BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES)
Device Facts
| Record ID | K143506 |
|---|---|
| Device Name | BIS STANDARD SENSOR,1-CHANNEL (3 ELECTRODES); BIS PEDI SENSOR,1-CHANNEL,3 ELECTRODES; BIS QUATRO SENSOR; BIS PEDI-XP SENSOR,2-CHANNEL (4 ELECTRODES); BIS EXTEND SENSOR; BIS BILATERAL SENSOR,4-CHANNEL (6 ELECRODES); BIS INSIGHT SENSOR,CVI-ENABLED,2-CHANNEL (4 ELECTRODES) |
| Applicant | Covidien |
| Product Code | GXY · Neurology |
| Decision Date | Apr 16, 2015 |
| Decision | SESE |
| Submission Type | Traditional |
| Regulation | 21 CFR 882.1320 |
| Device Class | Class 2 |
Indications for Use
The BIS Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Device Story
BIS Sensors are disposable, single-patient-use, low-impedance cutaneous electrodes applied to the patient's forehead and temple. The sensor array features a 'zipprep' design with flexible tines and hydrogel to part the outer skin layer and establish a conductive bridge. A silver/silver-chloride circuit on a mylar substrate transmits EEG signals to a Covidien BIS Monitor. The monitor processes these differential signals to calculate the Bispectral Index (BIS) value. The sensor includes an integrated smart card memory chip for identification and usage tracking. Used in clinical settings, the device facilitates EEG signal acquisition, which healthcare providers use to monitor patient brain activity and guide clinical decision-making, such as assessing depth of anesthesia.
Clinical Evidence
Bench testing only. Evidence includes electrical testing per AAMI EC12:2000, shelf-life validation, and biocompatibility testing (cytotoxicity, irritation, and sensitization). All results were reported as acceptable.
Technological Characteristics
Disposable, pre-gelled 4-electrode array. Materials: polyethylene basepad, polyurethane foam disk, aqueous hydrogel, silver/silver-chloride ink on mylar substrate, polyester insulation. Features 'zipprep' flexible tines for skin contact. Includes electronic smart card memory. Connectivity: wired connection to BIS monitor. Standards: AAMI EC12:2000, ISO 14971:2007.
Indications for Use
Indicated for patients requiring electrophysiological (EEG) signal monitoring via cutaneous electrodes applied to the frontal/temporal area.
Regulatory Classification
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.
Predicate Devices
- Aspect Medical Systems BIS Quatro (and Extend) Sensor (K093183)
- Aspect Medical Systems BIS Bilateral Sensor (K062692)
- Aspect Medical Systems BIS Pediatric Sensor (K041670)
Submission Summary (Full Text)
{0}------------------------------------------------
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
{1}------------------------------------------------
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
{2}------------------------------------------------
## 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)
## CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
## *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.*
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
> Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
{3}------------------------------------------------
BIS Sensor Gel Reformulation Traditional 510(k)
Prepared: November 21, 2014
.
Image /page/3/Picture/1 description: The image shows the word "COVIDIEN" in bold, black letters next to a black square with a white rectangle in the middle. The word is written in all capital letters. The logo is simple and modern.
| Device Name: | The device trade name and common classification names are : | | | | | | |
|---------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|--|--|--|--|
| | Device Trade Name Common/Classification Name BIS Quatro Sensor, BIS Extend, BIS<br>Pediatric Sensor, BIS Bilateral Sensor Common Name: Electrode, Cutaneous<br>Electrode | | | | | | |
| Address and<br>Registration #: | The address and registration number of the manufacturer and sterilization<br>sites for both catheters are: | | | | | | |
| | Manufacturer Contract Manufacturer Covidien<br>6135 Gunbarrel Ave<br>Boulder, CO 80301 Celestica Electronics PTE LTD.<br>6 Serangoon North Avenue 5 #05-03/04<br>Singapore Central Singapore, Singapore 554910 FDA Registration #:<br>2636999 FDA Registration #:<br>3008202779 | | | | | | |
| Device Class: | Cutaneous Electrodes have been classified by the Neurological Devices Panel<br>as Class II, 84 GXY. No performance standards have been established under<br>Section 514 of the Food, Drug and Cosmetic Act for Cutaneous Electrodes<br>(21 CFR 882.1320). | | | | | | |
| Predicate Device<br>Information | Note: Predicate clearances were filed under the technology's previous owner,<br>Aspect Medical Systems Inc., which was thereafter acquired by Covidien.<br>Predicate devices still meet the required element of a Special 510(k) that the<br>proposed changes be based on the company's existing technology as<br>Covidien now owns these technologies.<br><br>Aspect Medical Systems BIS Quatro (and Extend) Sensor K093183,<br>concurrence date October 23, 2009<br>Aspect Medical Systems BIS Bilateral Sensor K062692, concurrence date<br>December 13, 2006.<br>Aspect Medical Systems BIS Pediatric Sensor K041670, concurrence date<br>July 6, 2004<br><br>A reference to multiple predicates is intended to illustrate that the<br>reformulated sensor gel will be used with all four current BIS sensors. No<br>changes have been made to the sensors themselves outside the interaction<br>with the reformulated gel. | | | | | | |
| Labeling | There are no changes in the labeling or Instructions for Use from the<br>predicate devices. | | | | | | |
1
{4}------------------------------------------------
BIS Sensor Gel Reformulation Traditional 510(k) Prepared: November 21, 2014
. . .
