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The 8650D will be used as the air source to nebulize sterile water to provide humidification to patients with tracheostomies. The 8650Dxmay also be used to nebulize medications in the treatment of Asthma, Cystic Fibrosis, and chronic obstructive pulmonary disease.

The DeVilbiss 8650D Compressor is a portable AC powered air compressor that will act as an air source to operate a pneumatic nebulizer. The device has an internal cooling fan to allow continuous use operation. It uses a metal housing with sound barrier foam to provide a low noise level.

The DeVilbiss 8650D Compressor is a medical device intended for use as an air source to operate a pneumatic nebulizer. The submission K963349 focuses on demonstrating its substantial equivalence to a predicate device, the Allied Healthcare/Timeter PCS414, rather than presenting a detailed study proving specific clinical acceptance criteria of the device itself through a diagnostic study.

The provided text describes basic performance testing to ensure the device functions as intended and meets safety standards. It does not contain information about a diagnostic study with human subjects, ground truth establishment, or expert reviews as typically found for AI/imaging devices.

Here's an analysis based on the provided text, addressing the requested points where possible, and noting where information is not available:

1. Table of Acceptance Criteria and Reported Device Performance

Note on Acceptance Criteria: The document primarily relies on the concept of "substantial equivalence" to the predicate device (Allied Healthcare/Timeter PCS414). Therefore, the implied acceptance criteria for performance metrics are that the DeVilbiss 8650D performs comparably to the predicate device in terms of pressure and flow output, sound level, temperature rise, and electrical safety. The specific numerical values for these criteria or the test results are not detailed in this 510(k) summary.

2. Sample Size for the Test Set and Data Provenance

This information is not available in the provided text. The testing described is for the device's physical and electrical performance, not a clinical study with a "test set" of patient data.

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

This information is not available as the submission does not describe a study involving expert review for establishing ground truth on patient data. The "testing" mentioned refers to engineering and safety tests of the compressor itself.

4. Adjudication Method for the Test Set

This information is not applicable as there is no "test set" in the context of diagnostic performance involving human or AI interpretation.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done

No, an MRMC comparative effectiveness study was not done. The device is a compressor, not a diagnostic imaging or AI-assisted interpretation tool. The submission is for substantial equivalence based on engineering and safety performance.

6. If a Standalone (algorithm only without human-in-the-loop performance) was done

This is not applicable. The device is a physical compressor, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" for this type of device (a compressor) would be related to its engineering specifications and safety standards, rather than clinical outcomes or pathology.

• Engineering Specifications: For pressure and flow output, the ground truth would be the defined output characteristics of the predicate device and established engineering standards.
• Safety Standards: For electrical safety and temperature, the "ground truth" is compliance with recognized standards like UL-544.

8. The Sample Size for the Training Set

This is not applicable. There is no "training set" as this is not an AI/machine learning device. The device itself is manufactured, not "trained."

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

This is not applicable as there is no training set.

Summary of Device Performance Testing from Section 4 of the 510(k) Summary:

The DeVilbiss 8650D was subjected to performance testing focusing on:

• Pressure and Flow Output: To ensure it can adequately drive pneumatic nebulizers.
• Sound Pressure Level: To confirm it operates at a low noise level as described.
• Temperature Rise: To ensure safe continuous operation.
• Shipping Performance: To ensure the device integrity is maintained during transportation.
• Electromagnetic Compatibility: To ensure it functions without interference and does not cause interference.

Agency Approvals / Standards:
The device is stated to meet the UL-544 Standard for Safety, Medical and Dental Equipment.

Conclusion stated in the 510(k):
The performance testing results did not indicate any safety and effectiveness concerns when compared to the predicate device, Allied Healthcare PCS 414, thus supporting the claim of substantial equivalence.

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The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease.

The DeVilbiss Model 3650 Compressor / Nebulizer is designed for use on the order of a physician for the treatment of respiratory diseases such as asthma, cystic fibrosis and chronic obstructive pulmonary disease. In terms of function, safety and effectiveness this device is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases. The compressor is constructed of materials, both metal and plastic, that are similar or identical to legally marketed devices. 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, Attachment D).

Used in conjunction with a jet (pneumatic) 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 3650 compressor / nebulizer system produces an aerosol output with the majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E). This aerosol particle size performance is comparable to other legally marketed devices as noted in the Table of Comparison and the Discussion of Similarities and Performance Data (Sections 6.0 & 7.0).

