid placement of a number of EEG electrodes is desired. |
| Environmental Use | Electrophysiological | Electrophysiological |
| Target Patient | Adults and Children | Adults and Children |
| Where Used | On the head | On the head |
| Anatomical Contact Sites | Patient's skin (scalp) | Patient's skin (scalp) |
| Number of Contacts | 22 | 2 to 256 |
| Sterile | No | No |
| Size of Cap | Various- Extra Small to Extra Large | Various- Extra Small to Large |
| Style of Cap | Full Head Cap | Full Head Cap |
| Cap Material | EVA | Spandex |
| Location of Wiring | Inside Cap | Inside Cap |
| Type of Cables | Standard Ribbon Cable and Lead Wires | Standard Ribbon Cable and Lead Wires |
| Type of Electrode Drop | Detachable and Non Detachable | Detachable and Non Detachable |
| Electrode Material | Nylon 6/6 (101) and Pure Tin | Pure Tin |
| Electrode Placement System | The International 10-20 System is used as a basis for the electrode placement. | The International 10-20 System is used as a basis for the electrode placement. |
| Number of Recording Channels | 19 | 19 |
| Electrode Positions Utilized | Fp1, Fp2, F7, F3, Fz, F4, F8, T3, C3, Cz, C3, T4, T5, P3, Pz, P4, T6, 01, 02, A1, A2 | Fp1, Fp2, F7, F3, Fz, F4, F8, T3, C3, Cz, C3, T4, T5, P3, Pz, P4, T6, 01, 02, A1, A2 |
| Type of Connectors | D-Sub Connectors, Touch Proof Din Sockets and Special Connectors to Match EEG Equipment and Computers | D-Sub Connectors, Touch Proof Din Sockets and Special Connectors to Match EEG Equipment and Computers |
| Biocompatibility Testing | None was conducted | None was conducted |
The following is a side-by-side of the WAVi device compared to the Predicate:
5
| Performance
Requirements | Needs to transmit
electrophysiological signals from an
individual to data collection devices.
Does not transmit electrical current,
nor are they intended to be used for
stimulation. | Needs to transmit
electrophysiological signals from an
individual to data collection devices
with a maximum impedance of
5K/Ohms. Does not transmit
electrical current, nor are they
intended to be used for stimulation. |
| ----------------------------- | ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ | --------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
|---|
The electrical activity of the brain is acquired through 0.9% Normal Saline soaked eSocTM inserted into the electrode ports and connected through the Headset's wiring harness to the Patient Cable which is connected to the EEG device where brain activity may be recorded for evaluation.
Non-Clinical Testing:
The WAVI™ Headset and accessories are manufactured of medical grade materials including ethylene vinyl acetate (EVA), nylon 6/6 (101) and tin. Multiple 510 (k)'s have been cleared for each of these materials demonstrating no need for further biocompatibility testing.
The WAVI™ Headset and accessories' Quality Assurance testing includes visual inspection of the headset, label and labeling, dimensional verification, and individual electrode resistance of the components and finished product. The WA Vi™ Headset and accessories meet all performance specifications.
The WAVi™ Headset and the Electro-Cap™ System were compared for sizing, electrode placement and labeling, and was found to be substantially equivalent.
The WAVI™ Headset and the Electro-Cap™ were also compared side-by-side on three test subjects using a Lexicor Neurosearch-24 Brain mapper (K915820); the spectral shape and maximum frequency of the corresponding WAVi Headset and Electro-Cap spectrums at each of the 10/20 EEG locations were consistently similar within each subject.
Substantial Equivalence
The WAVi™ Headset, WAVi™ eSoc™ Single Use and Tin Ear Electrode Contacts are portable, non-sterile, non-invasive, non-radiation emitting, point of care, electroencephalogram (EEG) devices, and is intended for use in routine clinical and research settings where rapid placement of a number of EEG electrodes is desired.
All non-clinical tests demonstrate that the WAVI™ Headset and accessories are as safe, as effective, and perform as well as or better than the legally marketed predicate device.
The WAVi™ Headset is substantially equivalent to the predicate devices in the following manner:
- . Same intended use
- Same operating principle ●
- Same fundamental scientific technology
- Same or substantially equivalent materials, including headset and electrodes. .
There are no other substantial or significant differences between the WA Vi™ Headset and its' accessories and the predicate that would affect safety, effectiveness or performance, therefore the WAVi™ Headset and accessories' are substantially equivalent to the predicate device.