The Cadwell Flex system is indicated 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.

Device Description

The Cadwell Flex EEG/PSG system consists of: (1) acquisition hardware that can acquire, record, store, and transfer up to 32 channels of EEG data, 8 active-reference signal, and audio signals from a microphone, and has EzNet-module-compatibility, (2).software_that_allows_a_user to acquire, store, transmit, view and print data, and to create reports based on the data, (3) optional video recording, (4) an optional photic stimulator, and (5) a host electronic device (typically a PC) capable of running the software and interfacing with the acquisition, video recording, and photic stimulation devices.

The Cadwell Flex EEG/PSG system is capable of two modes of operation: (1) Ambulatory, where the acquisition hardware acquires, records, and stores physiological and/or 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.

AI/ML Overview

Here's an analysis of the provided text regarding the Cadwell Flex device, focusing on acceptance criteria and study information:

1. Table of Acceptance Criteria and Reported Device Performance

The provided text for the Cadwell Flex (K133356) does not explicitly state quantitative "acceptance criteria" for its performance in the typical sense of a medical device study (e.g., specific sensitivity, specificity, accuracy thresholds). Instead, the submission focuses on demonstrating substantial equivalence to predicate devices. This means that the device is deemed acceptable if it performs comparably to or better than existing, legally marketed devices.

The "performance" is largely described by comparing its technical specifications and capabilities with those of its predicate devices.

Characteristic	Predicate 1: EBNeuro BEmicro (K093728)	Predicate 2: Kilowin (K97214)	Cadwell Flex (Applicant Device)
Device class	Class II	Class II	Class II
Target Population	Pediatric through adult	Patients of all ages	Patients of all ages
Recording Modality	Attended and unattended	Attended	Attended or unattended
Use Environment	Hospital and home	Operating room or clinic	Hospital or home
Prescription Status	Available only on the order of a physician	By prescription only	By prescription only
Power	Battery powered or USB powered	AC power	Battery powered or USB powered
Number of EEG Channels	21	24-64	32
Other Inputs	1 digital	12 ECG and 1-16 EMG	8 active/reference, 2 other
A/D Resolution	16 bit	16 bit	16 bit
Sampling Rate	Up to 2048 samples/s	3200 Hz	3200 Hz
Impedance Check	Yes	Yes	Yes

Conclusion regarding performance: The text states, "The Cadwell Flex system is substantially equivalent to [The Cativen Tres] in design, use, technology, and function." This implies that its performance is considered acceptable because it meets or exceeds the capabilities of the predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

The document does not describe a clinical study with a "test set" in the context of diagnostic accuracy, sensitivity, or specificity. Instead, the testing appears to be primarily engineering verification and validation.

The relevant section states: "Software and hardware verification and validation, and electromagnetic compatibility and safety testing were performed."

Sample Size for Test Set: Not applicable in the context of a typical clinical performance study. The device's functionality was evaluated through engineering tests, likely involving a single or limited number of prototype devices and simulated or real-world signal inputs to verify its specifications.
Data Provenance: The document does not specify the origin of any data used for performance testing beyond the statement of "software and hardware verification and validation." It implies internal company testing rather than external clinical data. It is not retrospective or prospective clinical data in the usual sense.

3. Number of Experts Used to Establish Ground Truth for the Test Set and Their Qualifications

Not applicable. As there's no clinical "test set" for diagnostic performance being evaluated against a ground truth, there's no mention of experts establishing a ground truth. The evaluation focused on technical specifications and safety through engineering tests, not clinical interpretation.

4. Adjudication Method for the Test Set

Not applicable. There was no clinical test set requiring adjudication of findings by experts.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document makes no mention of an MRMC study or any comparison of human readers' performance with and without AI assistance. The device is an EEG/PSG acquisition system, not an AI-driven interpretation tool.

6. Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study

No. The Cadwell Flex is an EEG/PSG system designed to acquire and display physiological data for human interpretation. It is not an algorithm performing standalone diagnostic tasks. The "software" mentioned allows the user "to acquire, store, transmit, view and print data, and to create reports based on the data," and also "is capable of interfacing with additional software used to perform EEG/PSG waveform analysis," but the core device itself is not presented as an AI-driven interpretation tool.

7. Type of Ground Truth Used

Not applicable in the context of diagnostic accuracy. The "ground truth" for the engineering tests would be the established technical specifications, safety standards, and electromagnetic compatibility requirements.

8. Sample Size for the Training Set

Not applicable. This device is not an AI/ML algorithm that is "trained" on a dataset. It's a hardware and software system for data acquisition and display.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As there is no training set for an AI/ML algorithm, no ground truth was established for this purpose.

Summary

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K133356 JAN 2 9 2014

Submitter:	Cadwell909 N. Kellogg StreetKennewick, Washington 99336509-735-6481
Contact Person:	John Cadwell JrElectrical EngineerCadwell Laboratories, Inc.
Date Prepared:	October 31, 2013
Trade Name:	Cadwell Flex
Regulation Name:	Electroencephalograph, Evoked Response PhoticStimulator, 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)Cadwell Kilowin (K971214)
Device Description:	The Cadwell Flex EEG/PSG system consists of: (1)acquisition hardware that can acquire, record, store, andtransfer up to 32 channels of EEG data, 8 active-referencesignal, and audio signals from a microphone, and hasEzNet-module-compatibility, (2).software_that_allows_a_userto acquire, store, transmit, view and print data, and to createreports based on the data, (3) optional video recording, (4)an optional photic stimulator, and (5) a host electronicdevice (typically a PC) capable of running the software andinterfacing with the acquisition, video recording, and photicstimulation devices.The Cadwell Flex EEG/PSG system is capable of twomodes of operation: (1) Ambulatory, where the acquisitionhardware acquires, records, and stores physiological and/or

Section 05: 510K Summary

・・.

Page I of 3

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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	EBNeuroBEmicro	Kilowin	Cadwell Flex
510K	K093728	K97214	TBD
Device class	Class II	Class II	Class II
Product Codes	OLV, GWQ, GWL,MNR, DQA	GWE, GWF, GWJ,GWQ, IKN, JXE, OLT,OLV	GWQ, OLV, GWL, OLT,GWE
Target Population	Pediatric throughadult	Patients of all ages	Patients of all ages
RecordingModality	Attended andunattended	Attended	Attended or unattended
Use Environment	Hospital and home	Operating room or clinic	Hospital or home
PrescriptionStatus	Available only onthe order of aphysician	By prescription only	By prescription only
Power	Battery powered orUSB powered	AC power	Battery powered or USBpowered
Number of EEGChannels	21	24-64	32
Other Inputs	1 digital	12 ECG and 1-16 EMG	8 active/reference, 2other
A/D Resolution	16 bit	16 bit	16 bit
Sampling Rate	Up to 2048samples/s	3200 Hz	3200 Hz
Impedance Check	Yes	Yes	Yes

Section 05: 510K Summary

Page 2 of 3

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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

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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

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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

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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

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Regulation Number and Section

§ 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).