(307 days)
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:
| Characteristic Compared | Predicate Device (F & P RT 210) Acceptance Criteria | 510(k) Device (2026) Reported Performance |
|---|---|---|
| Volume (ml) | 1460 | 1106 |
| Tube Length (m) | 1.93 Ins & 1.48 Exp | 2.27 Ins & 1.46 Exp |
| Wire Resistance (ohms) | 17.2 Ins & 12.2 Exp | 14.7 Ins & 11.9 Exp |
| Tube material and designated diameter | Flex tube 22mm | Flex tube 22mm |
| Compliance (ml/Kpa) | 13.3 | 11.2 |
| Resistance to Flow (mb) | 3.1 Ins & 3.3 Exp | 2.9 Ins & 2.6 Exp |
| Sterility | NON STERILE | NON STERILE |
| Biocompatibility | Compliant with ISO 10993 | Compliant with ISO 10993 |
| Electrical safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Mechanical safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
| Chemical Safety | Compliant with ISO 8185 | Compliant with ISO 8185 |
For the 2310 Auto-Fill Humidification Chamber:
| Characteristic Compared | Predicate Device (F & P MR 290) Acceptance Criteria | 510(k) Device (2310) Reported Performance |
|---|---|---|
| Fill Volume (ml) | 355 But no fill lines | Full 369.9/ Max Line 147.1/ Min Line 51.1 |
| Weight (g) | 94 | 126 |
| Leakage (ml/min) |
§ 868.5270 Breathing system heater.
(a)
Identification. A breathing system heater is a device that is intended to warm breathing gases before they enter a patient's airway. The device may include a temperature controller.(b)
Classification. Class II (performance standards).