(13 days)
The BIS Click sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
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).
The provided Special 510(k) summary for the K091854 BIS Click Sensor does not contain the detailed information requested to describe the acceptance criteria and the study that proves the device meets those criteria in the format you've requested.
Here's why and what information is available:
- Type of Submission: This is a Special 510(k) submission. Special 510(k)s are used for changes to a manufacturer's own legally marketed device where the modifications do not require a new intended use or fundamental scientific technology. They typically rely heavily on comparison to the predicate device and verification/validation of the changes, rather than extensive clinical studies with specific performance metrics against a "ground truth" as might be found in a De Novo or traditional 510(k) for a novel device.
- Device Type: The BIS Click Sensor is a cutaneous electrode. Its primary function is to enable the recording of electrophysiological signals (like EEG) by providing a connection between the patient's skin and monitoring equipment. It is not an interpretive AI device; therefore, the types of "acceptance criteria" and "ground truth" associated with diagnostic algorithms (e.g., sensitivity, specificity, AUC compared to expert consensus or pathology) are not applicable here.
- Focus of the Submission: The 510(k) states that the BIS Click is a "minor modification" to a previously cleared device (BIS SRS, K#050313). The modifications primarily involve:
- Enabling a reusable cable for indefinite uses with disposable sensors.
- Adding a smart card memory device to the disposable sensor for information like lot number, expiration date, and number of connections.
- Testing Summary Provided: The document lists generic categories of tests performed: "Mechanical," "Electrical," "Multiple use," "Shelf Life," and "Hazard Analysis." It states that "Results indicate the device meets its performance specifications and validation test requirements, and is safe for its intended use." However, it does not provide specific numerical acceptance criteria for these tests, nor the reported device performance against those criteria. It also does not include details on sample sizes, data provenance, ground truth establishment, or expert involvement as would be relevant for an AI/diagnostic device.
Therefore, I cannot populate the table or provide specific answers to most of your numbered questions because that level of detail is not present in the provided FDA submission document.
Here is a summary of what can be extracted from the provided text, acknowledging the limitations:
1. Table of Acceptance Criteria and Reported Device Performance:
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Mechanical | Meets performance specifications and validation test requirements. |
| Electrical | Meets performance specifications and validation test requirements. |
| Multiple Use | Meets performance specifications and validation test requirements. |
| Shelf Life | Meets performance specifications and validation test requirements. |
| Hazard Analysis | All identified hazards have been sufficiently mitigated. |
| Specific Numerical Criteria | Not provided in this document. The document only states that the device "meets its performance specifications." |
2. Sample size used for the test set and the data provenance:
- Sample Size: Not specified for any of the tests.
- Data Provenance: Not specified. As an electrode, the testing would likely involve bench testing and possibly some limited in-vivo testing to confirm signal integrity, but no details are provided.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This is not applicable for this device and submission type. The device is a cutaneous electrode, not a diagnostic interpretive device requiring expert-established ground truth. Performance is assessed against engineering specifications, safety standards, and functional requirements.
4. Adjudication method for the test set:
- Not applicable as no expert adjudication is described or required for the type of testing performed (mechanical, electrical, etc.).
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:
- Not applicable. This device is not an AI-enabled diagnostic tool that would participate in an MRMC study.
6. If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- Not applicable. This device is a sensor, not an algorithm.
7. The type of ground truth used:
- For this type of device (cutaneous electrode), the "ground truth" for performance would be engineering specifications, industry standards (e.g., for electrical safety, biocompatibility), and functional requirements (e.g., signal quality, adhesive strength, material compatibility).
8. The sample size for the training set:
- Not applicable. This device is a hardware component (electrode), not an AI algorithm requiring a training set.
9. How the ground truth for the training set was established:
- Not applicable for a hardware device.
In conclusion: The provided documentation focuses on showing substantial equivalence through verification and validation of engineering changes for a Class II cutaneous electrode, rather than providing the detailed clinical study data and performance metrics typically associated with AI/diagnostic devices that require extensive "ground truth" and expert consensus.
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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
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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.
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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)
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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
§ 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).