CADWELL FLEX EEG/PSG

{0}------------------------------------------------ K133356 JAN 2 9 2014 : . | Submitter: | Cadwell<br>909 N. Kellogg Street<br>Kennewick, Washington 99336<br>509-735-6481 | |----------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| | Contact Person: | John Cadwell Jr<br>Electrical Engineer<br>Cadwell Laboratories, Inc. | | Date Prepared: | October 31, 2013 | | Trade Name: | Cadwell Flex | | Regulation Name: | Electroencephalograph, Evoked Response Photic<br>Stimulator, Physiological Signal Amplifier | | Regulation Number: | 21 CFR 882.1400, 21 CFR 882.1890, 21 CFR 882.1835 | | Regulatory Classification: | Class II | | Product Code: | GWQ, OMC, OLV, GWL, OLT, GWE, GWL | | Classification Panel: | Neurological | | Predicate Devices: | EB Neuro BE micro Trea (K093728)<br>Cadwell Kilowin (K971214) | | Device Description: | The Cadwell Flex EEG/PSG system consists of: (1)<br>acquisition hardware that can acquire, record, store, and<br>transfer up to 32 channels of EEG data, 8 active-reference<br>signal, and audio signals from a microphone, and has<br>EzNet-module-compatibility, (2).software_that_allows_a_user<br>to acquire, store, transmit, view and print data, and to create<br>reports based on the data, (3) optional video recording, (4)<br>an optional photic stimulator, and (5) a host electronic<br>device (typically a PC) capable of running the software and<br>interfacing with the acquisition, video recording, and photic<br>stimulation devices.<br><br>The Cadwell Flex EEG/PSG system is capable of two<br>modes of operation: (1) Ambulatory, where the acquisition<br>hardware acquires, records, and stores physiological and/or | Section 05: 510K Summary ・・. Page I of 3 {1}------------------------------------------------ ## 510k Summary environmental data to onboard mass-storage non-volatile memory, and said data is later transferred to a host electronic device, and (2) Clinical, where the host electronic device is connected to the acquisition hardware during data acquisition and recording, with mass-storage occurring on the host. The Cadwell Flex EEG/PSG system software is capable of interfacing with additional software used to perform EEG/PSG waveform analysis. Indications for Use: The Cadwell Flex system is indicated Indications for Use: for prescription use to acquire, record, transmit and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. ### Substantial Equivalence: Using the characteristics shown in the following table, the Cadwell Flex is shown to be substantially equivalent to the referenced predicate devices. | Product | EBNeuro<br>BEmicro | Kilowin | Cadwell Flex | |---------------------------|--------------------------------------------------|----------------------------------------------|-----------------------------------| | 510K | K093728 | K97214 | TBD | | Device class | Class II | Class II | Class II | | Product Codes | OLV, GWQ, GWL,<br>MNR, DQA | GWE, GWF, GWJ,<br>GWQ, IKN, JXE, OLT,<br>OLV | GWQ, OLV, GWL, OLT,<br>GWE | | Target Population | Pediatric through<br>adult | Patients of all ages | Patients of all ages | | Recording<br>Modality | Attended and<br>unattended | Attended | Attended or unattended | | Use Environment | Hospital and home | Operating room or clinic | Hospital or home | | Prescription<br>Status | Available only on<br>the order of a<br>physician | By prescription only | By prescription only | | Power | Battery powered or<br>USB powered | AC power | Battery powered or USB<br>powered | | Number of EEG<br>Channels | 21 | 24-64 | 32 | | Other Inputs | 1 digital | 12 ECG and 1-16 EMG | 8 active/reference, 2<br>other | | A/D Resolution | 16 bit | 16 bit | 16 bit | | Sampling Rate | Up to 2048<br>samples/s | 3200 Hz | 3200 Hz | | Impedance Check | Yes | Yes | Yes | Section 05: 510K Summary Page 2 of 3 {2}------------------------------------------------ Image /page/2/Picture/0 description: The image shows the word "CADWELL" in a stylized font. The "C" is replaced with a circle containing a symbol resembling a heartbeat. The letters are bold and have a textured appearance, giving them a slightly rough or grainy look. The overall design is simple yet distinctive, likely representing a brand or company name. # 510k Summary Testing: Conclusion: Software and hardware verification and validation, and clectromagnetic compatibility and safety testing were performed. The Cadwell Flex system is substantially equivalent to The Cativen Tres in design, use, technology, and function. Section 05: 510K Summary Page 3 of 3 {3}------------------------------------------------ DEPARTMENT OF HEALTH & HUMAN SERVICES Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it, placed within a circle. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged around the circumference of the circle. The logo is presented in black and white. Public Health Service Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 January 29, 2014 Cadwell Laboratories c/o Mr. John Cadwell Jr. 909 N. Kellogg Street Kennewick, WA 99336 Re: K133355 Trade/Device Name: Cadwell Flex Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalogram Regulatory Class: Class II Product Code: GWQ, OMC, OLV, GWL, OLT, GWE Dated: October 13, 2013 Received: October 13, 2013 Dear Mr. Cadwell: 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. 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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set {4}------------------------------------------------ Page 2 - Mr. John Cadwell Jr. 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 Small Manufacturers, International and Consumer Assistance at its tollfree 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/ReportalProblem/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 yours. Carlos L. Pena -S Carlos L. Peña, Ph.D., M.S. Director Division of Neurological and Physical Medicine Devices Office of Device Evaluation Center for Devices and Radiological Health Enclosure {5}------------------------------------------------ #### 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 on last page. #### 510(k) Number (if known) K133355 #### Device Name Cadwell Flex #### Indications for Use (Describe) The Cadwell Flex system is indicated for prescription use to acquire, record, transmit and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of all ages. #### 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) #### 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) (Signalure) Carlos L. Pena -S {6}------------------------------------------------ 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." The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." .