Search Results

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.

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

The submission describes non-clinical laboratory testing. There is no mention of a "test set" in the context of clinical data or patient samples. The tests were performed on the device prototypes themselves. The data provenance is laboratory testing conducted by Intersurgical Incorporated. There is no mention of country of origin for specific test data, but the company is based in Liverpool, NY, USA. The testing is prospective for the new devices, demonstrating their performance.

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

Not applicable. This is a non-clinical device performance study based on engineering specifications and physical measurements, not a diagnostic study requiring expert interpretation of results or establishment of "ground truth" as it would pertain to medical imaging or diagnostics.

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

Not applicable, as this is a non-clinical device performance study with objective measurements, not a study requiring adjudication of expert opinions.

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 is a medical device (exhalation valve) and not an AI or diagnostic imaging device that would typically undergo MRMC studies.

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

Not applicable. This is a mechanical medical device, not an algorithm.

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

For this non-clinical study, the "ground truth" is defined by established engineering principles, international standards (e.g., ISO 5356-1, ISO 10993-1), and the performance characteristics of the legally marketed predicate device. For example, resistance to flow is measured against a standard, and biocompatibility is confirmed against ISO 10993. The "performance" of the predicate device serves as a benchmark for substantial equivalence.

8. The sample size for the training set

Not applicable. There is no concept of a "training set" for a physical medical device submission of this nature. The devices themselves are the "samples" produced and tested.

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

Not applicable. No training set as per item 8.

Ask a specific question about this device

A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port. ISO connections: When assembling any connections use a push and twist action to ensure a secure fit. All ports should remain capped when not is use. Recommended Change: every 24 hours or more frequently if visible deterioration is observed. Single patient use. Non-conductive. Non-sterile. Do not autoclave. CAUTIONS: Federal law restricts this device to sale by or on the order of a physician.

A one-way valve that prevents the escape of inspiratory gases and rebreathing of expired gases while providing a means of egress for expired gases. Fits all 22 male T-pieces and allows the use of a PEEP valve as the gases exit the valve via a 22 mm port.

The provided text is a 510(k) clearance letter from the FDA for an "Exhalation Valve - PN 1922". It does not contain any information regarding acceptance criteria or a study that proves the device meets specific performance metrics.

The letter confirms that the device is substantially equivalent to legally marketed predicate devices and can therefore be marketed. However, it does not describe any specific performance studies, their results, or the methodology used to establish such results.

Therefore, I cannot provide the requested information. The document focuses on regulatory clearance based on substantial equivalence, not on a detailed scientific study of the device's performance against predefined acceptance criteria.

Ask a specific question about this device

Prevent escape of inspiratory gases and re-breathing of expired gases while providing a means of egress for expired gases

The reusable exhalation valves are designed for use with ventilators. The exhalation valve prevents the reasured gases from escaping through the passage that will be made available to expired gases via the inflatable balloon. Also, the re-breathing of the expired gases are prevented by the balloon action.

The provided text is a 510(k) premarket notification letter from the FDA, dated August 24, 1998, regarding Exhalation Valve Models BE 30-115-B, NS 30-115-U, NS 30-115-S, and PS 54-A.

Unfortunately, this document does not contain any information about acceptance criteria or a study that proves the device meets those criteria.

The letter is a regulatory approval, stating that the device is "substantially equivalent" to legally marketed predicate devices. This type of notification focuses on comparing a new device to an existing one that has already been approved, rather than presenting new performance study results against specific criteria.

Therefore, I cannot provide the requested information, including:

1. A table of acceptance criteria and reported device performance
2. Sample size and data provenance for the test set
3. Number and qualifications of experts for ground truth
4. Adjudication method for the test set
5. MRMC comparative effectiveness study results
6. Standalone performance study
7. Type of ground truth used
8. Sample size for the training set
9. Method for establishing ground truth for the training set

The document primarily states the device's classification, applicable regulations, and the FDA's decision regarding its marketability based on substantial equivalence. It does not delve into the detailed performance data or study methodologies that would typically be associated with demonstrating acceptance criteria.

Ask a specific question about this device