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The Inter-Therm Mini Pediatric HMEF Sterile is for use at the patient connections. The device is to be attached between the breathing circuit and patient connection. It is designed to reduce bacterial/viral transmission between the patient and equipment and to reduce the loss of patient heat and humidity. The filter is for single patient use only and therefore must be disposed of after a single patient usage and/or after its maximum duration of use at 24 hours. The device is a single use device that is required to be changed daily when used with devices (i.e. long-term ventilators) that are design to have patient body contact between 24 hours to

The Inter-Therm Mini Pediatric is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated, humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has a 22F/15M connector at the machine end and a 22M/15F connector at the patient end.

The Inter-Therm Mini Pediatric angled HMEF is a sterile HMEF used for passive humidification in pediatric patients under mechanical ventilation or anesthesia. The HMEF contains a HME paper and electrostatic filter pad incased in a plastic housing. The HME paper traps heat and moisture from the patient's exhaled air which is then returned in the inspiratory air to the patient. Therefore the patient receives heated humidified air. The electrostatic filter pad prevents bacterial and viral cross-contamination between the breathing system and the patient. The HMEF has an additional luer lock port for CO2 monitoring with a retainable luer port cap to block the port when it is not in use. The HMEF has an angled 15M machine connecter end, eliminating the need to use an elbow in the breathing circuit. The patient end is a straight 22M/15F connector.

This document describes the safety and effectiveness summary for two medical devices: the Inter-Therm Mini Pediatric HMEF sterile (Product # 1331030S) and the Inter-Therm Mini Pediatric angled HMEF sterile (Product # 1332030S). Both are Heat and Moisture Exchanger Filters (HMEFs) designed for passive humidification and bacterial/viral filtration in pediatric patients under mechanical ventilation or anesthesia. The submission seeks substantial equivalence to the Covidien 355U5430 DAR Infant - Pediatric Electrostatic Filter HME (Small - K941381- Hygroboy).

Here's the breakdown of the acceptance criteria and the study that proves the device meets them:

1. Table of Acceptance Criteria and Reported Device Performance:

The document provides a comparison table against a predicate device. For the purpose of this analysis, the "Acceptance Criteria" are implicitly defined by the performance characteristics of the predicate device (DAR Infant - Pediatric Electrostatic Filter HME - K941381), signifying that the new devices should perform similarly or better. The "Reported Device Performance" refers to the values for the new Intersurgical devices.

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

The document explicitly states: "Non-clinical test results are submitted to confirm product safety and substantial equivalence to predicate device." and "Nonclinical tests submitted to demonstrate substantial equivalence for moisture return, resistance to flow, weight, tapers and filtration efficiency."

• Sample Size for Test Set: Not explicitly stated as a number of devices tested. The data presented in the comparison table are performance metrics, implying that testing was conducted on a sufficient number of units to obtain these typical or representative values.
• Data Provenance: The tests are "non-clinical," meaning they were likely conducted in a laboratory or engineering environment. The country of origin for the data is not specified. It is a prospective evaluation as these tests were conducted on the new devices to demonstrate equivalence.

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

This information is not applicable in this context. The document describes a 510(k) submission for substantial equivalence based on non-clinical, performance testing of a medical device, not an AI or diagnostic tool where expert ground truth interpretation would be required. The "ground truth" here is objective physical and performance measurements (e.g., moisture return, resistance to flow, weight) as per established international standards.

4. Adjudication method for the test set:

This information is not applicable. As stated above, this is non-clinical performance testing against objective standards and comparison with a predicate device, not a study involving human interpretation of medical data that would require an adjudication method.

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 applicable. This is a 510(k) submission for a physical medical device (HMEF) and not an AI-assisted diagnostic tool. Therefore, no MRMC study or AI improvement metrics are provided or relevant.

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

This information is not applicable. This submission is for a physical medical device (HMEF) and does not involve an algorithm or AI.

7. The type of ground truth used:

The "ground truth" for this submission are the performance specifications and measurements obtained through standardized non-clinical testing. These include:

• Objective physical measurements (e.g., compressible volume, weight).
• Functional performance measurements according to international standards (e.g., moisture return per ISO 9360-1:1992, resistance to flow, filtration efficiency).
• Compliance with connector standards (ISO 5356-1:2004, ISO 594-2:1998).
• Biocompatibility testing against a regulatory memo (Bluebook Memo, G95-1).

The ground truth is established by these objective, reproducible tests and comparison to a legally marketed predicate device.

8. The sample size for the training set:

This information is not applicable. This medical device submission 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:

This information is not applicable. As explained above, there is no "training set" for this device submission.

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The exhalation valves are used to control Inspiratory pressure and expel the expired air from a patient being ventilated via a single limb breathing system. The exhalation valve and single limb breathing systems are used with adults/pediatrics and prescribed by a physician. A pediatric is defined as 10 kg in weight. The product is not for use in neonates. The device can be used within hospitals and for home care use. It is a single patient use device and can be used for a maximum of 30 days.

Double limb breathing systems comprising of an inspiratory and expiratory limb is commonly used for respiratory care. To reduce waste and clutter single limb breathing systems can be used with an exhalation valve to dispel exhaled air from the patient. Some ventilator designs or specifications do not require proximal pressure monitoring; airway pressure is monitored inside the ventilator. There are three variants of the exhalation valve in this submission.

