(127 days)
The BIS Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
The BIS Sensor, generally speaking with regard to the four variations of the sensor, is a rectangular shaped, pre-gelled array of four zipprep electrodes that is applied to the patient's skin to record electrophysiological signals, such as EEG signals.
It is a low impedance, single patient use, disposable electrode sensor designed for application to the frontal/temporal area. The sensor is designed to provide ease of use and electrode placement accuracy. It is in conjunction with Covidien BIS Monitors.
The body of the sensor houses three (3) electrodes which are placed on the forehead, and a fourth electrode placed over the temple area. The sensor collects EEG signals from these areas, and the differential signals from the temple and above the eye relative to the center of the forehead are used to calculate the Bispectral Index (BIS) value.
The "zipprep" design is constructed using flexible tine disks placed in pockets on a polyethylene basepad. A polyurethane foam disk and hydrogel is placed over the tines. The basepad has a medical grade pressure sensitive adhesive for adhering to the skin. A mylar substrate with conductive silver / silver chloride ink circuit is adhered to the other side of the basepad. 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 silver / silver chloride circuit provides signal continuity from each electrode (gel/tine/foam) to the monitor. A polyester insulation is used to restrict electrical contact to the electrode area.
The sensor connects to the monitor at a single point (paddle tab) that is low profile and easy to insert and remove. The tab has an electronic smart card memory device that contains identification information (date of manufacture, number of connections, lot number).
Each sensor is presented on a silicone liner tray and packed in individual heat-sealed pouches. Twenty-five (25) sealed pouches are packed into a cardboard box.
The provided text describes a 510(k) premarket notification for a reformulation of the gel in Covidien BIS Sensors. The document focuses on demonstrating substantial equivalence to previously cleared devices rather than reporting on a study demonstrating clinical performance against acceptance criteria for an AI-based device.
Therefore, many of the requested categories for AI device evaluation (such as sample size for test set, data provenance, number of experts for ground truth, adjudication method, MRMC study, effect size, standalone performance, training set sample size, and ground truth for training set) are not applicable or not provided in this document, as it concerns a change in a physical component (gel) of a medical device, not an AI algorithm.
However, I can extract the relevant information regarding acceptance criteria and reported device performance from the provided text, specifically related to the gel reformulation, even though it's not in the context of an AI study.
Here's a summary based on the provided text, adapted to the context of a physical device component change:
Acceptance Criteria and Study for Covidien BIS Sensor Gel Reformulation
The provided document describes a Traditional 510(k) submission (K143506) for a reformulation of the gel used in Covidien BIS Sensors (BIS Quatro Sensor, BIS Extend, BIS Pediatric Sensor, BIS Bilateral Sensor). The study aims to demonstrate that the new gel formulation does not change the device's fundamental safety and effectiveness and that the device remains substantially equivalent to its predicate devices.
1. Table of Acceptance Criteria and the Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Implied/Explicit) | Reported Device Performance (with new gel formulation) |
|---|---|---|
| Electrical Performance | Meets AAMI standard EC12:2000 (standard for disposable ECG electrodes) | "All testing results are considered acceptable." The electrical testing results demonstrated compliance with the AAMI standard EC12:2000. |
| Shelf Life | Maintains performance over its intended shelf life. | "All testing results are considered acceptable." Shelf life testing was performed, and results were acceptable. |
| Biocompatibility - Cytotoxicity | Non-cytotoxic. | "All testing results are considered acceptable." Biocompatibility tests for Cytotoxicity were performed and passed. |
| Biocompatibility - Irritation | Non-irritating. | "All testing results are considered acceptable." Biocompatibility tests for Irritation were performed and passed. |
| Biocompatibility - Sensitization | Non-sensitizing. | "All testing results are considered acceptable." Biocompatibility tests for Sensitization were performed and passed. |
| Hazard Analysis | No new hazards introduced. | "This change does not result in any changes to the hazard analysis." |
| Substantial Equivalence | Remains safe and effective and substantially equivalent to predicate devices. | "Covidien has concluded that the device is substantially equivalent to the predicate devices, with specific regard to the gel, and is safe and effective for its intended use." |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not explicitly stated in the provided text. The document refers to "test results" and "testing" without specifying the number of units or patients involved in each test category (electrical, shelf life, biocompatibility).
