(13 days)
Not Found
No
The summary describes a sensor and cable system with a smart card for storing basic information (lot number, expiration, connections). There is no mention of algorithms, data processing beyond basic information retrieval, or any terms related to AI/ML. The modifications are focused on hardware and information storage for end-user messaging.
No
The device is a sensor used to record electrophysiological signals (EEG) and does not directly provide therapy. It is used for monitoring, not treatment.
Yes
Explanation: The device is described as enabling "recordings of electrophysiological (such as EEG) signals." The collection and interpretation of physiological signals, such as EEG, are fundamental to diagnostic processes in medicine, as they provide information about a patient's health status. While the document focuses on the sensor's modification, its core function is to acquire data that would then be used for diagnostic purposes by a monitor (as implied by "information is used by the monitor for end user messaging").
No
The device description explicitly states it is a system comprised of a disposable sensor and a reusable cable, both of which are hardware components. The 510(k) is for modifications to these hardware components.
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) from the patient's skin. This is a direct measurement of physiological activity within the body, not an analysis of samples taken from the body (like blood, urine, or tissue).
- Device Description: The device is applied directly to the patient's skin and measures electrical signals. This aligns with in vivo (within the living body) measurement, not in vitro (in glass or outside the living body) testing.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or laboratory procedures typically associated with IVD devices.
Therefore, the BIS Click sensor is a medical device used for physiological monitoring, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The BIS Click sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Product codes
GXY
Device Description
The BIS Click Sensor is a system comprised of the BIS Click disposable sensor and the reusable cable. This 510(k) is being submitted for the BIS Click which is a minor modification to the BIS SRS (K#050313) to enable the reusable cable to be used for indefinite uses with the disposable sensors and to recognize the smart card on the disposable sensor. The disposable sensor has been modified to add a smart card memory device containing information for lot number, expiration date, and number of connections. This information is used by the monitor for end user messaging, like in the Enhanced Sensor (K#002734).
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin
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
A hazard analysis was conducted for the device. All identified hazards have been sufficiently mitigated. A summary of validation test results is included in this 510(k). All the results are acceptable.
The following tests/analyses have been completed for the BIS Click Sensor:
- 0 Mechanical
- Electrical .
- Multiple use ●
- Shelf Life .
- Hazard Analysis ●
Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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
SECTION 6
510(k) SUMMARY Date Prepared: May 22, 2009
1. Company Name and Address
JUL - 2 2009
Aspect Medical Systems, Inc. One Upland Road Norwood, MA 01532
Contact Person:
Vikram Verma Manager, RA/QA Telephone (direct dial): (617) 559-7134 Fax #: (617) 559-7948
2. Device Name
Proprietary Name: BIS Click Sensor Common Name: Electrode, Cutaneous Electrode
3. Classification
Cutaneous Electrodes have been classified by the Neurological Devices Panel as Class II, 84 GXY. No performance standards have been established under Section 514 of the Food, Drug and Cosmetic Act for cutaneous electrodes. (21 CFR 882.1320).
6. Predicate Device
Aspect Medical Systems BIS SRS This 510(k), #K050313, received FDA clearance on February 24, 2005
Aspect Medical Systems Enhanced BIS Sensor This 510(k), # K002734, received FDA clearance on September 14, 2000
7. Device Description
The BIS Click Sensor is a system comprised of the BIS Click disposable sensor and the reusable cable.
This 510(k) is being submitted for the BIS Click which is a minor modification to the BIS SRS (K#050313) to enable the reusable cable to be used for indefinite uses with the disposable sensors and to recognize the smart card on the disposable sensor. The disposable sensor has been modified to add a smart card memory
6-2
1
device containing information for lot number, expiration date, and number of connections. This information is used by the monitor for end user messaging, like in the Enhanced Sensor (K#002734).
A hazard analysis was conducted for the device. All identified hazards have been sufficiently mitigated. A summary of validation test results is included in this 510(k). All the results are acceptable.
Aspect Medical Systems has concluded that the device is substantially equivalent to the predicate devices (BIS SRS, K#050313, and BIS Enhanced Sensor, K#002734), and is safe and effective for its intended use.
Indications for use for BIS Click Sensor:
The BIS Click sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Summary of Technological Characteristics Compared to Predicate Device
The BIS Click has the same intended use and fundamental scientific technology as the predicate devices, BIS SRS (K#050313) and Enhanced Sensor (K#002734).
Summary of Testing
r
The following tests/analyses have been completed for the BIS Click Sensor:
- 0 Mechanical
- Electrical .
- Multiple use ●
- Shelf Life .
- Hazard Analysis ●
Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use.
Conclusion:
Based on the above, Aspect Medical Systems believes the BIS Click Sensor is substantially equivalent to the predicate devices, and is safe and effective for its intended use.
6-7
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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract image of an eagle with its wings spread.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Aspect Medical Systems, Inc. c/o Casey Conry Senior Project Engineer Underwriters Laboratories, Inc. 1285 Walt Whitman Rd. Melville. NY 11747
Re: K091854
Trade/Device Name: BIS Click Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: June 19, 2009 Received: June 19, 2009
Dear Ms. Conry:
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.
JUL - 2 2009
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 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); medical device reporting (reporting of medical device-related adverse events} (21 CFR 803); 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.
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If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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,
Rohm, m br
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known).
Device Name
BIS Click Sensor/Cable
Indications for Use
The BIS Click 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-TheCounter Use (21 CFR 807 Subpart C)
Page 1 of 1
PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER. PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE) Kristen Bousshe
(Division Sign-Off) Division of Ophthalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number C