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510(k) Data Aggregation
(424 days)
The I-neb AAD system with TIM is a nebulizer system designed to aerosolize liquid medication for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
The I-neb Insight AAD System is monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician. It is an accessory to an accessory for use with the I-neb AAD system.
The I-neb AAD system with TIM is intended for patients 3 years and older who can coordinate breathing.
The I-neb AAD System is an ultrasonic (vibrating mesh) nebulizer system designed to aerosolize liquid medication (except pentamidine) for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment.
The I-neb Insight AAD System is an accessory for use with the I-neb AAD system and controls monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician.
The I-neb AAD system with TIM incorporates a modification of the predicate I-neb AAD system with (tidal breathing mode (TBM)), K042991. While the I-neb Insight incorporates updated software to accommodate the added TIM feature, it is a modification of the predicate I-neb Insight AAD System, K052941.
The provided text describes a 510(k) summary for the I-neb AAD Systems with TIM and I-neb Insight AAD System. The primary method for demonstrating substantial equivalence is through comparative bench testing against predicate devices. The document does not describe a study in the context of AI/ML device performance, as it is a medical device from 2011, long before the widespread use of AI in medical imaging. Therefore, many of the questions related to AI device performance are not applicable.
Here's an analysis based on the provided text:
Acceptance Criteria and Reported Device Performance
The acceptance criteria for this device are implicitly tied to demonstrating substantial equivalence to existing predicate devices (K062263 – Omron U-22, K870027 - Salter 8900 nebulzier, K072019 - Activaero - AKITA2 APIXNEB, K042991 - I-neb AAD, K052491 - I-neb Insight). The "acceptance criteria" are not explicitly stated as numerical thresholds but rather as the proposed device exhibiting comparable performance characteristics to the predicates in specific areas.
| Acceptance Criteria (Implied by Substantial Equivalence) | Reported Device Performance (I-neb AAD with TIM & I-neb Insight AAD) |
|---|---|
| Particle Characterization (MMAD, GSD, Respirable Fraction %) comparable to predicates. | "Comparison of particle characterization testing included the evaluation of MMAD, GSD, Respirable Fraction (%) the predicates and the proposed device were found to be substantially equivalent." |
| Comparative Dosing (gravimetric dose, Filter dose, Treatment time) equivalent to predicates. | "Comparative Dose for the I-neb AAD system in TBM vs. TIM mode and to the predicates Omron U22 (K062263) and Salter 8900 (K870027) was performed. Parameters measured and compared included gravimetric dose, Filter dose and Treatment time. Results the predicates and the proposed device were substantially equivalent." |
| Indications for Use for general purpose nebulization (I-neb AAD with TIM) and monitoring accessory (I-neb Insight AAD). | I-neb AAD with TIM: "General Purpose use." "a nebulizer system designed to aerosolize liquid medication for inhalation by the patient in the home care, nursing home, sub-acute institution, or hospital environment." |
| I-neb Insight AAD: "monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician." | |
| Technology: Vibrating mesh nebulizer and breath-triggered nebulization. | "Identical vibrating mesh nebulizer technology to predicates." "Identical breath triggered nebulization technology to predicate." |
| Materials: Gas and fluid pathway materials identical to predicate I-neb AAD. | "The materials in the gas and fluid pathway are identical to predicate device - K042991 -- I-neb AAD System." |
| Environment of Use: Home care, nursing home, sub-acute institution, or hospital environment. | "Identical to predicate." |
| Patient Population: 3 years and older who can coordinate breathing. | "Identical to predicates." |
| I-neb Insight Technology/Indications: Monitoring software and feedback. | "Identical technology to predicate - K052491 - I-neb Insight AAD system." "The I-neb Insight is monitoring software that provides feedback to the patient recording treatment events, including treatment times and compliance data which is also available to the clinician." |
Study Details:
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Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- The document mentions "3 drugs" were used for particle characterization.