- Data Provenance: Not explicitly stated. The manufacturer is Covidien (Boulder, CO, USA), and a contract manufacturer is Celestica Electronics PTE LTD. (Singapore). The testing would presumably have been conducted in facilities associated with these entities or their designated testing laboratories. The data is retrospective in the sense that it's reported after the completion of tests for submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not Applicable: This information is not relevant to the evaluation of a gel reformulation for a cutaneous electrode. The "ground truth" for the tests (e.g., cytotoxicity, electrical performance) would be determined by standard laboratory methods and equipment, not by human expert consensus or interpretation of complex medical data.
4. Adjudication method for the test set
- Not Applicable: Adjudication methods (like 2+1, 3+1) are typically used for interpreting subjective medical data or resolving disagreements among human readers in diagnostic studies. This is not reported for the technical and biological tests performed on a material reformulation.
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 document describes changes to a physical medical device (electrode gel), not an AI-powered diagnostic system. Therefore, an MRMC study related to AI assistance is not relevant or reported here.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not Applicable: This document is not about an algorithm or AI.
7. The type of ground truth used
- For electrical testing: Compliance with AAMI standard EC12:2000, which has defined objective electrical performance parameters.
- For shelf life testing: Stability and performance of the device over time, likely assessed against engineering specifications.
- For biocompatibility testing: Compliance with ISO 10993 standards (implied by "biocompatibility tests for Cytotoxicity, Irritation, and Sensitization" mentioned). These standards define objective criteria for biological safety.
8. The sample size for the training set
- Not Applicable: This is not an AI device, so there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable: This is not an AI device, so there is no "training set."
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Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized representation of three human profiles facing right, stacked on top of each other. The profiles are rendered in a dark color, possibly black or a dark shade of gray. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the profile graphic.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
April 16, 2015
Covidien Timothy Holwick Sr. Regulatory Affairs Specialist 6135 Gunbarrel Avenue Boulder, CO 80301
Re: K143506
Trade/Device Name: Covidien BIS Sensors (BIS Quatro Sensor, BIS Extend, BIS Pediatric Sensor, BIS Bilateral Sensor) Regulation Number: 21 CFR 882.1320 Regulation Name: Cutaneous Electrode Regulatory Class: Class II Product Code: GXY Dated: March 13, 2015 Received: March 16, 2015
Dear Mr. Holwick.
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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 of medical device
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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 contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Felipe Aquel - S
for
Carlos L. Peña. PhD. MS Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K143506
Device Name
Covidien BIS Sensors (BIS Quatro Sensor, BIS Extend, BIS Pediatric Sensor, BIS Bilateral Sensor)
Indications for Use (Describe)
The BIS Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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BIS Sensor Gel Reformulation Traditional 510(k)
Prepared: November 21, 2014
.
