The Asthmapolis System includes the Asthmapolis Sensor which is an electronic accessory device intended for single-patient use to assist physicians and patients in recording and monitoring the actuations of prescribed MDI usage.

The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.

The Asthmapolis Web Application is software intended to allow users to review the collected information and characteristics of MDI use, to add detail associated with a recorded usage event, and to share that information with their physician in order to provide additional information associated with the condition for which their MDI medication(s) are prescribed.

The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.

The output of the Asthmapolis System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The Asthmapolis system is not intended for use as a MDI medication dose counter, nor is it intended to indicate the quantity of medication remaining in an MDI.

Device Description

Electronic MDI Accessory

AI/ML Overview

The Asthmapolis System is an electronic accessory device (Asthmapolis Sensor) paired with a mobile and web application. Its intended use is to record and monitor actuations of prescribed Metered Dose Inhaler (MDI) usage for physicians and patients, and for use in clinical trials to track MDI medication use. It is not intended for diagnosis, as a MDI dose counter, or to indicate remaining medication.

The device was determined to be substantially equivalent to the SmartTrack System (K091803).

Here's an analysis of the acceptance criteria and study information provided:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria / Test	Reported Device Performance
Functional Verification & Performance (MDI Actuation Sensor)	"Non-clinical testing has been carried out to cover functional verification and device performance. This included completion of software verification and validation procedures, with performance testing of the MDI actuation sensor system to ensure data is logged accurately for MDI usage. This established correct functionality of the Asthmapolis System according to the requirements."
Software Verification & Validation	"Test results indicate that the Asthmapolis System complies with its predetermined specifications."
Electrical Safety (IEC 60601-1)	"The Asthmapolis Sensor has successfully completed patient safety testing according to IEC 60601-1."
Electromagnetic Compatibility (IEC 60601-1-2)	"The Asthmapolis Sensor has successfully completed EMC testing according to IEC 60601-1-2."
Wireless/Bluetooth Technology Performance	"The Asthmapolis System has successfully completed performance testing... for wireless/Bluetooth technology in accordance with specifications and also with, 'FDA's Guidance on Radio-Frequency Wireless Technology in Medical Devices'." Also, "tests required for FCC licensing were successful."
Equivalence to Predicate Device	"This information indicates that the Asthmapolis System is equivalent to the predicate device in terms of device safety and effectiveness. Based upon this comparison of the predicate, and the accompanying testing results for the Asthmapolis System, the Asthmapolis System is substantially equivalent to the predicate device."
Biocompatibility, Cleaning Validation	"The Asthmapolis System also meets standard requirements for... biocompatibility, cleaning validation..." (No specific performance details provided in the summary, just a statement of compliance).

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

The provided text describes non-clinical performance and engineering testing (software, electrical safety, EMC, wireless). It does not mention a "test set" in the context of patient data or clinical data. The performance testing appears to be primarily bench testing and software validation. Therefore, there is no information provided regarding a sample size for a test set of patient data, nor its provenance (country of origin, retrospective/prospective).

3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of those Experts

As the testing described is primarily non-clinical (bench, software, electrical), the concept of "ground truth" derived from expert review in a clinical context does not apply here. The "ground truth" would be related to engineering specifications and functional requirements. Therefore, no information on the number or qualifications of experts for establishing ground truth for a clinical test set is provided.

4. Adjudication Method for the Test Set

Given that the document describes non-clinical, bench, and software testing, a clinical "adjudication method" like 2+1 or 3+1 is not relevant. The verification and validation processes would involve reviewing test results against predefined specifications and requirements.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done. The device's primary function is to automatically record MDI actuations, not to aid human readers in interpreting clinical images or data in a way that would necessitate an MRMC study. The comparison is between the performance of the Asthmapolis System and its predicate device (SmartTrack System) in terms of fundamental technological characteristics and safety.

6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Study was Done

The performance testing described focuses on the standalone functionality of the device components:

MDI actuation sensor system: "to ensure data is logged accurately for MDI usage."
Software verification and validation: "device features are effective, and that the system configuration functions equivalently to the predicate device."
Wireless/Bluetooth technology: "successfully completed performance testing... in accordance with specifications."

These tests evaluate the device's ability to perform its specified functions independently (e.g., accurately detecting an MDI actuation and transmitting data). While the system is intended to assist physicians and patients, the core performance validation relates to the device's inherent functional accuracy rather than its human-in-the-loop impact. So, yes, the described performance testing reflects a standalone evaluation of the device's core functionalities.

7. The Type of Ground Truth Used

The ground truth used for these non-clinical tests would be:

Engineering Specifications/Requirements: For functional verification, software validation, electrical safety, EMC, and wireless performance, the "ground truth" is defined by the established technical specifications and performance requirements derived from applicable standards (e.g., IEC 60601-1, IEC 60601-1-2, FDA guidance for wireless technology) or internal design documentation.
Predicate Device Performance: For demonstrating substantial equivalence, the "ground truth" for comparative technological characteristics is the known performance and characteristics of the legally marketed SmartTrack System (K091803).

In summary, the ground truth is based on engineering specifications, regulatory standards, and the characteristics of the predicate device's performance.

8. The Sample Size for the Training Set

The document describes non-clinical verification and validation testing, not a machine learning model that would require a "training set" in the sense of a large dataset for algorithm development. Therefore, no information is provided regarding a sample size for a training set. The "training" here refers to the software development process aligned with specific guidelines.

