The Cadwell Apollo 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 Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for ambulatory electroencephalograph (EEG) and polysomnography (PSG) and/or clinical studies of patients of all ages.

The Apollo system consists of a Recorder, a 64-channel and/or 32-channel Amplifier, a patient event button, a microphone, and various connecting cables. Optional accessories include the Arc photic stimulator, a video recording camera, and a cart for the equipment. Previously FDA cleared accessories used with the Apollo system consist of various electrodes, leads, and cables.

The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K133355) with support for Apollo hardware using single or combinations of amplifiers, and a photic stimulator.

Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.

AI/ML Overview

The provided document is a 510(k) summary for the Cadwell Apollo System, an electroencephalograph (EEG) and polysomnograph (PSG) device. It describes the device's indications for use, technological characteristics compared to a predicate device, and nonclinical testing performed to demonstrate substantial equivalence.

Here's an analysis of the acceptance criteria and the study that proves the device meets them, based on the provided text:

Acceptance Criteria and Reported Device Performance

The document describes nonclinical testing for various aspects of the device, with the "reported device performance" being that the device conforms to the specified standards and its predetermined specifications.

Acceptance Criteria Category	Standard/Requirement	Reported Device Performance
Software	• Predetermined specifications for Arc acquisition software (MODERATE level of concern)	Conforms to predetermined specifications and applicable software guidance documents.
	• FDA guidance: The content of premarket submissions for software contained in medical devices, issued May 11, 2005.
	• FDA guidance: Off-the-shelf software use in medical devices, issued September 09, 1999.
	• FDA guidance: General principles of software validation; Final guidance for industry and FDA staff, issued January 02, 2011.
	• FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, October 02, 2014.
	• IEC 62304: 2006, Medical device software - Software life cycle processes
Electrical Safety	• IEC 60601-1: 2005, Medical electrical equipment – Part 1: General requirements for basic safety and essential performance.	Conforms to the above standards.
	• IEC 60601-1-11: 2010, Medical electrical equipment – Part 1-11: General requirements for basic safety and essential performance – Collateral Standard: Requirements for medical electrical equipment and medical electrical systems used in the home healthcare environment
	• ISO 15004-2: 2007, Ophthalmic Instruments – Fundamental requirements and test methods – Part 2: Light hazard protection
Electromagnetic Compatibility	• IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2: General requirements for basic safety and essential performance – Collateral standard: Electromagnetic disturbances – Requirements and tests.	Conforms to the above standard.
Performance Testing – Bench	• Internal requirements and predetermined specifications	Conforms to its predetermined specifications and the above standards.
	• IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26: Particular requirements for the basic safety and essential performance of electroencephalographs
	• IEC 60601-1-6: 2010, Medical electrical equipment - Part 1-6: General requirements for basic safety and essential performance - Collateral standard: Usability
	• IEC 62366: 2007, Medical devices – Application of usability engineering to medical devices.

Study Details

Based on the provided text for K180269, this submission is for a medical device (Cadwell Apollo System) to acquire, record, transmit, and display physiological and environmental data for EEG and PSG studies. The provided document details nonclinical testing to demonstrate substantial equivalence to a predicate device (K133355 Cadwell Flex EEG/PSG), rather than a clinical study evaluating diagnostic performance of an AI algorithm.

Therefore, many of the requested details related to clinical studies, AI algorithms, human readers, and ground truth establishment are not applicable or not provided in this specific 510(k) summary.

Here's an assessment based on the available information:

