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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 Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP therapy.

The Aura™ CPAP Patient Interface is an accessory to continuous positive airway pressure (CPAP) devices, which are applied to treat Obstructive Sleep Apnea with CPAP or Bi-Level CPAP. The Aura™ CPAP Patient Interface has three significant components: 1) Headgear Assembly, 2) Nasal Seal Assembly, and 3) Tubing and Adjustment Assembly. The Headgear Assembly holds the device Tubing and Adjustment Assembly, and the Nasal Seal Assembly in place on the user's head. The Headgear Assembly is adjustable by the user. The Nasal Seal Assembly is made from a silicone material which connects to the Tubing and Adjustment Assembly. The Nasal Seal Assembly provides the airflow pathway to the user's nasal openings. The Tubing and Adjustment Assembly connects to the CPAP System. The Tubing and Adjustment Assembly passes the constant air pressure of the CPAP System to the Nasal Seal Assembly. The Tubing and Adjustment Assembly allows the positioning of the Nasal Seal Assembly for the comfort of the user. The Tubing and Adjustment Assembly allows for the positions of the Nasal Seal Assembly in both dimensions: away from the face and in the vertical direction.

This document is a 510(k) premarket notification for the Aura™ CPAP Patient Interface. It primarily focuses on demonstrating substantial equivalence to predicate devices rather than proving performance against specific acceptance criteria through a clinical study with detailed statistical outcomes. Therefore, many of the requested elements (e.g., sample sizes, expert qualifications, MRMC studies, training set details) are not explicitly present in the provided text.

Based on the information provided in the document:

1. Table of Acceptance Criteria and Reported Device Performance:

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

• Sample Size: Not explicitly stated. The document refers to "Laboratory and standards compliance" being provided, suggesting a bench study or testing against recognized standards rather than a clinical human test set with a specific sample size.
• Data Provenance: Not explicitly stated, given the nature of the submission focusing on substantial equivalence based on technical specifications and standards compliance, rather than a clinical trial.

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

• Not applicable/Not mentioned. Ground truth in the context of device performance for substantial equivalence is typically established through engineering specifications, material testing, and compliance with industry standards, not by expert consensus on clinical cases in the way an AI diagnostic algorithm might be evaluated.

4. Adjudication method for the test set:

• Not applicable/Not mentioned. Adjudication methods are relevant for clinical studies involving human interpretation or challenging diagnoses, which is not the primary focus of this 510(k) 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:

• No. An MRMC comparative effectiveness study was not done. This device is a physical medical accessory (CPAP mask), not an AI-powered diagnostic or assistive tool for human readers.

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

• Not applicable. This is a physical device, not an algorithm.

7. The type of ground truth used:

• The ground truth in this context is based on engineering specifications, material properties, laboratory testing against recognized standards (e.g., biocompatibility, pressure performance, leak rates for CPAP masks), and functional equivalence to legally marketed predicate devices. It does not involve expert consensus on clinical cases or pathology reports in the manner of a diagnostic device.

8. The sample size for the training set:

• Not applicable. Training sets are relevant for machine learning algorithms. This device is a physical medical accessory.

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

• Not applicable. As this is not an algorithm, there is no training set or ground truth established in that manner.

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The Tiara Medical Systems SNAPP is intended to be used with continuous positive airway pressure devices (CPAP), operating at or above 3 cmH20 for the treatment of obstructive sleep apnea. The SNAPP is intended for single patient use and can be used in the home or in a hospital/institutional environment. The SNAPP is to be used on adult patients (>30Kg) for whom continuous positive airway pressure has been prescribed.

The Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure is a nasal cannula with inserts intended to be used with positive anway pressure devices such as CPAP (Continuous Possure). It provides a seal such that positive pressure from a positive pressure source is directed into the patient's nose. It is held in place with an adjustable headgear. It may be cleaned with mild soap and water. The cleaning process does not require disassembly.

The device consists of latex-free silicone air delivery tubes connecting a polycarbonate Wye adapter / swivel with a latex-free silicone soft, resilient nasal inserts which form a seal with the nostrils.

The device connects to a conventional air delivery hose between itself and the positive airway pressure source via a standard 22 mm polycarbonate fitting on the combination Wye adapter / swivel. The built in vent slots are molded into the underside of the nasal insert body to direct air away from the patient's face and chest, and eliminate the need for a separate exhalation device. The vent slots may be visually checked for obstruction prior to use. The SNAPP Headgear is available in three sizes to fit a broad range of facial structures, and attaches to the SNAPP via slots molded into the nasal insert body.

The provided text is a 510(k) summary for the Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure, a nasal cannula for use with CPAP devices. It details the device's description, intended use, and claims of substantial equivalence to predicate devices. However, it does not contain the specific information requested regarding acceptance criteria or a detailed study proving the device meets said criteria.

The document states that "bench testing demonstrated there was no difference in the performance, safety, or effectiveness between the Tiara Medical Systems SNAPP Soft Nasal Accessory for Positive Pressure and the specified predicate devices." This is a general statement of equivalence, not a report of a specific study against predefined acceptance criteria.

Therefore, I cannot provide the requested table or detailed answers to questions 1-9 as the necessary information is not present in the provided text. The document focuses on establishing substantial equivalence based on overall comparison to predicate devices rather than reporting on a study with explicit acceptance criteria for the new device.

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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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