(274 days)
The Seal Rite Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask (without oxygen port) to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation ("CPR") rescue techniques. It is intended for over-the-counter use.
The Seal Rite™ Non-Rebreathing Valve ("Seal Rite Valve") is a resuscitation valve designed for resuscitation using expired air for ventilation. It has fittings on the grooved patient end that will adapt to standard masks (22 mm ID) used for resuscitation. The Seal Rite Valve allows the rescuer to blow air into a mask through its silicone one-way valve and directs the patient's exhaled air away from the rescuer via a rigid one-way valve and multiple exhaust ports. The Seal Rite Valve helps protect the rescuer from potential patient contamination. The Seal Rite Valve does not have an oxygen port.
The provided text is a 510(k) summary for the Seal Rite Non-Rebreathing Valve (K152521). It describes the device, its intended use, and the testing conducted to establish its substantial equivalence to a predicate device.
Here's an analysis of the acceptance criteria and study information based on the provided text:
1. Table of Acceptance Criteria and Reported Device Performance
The device was tested to ensure conformance with the FDA Recognized AS 4259-1995 standard ("Ancillary devices for expired air resuscitation") and passed all testing requirements. The table below summarizes the key performance parameters tested and the reported results. The explicit acceptance criteria (e.g., maximum allowable resistance values per the standard) are not fully detailed in the provided text, but the text states that the device "passed all testing requirements" and "performs as intended and meets the requirements of the AS 4259-1995 standard." I've extracted specific quantitative performance values where available and indicated "Pass" for qualitative tests.
| Acceptance Criteria (Implied by standard AS 4259-1995) | Reported Device Performance (Seal Rite™ Non-Rebreathing Valve) | Predicate Device Performance (Respironics Rescue Valve) |
|---|---|---|
| Biocompatibility: | ||
| Meet Cytotoxicity requirements (ISO 10993-5) | Pass | Not explicitly stated for predicate in this document |
| Meet Irritation requirements (ISO 10993-10) | Pass | Not explicitly stated for predicate in this document |
| Meet Sensitization requirements (ISO 10993-12) | Pass | Not explicitly stated for predicate in this document |
| Bench Testing (Functional Performance/Conformity to AS 4259-1995): | ||
| Ventilation Performance requirements | Pass | Not explicitly stated for predicate in this document |
| Expiratory Resistance for the Patient requirements | Pass | Not explicitly stated for predicate in this document |
| Expiratory Resistance for the Rescuer requirements | Pass | Not explicitly stated for predicate in this document |
| Inspiratory Resistance for a Spontaneously Breathing Patient requirements | Pass | Not explicitly stated for predicate in this document |
| Function After Contamination with Stomach Contents requirements | Pass | Not explicitly stated for predicate in this document |
| Function After Immersion in Water requirements | Pass | Not explicitly stated for predicate in this document |
| Measurement of Dead Space requirements | Pass | Not explicitly stated for predicate in this document |
| Resistance to Disengagement of Parts requirements | Pass | Not explicitly stated for predicate in this document |
| High and Low Storage Conditions requirements | Pass | Not explicitly stated for predicate in this document |
| High Temperature Operation requirements | Pass | Not explicitly stated for predicate in this document |
| Low Temperature Operation requirements | Pass | Not explicitly stated for predicate in this document |
| Attempted Displacement of Valve by Finger, Function After Dropping, Function After Potentially Deforming Weight requirements | Pass | Not explicitly stated for predicate in this document |
| Conformance of Connectors requirements | Pass | Not explicitly stated for predicate in this document |
| ISTA Procedure 2A Shipping Testing requirements | Pass | Not explicitly stated for predicate in this document |
| Expiratory Resistance at 50 LPM | 0.327 cm H2O (0.0321 kPa) | 0.25 cm H2O at 50 LPM (per K142402 510(k) Summary) |
| Inspiratory Resistance at 50 LPM | 1.15 cm H2O (0.113 kPa) | 1.85 cm H2O at 50 LPM (per K142402 510(k) Summary) |
| Inlet Connector | Standard 22 mm ID | Standard 22 mm ID |
| Outlet Connector | Standard 22 mm OD/15 mm ID | Standard 22 mm OD/15 mm ID |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes for the non-clinical tests (biocompatibility and bench testing). It mentions that the testing was conducted according to recognized standards (FDA Blue Book Memo G95-1, ISO 10993 series, AS 4259-1995, ISTA Procedure 2A). Typically, these standards specify the number of samples required for each test. The data provenance is implied to be from laboratory testing as mandated by these standards, not from human subjects or real-world use. It is retrospective in the sense that the testing was performed to support the 510(k) submission.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the evaluation relies on a non-clinical, benchtop and laboratory testing against established engineering and biocompatibility standards, not on expert interpretation of medical data.
4. Adjudication Method for the Test Set
This information is not applicable as the evaluation relies on a non-clinical, benchtop and laboratory testing against established engineering and biocompatibility standards. There is no human adjudication process 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
This information is not applicable. The Seal Rite Non-Rebreathing Valve is a mechanical medical device, not an AI or imaging diagnostic tool. Therefore, an MRMC study with human readers (or AI assistance) would not be relevant.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a mechanical non-rebreathing valve, not an algorithm or AI system. The performance evaluated is the standalone performance of the physical device according to engineering and biocompatibility standards.
7. The Type of Ground Truth Used
The "ground truth" for this device's performance is based on established engineering standards and biocompatibility standards. Specifically:
- AS 4259-1995: "Ancillary devices for expired air resuscitation"
- FDA Blue Book Memo G95-1: Guidance for biocompatibility testing.
- ISO 10993-5: Biocompatibility testing (Cytotoxicity)
- ISO 10993-10: Biocompatibility testing (Irritation)
- ISO 10993-12: Biocompatibility testing (Sensitization)
- ISTA Procedure 2A: Shipping testing.
These standards define the acceptable performance parameters and test methods for such devices.
8. The Sample Size for the Training Set
This information is not applicable. The device is a mechanical non-rebreathing valve, not a machine learning model. Therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as there is no training set for this type of device.
§ 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).