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Breathing system heaters are defined as a device that is intended to warm breathing gases before they enter a patient's airway.
Humidification chambers are intended for use to hold water required to humidify the air being delivered to patients.

The 2026 and 2026-CH dual heated wire breathing circuits are classified as "Breathing System Heater" according to 21 CFR 868.5270. The breathing circuits form part of the respiratory humidification system in which the inspiratory limb delivers humidified gas to the patient and the expiratory limb carries the expired gas away from the patient. Heater wires in the inspiratory and expiratory limb minimizes the formation of condensate.

The 2310 Auto-Fill Humidification Chamber, 2320 Manual Fill Humidification Chamber and the 2330 Low Volume Manual Fill Humidification Chamber are classified as accessories to "Breathing System Heater" according to 21 CFR 868.5270. Chambers are an integral part of the breathing system and allow the system to interface with the heated humidifier base. Chambers are commonly used with heated wire breathing systems. The chamber simply slides into position on the hot plate of the base controller allowing the inspiratory gas to pass over the heated water. This provides optimum humidification to the patient.

The 2310 Auto-Fill Chamber offers a fixed level of water within the chamber, ensuring a constant system volume. The float mechanism along with the webs inside the chamber and baffles at the base of the 22mm male connectors, ensure that the chamber gives maximum humidity output without compromising resistance to flow.

The 2320 Manual-Fill Chamber is supplied with a complete fill set and clamp in order to manually control the water level in the chamber.

The 2330 Low-Volume Chamber is suitable for use with high frequency ventilation and many neonatal applications. The chamber is supplied with a fill set and clamp in order to manually control the water level in the chamber.

The provided document describes a 510(k) submission for Interurgical Inc.'s heated wire breathing systems and humidification chambers, demonstrating substantial equivalence to predicate devices rather than proving the device meets acceptance criteria through a traditional clinical study. The "acceptance criteria" are implicitly defined by the performance characteristics of the predicate devices and relevant industry standards. The "study" refers to nonclinical tests performed to show comparability.

Here's a breakdown of the requested information based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

The document presents performance characteristics of the proposed devices (Intersurgical 2026, 2310, 2320, 2330) and compares them to their respective predicate devices. The "acceptance criteria" can be inferred as being similar to or meeting the performance of the predicate devices and complying with relevant standards.

For the 2026 Heated Wire Breathing Circuit:

For the 2310 Auto-Fill Humidification Chamber:

For the 2320 Manual Fill Humidification Chamber:

For the 2330 Low Volume Manual Fill Humidification Chamber:

2. Sample Size Used for the Test Set and Data Provenance

The document does not explicitly state sample sizes for individual tests. It refers to "Test Results" and "Summary Conformance" with numerous page numbers (e.g., "See Pages 19 to 44 for Summary Conformance," "See Pages 45 to 86 for test reports"). The provenance of the data is retrospective, as the comparisons are made against existing predicate devices and in-house testing. The country of origin for the data is implied to be internal testing by Intersurgical Incorporated and Nelson Laboratories (for biocompatibility), likely in the USA where the company address is located, but it's not explicitly stated for all tests.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts

This type of information is not applicable to this submission. The "ground truth" here is based on objective measurements and compliance with established industry standards (ISO 5367, ISO 9360, ISO 8185, ISO 10993, ISO 5356, EN 12342), not expert consensus on qualitative data.

4. Adjudication Method for the Test Set

Not applicable. Adjudication methods (like 2+1 or 3+1) are typically used for subjective assessments where expert agreement is needed to establish ground truth, which is not the case for these objective performance tests.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, and Effect Size

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This is a technical device performance study, not an AI-assisted diagnostic study.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done

Not applicable. This document describes the performance of a physical medical device (breathing circuit and humidification chambers), not a software algorithm.

7. The Type of Ground Truth Used

The ground truth used for the device evaluation is based on:

• Established Industry Standards: ISO 5367, ISO 9360, ISO 8185, ISO 10993, ISO 5356, EN 12342.
• Performance Metrics of Legally Marketed Predicate Devices: The specific values for characteristics like volume, resistance to flow, weight, leakage, moisture output, etc., of the Fisher & Paykel predicate devices (RT210, MR 290, MR 210, MR 225).
• Laboratory Testing: For properties like biocompatibility (per ISO 10993) by Nelson Laboratories, and various electrical, mechanical, chemical, and thermal safety tests.

8. The Sample Size for the Training Set

Not applicable. This document pertains to a physical medical device and its performance testing, not a machine learning model that requires a training set.

9. How the Ground Truth for the Training Set Was Established

Not applicable, as there is no training set for this type of device submission.

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