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510(k) Data Aggregation
(164 days)
The Portable Nebulizer (MBPN002) is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatric (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
The Portable Nebulizer (MBPN002) is a small, handheld general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The provided text describes a 510(k) submission for a modified Portable Nebulizer (MBPN002). This submission does not include a study involving AI, human readers, or a test set as would typically be described for an AI/ML device.
The "acceptance criteria" discussed are primarily related to performance specifications and compliance with standards for a medical device, rather than the performance of an AI algorithm based on a test set. The "study" mentioned is a set of non-clinical performance tests and verifications to demonstrate that the modified device is substantially equivalent to its predicate.
Here's an analysis based on the provided text, addressing the requested points where applicable, and noting when information is not present:
1. Table of Acceptance Criteria and Reported Device Performance
Note: The acceptance criteria here are drawn from the performance specifications and the "Comparison to Predicate" table, which highlight what the device should do, and the "reported device performance" is essentially the confirmation that it meets these as identical to the predicate or through specific tests.
| Acceptance Criteria (from Predicate/Modified Device Specifications) | Reported Device Performance (as demonstrated by testing/comparison) |
|---|---|
| Indications for use remain identical: Aerosolize liquid medications for inhalation by pediatric (5+ years) and adult patients in hospital/institutional, home care, school, and long-term care facilities. | Identical to predicate K170916. |
| Patient Population remains identical: Pediatric (5+ years) and adult patients. | Identical to predicate K170916. |
| Environment of Use remains identical: Hospital/institutional, home care, schools, and long-term care facilities. | Identical to predicate K170916. |
| Contraindications remain identical: None. | Identical to predicate K170916. |
| Principle of Operation remains identical: Vibrating mesh technology. | Identical to predicate K170916. |
| Aerosolization remains identical: Continuous during inhalation and exhalation. | Identical to predicate K170916. |
| Compressed gas source: None needed. | Identical to predicate K170916. |
| Reservoir volume: 6 ml. | Identical to predicate K170916. |
| Nebulization rate: > 0.25 ml/min. | Identical to predicate K170916. Particle characterization and nebulization rate are unchanged as the main unit operates at a consistent 15V. |
| Duration of Use: Single patient, multi-use. | Identical to predicate K170916. |
| Nebulizer components cleanable: Yes. | Identical to predicate K170916. Cleaning and disinfection validated. |
| Software driven: Yes (firmware). | Identical to predicate K170916. |
| Power source: 2 "AA" batteries OR external Class II IEC 60601-1 compliant supply. | The modified device adds external power, but "no change to device performance" is noted due to controlled 15V operation. Electrical safety and EMC testing confirmed compliance with relevant standards (ANSI/AAMI/ES 60601-1, IEC 60601-1-2, IEC 60601-1-11). |
| Power consumption: < 1.5 W. | Identical to predicate K170916. |
| Weight: 74 gm w/o batteries. | Identical to predicate K170916. |
| Dimensions (mm): 77 x 41 x 73. | Identical to predicate K170916. |
| Operating Conditions: 10 to 40°C / 30-85% RH. | Identical to predicate K170916. |
| Storage Conditions: -20 to + 70°C / 20-75% RH. | Identical to predicate K170916. |
| User interface: On/Off switch, LED indicators. | Identical to predicate K170916. |
| Standards met: ANSI/AAMI/ES60601-1, IEC 60601-1-2, IEC 60601-1-6, IEC 60601-1-11. | Electrical safety and EMC testing confirmed compliance (ANSVAAMI/ES 60601-1:2005+A1:2012; IEC 60601-1-2:2014; IEC 60601-1-11:2015). |
| Biocompatibility (ISO 10993-1): External Communicating (Indirect gas pathway), Tissue/Bone/Dentin communicating (permanent), Surface Contact (Mucosal membrane, permanent). | Cytotoxicity, Sensitization, Irritation, Sub-chronic Systemic toxicity, Acute Systemic Toxicity, Leachable and Extractables, Gas Emission (VOC, Inorganic compounds, PM2.5) concluded biocompatible. |
| Cleaning and Disinfection: Effective manual cleaning and thermal disinfection. | Validation confirmed effective cleaning and disinfection by listed methods. |
| Particle Characterization (MMAD): Equivalent to predicate. | Verified after two years of real-time aging using cascade impactor and laser light scattering. |
2. Sample Size Used for the Test Set and Data Provenance
This information is not applicable or not provided in the context of an AI/ML device test set. The submission describes non-clinical testing of the physical medical device.
