(90 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 indicated for acquiring, recording, transmitting, and displaying physiological and environmental data for diagnostic purposes, not for treating any condition.
Yes
Explanation: The device is used to acquire, record, transmit, and display physiological and environmental data for electroencephalographic (EEG) and polysomnographic (PSG) studies, which are diagnostic procedures to understand a patient's neurological and sleep conditions.
No
The device description explicitly states that the system "utilizes Cadwell Arc acquisition software... with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices." It also includes sections on Electrical Safety, Electromagnetic Compatibility, and Wireless Co-existence Testing, which are relevant to hardware components.
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 electroencephic (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 reinforces this by mentioning the acquisition of "physiological and environmental data" and the use of amplifiers and interfaces with oximeters.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or screening. IVDs typically involve analyzing biological samples.
The Cadwell Apollo System is a medical device used for physiological monitoring and recording, specifically for neurological and sleep studies. This falls under a different category of medical devices than IVDs.
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 electroencephalographic (EEG) and polysomnographic (PSG) ambulatory and/or clinical studies of patients of all ages. The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. 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
patients of 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
Software: The Arc acquisition software contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Test results indicate that the Arc acquisition software complies with its predetermined specifications and the applicable guidance documents.
Electrical Safety: The Apollo was tested for performance in accordance with IEC 60601-1: 2005, IEC 60601-1-11: 2010, and ISO 15004-2: 2007. Test results indicate that the Apollo complies with the applicable standards.
Electromagnetic Compatibility: The Apollo was tested for performance in accordance with IEC 60601-1-2: 2007. Test results indicate that the Apollo complies with the applicable standards.
Wireless Co-existence Testing: The Apollo was tested for performance in accordance with ANSI C63.27:2017, AIM 7351731:2017, FCC 15C Intentional Radiators, and 47 CFR1.1307(b), 1.1310 SAR Requirements.
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 indicate that the Apollo complies with its predetermined specifications and the applicable standards.
Conclusion: Verification and validation activities were conducted to establish the performance and safety characteristics of the Apollo. The results of these activities demonstrate that the Apollo is as safe, as effective, and performs as well as or better than the predicate devices. Therefore, the Apollo is considered substantially equivalent to the predicate devices.
Key Metrics
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).
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September 29, 2020
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
Cadwell Industries, Inc. Brad Weeks QA/RA Engineer 909 North Kellogg Street Kennewick, Washington 99336
Re: K201819
Trade/Device Name: Cadwell Apollo System Regulation Number: 21 CFR 882.1400 Regulation Name: Electroencephalograph Regulatory Class: Class II Product Code: GWQ Dated: June 30, 2020 Received: July 1, 2020
Dear Brad Weeks:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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) for
1
devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
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/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
for Jay Gupta Assistant Director DHT5A: Division of Neurosurgical, Neurointerventional and Neurodiagnostic Devices OHT5: Office of Neurological and Physical Medicine Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K201819
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) | |
|---|---|
| ------------------------------------------------- | -- |
Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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| Date Prepared: | September 29, 2020 | ||
|---|---|---|---|
| Submitter: | Cadwell Industries, Inc. | ||
| 909 North Kellogg Street | |||
| Kennewick, WA 99336 | |||
| Submitter and | |||
| Application | |||
| Correspondent | Mr. Brad Weeks | ||
| Phone: +1 (800) 245-3001, Extension 232 | |||
| Email: bradw@cadwell.com | |||
| Manufacturing Site: | Cadwell Industries, Inc. | ||
| 909 North Kellogg Street | |||
| Kennewick, WA 99336 | |||
