(66 days)
The SNAP II is intended to monitor the state of the brain by data acquisition of EEG signals. A dcrived measure provided by the SNAP II, the SNAP Index, indicates the patient's brain activity level.
The SNAP II is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use, within a hospital or medical facility providing patient care.
The Everest Biomedical SNAP II EEG monitor is an Electroencephalograph per 21 CFR 882.1400, which has an intended use that is consistent with the CAV/ classification.
The SNAP II is substantially equivalent in design, construction, materials, intended use and performance characteristics to the predicate devices.
The provided FDA submission for the Everest SNAP II EEG Monitor (K660997) does not contain detailed information regarding acceptance criteria or the specific study that proves the device meets such criteria in terms of clinical performance or accuracy of the "SNAP Index."
Instead, the submission primarily focuses on establishing substantial equivalence to a predicate device (Nicolet SNAP EEG Monitor, K020218) by demonstrating similar design, construction, materials, intended use, and performance characteristics. The "performance" mentioned in this context refers to in-vitro testing confirming the device meets "similar performance specifications" to the predicate, likely related to electrical safety, EMC, and basic signal acquisition, rather than a clinical performance study evaluating the accuracy of the SNAP Index.
Therefore, many of the requested details cannot be extracted from the provided text.
Here is a breakdown of what can and cannot be answered based on the input:
1. A table of acceptance criteria and the reported device performance
The document does not specify quantitative acceptance criteria for the "SNAP Index" or overall clinical performance of the device. It only states: "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices."
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not specified for clinical performance or SNAP Index accuracy. The document focuses on regulatory compliance and equivalence to predicate device specifications without detailing specific performance metrics for the SNAP Index. | "In vitro testing shows that the device meets similar performance specifications as those for the predicate devices." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The submission mentions "in vitro testing" but gives no details about participant sample size, characteristics, or data provenance for any performance evaluation specific to the SNAP Index.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This information is not provided. The document makes no mention of expert-established ground truth or clinical studies with expert reviewers for the SNAP Index.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This information is not provided. No adjudication method is described, as there are no details of a clinical test set with expert review.
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
An MRMC comparative effectiveness study is not mentioned or implied. The device is an EEG monitor with a derived index, not an AI-assisted diagnostic tool for human readers in the context of the typical MRMC study design.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
A standalone performance study specifically for the "SNAP Index" (algorithm only) is not detailed. The submission primarily focuses on the device's electrical safety and functional equivalence, not the clinical accuracy or performance of the SNAP Index as a standalone measure.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The type of ground truth used for evaluating the "SNAP Index" is not specified. The document does not describe how the accuracy or clinical utility of the SNAP Index was validated with a ground truth.
8. The sample size for the training set
This information is not provided. The document does not discuss any training sets, implying that the device's development and validation for regulatory purposes did not involve machine learning models with specific training data as might be expected in modern AI submissions.
9. How the ground truth for the training set was established
This information is not provided. As no training set is mentioned, the method for establishing its ground truth is also absent.
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Page ① of 2.
510(k) Summary
JUN 15 2006
As required by section 21 CFR 807.92(c)
Date of Submission
March 31, 2006
General Provisions
Common/Usual Name
Electroencephalograph
Proprietary Name:
Everest SNAP II
Applicant Name and Address
EVEREST BIOMEDICAL INSTRUMENTS CO. 16690 Swingley Ridge Rd. Suite 140 Chesterfield, MO 63017
Phone: 636-519-7770 ext. 109 Fax: 636-519-7991
Contact Person:
Prepared by Randall J. Krohn
Classification
The Everest Biomedical SNAP II EEG monitor is an Electroencephalograph per 21 CFR 882.1400, which has an intended use that is consistent with the CAV/ classification.
Performance Standards
Performance standards for Electroencephalographs have not been established by the FDA under Section 514 of the Food, Dug and Cosmetic Act after the withdrawl of the FDA
Document: Fleatreanceshalogaph Douin Cosmetic Act after the withdrawl of "Guidance Document: Electroencephalograph Devices Draft Guidance for 510(k) Content". IEC 60601-2-26 "Particular requirements for the safety of electroencephalographs" has been followed in the development of this device per CDRH recommendations. The FDA Performance Standard for Lead Wires and Patient Cables, 21 CFR $ 898, has been referenced in the preparation of this submission.
The IEC60601-1 family of electrical safety and EMC standards has been followed in the development of this device.
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page ② of 2
Predicate Device Table
| Predicate | Classification(s) |
|---|---|
| Nicolet SNAP EEG Monitor(K020218) | Class II882.1400 GWQ |
Intended Use
The SNAP II is intended to monitor the state of the brain by data acquisition of EEG signals. A derived measure provided by the SNAP II, the SNAP Index, indicates the patient's brain activity level.
The SNAP II is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use, within a hospital or medical facility providing patient care.
Biocompatibility
All appropriate biocompatibility tests have been performed by the manufacturer of the electrodes and are documented in previously cleared submissions for substantially equivalent electrodes (incorporating the same patient contact materials).
No part of the SNAP II system is supplied as sterile.
Summary of Substantial Equivalence
The SNAP II is substantially equivalent in design, construction, materials, intended use and performance characteristics to the predicate devices. In vitro testing shows that the device meets similar performance specifications as those for the predicate devices. No new issues of safety or effectiveness are introduced by using this device.
Any statement made in conjunction with this submission regarding substance to any other product only relates to whether the product can be lawfully market without or reclassification and is not to be interpreted as as admission or used as evidence in patent infringement Uligation. As the FDA bas indicated, " . . a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act relates to the fact the product can be lawfully marketed without pre-market approval or reclassification is not intended to have any bearing whatsoever on the resolution of patent infringement suits." 42 Fed. Reg. (1971).
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Image /page/2/Picture/1 description: The image is a black and white circular logo for the Department of Health & Human Services USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" is arranged around the top half of the circle. The eagle is facing to the right and appears to be in flight.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Everest Biomedical Instruments Co. c/o Mr. Randall J. Krohn VP Engineering/Regulatory Affairs Manager 16690 Swingley Ridge Rd. Suite 140 Chesterfield, MO 63017
APR - 9 2012
Re: K060997
Trade/Device Name: SNAP II EEG Monitor Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: II Product Code: OLW, OMC, GXY, ORT Dated (Date on orig SE ltr): June 5, 2006 Received (Date on orig SE Itr): June 6, 2006
Dear Mr. Krohn:
This letter corrects our substantially equivalent letter of June 15, 2006.
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 (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 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.
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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 (reporting of medical device-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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 Small Manufacturers, International and Consumer Assistance 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 vours.
Kesia Alexander
Malvina B. Eydelman, M.D. Director Division of Ophthalmic, Neurological, and Ear, Nose and Throat Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K060997
Device Name: SNAP II EEG Monitor
Indications for Use:
The SNAP II is intended to monitor the state of the brain by data acquisition of EEG signals. A dcrived measure provided by the SNAP II, the SNAP Index, indicates the patient's brain activity level.
The SNAP II is intended for use under the direct supervision of a licensed healthcare practitioner or by personnel trained in its proper use, within a hospital or medical facility providing patient care.
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)
Huler Lemen
(Division Sign-Off)
Page 1 of 1
Division of General, Restorative, and Neurological Devices
Colo997 510(k) Number
Section 4 - Page 2 of 2
§ 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).