(167 days)
No
The document explicitly states "Mentions AI, DNN, or ML: Not Found" and the description focuses on data acquisition and display, not analysis using AI/ML.
No
The device is described as an acquisition, recording, transmission, and display system for physiological and environmental data for diagnostic purposes (EEG and PSG studies), not for treatment or therapy.
Yes
The device is indicated for "acquiring, recording, transmitting, and displaying physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies." EEG and PSG are diagnostic procedures used to assess brain activity and sleep disorders, respectively, which directly contributes to diagnosing medical conditions.
No
The device description explicitly lists hardware components such as a Recorder, Amplifier, patient event button, microphone, cables, and optional accessories like a photic stimulator and camera. While it utilizes software, it is not solely software.
Based on the provided information, the Cadwell Apollo System is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used to "acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies." This involves measuring electrical activity in the brain (EEG) and various physiological parameters during sleep (PSG).
- Device Description: The description details hardware components like amplifiers, electrodes, and cables, which are used to directly interface with the patient's body to capture physiological signals.
- Lack of In Vitro Activity: IVD devices are designed to examine specimens from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information about a patient's health. The Cadwell Apollo System directly measures physiological signals in vivo (within the body).
The device is a medical device used for physiological monitoring and recording, specifically for neurological and sleep studies.
N/A
Intended Use / Indications for Use
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.
Product codes
GWQ, GWE, GWL, OLT, OLV, OMC
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
all ages
Intended User / Care Setting
Home healthcare and professional healthcare environments.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The Cadwell Apollo System was subjected to nonclinical testing for software, electrical safety, electromagnetic compatibility, and performance (bench testing) to demonstrate substantial equivalence.
Software: The Arc acquisition software corresponds to a MODERATE level of concern. Software was designed and developed per a robust software development process, and was verified and validated. Test results indicated that the Arc acquisition software conforms to predetermined specifications and applicable software guidance documents.
Electrical Safety: The Apollo System was tested for performance in accordance with IEC 60601-1: 2005, IEC 60601-1-11: 2010, and ISO 15004-2: 2007. Test results indicated that the Apollo System conforms to these standards.
Electromagnetic Compatibility: The Apollo was tested for performance in accordance with IEC 60601-1-2: 2007. Test results demonstrated that the Apollo conforms to this standard.
Performance Testing – Bench: The Apollo was tested for performance in accordance with internal requirements and IEC 60601-2-26: 2012, IEC 60601-1-6: 2010, and IEC 62366: 2007. Test results indicated that the Apollo conforms to its predetermined specifications and the above standards.
Conclusion: The results of the aforementioned performance data demonstrate that the Cadwell Apollo System is substantially equivalent to the Cadwell Flex EEG/PSG.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image shows the logos of the Department of Health & Human Services and the U.S. Food & Drug Administration (FDA). The Department of Health & Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text. The word "Administration" is on the second line.
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.
1
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 Name
and Address | Cadwell Industries, Inc.
909 North Kellogg Street
Kennewick, WA 99336 |
|---------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person | Ms. Alison Hull
Phone: +1 (800) 245-3001, Extension 210
Email: alisonh@cadwell.com |
| Date Summary
Prepared | July 6, 2018 |
| Trade Name | Cadwell Apollo System |
| Common Name | Electroencephalograph (EEG) |
| Classification Name
& Product Code | PRIMARY
Class II
21 CFR 882.1400 GWQ Full-montage Standard
Electroencephalograph
SUBSEQUENT
21 CFR 882.1400 OLT Non-normalizing Quantitative
Electroencephalograph Software
21 CFR 882.1400 OLV Standard Polysomnograph (PSG) with
Electroencephalograph
21 CFR 882.1400 OMC Reduced-Montage Standard
Electroencephalograph
21 CFR 882.1890 GWE Evoked Response Photic Stimulator
21 CFR 882.1835 GWL Physiological Signal Amplifier |
| Predicate Device | K133355 Cadwell Flex EEG/PSG
21 CFR 882.1400; GWQ
Subsequent
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.
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 of
Technological
Characteristics to
Predicate Device | Characteristic | K133355
Predicate Device | K180269
Subject Device |
| | Intended Patient
Population | All ages | Same |
| | System
Configuration | Computer based equipment with
dedicated hardware
peripherals/components | Same |
| | Recording
Modality | Attended and unattended | Same |
| | Intended
Environment of
Use | Hospital or home | Same |
| | Recorder to
Personal
Computer (PC)
Connectivity/
Networking | Wired via an Ethernet cable | Wired via a USB cable |
| | Recorder to
Amplifier
Connectivity | Wired via a cable | Same |
| | Amplifiers
Available | 32 channel amplifier | 32 channel amplifier
64 channel amplifier |
| | Sampling Rage | 3200 Hz | 1 MHz |
| | Other Inputs | 8 active/ reference, 2 other | Up to 10 active/reference, 2 other |
| | Impedance
Check | Yes | Yes |
| | Number of
Amplifiers that
can Connect to | One (1) | Two (2) |
| Continued: Comparison of Technological Characteristics | | | |
| Characteristic | K133355
Predicate Device | K180269
Subject Device | |
| Power Source | Rechargeable Batteries (D Alkaline)
or USB powered | Rechargeable Batteries (3.8V 3880
mAh Lithium Ion Battery) or USB
powered | |
| Acquisition
Software | Arc | Same | |
| Arc Sentinel
Software, a
Central Nurse
Station | No | Yes; for viewing and monitoring
multiple data records | |
| Remote
Monitoring | Yes | Same | |
| Photic Flash
Rate | 1 to 60 Hz | Same | |
| Photic Interface | USB | Same | |
| Microphone
Input Ability | Yes | Yes | |
| Wireless
Communication
Capability | No | Yes; wireless
communication capability
between Recorder and PC
with Arc acquisition
software. | |
| CMMR | > 92 dB | Improved; > 110 dB | |
| Recording
Duration | > 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 Button
Patient Microphone
Q-Video Mobile 2 (in-home
recordings) | Patient Event Button
Patient Microphone
Q-Video Mobile 3 (in-home
recordings) | |
| 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 of |
| concern. Software was designed and developed per a robust software | |
| development process, and was verified and validated. Software | |
| information is provided in accordance with internal requirements, the | |
| following guidance documents, and IEC software standard: | |
| • 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 | |
| Test results indicate that the Arc acquisition software conforms to | |
| predetermined specifications and the applicable software guidance | |
| documents. | |
| Electrical Safety | The Apollo System was tested for performance in accordance with the |
| following standard: | |
| • IEC 60601-1: 2005, Medical electrical equipment – Part 1: General | |
| requirements 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 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 | |
| Test results indicate that the Apollo System conforms to the above | |
| standards. | |
| Electromagnetic Compatibility | The Apollo was tested for performance in accordance with the following |
| standard: | |
| • 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. | |
| Test results demonstrate that the Apollo conforms to the above standard. | |
| Performance | |
| Testing – Bench | The Apollo was tested for performance in accordance with internal |
| requirements and the following 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. Test results indicate that the Apollo conforms to its predetermined | |
| specifications and the above standards. | |
| Conclusion | The results of the aforementioned performance data demonstrate that the |
| Cadwell Apollo System is substantially equivalent to the Cadwell Flex | |
| EEG/PSG. |
T
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