(93 days)
Not Found
No
The summary describes a sensor for recording electrophysiological signals and mentions an electronic smart card for configuration and identification. There is no mention of AI, ML, or any processing of the recorded signals using such technologies.
No
The device is a sensor used to record electrophysiological signals (EEG), which are diagnostic in nature, not therapeutic. It does not provide any treatment or therapy.
No
The device records electrophysiological signals but the "Intended Use" does not mention diagnosing a disease or condition. Recording signals alone does not make it a diagnostic device.
No
The device description explicitly states it is a "pre-gelled 6 electrode array" with an "electronic smart card memory device," indicating it is a physical hardware component, not software only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to record electrophysiological signals (like EEG) directly from the patient's skin. This is a measurement of physiological activity within the body, not an analysis of a sample taken from the body (like blood, urine, or tissue).
- Device Description: The device is applied directly to the patient's forehead to record signals. This reinforces that it's interacting with the patient's body directly, not processing a sample in vitro.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
In summary, the device is a sensor for measuring physiological signals in vivo (within the living body), which is distinct from in vitro diagnostics.
N/A
Intended Use / Indications for Use
The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
The Sensor is a single patient use, disposable, pre-gelled 6 electrode array that is applied directly to the patient's forehead to record electro-physiological signals. It has an electronic smart card memory device in the tab area that contains configuration and identification information.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's forehead, patient's skin, head
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
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
K062692
Page 1 of 2
DEC 1 3 2006
:
Appendix E
:
510(k) Summary
| Date: | September 7, 2006 |
|---|---|
| Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464 | |
| Contact Person: | Renee Gould (617) 559-7788 |
| Proprietary Name: | BIS Bilateral Sensor |
| Common Name: | Electrode, Cutaneous Electrode |
| Classification: | Class II device. Refer to 21 CFR 882.1320 |
| Product Code: | GXY |
| Predicate | |
| Device: | K002734, Aspect Enhanced XP BIS Sensor cleared September 14, |
| 2000 | |
| Device Description: | The Sensor is a single patient use, disposable, pre-gelled 6 electrode |
| array that is applied directly to the patient's forehead to record electro- | |
| physiological signals. It has an electronic smart card memory device | |
| in the tab area that contains configuration and identification | |
| information. | |
| Indications for Use: | The BIS Bilateral Sensor is applied directly to the patient's skin to |
| enable recordings of electrophysiological (such as EEG) signals. | |
| Similarities: | |
| • same indications for use, | |
| • same intended use, | |
| • same fundamental scientific technology, | |
| • incorporates the same basic design, | |
| • 2 channels of BIS, | |
| • incorporates the same materials and biocompatibility, | |
| • has the same shelf life, | |
| • is packaged using the same materials and processes, and | |
| • incorporates smart card memory device. | |
| Differences: | |
| • | addition of montage on the other side of the head, |
- addition of the 2 electrodes, and .
- 4 channels of EEG collected. .
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K062692
Page 2 of 2
In summary, the BIS Bilateral Sensor is substantially equivalent to the predicate device. Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness. The intended use is the same as the predicate device. The indications for use remain the same as the Enhanced Sensor. The fundamental scientific technology remains the same as the Enhanced Sensor predicate device.
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 features a stylized eagle with three tail feathers, representing the three branches of government. The eagle is encircled by the words "DEPARTMENT OF HEALTH & HUMAN SERVICES. USA" in a circular arrangement.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aspect Medical Systems, Inc. % Ms. Renee Gould Director, Regulatory, Quality Assurance 141 Needham Street Newton, Massachusetts 02464
Rc: K062692
Trade/Device Name: BIS Bilateral Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous electrode Regulatory Class: Class II Product Code: GXY Dated: November 9, 2006 Received: November 13, 2006
Dear Ms. Gould:
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.
DEC 1 3 2006
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 – Ms. Renee Gould
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 vours.
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Appendix C
Indications for Use Statement
510(k) Number (if known)
Device Name
BIS Bilateral Sensor
Indications For Use
The BIS Bilateral Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Prescription Use X (Per 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (21 CFR 807 Subpart C)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of nice Evaluation (ODE) DRH O
Mark H. Mcllwra
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(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Numb