(50 days)
The SACS EEG Workstation A7 is intended to be used for the measurement and recording of the electrical activity in a patient's brain, using electrodes placed on the patient's head.
The SACS EEG Workstation A7 is intended for use by qualified medical personnel trained in the use of electroencephalographs.
The SACS EEG Workstation A7 ("SACS A7") is a line-powered electroencephalograph that measures and records the electrical activity in a patient's brain via electrodes placed on the patient's head. The SACS A7 System device is comprised of a flat-panel monitor, an Intel Pentium-based computer with proprietary software installed, a separate EEG amplifier, a separate photic stimulator, and a standard computer keyboard. The components can be mounted on a customer's mobile stand or cart, or on a desk or work table. A USB cable connects the computer to the EEG amplifier, which is in turn connected to patient electrodes that are applied to specified locations on the patient's head. The system is controlled by a Windows XP-based operating system. EEG results are stored either on the Workstation itself in the SACS Database on the hard drive, or on a network server. If results are stored on the SACS Server Database on a network server, they can be reviewed from any SACS Review Workstation.
This appears to be a 510(k) summary for the SACS EEG Workstation A7. Based on the provided text, there is no detailed study described that establishes specific acceptance criteria and then proves the device meets those criteria.
The document primarily focuses on establishing substantial equivalence to a predicate device (DG Nervus EEG, K964280) rather than presenting a performance study with defined acceptance criteria.
Here's a breakdown of why the requested information cannot be fully provided from the given text:
- No specific acceptance criteria are listed for device performance. The document states "There are no significant differences between the SACS EEG Workstation A7 and the predicate device that would adversely affect the use of the proposed device" and "The SACS EEG Workstation A7 is substantially equivalent to the predicate device in design, function, and indications for use/intended use." This implies that the acceptance criterion is substantial equivalence, not a set of specific measurable performance metrics.
- No detailed study is outlined. The document is a 510(k) summary, which is a regulatory submission, not a scientific publication detailing a clinical or technical performance study. It does not describe how substantial equivalence was proven beyond a general comparison of features and intended use.
Therefore, many of the specific points requested cannot be answered from the provided text.
However, I can extract the information that is present:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate device (DG Nervus EEG, K964280) in design, function, and indications for use/intended use. | "The SACS EEG Workstation A7 is substantially equivalent to the predicate device in design, function, and indications for use/intended use." "There are no significant differences between the SACS EEG Workstation A7 and the predicate device that would adversely affect the use of the proposed device." |
| Intended Use: Measurement and recording of electrical activity in brain | The device is described as "a line-powered electroencephalograph that measures and records the electrical activity in a patient's brain via electrodes placed on the patient's head." This directly matches the intended use. |
2. Sample size used for the test set and the data provenance
- Sample Size for Test Set: Not specified. (No independent test set is described as part of a performance study.)
- Data Provenance: Not applicable, as no specific performance data or test set is presented.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable, as no test set with ground truth established by experts is described.
4. Adjudication method for the test set
- Not applicable.
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
- No MRMC or AI comparative effectiveness study is mentioned. This device is an EEG workstation, not an AI-driven diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. The device is an EEG workstation for human medical personnel to operate.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable, as no ground truth data from a specific study is presented. The "ground truth" for substantial equivalence is the predicate device's established regulatory status and performance.
8. The sample size for the training set
- Not applicable. This document does not describe a machine learning algorithm or a training set.
9. How the ground truth for the training set was established
- Not applicable.
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Image /page/0/Picture/1 description: The image contains a sequence of handwritten alphanumeric characters. The characters are "KO71109" and they are written in black ink on a white background. A horizontal line is drawn underneath the characters. The characters appear to be part of a label or code.
Traditional 510(k) Application
510(k) Summary of Safety and Effectiveness
SACS Medical EEG Workstation A7 JUN - 7 2007
JUN - 7 2002
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
- A. Submitter: SACS Medical AB Ekonomivägen 5 SE-436 33 Askim. Sweden
+46 31 748 49 50 Phone: Fax: +46 31 68 39 51
Contact: Sheila Ramerman, RAC SJR Associates (regulatory consultant to SACS Medical AB
Date Prepared: April 16, 2007
B. Device Names:
| Trade Name: | SACS EEG Workstation A7 |
|---|---|
| Common/usual Name: | Electroencephalograph, EEG |
| Classification Name: | Electroencephalograph |
C. Predicate Device:
The SACS EEG Workstation A7 is substantially equivalent to the DG Nervus EEG, K964280, currently marketed by VIASYS Healthcare.
D. Device Description:
The SACS EEG Workstation A7 ("SACS A7") is a line-powered electroencephalograph that measures and records the electrical activity in a patient's brain via electrodes placed on the patient's head. The SACS A7 System device is comprised of a flat-panel monitor, an Intel Pentium-based computer with proprietary software installed, a separate EEG amplifier, a separate photic stimulator, and a standard computer keyboard. The components can be mounted on a customer's mobile stand or cart, or on a desk or work table. A USB cable connects the computer to the EEG amplifier, which is in turn connected to patient electrodes that are applied to specified locations on the patient's head. The system is controlled by a Windows XP-based operating system. EEG results are stored either on the Workstation itself in the SACS Database on the hard drive, or on a network server. If results are stored on the SACS Server Database on a network server, they can be reviewed from any SACS Review Workstation.
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E. Intended Use:
The SACS EEG Workstation A7 is intended to be used for the measurement and recording of the electrical activity in a patient's brain, using electrodes placed on the patient's head.
Traditional 510(k) Application
The SACS EEG Workstation A7 is intended for use by qualified medical personnel trained in the use of electroencephalographs.
F. Comparison with the Predicate Device:
There are no significant differences between the SACS EEG Workstation A7 and the predicate device that would adversely affect the use of the proposed device. The SACS EEG Workstation A7is substantially equivalent to the predicate device in design, function, and indications for use/intended use.
000003
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Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three stripes forming its wing and tail feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN - 7 2007
SJR Associates % Ms. Sheila Ramerman Consultant to SACS Medical AB SACS Medical AB 3684 N. Shasta Loop Eugene, Oregon 97405
Re: K071109
Trade/Device Name: SACS EEG Workstation Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: GWQ Dated: April 17, 2007 Received: April 26, 2007
Dear Ms. Ramerman:
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.
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 Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set
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Page 2 -- Ms. Sheila Ramerman
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. 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 toll-free number (800) 638-2041 or (240) 276-3150 or at the Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours,
Melkerson Mark N. Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Traditional 510(k) Application
| 510(k) Number (if known): | K071109 |
|---|---|
| Device Name: | SACS EEG Workstation A7 |
| Indications for Use |
Indications for Use:
The SACS EEG Workstation A7 is intended to be used for the measurement and recording of the electrical activity in a patient's brain, using electrodes placed on the patient's head.
The SACS EEG Workstation A7 is intended for use by qualified medical personnel trained in the use of electroencephalographs.
Prescription Use X (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
M.O.
Division Sign-Off
Division of Ger Division and Neurological
510(k) Number.
000001
§ 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).