(15 days)
Not Found
No
The summary describes a sensor for recording electrophysiological signals and mentions electrical and mechanical testing, but there is no mention of AI, ML, or any algorithms that would process the signals using such technologies.
No
This device is described as a sensor used to record electrophysiological signals (e.g., EEG), not to provide therapy or treatment. Its function is diagnostic or monitoring, not therapeutic.
No
Explanation: The device is described as enabling recordings of electrophysiological (such as EEG) signals, which are then used as input for a diagnostic device. However, the device itself is a sensor that records the signals, not the diagnostic device that interprets those signals. The predicate devices are also sensors, which reiterates the function of this device as a sensor.
No
The device description explicitly states it is a "pre-gelled 4 electrode array" and includes a "multiple use cable" with an "electronic smart card memory device," indicating it is a hardware device with software components, not a software-only medical 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 applied directly to the patient's forehead and records electrical signals. It does not involve the analysis of a biological sample.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples, reagents, or the diagnosis of a disease or condition based on the analysis of such samples.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device is a physiological monitoring device.
N/A
Intended Use / Indications for Use
The BIS SRS is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Product codes
GXY
Device Description
The BIS SRS (Semi-reusable sensor) is a single patient use, disposable, pre-gelled 4 electrode array with a patented Zipprep design that is applied directly to the patient's forehead to record electro-physiological signals. The electrodes have a standard snap construction. There is an electronic smart card memory device in the multiple use cable. The SRS will be packaged as a set, composed of 100 disposable electrode arrays along with 1 multiple use cable.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's forehead
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)
Electrical and mechanical testing was conducted. Results indicate the device 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
§ 882.1750 Pinwheel.
(a)
Identification. A pinwheel is a device with sharp points on a rotating wheel used for testing pain sensation.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 882.9.
0
FEB 2 4 2005
| 510(k) Summary | |
|---|---|
| Date: | |
| Company: | |
| Contact Person: | January 20, 2005 |
| Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464 | |
| Christine Vozella phone: 303-926-5624 fax: 303-604-6477 | |
| Proprietary Name: | |
| Common Name: | |
| Classification: | Aspect Medical Systems BIS SRS |
| Electrode, Cutaneous Electrode | |
| Class II device. Refer to 21 CFR 882.1320 | |
| Predicate Devices: | The Aspect Enhanced BIS Sensor, K002734, cleared September 14, 2000 |
| and the Aspect Zipprep Electrode, K940802, cleared June 22, 1994 | |
| Device Description: | The BIS SRS (Semi-reusable sensor) is a single patient use, disposable, |
| pre-gelled 4 electrode array with a patented Zipprep design that is applied | |
| directly to the patient's forehead to record electro-physiological signals. | |
| The electrodes have a standard snap construction. There is an electronic | |
| smart card memory device in the multiple use cable. The SRS will be | |
| packaged as a set, composed of 100 disposable electrode arrays along with | |
| 1 multiple use cable. | |
| Indications for Use: | The BIS SRS is applied directly to the patient's skin to enable recordings |
| of electrophysiological (such as EEG) signals. | |
| Similarities: | |
| • | |
| • | |
| • | |
| • | |
| • | same indications for use as the Predicate devices |
| 4 electrodes – same as Enhanced BIS Sensor predicate device | |
| same operating principle (Zipprep technology) as both predicate devices | |
| same biocompatible skin contacting materials as the Zipprep Electrode predicate device | |
| same standard snap and eyelet construction as the Zipprep Electrode predicate device | |
| Differences: | |
| • | |
| • | |
| • | minor construction differences |
| smart card memory device is located in the multiple use cable rather than the | |
| sensor paddle | |
| No flexible circuit technology | |
| Electrical and mechanical testing was conducted. Results indicate the device is safe for its | |
| intended use. |
Aspect Medical Systems believes these modifications do not raise new questions of safety or effectiveness. The intended use is the same as both predicate devices. The fundamental scientific technology remains the same as the predicate devices. In summary, the BIS SRS described in this submission is substantially equivalent to the predicate devices.
1
Image /page/1/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services USA. The logo features a stylized eagle with three heads facing right. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circle around the eagle.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Aspect Medical Systems Inc. c/o Mr. Ned E. Devine, Jr. Entela Inc. 3033 Madison Avenue, SE Grand Rapids, Michigan 49548
APR - 9 20W
Re: K050313
Trade/Device Name: BIS SRS (Semi-Reusable Sensor) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: II Product Code: GXY Dated (Date on orig SE ltr): February 7, 2005 Received (Date on orig SE Itr): February 9, 2005
Dear Mr. Devine:
This letter corrects our substantially equivalent letter of February 24, 2005.
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 (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 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.
2
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.
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/CDRH0ffices/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/ReportaProblem/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.
Kesia Alexander
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
3
Indications for Use Statement
510(k) Number (if known)
BIS SRS (Semi-Reusable Sensor) Device Name Indications The Aspect Medical Systems Semi-Reusable Sensor is applied For Use
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 CDRH, Office of Device Evaluation (ODE)
Page | of |
Miriam C. Provost
(Division Sign-Off) Division of General, Restorative, and Neurological Devices
510(k) Number K050313