(66 days)
The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.
The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording. The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices. The BraiNet is made from elastic and Velcro commercial garment grade materials.
The provided text is a 510(k) premarket notification for the Nicolet BraiNet device. It focuses on establishing substantial equivalence to a predicate device rather than detailing specific acceptance criteria and a study to prove meeting those criteria.
Therefore, the document does not contain the information requested regarding acceptance criteria and a study proving the device meets those criteria.
Specifically, the following points from your request cannot be extracted from the provided text:
- A table of acceptance criteria and the reported device performance: This information is not present. The document concludes that the "intended use and technology...is substantially equivalent to the predicate device" and that "No new questions of safety or effectiveness are raised," but it does not provide specific performance metrics or acceptance criteria.
- Sample size used for the test set and the data provenance: Not mentioned.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not mentioned.
- Adjudication method for the test set: Not mentioned.
- 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: Not mentioned. This type of study is typically for evaluating AI-assisted diagnostic tools, which the BraiNet (an electrode cap) is not.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not mentioned. Similarly, this is not relevant for the type of device.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.): Not mentioned.
- The sample size for the training set: Not mentioned.
- How the ground truth for the training set was established: Not mentioned.
The document primarily focuses on:
- Description of the Device: BraiNet, an electrode cap for EEG electrode placement.
- Intended Use: Supports EEG electrode placement.
- Technological Characteristics: Made from elastic and Velcro commercial garment grade materials.
- Predicate Device: Electro-Cap (K780045).
- Conclusion: Substantial equivalence to the predicate device.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for Nicolet Biomedical. The word "Nicolet" is in a large, bold, sans-serif font. Underneath the word "Nicolet" is a horizontal line. Below the line, the word "BIOMEDICAL" is written in a smaller, sans-serif font, with a space between each letter.
AUG 2 3 2002
Summary of Safety and Effectiveness
| Company Name: | Nicolet Biomedical5225 Verona RoadMadison, WI 53711 | |
|---|---|---|
| Contact:Phone:Fax: | Glen Hermanson, Manager of Standards and Compliance608 441-2065608 441-2007 | |
| Summary Date: | June 17, 2002 | |
| Trade Name: | BraiNet | |
| Common Name: | Electrode Cap | |
| Classification Name: | 21 CFR 882.1320; Product Code: GXY | |
| Predicate Device: | 510(k) Number: K780045Manufacture: Electro-Cap International |
Trade Name:
1.0 Description of Device
The BraiNet is used by licensed medical professionals to support placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of stimulation and recording.
Electro-Cap, Infa-Cap
The BraiNet is provided to the user non-sterile. The BraiNet is a single patient use, disposable devices.
2.0 Intended Use
The intended use of the Nicolet BraiNet is the same as the predicate Electro-Cap. The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.
File: BraiNet 510(k)
Page 36
1 of 2
{1}------------------------------------------------
Ko2/986
3.0 Technological
The BraiNet is made from elastic and Velcro commercial garment grade materials.
4.0 Conclusions
The intended use and technology of the Nicolet BraiNet is substantially equivalent to the predicate device. No new questions of safety or effectiveness are raised.
Page 37
pg 2 of 2
{2}------------------------------------------------
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three heads facing to the right. The eagle is surrounded by a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" written around it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2002
Nicolet Biomedical, Inc. c/o Gary Syring Ouality & Regulatory Associates, LLC 800 Levanger Lane Stoughton, Wisconsin 53589
Re: K021986
Trade/Device Name: BraiNet Regulation Number: 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: June 17, 2002 Received: June 18, 2002
Dear Mr. Syring:
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. Iisting 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 such 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); 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.
{3}------------------------------------------------
Page 2 - Mr. Gary Syring
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification 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 and additionally 21 CFR Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4659. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers, International 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,
Mark N. Millerson
Colin M. Wittes, Ph.D., M.D.
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
{4}------------------------------------------------
510(k) Number (if known):
Device Name: Nicolet BraiNet
Indications For Use:
The Nicolet BraiNet is placed on the scalp to support electroencephalograph (EEG) electrode placement.
(PLEASE: DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF needed)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Optional Format 3-10-98)
R. Mark N. Melleusen
(Div. on Sign-Cff) Division of General, Restorative and Neckological Devices
510(k) Number _
19
§ 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).