Cadwell Apollo System

K180269 · Cadwell Industries, Inc. · GWQ · Jul 17, 2018 · Neurology

Device Facts

• Record ID: K180269
• Device Name: Cadwell Apollo System
• Applicant: Cadwell Industries, Inc.
• Product Code: GWQ · Neurology
• Decision Date: Jul 17, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 882.1400
• Device Class: Class 2

Intended 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.

Device Story

Cadwell Apollo System acquires, records, transmits, and displays physiological/environmental data for EEG/PSG studies; used in home and clinical environments. System components: recorder, 32/64-channel amplifiers, patient event button, microphone, cables; optional photic stimulator, video camera, cart. Operates via Arc acquisition software; supports wired (USB/Ethernet) or wireless connectivity to PC. Healthcare providers use Arc Sentinel software at central nurse stations for monitoring multiple records. Device provides high-fidelity signal acquisition (1 MHz sampling, >110 dB CMRR) to assist clinicians in diagnostic EEG/PSG interpretation. Benefits include extended recording duration (up to 96 hours) and improved signal quality for patient monitoring.

Clinical Evidence

Bench testing only. No clinical data provided. Performance verified against IEC 60601-2-26 (EEG safety/performance), IEC 60601-1 (general safety), IEC 60601-1-11 (home healthcare), and IEC 60601-1-2 (EMC). Software verified and validated per IEC 62304 and FDA guidance.

Technological Characteristics

System includes recorder, 32/64-channel amplifiers, photic stimulator. Connectivity: USB, Ethernet, wireless. Power: 3.8V 3880 mAh Li-ion battery or USB. Sampling: 1 MHz. CMRR: >110 dB. Software: Arc acquisition software (Moderate level of concern). Standards: IEC 60601-1, IEC 60601-1-11, IEC 60601-1-2, IEC 60601-2-26, IEC 62304, ISO 15004-2.

Indications for Use

Indicated for prescription use in patients of all ages requiring EEG or PSG ambulatory or clinical studies to acquire, record, transmit, and display physiological and environmental data.

Regulatory Classification

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.

Predicate Devices

• Cadwell Flex EEG/PSG (K133355)

Submission Summary (Full Text)

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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 ([e-mail]) or phone [phone] 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 Name<br>and Address | Cadwell Industries, Inc.<br>909 North Kellogg Street<br>Kennewick, WA 99336 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Alison Hull<br>Phone: [phone], Extension 210<br>Email: [e-mail] |
| Date Summary<br>Prepared | July 6, 2018 |
| Trade Name | Cadwell Apollo System |
| Common Name | Electroencephalograph (EEG) |
| Classification Name<br>& Product Code | <b>PRIMARY</b><br>Class II<br>21 CFR 882.1400     GWQ     Full-montage Standard<br>Electroencephalograph<br><br><b>SUBSEQUENT</b><br>21 CFR 882.1400     OLT     Non-normalizing Quantitative<br>Electroencephalograph Software<br>21 CFR 882.1400     OLV     Standard Polysomnograph (PSG) with<br>Electroencephalograph<br>21 CFR 882.1400     OMC     Reduced-Montage Standard<br>Electroencephalograph<br>21 CFR 882.1890     GWE     Evoked Response Photic Stimulator<br>21 CFR 882.1835     GWL     Physiological Signal Amplifier |
| Predicate Device | K133355     Cadwell Flex EEG/PSG<br>21 CFR 882.1400; GWQ<br><br>Subsequent<br>Product 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.<br><br>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.<br><br>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.<br><br>Additional channels can be added with multiple amplifiers. Apollo is intended for use in both home healthcare and professional healthcare environments. | | |
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| 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 of<br>Technological<br>Characteristics to<br>Predicate Device | Characteristic | K133355<br>Predicate Device | K180269<br>Subject Device |
| | Intended Patient<br>Population | All ages | Same |
| | System<br>Configuration | Computer based equipment with<br>dedicated hardware<br>peripherals/components | Same |
| | Recording<br>Modality | Attended and unattended | Same |
| | Intended<br>Environment of<br>Use | Hospital or home | Same |
| | Recorder to<br>Personal<br>Computer (PC)<br>Connectivity/<br>Networking | Wired via an Ethernet cable | Wired via a USB cable |
| | Recorder to<br>Amplifier<br>Connectivity | Wired via a cable | Same |
| | Amplifiers<br>Available | 32 channel amplifier | 32 channel amplifier<br>64 channel amplifier |
| | Sampling Rage | 3200 Hz | 1 MHz |
| | Other Inputs | 8 active/ reference, 2 other | Up to 10 active/reference, 2 other |
| | Impedance<br>Check | Yes | Yes |
| | Number of<br>Amplifiers that<br>can Connect to | One (1) | Two (2) |
| Continued: Comparison of Technological Characteristics | | | |
| Characteristic | K133355<br>Predicate Device | K180269<br>Subject Device | |
| Power Source | Rechargeable Batteries (D Alkaline)<br>or USB powered | Rechargeable Batteries (3.8V 3880<br>mAh Lithium Ion Battery) or USB<br>powered | |
| Acquisition<br>Software | Arc | Same | |
| Arc Sentinel<br>Software, a<br>Central Nurse<br>Station | No | Yes; for viewing and monitoring<br>multiple data records | |
| Remote<br>Monitoring | Yes | Same | |
| Photic Flash<br>Rate | 1 to 60 Hz | Same | |
| Photic Interface | USB | Same | |
| Microphone<br>Input Ability | Yes | Yes | |
| Wireless<br>Communication<br>Capability | No | Yes; wireless<br>communication capability<br>between Recorder and PC<br>with Arc acquisition<br>software. | |
| CMMR | > 92 dB | Improved; > 110 dB | |
| Recording<br>Duration | > 48 hours per 2 D batteries | Up to 96 hours on battery;<br>Unlimited on battery | |
| Storage Rate | 250 Hz | 16 kHz | |
| Other Inputs | Patient Event Button<br>Patient Microphone<br>Q-Video Mobile 2 (in-home<br>recordings) | Patient Event Button<br>Patient Microphone<br>Q-Video Mobile 3 (in-home<br>recordings) | |
| Cameras | IP and USB Cameras | IP and USB Cameras | |