Given the provided text, it is not possible to provide a detailed response to the requested information regarding acceptance criteria and a study proving device conformance. The document is a 510(k) summary from 1997 for the DeVilbiss Model 3650 Compressor/Nebulizer, which pre-dates many of the modern requirements and practices for AI/ML device evaluations implicit in your questions.

Here's why and what can be extracted:

The document explicitly states: "The DeVilbiss Model 3650 Compressor / Nebulizer is substantially equivalent to other legally marketed compressor / nebulizers commonly used for the treatment of respiratory diseases." This indicates a predicate device comparison rather than a standalone clinical study with the kind of modern metrics you're requesting.

Here's what can be gathered, and what cannot:

1. A table of acceptance criteria and the reported device performance

   • Acceptance Criteria Mentioned (Implicit/Explicit):
     • "majority of the aerosol by mass contained in particles less than 5 microns in diameter (per the requirements of the BSI standard, Attachment E)."
     • Compliance with electrical and mechanical safety standards (Underwriter's Laboratory Standard UL1431, Attachment D).
     • Functional and safety equivalence to legally marketed predicate devices.
   • Reported Device Performance:
     • "This aerosol particle size performance is comparable to other legally marketed devices." No specific numerical value for "majority" is given within this summary, only that it meets the BSI standard requirement.
     • Functionally, converts liquid medication into aerosol.
     • Electrically and mechanically safe per UL1431.

   Acceptance Criteria	Reported Device Performance
   Majority of aerosol by mass

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Not Found

The Pulse Dose Series devices are fundamentally repackaged versions of the OMS 20 and 50, DeVilbiss' current Oxygen Management Systems. The devices provide a bolus of oxygen to a patient at the start of inhalation. The devices assist patients, who require prescribed doses of supplemental gases such as oxygen, to conserve gas from the various gaseous cylinders or liguid oxygen reservoirs. By allowing oxygen to flow only from the cylinder or liquid oxygen reservoirs during the inspiratory segment of a patient's breathing cycle, conservation occurs.

The provided text describes a 510(k) summary for DeVilbiss Health Care's "Oxygen Management Systems" (Pulse Dose Series). This document focuses on demonstrating substantial equivalence to predicate devices (OMS 20 and 50) rather than presenting a study against specific acceptance criteria for a novel device. As such, the information needed to fill out all the requested sections for a study proving device meets acceptance criteria is largely absent.

Here's a breakdown of what can be inferred and what is missing:

1. Table of Acceptance Criteria and Reported Device Performance:

The document doesn't explicitly list "acceptance criteria" in the traditional sense for a new medical device study. Instead, it focuses on demonstrating that the performance of the Pulse Dose Series is identical to the predicate devices (OMS 20 and 50).

2. Sample size used for the test set and the data provenance:

• Sample Size: Not specified. The document refers to "various comparison matrices and testing reports" and "non-clinical testing" but does not provide details on the number of units tested or the duration/scope of these tests.
• Data Provenance: Not specified. It's likely internal testing by DeVilbiss Health Care, Inc. The nature of a 510(k) submission generally involves in-house testing for substantial equivalence. It does not mention country of origin or whether it was retrospective or prospective.

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. The assessment relies on engineering and technical comparisons to the predicate devices, not on expert clinical evaluation for establishing a "ground truth" in the clinical sense.

4. Adjudication method for the test set:

This information is not provided. As implied in point 3, there's no mention of expert consensus or adjudication. The determination of "identical" or "substantially equivalent" would be based on comparison of technical specifications and test results.

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 is not applicable. The device is an oxygen management system, not an AI-powered diagnostic tool requiring human reader interpretation. No MRMC study was conducted.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:

This is not applicable. This is a hardware medical device with some "technological improvements (microprocessor control)," but it's not an algorithm meant to operate independently in a diagnostic or interpretive capacity.

7. The type of ground truth used:

The "ground truth" in this context is the performance and specifications of the predicate devices (OMS 20 and 50). The Pulse Dose Series is being compared directly against these established devices to demonstrate equivalency. This is a technical comparison rather than a clinical ground truth like pathology or patient outcomes.

8. The sample size for the training set:

This is not applicable. This is not a machine learning or AI device that requires a "training set."

9. How the ground truth for the training set was established:

This is not applicable as there is no training set mentioned.

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