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The RespCare Hybrid AV Mask is intended for use by adults (> 30 kg) as a patient interface for CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea.

(Applies to the standard version):

For homecare applications, the Hybrid AV Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.

(Applies to the Disposable version): The Hybrid AV Disposable Mask is a single patient, single use interface.

The RespCare Hybrid AV Mask is a patient interface accessory to a positive pressure ventilator intended for treatment of respiratory insufficiencies and obstructive sleep apnea. The device delivers positive airway pressure from a CPAP or bi-level device to the patient's oral and nasal passages. Connection to the ventilator device is made by a standard 22 mm fitting. The mask is held in place on the face by headgear worn around the head. The device includes anti-asphyxia valve and oxygen entrainment port features.

This device is a RespCare Hybrid AV Mask, a patient interface accessory for positive pressure ventilators. The submission is a Special 510(k) and focuses on modifications to an existing predicate device (K052227). As such, the presented information does not include a traditional study with acceptance criteria and device performance as typically expected for novel or substantially altered devices. Instead, the submission relies on demonstrating substantial equivalence to the predicate device.

Here's an analysis based on the provided text, addressing the requested points:

1. Table of acceptance criteria and the reported device performance:

   Not applicable in the conventional sense for this Special 510(k). The submission relies on demonstrating substantial equivalence to a predicate device (K052227, RespCare Face Mask). The "performance" is implicitly tied to the predicate device's established safety and effectiveness.

   Acceptance Criterion (Implicit)	Reported Device Performance (Implicit/Claimed)
   Same Intended Use and Indications: The modified device must serve the same purpose and be indicated for the same patient population and conditions as the predicate device.	"The intended use and indications of the modified device are the same as the intended uses and indications as the predicate device."
   Same Fundamental Scientific Technology: The underlying principles of operation and design should be consistent with the predicate.	"The modified device uses the same fundamental scientific technology as the predicate device."
   No New Issues of Safety and Effectiveness: Design changes should not introduce new risks or compromise existing safety/effectiveness.	"Changes to the design do not raise new issues of safety and effectiveness..."
   Safety and Effectiveness Verified by Same Methods as Predicate: For any changes, their impact should be assessed using methods comparable to those used for the predicate.	"...and safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance."
   Design Modifications: Specific changes related to exhalation ports and coupling adapters must be properly addressed and not negatively impact performance when used as intended (i.e., with a separate exhalation device and appropriate male hose fitting).	The exhalation ports are removed from the mask shell to accommodate systems with built-in exhalation devices. The male coupling adaptor is eliminated, using a female coupling for a separate exhalation device. Labeling specifies use with a separate exhalation device and connection to a male hose fitting. This implies the device performs as intended when these conditions are met, mirroring the predicate's overall function in its respective system. The phrase "Other than these differences, the Hybrid AV Mask is essentially similar to the predicate device" underscores the claim of comparable performance.

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

   No specific test set or sample size is explicitly mentioned for this Special 510(k) submission. The submission states that "safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance." This implies a reliance on the data and testing that supported the original predicate device clearance, rather than new, independent testing for this specific modification. Therefore, details about data provenance (e.g., country of origin, retrospective/prospective) are not provided in this document.

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:

   Since no new test set is explicitly described for this modification, there's no mention of experts establishing a ground truth for a test set in this document. The assessment relies on the regulatory review (FDA's evaluation of the K052227 clearance) that validated the predicate device's safety and effectiveness.

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

   Not applicable. No new test set requiring adjudication is described for this submission.

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 passive respiratory mask, not an AI-powered diagnostic or assistive tool. MRMC studies are irrelevant here.

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

   Not applicable. This device is a passive respiratory mask and does not involve an algorithm.

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

   Not explicitly stated for the modified device. The claim is that "safety and effectiveness are verified using the same methods as reviewed in the K052227 clearance." This implies that whatever ground truth (e.g., performance testing against established engineering standards, clinical observations for safety and comfort, or other relevant data) was used for the predicate device, it is considered sufficient for the modified device given the nature of the changes.

8. The sample size for the training set:

   Not applicable. As a physical medical device (mask), it does not involve a "training set" in the context of machine learning or AI.

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

   Not applicable for the same reason as point 8.

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The Utopia is intended for use by adults (> 30 kg) as a patient interface for currently-marketed CPAP or Bi-Level positive-pressure ventilation devices for treatment of respiratory insufficiencies and obstructive sleep apnea.

(Applies to the standard version):
For homecare applications, the Utopia may be reused multiple times by a single patient. For non-homecare applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.

