(26 days)
The EEG Sensor (BIS Sensor +) is applied directly to the patient's skin to enable recording of electrophysiological (such as EEG) signals.
The Aspect Medical Systems, Inc. EEG Sensor (hereafter referred to as the Aspect Sensor, Aspect EEG Sensor, or BIS Sensor +), is a rectangular shaped, pre-gelled array of three (3) Zipprep ® electrodes that is applied to the patient's skin to record electrophysiological (such as EEG) signals. It is a low impedance, single patient use, disposable electrode sensor that is designed for application to the frontal/temporal area. The Aspect Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with Aspect monitors. The main body of the Aspect Sensor, which houses two (2) electrodes, is placed on the forehead. The satellite area, which houses one (1) electrode, is placed over the temple area. The Aspect Sensor collects EEG signals from these areas, and the differential signal from the temple to the center of the forehead is used to calculate the BIS. The area and distance between electrodes was chosen for ease of application, and to obtain maximum amplitude of the EEG signal, with a minimum of artifact. The "Zipprep" patented electrode design is constructed using flexible tines mounted on a polyethylene basepad with an adhesive. The flexible tines, surrounded by hydrogel, are used to part the outermost layer of skin. While the flexible tines part the skin, hydrogel flows around the tines and forms a conductive bridge with the skin. The Aspect Sensor connects to a monitor at a single point (tab) that is low profile and easy to insert and remove. The tab has an electronic smart card memory device that contains configuration and identification information. This allows better tracking/traceability of the product for Aspect, as well as communicating product information to the user. All materials are biocompatible, and have been tested in accordance with ISO 10993. Skin contacting materials are the same as the Predicate Device.
The provided text describes a 510(k) submission for the "Aspect Medical Systems EEG Sensor" (also referred to as the Aspect Sensor, Aspect EEG Sensor, or BIS Sensor +). This submission is for a cutaneous electrode, which is a Class II device.
The submission focuses heavily on demonstrating substantial equivalence to a predicate device (Aspect Medical Systems Zipprep EEG Sensor, 510(k) #K961821). The key difference in the new device is the addition of a "smart card memory device" for enhanced configuration, tracking, and traceability.
Here's an analysis of the acceptance criteria and study information, based on the provided text:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state formal acceptance criteria with numerical targets. Instead, it states that "All tests passed in accordance with their specification." This implies that the acceptance criteria were defined by the specifications of each test conducted.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Compliance with electrical specifications | All electrical tests passed in accordance with specification |
| Compliance with mechanical specifications | All mechanical tests passed in accordance with specification |
| Compliance with software specifications (related to smart card) | All software tests passed in accordance with specification |
| Compliance with hardware specifications (related to smart card) | All hardware tests passed in accordance with specification |
| Compliance with EMI standards (related to smart card components) | All EMI tests passed in accordance with specification |
| Biocompatibility (for skin-contacting materials) | All materials are biocompatible, and have been tested in accordance with ISO 10993. Skin contacting materials are the same as the Predicate Device. |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for the electrical, mechanical, software, hardware, or EMI testing. It also does not provide any information about the data provenance (e.g., country of origin, retrospective or prospective data) as these tests are likely laboratory-based engineering and performance evaluations.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable and not provided. The testing described is primarily engineering and performance testing of the device's components and characteristics, not ground truth establishment for a diagnostic output.
4. Adjudication method for the test set.
This information is not applicable and not provided. The testing described is primarily engineering and performance testing.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
There is no mention of a multi-reader multi-case (MRMC) comparative effectiveness study. This device is an EEG sensor, a data collection component, not a diagnostic algorithm that would typically involve human readers interpreting AI output.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
The device itself is a "standalone" component in the sense that it collects EEG signals. However, "standalone performance" in the context of AI/algorithm evaluation usually refers to the performance of a diagnostic algorithm without human input. This submission does not describe such an algorithm; it describes an EEG sensor. The device's performance is gauged through electrical, mechanical, and biocompatibility testing.
7. The type of ground truth used
The ground truth for the testing conducted (electrical, mechanical, software, hardware, EMI, biocompatibility) is based on engineering specifications and established standards (e.g., ISO 10993 for biocompatibility). There is no "expert consensus," "pathology," or "outcomes data" ground truth in the typical diagnostic sense for this type of device submission.
8. The sample size for the training set
This information is not applicable and not provided. The device is a hardware sensor, not an AI algorithm that requires a training set.
9. How the ground truth for the training set was established
This information is not applicable and not provided, as there is no training set for this hardware device.
Summary of the study:
The study described is an engineering and performance evaluation aimed at demonstrating the substantial equivalence of the "Aspect Medical Systems EEG Sensor" to its predicate device. This was achieved through a series of tests:
- Electrical Testing: To ensure the sensor meets electrical performance specifications.
- Mechanical Testing: To ensure the sensor's structural integrity and functionality.
- Software Testing: Specifically for the components affected by the new "smart card memory device."