Sample size used for the test set and the data provenance:
- The document describes nonclinical testing (software verification/validation, electrical safety, EMC, and bench performance testing). These tests typically involve engineered test cases, simulations, and measurements on the device itself, rather than patient data test sets.
- Not applicable / Not provided in terms of patient data test sets. The tests are focused on hardware and software functionality and compliance with engineering standards.
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Since this is nonclinical testing against engineering standards and predetermined specifications, the concept of "ground truth" derived from expert consensus on patient data (e.g., radiologist reads) does not apply.
- Expertise would be in engineering, quality assurance, and regulatory compliance for medical devices.
- Not applicable.
Adjudication method (e.g., 2+1, 3+1, none) for the test set:
- Not applicable. This relates to clinical interpretation of patient data, which is not the focus of the nonclinical tests described.
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, an MRMC study was not done. This 510(k) submission is for an EEG/PSG acquisition and display system, not a device with an AI-driven diagnostic component that assists human readers in interpreting clinical cases.
If a standalone (i.e., algorithm only without human-in-the loop performance) was done:
- No, a standalone AI algorithm performance study was not done. The Cadwell Apollo System, as described, is a hardware system with acquisition software, not a standalone diagnostic AI algorithm.
The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the nonclinical tests, the "ground truth" consists of the established engineering standards (IEC, ISO, FDA guidance) and the device's predetermined functional and performance specifications. The tests verify that the device's behavior matches these predefined requirements.
- Engineering standards and predetermined product specifications.
The sample size for the training set:
- This question is only relevant for AI/ML-driven devices that require a training set of data. The Cadwell Apollo System is an acquisition and display system, and while its software was developed, the document does not describe it as an AI/ML device requiring a training set in the conventional sense for diagnostic performance.
- Not applicable.
How the ground truth for the training set was established:
- Not applicable, as there is no described AI/ML training set in the document.

Summary

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July 17, 2018

Cadwell Industries, Inc. Alison Hull EEG Product Manager 909 North Kellogg Street Kennewick, Washington 99336

Re: K180269

Trade/Device Name: Cadwell Apollo System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ, GWE, GWL, OLT, OLV, OMC Dated: April 17, 2018 Received: April 18, 2018

Dear Alison Hull:

We have reviewed vour 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 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 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.

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Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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 comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (http://www.fda.gov/DICE) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely.

Jay R. Gupta -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

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Indications for Use

510(k) Number (if known) K180269

Device Name Cadwell Apollo System

Indications for Use (Describe)

The Cadwell Apollo System is indicated for prescription use to acquire, record, transmit, and display physiological and environmental data for electroencephic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients 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)

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K180269 510(k) Summary

Submitter's Nameand Address	Cadwell Industries, Inc.909 North Kellogg StreetKennewick, WA 99336
Contact Person	Ms. Alison HullPhone: +1 (800) 245-3001, Extension 210Email: alisonh@cadwell.com
Date SummaryPrepared	July 6, 2018
Trade Name	Cadwell Apollo System
Common Name	Electroencephalograph (EEG)
Classification Name& Product Code	PRIMARYClass II21 CFR 882.1400 GWQ Full-montage StandardElectroencephalographSUBSEQUENT21 CFR 882.1400 OLT Non-normalizing QuantitativeElectroencephalograph Software21 CFR 882.1400 OLV Standard Polysomnograph (PSG) withElectroencephalograph21 CFR 882.1400 OMC Reduced-Montage StandardElectroencephalograph21 CFR 882.1890 GWE Evoked Response Photic Stimulator21 CFR 882.1835 GWL Physiological Signal Amplifier
Predicate Device	K133355 Cadwell Flex EEG/PSG21 CFR 882.1400; GWQSubsequentProduct Codes GWE, GWL OLT, OLV, OMC