- No specific "test set" in terms of patient data or images is mentioned.
- The tests performed are for electrical safety, EMC, shelf-life, useful-life, durability, cleaning, particle characterization, and biocompatibility, using physical samples of the device and materials.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This information is not applicable or not provided. "Ground truth" in the context of expert consensus on data is not relevant to this type of device submission. Device performance was evaluated against engineering specifications and regulatory standards by qualified testing facilities or personnel.
4. Adjudication Method for the Test Set
This information is not applicable or not provided. Adjudication methods are typically used for establishing ground truth in clinical studies involving interpretation, which is not what this submission describes.
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
This information is not applicable or not provided. This is not an AI-powered device, and therefore no MRMC study, human reader improvement, or AI assistance is mentioned.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This information is not applicable or not provided. This is not an algorithmic device.
7. The Type of Ground Truth Used
For this medical device, the "ground truth" refers to established engineering specifications, regulatory standards (e.g., IEC 60601 series, ISO 10993-1), and the performance characteristics of the legally marketed predicate device (K170916).
The tests performed (electrical safety, EMC, biocompatibility, particle characterization, cleaning/disinfection validation) were conducted against predefined, measurable criteria and standards.
8. The Sample Size for the Training Set
This information is not applicable or not provided. There is no mention of a training set as this is not an AI/ML device.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable or not provided. There is no mention of a training set or ground truth establishment for such.
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(244 days)
The Portable Nebulizer is a vibrating mesh nebulizer system designed to aerosolize liquid medications for inhalation by the patient. The device may be used with pediatic (5 years and older), defined by the prescribed medication, and adult patients in hospital/institutional settings, home care use, schools, and long term care facilities.
The Portable Nebulizer is a small, handheld, internally powered general purpose nebulizer which utilizes vibrating mesh technology to generate aerosol.
The Portable Nebulizer, a vibrating mesh nebulizer system, underwent non-clinical performance testing to demonstrate its equivalence to the predicate device, Omron NE-U22 (K062263). The assessment primarily focused on aerosol characterization, electrical safety, software verification, biocompatibility, and cleaning/disinfection validation.
Here's an overview of the acceptance criteria and study details:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" for each performance metric with defined thresholds. Instead, it presents a comparative analysis against the predicate device to support substantial equivalence. The reported device performance is generally considered acceptable if it is "similar" or "substantially equivalent" to the predicate, or if it meets established standards.
| Feature | Acceptance Criteria (Implied: Similar to predicate or meeting standards) | Reported Device Performance |
|---|---|---|
| Indications for Use | To aerosolize liquid medications for inhalation; pediatric (5 years and older) and adult patients in various settings. | "The indications for use are identical for the proposed device and the predicate." Pediatric population description refined but deemed substantially equivalent to predicate based on other reference nebulizers. |
| Patient Population | Pediatric (defined by prescribed medication) and adult patients. | "The patient population is similar for the proposed device and the predicate." Pediatric age range (5 years and older) considered substantially equivalent to predicate based on other reference devices. |
| Environment of Use | Hospital/institutional settings, home care, schools, long term care facilities. | "The environment of use is identical for the proposed device and the predicate." |
| Technology / Principle of Operation | Vibrating mesh nebulizer. | "The technology is identical for the proposed device as compared to the predicate." |
| Nebulization rate | ≥ 0.25 ml/min (Predicate: 0.25 ml/min to 0.9 ml/min). | Reported: ≥ 0.25 ml/min. |
| Power consumption | < 1.5 W (Predicate: 1.5 W). | Reported: < 1.5 W. |
| Electrical Safety Standards | Compliance with IEC 60601-1:2012, IEC 60601-1-2:2007, IEC 60601-1-11:2012. | "Testing established that, with respect to electrical safety, the device meets the applicable requirements of: (1) IEC 60601-1:2012; (2) IEC 60601-1-2:2007; (3) IEC 60601-1-11:2012." |
| Software Level of Concern | Moderate. | "The software for this device is of a 'moderate' level of concern." Software Verification and Validation testing conducted in accordance with FDA's Guidance 337. |