- Hardware Testing: Specifically for the components affected by the new "smart card memory device."
- EMI Testing: For the components affected by the new "smart card memory device," to ensure electromagnetic compatibility.
- Biocompatibility Testing: According to ISO 10993, to ensure the materials contacting the patient's skin are safe.
All tests reportedly "passed in accordance with their specification." The primary change from the predicate device was the addition of a smart card memory device, and testing focused on the implications of this change. The submission is a 510(k), which seeks to establish substantial equivalence for a medical device, not to prove clinical efficacy or diagnostic accuracy through large-scale clinical trials in the way an AI algorithm might require.
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JAN | 8 2000
V 510(k) SUMMARY
Prepared December 21, 1999
Company Name and Address
Aspect Medical Systems, Inc 2 Vision Drive Natick, MA 01760-2059
Contact Person:
Christine Morgida Manager, Regulatory Affairs and Quality Assurance Telephone: (508) 653-0603 x2026
Device Name
| Proprietary Name: | Aspect Medical Systems EEG Sensor |
|---|---|
| Common Name: | Electrode, Cutaneous Electrode |
Classification
Cutaneous Electrodes have been classified by the Neurological Devices Panel as Class II devices. Refer to 21 CFR 882.1320.
Predicate Device
Aspect Medical Systems Zipprep EEG Sensor 510(k) #K961821, clearance date 10/4/96
Description
The Aspect Medical Systems, Inc. EEG Sensor (hereafter referred to as the Aspect Sensor, Aspect EEG Sensor, or BIS Sensor +), is a rectangular shaped, pre-gelled array of three (3) Zipprep ® electrodes that is applied to the patient's skin to record electrophysiological (such as EEG) signals.
It is a low impedance, single patient use, disposable electrode sensor that is designed for application to the frontal/temporal area. The Aspect Sensor is designed to provide ease of use and electrode placement accuracy. It is used in conjunction with Aspect monitors.
The main body of the Aspect Sensor, which houses two (2) electrodes, is placed on the forehead. The satellite area, which houses one (1) electrode, is placed over the temple area. The Aspect Sensor collects EEG signals from these areas, and the differential signal from the temple to the center of the forehead is used to calculate the BIS. The area and distance between electrodes was chosen for ease of application, and to obtain maximum amplitude of the EEG signal, with a minimum of artifact.
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The "Zipprep" patented electrode design is constructed using flexible tines mounted on a polyethylene basepad with an adhesive. The flexible tines, surrounded by hydrogel, are used to part the outermost layer of skin. While the flexible tines part the skin, hydrogel flows around the tines and forms a conductive bridge with the skin.
The Aspect Sensor connects to a monitor at a single point (tab) that is low profile and easy to insert and remove. The tab has an electronic smart card memory device that contains configuration and identification information. This allows better tracking/traceability of the product for Aspect, as well as communicating product information to the user.
All materials are biocompatible, and have been tested in accordance with ISO 10993. Skin contacting materials are the same as the Predicate Device.
Indications for Use
The Aspect Sensor is applied directly to the patient's skin to enable recording of electrophysiological (such as EEG) signals.
Summary of Technological Characteristics
The Aspect Sensor has the same technological characteristics with regard to Zipprep design, some configuration capability, and materials. However, the smart card memory device, with its expanded configuration capabilities, could be considered a minor technological difference, in that with the addition of the smart card memory device, configuration capabilities are expanded further. The smart card memory device contains information concerning the lot number, date of manufacture and expiration date.
Summary of Testing
Aspect Medical Systems has conducted electrical and mechanical testing on the Sensor. In addition, software and hardware testing (including EMI testing) were conducted on the components of the system affected by the inclusion of the smart card memory device.
All tests passed in accordance with their specification.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of a caduceus, which is a symbol of medicine.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 18 2000
Ms. Christine Morgida Manager. Regulatory Affairs and Ouality Assurance Aspect Medical Systems, Inc. 2 Vision Drive Natick, Massachusetts 01760-2059
K994330 Re:
Trade Name: Aspect Medical Systems EEG Sensor, Model 186-0076 Regulatory Class: II Product Code: GXY Dated: December 22, 1999 Received: December 23, 1999
Dear Ms. Morgida:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed
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Page 2 - Ms. Christine Morgida
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4595. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Styp L. Rhodes
James E. Dillard III Acting Director Division of General and Restorative Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use Statement
| 510(k)Number(if known) | K 99 4330 |
|---|---|
| Device Name | Aspect Medical Systems, Inc.EEG Sensor(BIS Sensor +) |
| Indications forUse | The EEG Sensor (BIS Sensor +) is applied directlyto the patient's skin to enable recording ofelectrophysiological (such as EEG) signals. |
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED
Concurrence of CDRH, Office of Device Evaluation (ODE)
Styph Rlvels
(Division Sign-Off) Division of General Restorative Devices K994J30 510(k) Number_
× Prescription Use _ (Per 21 CFR 801.109) OR
Over-The-Counter Use
§ 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).