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| Device Name: | The device trade name and common classification names are : | ||||||
|---|---|---|---|---|---|---|---|
| Device Trade Name Common/Classification Name BIS Quatro Sensor, BIS Extend, BISPediatric Sensor, BIS Bilateral Sensor Common Name: Electrode, CutaneousElectrode | |||||||
| Address andRegistration #: | The address and registration number of the manufacturer and sterilizationsites for both catheters are: | ||||||
| Manufacturer Contract Manufacturer Covidien6135 Gunbarrel AveBoulder, CO 80301 Celestica Electronics PTE LTD.6 Serangoon North Avenue 5 #05-03/04Singapore Central Singapore, Singapore 554910 FDA Registration #:2636999 FDA Registration #:3008202779 | |||||||
| Device Class: | Cutaneous Electrodes have been classified by the Neurological Devices Panelas Class II, 84 GXY. No performance standards have been established underSection 514 of the Food, Drug and Cosmetic Act for Cutaneous Electrodes(21 CFR 882.1320). | ||||||
| Predicate DeviceInformation | Note: Predicate clearances were filed under the technology's previous owner,Aspect Medical Systems Inc., which was thereafter acquired by Covidien.Predicate devices still meet the required element of a Special 510(k) that theproposed changes be based on the company's existing technology asCovidien now owns these technologies.Aspect Medical Systems BIS Quatro (and Extend) Sensor K093183,concurrence date October 23, 2009Aspect Medical Systems BIS Bilateral Sensor K062692, concurrence dateDecember 13, 2006.Aspect Medical Systems BIS Pediatric Sensor K041670, concurrence dateJuly 6, 2004A reference to multiple predicates is intended to illustrate that thereformulated sensor gel will be used with all four current BIS sensors. Nochanges have been made to the sensors themselves outside the interactionwith the reformulated gel. | ||||||
| Labeling | There are no changes in the labeling or Instructions for Use from thepredicate devices. |
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BIS Sensor Gel Reformulation Traditional 510(k) Prepared: November 21, 2014
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| Intended Use/Indications forUse | The BIS Sensor is applied directly to the patient's skin to enable recordings ofelectrophysiological (such as EEG) signals. |
|---|---|
| DeviceDescription andComparison | The BIS Sensor, generally speaking with regard to the four variations of thesensor, is a rectangular shaped, pre-gelled array of four zipprep electrodesthat is applied to the patient's skin to record electrophysiological signals, suchas EEG signals.It is a low impedance, single patient use, disposable electrode sensor designedfor application to the frontal/temporal area. The sensor is designed to provideease of use and electrode placement accuracy. It is in conjunction withCovidien BIS Monitors.The body of the sensor houses three (3) electrodes which are placed on theforehead, and a fourth electrode placed over the temple area. The sensorcollects EEG signals from these areas, and the differential signals from thetemple and above the eye relative to the center of the forehead are used tocalculate the Bispectral Index (BIS) value.The "zipprep" design is constructed using flexible tine disks placed in pocketson a polyethylene basepad. A polyurethane foam disk and hydrogel is placedover the tines. The basepad has a medical grade pressure sensitive adhesivefor adhering to the skin. A mylar substrate with conductive silver / silverchloride ink circuit is adhered to the other side of the basepad. The flexibletines, surrounded by hydrogel, are used to part the outermost layer of skin.While the flexible tines part the skin, hydrogel flows around the tines andforms a conductive bridge with the skin. The silver / silver chloride circuitprovides signal continuity from each electrode (gel/tine/foam) to the monitor.A polyester insulation is used to restrict electrical contact to the electrodearea.The sensor connects to the monitor at a single point (paddle tab) that is lowprofile and easy to insert and remove. The tab has an electronic smart cardmemory device that contains identification information (date of manufacture,number of connections, lot number).Each sensor is presented on a silicone liner tray and packed in individualheat-sealed pouches. Twenty-five (25) sealed pouches are packed into acardboard box. |
303-305-2400 [T]
,在第一次
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BIS Sensor Gel Reformulation Traditional 510(k) Prepared: November 21, 2014
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| SubstantialEquivalence | This 510(k) is being submitted for modification to the 510(k) cleared sensorslisted in the predicate section above. The gel formulation of the aqueoushydrogel is being changed.This change does not result in any changes to the hazard analysis. Asummary of test results, which includes testing to AAMI standardEC12:2000, shelf life testing, and biocompatibility tests for Cytotoxicity,Irritation, and Sensitization is enclosed. All testing results are consideredacceptable.Covidien has concluded that the device is substantially equivalent to thepredicate devices, with specific regard to the gel, and is safe and effective forits intended use. |
|---|---|
| Summary ofDesign ControlActivities | Risk analysis was conducted per ISO 14971: 2007 – Medical devices –Application of risk management to medical devices . The design verificationtests that were performed as a result of this risk analysis are listed in table #1on the following page.The test methods used are the same as those submitted in the originalsubmission. |
| Summary of Testing |
The following testing was conducted in support of this submission:
- Electrical Testing ●
- Shelf Life Testing .
- Biocompatibility .
、
§ 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).