| Biocompatibility | ISO 10993-1 tests (Cytotoxicity, Sensitization, Irritation, Sub-chronic Systemic toxicity, Acute Systemic Toxicity, Leachable and Extractables with Risk Based Assessment, Gas Emission VOC plus Inorganic compounds - CO, CO2, and Ozone, PM25). | "Under the parameters of the tests it is concluded that they are biocompatible, and that there are no new issues of biocompatibility regarding their use as intended." |
| Cleaning and Disinfection Validation | Effective cleaning and disinfection by methods stated in IFU. | "All testing concluded that the nebulizer could be cleaned and disinfected effectively by use of the methods stated in the IFU." |
| Particle Size (MMAD) | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1.9–2.8*, Ipratropium 2.0–2.7, Cromolyn 2.1–2.8. For pediatric flow: Albuterol 3.31–4.95*, Ipratropium 4.34–5.72*, Cromolyn 3.68–5.38*. Overall deemed "very similar compared to that of the predicate." |
| Total Dose | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1719–2082*, Ipratropium 347–403*, Cromolyn 13372–14329*. For pediatric flow: Albuterol 2159–2592, Ipratropium 429–505, Cromolyn 17733–18426. Overall deemed "very similar compared to that of the predicate." |
| Total Respirable Dose (0.5-5 microns) | Similar to predicate (ranges provided in Tables 3 & 4). | For adult flow: Albuterol 1274–1487*, Ipratropium 237–275*, Cromolyn 8645–9954*. For pediatric flow: Albuterol 1071–1596*, Ipratropium 198–219*, Cromolyn 7925–10601*. Overall deemed "very similar compared to that of the predicate." |
| Other Particle Characteristics (GSD, Coarse, Fine, Ultra-fine Particle Dose) | Similar to predicate (ranges provided in Tables 3 & 4). | Generally shown to be within "very similar" ranges compared to the predicate. Asterisks indicate values that are higher/lower than predicate ranges, but the overall conclusion is still "substantially equivalent." |
| Shelf-life, Useful-life, Durability Testing | Not explicitly stated but implied to meet performance criteria. | Testing was performed. Specific performance not detailed in this summary. |
| Simulated Life Cycle Testing | Not explicitly stated but implied to meet performance criteria. | Testing was performed. Specific performance not detailed in this summary. |
Note: Asterisks () in the "Reported Device Performance" column for particle characterization often indicate that the device's range is different from the predicate's range. However, the overall conclusion in the document is that the results support a substantial equivalence argument.*
2. Sample Size Used for the Test Set and the Data Provenance:
The document does not explicitly state the sample sizes (number of units or test replicates) for all non-clinical tests. For the particle characterization, the tables show ranges of values for different medications (Albuterol, Ipratropium, Cromolyn), which suggests multiple tests were conducted for each.
The data provenance is not specified in terms of country of origin. The study appears to be entirely retrospective for the purpose of this 510(k) submission, utilizing pre-existing test data to demonstrate equivalence.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts:
This information is not provided in the document. The nature of the non-clinical tests (e.g., electrical safety, biocompatibility, particle characterization) typically relies on objective measurements and established standards, rather than expert interpretation of a "ground truth" in the way a clinical study would.
4. Adjudication Method for the Test Set:
This information is not applicable/provided for the non-clinical tests described. Adjudication methods (e.g., 2+1, 3+1) are typically used in clinical studies involving interpretation of data by multiple experts to establish a "ground truth" for diagnostic accuracy or similar endpoints. The tests performed here are objective engineering and material science evaluations.
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:
An MRMC study was not performed as this device is a nebulizer and not an AI-powered diagnostic device involving human readers or interpretation.
6. If a Standalone (i.e. Algorithm Only Without Human-in-the-Loop Performance) Was Done:
This is not applicable as the device is a medical device (nebulizer), not an algorithm or AI system. The "software" mentioned refers to firmware controlling the vibrating mesh, not a standalone AI diagnostic tool.
7. The Type of Ground Truth Used:
For the non-clinical tests, the "ground truth" is established by:
- Established Standards: For electrical safety (IEC 60601 series), biocompatibility (ISO 10993-1), and software verification (FDA Guidance 337).
- Objective Measurements: For particle characterization (using Cascade Impactor and laser light scattering techniques), nebulization rate, power consumption, etc.
- Comparison to Predicate Device: The performance of the Portable Nebulizer is compared directly to the legally marketed Omron NE-U22 (K062263) as key evidence for substantial equivalence.
8. The Sample Size for the Training Set:
This is not applicable as this is a traditional medical device (nebulizer) and not an AI/ML-based device that requires a "training set."
9. How the Ground Truth for the Training Set Was Established:
This is not applicable for the same reason as point 8.
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