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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 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 InnoMed Technologies IT Nasal Mask is intended to be used as a patient interface for currently-marketed CPAP and Bi-Level positive-pressure ventilation devices capable of generating pressures up to 20cm H₂O. It is indicated for use in non-critical care applications such as treatment of adult obstructive sleep apnea and ventilatory support during respiratory insufficiency.

The InnoMed Technologies IT Nasal Mask is available by prescription, and is intended for single patient use only for adult patients (>30kg) in home or hospital settings.

The IT Nasal mask consists of a polycarbonate faceplate shaped to fit around the patient's nose, and a silicon cushion covering the edge of the faceplate where the mask makes contact with the patient's face. At the front of the mask's faceplate is a 90-degree elbow attached so as to allow it to rotate 360 degrees relative to the faceplate.

The other end of the elbow is configured as a standard female 22mm fitting for the attachment of a separate exhalation port/swivel that is supplied with each IT Nasal Mask. This exhalation port is configured so as to sufficiently exhaust exhaled air from the patient at a proper flow rate. The other end of the exhalation port/swivel allows connection to a CPAP or bi-level positive pressure ventilator's flexible breathing circuit tubing.

The IT Nasal mask is available in seven different sizes in order to accommodate a broad range of facial feature variations.

The IT Nasal Mask is secured to the patient by a single-piece nylon cloth headset. The headset has four straps which allow the mask to be adjusted for proper fit and patient comfort, and provide for quick removal of the mask.

The InnoMed IT Nasal Mask is intended to be used as a patient interface for CPAP and Bi-Level positive-pressure ventilation devices. The study conducted for this device was to demonstrate substantial equivalence to legally marketed predicate devices, not a comparative effectiveness study with human readers or a standalone algorithm performance study.

Here's the information regarding the acceptance criteria and study as requested, based on the provided text:

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

The provided document describes the general performance characteristics that were tested for equivalence to predicate devices, but does not list specific numerical acceptance criteria with corresponding device performance metrics in a tabular format. Instead, it states that "Testing demonstrated that the important clinical performance characteristics were equivalent to those of the predicate devices."

2. Sample sized 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 the sample size used for the test set, nor does it explicitly state the data provenance (e.g., country of origin, retrospective or prospective). The testing appears to be primarily laboratory-based to establish equivalence in performance characteristics.

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)

This section is not applicable as the study described is for device performance characteristics (flow rate, resistance, volume, biocompatibility) rather than a study requiring expert-established ground truth related to clinical outcomes or interpretations.

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

This section is not applicable for the type of device performance testing 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

No MRMC comparative effectiveness study was done, as this is a physical medical device (nasal mask) and not an AI-powered diagnostic tool. The study aimed to demonstrate equivalence to predicate devices, not an improvement in human reader performance with AI assistance.

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

This section is not applicable as the device is a physical nasal mask, not an algorithm.

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

The "ground truth" for the performance characteristics mentioned (exhalation port flow rate, exhalation port resistance, and mask volume) would be objective physical measurements, typically obtained through standardized laboratory testing methods, not expert consensus, pathology, or outcomes data. For biocompatibility, the ground truth would be adherence to industry standards, again through laboratory testing.

8. The sample size for the training set

This section is not applicable. The device is a physical medical device and does not involve AI or machine learning models that require a training set.

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

This section is not applicable. The device does not involve AI or machine learning models, and therefore no training set or its associated ground truth establishment is mentioned.

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Nasal-Aire Critical Care ventilator interface is intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Nasal-Aire Criticial Care is ventilator interface accessory intended for use with a CPAP or Bi-Level device to provide noninvasive ventilation in adult patients for the treatment of respiratory insufficiencies or obstructive sleep apnea. This single use disposable interface is intended for hospital settings.

Nasal-Aire Critical Care consists of a soft nosepiece with two exhaust ports and two soft nasal cannula for fitting into the nasal openings. Connected on each side of the nosepiece is a length of tubing. The two lengths of tubing are joined at the opposite ends by a "Y"-shaped coupling, forming a loop with the nosepiece at one end and the "Y" coupling at the other. At the base of the "Y" coupling is a port for connection of the Nasal-Aire Critical Care to a positive pressure ventilation device. The Nasal-Aire Critical Care is compatible with any positive pressure ventilator containing a 22mm connection. Nasal-Aire Critical Care will be offered in various sizes designed for a comfortable and compliant fit for a wide variety of nare sizes.

The provided document is a 510(k) summary for the Nasal-Aire Critical Care device. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than providing extensive clinical study data with acceptance criteria or performance metrics directly comparable to what is typically found in AI/ML device studies.

Therefore, the requested information, specifically regarding acceptance criteria and a study proving the device meets those criteria (especially in the context of an AI/ML device study), is largely not present in this regulatory document. This document outlines functional equivalence to existing devices through comparison of attributes.

Here's an analysis based on the provided text, highlighting what is (and isn't) available:

1. A table of acceptance criteria and the reported device performance
   The document does not explicitly state "acceptance criteria" for performance metrics in the way one would see for an AI/ML diagnostic or prognostic device (e.g., target sensitivity, specificity). Instead, it relies on a comparison of attributes of the "Nasal-Aire Critical Care (Subject device)" against several "Predicate devices" to demonstrate substantial equivalence.

