(90 days)
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.
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.
The provided text does not contain information about acceptance criteria and a study that proves the device meets those criteria in the context of an AI/ML powered device. The document is a 510(k) premarket notification for the Cadwell Apollo System, an electroencephalograph, and focuses on demonstrating substantial equivalence to a predicate device through engineering and software testing for safety and performance against established standards.
Therefore, the requested table and detailed information regarding acceptance criteria, device performance, sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, ground truth, and training set details for an AI/ML component cannot be extracted from this document. The document describes traditional device testing, not AI/ML model validation.
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September 29, 2020
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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
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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 StreetKennewick, WA 99336 | ||
| Submitter andApplicationCorrespondent | Mr. Brad WeeksPhone: +1 (800) 245-3001, Extension 232Email: bradw@cadwell.com | ||
| Manufacturing Site: | Cadwell Industries, Inc.909 North Kellogg StreetKennewick, WA 99336 | ||
| Trade Name: | Cadwell Apollo System | ||
| Common andClassificationName: | Electroencephalograph | ||
| PrimaryClassificationRegulation: | 21 CFR §882.1400 | ||
| Primary ProductCode: | GWQ- Full-Montage Standard Electroencephalograph | ||
| Secondary ProductCodes &Regulations: | GWE, GWL, OLT, OLV, OMC21 CFR §882.1890; 21 CFR §882.1835 | ||
| Predicate Device: | Cadwell Model | Predicate510(k) Number | PredicateManufacturer / 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: | |
| TechnologyComparison: | The Apollo employs the same technological characteristics as the predicate device. |
| Characteristic | Predicate DeviceK180269 | Subject DeviceK201819 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 toAmplifierConnectivity | Wired | Same. |
|---|---|---|
| AmplifiersAvailable | 32 channel amplifier64 channel amplifier | Same. |
| OximetersAvailable | No. | 3rd party or a Cadwell oximeterinterface compatible |
| Number ofAmplifiers thatcan Connect toRecorder | Two (2) | Same |
| AcquisitionSoftware | Arc | Same. |
| Arc Sentinel | Yes. | Same. |
| RemoteMonitoring | 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. | |
| ElectromagneticCompatibility | 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 | |
| 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 complies with its predeterminedspecifications and the applicable standards. | |
| Conclusion | Verification and validation activities were conducted to establish theperformance and safety characteristics of the Apollo. The results of theseactivities demonstrate that the Apollo is as safe, as effective, andperforms as well as or better than the predicate devices. |
| Therefore, the Apollo is considered substantially equivalent to thepredicate devices. |
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§ 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).