(88 days)
The MedSource CPR Mask is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring oxygen support (inhalation) or cardiopulmonary resuscitation (CPR) rescue techniques.
The CPR Mask with Oxygen Port is for prescription use.
A one piece, single use, full-size, light-weight PVC mask system which includes:
- A Universal breathing tube.
- A One-way filtered valve.
- A Head strap.
- With Oxygen Port or Without Oxygen Port.
- Packaged for easy portability and quick access.
Here's a breakdown of the acceptance criteria and the study details for the MedSource CPR Mask, based on the provided text:
MedSource CPR Mask: Acceptance Criteria and Study Details
The provided document describes a 510(k) premarket notification for the MedSource CPR Mask, which focuses on demonstrating substantial equivalence to predicate devices rather than proving novel clinical efficacy. Therefore, the "acceptance criteria" are related to performance standards and biocompatibility, not clinical outcomes for patients. The "study" refers to the performance testing and biocompatibility assessments conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are primarily derived from the performance expected of similar devices and recognized consensus standards, particularly AS-4259-1995 for respiratory resistance and ISO 10993 for biocompatibility.
| Acceptance Criteria Category | Specific Criteria / Standard Reference | MedSource CPR Mask Performance | Predicate Device Performance (Spiracle CPR Mask) |
|---|---|---|---|
| Inspiratory Resistance | AS-4259-1995 methods (Implicit criterion: generally comparable to predicate, ideally lower) | 1.94 cm H2O @ 50 lpm flow | 2.04 cm H2O @ 50 lpm flow |
| Expiratory Resistance | AS-4259-1995 methods (Implicit criterion: generally comparable to predicate, ideally lower) | 2.04 cm H2O @ 50 lpm flow | 2.14 cm H2O @ 50 lpm flow |
| Cytotoxicity | ISO 10993 Requirement | Passes | Not applicable (raw material testing) |
| Sensitization | ISO 10993 Requirement | Passes | Not applicable (raw material testing) |
| Irritation / Intracutaneous Reactivity | ISO 10993 Requirement | Passes | Not applicable (raw material testing) |
| Pyrogen | ISO 10993 Requirement (Not required, but tested as "beyond requirements") | Passes | Not applicable (raw material testing) |
| Haemocompatibility | ISO 10993 Requirement (Not required, but tested as "beyond requirements") | Passes | Not applicable (raw material testing) |
| Systemic Toxicity | ISO 10993 Requirement (Not required, but tested as "beyond requirements") | Passes | Not applicable (raw material testing) |
Discussion of Results: The MedSource CPR Mask showed better performance (lower resistance) than the predicate device (Spiracle CPR Mask) for both inspiratory and expiratory resistance. The difference was stated as 5%, deemed to demonstrate "substantially the same performance" given inherent variations in test methods. All required and extra biocompatibility tests were passed.
2. Sample Size and Data Provenance
- Test Set Sample Size: For the respiratory resistance testing, the exact number of individual devices or tests performed is not specified, but the results are presented as single values for "MedSource CPR Mask" and "Spiracle CPR Mask," implying a representative sample was tested and reported.
- Data Provenance: The testing was presumably conducted by or for MedSource International, LLC as part of their submission to the FDA. The specific country of origin for the data is not stated, but the manufacturer is based in Minnesota, USA. The testing is prospective as it was specifically performed to support the 510(k) submission.
3. Number of Experts and Qualifications for Ground Truth
- Not Applicable. This type of device (CPR mask) and submission (510(k) for substantial equivalence) typically relies on objective performance measurements (like resistance) and standardized biocompatibility tests, not subjective expert assessment of images or clinical outcomes that require establishing a "ground truth" through expert consensus.
4. Adjudication Method for the Test Set
- Not Applicable. As mentioned above, there was no expert assessment or adjudication process involved in performance or biocompatibility testing. The results are objective measurements.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
- No. An MRMC study is relevant for diagnostic devices where human readers interpret results, often with and without AI assistance, to assess changes in accuracy or efficiency. This type of study is not applicable to a CPR mask, which is a physical medical device for mechanical assistance, not a diagnostic tool requiring interpretation.
6. Standalone (Algorithm Only) Performance Study
- Not Applicable. This is not an AI-powered device or algorithm. The performance testing was for the physical device itself.
7. Type of Ground Truth Used
- Objective Measurements and Standardized Test Results:
- For respiratory resistance: The "ground truth" is the measured physical property of the device (pressure drop at a given flow rate) as determined by methods outlined in AS-4259-1995.
- For biocompatibility: The "ground truth" is determined by standardized laboratory assays (e.g., cell culture for cytotoxicity, animal models for sensitization/irritation) that assess biological responses to the materials, against passing criteria defined by ISO 10993.
8. Sample Size for the Training Set
- Not Applicable. There is no "training set" as this is not an AI/machine learning device. The design, materials, and manufacturing processes are developed through traditional engineering methods, not data-driven machine learning training.
9. How the Ground Truth for the Training Set was Established
- Not Applicable. As there is no training set, this question is not relevant.
§ 868.5870 Nonrebreathing valve.
(a)
Identification. A nonrebreathing valve is a one-way valve that directs breathing gas flow to the patient and vents exhaled gases into the atmosphere.(b)
Classification. Class II (performance standards).