(126 days)
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Not Found
No
The summary describes a physical electrode for recording EEG and does not mention any software or analytical components that would utilize AI/ML.
No
The device is described as being for "temporary recording of EEG" and "intended for use in a similar manner to that of a subdermal needle electrode," indicating a diagnostic or monitoring function rather than a therapeutic one.
Yes
The device is intended for "temporary recording of EEG," which is a diagnostic procedure to assess brain activity for medical diagnosis.
No
The device is described as a "pediatric subdermal wire electrode," which is a physical, disposable hardware component used for recording EEG. The description does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "temporary recording of EEG in comatose pediatric patients". This is a direct measurement of electrical activity within the body (in vivo), not an examination of specimens derived from the human body (in vitro).
- Device Type: It's described as a "subdermal wire electrode", which is a device used to acquire physiological signals directly from the patient.
- Lack of IVD Characteristics: There is no mention of analyzing blood, urine, tissue, or any other biological specimen. The device is used to record electrical signals from the brain.
Therefore, this device falls under the category of a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU).
The pSWE is a disposable, single use device.
The pSWE is intended for use in a similar manner to that of a subdermal needle electrode.
Product codes
GXZ
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
6 to 21 years
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
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)
Not Found
Reference Device(s)
Not Found
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
Public Health Service
Image /page/0/Picture/2 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES . USA" around the perimeter. Inside the circle is a stylized symbol of three human profiles facing right, arranged in a stacked, overlapping manner.
MAY 3 0 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ives EEG Solutions, Inc. % Mr. John Ives President 6325 Rideau Valley Drive Manotick, Ontario Canada K4M 1B3
Re: K060189
Trade/Device Name: Pediatric Subdermal Wire Electrode (pSWE) Regulation Number: 21 CFR 882.1350 Regulation Name: Needle electrode Regulatory Class: II Product Code: GXZ Dated: April 10, 2006 Received: April 17, 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. 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
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Page 2 - Mr. John Ives
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 our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson
Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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4. Indications for Use
510(k) Number: Device Name:
K060189 Pediatric Subdermal Wire Electrode (pSWE)
Indications for Use: The pediatric subdermal wire electrode (pSWE) is intended for temporary recording of EEG in comatose pediatric patients (range: 6 to 21 years) in hospital based Intensive Care Units (ICU).
The pSWE is a disposable, single use device.
The pSWE 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)
Hulur Remunho
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K060189