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

As there's no mention of a traditional machine learning "training set" in this context, the question of how its ground truth was established is not applicable. The software development process followed established guidelines ("Design Control Guidance for Medical Device Manufacturers," "Guidance for the Content of Premarket Submissions for Software Contained in Medical Devices," "Guidance for Off the Shelf Software Use in Medical Devices," and "General Principles of Software Validation"), which define the "ground truth" for compliant and effective software.

Summary

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. JUL = =2 *2012

510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System

121609 510(k) Summary

Submission Date:	March 8, 2012
Submitter:	Reciprocal Labs Corporation612 W. Main Street, Ste. 201Madison, WI 53703
Submitter andOfficial Contact:	Ms. Inger L. CoutureChief Regulatory OfficerReciprocal Labs612 W. Main Street, Ste. 201Madison, WI 53703+1 (608) 251-0470+1 (608) 338-0883 (fax)Inger.Couture@asthmapolis.com
Manufacturing Site:	Reciprocal Labs Corporation612 W. Main Street, Ste. 201Madison, WI 53703
Trade Name:	Asthmapolis System
Common Name:	Nebulizer
ClassificationName:	NEBULIZER (DIRECT PATIENT INTERFACE)
ClassificationRegulation:	21 CFR §868.5630
Product Code:	CAF
Device Description:	Electronic MDI Accessory
SubstantiallyEquivalent Devices:	SmartTrack System	K091803

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510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System

Intended Use:

The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.

The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.

Technological characteristics of the Asthmapolis System and the SmartTrack System are largely equivalent. Similarities include the indications for use, basic principle of operation, data collection information, time of data recording via internal clock, utilization of software for varving types of data review and modification, dose counting characteristics and internal power source type.

The Asthmapolis System employs these technological characteristics in a similar way as the predicate device. Differences include the method used to detect sensor actuation, and the method used to send the usage data from the sensor to the database. These aspects of the device have been verified and validated in order to establish equivalent performance to the equivalent device. This information indicates that the Asthmapolis System is equivalent to the predicate device in terms of device safety and effectiveness.

Based upon this comparison of the predicate, and the accompanying testing results for the Asthmapolis System, the Asthmapolis System is substantially equivalent to the predicate device.

Technology Comparison:

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510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System

PerformanceTesting Summary:	Non-clinical testing has been carried out to cover functional verificationand device performance. This included completion of softwareverification and validation procedures, with performance testing of theMDI actuation sensor system to ensure data is logged accurately forMDI usage. This established correct functionality of the AsthmapolisSystem according to the requirements.
Software:	Software and Firmware for the Asthmapolis System was designed anddeveloped according to a robust software development processaligned with "Design Control Guidance for Medical DeviceManufacturers", "The Guidance for the Content of PremarketSubmissions for Software Contained in Medical Devices", "Guidancefor Off the Shelf Software Use in Medical Devices", and verified andvalidated using guidance from the "General Principles of SoftwareValidation" as recommended by FDA.Test results indicate that the Asthmapolis System complies with itspredetermined specifications.
Electrical Safety:	The Asthmapolis Sensor has successfully completed patient safetytesting according to IEC 60601-1.
ElectromagneticCompatibilityTesting:	The Asthmapolis Sensor has successfully completed EMC testingaccording to IEC 60601-1-2.
PerformanceTesting - Bench:	The Asthmapolis System has successfully completed performancetesting according to applicable standards and internal testing.Important to highlight in this summary, is the successful performancetesting that was completed for wireless/Bluetooth technology inaccordance with specifications and also with, "FDA's Guidance onRadio-Frequency Wireless Technology in Medical Devices". Inaddition, tests required for FCC licensing were successful.

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510(k) Premarket Notification Reciprocal Labs Corporation Asthmapolis System

Conclusion:

Hardware testing carried out for the Asthmapolis System indicates it meets design and performance functional requirements. Software verification demonstrates that device features are effective, and that the system configuration functions equivalently to the predicate device. The Asthmapolis System also meets standard requirements for electrical safety, electromagnetic compatibility, biocompatibility, cleaning validation, and wireless technology in medical devices.

This information indicates that the Asthmapolis System is equivalent to the predicate device in terms of device safety and effectiveness.

Based upon this comparison of the predicate, and the accompanying testing results for the Asthmapolis System, the Asthmapolis System is substantially equivalent to the predicate device.

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Image /page/4/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with three lines forming its body and wings. The eagle is facing to the right. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle.

DEPARTMENT OF HEALTH & HUMAN SERVICES

2 2012

Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002

Reciprocal Laboratories Corporation c/o Mr. Mark Job Responsible Third Party Official Regulatory Technology Services LLC 1394 25th Street NW Buffalo, Minnesota 55313

Re: K121609

Trade/Device Name: Asthmapolis System Regulation Number: 21 CFR 868.5630 Regulation Name: Nebulizer Regulatory Class: II Product Code: CAF Dated: June 18, 2012 Received: June 19, 2012

Dear Mr. Job:

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. 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 Eederal Register.

•

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Page 2- Mr. Job

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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to

http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucml 15809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.

Sincerely vours.

Rh fo.

Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known): K121609

Device Name: Asthmapolis System

Indications for use:

The Asthmapolis Mobile Application records, stores, and transmits usage events from the Asthmapolis Sensor to a remote storage system.

The Asthmapolis System may also be used in clinical trials where researchers need to know information about use of a MDI Medication(s) by a participant.

Prescription X AND/OR Use

Over-The-Counter Use

(21 CFR 801 Subpart D)

(21 CFR 801 Subpart C)

(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

510/k) Numb

L. Schultheis

sion of Anesthesiology, General Hospital

Page 1 of 1

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).