(Applies to the Disposable version): The Utopia Disposable is a single patient, single use interface.

The Utopia is a patient interface accessory to a positive pressure ventilator intended for treatment of respiratory insufficiencies and obstructive sleep apnea. The device delivers positive airway pressure from a CPAP or bi-level device to the patient's oral and nasal passages. Connection to the ventilator device is made by a standard 22 mm fitting. The mask is held in place on the face by a forehead pad and headgear worn around the head. The device includes exhalation port. anti-asphyxia valve, and oxygen entrainment port features.

This 510(k) Premarket Notification (K052249) describes the Utopia Face Mask, an accessory to a noncontinuous ventilator. The submission focuses on demonstrating substantial equivalence to predicate devices rather than presenting a study with specific acceptance criteria and performance metrics for a novel technology.

Therefore, many of the requested sections (Table of acceptance criteria and reported device performance, sample size for test set, number of experts for ground truth, adjudication method, MRMC study, standalone performance, type of ground truth, training set size, and how training set ground truth was established) are not applicable or available in this document.

The document details the device description, comparison to predicate devices, and the FDA's decision regarding substantial equivalence. It confirms the Utopia mask is "substantially equivalent to the legally marketed predicate interfaces listed above in function, intended use, materials, and features." This implies that the device meets the safety and effectiveness standards established by the predicate devices through similar design and materials.

Here's a breakdown of the available information relevant to your request:

1. Table of Acceptance Criteria and Reported Device Performance:

• Not applicable. This submission doesn't define specific numerical acceptance criteria (e.g., a certain percentage of efficacy or specific measurement ranges) or report novel performance data against such criteria. Instead, it relies on demonstrating substantial equivalence to existing legally marketed predicate devices. The "performance" is implicitly tied to being as safe and effective as the predicates.

2. Sample Size Used for the Test Set and Data Provenance:

• Not applicable. There is no mention of a "test set" in the context of new performance data or clinical trials to prove device effectiveness. The submission relies on a comparison of the Utopia's design, materials, and intended use against predicate devices.

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

• Not applicable. As there is no "test set" requiring ground truth establishment through expert review for novel performance, this information is not present.

4. Adjudication Method for the Test Set:

• Not applicable. No test set requiring expert adjudication is described.

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 face mask, not an AI-powered diagnostic tool. MRMC studies are not relevant to its regulatory pathway.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done:

• Not applicable. This device is a physical medical device (face mask), not a software algorithm.

7. The Type of Ground Truth Used:

• Not applicable. No new "ground truth" derived from expert consensus, pathology, or outcomes data for performance evaluation is mentioned. The ground truth for this submission is essentially the established safety and effectiveness of the predicate devices based on their legal marketing and performance history.

8. The Sample Size for the Training Set:

• Not applicable. This device is a physical medical device and does not involve machine learning or a "training set."

9. How the Ground Truth for the Training Set Was Established:

• Not applicable. As there is no training set, this information is not relevant.

Summary of the Study/Evidence Presented:

The "study" in this context is a comparison to predicate devices to establish substantial equivalence.

• Methodology: The submitter (RespCare Inc.) conducted an analysis comparing the Utopia face mask to three legally marketed predicate devices: K030822 (Hans Rudolph 7600 Vmask), K040506 (Fisher & Paykel HC431), and K002465 (Respironics PerformaTrak).
• Basis for Equivalence: The comparison highlighted similarities in:
  • Function: Delivers positive airway pressure from CPAP or bi-level devices.
  • Intended Use: Patient interface for treating respiratory insufficiencies and obstructive sleep apnea.
  • Environment of Use: Homecare and hospital/clinical settings.
  • Patient Population: Adults (> 30 kg).
  • Frequency of Use: Single-use and multiple-use versions (matching predicates).
  • Basic Method of Operation and Design: Provides a seal, held by headgear, includes exhalation ports, anti-asphyxia valve, and oxygen entrainment ports.
  • Materials: Stated to be comparable to predicates.
• Conclusion: RespCare Inc. concluded that the Utopia is "substantially equivalent to the predicate devices" because "materials information and functional testing relative to the intended use of the Utopia show that it is as safe and effective as the predicate devices." (Note: The submission states that functional testing was done but does not provide details or results of that testing in this document).
• FDA Decision: The FDA reviewed the submission and determined that the device is substantially equivalent to legally marketed predicate devices. This determination implies that the FDA agreed with RespCare's assessment that the Utopia mask meets the necessary safety and effectiveness standards, as demonstrated by its similarity to already approved devices.

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