- The testing was "performed at flow rates of 15 lpm and 30 lpm."
- The sample sizes for "comparative dosing" are not explicitly stated, but it was done between the I-neb AAD system in TBM vs. TIM mode and compared to Omron U22 and Salter 8900.
- This was bench testing, not human clinical data. Therefore, the concept of "country of origin for data" or "retrospective/prospective" human data does not apply here.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
- Not applicable. This submission relies on bench testing, not expert-adjudicated ground truth from human data for AI/ML performance.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This was bench testing, not a human consensus or adjudication study.
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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. This is a 2011 submission for a nebulizer, not an AI/ML diagnostic tool. An MRMC study was not conducted, nor would it be relevant for this device.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device is a nebulizer system, not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The "ground truth" for this submission are the performance specifications and characteristics of the predicate devices, against which the proposed device's bench test results (e.g., MMAD, GSD, gravimetric dose) were compared to demonstrate substantial equivalence.
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The sample size for the training set
- Not applicable. This device does not involve an AI/ML algorithm requiring a training set.
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How the ground truth for the training set was established
- Not applicable. This device does not involve an AI/ML algorithm.
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(213 days)
The intended use of the Happyneb II. Happyneb III. Speedy, Nebby Plus and the Myneb is to spray liquids in aerosol form into gases that are delivered directly to adult or pediatric patients who have been prescribed inhalation therapy or medication. Each of these devices must be used exclusively with their own nebulizer and mouthpiece.
The devices Happyneb II, Happyneb III, Speedy, and the Nebby Plus are intended to be used primarily by patients in the home care market, although they may also be used by trained hospital staff personnel as well. The Myneb model is intended to be used only in home health care.
The Happyneb II, Happyneb III. Speedy, Nebby Plus and the Myneb are intended for multiple use, are non-sterile and for use with pharmaceutical products which are under physician prescription.
The family of 3A Health Care nebulizers include 5 different devices: 4 are AC powered devices (Happyneb II, Happyneb III, Speedy, Nebby Plus) and one model (Myneb) with a DC motor, a rechargeable battery pack and an external charger/power supplier.
The 4 AC compressors (Happyneb II, Happyneb III, Speedy, and Nebby Plus) have different plastic housings. There are three different types of electrical motors for AC models and one type for the DC model (Myneb). The 5 models of compressors are designed to use two nebulizers, the Fasterjet and Nebjet.
The provided text is for a 510(k) Summary for nebulizers. Nebulizers are medical devices used to deliver medication to the respiratory system. The submission focuses on demonstrating substantial equivalence to predicate devices based on performance bench tests, not on diagnostic accuracy or clinical outcomes as would be typical for many AI-powered medical devices. Therefore, many of the requested categories related to AI performance, expert review, and clinical studies are not applicable or not detailed in this document.
Here's an analysis based on the provided text:
Acceptance Criteria and Study to Prove Device Meets Acceptance Criteria
The acceptance criteria for these nebulizers are based on demonstrating equivalent performance parameters to legally marketed predicate devices through non-clinical bench tests. The study performed aimed to show this equivalency.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Acceptance Criteria (Equivalent to predicate devices) | Reported Device Performance (as demonstrated by tests) |
|---|---|---|
| Aerosol Particle Size | Equivalent Mass Median Aerodynamic Diameter (MMAD) to predicate devices | Demonstrated equivalent MMAD |
| Particle Size Distribution | Equivalent Geometric Standard Deviation (GSD) to predicate devices | Demonstrated equivalent GSD |
| Fine Particle Fraction | Equivalent Fine Particle Fraction (FPF) to predicate devices | Demonstrated equivalent FPF |
| Fine Particle Dose | Equivalent Fine Particle Dose (PFD) to predicate devices | Demonstrated equivalent PFD |
| Clinical Efficacy | Clinical data not required due to demonstrated equivalent performance parameters to predicate devices. | (No clinical data presented) |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify a "sample size" in the context of patients or data points, as the testing was non-clinical performance bench tests. The data provenance is from 3A Health Care Srl, the submitter, and the tests were executed as requested in the "Reviewer guidance for nebulizers, metered dose inhalers, spacers and actuators" issued in October 1993. These were prospective bench tests conducted on the newly designed nebulizer models.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. This was a non-clinical bench test study evaluating physical performance parameters of a medical device, not a diagnostic or AI-powered system that requires expert interpretation to establish ground truth.
