CADWELL SPIKE AND SEIZURE DETECTOR

{0}------------------------------------------------ Image /page/0/Picture/0 description: The image shows the logo for "OCADVELL" on the left and the text "510k Summary" on the right. The logo consists of a circle with a heartbeat symbol inside, followed by the text "OCADVELL" in bold, sans-serif font. The text "510k Summary" is also in a bold, sans-serif font and is positioned to the right of the logo. : | Submitter: | Cadwell Laboratories, Inc. | K140552<br>JUL 2 3 2014 | |------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------| | Contact Person: | Chris Bolkan<br>Safety / Regulatory Specialist<br>Cadwell Laboratories, Inc.<br>909 N. Kellogg Street<br>Kennewick, WA 99336<br>Phone: (509) 735-6481<br>Fax: (509) 783-6503 | | | Date Prepared: | February 27, 2014 | | | Trade Name: | Cadwell Spike and Seizure Detector | | | Common Name: | Spike and Seizure Detector | | | Classification Name<br>and Number: | Electroencephalograph, Class II, 21 CFR 882.1400 | | | Product Code: | OMB | | | Classification Panel: | Neurology | | | Predicate Device: | Persyst Reveal (K011397) | | | Device Description: | Cadwell Spike and Seizure Detector is a software-only<br>product with an algorithm intended to analyze and mark<br>events that correspond to spikes and seizures for the<br>purpose of reviewing EEG recording. This application is for<br>use by trained users such as neurologists, clinicians,<br>registered EEG technicians. It requires EEG data recorded<br>with a standard montage using the 10/20 electrode<br>placement. The detected events are annotated on the EEG<br>record for review by a trained user. | | | Indications for Use: | Cadwell Spike and Seizure Detector is a software-only<br>product with an algorithm intended to analyze and mark<br>events that may correspond to epileptiform discharge | | (spike) and electrographic seizure for the purpose of reviewing scalp EEG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical {1}------------------------------------------------ Image /page/1/Picture/0 description: The image shows the logo for CADWELL along with the text "510k Summary". The CADWELL logo is on the left side of the image, and the text "510k Summary" is on the right side of the image. The text is in a larger font than the logo. practitioners who will exercise professional judgment in using the information. This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over. This device does not provide any diagnostic conclusion about the patient to the user. #### Summary of technology characteristics: | | Comparison | | |-----------------------------------|-------------------------------------------------|-----------------------------| | Key Attributes | Cadwell Spike and Seizure<br>Detector (K123927) | Persyst Reveal<br>(K011397) | | Identifies spikes | Yes | Yes | | Identifies seizures | Yes | Yes | | Displays calculated EEG measures | No | No | | User-adjustable seizure detection | No | Yes | | Users can add/delete events | Yes | Yes | | Type of EEG recording supported | Scalp EEG only | Unknown | | Type of EEG analysis | Post-hoc only | Post-hoc only | | Population age | Adult | Unknown | | Product Code | OMB | GWS | Table 1: Device Comparison Table Substantial Equivalence: The Cadwell Spike and Seizure Detector is a software package that identifies spike and seizures in scalp EEG recordings. Persyst Reveal is commercially available software package that identifies spike and seizures in scalp EEG recordings and is an accepted standard in automated spike and seizure detection programs. > The Cadwell Spike and Seizure Detector is substantially equivalent to the Persyst Revel in terms of: - Indications for use t - Technology characteristics . - . Performance characteristics Cadwell Spike and Seizure Detector 510k Summary Rev. 4 Page 2 of 6 {2}------------------------------------------------ ### VELL 510k Summary - . Testing results from clinical data Validation: 76 records were selected from unique patients with the following inclusion criteria: - Patient age 18 years or over on the date of recording ● - . Full montage scalp EEG using the 10-20 montage was acquired - . Total recording duration of minimum 6 hours All recordings were acquired in an epilepsy monitoring unit as part of routine clinical protocol using the standard 10-20 montage. The patient age range for the selected recordings was 18-92 years with an average age of 48.2 years. The recording duration was in the range of 6-71 hours with an average of 24.6 hours. Three human experts reviewed the complete raw EEG for each record and marked spike and seizure events. Majority rule (agreement between any two of three experts) using any overlap method was applied to construct the reference set. The reference set for spike detector validation contained a total of 946 events. Figures 1 and 2 show the performance for each of the experts, Persyst Reveal and Cadwell Spike Detector. {3}------------------------------------------------ ## 510k Summary Image /page/3/Figure/1 description: The image is a plot titled "Spike Detection Sensitivity". The plot shows the positive percent agreement and 95% confidence interval for different experts and systems. The x-axis ranges from 40% to 100%, and the y-axis lists the experts and systems: Expert 1, Expert 2, Expert 3, Persyst, and Cadwell. Figure 1: Positive percent agreement and 95% confidence interval using bootstrap