Exhalation valve with proximal pressure port (1924501 &1924504): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. A pressure monitor line and exhalation valve control line directly connects the valve to the ventilator. Via exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases yet allowing for a single limb breathing system to be used instead of a double limb system. The pressure line monitors the pressure in the valve body. The patient end of the exhalation valve has a swivel connector end.

Exhalation valve without proximal proximal prossure port (1923500): A single breathing tube connects the patient to the ventilator allowing the patient to receive respiratory care. The exhalation valve is connected at the patient end onto the breathing tube. An exhalation valve control line directly connects the valve to the ventilator. Via the exhalation valve control line, the ventilator applies a pressure which controls the balloon valve. During the Inspiratory phase the balloon is inflated to close off the exhalation port in the valve body. During the expiratory phase the pressure is released in the valve chamber and the balloon deflates allowing air to be expelled to the surrounding environment via the exhalation port. This prevents the patient rebreathing exhaled gases vet allowing for a single limb breathing system to be used instead of a double limb system. The patient end of the exhalation valve has a swivel connector end.

Different ventilators require valves which work with different pressure ratios. The MKIII exhalation valve (1923500 and 1924501) has a 1:1.5 pressure ratio which caters for the majority of ventilators. However, there are markets which have applications for ratio of 1:1, and 1:2. The MK3b exhalation valve (1924504) has a 1:2 pressure ratio. The pressure ratio is the pressure difference between the control line pressure and the pressure that will be generated on the patient side of the valve.

This K132143 submission describes the Intersurgical Exhalation Valve (MK3 and MK3b models) and demonstrates its substantial equivalence to a predicate device (Intersurgical 1922500 exhalation valve) through non-clinical testing.

Here's a breakdown of the requested information:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not explicitly list "acceptance criteria" in a numerical format that would typically be seen for a device like software. Instead, it presents a comparison of key performance characteristics between the new devices and the predicate, implying that performance comparable to the predicate is the acceptance criteria for substantial equivalence. The "Acceptance Criteria" below are inferred from the predicate's performance or internal requirements.

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The FaceFit Ported Mask channels airflow noninvasively to a patient from a positive airway pressure device such as a continuous positive airway pressure (CPAP) or bi-level system. This is a disposable mask. It is intended to be used for 24 hours of treatment of a single patient only, and then discarded. The masks are intended to be used in hospitals.

The Intersurgical FaceFit Ported NIV Mask provides a seal such that air flow from a positive pressure source is directed to the patient's nose or mouth. The mask is held in place with adjustable headgear that straps the mask to the face. The Intersurgical Face Fit Mask is safe when used under the conditions and purposes intended as indicated in the labeling provided with the product. FaceFit Ported Mask with a CO2 port for use with BIPAP and CPAP machines. The FaceFit Ported Mask features an anti-asphyxiation valve that will allow patients using a CPAP or BIPAP machine to breathe spontaneously through the mask in the event of a machine failure or system disconnection. The FaceFit ported mask is available in small, medium and large sizes.

The Intersurgical FaceFit Ported NIV Mask (K121747) was cleared based on substantial equivalence to the Resmed Mirage Full Face Mask (K063011). The device is a non-invasive ventilation mask intended to channel airflow from a positive airway pressure device to a patient.

Here's an analysis of the acceptance criteria and the study that proves the device meets them:

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

The acceptance criteria are implicitly defined by demonstrating similar performance characteristics to the predicate device. The following table summarizes key performance characteristics compared between the proposed device and the predicate device:

2. Sample size 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 a "sample size" in terms of number of patients or masks tested for the performance evaluations. Instead, the testing appears to be based on a comparison of technical specifications and measured physical characteristics of the device and its predicate.

The data provenance is not explicitly stated, but as this is a premarket notification to the FDA, it is expected that the testing was conducted by the manufacturer (Intersurgical Incorporated) likely in the country of origin of the manufacturer or in accredited testing facilities. The specific type of study (retrospective or prospective) is not applicable here as these are laboratory/bench tests, not clinical evaluations on human subjects for performance comparison against the predicate.

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 applicable. The "ground truth" for this device's performance metrics (CO2 rebreathing, respiratory resistance, valve function, volume) is established through standardized engineering and laboratory testing, not through expert clinical consensus or interpretation as would be the case for diagnostic imaging AI.

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

This information is not applicable as the "test set" in this context refers to laboratory performance measurements, not clinical interpretation or diagnostic outcomes requiring adjudication.

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

A multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for AI-powered diagnostic devices that assist human interpretation, not for physical medical devices like NIV masks.

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

This information is not applicable. The device is a physical medical device, not an algorithm, so "standalone performance" in the context of AI does not apply. The performance data provided are inherent to the device's physical design and function.

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

The "ground truth" for the performance characteristics of the NIV mask is derived from objective, quantitative measurements in a laboratory setting based on established engineering and physiological testing standards (e.g., measuring CO2 rebreathing as a percentage, respiratory resistance in millibars, and valve flow rates). This is analogous to "bench testing" data rather than clinical ground truth obtained from patients or experts.

8. The sample size for the training set

This information is not applicable. This device is a physical product and does not involve machine learning or AI algorithms with "training sets."

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

This information is not applicable as there is no training set for this device.

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