(188 days)
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850. The AirLife Infant Single Limb Heated Wire Circuit is intended for use with pediatic population, specifically the neonate (birth to 1 month of age) and infant (greater than 1 month to 2 years of age) pediative subgroups. The product is single use device, non-sterile and used in professional healthcare environments and intra-hospital transport environments under a supervision and by skilled clinicians.
The heated breathing circuit is intended to deliver and warm breathing gases before they enter the patient's airway. It is provided non sterile for single patient use. The heated breathing circuit is used with Fisher and Paykel heated humidifier MR850.
The provided text describes a 510(k) premarket notification for a medical device called the "AirLife Infant Single Limb Heated Wire Circuit." It focuses on demonstrating substantial equivalence to a predicate device. The information required for outlining acceptance criteria and a study proving a device meets them is not fully contained within this document because it is a submission for substantial equivalence, not a detailed clinical study report for a novel device.
However, based on the provided text, I can infer and extract some relevant details pertaining to performance testing and general acceptance principles for this type of device.
Here's an attempt to answer your request using the available information, with clear indications of where information is directly stated versus inferred as typical for a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
The document lists performance characteristics and the relevant standards they were tested against. For a 510(k) submission demonstrating substantial equivalence, the "acceptance criteria" are implied to be meeting the requirements set forth in these standards. The "reported device performance" is a general statement of compliance, rather than specific numerical results.
| Performance Characteristic | Acceptance Criteria (Implied by Standard) | Reported Device Performance |
|---|---|---|
| Biocompatibility | Compliance with ISO 10993 series for cytotoxicity, sensitization, irritation, muscle implantation, genotoxicity, and extractables/leachables. | Tested to ensure compliance; implied acceptable results. |
| Length | Compliance with ISO 5367:2000 (specific length tolerances would be defined within the standard, but not explicitly stated here). | Compliance with ISO 5367:2000 demonstrated. |
| Resistance to flow/Rated Flow | Compliance with ISO 5367:2000 (specific resistance limits would be defined within the standard). | Compliance with ISO 5367:2000 demonstrated. |
| Resistance to Flow @ 2.5 lpm | Compliance with ISO 5367:2014 (specific resistance limits would be defined within the standard). | Compliance with ISO 5367:2014 demonstrated. |
| Increase in Flow Resistance with Bending | Compliance with ISO 5367:2000, ISO 5367:2014. | Compliance with ISO 5367:2000, ISO 5367:2014 demonstrated. |
| Conical Connectors | Compliance with ISO 5367:2000, ISO 5356-1:2004, ISO 8185:2008 (ensuring proper fit and function). | Compliance with relevant ISO standards demonstrated. |
| Security of Attachment | Compliance with ISO 5367:2000 (ensuring connections remain secure). | Compliance with ISO 5367:2000 demonstrated. |
| Leakage | Compliance with ISO 5367:2000 (ensuring no unintended gas escape). | Compliance with ISO 5367:2000 demonstrated. |
| Compliance | Compliance with ISO 5367:2000, ISO 8185:2008 (regarding elasticity/flexibility requirements). | Compliance with relevant ISO standards demonstrated. |
| Humidity Output | Compliance with ISO 8185:2008 (ensuring adequate humidification levels are maintained). | Compliance with ISO 8185:2008 demonstrated. |
| Security of Engagement Temperature Sensor | Compliance with ISO 8185:2008 (ensuring temperature sensor is securely attached). | Compliance with ISO 8185:2008 demonstrated. |
| Leakage from Sensing Port | Compliance with ISO 8185:2008 (ensuring no leakage from the temperature sensing port). | Compliance with ISO 8185:2008 demonstrated. |
| Specific Enthalpy | Compliance with ISO 8185:2008 (related to humidification performance). | Compliance with ISO 8185:2008 demonstrated. |
| Surface Temperature | Compliance with ISO 8185:2008 (ensuring safe surface temperatures). | Compliance with ISO 8185:2008 demonstrated. |
| Steady State Noise | Compliance with ISO 8185:2008 (ensuring noise levels are within acceptable limits). | Compliance with ISO 8185:2008 demonstrated. |
| Electrical safety (Patient Leakage Current) | Compliance with IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) (ensuring electrical safety for patients). | Compliance with IEC 60601-1:2005 demonstrated. |
| Electrical safety (Dielectric Strength Means) | Compliance with IEC 60601-1:2005, 3rd Edition (AAMI ES60601-1:2005) (ensuring electrical insulation integrity). | Compliance with IEC 60601-1:2005 demonstrated. |
Regarding the study proving the device meets acceptance criteria:
The document broadly states: "The following tests were performed for the proposed device to support the substantial equivalence decision," and "The test results demonstrate that the device is as safe and effective as the predicate and therefore substantially equivalent to the predicate device." This indicates that a series of performance bench tests were conducted to verify compliance with the listed international standards (ISO, IEC, AAMI). These are typically laboratory-based engineering and material tests, not clinical studies involving human subjects in an "AI" context.
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified in the provided document. For engineering/bench tests, sample sizes would typically be determined by the specific standard's requirements (e.g., n=3, n=5, n=10 per test), but these details are not present.
- Data Provenance: The tests were performed by the manufacturer, CareFusion Inc., in support of their 510(k) submission to the FDA. The country of origin of the data would be the location where CareFusion conducted these tests, which is not explicitly stated but can be inferred as the US based on the company's US address. The data is retrospective in the sense that the tests were completed before the submission.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This is not applicable to this type of device and study. The testing described involves physical and electrical performance verification against defined standards, not evaluation by human experts or clinical ground truth.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods like 2+1 or 3+1 are used in clinical studies where expert consensus is needed for image interpretation or diagnosis. Bench testing against standards does not typically involve such 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
This is not applicable. This device is a heated breathing circuit, not an AI-powered diagnostic or assistive tool. Therefore, no MRMC study or AI-related comparative effectiveness was conducted or reported.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device does not involve any algorithms or AI for standalone performance evaluation.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this device's performance testing is adherence to the technical specifications and safety requirements outlined in the referenced international standards (e.g., ISO, IEC, AAMI). For biocompatibility, it's the results of specific biological assays. For mechanical and electrical properties, it's measurement against defined limits.
8. The sample size for the training set
This is not applicable. The device is a physical medical device (breathing circuit), not a machine learning model. Therefore, there is no "training set" in the context of an AI/ML algorithm.
9. How the ground truth for the training set was established
This is not applicable. As stated above, there is no training set for this device.
§ 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).