(72 days)
Not Found
No
The summary describes a physical kit for placing EEG electrodes and does not mention any software, algorithms, or AI/ML capabilities.
No
The device is used to support EEG electrode placement for diagnostic recording of brain electrophysiology, not for therapeutic intervention.
No
The device description indicates it is used to support EEG electrode placement and connect to medical equipment for brain electrophysiology recording. It simplifies the setup for a diagnostic procedure (EEG) but does not itself perform any diagnostic function or analysis of data.
No
The device description explicitly states the kit contains physical components placed on the scalp, including electrodes and other disposable items, indicating it is a hardware device, not software-only.
Based on the provided information, the BraiNet® Kit 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.
- BraiNet® Kit Function: The BraiNet® Kit is a device used to support the placement of electrodes on the scalp for electroencephalography (EEG). EEG is a method of recording electrical activity of the brain from the scalp.
- No Sample Analysis: The BraiNet® Kit itself does not analyze any biological samples from the patient. It is a physical aid for electrode placement.
Therefore, the BraiNet® Kit falls under the category of a medical device used for a diagnostic procedure (EEG), but it is not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BraiNet® Kit contents are placed on the scalp to support electroencephalograph (EEG) electrode placement.
Product codes (comma separated list FDA assigned to the subject device)
GXY, GXZ
Device Description
The BraiNet® Kit components are used by medical professionals and paraprofessionals to simplify placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of brain electrophysiology recording.
The BraiNet® Kit is provided to the user non-sterile, with the exception of the subdermal EEG needle electrodes which are provided sterile and prepackaged. The BraiNet® Kit & individual components is a single patient use, disposable device.
The BraiNet® is made from commercial grade elastic and Velcro materials common to the garment industry.
The BrainDisc™ is made from medium grade polycarbonate with silver/silverchloride center with attached insulated copper lead wire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
scalp
Indicated Patient Age Range
Not Found
Intended User / Care Setting
medical professionals and paraprofessionals
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)
Not Found
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
§ 882.1320 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
JAN 1 2 2005
510(k) Summary of 510(k) Information
Summary of 510(k) Information
| Company Name: | Jordan NeuroScience, Inc.
399 E. Highland Ave., Suite 316
San Bernardino CA 92404 |
|----------------------|-----------------------------------------------------------------------------------------|
| Contact: | Anne Perry |
| Phone: | 909 881-2694 |
| Fax: | 909 882-2891 |
| Summary Date: | October 22, 2004 |
| Trade Names: | BraiNet Kit (BraiNet® and BrainDisc™) |
| Common Name: | Electrode Cap & Subdermal EEG Needle electrodes and Cutaneous EEG electrodes |
| Classification Name: | 21 CFR 882.1320; Product Code: GXY |
| Predicate Device: | 510(k) Number: K780045 |
Manufacture: Electro-Cap International Trade Name: Electro-Cap, Infa-Cap
1.0 Description of Device
The BraiNet® Kit components are used by medical professionals and paraprofessionals to simplify placement of electroencephalograph (EEG) electrodes on the scalp. The electrodes connect to medical equipment in support of brain electrophysiology recording.
The BraiNet® Kit is provided to the user non-sterile, with the exception of the subdermal EEG needle electrodes which are provided sterile and prepackaged. The BraiNet® Kit & individual components is a single patient use, disposable device.
1
2.0 Intended Use
The intended use of the BraiNet® is the same as the predicate Eletro-Cap, Infa-Cap. The BraiNet® template is placed on the scalp to support electroencephalograph (EEG) electrode placement.
The intended use of the BrainDisc™ cutaneous electrode is the same as the predicate AMBU Disposable Cup Electrode. The BrainDisc™ is placed on the scalp to support electroencephalograph (EEG) recording.
3.0 Technological
The BraiNet® is made from commercial grade elastic and Velcro materials common to the garment industry.
The BrainDisc™ is made from medium grade polycarbonate with silver/silverchloride center with attached insulated copper lead wire.
4.0 Conclusions
The intended use and technology of the BraiNet® Kit and contents is substantially equivalent to the predicate devices. No new questions of safety or effectiveness are raised.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three curved lines.
JAN 1 2 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Anne Perry CFO Jordan NeuroScience, Inc. 399 E. Highland Avenue, Suite 316 San Bernardino, California 92404
Re: K043009
Trade/Device Name: BraiNet® Kit Regulation Number: 21 CFR 882.1320, 21 CFR 882.1350 Regulation Name: Cutaneous electrode; Needle electrode Regulatory Class: II Product Code: GXY and GXZ Dated: October 22, 2004 Received: November 1, 2004
Dear Ms. Perry:
We have reviewed your Section 510(k) premarket notification of intent to market the device wo have roviewed your be determined the device is substantially equivalent to legally marketed relevelocate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of preated at Device Amendments or to devices that have been reclassified in accordance with the the Moureal Do Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the provisions or the general controls provisions of the Act. However, you are responsible to determine that the medical devices you use as components in the [kit/tray] have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28, 1976, the enactment date of the of the act, of were regarly ents. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before (1.0., annintened) and rares in your kit/tray. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, and 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
3
Page 2 - Ms. Anne Perry
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.
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 the labeling regulation, please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification"(21 CFR Part 807.97). 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 (301) 443-6597, or at its Internet address http://www.fda.gov/cdrh.dsmaldsmamain.html.
Sincerely yours,
Miriam C. Provost
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
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Attachment A
Indications for Use Form
Page 1 of 1
KO43009 510(k) Number (if known): 3004622056 (Specification Developer)
Device Name: BraiNet® Kit
Indications For Use:
The BraiNet® Kit contents are placed on the scalp to support electroencephalograph (EEG) electrode placement.
iriam C. Provost
Division of General, Restorative. and Neurological Devices
510(k) Number K043009
Over-The-Counter Use Prescription Use _ X OR PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NECESSARY Concurrence of CDRH, Office of Device Evaluation (ODE) (Per 21 CFR 801.109) (Optional format 1-2-96)