method. Image /page/3/Figure/3 description: The image is a plot titled "False Detection Rate for Spike Detection". The x-axis is labeled "Negative Disagreement Rate and 95% Confidence Interval" and ranges from 0 to 300. There are 5 different experts/systems plotted on the y-axis: Expert 1, Expert 2, Expert 3, Persyst, and Cadwell. Each expert/system has a range of values plotted, with a diamond indicating the mean value. Figure 2: Negative disagreement rate and 95% confidence interval using bootstrop method. The reference set for seizure detector validation contained a total of 332 events. Figures 3 and 4 show the performance for each of the experts, Persyst Reveal and Cadwell Seizure Detector. « Cadwell Spike and Seizure Detector 510k Summary Rev. 4 Page 4 of 6 {4}------------------------------------------------ Image /page/4/Picture/0 description: The image shows the word "CADWELL" in a bold, sans-serif font. To the left of the word is a circle with a line going through it that resembles a heartbeat. The letters are all capitalized and black, and the background is white. The font is uniform in size and thickness. ## 510k Summary Image /page/4/Figure/2 description: The image is a plot titled "Seizure Detection Sensitivity". The x-axis is labeled "Positive Percent Agreement and 95% Confidence Interval" and ranges from 40% to 100%. The y-axis shows the labels Expert 1, Expert 2, Expert 3, Persyst, and Cadwell. Each label has a line with a diamond in the middle, representing the range of values for each label. Figure 3: Positive percent agreement and 95% confidence interval using bootstrap method. Image /page/4/Figure/4 description: The image is a plot titled "False Detection Rate for Seizure Detection". The x-axis is labeled "Negative Disagreement Rate and 95% Confidence Interval" and ranges from 0 to 8. The y-axis shows the names of experts and systems, including Expert 1, Expert 2, Expert 3, Persyst, and Cadwell. Each expert and system has a horizontal line representing the disagreement rate and confidence interval. Figure 4: Negative disagreement rate and 95% confidence interval using bootstrap method. {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the word "CADWELL" in a bold, sans-serif font. To the left of the word, there is a circular graphic with a waveform inside, resembling an EKG or heart rhythm tracing. The letters are closely spaced, creating a solid block of text. Conclusion: The validation results show that the Cadwell Spike and Seizure Detector meets the objective for device effectiveness and substantial equivalence. 510k Summary | Test Criteria | Spike Detector | Seizure Detector | |-------------------------|----------------|------------------| | Device effectiveness | Pass | Pass | | Substantial equivalence | Pass | Pass | Table 2: Summary of the test results for the Cadwell Spike and Seizure Detector {6}------------------------------------------------ Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 July 23, 2014 Cadwell Laboratories Jinesh Jain. Software Manager 909 N. Kellogg Street Kennewick, WA 99336 Re: K140552 Trade/Device Name: Cadwell Spike and Scizure Detector Software Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: OMB Dated: June 9, 2014 Received: June 17. 2014 Dear Mr. Jain: 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 cither 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 (reporting of medical Image /page/6/Picture/11 description: The image shows the seal of the Department of Health & Human Services (HHS). The seal features a stylized eagle with three lines representing its body and wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle. {7}------------------------------------------------ Page 2 - Jinesh Jain 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 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" (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 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/Resourcesfor You/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 {8}------------------------------------------------ #### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration #### Indications for Use Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below. 510(k) Number (if known) K140552 Device Name Cadwell Spike and Seizure Detector #### Indications for Use (Describe) Cadwell Spike and Scizure Detector is a software-only product with an algorithm intended to analyze and mark evens that may correspond to epileptiform discharge (spike) and clectrographic seizure for the purpose of reviewing scale EFG recordings. The marked events are reviewed, deleted, and interpreted by qualified clinical practitioners who will exercise professional judgment in using the information. This device does not control the delivery of energy, administration of drugs, or another form of life sustaining function to the patient. It is intended for use in patients who are 18 years or over. This device does not provide any diagnostic conclusion about the patient to the user. Type of Use (Select one or both, as applicable) 2 Prescription Use (Part 21 CFR 801 Subpart D) Over-The-Counter Use (21 CFR 801 Subpart C) PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED. #### FOR FDA USE ONLY Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) # - Date: 2014.07.23 19:45:51 > -04'00' 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." 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