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| Summary of Nonclinical Testing to Demonstrate Substantial Equivalence | |
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| Software | The Arc acquisition software corresponds to a MODERATE level of<br>concern. Software was designed and developed per a robust software<br>development process, and was verified and validated. Software<br>information is provided in accordance with internal requirements, the<br>following guidance documents, and IEC software standard: |
| | • FDA guidance: The content of premarket submissions for software<br>contained in medical devices, issued May 11, 2005. |
| | • FDA guidance: Off-the-shelf software use in medical devices, issued<br>September 09, 1999. |
| | • FDA guidance: General principles of software validation; Final<br>guidance for industry and FDA staff, issued January 02, 2011. |
| | • FDA guidance: Content of premarket submissions for management of<br>cybersecurity in medical devices, October 02, 2014. |
| | • IEC 62304: 2006, Medical device software - Software life cycle<br>processes |
| | Test results indicate that the Arc acquisition software conforms to<br>predetermined specifications and the applicable software guidance<br>documents. |
| Electrical Safety | The Apollo System was tested for performance in accordance with the<br>following standard: |
| | • IEC 60601-1: 2005, Medical electrical equipment – Part 1: General<br>requirements for basic safety and essential performance. |
| | • IEC 60601-1-11: 2010, Medical electrical equipment – Part 1-11:<br>General requirements for basic safety and essential performance –<br>Collateral Standard: Requirements for medical electrical equipment<br>and medical electrical systems used in the home healthcare<br>environment |
| | • ISO 15004-2: 2007, Ophthalmic Instruments – Fundamental<br>requirements and test methods – Part 2: Light hazard protection |
| | Test results indicate that the Apollo System conforms to the above<br>standards. |
| Electromagnetic Compatibility | The Apollo was tested for performance in accordance with the following<br>standard: |
| | • IEC 60601-1-2: 2007, Medical electrical equipment – Part 1-2:<br>General requirements for basic safety and essential performance –<br>Collateral standard: Electromagnetic disturbances – Requirements<br>and tests. |
| | Test results demonstrate that the Apollo conforms to the above standard. |
| Performance<br>Testing – Bench | The Apollo was tested for performance in accordance with internal<br>requirements and the following standards:<br>IEC 60601-2-26: 2012, Medical electrical equipment – Part 2-26:<br>Particular requirements for the basic safety and essential<br>performance of electroencephalographs IEC 60601-1-6: 2010, Medical electrical equipment - Part 1-6:<br>General requirements for basic safety and essential performance -<br>Collateral standard: Usability IEC 62366: 2007, Medical devices – Application of usability<br>engineering to medical devices. Test results indicate that the Apollo conforms to its predetermined<br>specifications and the above standards. |
| Conclusion | The results of the aforementioned performance data demonstrate that the<br>Cadwell Apollo System is substantially equivalent to the Cadwell Flex<br>EEG/PSG. |

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