(15 days)
The BIS SRS is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
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.
This document is a 510(k) summary for the Aspect Medical Systems BIS SRS (Semi-reusable sensor), which is a cutaneous electrode for recording electrophysiological signals.
Here's an analysis of the provided text in relation to the requested information:
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not specify explicit acceptance criteria or quantifiable device performance metrics in terms of diagnostic accuracy, sensitivity, specificity, or other clinical outcomes for the BIS SRS. The submission focuses on substantial equivalence based on technical and functional similarities to predicate devices.
The document states:
"Electrical and mechanical testing was conducted. Results indicate the device is safe for its intended use."
This is a general statement about safety and does not provide specific performance data or acceptance criteria.
2. Sample Size Used for the Test Set and Data Provenance
The document does not mention any human subject test set or clinical study for performance evaluation that would involve a sample size. The testing appears to be limited to "electrical and mechanical testing."
- Sample Size for Test Set: Not applicable/Not mentioned.
- Data Provenance: Not applicable/Not mentioned, as no human subject data for performance claims is presented.
3. Number of Experts Used to Establish Ground Truth and Their Qualifications
Since no human subject testing or clinical performance study is described, there is no mention of experts establishing ground truth.
4. Adjudication Method for the Test Set
Not applicable, as no human subject test set requiring ground truth establishment is described.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No MRMC study is mentioned. The submission focuses on substantial equivalence to predicate devices rather than comparative effectiveness with human readers or an AI-assisted workflow.
6. Standalone (Algorithm Only Without Human-in-the-Loop) Performance
This device is an electrode, not an algorithm or AI system. Therefore, the concept of "standalone performance" for an algorithm is not applicable. The device's function is to enable the recording of electrophysiological signals, not to interpret them or make diagnoses autonomously.
7. Type of Ground Truth Used
Not applicable, as no clinical performance study requiring ground truth is described for this device. The regulatory submission primarily relies on technical and material equivalence to predicate devices.
8. Sample Size for the Training Set
The device itself is a piece of hardware (an electrode). It does not involve a "training set" in the context of machine learning or AI.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no training set for this hardware device.
In summary, the provided 510(k) document is concerned with demonstrating substantial equivalence of a new medical device (an electrode) to already cleared predicate devices, based on its design, materials, manufacturing, and intended use. It does not contain information typically found in submissions for AI/ML-based devices regarding clinical performance studies, acceptance criteria, sample sizes for test/training sets, or expert ground truth establishment.
{0}------------------------------------------------
FEB 2 4 2005
| 510(k) Summary | |
|---|---|
| Date:Company:Contact Person: | January 20, 2005Aspect Medical Systems, Inc., 141 Needham St., Newton, MA 02464Christine Vozella phone: 303-926-5624 fax: 303-604-6477 |
| Proprietary Name:Common Name:Classification: | Aspect Medical Systems BIS SRSElectrode, Cutaneous ElectrodeClass II device. Refer to 21 CFR 882.1320 |
| Predicate Devices: | The Aspect Enhanced BIS Sensor, K002734, cleared September 14, 2000and 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 applieddirectly to the patient's forehead to record electro-physiological signals.The electrodes have a standard snap construction. There is an electronicsmart card memory device in the multiple use cable. The SRS will bepackaged as a set, composed of 100 disposable electrode arrays along with1 multiple use cable. |
| Indications for Use: | The BIS SRS is applied directly to the patient's skin to enable recordingsof electrophysiological (such as EEG) signals. |
| Similarities:••••• | same indications for use as the Predicate devices4 electrodes – same as Enhanced BIS Sensor predicate devicesame operating principle (Zipprep technology) as both predicate devicessame biocompatible skin contacting materials as the Zipprep Electrode predicate devicesame standard snap and eyelet construction as the Zipprep Electrode predicate device |
| Differences:••• | minor construction differencessmart card memory device is located in the multiple use cable rather than thesensor paddleNo flexible circuit technology |
| Electrical and mechanical testing was conducted. Results indicate the device is safe for itsintended 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
§ 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.