(87 days)
Not Found
Not Found
No
The summary describes a physical electrode for recording EEG and does not mention any software or algorithms that would utilize AI or ML.
No
The device is intended for temporary recording of EEG, which is a diagnostic function, not a therapeutic one. It gathers information rather than directly treating a condition.
No
The device is intended for "temporary recording of EEG," which is a measurement function, not a diagnostic one. It gathers data that a clinician might use for diagnosis, but the device itself does not make a diagnosis.
No
The device description explicitly states "Subdermal Wire Electrode (SWE)", which is a hardware component used for recording EEG. The intended use also describes a physical electrode.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples such as blood, urine, or tissue that have been taken from the human body to detect diseases or other conditions. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The description clearly states the device is a "subdermal wire electrode" intended for "temporary recording of EEG". This means it is a device that is inserted into the body to measure electrical activity (brain waves) directly from the patient.
- Lack of Sample Analysis: There is no mention of the device analyzing any biological samples taken from the patient. It is directly interacting with the patient's body.
Therefore, this device falls under the category of a medical device that is used in vivo (within the living body) for diagnostic purposes (recording EEG to aid in diagnosis or monitoring), but it is not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The subdermal wire electrode (SWE) is intended for temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU). The SWE is a disposable, single use device. The SWE is intended for use in a similar manner to that of a subdermal needle electrode.
Product codes
GXZ
Device Description
Subdermal Wire Electrode (SWE)
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
Not Found
Indicated Patient Age Range
6 years and up
Intended User / Care Setting
hospital based Intensive Care Units (ICU)
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
Not Found
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.
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Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.1350 Needle electrode.
(a)
Identification. A needle electrode is a device which is placed subcutaneously to stimulate or to record electrical signals.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ives EEG Solutions, Inc. % Mr. John R. Ives President 6325 Rideau Valley Drive Manotick, Ontario K4M 1B3
DEC 2 2 2 2006
Re: K062880
Trade/Device Name: Subdermal Wire Electrode (SWE) Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: September 25, 2006 Received: September 26, 2006
Dear Mr. Ives:
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 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.
1
Page 2 - Mr. John R. Ives
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), please contact the Office of Compliance at (240) 276-0120. 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Barbara Powell
for
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
4. Indications for Use
510(k) Number:
KOLOZECO
Device Name:
Subdermal Wire Electrode (SWE)
The subdermal wire electrode (SWE) is intended for Indications for Use: temporary recording of EEG in comatose patients (age range: 6 years and up) in hospital based Intensive Care Units (ICU).
The SWE is a disposable, single use device.
The SWE is intended for use in a similar manner to that of a subdermal needle electrode.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Calvase Brienus
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number_KO(k) Number_KO(
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