| Trade Name: | Cadwell Apollo System | ||
| Common and | |||
| Classification | |||
| Name: | Electroencephalograph | ||
| Primary | |||
| Classification | |||
| Regulation: | 21 CFR §882.1400 | ||
| Primary Product | |||
| Code: | GWQ- Full-Montage Standard Electroencephalograph | ||
| Secondary Product | |||
| Codes & | |||
| Regulations: | GWE, GWL, OLT, OLV, OMC | ||
| 21 CFR §882.1890; 21 CFR §882.1835 | |||
| Predicate Device: | Cadwell Model | Predicate | |
| 510(k) Number | Predicate | ||
| Manufacturer / Model | |||
| Cadwell Apollo System | K180269 | Cadwell Industries Inc. / | |
| Cadwell Apollo System |
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| Device Description: | The Cadwell Apollo System (Apollo) is used 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. |
|---|---|
| The Apollo system utilizes Cadwell Arc acquisition software (previously cleared in K180269) with support for Apollo hardware using single or combinations of amplifiers, a photic stimulator, and interfaces with a Cadwell or 3rd party oximeter devices. Additional channels can be added with multiple amplifiers. | |
| Apollo is intended for use in both home healthcare and professional healthcare environments. | |
| Indications for Use: | |
| Technology | |
| Comparison: | The Apollo employs the same technological characteristics as the predicate device. |
| Characteristic | Predicate Device
K180269 | Subject Device
K201819 Cadwell Apollo System |
|------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------|
| Population | Patients of all ages. | Same. |
| 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. | Same; No changes to the IFU |
| System Configuration | Computer based equipment with dedicated hardware peripherals/components | Same. |
| Recording Modalities | Attended or unattended | Same. |
| Use Environment | Hospital or home | Same. |
| Recorder to Personal Computer (PC) Connectivity/Networking | Wired | Wired or Wireless |
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| Recorder to
Amplifier
| Connectivity | Wired | Same. |
|---|---|---|
| Amplifiers | ||
| Available | 32 channel amplifier | |
| 64 channel amplifier | Same. | |
| Oximeters | ||
| Available | No. | 3rd party or a Cadwell oximeter |
| interface compatible | ||
| Number of | ||
| Amplifiers that | ||
| can Connect to | ||
| Recorder | Two (2) | Same |
| Acquisition | ||
| Software | Arc | Same. |
| Arc Sentinel | Yes. | Same. |
| Remote | ||
| Monitoring | Yes | Same. |
| Photic Flash Rate | 1 to 60 Hz | Same. |
| Photic Interface | USB | Same. |
Summary of Performance Testing:
Software
The Arc acquisition software contains MODERATE level of concern software. Software was designed and developed according to a robust software development process, and was rigorously verified and validated. Software information is provided in accordance with internal requirements and the following guidance documents:
- FDA guidance: The content of premarket submissions for software contained in medical devices, 11 May 05.
- FDA guidance: Off-the-shelf software use in medical devices, 09 Sep ● 99.
- FDA guidance: General principles of software validation; Final ● guidance for industry and FDA staff, 11 Jan 02.
- FDA guidance: Content of premarket submissions for management of cybersecurity in medical devices, 02 Oct 14.
- IEC 62304: 2006, Medical device software Software life cycle ● processes
Test results indicate that the Arc acquisition software complies with its predetermined specifications and the applicable guidance documents.
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| Electrical Safety | The Apollo 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 complies with the applicable 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 indicate that the Apollo complies with the applicable standards. | |
| Wireless Co- | |
| existence Testing | The Apollo was tested for performance in accordance with the following standard: |
| ANSI C63.27:2017, American National Standard for Evaluation of Wireless Coexistence AIM 7351731:2017, Medical Electrical Equipment and System Electromagnetic Immunity Test for Exposure to Radio Frequency Identification Readers FCC 15C Intentional Radiators 47 CFR1.1307(b), 1.1310 SAR Requirements | |
| 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 complies with its predetermined | |
| specifications and the applicable standards. | |
| Conclusion | Verification and validation activities were conducted to establish the |
| performance and safety characteristics of the Apollo. The results of these | |
| activities demonstrate that the Apollo is as safe, as effective, and | |
| performs as well as or better than the predicate devices. | |
| Therefore, the Apollo is considered substantially equivalent to the | |
| predicate devices. |
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