(14 days)
The BIS Quatro sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
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.
This 510(k) submission (K093183) is for the BIS Quatro Sensor, a cutaneous electrode intended to enable recordings of electrophysiological signals (such as EEG) from the patient's skin. The submission primarily focuses on a minor modification to the predicate device, the Enhanced BIS Sensor (K002734), specifically a change in the formulation of the aqueous hydrogel.
Given the nature of the device (a minor modification to an existing electrode design) and the information provided, the "acceptance criteria" and "device performance" are centered around demonstrating that the modified device remains safe and effective for its intended use, and performs equivalently to the predicate device, particularly regarding its electrical and mechanical properties, shelf life, and biocompatibility.
Absence of a Traditional Clinical Study (MRMC or Standalone AI Performance):
It is crucial to note that this submission does not involve a multi-reader multi-case (MRMC) comparative effectiveness study or a standalone algorithm-only performance study because the device is a simple medical electrode, not an AI-powered diagnostic or therapeutic tool. The "performance" here refers to physical and material properties rather than diagnostic accuracy or algorithmic output. Therefore, sections related to expert ground truth, adjudication, training sets, and AI-specific metrics are not applicable and will be marked as "N/A" (Not Applicable).
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating that the modified BIS Quatro Sensor is substantially equivalent to the predicate device and meets its specified performance requirements after the hydrogel formulation change. The device performance is reported as meeting these specifications.
| Acceptance Criterion (Implicit) | Reported Device Performance |
|---|---|
| Electrical Performance: Equivalent to predicate device. | "Results indicate the device meets its performance specifications." |
| Mechanical Performance: Equivalent to predicate device. | "Results indicate the device meets its performance specifications." |
| Shelf Life: Maintained or equivalent to predicate device. | "Results indicate the device meets its performance specifications." |
| Biocompatibility: Safe for patient contact. | "Results indicate the device meets its performance specifications." |
| Hazard Analysis: All identified hazards sufficiently mitigated. | "All identified hazards have been sufficiently mitigated." |
| Intended Use: Consistent with predicate device. | "The BIS Quatro has the same intended use... as the predicate device." |
| Fundamental Scientific Technology: Consistent with predicate device. | "The BIS Quatro has the same... fundamental scientific technology as the predicate device." |
2. Sample Size Used for the Test Set and Data Provenance
The submission does not detail specific sample sizes for tests such as electrical, mechanical, shelf life, or biocompatibility. Given it's a materials-based modification, these tests would typically involve a statistically relevant number of manufactured units or samples of the modified hydrogel and assembled sensors.
- Sample Size for Test Set: Not specified in the provided summary. These would be laboratory tests on a representative sample of devices.
- Data Provenance: Not specified, but likely from internal laboratory testing conducted by Aspect Medical Systems, Inc. (USA-based company). The origin would be prospective manufacturing and testing of the modified device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
- Number of Experts: N/A (Not Applicable). This is a physical device and material testing, not a diagnostic interpretation task requiring expert consensus for ground truth.
- Qualifications of Experts: N/A
4. Adjudication Method for the Test Set
- Adjudication Method: N/A. Ground truth establishment through adjudication by experts is not applicable for this type of device submission.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
- MRMC Study: No. This is a medical device, specifically an electrode, not a diagnostic imaging or AI system that would typically undergo an MRMC study.
- Effect Size of Human Readers Improvement with AI vs. without AI assistance: N/A, as no AI component is involved.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study Was Done
- Standalone Study: No. This is a physical medical device; there is no standalone algorithm to evaluate.
7. The Type of Ground Truth Used
- Type of Ground Truth: For the various tests (electrical, mechanical, shelf life, biocompatibility), the "ground truth" would be the established engineering specifications, industry standards (e.g., for biocompatibility), and performance benchmarks set by the predicate device. These are objective, rather than subjective, data points (e.g., resistance values, tensile strength, sterility, non-cytotoxicity).
8. The Sample Size for the Training Set
- Sample Size for Training Set: N/A. There is no AI model or "training set" in the context of this device.
9. How the Ground Truth for the Training Set Was Established
- How Ground Truth for Training Set Was Established: N/A.
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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.
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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.
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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.
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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/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
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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
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§ 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).