(182 days)
The Hudson RCI Comfort Flo® CubCannula™ is a single use nasal cannula intended to administer respiratory gas to a spontaneously breathing patient through both nostrils delivering flow rates ranging from 1 to 25 LPM.
CubCannula™ is a patient interface used to deliver heated and humidified gas to the following populations:
- · Neonates, birth to 1 month of age
- · Infants, 1 month to 2 years of age
- · Children, 2 to 12 years of age
CubCannula™ is designed for use in professional healthcare environments and must be prescribed by a physician.
CubCannula is used in conjunction with the Humidification System intended to provide a continuous flow of heated and humidified air/oxygen mixtures to spontaneously breathing patients.
The Comfort Flo® CubCannula™ is a single patient use nasal cannula containing two-prongs intended to administer gas to a spontaneously breathing patient through both nostrils. CubCannula™ is a patient interface used as a conduit to deliver heated and humidified gas to the following pediations: neonates, infants, children. The nasal cannula incorporates soft prongs, a soft, silicone, kink and crush resistant lariat, in addition to a color-coded bolo for easy size identification. The CubCannulas will be available in five sizes: Extra Small (XS), Small (XS), Small (XS), Small (XS), Medium (M), Large (L), and Extra Large (XL). The nasal cannula will be secured to the patient's face via use of Hydrocolloid pads (CubPads™) to assist with easy positioning and change out of the cannula during use.
The CubCannula™ will be individually packaged with a pair (2) of CubPad™ replacements will be available in a separate package.
Based on the provided text, the device in question is the Hudson RCI Comfort Flo® CubCannula™, a nasal cannula. The document is a 510(k) Premarket Notification, which demonstrates substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a clinical study as might be done for a novel device or pre-market approval (PMA) pathway.
Therefore, the information regarding "acceptance criteria" and a "study that proves the device meets the acceptance criteria" in the traditional sense of a clinical trial with pre-defined primary and secondary endpoints is not explicitly present for this 510(k) submission. Instead, the focus is on demonstrating equivalence through non-clinical testing (biocompatibility and bench testing).
Here's an analysis of the provided information relative to your questions, with specific callouts where information is not available due to the nature of a 510(k) substantial equivalence submission:
1. A table of acceptance criteria and the reported device performance
The document does not present a formal table of acceptance criteria with corresponding performance results in the way a clinical study report would. Instead, it lists the non-clinical tests performed and states that they revealed "passing results" or that "emissions are well below the health-based thresholds." The "acceptance criteria" are implied by the standards cited and the statement of compliance.
Implied Acceptance (Compliance) and Reported Performance (Statement of Passing):
| Test Category | Implied Acceptance (Standard/Requirement) | Reported Device Performance |
|---|---|---|
| Biocompatibility | ISO 10993-1:2018 (General Evaluation), ISO 10993-5: 2009 (Cytotoxicity), ISO 10993:10: 2010 (Irritation & Sensitization), ISO 10993-11:2017 (Systemic Toxicity), ISO 10993-6:2016 (Local Effects after Implantation), ISO 10993-3:2014 (Genotoxicity, Carcinogenicity, Reproductive Toxicity), ISO 10993-12:2012 (Sample Prep), ISO 10993-17:2002 (Allowable Limits for Leachables), ISO 10993-18:2005 (Chemical Char.); ISO 18562-1:2017 (Breathing Gas), ISO 18562-2:2017 (Particulate Matter), ISO 18562-3:2017 (VOCs). | "All biological endpoint testing including cytotoxicity, sensitization, irritation, acute systemic toxicity, and genotoxicity revealed passing results." |
| "The extractables/leachables testing on the humidified gas pathway components revealed MOS values greater than 1.0 after clinically relevant considerations and condensate attenuation." | ||
| "VOC and Particulates that the CubCannula emissions are well below the health-based thresholds for both volatile organic compounds and particulates." | ||
| "the CubCannula referenced in this document is biocompatible and does not present a foreseen biological and/or toxicological risk." | ||
| Performance (Bench) | ISO 5356-1:2015 (Conical connectors), ISO 80601-2-74:2017 (Respiratory devices), ASTM F1980-21 (Accelerated Aging), ASTM D4169-22 (Shipping Containers). | Performed tests include: Post aging Visual Inspection, Relevant Humidity Output testing, Thermal Overshoot testing, Connection strength testing, Flow Leak Test/Gas path leak testing, Shelf Life Testing, Useful Life Testing, Peel Testing, Transportation simulation, ISO gauging. All are implicitly stated as having demonstrated substantial equivalence. Specific quantitative results are not provided in this summary. For "Useful Life," it states: "Testing has been performed to validate the 10-day useful life (safety factor included)." |
| Product Characteristics | Maintain functional equivalence (e.g., flow rates, patient population, counter-indications) to predicate device. | Flow rates (1-25 LPM) are similar to the predicate (0.5-25 LPM, max 36LPM for XXL size not included). Useful life (10 days) has been validated vs predicate (7 days). Shelf life (2 years) vs predicate (3 years). These differences were assessed not to raise new safety/effectiveness concerns. |
2. Sample sized 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 the document as it pertains to a 510(k) submission based on non-clinical (bench) testing, not a clinical study. The "test set" would refer to the physical units of the device tested in the lab, but the number of units is not specified. There is no patient data or country of origin for the data as no clinical testing was performed ("No clinical testing was performed").
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)
This is not applicable as there was no clinical study, no patient data, and therefore no "ground truth" established by experts in the context of clinical interpretation or outcomes. The ground truth for the non-clinical tests would be the established performance standards set by the cited ISO and ASTM documents.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable as there was no clinical study or expert review for 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. The device is a physical medical device (nasal cannula), not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as it is not an algorithm-based device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Since no clinical study comparing the new device's performance against a "ground truth" in patients was conducted per the document ("No clinical testing was performed"), the concept of "ground truth" in a clinical sense is not applicable. For the non-clinical testing, the "ground truth" is adherence to the specified performance characteristics and safety profiles as measured against the requirements of the cited ISO and ASTM standards. These standards define the acceptable range for each test parameter (e.g., cytotoxicity, leachable substances thresholds, connection strength, leak rates).
8. The sample size for the training set
This is not applicable. This is a physical device, not an AI/machine learning model that requires a training set.
9. How the ground truth for the training set was established
This is not applicable for the reasons stated in point 8.
§ 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).