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510(k) Data Aggregation
(140 days)
The CPR Mask with Oxygen Port 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 intended for prescription use.
The CPR Mask without Oxygen Port is designed to assist in providing immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The CPR Mask without Oxygen Port is intended for over-the-counter use.
The Infant CPR Mask without Oxygen Port is designed to provide immediate life support (mouth to mask ventilation) to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. The Infant CPR mask is indicated for use on infants with body weight up to 10 kg (22 lbs). The Infant CPR Mask is intended for over-the-counter use.
The Non-Rebreathing Valve is a single-use, non-sterile device intended to be used with a ventilation mask to provide mouth-to-mask ventilation to health emergency victims requiring cardiopulmonary resuscitation (CPR) rescue techniques. It is intended for over-the-counter use.
Compower Emergency CPR masks with non-rebreathing valves are designed to assist in providing immediate life support to health emergency victims requiring oxygen support and cardiopulmonary resuscitation rescue techniques. The devices subject to this 510(k) include the following: CPR Mask with Oxygen Port, CPR Mask without Oxygen Port, Infant CPR Mask without Oxygen Port, Non-Rebreathing Valve (15mmOD), Non-Rebreathing Valve (18.5mm).
CPR Mask with Oxygen Port: comprised of an air cushion, foldable mask cover with oxygen port, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.
CPR Mask without Oxygen Port: comprised of an air cushion, foldable mask cover, a non-rebreathing valve and an elastic head strap. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.
Infant CPR Mask without Oxygen Port: comprised of an air cushion, mask cover and non-rebreathing valve. Constructed of transparent polyvinyl chloride. Provided non-sterile and is intended for single use only.
Non-Rebreathing Valve: a non-sterile, single-use device designed with a rigid styrene-butadiene copolymer housing, a silicone valve plate and polypropylene filter. Compatible for use with 22mm connectors used in standard ventilation masks. Designed with 15mmOD and 18.5mm ports.
Here's a breakdown of the acceptance criteria and study information based on the provided document:
1. Table of Acceptance Criteria and Reported Device Performance
The document presents performance data primarily in the context of comparison to predicate devices, rather than explicit acceptance criteria with pass/fail values. The "acceptance criteria" are implied by meeting or falling within ranges comparable to the predicate devices and adherence to relevant standards.
Comparison of Compower CPR Mask (with/without Oxygen Port) to KYOLING CPR Mask (Predicate)
| Metric | Acceptance Criteria (Implied by Predicate & Standard) | Reported Compower CPR Mask Performance | Reported KYOLING CPR Mask Performance (Predicate) |
|---|---|---|---|
| Inspiratory Resistance Specification | ≤0.5 kPa at 50 L/min (from AS 4259) | 0.40 - 0.49 kPa at 50 L/min | 0.30 - 0.31 kPa at 50 L/min |
| Expiratory Resistance Specification | ≤0.5 kPa at 50 L/min (from AS 4259) | 0.20 - 0.30 kPa at 50 L/min | 0.31 - 0.32 kPa at 50 L/min |
| Biocompatibility - Cytotoxicity | Pass (ISO 10993-5) | Pass | Same (Implied by Predicate Comparison) |
| Biocompatibility - Sensitization | Pass (ISO 10993-10) | Pass | Same (Implied by Predicate Comparison) |
| Biocompatibility - Irritation | Pass (ISO 10993-10) | Pass | N/A (Not explicitly listed for predicate) |
| Standards Used | Conformance to ISO 5356-1 and AS 4259-1995 | Conformance demonstrated | Conformance demonstrated |
| Visual Inspection | Implied to meet specifications | Passed | N/A |
| Dimensional Measurement | Implied to meet specifications | Passed | N/A |
| Transparency | Implied to meet specifications | Passed | N/A |
| Function after Contamination/Immersion | Implied to meet specifications | Passed | N/A |
| Performance After Storage and Aging | Implied to meet specifications | Passed | N/A |
| Mean Delivered Oxygen Concentration | Implied to meet specifications | Passed | N/A |
Comparison of Compower Infant CPR Mask to EMS Child/Infant Mask (Primary Predicate) & Laerdal Paediatric Pocket Mask (Reference)
| Metric | Acceptance Criteria (Implied by Predicate/Reference & Standard) | Reported Compower Infant CPR Mask Performance | Reported EMS Child/Infant Mask Performance (Predicate) | Reported Laerdal Paediatric Pocket Mask Performance (Reference) |
|---|---|---|---|---|
| Inspiratory Resistance Specification |
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