The CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician.

The CapMedic device is an accessory intended for single-patient use to assist physicians and patients in recording and monitoring the MDI (Metered Dose Inhaler) actuations and conducting PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume for 1 second) spirometry tests. CapMedic measures of MDI use and records it for review by the physician and/or the patient. Furthermore, CapMedic reminds the patient on important steps of MDI use through audio-visual-haptic cues during their MDI use. With the provided PEF/FEV 1 adapter, CapMedic can also perform PEF/FEV1 spirometry test and provides LED feedback based on the measured FEV1. CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection.

CapMedic can be used in the home, work, healthcare, and clinical use environments/settings.

The CapMedic device may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant.

CapMedic may be used with any of the following MDIs: Ventolin HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, and Asmanex HFA and is attached with a specific adapter for the MDIs.

Device Description

The CapMedic device includes a reusable sensing module that attaches to the Metered Dose Inhaler (MDI) to measure when and how patients use their inhalers. CapMedic has on-board visual, audio and haptic user interfaces (Uls) to remind patients to use their inhaler correctly through Ul prompts. The recorded parameters of MDI use are MDI shaking, orientation, coordination between MDI actuation and the start of inspiration, and inhalation duration. During MDI use, CapMedic can provide just-in-time reminders, in the form of Ul prompts, for various steps of MDI use, namely, MDI shaking, MDI upright orientation, correct coordination, breathe long and hold breath at the end. CapMedic also optionally provides dosing reminders through UI prompts at times preset by the user.

Further, CapMedic has a built-in peak-flow meter functionality with a separate mouthpiece attachment to the bottom of the sensing module to measure peak expiratory flow (PEF) and forced expiratory volume in 1 second (FEV1). CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection. The CapMedic is powered by a rechargeable Lithium Polymer battery and can be charged via a micro-USB cable.

AI/ML Overview

Here's a summary of the acceptance criteria and study information for the CapMedic device, based on the provided FDA 510(k) summary:

Acceptance Criteria and Device Performance for CapMedic (K183586)

1. Table of Acceptance Criteria and Reported Device Performance

The FDA 510(k) summary does not explicitly list numerical acceptance criteria with corresponding device performance metrics in a table format. Instead, it broadly states that extensive testing was conducted to demonstrate performance and substantial equivalence to predicate devices. The document indicates that the device's performance benchmarks were met for MDI use measurement and lung function parameters.

Therefore, the acceptance criteria are implicitly defined by the successful demonstration of:

MDI use measurement parameters: MDI shaking, orientation, coordination between MDI actuation and start of inspiration, and inhalation duration.
Lung function parameters: Peak Expiratory Flow (PEF) and Forced Expiratory Volume in 1 second (FEV1), measured according to ATS guidance.
Compatibility: Aerosol Particle Size Distribution (APSD) and Delivered Drug Uniformity (DDU) with specified MDIs.
Safety: Biocompatibility (ISO 10993-1) and electrical requirements (IEC 60601-1, IEC 60601-1-2, IEC 60601-1-11, IEC 60601-1-8, IEC 60601-1-6).
Connectivity and Security: Bluetooth data transfer complying with "Radio Frequency Wireless Technology in Medical Devices guidance" and "Management of Cybersecurity in Medical Devices" guidance.
Usability, Software, and System Verification.

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state the sample size used for the test set in terms of patient data. The provided information focuses on nonclinical testing (bench testing):

MDI use measurement parameters and UI: "extensively tested to demonstrate the performance and substantial equivalence." No specific number of tests or samples (e.g., number of MDI actuations or inhalers) is provided.
Lung function parameters: "tested according to the ATS guidance on standardization of spirometry, published in 2005." This implies adherence to a standard, but doesn't specify the number of tests or subjects.
Aerosol Particle Size Distribution (APSD) and Delivered Drug Uniformity (DDU) tests: Conducted to demonstrate compatibility with supported MDIs. No specific number of MDIs or tests specified.
Biocompatibility tests: Conducted and passed according to ISO 10993-1.
Electrical requirements tests: Conducted for IEC 60601 series standards.
Bluetooth data transfer and interfaces tests: Conducted to comply with FDA guidance.
Usability testing, software, and system verification: Conducted.

Data Provenance: All listed tests are "nonclinical tests," indicating they were likely conducted in a laboratory or simulated environment, rather than with human subjects in a clinical setting. No country of origin is specified for these tests, but the company is US-based. These appear to be prospective tests conducted for the purpose of the 510(k) submission.