   The "performance" here is described in terms of functional attributes and intended use. The table below summarizes the comparison, which serves as the basis for demonstrating that the device is "as safe and effective as the predicate devices."

   | Attribute | Nasal-Aire Critical Care
   (Subject device) | Predicate Devices (Composite from listed predicates) |
   | :-------------------------------------------------------- | :---------------------------------------------------------------------------------------------------------------------------------------------------------------------------- | :------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------- |
   | Intended Use | Intended for use with CPAP or Bi-Level device to provide noninvasive ventilation for the treatment of respiratory insufficiencies or obstructive sleep apnea. | Similar intended uses, including non-invasive treatment for respiratory insufficiency and/or obstructive sleep apnea with CPAP/bi-level therapy. |
   | Intended Environment | Hospital/Institutional Use: Yes | Hospital/Institutional Use: Yes |
   | Offered in Various sizes | Yes | Yes (for interfaces) |
   | Intended for Single Patient Use | Yes | Yes (for interfaces, some predicates indicated "No, multiple patient" for full mask series, but the Nasal-Aire is single-use) |
   | Provided Non-Sterile | Yes | Yes (for interfaces) |
   | Compatible with 22mm ventilator connection | Yes | Yes |
   | Treatment delivered through Nasal Passages | Yes | Yes (for interfaces; one predicate mentions "Yes and mouth") |
   | Pressure delivery | 3-35 cm H2O: Yes | 3-35 cm H2O: Yes |
   | Allows for pressure monitoring | Yes | Yes |
   | Intended Population | Adult | Adult |
   | Patient Contact Material | Silicone | Silicone |
   | Interface: Tubing Length | 7" | Varies (15/18" for one predicate, unknown for others; 7" is within reasonable range for such a device compared to longer ventilator tubing) |
   | Latex Free | Yes | Yes (where specified) |

   Acceptance Criteria (Implied): The implied acceptance criteria are the attributes and performance characteristics of the predicate devices. The "study" (or rather, the justification for substantial equivalence) involved demonstrating that the Nasal-Aire Critical Care met or was comparable to these attributes.

2. Sample sizes used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
   This information is not provided in the 510(k) summary. Given that this is a physical medical device (ventilator interface) and not an AI/ML software device, the concept of "test set" in the context of data validation is not applicable in the way it would be for AI/ML. The "study" mentioned ("Biocompatability requirements and functional testing") would involve laboratory tests and potentially limited human factor testing, but details on sample sizes or data provenance are not included in this summary.

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)
   This information is not provided and is not typically relevant for a 510(k) submission for a physical device like a ventilator interface. "Ground truth" in the context of expert consensus is specific to diagnostic AI/ML algorithms, not general medical devices. Functional testing would rely on engineering standards and measurement accuracy, not expert consensus on interpretations.

4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
   This information is not provided and is not relevant for this type of device submission. Adjudication methods are specific to processes involving human interpretation outcomes for establishing ground truth, typically in AI/ML validation.

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 information is not provided. MRMC studies are specific to evaluating AI/ML systems that assist human readers in tasks like image interpretation. This device is a physical ventilator interface, not an AI/ML assistant, so such a study would not apply.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
   This information is not provided. This question is specific to AI/ML algorithms and is not applicable to a physical medical device like the Nasal-Aire Critical Care.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)
   For the functional and biocompatibility testing mentioned, the "ground truth" would be established by scientific and engineering standards, not expert consensus, pathology, or outcomes data in the sense used for AI/ML or clinical trials. For instance, biocompatibility testing would adhere to ISO standards, and functional testing would involve measuring parameters against predefined specifications (e.g., pressure delivery, connection compatibility). The document states "Biocompatability requirements and functional testing relative to the intended use of the Nasal-Aire Critical Care have been satisfactorily completed," implying compliance with relevant standards.

8. The sample size for the training set
   This information is not provided and is not applicable. There is no "training set" for a physical device in the way there is for an AI/ML algorithm.

9. How the ground truth for the training set was established
   This information is not provided and is not applicable for the same reasons as point 8.

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The Nasal-Aire //™ Interface is an accessory to positive pressure ventilation devices for patients suffering from Obstructive Sleep Apnea requiring positive pressure breathing therapy (i.e. CPAP, BiLevel)

Nasal-Aire IITM Accessory to a Positive Pressure Ventilation Device

This looks like a 510(k) clearance letter for a medical device (Nasal-Aire II accessory) that does not contain information about acceptance criteria or a study that proves the device meets specific performance criteria.

The provided text is a standard FDA 510(k) clearance letter, which states that the device is "substantially equivalent" to legally marketed predicate devices. This type of clearance generally relies on demonstrating similarity to existing devices rather than presenting novel performance studies with specific acceptance criteria.

Therefore, I cannot extract the requested information from the provided text. To answer your questions, I would need a different type of document, such as a summary of safety and effectiveness (SSE) or a clinical study report submitted with the 510(k) application, which would detail any performance testing conducted.

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