FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview

Intended Use

The BreatheSuite MDI Device is an electronic device intended for single-patient use of patients 5 years of age and older. It assists patients in recording and monitoring the actuations and technique of prescribed metered dose inhaler (MDI) usage. The BreatheSuite System is composed of the disposable, battery powered, portable BreatheSuite MDI Device and a mobile application.

The BreatheSuite MDI Device is an accessory designed to work with an MDI by attaching to the top of the canister of the inhaler. The BreatheSuite MDI Device does not interfere with regular MDI usage and can be reattached with ease. The BreatheSuite MDI Device does not actuate the inhaler but rather gathers information based on manual MDI usage.

The BreatheSuite MDI Device measures the parameters of MDI use and records them for review by the patient. The BreatheSuite application records, stores, and transmits usage events from the BreatheSuite MDI Device to a remote storage system. Furthermore, BreatheSuite MDI reminds the patient of important steps of MDI use through visual feedback in the BreatheSuite application.

The output of the BreatheSuite System is not intended to diagnose or replace a diagnosis provided by a licensed physician. The BreatheSuite 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. The BreatheSuite MDI Device is not intended to replace a physician's advice or inhaler labels; patients are expected to always follow their doctor's advice and inhaler labels.

The BreatheSuite System can be used both indoors as well as in home and work settings.

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

Device Description

The BreatheSuite MDI Device is a Metered Dose Inhaler (MDI) accessory that monitors inhaler usage and inhaler technique metrics.

The BreatheSuite MDI Device mounts on top of an MDI to measure when and how patients use their inhalers. The device uses internal sensors to record parameters of MDI use and technique including date and time of usage; MDI shaking duration; coordination between MDI actuation and the start of inhalation; and inhalation duration.

By pairing with the BreatheSuite app via Bluetooth Low Energy (BLE) communications, the user receives reports on each inhaler dosage and on their inhalation technique. The user may share their use and technique information with their physicians and/or healthcare providers.

AI/ML Overview

This document, an FDA 510(k) summary for the BreatheSuite MDI Device (K203155), does not describe a study involving an AI/algorithm to improve human reader performance or a standalone algorithm-only performance study. Instead, it focuses on demonstrating the substantial equivalence of the BreatheSuite MDI Device (a hardware accessory for Metered Dose Inhalers) to a predicate device, primarily through non-clinical performance testing.

Therefore, many of the requested details about acceptance criteria for AI and the study proving it are not present in this document.

However, I can extract the acceptance criteria and study information related to the BreatheSuite MDI Device's hardware performance and its comparison to the predicate device.

Acceptance Criteria and Device Performance (for the hardware device)

Based on the "9. Non-Clinical Performance Testing" and "13. Conclusion - Statement of Substantial Equivalence" sections, here's a table summarizing the acceptance criteria (inferred from the testing performed to show equivalence) and the reported device performance:

Acceptance Criterion (Inferred)	Reported Device Performance
Biocompatibility: Device components in contact with the user should be biocompatible according to ISO 10993 standards.	The biocompatibility evaluation for the BreatheSuite MDI Device was conducted in accordance with FDA guidance Use of International Standard ISO 10993-1. It met requirements from:

