(31 days)
The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation.
(Applies to the standard version):
For homecare applications, the Hybrid NE Mask may be reused multiple times by a single patient. For institutional applications (i.e. hospital or other clinical settings), this interface may be reused multiple times by multiple patients.
(Applies to the Disposable version): The RespCare Hybrid NE Mask Disposable is a single patient, single use interface.
A specialized interface for Non-Invasive Ventilation. It will be modeled after the RespCare Face Mask (K052227), with intentional exhalation features removed for use with ventilators equipped with an active safety valve.
This K062019 submission describes a medical device, the RespCare Hybrid NE Mask, and its substantial equivalence to predicate devices, rather than presenting a study demonstrating its performance against specific acceptance criteria. Therefore, the information typically requested for a performance study (acceptance criteria, sample sizes, expert ground truth, etc.) is not present in this document.
The document is a 510(k) summary for a new medical device submission to the FDA. The purpose of a 510(k) is to demonstrate that the new device is "substantially equivalent" to a legally marketed predicate device. This is done by comparing the new device's intended use, technological characteristics, and safety and effectiveness information to those of the predicate. It does not typically involve a clinical study with detailed performance metrics and acceptance criteria in the way a PMA (Pre-Market Approval) submission might.
Here's an breakdown of why the requested information isn't available based on the provided text, and what is available:
1. A table of acceptance criteria and the reported device performance:
- Not Applicable. The document explicitly states, "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." This is a summary statement of the testing performed to demonstrate substantial equivalence, but it does not specify quantitative acceptance criteria or detailed performance results in the format requested. The detailed functional testing data and acceptance criteria would have been included in the full 510(k) submission, but are not part of this publicly available summary.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Not Applicable. No human clinical study or "test set" in the context of an algorithm's performance is described. The "functional testing" mentioned would likely refer to bench testing (e.g., flow resistance, sealing capabilities) rather than 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. No "ground truth" establishment by experts is mentioned, as there is no diagnostic or interpretive task being performed by the device that would require such validation.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Not Applicable. No test set or expert adjudication is described.
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. The device is a face mask for ventilation, not an AI-powered diagnostic or assistive tool. Therefore, an MRMC study is irrelevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not Applicable. This is a physical medical device (a mask), not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- Not Applicable. As a face mask, the concept of "ground truth" as it applies to diagnostic devices or algorithms is not relevant. The "ground truth" for a mask would be its physical properties and performance against engineering standards (e.g., seal integrity, pressure drop).
8. The sample size for the training set:
- Not Applicable. The device is a physical product and does not involve machine learning or a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. No training set is used.
Summary of what is presented in the provided document:
The provided document, K062019, is a 510(k) summary for the RespCare Hybrid NE Mask. It focuses on demonstrating substantial equivalence to existing predicate devices, rather than presenting a performance study with specific acceptance criteria.
Key information from the document:
- Device Name: RespCare Hybrid NE Mask
- Intended Use: "The Hybrid NE Mask is intended to provide a patient interface for application of noninvasive ventilation. The mask is to be used as an accessory to ventilators that have adequate alarms and safety systems for ventilator failure, and which are intended to administer positive pressure ventilation. The mask will be offered in a disposable version and a multiuse version. It is intended for use on adult patients (>30 kg), who are appropriate candidates for noninvasive ventilation."
- Predicate Devices:
- Basis for Substantial Equivalence: The document states the device is "essentially similar to the legally marketed predicate interfaces listed above in function, intended use, materials, and features." The essential difference is identified as "the shape of the interface." It further clarifies equivalence in "intended use, environment of use, patient population, and frequency of use," and that its "basic method of operation and design is also equivalent to the predicates."
- Evidence of Safety and Effectiveness: "Materials information and functional testing relative to the intended use of the RespCare Hybrid NE Mask show that it is as safe and effective as the predicate devices." (Note: specific details of this testing, including acceptance criteria, are not provided in this summary but would be in the full submission).
This submission is purely for regulatory clearance based on substantial equivalence to existing devices, meaning it relies on the safety and effectiveness established for the predicate devices.
§ 868.5895 Continuous ventilator.
(a)
Identification. A continuous ventilator (respirator) is a device intended to mechanically control or assist patient breathing by delivering a predetermined percentage of oxygen in the breathing gas. Adult, pediatric, and neonatal ventilators are included in this generic type of device.(b)
Classification. Class II (performance standards).