: 2
.
Image /page/4/Picture/1 description: The image shows the word "COVIDIEN" in bold, sans-serif font. To the left of the word is a black square with a white rectangle in the middle. The black square has two black bars running vertically through it.
| Intended Use<br>/Indications for<br>Use | The BIS Sensor is applied directly to the patient's skin to enable recordings of<br>electrophysiological (such as EEG) signals. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device<br>Description and<br>Comparison | The BIS Sensor, generally speaking with regard to the four variations of the<br>sensor, is a rectangular shaped, pre-gelled array of four zipprep electrodes<br>that is applied to the patient's skin to record electrophysiological signals, such<br>as EEG signals.<br>It is a low impedance, single patient use, disposable electrode sensor designed<br>for application to the frontal/temporal area. The sensor is designed to provide<br>ease of use and electrode placement accuracy. It is in conjunction with<br>Covidien BIS Monitors.<br>The body of the sensor houses three (3) electrodes which are placed on the<br>forehead, and a fourth electrode placed over the temple area. The sensor<br>collects EEG signals from these areas, and the differential signals from the<br>temple and above the eye relative to the center of the forehead are used to<br>calculate the Bispectral Index (BIS) value.<br>The "zipprep" design is constructed using flexible tine disks placed in pockets<br>on a polyethylene basepad. A polyurethane foam disk and hydrogel is placed<br>over the tines. The basepad has a medical grade pressure sensitive adhesive<br>for adhering to the skin. A mylar substrate with conductive silver / silver<br>chloride ink circuit is adhered to the other side of the basepad. The flexible<br>tines, surrounded by hydrogel, are used to part the outermost layer of skin.<br>While the flexible tines part the skin, hydrogel flows around the tines and<br>forms a conductive bridge with the skin. The silver / silver chloride circuit<br>provides signal continuity from each electrode (gel/tine/foam) to the monitor.<br>A polyester insulation is used to restrict electrical contact to the electrode<br>area.<br>The sensor connects to the monitor at a single point (paddle tab) that is low<br>profile and easy to insert and remove. The tab has an electronic smart card<br>memory device that contains identification information (date of manufacture,<br>number of connections, lot number).<br>Each sensor is presented on a silicone liner tray and packed in individual<br>heat-sealed pouches. Twenty-five (25) sealed pouches are packed into a<br>cardboard box. |
303-305-2400 [T]
,在第一次
{5}------------------------------------------------
BIS Sensor Gel Reformulation Traditional 510(k) Prepared: November 21, 2014
Image /page/5/Picture/1 description: The image shows the word "COVIDIEN" in bold, black letters. To the left of the word is a black square with a white rectangle in the middle. The word is in all caps and is a sans-serif font.
| Substantial<br>Equivalence | This 510(k) is being submitted for modification to the 510(k) cleared sensors<br>listed in the predicate section above. The gel formulation of the aqueous<br>hydrogel is being changed.<br><br>This change does not result in any changes to the hazard analysis. A<br>summary of test results, which includes testing to AAMI standard<br>EC12:2000, shelf life testing, and biocompatibility tests for Cytotoxicity,<br>Irritation, and Sensitization is enclosed. All testing results are considered<br>acceptable.<br><br>Covidien has concluded that the device is substantially equivalent to the<br>predicate devices, with specific regard to the gel, and is safe and effective for<br>its intended use. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of<br>Design Control<br>Activities | Risk analysis was conducted per ISO 14971: 2007 – Medical devices –<br><i>Application of risk management to medical devices</i> . The design verification<br>tests that were performed as a result of this risk analysis are listed in table #1<br>on the following page.<br><br>The test methods used are the same as those submitted in the original<br>submission. |
| Summary of Testing | |
The following testing was conducted in support of this submission:
- Electrical Testing ●
- Shelf Life Testing .
- Biocompatibility .
、