ISO 10993-1:2009 (biocompatibility)
ISO 10993-5:2009 (cytotoxicity)
ISO 10993-10:2010 (sensitization and intracutaneous irritation). |
| Electrical Safety: Device must comply with general and home-use electrical safety standards. | The device complies with:
IEC 60601-1:2012 (general safety)
IEC 60601-1-11:2015 (home-use safety). |
| Electromagnetic Compatibility (EMC): Device must comply with EMC standards. | The device complies with:
IEC 60601-1-2:2014 Ed 4.0
FCC Part 15 Subpart B & ICES-003:2019 (electromagnetic compatibility). Information was provided according to FDA guidance. |
| Software Functionality: Software components should be verified and validated for correct functionality and cybersecurity. | Software verification and validation testing was conducted to ensure correct functionality for the BreatheSuite MDI software release, for all software components. Documentation was provided as recommended by FDA guidances. "Software verification demonstrates that the device should perform as intended in the specified use conditions, and equivalently to the predicate for common software functions." |
| Delivered Dose Uniformity (DDU) & Aerosol Particle Size Distribution (APSD): The device should not adversely affect drug delivery. | DDU and APSD testing confirmed that the addition of the BreatheSuite MDI Device does not have an effect on medication delivery for compatible MDIs. "Inhaler usage parameters are measured with sufficient accuracy for monitoring inhaler use, and the addition of the new sensors does not adversely affect use of the inhaler." |
| Battery Performance (Shelf Life): Battery shelf life should be substantially equivalent to the predicate. | Battery performance (Shelf Life) testing confirmed substantial equivalence to the shelf life of the predicate. |
| MDI Compatibility: Compatibility with MDIs should be equivalent to the predicate. | MDI Compatibility testing confirmed substantial equivalence to the predicate in terms of compatible MDIs. |
| Dose Counting: The device should not inhibit the dose counter on compatible MDIs. | Dose counting testing confirmed the BreatheSuite MDI Device does not inhibit the dose counter on any compatible metered dose inhaler. |
| Depression Force: The device should not change the actuation force of compatible MDIs. | Depression Force Testing confirmed the BreatheSuite MDI Device does not change the force required to actuate any compatible metered dose inhaler. |
| Device Fit and Label Obscuration: The device should not permanently obscure the MDI label. | Device Fit and Label Obscuration testing confirmed the BreatheSuite MDI Device does not permanently obscure the MDI label. |
| Technique Measurement: The device should obtain and record correct technique information (shaking, orientation timing, inhalation duration). | Technique Measurement testing confirmed the BreatheSuite MDI Device obtains and records correct technique information including inhaler shaking, orientation timing and inhalation duration for all compatible MDIs according to requirements. |
| Usability: The device should be safely and effectively usable, with critical tasks evaluated. | Usability evaluation was carried out to evaluate use scenarios and critical tasks, and established validity of the results obtained from testing carried out in accordance with FDA guidance. "The usability evaluation indicates there are no issues for successful use with the compatible inhaler." |
| OTC Validation: For Over-The-Counter use, the device and labeling should provide necessary information and not introduce new safety concerns. | Validation testing confirmed the device and its provided OTC labeling provided all necessary information to support over-the-counter use. Hazard Analysis for OTC identified no new safety concerns related to patient interaction with the system (obtaining, learning, registering, installing, using, reviewing data, support). |

Here's the information regarding the study design based on the provided text:

1. A table of acceptance criteria and the reported device performance: (See table above)
2. Sample size used for the test set and the data provenance:
- The document states "Non-clinical testing and evaluation of the BreatheSuite MDI has been completed..." and lists various tests (Biocompatibility, Electrical Safety, EMC, Software V&V, Performance Testing, Usability).
- Specific sample sizes for each test are NOT provided in this summary. For example, it does not state how many devices were tested for DDU, or how many users were in the usability study.
- Data Provenance: The studies were non-clinical, likely conducted in laboratories by the manufacturer or external labs. No information is provided about the country of origin of testing data, or if it was retrospective/prospective studies on patient data as it's a hardware device performance study, not a clinical data study of an AI.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable in the context of this 510(k) summary. This document describes performance testing of a physical device and its software's functionality, not an AI interpreting medical images or clinical data. Ground truth for the tests (e.g., whether DDU is affected, if a button registered a press) would be established by the test protocols and instrument readings, not expert consensus on medical interpretation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not applicable. This is not a study involving human interpretation or adjudication of outputs.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- No, an MRMC comparative effectiveness study was not done. This 510(k) is for a hardware device accessory to an MDI, not an AI diagnostic tool that assists human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- While the device has software and "technique measurement" capabilities, the 510(k) does not present these as a standalone AI algorithm that would typically undergo such a performance evaluation (e.g., an algorithm diagnosing a condition). The "standalone" performance here refers to the device's ability to accurately capture defined parameters (shaking, orientation, inhalation duration), which was validated through "Technique Measurement testing." The summary conclusion states: "Inhaler usage parameters are measured with sufficient accuracy for monitoring inhaler use."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- For the physical device and its software functionality, the "ground truth" would be established by:
  - Standardized test methods and calibrated equipment: For tests like DDU, APSD, electrical safety, EMC, depression force, etc., the "ground truth" is derived from measurements against established metrological standards and limits.
  - Design requirements/specifications: For software verification and validation, the ground truth is whether the software performs according to its documented requirements.
  - Observed behavior: For usability, the ground truth relates to successful completion of tasks and identification of use errors, which are observed and evaluated against predefined criteria.
8. The sample size for the training set:
- Not applicable. There is no mention of a "training set" in the context of machine learning/AI for this device. The software "learns" from sensors, not a large training dataset.
9. How the ground truth for the training set was established:
- Not applicable, as there is no mention of a training set for an AI/ML model.

§ 868.5630 Nebulizer.