(67 days)
The Hudson Heated Wire Ventilator Circuit is intended as a conduit for respiratory gas between a patient and a ventilator, and includes heated wires for use with a Concha Column Humidifier; the heated wires are intended to minimize condensation in the ventilator tubing.
Breathing circuit that is intended to administer medical gases to a patient. It provides both an inhalation and exhalation route and may include a connector, adaptor, and Y piece. The heated wires are intended to minimize condensation in the ventilator tubing.
The provided document is a 510(k) summary for a medical device called the "Hudson RCI Heated Wire Ventilator Circuit." This type of submission is for demonstrating substantial equivalence to a predicate device, not for proving the device meets acceptance criteria through a clinical study involving AI or human readers.
Therefore, most of the requested information regarding acceptance criteria, study details, sample sizes, ground truth establishment, expert qualifications, adjudication methods, MRMC studies, standalone performance, and training sets is not applicable to this document. This document outlines the physical and performance characteristics of the proposed device and compares them to a legally marketed predicate device to establish substantial equivalence.
Here's a breakdown of the relevant information from the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't explicitly state "acceptance criteria" in the way a clinical study would for efficacy. Instead, it provides a comparison of specifications and performance tests between the proposed device and its predicate. The "acceptance criteria" are implied by the performance of the predicate device, which the new device aims to be substantially equivalent to or improve upon.
| Feature / Performance Test (Predicate Device K881625) | Acceptance Criteria (Implied by Predicate) | Reported Device Performance (Proposed Device K031383) |
|---|---|---|
| Length | 1.83 meters | 1.52 meters |
| Resistance (per ISO 5367): | ||
| Inspiratory @ 30 LPM, air | 0.9 cmH2O (0.09 kPa)/L/sec | 0.8 cmH2O (0.08 kPa)/L/sec |
| Inspiratory @ 60 LPM, air | 1.5 cmH2O (0.15 kPa)/L/sec | 1.3 cmH2O (0.13 kPa)/L/sec |
| Inspiratory @ 90 LPM, air | 2.2 cmH2O (0.22 kPa)/L/sec | 1.9 cmH2O (0.19 kPa)/L/sec |
| Inspiratory @ 120 LPM, air | 2.8 cmH2O (0.28 kPa)/L/sec | 2.4 cmH2O (0.24 kPa)/L/sec |
| Expiratory @ 30 LPM, air | 0.7 cmH2O (0.07 kPa)/L/sec | 0.8 cmH2O (0.08 kPa)/L/sec |
| Expiratory @ 60 LPM, air | 1.3 cmH2O (0.13 kPa)/L/sec | 1.3 cmH2O (0.13 kPa)/L/sec |
| Expiratory @ 90 LPM, air | 1.9 cmH2O (0.19 kPa)/L/sec | 1.9 cmH2O (0.19 kPa)/L/sec |
| Expiratory @ 120 LPM, air | 2.4 cmH2O (0.24 kPa)/L/sec | 2.4 cmH2O (0.24 kPa)/L/sec |
| Compliance (per ISO 5367): | ||
| @ 60 cmH2O (6 kPa) | 2.25 ml/ cmH2O | 2.25 ml/ cmH2O |
| @ 90 cmH2O (8.8 kPa) | 2.16 ml/ cmH2O | 2.16 ml/ cmH2O |
| @ 110 cmH2O (11kPa) | 2.22 ml/ cmH2O | 2.22 ml/ cmH2O |
| Leak Rate | less than 60 ml/min @ 90 cmH2O | less than 60 ml/min @ 90 cmH2O |
| Materials of Construction (Key Differences) | Inspiratory circuit to humidifier adapter: High Density Polypropylene; Expiratory circuit to ventilator adapter: Low Density Polypropylene; Heated Wire Harness: copper conductor, polyethylene core, polyvinylchloride insulator; Wire connector: Brass with tin plate. | Inspiratory circuit to humidifier adapter: High Density Polyethylene; Expiratory circuit to ventilator adapter: Low Density Polyethylene; Heated Wire Harness: copper / nickel conductor, polyvinylchloride insulator; Wire connector: Phosphor bronz with tin/lead plate. |
| Design (Key Differences) | Inspiratory circuit to humidifier adapter: Single piece, right angle elbow adapter; Corrugated tubing: Seventy-two (72") inch; Expiratory circuit to ventilator adapter: Single piece, straight adapter; Heated Wire entry grommet: Insert molded; Heated Wire Harness: Single strand (Inspiratory & Expiratory). | Inspiratory circuit to humidifier adapter: Two piece, 60 degree angle adapter; Corrugated tubing: Sixty (60") inch; Expiratory circuit to ventilator adapter: Two piece, 60 degree angle adapter; Heated Wire entry grommet: Injection molded "clam shell grommet"; Heated Wire Harness: Seven strand (Inspiratory & Expiratory). |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in a 510(k) summary for a physical device. The testing described (e.g., resistance, compliance, leak rate) is laboratory-based performance testing of the device itself, not a clinical study with a "test set" of patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. There is no concept of "ground truth" or "experts" in the context of this device's performance testing described in the summary. The tests evaluate physical properties against established standards (ISO 5367).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. See point 3.
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 physical breathing circuit, not an AI-powered diagnostic device.
6. If a standalone (i.e. algorithm only without human-in-the loop performance) was done
Not applicable. This is a physical breathing circuit, not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
Not applicable. The "ground truth" for this device's performance is derived from standardized physical measurements and engineering specifications, primarily based on the ISO 5367 standard for breathing tubes and connectors.
8. The sample size for the training set
Not applicable. There is no training set for this type of device submission.
9. How the ground truth for the training set was established
Not applicable. There is no training set for this type of device submission.
§ 868.5450 Respiratory gas humidifier.
(a)
Identification. A respiratory gas humidifier is a device that is intended to add moisture to, and sometimes to warm, the breathing gases for administration to a patient. Cascade, gas, heated, and prefilled humidifiers are included in this generic type of device.(b)
Classification. Class II (performance standards).