(110 days)
The disposable heated wire circuit is a heated wire breathing circuit intended to provide warmed and/or humidified breathing gases before they enter a patient's airway. The disposable heated wire circuit is indicated for use by a single adult or pediatric patient in the home, hospital and/or institutional settings. It may be used for both invasive and non-invasive ventilation.
The Respironics heated wire breathing circuit is a disposable device compromised of 15 or 22 mm corrugated plastic tubing, and 22 mm plastic tube connectors, and an electrical heater wire harness subassembly. The Respironics disposable heated wire circuit consists of a single limb single lumen smooth interior tube (15 or 22 mm diameter) containing 2 heater wires that are located in the tubing construction of which the tube is formed having a supporting structure; the tube is spiral and the wire has a single loop form. After the gas is warmed and humidified in the water chamber it is delivered through the breathing circuit to the patient. Heating of the breathing tube is provided and controlled by a compatible heated humidifier. This disposable heated wire circuit is designed to be used with the HC500 Fisher and Paykel humidifier. The heating wires are physically separated from the lumen of the tubing. As such, there is no direct contact between the heating wires and the air flow. When a voltage is applied, a current flows through the heating wires. Due to the wire resistance, heat is dissipated through the wall of the tube construction into the air flow in the lumen of the tubing.
There are four types of disposable breathing circuits:
- l . Disposable Pediatric, Heated Wire Active Circuit
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- Disposable Adult, Heated Wire Active Circuit
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- Disposable Pediatric, Heated Wire Passive Circuit
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- Disposable Adult, Heated Wire Passive Circuit
The purpose of the heated wire breathing circuits is to maintain or raise the gas temperature to or above the dew point thus reducing or eliminating water condensation and/or pooling of water in the breathing circuit.
The Respironics disposable heated wire breathing circuit has standard cuffs on both the machine-end cuff and mask-end cuff. As such, the disposable heated wire breathing circuit can be connected to heated humidifiers and flow generators that have standard male outlet connectors. The Respironics disposable heated wire breathing circuit is intended for incorporation into ventilator devices and is intended to act as a conduit for the breathing gasses delivered from the humidifier to the patient. It can also be used in conjunction with supplemental Oxygen.
The environment of use for the disposable heated wire breathing circuit will be for in the home, institutional, nursing, extended care, and clinical sleep lab settings.
Operators of the disposable heated wire breathing circuit are expected to be: Patients, Lay caregivers (includes family members of patients and aides), Nurses, Respiratory therapists, Physicians and Home care providers.
The disposable heated wire breathing circuit is intended to be used with ventilators that provide both pressure support and volume modes of therapy.
Other accessories such as water traps, etc. can be added in to the overall assembly creating different product variations.
Acceptance Criteria and Study for Respironics Disposable Heated Wire Circuits (K110398)
This submission describes a medical device, the Respironics Disposable Heated Wire Circuits, which is a breathing circuit designed to warm and/or humidify breathing gases for patients. The application for clearance is an Abbreviated 510(k), indicating reliance on recognized standards and predicate devices.
1. Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Respironics Disposable Heated Wire Circuits are not explicitly stated in a quantitative table within the provided document. Instead, the submission demonstrates substantial equivalence to predicate devices by showing similar values for key performance characteristics and compliance with recognized standards.
The criteria for acceptance are implicitly derived from the comparison to predicate devices and adherence to the listed standards. The reported device performance is that the Respironics Disposable Heated Wire Circuits achieved "passing all test protocols" for general requirements.
