(53 days)
Not Found
No
The description mentions "digital signal processing techniques" and a "proprietary computed EEG variable (PSI)", but does not explicitly mention AI or ML, nor does it describe any training or test sets typically associated with such technologies.
No
The device is a monitoring device that provides real-time data related to the effect of anesthetic agents and displays EEG waveforms; it does not directly treat or alleviate a medical condition.
Yes
The device monitors the state of the brain by real-time data acquisition and processing of EEG signals. This monitoring provides information about a patient's physiological state (effect of anesthetic agents), which is characteristic of a diagnostic device.
No
The device description explicitly lists hardware components (monitor, amplifier, patient cable, electrode set) in addition to the software (PSI algorithm).
Based on the provided information, the SEDLine Sedation Monitor is not an In Vitro Diagnostic (IVD) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body. The SEDLine Sedation Monitor directly monitors the brain's electrical activity (EEG signals) from the patient's head using electrodes. It does not analyze samples like blood, urine, or tissue.
- The intended use is to monitor the state of the brain in real-time. This is a direct physiological measurement, not an analysis of a biological sample.
- The device description focuses on acquiring and processing real-time EEG data. This further reinforces that it's a physiological monitoring device.
Therefore, the SEDLine Sedation Monitor falls under the category of a physiological monitoring device, not an IVD.
N/A
Intended Use / Indications for Use
The SEDLine Sedation Monitor is indicated for use in the operating room (OR), intensive care unit (ICU), and clinical research laboratory. It is intended to monitor the state of the brain by real-time data acquisition and processing of EEG signals. The system includes the Patient State Index (PSI), a proprietary computed EEG variable that is related to the effect of anesthetic agents.
Product codes (comma separated list FDA assigned to the subject device)
GWO
Device Description
SEDLine is an EEG monitor designed for use in the OR, ICU, EEG laboratory and for clinical research. It provides the ability to acquire and display real-time EEG waveforms, process the real time EEG data using digital signal processing techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review.
The SEDLine System consists of five components, the monitor, PSI algorithm, amplifier, patient cable and SEDTrace EEG Electrode Set. The device performs automatic self tests upon power up to ensure that the monitor and its components are functioning properly.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
brain
Indicated Patient Age Range
Not Found
Intended User / Care Setting
operating room (OR), intensive care unit (ICU), and clinical research laboratory.
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 tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing.
The PSA4000 has been testing in accordance with the following standards.
• UL 60601-1
• CSA 22.2 No. 60601-1
• IEC 60601-1
• IEC 60601-2-26
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
§ 882.1400 Electroencephalograph.
(a)
Identification. An electroencephalograph is a device used to measure and record the electrical activity of the patient's brain obtained by placing two or more electrodes on the head.(b)
Classification. Class II (performance standards).
0
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of three human profiles facing to the right, with flowing lines representing hair or clothing.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 1 9 2005
Ms. Dawn E. Frazer, Vice President Regulatory Affairs and Quality Assurance Physiometrix, Inc. Five Billerica Park 101 Billerica Avenue North Billerica, Massachusetts 01862
Re: K051874
Trade/Device Name: SEDLine Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph electrode/lead tester Regulatory Class: II Product Code: GWO Dated: August 8, 2005 Received: August 9, 2005
Dear Ms. Frazer:
This letter corrects our substantially equivalent letter of September 2, 2005.
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 such 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 Acts requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
1
Page 2 - Ms. Dawn E. Frazer
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115 . Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Barbara Buend
Mark N. Melkersen Acting Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
INDICATIONS FOR USE STATEMENT
| Applicant: | Physiometrix, Inc. |
|---|---|
| 510(k) Number (if known) | Not assigned K051874 |
| Device Name | SEDLine Sedation Monitor with Frontal PSI and SEDTrace EEG |
| Electrode Set | |
| Indications For Use | The SEDLine Sedation Monitor is indicated for use in the operating |
| room (OR), intensive care unit (ICU), and clinical research | |
| laboratory. It is intended to monitor the state of the brain by real- | |
| time data acquisition and processing of EEG signals. The system | |
| includes the Patient State Index (PSI), a proprietary computed EEG | |
| variable that is related to the effect of anesthetic agents. |
(PLEASE DO NOT WRITE BELOW THIS LINE -- CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use
X
(Per 21 CFR 801.109)
OR Over-The-Counter Use __
Chas bare Buchnd forman
(Division Sign-Off)
Division of General, Restorative, and Neurological Devices
510(k) Number K051874
3
K051874
510(K) SUMMARY
| Date: | July 7, 2005 |
|---|---|
