(98 days)
The DeVilbiss compressor / nebulizer Model 3655 includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients.
The DeVilbiss Model 3655 Compressor/Nebulizer is a small, piston-type air compressor, sized to provide the proper flow and pressure sufficient to power jet (pneumatic) nebulizers. The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and IEC 60601-1). When the compressor is used in conjunction with a therapeutic nebulizer, the system converts liquid medication into an aerosol form that can be inhaled by the patient for the treatment of a variety of respiratory disorders. The DeVilbiss Model 3655 compressor/nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter.
The provided documents describe a 510(k) premarket notification for the DeVilbiss Model 3655 Compressor/Nebulizer. The primary objective of a 510(k) submission is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is achieved by comparing the new device's technological characteristics, performance, and indications for use to those of the predicate device.
Based on the provided text, a direct acceptance criteria table and a detailed study report proving the device meets specific performance criteria are not present in the typical format one might expect for a clinical study on diagnostic accuracy or treatment efficacy. Instead, the documents focus on demonstrating substantial equivalence to a predicate device (DeVilbiss Model 3650, K970289).
Here's an analysis based on the information provided, framed to address your questions as much as possible within the context of a 510(k) submission for sub-equivalence:
1. A table of acceptance criteria and the reported device performance
The document doesn't present an explicit "acceptance criteria" table with numerical targets, but rather discusses equivalence. The criteria for acceptance in a 510(k) for this type of device typically revolve around demonstrating that the new device performs similarly or no worse than the predicate device in key functional areas.
| Acceptance Criteria (Implied for Substantial Equivalence) | Reported Device Performance (DeVilbiss Model 3655) |
|---|---|
| Intended Use Equivalence: Provide compressed air for jet nebulizers to convert liquid medication into aerosol for inhalation by adult or pediatric patients for respiratory disorders. | "Includes an AC powered air compressor that provides a source of compressed air for home health care use. The compressor is used in conjunction with a jet (pneumatic) nebulizer to convert certain inhalable drugs into an aerosol form for inhalation by a patient. The device can be used with adult or pediatric patients." |
| Aerosol Particle Size Performance: Produce an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter. | "The DeVilbiss Model 3655 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter." |
| Safety and Effectiveness: Comparable to legally marketed predicate devices. | "The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in both function and indications for use to the DeVilbiss Model 3650 aerosol compressor / nebulizer legally marketed predicate device." |
| "The Table of Comparison and the Performance Evaluations (Sections 4.0 & 7.0) show that in terms of safety and effectiveness, the new DeVilbiss Model 3655 Compressor / Nebulizer is substantially equivalent to legally marketed predicate devices." | |
| Technological Characteristics: Equivalent functional characteristics to existing legally marketed predicate devices (AC motor driven air compressor for jet nebulizer operation). | "The DeVilbiss Model 3655 aerosol compressor / nebulizer is equivalent in functional characteristics to the existing legally marketed predicate devices. The devices all utilize an AC motor driven air compressor to provide a source of compressed air for operating a jet (pneumatic) nebulizer." |
| Compliance with Safety Standards: Comply with electrical and mechanical safety standards (e.g., UL1431, IEC 60601-1). | "The unit is designed and manufactured to comply with electrical and mechanical safety standards applicable to this type of device (Underwriter's Laboratory Standard UL1431 and IEC 60601-1)." |
| "All of the devices are tested and approved to recognized agency safety standards." |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify a "test set" in the context of clinical trials or AI/algorithm evaluation. For a compressor/nebulizer, testing would typically involve engineering and bench testing, not human patient studies for performance metrics like accuracy. The "aerosol output and particle size" testing mentioned would be benchtop measurements.
- Sample Size: Not applicable in the context of human subject testing for performance. The "sample" would be the manufactured devices undergoing testing. The number of units tested is not specified.
- Data Provenance: Not applicable in the sense of geographic origin of data from subjects. The testing described (aerosol output, particle size, safety) would be performed in a laboratory setting, likely at the manufacturer's facility (Sunrise Medical HHG, Inc., Somerset PA, USA) or a certified testing lab. This would be considered prospective testing of the device units.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable to this type of device and submission. "Ground truth" for a compressor/nebulizer is established through physical measurements (e.g., particle size analysis using instruments, airflow measurements, pressure measurements) and compliance with engineering standards, not expert clinical consensus on interpreting medical images or outcomes.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. This concept relates to expert review and consensus, which is not the method for determining the performance or safety of a mechanical device like a nebulizer. Performance is determined by objective measurements and adherence to specifications.
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
Not applicable. This device is a medical compressor/nebulizer, not an AI-powered diagnostic tool. Therefore, MRMC studies are irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This refers to AI algorithm performance and is not relevant to a mechanical device. The device's "standalone" performance means its function in compressing air and producing aerosol, which is evaluated through bench testing.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for a device like this is based on:
- Physical measurements: For aerosol output, particle size, airflow, pressure.
- Engineering specifications & standards: Compliance with recognized safety standards (UL1431, IEC 60601-1).
- Comparison to predicate device: The predicate device's established performance serves as the benchmark for "equivalence."
8. The sample size for the training set
Not applicable. This device does not involve machine learning or AI that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. No training set is used for this type of device.
Summary of the Study:
The "study" presented here is not a clinical trial in the traditional sense, nor is it an AI performance evaluation. It is a 510(k) Premarket Notification submission to the FDA, which aims to demonstrate substantial equivalence of a new medical device (DeVilbiss Model 3655 Compressor/Nebulizer) to an already legally marketed predicate device (DeVilbiss Model 3650).
The "proof" that the device meets "acceptance criteria" (which are implied and based on equivalence to the predicate) comes from:
- Benchtop Testing: Measuring parameters like aerosol output and particle size, and showing they are comparable to the predicate. While specific data is not in this summary, it refers to "Performance Evaluations (Sections 4.0 & 7.0)" which would contain this data.
- Compliance with Recognized Standards: Demonstrating adherence to electrical and mechanical safety standards (UL1431, IEC 60601-1).
- Comparison of Specifications: Showing that intended use, technological characteristics (e.g., piston-type air compressor, AC powered), and materials are similar or identical to the predicate device.
The FDA's review of this submission and the subsequent "substantially equivalent" determination (as indicated by the letter from Donna-Bea Tillman, Ph.D. in K020932) confirms that the device has met the regulatory requirements for market entry based on this comparative assessment.
§ 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).