Here's a table summarizing the comparison to predicate devices, which serves as the basis for demonstrating equivalence and thus, meeting implicit acceptance criteria:
| Feature/Function | Predicate Device: Plastiflex Healthcare Hybernite Rainout Control System (K100104) | Predicate Device: Intersurgical Heated Wire Breathing System (K092129) | Predicate Device: Fisher & Paykel Respiratory Humidifier (K983112) | Respironics Disposable Heated Wire Circuits (New Device) | Similarity/Difference | Impact on Safety and Effectiveness |
|---|---|---|---|---|---|---|
| Common or usual name | Heated Breathing Tube, Breathing system heater | Heated Breathing Tube, Breathing system heater | Respiratory humidifier with accessories (including heated wire circuits) | Heated Breathing Tube, Breathing system heater | Similar | No impact |
| Classification | Class II | Class II | Class II | Class II | Same | No impact |
| Classification Panel | Anesthesiology | Anesthesiology | Anesthesiology | Anesthesiology | Same | No impact |
| Product Code | BZE - heater, breathing system w/wo controller | BZE - heater, breathing system w/wo controller | BTT - humidifier, respiratory gas | BZE - heater, breathing system w/wo controller | Same | No impact |
| CFR Regulation Number | 21 CFR 868.5270 | 21 CFR 868.5270 | 21 CFR 868.5270 & 21 CFR 868.5450 | 21 CFR 868.5270 | Same | No impact |
| Intended Use | Provide warmed and/or humidified breathing gases; non-invasive ventilation; home or sleep-lab setting; single adult patient | Warm breathing gases before entering patient's airway (general definition) | Add moisture to, and sometimes to warm, breathing gases; all settings; mechanical ventilation etc. | Provide warmed and/or humidified breathing gases; invasive & non-invasive ventilation; home, hospital, institutional settings; single adult or pediatric patient | N/A (Similar) | No impact |
| Anatomical Sites | Non-invasive | Not Specified | Invasive & Non-invasive | Invasive & Non-invasive | Same | No impact |
| Target Patient Population | Adult | Any patient using a heated humidifier | Any patient using a heated humidifier | Pediatric (>= 5kg) to Adult | Similar | No impact |
| Environment of Use | Home or Sleep Lab Setting | Hospital Setting | Home, Institution/Hospital Setting, Extended Care and Clinical Sleep settings | Home, Institution/Hospital Setting, Extended Care and Clinical Sleep settings | Same | No impact |
| Sterility | Non-Sterile | Not Specified | Non-Sterile | Non-Sterile | Similar | No impact |
| Compatible with Humidifiers | Universal | For use with Intersurgical model humidifiers | For use with F&P model humidifiers | For use with F&P 500 | Similar | No impact |
| Breathing Gases Specified | Air & Supplemental Oxygen | Not Specified | Air & Supplemental Oxygen | Air & Supplemental Oxygen | Similar | No impact |
| Standard Polymeric Materials | Yes | Yes | Yes | Yes | Similar | No impact |
| Tube Diameter | 15 and 22 mm configurations | 22mm | 15 and 22 mm configurations | 15 and 22 mm configurations | Similar | No impact |
| Tube Length | ~1.5 m | ~1.5 m | 1.5 m | 1.83 m | Same | No impact |
| Power Source | Separate | Incorporated (humidifier controlled) | Incorporated (humidifier controlled) | Incorporated (humidifier controlled) | Similar | No impact |
| Heating Wire | Encased | Encased | Encased | Encased | Same | No impact |
| Wire Resistance (ohms) | Not specified | 14.7 Ins & 11.9 Exp | Not specified | 30 +/- 5% | Similar | No impact |
| Active Controller | No – Power source controlled | No - Humidifier Controlled | No – Humidifier Controlled | No – Humidifier Controlled | Similar | No impact |
| Standards of Conformity | ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1, ISO 14971 | ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1 | ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1, ISO 14971 | ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, IEC 60601-1-2, AAMI/ANSI/ISO 10993-1, ISO 14971 | Similar | No impact |
| Electrical Safety | IEC 60601-1 compliant | IEC 60601-1 compliant | IEC 60601-1 compliant | IEC 60601-1 compliant | Same | No impact |
The submission asserts that the new device "does not raise any new issues of safety and effectiveness" due to these similarities and successful performance testing.
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 refers extensively to "performance testing" and "non-clinical testing" for the device, including mechanical, electrical, and temperature accuracy under environmental conditions, as well as electromagnetic immunity. However, specific sample sizes for these test sets are not provided within the given text.
The data provenance is not explicitly stated as retrospective or prospective, nor is a country of origin for the data provided. The studies were conducted by the manufacturer, Respironics, Inc. (Monroeville, PA, USA) and potentially their contract manufacturer, WILAmed GMBH (Kammerstein, Germany).
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This document describes a medical device (heated wire breathing circuits) and its performance based on bench testing and comparison to predicate devices and recognized standards. There is no mention of a "test set" requiring ground truth established by human experts in the context of diagnostic interpretation or clinical outcomes. Therefore, this question is not applicable to the information provided.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
As there is no mention of a test set requiring human expert adjudication (such as in an AI/diagnostic imaging study), this question is not applicable. The testing described is primarily bench testing against engineering standards and specifications.
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 is not applicable as the device is a heated wire breathing circuit, not an AI or diagnostic imaging device that would involve human readers or an MRMC study.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable as the device is a medical accessory (heated wire breathing circuit) and does not involve an algorithm or AI. The performance testing refers to the physical and electrical characteristics of the device itself.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is typically established by:
- Engineering specifications: The device is designed to meet specific technical parameters (e.g., resistance to flow, temperature range, wire resistance).
- Voluntary consensus standards: Compliance with international and national standards like ISO 5367, ISO 5356-1, ISO 8185, IEC 60601-1, AAMI/ANSI/ISO 10993-1 constitutes the "truth" of its performance and safety in specific areas.
- Predicate device characteristics: The performance of legally marketed predicate devices serves as a benchmark for comparison to demonstrate substantial equivalence.
There is no mention of ground truth derived from expert consensus, pathology, or outcomes data, as this is a non-clinical submission for a device component.
8. The sample size for the training set
This is not applicable as the device is a physical breathing circuit, not an AI or machine learning algorithm that requires a "training set."
9. How the ground truth for the training set was established
This is not applicable as the device is a physical breathing circuit and does not involve a training set.
§ 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).