| SEP 02 2005 | |
| Company: | Physiometrix, Inc. |
| Five Billerica Park | |
| 101 Billerica Avenue | |
| N. Billerica, MA 01862 | |
| www.physiometrix.com | |
| Contact: | Dawn E. Frazer |
| Vice President | |
| Regulatory Affairs & Quality Assurance | |
| (978) 670-2422 x243 | |
| dfrazer@physiometrix.com | |
| Subject Device: | SEDLine Sedation Monitor with Frontal PSI and SEDTrace EEG Electrode Set |
| Classification: | Class II, 21 CFR Part 882.1400, Electroencephalograph |
| Class II, CFR 21 Part 882.1320, Cutaneous Electrodes | |
| Intended Use: | The SEDLine Sedation Monitor is indicated for use in the operating room (OR), |
| intensive care unit (ICU), and clinical research laboratory. It is intended to | |
| monitor the state of the brain by real-time data acquisition and processing of EEG | |
| signals. The system includes the Patient State Index (PSI), a proprietary | |
| computed EEG variable that is related to the effect of anesthetic agents. | |
| Description: | SEDLine is an EEG monitor designed for use in the OR, ICU, EEG laboratory and |
| for clinical research. It provides the ability to acquire and display real-time EEG | |
| waveforms, process the real time EEG data using digital signal processing | |
| techniques, display the processed EEG data in several different formats, and archive the real-time or processed EEG data for future review. |
The SEDLine System consists of five components, the monitor, PSI algorithm,
amplifier, patient cable and SEDTrace EEG Electrode Set. The device performs
automatic self tests upon power up to ensure that the monitor and its components are functioning properly. |
Image /page/3/Picture/5 description: The image shows a medical device with a screen displaying the number 65. Several wires and attachments are laid out on the table in front of the device. The device appears to be used for medical diagnostics or monitoring. The lighting in the image is dim, creating a spotlight effect on the device and its components.
Monitor
4
The monitor provides signal processing and display capabilities for the 4 channels of real-time EEG data acquired from the preamplifier.
The monitor dimensions are 9" W x 8" H x 6" D. The color display area is 3.8" H x 5.2" W. In addition to the display area, the front panel is configured with a number of buttons to allow for configuration of the display and data acquisition settings. The monitor includes a base and a clamp that can be used to secure the unit on a flat surface or on a pole (respectively).
The processor is a PC-based CPU that processes the EEG data, calculates the processed parameters and displays the real-time EEG data and processed data. Processed parameters include Electromyograph (EMG), Artifact (ART), Suppression Ratio (SR), and the Patient State Index (PSI).
The monitor is powered through either standard wail outlet through a power cable or by the internal back-up battery power.
PSI Algorithm
The PSI algorithm in the SEDLine Monitor is used to convert EEG acquired from four active (F7, F8, Fp1 and Fp2), ground (FpZ) and reference (AFZ) into a proprietary index, the PSI. The PSI is an EEG variable that is related to the effect of anesthetic agents.
Patient Module
The patient module is an electrically isolated, low noise, high gain, analog to digital signal converter that can process up to 4 channels of real-time data.
The preamplifier dimensions are 4.25" W x 1.75" D x 5.5" H. The patient module includes a clamp that can be used to secure the unit. The clamp can accommodate a pole, bed rail or bed sheet with a thickness of up to 1". The preamplifier is connected to the patient and monitor through flexible, shielded cabling.
Patient Cable
The patient cable is used to connect the patient module to the SEDTrace. The cable is 6 feet in length and terminated on one end with a 12 pin round connector design to mate with the patient module, and on the other end with a custom connector designed to mate with the SEDTrace.
SEDTrace
The SEDTrace is an EEG Electrode Set designed for use with the SEDLine System. It is comprised of six EEG electrodes that are located in a flexible substrate. The SEDTrace connects to the patient cable with a custom connector.
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SEDLine Sedation Monitor with Frontal PSI (K033999) Predicate Device: PSArray2 EEG Electrode Set (K020670)
The subject device is similar to the predicate device in the following way(s): Similarities: -
Both systems are EEG monitors. a.
5
| b. | Both systems provide a variety of processed parameters, EMG, SR, ART and PSI. | |
|---|---|---|
| c. | Both systems include the PSI, a proprietary computed EEG variable that is related to the affects of anesthetics. | |
| d. | Both conduct self tests at start up to assure that the device is operating. | |
| e. | Both electrodes use the same materials. | |
| f. | Both electrodes collect data from the same electrode locations. | |
| Differences: | The subject device is different from the predicate device in the following way(s): | |
| a. | The connection system from the electrode set to the patient cable has been modified. | |
| Test Results: | The following tests have been conducted in order to verify and validate the device: software, mechanical and electrical validation testing and EMC testing. | |
| The PSA4000 has been testing in accordance with the following standards. | ||
| • UL 60601-1 | ||
| • CSA 22.2 No. 60601-1 | ||
| • IEC 60601-1 | ||
| • IEC 60601-2-26 |
- FDA Reviewer Guidance for Premarket Notification Submissions, Section 7, . Electromagnetic Compatibility dated November 1993.