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Device Description	The Cadwell Apollo System (Apollo) is used to acquire, record, transmit, and display physiological and environmental data for ambulatory electroencephalograph (EEG) and polysomnography (PSG) and/or clinical studies of patients of all ages.The Apollo system consists of a Recorder, a 64-channel and/or 32-channel Amplifier, a patient event button, a microphone, and various connecting cables. Optional accessories include the Arc photic stimulator, a video recording camera, and a cart for the equipment. Previously FDA cleared accessories used with the Apollo system consist of various electrodes, leads, and cables.The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K133355) with support for Apollo hardware using single or combinations of amplifiers, and a photic stimulator.Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments.
Indications for Use	The Cadwell Apollo 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.
Comparison ofTechnologicalCharacteristics toPredicate Device	Characteristic	K133355Predicate Device	K180269Subject Device
	Intended PatientPopulation	All ages	Same
	SystemConfiguration	Computer based equipment withdedicated hardwareperipherals/components	Same
	RecordingModality	Attended and unattended	Same
	IntendedEnvironment ofUse	Hospital or home	Same
	Recorder toPersonalComputer (PC)Connectivity/Networking	Wired via an Ethernet cable	Wired via a USB cable
	Recorder toAmplifierConnectivity	Wired via a cable	Same
	AmplifiersAvailable	32 channel amplifier	32 channel amplifier64 channel amplifier
	Sampling Rage	3200 Hz	1 MHz
	Other Inputs	8 active/ reference, 2 other	Up to 10 active/reference, 2 other
	ImpedanceCheck	Yes	Yes
	Number ofAmplifiers thatcan Connect to	One (1)	Two (2)
Continued: Comparison of Technological Characteristics
Characteristic	K133355Predicate Device	K180269Subject Device
Power Source	Rechargeable Batteries (D Alkaline)or USB powered	Rechargeable Batteries (3.8V 3880mAh Lithium Ion Battery) or USBpowered
AcquisitionSoftware	Arc	Same
Arc SentinelSoftware, aCentral NurseStation	No	Yes; for viewing and monitoringmultiple data records
RemoteMonitoring	Yes	Same
Photic FlashRate	1 to 60 Hz	Same
Photic Interface	USB	Same
MicrophoneInput Ability	Yes	Yes
WirelessCommunicationCapability	No	Yes; wirelesscommunication capabilitybetween Recorder and PCwith Arc acquisitionsoftware.
CMMR	> 92 dB	Improved; > 110 dB
RecordingDuration	> 48 hours per 2 D batteries	Up to 96 hours on battery;Unlimited on battery
Storage Rate	250 Hz	16 kHz
Other Inputs	Patient Event ButtonPatient MicrophoneQ-Video Mobile 2 (in-homerecordings)	Patient Event ButtonPatient MicrophoneQ-Video Mobile 3 (in-homerecordings)
Cameras	IP and USB Cameras	IP and USB Cameras

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Summary of Nonclinical Testing to Demonstrate Substantial Equivalence
Software	The Arc acquisition software corresponds to a MODERATE level ofconcern. Software was designed and developed per a robust softwaredevelopment process, and was verified and validated. Softwareinformation is provided in accordance with internal requirements, thefollowing guidance documents, and IEC software standard:
	• FDA guidance: The content of premarket submissions for softwarecontained in medical devices, issued May 11, 2005.
	• FDA guidance: Off-the-shelf software use in medical devices, issuedSeptember 09, 1999.
	• FDA guidance: General principles of software validation; Finalguidance for industry and FDA staff, issued January 02, 2011.
	• FDA guidance: Content of premarket submissions for management ofcybersecurity in medical devices, October 02, 2014.
	• IEC 62304: 2006, Medical device software - Software life cycleprocesses
	Test results indicate that the Arc acquisition software conforms topredetermined specifications and the applicable software guidancedocuments.
Electrical Safety	The Apollo System was tested for performance in accordance with thefollowing standard:
	• IEC 60601-1: 2005, Medical electrical equipment – Part 1: Generalrequirements for basic safety and essential performance.
	• IEC 60601-1-11: 2010, Medical electrical equipment – Part 1-11:General requirements for basic safety and essential performance –Collateral Standard: Requirements for medical electrical equipmentand medical electrical systems used in the home healthcareenvironment
	• ISO 15004-2: 2007, Ophthalmic Instruments – Fundamentalrequirements and test methods – Part 2: Light hazard protection
	Test results indicate that the Apollo System conforms to the abovestandards.
Electromagnetic Compatibility	The Apollo was tested for performance in accordance with the followingstandard:
	• IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2:General requirements for basic safety and essential performance –Collateral standard: Electromagnetic disturbances – Requirementsand tests.
	Test results demonstrate that the Apollo conforms to the above standard.
PerformanceTesting – Bench	The Apollo was tested for performance in accordance with internalrequirements and the following standards:IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26:Particular requirements for the basic safety and essentialperformance of electroencephalographs IEC 60601-1-6: 2010, Medical electrical equipment - Part 1-6:General requirements for basic safety and essential performance -Collateral standard: Usability IEC 62366: 2007, Medical devices – Application of usabilityengineering to medical devices. Test results indicate that the Apollo conforms to its predeterminedspecifications and the above standards.
Conclusion	The results of the aforementioned performance data demonstrate that theCadwell Apollo System is substantially equivalent to the Cadwell FlexEEG/PSG.

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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).