(127 days)
Not Found
No
The description focuses on the sensor's physical components, electrode placement, and signal acquisition for calculating the Bispectral Index (BIS) value, which is a standard physiological measurement. There is no mention of AI or ML being used in the sensor itself or in the calculation of the BIS value. The "smart card memory device" stores identification information, not AI/ML algorithms.
No.
The device is described as an electrode sensor used to record electrophysiological signals (EEG) for diagnostic purposes (calculating the Bispectral Index value in conjunction with BIS Monitors), not to treat a condition.
Yes
The device records electrophysiological signals (EEG) from the patient's skin, and the extracted signals are used to calculate the Bispectral Index (BIS) value in conjunction with a BIS monitor. This process of collecting physiological data to derive a specific value (BIS) that indicates a patient's state (e.g., level of consciousness) is characteristic of a diagnostic device.
No
The device description clearly details a physical sensor with electrodes, hydrogel, adhesive, and a smart card memory device. This is a hardware component, not software only.
Based on the provided information, this device is not an In Vitro Diagnostic (IVD).
Here's why:
- IVDs are used to examine specimens derived from the human body. The intended use and device description clearly state that the BIS Sensor is applied directly to the patient's skin to record electrophysiological signals (like EEG). It does not involve the analysis of blood, urine, tissue, or any other bodily fluid or substance.
- The device measures electrical activity from the body. It is a sensor designed to pick up electrical signals generated by the brain. This is a direct measurement from the living patient, not an analysis of a sample taken from the patient.
Therefore, the BIS Sensor falls under the category of a medical device that is used for monitoring physiological signals, but it is not an IVD.
N/A
Intended Use / Indications for Use
The BIS Sensor is applied directly to the patient's skin to enable recordings of electrophysiological (such as EEG) signals.
Product codes (comma separated list FDA assigned to the subject device)
GXY
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's skin, frontal/temporal area, forehead, temple area
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Prescription Use
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The following testing was conducted in support of this submission:
- Electrical Testing
- Shelf Life Testing
- Biocompatibility
Risk analysis was conducted per ISO 14971: 2007 – Medical devices – Application of risk management to medical devices. The design verification tests that were performed as a result of this risk analysis are listed in table #1 on the following page. The test methods used are the same as those submitted in the original submission.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
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.
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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 | |||||||
| Pediatric Sensor, BIS Bilateral Sensor Common Name: Electrode, Cutaneous | |||||||
| Electrode | |||||||
| Address and | |||||||
| Registration #: | The address and registration number of the manufacturer and sterilization | ||||||
| sites for both catheters are: | |||||||
| Manufacturer Contract Manufacturer Covidien | |||||||
| 6135 Gunbarrel Ave | |||||||
| Boulder, CO 80301 Celestica Electronics PTE LTD. | |||||||
| 6 Serangoon North Avenue 5 #05-03/04 | |||||||
| Singapore Central Singapore, Singapore 554910 FDA Registration #: | |||||||
| 2636999 FDA Registration #: | |||||||
| 3008202779 | |||||||
| Device Class: | 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 | |||||||
| Information | 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 the | |||||||
| proposed changes be based on the company's existing technology as | |||||||
| Covidien now owns these technologies. |
Aspect Medical Systems BIS Quatro (and Extend) Sensor K093183,
concurrence date October 23, 2009
Aspect Medical Systems BIS Bilateral Sensor K062692, concurrence date
December 13, 2006.
Aspect Medical Systems BIS Pediatric Sensor K041670, concurrence date
July 6, 2004
A reference to multiple predicates is intended to illustrate that the
reformulated sensor gel will be used with all four current BIS sensors. No
changes have been made to the sensors themselves outside the interaction
with the reformulated gel. | | | | | | |
| Labeling | There are no changes in the labeling or Instructions for Use from the
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
/Indications for
Use | The BIS Sensor is applied directly to the patient's skin to enable recordings of
electrophysiological (such as EEG) signals. |
|-----------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device
Description and
Comparison | 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. |
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
Equivalence | This 510(k) is being submitted for modification to the 510(k) cleared sensors
listed in the predicate section above. The gel formulation of the aqueous
hydrogel is being changed.
This change does not result in any changes to the hazard analysis. A
summary of test results, which includes testing to AAMI standard
EC12:2000, shelf life testing, and biocompatibility tests for Cytotoxicity,
Irritation, and Sensitization is enclosed. All testing results are considered
acceptable.
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. |
|--------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Summary of
Design Control
Activities | Risk analysis was conducted per ISO 14971: 2007 – Medical devices –
Application of risk management to medical devices . The design verification
tests that were performed as a result of this risk analysis are listed in table #1
on the following page.
The test methods used are the same as those submitted in the original
submission. |
| Summary of Testing | |
The following testing was conducted in support of this submission:
- Electrical Testing ●
- Shelf Life Testing .
- Biocompatibility .
、