(14 days)
K#002734
No
The summary describes a sensor that records electrophysiological signals and mentions a minor modification to the hydrogel formulation. There is no mention of AI, ML, or any processing of the signals beyond recording. The performance studies listed are standard for a sensor and do not suggest AI/ML processing.
No
The device is described as a sensor that records electrophysiological signals, which is for diagnostics or monitoring, not for treating a condition.
No
The device is a sensor used to record electrophysiological signals (like EEG), which is a component for data acquisition rather than a diagnostic device itself. Diagnostic devices typically analyze or interpret collected data to provide a diagnosis.
No
The device description explicitly states it is a sensor applied to the patient's skin and mentions electrical and mechanical testing, indicating it is a physical hardware device.
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 a sensor applied to the skin. This aligns with a device used for direct physiological measurement, not for testing a sample.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any of the typical components or processes associated with in vitro diagnostics.
IVDs are devices used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device's function is to capture electrical signals from the body itself, which falls outside the scope of IVD.
N/A
Intended Use / Indications for Use
The BIS Quatro sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Product codes
GXY
Device Description
This 510(k) is being submitted for the BIS Quatro which is a minor modification to the 510(k) cleared Enhanced Sensor (K#002734). The formulation of the aqueous hydrogel is being changed.
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.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
The following tests/analyses have been completed for the BIS Quatro:
- . Electrical
- Mechanical .
- Shelf Life .
- . Biocompatibility
- Hazard Analysis .
Results indicate the device meets its performance specifications and is safe for its intended use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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
k 693183 510 k :
SECTION 6
OCT 2 3 2009
510(k) SUMMARY Date Prepared: August 31, 2009
1. Company Name and Address
Aspect Medical Systems, Inc. One Upland Road Norwood, MA 01532
Contact Person:
Vikram Verma Sr. Manager, RA/QA Telephone (direct dial): (617) 559-7134 Fax #: (617) 559-7948
2. Device Name
ﻪ
| Proprietary Name: | BIS Quatro 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).
Predicate Device 6.
Aspect Medical Systems Enhanced BIS Sensor This 510(k), # K002734, received FDA clearance on September 14, 2000
7. Device Description
This 510(k) is being submitted for the BIS Quatro which is a minor modification to the 510(k) cleared Enhanced Sensor (K#002734). The formulation of the aqueous hydrogel is being changed.
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.
1
Aspect Medical Systems has concluded that the device is substantially equivalent to the predicate device (BIS Enhanced Sensor, K#002734), and is safe and effective for its intended use.
Indications for use for Quatro Sensor:
The BIS Quatro 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 Quatro has the same intended use and fundamental scientific technology as the predicate device, Enhanced Sensor (K#002734).
Summary of Testing
The following tests/analyses have been completed for the BIS Quatro:
- . Electrical
- Mechanical .
- Shelf Life .
- . Biocompatibility
- Hazard Analysis .
Results indicate the device meets its performance specifications and is safe for its intended use.
Conclusion:
Based on the above, Aspect Medical Systems believes the BIS Quatro Sensor is substantially equivalent to the predicate device, and is safe and effective for its intended use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three stripes representing the department's mission. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Mail Center - WO66-G609 Silver Spring, MD 20993-0002
Aspect Medical Systems, Inc. c/o Mr. Casey Conry Underwriters Laboratories, Inc. 1285 Walt Whitman Rd Melville, NY 11747
Re: K093183
OCT 2 3 2009
Trade/Device Name: BIS Quatro Sensor Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated: October 8, 2009 Received: October 9, 2009
Dear Mr. 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. 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 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.
3
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/MedicalDevices/Safety/ReportalProblem/default.htm 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 (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerely yours,
Eva Kimm
Malvina B. Fudakowski M.D.
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
4
Indications for Use
510(k) Number (if known)
大093183
Device Name
BIS Quatro Sensor
Indications for Use
The BIS Quatro 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)
PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Raff
(Division Sign-Off Division of Opethalmic, Neurological and Ear, Nose and Throat Devices
510(k) Number: K095183
Page 1 of 1