3. Number of Experts Used to Establish Ground Truth and Qualifications

This information is not provided in the document. As the listed tests are primarily nonclinical (bench tests), the concept of "experts establishing ground truth for a test set" in a clinical sense (e.g., radiologists interpreting images) is not directly applicable. The "ground truth" for these tests would be defined by the specifications of the MDI device, spirometry standards (ATS), biocompatibility standards (ISO), and electrical/connectivity standards (IEC, FDA guidance).

4. Adjudication Method for the Test Set

This information is not provided and is not typically applicable to nonclinical bench testing. Adjudication methods like 2+1 or 3+1 are used in clinical studies for resolving discrepancies among expert readers, which was not performed here.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

No. The document explicitly states: "Clinical testing was not required to determine substantial equivalence of CapMedic." Therefore, an MRMC comparative effectiveness study was not conducted.

6. Standalone (Algorithm Only) Performance

The device is a physical accessory with sensors and embedded logic, not a pure "algorithm only" device in the typical sense (e.g., AI for image analysis). Its performance is inherently linked to its interaction with the MDI and the patient. However, the nonclinical testing described (e.g., MDI use measurement parameters, lung function parameters) reflects the device's standalone technical performance in measuring and recording these physical parameters, independent of human interpretation or assistance beyond operating the device. The reported "performance bench-marked" indicates its technical accuracy in these measurements.

7. Type of Ground Truth Used

The ground truth for the nonclinical tests was based on:

Industry Standards: ATS guidance on standardization of spirometry, ISO 10993-1 for biocompatibility, IEC 60601 series for electrical requirements, and FDA guidance for wireless technology and cybersecurity.
Device Specifications/Engineering Standards: For MDI use measurement parameters (shaking, orientation, coordination, inhalation duration) and compatibility with MDIs (APSD, DDU).
Pre-defined Parameters: For usability testing, software, and system verification, where ground truth would be adherence to design specifications and user requirements.

8. Sample Size for the Training Set

This information is not provided. The document describes performance testing for regulatory submission rather than a machine learning model development process that typically involves a distinct training set. The device's functionality appears to be based on embedded logic and sensor interpretation rather than a learned AI model that requires a "training set" in the common sense.

9. How the Ground Truth for the Training Set Was Established

As no "training set" in the context of machine learning is explicitly mentioned or implied, this question is not applicable. The device's operation is based on pre-programmed algorithms and sensor thresholds, not a learned model from a data training set.

Summary

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September 13, 2019

Cognita Labs, LLC Rajoshi Biswas Architect and Clinical Lead 700 N Main St. Ste C1 Santa Ana, California 92701

Re: K183586

Trade/Device Name: CapMedic Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: Class II Product Code: CAF, BZG Dated: August 14, 2019 Received: August 15, 2019

Dear Rajoshi Biswas:

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

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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for 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 (QS) 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 mediation-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,

James Lee Assistant Director DHT1C: Division of ENT, Sleep Disordered Breathing, Respiratory and Anesthesia Devices OHT1: Office of Ophthalmic, Anesthesia, Respiratory, ENT and Dental 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) K183586

Device Name CapMedic

Indications for Use (Describe)

The CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician.

CapMedic can be used in the home, work, healthcare, and clinical use environments/settings.

The CapMedic device may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant.

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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K183586 510(k) Summary

Image /page/3/Picture/2 description: The image shows the logo for Cognita Labs. The word "Cognita" is written in blue, except for the "o", which is a green drawing of a brain. Below the word "Cognita" is the word "Labs" in gray.

September 13th, 2019 Cognita Labs, LLC 700 N Main St. Ste C1 Santa Ana CA 92701 info@cognitalabs.com

This summary of 510(k) information is submitted in accordance with the requirements of 21 CFR 807.92:

(a)(1) Submitter Information

Company	Cognita Labs LLC700 N Main St Ste C1Santa AnaCalifornia 92701
Contact Person	Rajoshi Biswas, Architect and Clinical Lead
Telephone #	+1-832-538-3042
Date of preparation	September 13, 2019

(a)(2) Name of the Device

Device Name	CapMedic
Common Name	Inhaler Guidance Tool and Home Spirometer (PEF/FEV1)
Product Code andClassification Name	Primary product code: CAF, 21 CFR 868.5630, Class II, NebulizerSecondary product code: BZG, 21 CFR 868.1840, Class II, Diagnostic spirometer

(a)(3) An identification of the legally marketed devices

The predicate devices to which substantial equivalence is claimed are: K990185, MDLog System MDC-512 marketed by Medtrac Technologies, Inc., K140638, Propeller Model 2 Sensor marketed by Reciprocal Labs Corporation, and K133722 Asthma Monitor AM3 GSM (PEF and FEV1 meter) marketed by eResearchTechnology.