4. Adjudication Method for the Test Set
Not applicable. As stated above, this was a bench test, not a study requiring adjudication of expert opinions or interpretations.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study was Done
No. This was not an MRMC study. The comparison was device-to-device (new nebulizer models to predicate nebulizer models) based on physical performance parameters, not an evaluation of human reader performance with or without AI assistance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. This device is a nebulizer, not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" in this context refers to the established performance benchmarks and specifications for nebulizer characteristics (MMAD, GSD, FPF, PFD) as defined by regulatory guidance and demonstrated by legally marketed predicate devices. The new devices' performance was measured and compared against these established physical and functional parameters.
8. The Sample Size for the Training Set
Not applicable. This document describes a medical device, not an AI model, and therefore there is no concept of a "training set" for an algorithm.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set, this question is not relevant to the provided document.
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(90 days)
The Model 8660 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a reusable single patient use device (whereas the 8900 is a disposable single patient use device) which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted . It does not use software, nor is it sterile, although it must be cleaned or disinfected per the label instructions before reuse. The device is for single patient use. It is intended to be used with accessories, such tubing which is an industry standard device used with nebulizers.
Each of the Salter Labs 8660 Series Nebulizers consists of a Nebulizer Top which is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. Liquids to be nebulized are placed in the nebulizer cup. The nebulizer housing is then applied, and the supply line for the nebulizing gas source is then connected to the bottom of the nebulizer cup. After the pressurized nebulizing gas is applied to the nebulizer, the solution in the cup is nebulized and pushed from the unit in aerosol form that can be inhaled by the patient.
This 510(k) summary does not contain information regarding acceptance criteria or a study proving the device meets said criteria. It outlines the device's purpose, identification, predicate device comparison, and intended use, but lacks details on performance metrics or validation studies typically found in such reports.
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(89 days)
The Model 8960 Series Nebulizers have the same intended use as their predicate device, The Salter Model 8900 Nebulizer, which was cleared for marketing by 510(k) No. K870027. The nebulizer is a disposable device which is used where liquids are to be delivered to a patient in an aerosol form. The device is not life-supporting or life-sustaining, nor is it implanted . It does not use software, nor is it sterile. The device is for single patient use. It is intended to be used with accessories, such as masks and tubing which are industry standard devices used with nebulizers.
Each of the Salter Labs 8960 Series Nebulizers consists of a Nebulizer Top which is screwed onto a Nebulizer Cup. The bottom of the cup has a fitting to accept a source of nebulizing gas. Liquids to be nebulized are placed in the nebulizer cup. The nebulizer housing is then applied, and the supply line for the nebulizing gas source is then connected to the bottom of the nebulizer cup. After the pressurized nebulizing gas is applied to the nebulizer, the solution in the cup is nebulized and pushed from the unit in aerosol form that can be inhaled by the patient.
The provided text is a 510(k) summary for a medical device (nebulizer). It does not contain information about acceptance criteria, performance studies, or any of the other requested details regarding an AI/ML medical device.
The document describes a mechanical device (nebulizer) and compares it to a predicate device, focusing on its physical characteristics and intended use. There is no mention of algorithms, software, AI, or any data analysis that would require the information requested in your prompt (e.g., sample sizes, expert ground truth, adjudication methods, MRMC studies, training sets).
Therefore, I cannot fulfill your request based on the provided input.
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