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The Vapotherm 2000i and 2000h are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infants, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments for use -- Home, Hospital, Sub-acute Institutions.

The Vapotherm 2000i device is a modification to cleared Vapotherm 2000i device. The base device of the modified Vapotherm 2000i device has the same technological characteristic as the predicate Vapotherm 2000i device. The software contained in the modified device has not been modified as a result of the corrections being effected and remains identical to the software resident in the predicate device.

The provided 510(k) summary for Vapotherm's 2000i Respiratory Gas Humidifier is for a Special 510(k) Corrective Action Being Effected. This means the submission is for a modification to an already cleared device, and the focus is on demonstrating that the modifications do not raise new issues of safety or effectiveness.

Therefore, the document does not contain specific acceptance criteria, study details, sample sizes, expert qualifications, or ground truth establishment methods in the way a traditional de novo or full 510(k) submission for a novel device or significant change might.

Here's an analysis based on the provided text, addressing your points where possible and noting where information is absent:

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

• Explanation: The document states that the software has not been modified and remains identical to the predicate device. The modifications are implied to be non-software related and do not raise new issues of safety or effectiveness. The "extensive testing" would likely have focused on verifying that the changes did not negatively impact the device's original performance specifications (e.g., humidification output, temperature control, safety alarms), rather than establishing new performance criteria.

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

• Sample Size for Test Set: Not mentioned.

• Data Provenance: Not mentioned.

• Explanation: Given this is a Special 510(k) for corrective action on an existing device, the testing would likely be internal verification and validation testing, not a clinical study on a patient population.

3. 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)

• Number of Experts: Not applicable.

• Qualifications of Experts: Not applicable.

• Explanation: As this is a medical device humidifier, not an AI or diagnostic device, the concept of "ground truth" derived from expert consensus for a test set is not relevant in this context. Performance would be measured against engineering specifications and regulatory standards for humidification.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Adjudication Method: Not applicable.

• Explanation: Again, this is for a hardware modification to a humidifier, not a diagnostic or AI device where adjudication of expert opinions would typically be required for ground truth.

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

• MRMC Study: No.

• Effect Size: Not applicable.

• Explanation: This type of study is relevant for AI-powered diagnostic tools. It is not applicable to a respiratory gas humidifier.

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

• Standalone Performance Test: Not applicable in the context of an algorithm.

• Explanation: The device is a physical humidifier. While it has embedded software, the performance assessment would be of the device's physical functions (e.g., humidification, temperature control, flow rates), not a standalone algorithm's diagnostic or predictive capabilities. The document explicitly states the software "has not been modified" and "remains identical to the software resident in the predicate device."

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

• Type of Ground Truth: Not explicitly stated, but for a humidifier, "ground truth" would be established through engineering specifications and quantifiable physical measurements (e.g., hygrometry, thermometry, flow meters) against established performance standards for respiratory gas humidifiers.

8. The sample size for the training set

• Sample Size for Training Set: Not applicable.

• Explanation: The term "training set" is typically used for machine learning models. This device is a traditional medical device, not an AI model, so there is no training set in that sense.

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

• Ground Truth Establishment for Training Set: Not applicable.

• Explanation: Similar to point 8, this pertains to AI/ML development and is not relevant for this device.

Summary of Device and Approval:

• Device Name: Vapotherm™ 2000i and 2000h Respiratory Gas Humidifier
• Submission Type: Special 510(k) Corrective Action Being Effected
• Purpose of Submission: Modification to a previously cleared Vapotherm 2000i device (K042245).
• Key Statement for Performance: "Vapotherm has conducted extensive testing to verify and validate the changes to the previously marketed Vapotherm 2000i device."
• Reason for Approval: The modified device has the same intended use and indications for use, similar principles of operation, and similar technological characteristics as the previously cleared predicate, and the modifications "do not raise any new issues of safety or effectiveness." The software was explicitly not modified.
• Regulatory Outcome: Found substantially equivalent to the predicate device (K042245).

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The Vapotherm™ 2000h and 2000i are designed to add moisture to and to warm breathing gases for administration to patients, including neonates/infant, pediatrics, and adults. The flow rates may be from 1 to 40 liters per minute via nasal cannula. Environments of use - Home, Hospital, Sub-acute Institutions

The Vapotherm 2000i and Vapotherm 2000h are identical and share the concept of humidification by transpiration of water vapor across a membrane by the use of a low or high flow cartridge with membrane bundles. The difference in the cartridges is only the number of membrane bundles included, fewer in the low flow. Both units and cartridges produce a highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above at flow rates from 1 to 40 lpm via a nasal cannula. The water content at 41℃ is 40-50 mg/liter, about fourfold higher than can be achieved by humidification at room temperature. The unique combination of high flow and high vapor-phase humidity allow an unusually wide range of clinical applications. Applications previously considered impractical because of limited patient tolerance for high nasal flow can now be routine because of the comfort provided by warmth and high humidity.

The provided text primarily consists of regulatory summaries and approval letters for the Vapotherm 2000h and 2000i devices. It details the device's function, indications for use, and a comparison to predicate devices. However, it does not contain information about acceptance criteria, specific studies conducted to demonstrate performance against those criteria, sample sizes, expert involvement, or any statistical evaluation of device performance.

Therefore, I cannot directly answer your request based on the provided input. The document focuses on regulatory equivalence rather than an empirical study demonstrating performance against specific acceptance criteria.

To elaborate, the document states:

• Device Description: The Vapotherm 2000i and 2000h produce "a highly humidified air (relative humidity >95%), virtually free of droplets, at body temperature or above at flow rates from 1 to 40 lpm via a nasal cannula. The water content at 41℃ is 40-50 mg/liter..."
• Comparison to Predicate Devices: It highlights "Same" or "No changes" for several attributes when comparing to predicate devices (K000401, K013486, K040862).

These descriptions are technical specifications and comparisons, not acceptance criteria for a validation study. The FDA approval K042245 is based on substantial equivalence to predicate devices, meaning it largely relies on the predicate devices having already met safety and effectiveness standards, rather than requiring extensive new clinical trial data for this specific iteration.

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Ask a specific question about this device