(a)(4) A description of the device

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(a)(5) Intended use of the device

The CapMedic is intended to be used in adults and children 5 years of age and above, who are prescribed CapMedic to be used with their MDIs by their physician.

The CapMedic device is an accessory intended for single-patient use to assist physicians and patients in recording and monitoring the MDI (Metered Dose Inhaler) actuations and conducting PEF (Peak Expiratory Flow) and FEV1 (Forced Expiratory Volume for 1 second) spirometry tests. CapMedic measures the parameters of MDI use and records it for review by the physician and/or the patient. Furthermore, CapMedic reminds the patient on important steps of MDI use through audio-visual-haptic cues during their MDI use. With the provided PEF/FEV1 adapter, CapMedic can also perform PEF/FEV1 spirometry test and provides LED feedback based on the measured FEV1. CapMedic can securely transmit MDI usage data and PEF/FEV1 test results to a Bluetooth enabled device running data collection software meeting the CapMedic secure interface protocol over a Bluetooth connection.

CapMedic can be used in the home, work, healthcare, and clinical use environments/settings.

The CapMedic device may also be used in clinical trials where researchers need to know information about the use of MDI medication(s) by a participant.

CapMedic may be used with any of the following MDIs: Ventolin HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA, and Asmanex HFA and is attached with a specific adapter for the MDIs.

(a)(6) Technological Characteristics

The CapMedic device is technologically equivalent to the three predicates identified above for the three main functions, MDI use measurement, lung function measurement, and data transfer. For the MDI use measurement functions, the CapMedic is similar to both MDLog system and Propeller sensors for monitoring MDI medication use. Both predicates and CapMedic measure the timestamp of MDI use. MDILog also measures MDI use parameters such as MDI shaking, canister actuation and inhalation, all of which are also measured by CapMedic. All devices are battery-powered. Further, both the Propeller device and CapMedic transfer data using Bluetooth Low Energy. The Asthma Monitor measures spirometry parameters of PEF and FEV1, is battery powered and transfers data through Bluetooth Low Energy, same as CapMedic.

The CapMedic device measures the MDI orientation as an additional parameter of MDI use as compared with MDILog. Further, CapMedic also provides UI prompts to remind the user of the correct steps for MDI use and contains a rechargeable battery. All of these parameters were extensively tested, the performance bench-marked and thorough risk analysis conducted to demonstrate that the difference does not affect the substantial equivalence.

(b) 510(k) summaries for those premarket submissions in which a determination of substantial equivalence is also based on an assessment of performance data shall contain the following information:

(1) A brief discussion of the nonclinical tests submitted:

The MDI use measurement parameters and UI are tested extensively to demonstrate the performance and substantial equivalence.
The lung function parameters measured by CapMedic have been tested according to the ATS guidance on standardization of spirometry, published in 2005.
The Aerosol Particle Size Distribution (APSD) and Delivered Drug Uniformity (DDU) tests have been conducted to demonstrate the compatibility of CapMedic's use with the supported MDIs.
· Biocompatibility tests have been conducted and passed according to ISO 10993-1.

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CapMedic has been tested for the electrical requirements: IEC 60601-1:2005 + A1:2012, IEC 60601-1-2:2014, IEC 60601-1-11:2015, IEC 60601-1-8:2006+AMD1:2012, and IEC 60601-1-6:2010+AMD1:2013.
Bluetooth data transfer and interfaces are tested to comply with "Radio Frequency Wireless Technology in Medical Devices guidance for industry and FDA, 2013" and FDA's guidance on "Management of Cybersecurity in Medical Devices, 2014".
· Additionally, usability testing, software, and system verification activities have been conducted.

The tests demonstrate the performance and compatibility of CapMedic with the MDIs Ventolin HFA, ProAir HFA, Advair HFA, Flovent HFA, Xopenex HFA, Symbicort HFA, Atrovent HFA, Proventil HFA, Alvesco HFA, Dulera HFA and Asmanex HFA.

(2) A brief discussion of the clinical tests submitted

Clinical testing was not required to determine substantial equivalence of CapMedic.

(3) The conclusions drawn from the nonclinical and clinical tests

Based upon the foregoing performance testing and comparison to the legally marketed predicate devices for indications for use, technology, and performance it is demonstrated that the CapMedic is substantially equivalent to the predicates.

Regulation Number and Section

§ 868.5630 Nebulizer.

(a)
Identification. A nebulizer is a device intended to spray liquids in aerosol form into gases that are delivered directly to the patient for breathing. Heated, ultrasonic, gas, venturi, and refillable nebulizers are included in this generic type of device.(b)
Classification. Class II (performance standards).