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The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments.

The Nasal-Aire II Pediatric is intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

The Nasal-Aire II Pediatric has been modified from the Nasal-Aire II to meet the requirements of the pediatric population and adults requiring smaller sizes to achieve the proper fit and comfort. The Nasal-Aire II Pediatric provides therapy through the nose only.

The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in hospital, clinic, or home environments.

For homecare applications, the Nasal-Aire II Pediatric may be reused multiple times by a single patient. For institutional applications (i.e. sleep lab, other clinical settings), the interface may be reused multiple times by multiple patients.

The Nasal-Aire II Pediatric interface has a soft nasal cannula to form a seal with the nasal openings. The nasal cannula has two nasal inserts and has integrated exhalation ports. The interface also has tubing, connectors to attach the tubing to the nasal cannula, and a swivel coupling that allows the interface to connect to the ventilation device. Headgear is attached to the device to secure the interface on the patient.

There are five nasal cannula sizes available, ranging from A (largest) to E (smallest).

The device is available by prescription only.

This document is a 510(k) summary for the Nasal-Aire II Pediatric device, which is an accessory to positive pressure ventilation devices. It primarily focuses on demonstrating substantial equivalence to predicate devices, rather than presenting a study of the device's performance against specific acceptance criteria.

Therefore, many of the requested items related to acceptance criteria and specific study details (like sample sizes, expert qualifications, adjudication methods, MRMC studies, standalone performance, and ground truth establishment) are not present in the provided text for the Nasal-Aire II Pediatric device.

The document states that "functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices." However, it does not detail what specific functional tests were performed, what the acceptance criteria for those tests were, or what the reported performance was.

Here's a breakdown of what can and cannot be answered based on the provided text:

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

• Cannot provide. The document does not specify quantitative acceptance criteria or report specific performance metrics for the Nasal-Aire II Pediatric. It broadly claims "functional testing" shows it is "as safe and effective as the predicate devices," but no details are given.

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

• Cannot provide. No information about a specific test set, its sample size, or data provenance is mentioned.

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)

• Cannot provide. No ground truth establishment for a test set is discussed.

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

• Cannot provide. No information on adjudication methods is present.

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

• Cannot provide. This is a medical device (nasal cannula), not an AI/imaging device that would typically involve human readers or MRMC studies.

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

• Cannot provide. This device is a passive accessory and does not involve an algorithm.

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

• Cannot provide. No ground truth is discussed beyond the general assertion that functional testing supports safety and effectiveness.

8. The sample size for the training set

• Cannot provide. No training set is mentioned as this is not an AI/machine learning device.

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

• Cannot provide. No training set or ground truth establishment for a training set is mentioned.

Summary of available information related to equivalence:

• Device Trade Name: Nasal-Aire II Pediatric
• Common/Usual Name: Accessory to Non-Continuous Ventilator
• Predicate Devices:
  • K060105: Kidsta Mask System (ResMed)
  • K022465: Nasal-Aire II (Innomed Technologies Inc. - likely the original version from which this pediatric version was modified)
  • K002001: Breeze Sleepgear with Nasal Pillows (Puritan Bennett Corp.)
  • K072993: Reusable Headrest® with Nasal Seal (AEIOMed, Inc.)
  • Unknown K number: Infant Nasal CPAP Set (Hudson RCI)
• Conclusion on Equivalence (from the submission): The Nasal-Aire II Pediatric device is substantially equivalent to the predicate devices in intended use, environment of use, patient population, and frequency of use. Its basic method of operation and design are also substantially equivalent to the predicates. Materials information and functional testing relative to the intended use of the Nasal-Aire II Pediatric show that it is as safe and effective as the predicate devices.
• Intended Use (as stated by FDA in the letter): The Nasal-Aire II Pediatric interface is an accessory to positive pressure ventilation devices (i.e. CPAP, Bi-Level) for both adult and pediatric patients aged seven and older or weighing more than 40 lbs, in the hospital, clinic or home environments. Intended for single-patient re-use in the home environment and multiple-patient re-use in the hospital / institutional environment.

This 510(k) summary focuses on demonstrating that the new pediatric version of the Nasal-Aire II maintains the same safety and effectiveness as already cleared predicate devices through design similarity and general functional testing, rather than presenting a performance study against specific, novel acceptance criteria.

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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 Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.

(Applies to the standard version):

For homecare applications, the Hybrid NE 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 RespCare Hybrid NE Mask Disposable is a single patient, single use interface.

A specialized interface for Non-Invasive Ventilation. It will be modeled after the RespCare Face Mask (K052227), with intentional exhalation features removed for use with ventilators equipped with an active safety valve.

This K062019 submission describes a medical device, the RespCare Hybrid NE Mask, and its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, the information typically requested for a performance study (acceptance criteria, sample sizes, expert ground truth, etc.) is not present in this document.

The document is a 510(k) summary for a new medical device submission to the FDA. The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is done by comparing the new device's intended use, technological characteristics, and safety and effectiveness information to those of the predicate. It does not typically involve a clinical study with detailed performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) submission might.

Here's an breakdown of why the requested information isn't available based on the provided text, and what is available:

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

• Not Applicable. The document explicitly states, "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." This is a summary statement of the testing performed to demonstrate substantial equivalence, but it does not specify quantitative acceptance criteria or detailed performance results in the format requested. The detailed functional testing data and acceptance criteria would have been included in the full 510(k) submission, but are not part of this publicly available summary.

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

• Not Applicable. No human clinical study or "test set" in the context of an algorithm's performance is described. The "functional testing" mentioned would likely refer to bench testing (e.g., flow resistance, sealing capabilities) rather than patient data.

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):

• Not Applicable. No "ground truth" establishment by experts is mentioned, as there is no diagnostic or interpretive task being performed by the device that would require such validation.

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

• Not Applicable. No test set or 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. The device is a face mask for ventilation, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.

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

• Not Applicable. This is a physical medical device (a mask), not an algorithm.

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

• Not Applicable. As a face mask, the concept of "ground truth" as it applies to diagnostic devices or algorithms is not relevant. The "ground truth" for a mask would be its physical properties and performance against engineering standards (e.g., seal integrity, pressure drop).

8. The sample size for the training set:

• Not Applicable. The device is a physical product and does not involve machine learning or a "training set."

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

• Not Applicable. No training set is used.

Summary of what is presented in the provided document:

The provided document, K062019, is a 510(k) summary for the RespCare Hybrid NE Mask. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria.

Key information from the document:

• Device Name: RespCare Hybrid NE Mask
• Intended Use: "The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation."
• Predicate Devices:
  • K030515 – Hans Rudolph 7500 Vmask
  • K023135 - Respironics Image3 SE
• Basis for Substantial Equivalence: The document states the device is "essentially similar to the legally marketed predicate interfaces listed above in function, intended use, materials, and features." The essential difference is identified as "the shape of the interface." It further clarifies equivalence in "intended use, environment of use, patient population, and frequency of use," and that its "basic method of operation and design is also equivalent to the predicates."
• Evidence of Safety and Effectiveness: "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." (Note: specific details of this testing, including acceptance criteria, are not provided in this summary but would be in the full submission).

This submission is purely for regulatory clearance based on substantial equivalence to existing devices, meaning it relies on the safety and effectiveness established for the predicate devices.

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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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