(121 days)
The Ambu® Oval Silicone resuscitator is intended for manual pulmonary resuscitation and emergency respiratory support.For use by CPR-trained personnel only, in hospital and pre-hospital settings.
The Ambu Oval Silicone resuscitator is reusable. The range of application for the sizes are:
Adult: Adults and children with a body weight of more than approx. 30 kg (66 lbs.). Paediatric: Infants and children with a body weight between approx. 10-30 kg (22~66 lbs.)
Ambu Oval Resuscitators is for manual pulmonary resuscitation and emergency respiratory support. Ambu Oval Resuscitators are in two sizes; Adult & Pediatric. It is a reusable product.
The product consists of a resuscitator bag, inlet valve and outlet valve. Oxygen reservoirs can be mounted to the inlet valve.
Facemask, Endotracheal Tube or similar device is connected to the resuscitator patient valve to ensure contact to the patient's airway.
The inlet valve allows ambient air with or without supplementary oxygen to flow into the bag and prevents air flowing backwards from the bag through the inlet valve during ventilation.
When the resuscitator bag is compressed air is delivered via the patient valve to the patient. The bag is made of a self-expanding material, which ensures the bag to have sufficient compression and recoiling properties.
Pressure limiting valve (40 cmH2O) with an override mechanism is placed in patient valve housing. On Pediatric resuscitators there are always a Pressure limiting valve and on Adult resuscitators there are product types available with and without Pressure limiting valve.
Ambu Ova! Resuscitator complies with ISO 10651-4: Particular requirements for operator powered resuscitators.
Ambu Oval Resuscitators have the following physical and performance characteristics:
- Provided in two sizes: Adult & Pediatric .
- -Reusable
- 22 mm (outside) / 15 mm (inside) Patient Connector -
- 30 mm Expiratory Connector -
- Resuscitator Volume: Pediatric: 635 ml Adult: 1475 ml .
- Stoke Volume one hand: Pediatric: 450 ml Adult: 700 ml ・
- Stroke Volume two hands: Pediatric: NA Adult: 1475 ml -
- Can be used with ambient air and/or supplementary oxygen.
- : Pressure Limiting Valve: 40 cmH2O / 4.0 kPa, and port for attachment of manometer
The Ambu® Oval Silicone Resuscitator's acceptance criteria and the study proving its compliance are described below. The device is a manual resuscitator for pulmonary resuscitation and emergency respiratory support, available in adult and pediatric sizes.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria for the Ambu® Oval Silicone Resuscitator are primarily based on conformance to recognized consensus standards and performance characteristics comparable to legally marketed predicate devices.
| Acceptance Criteria Category | Specific Criteria/Standard | Reported Device Performance |
|---|---|---|
| Regulatory Compliance | Declaration of conformity to ISO 10651-4 | Complies |
| Declaration of conformity to ISO 5356-1 | Complies | |
| Biocompatibility | Conformance to ISO 10993-1 (cytotoxicity, sensitization, intracutaneous reactivity) | Complies with requirements of ISO 10993-1 (Cytotoxicity, Sensitization, Intracutaneous reactivity tests performed) |
| Cleaning/Sterilization | Automated Cleaning Validation (per AAMI TIR 12 and TIR 30) | Data submitted demonstrated compliance |
| Steam Sterilization Validation (per AAMI TIR 12 and TIR 30) | Data submitted demonstrated compliance | |
| Physical Characteristics | Provided in two sizes | Adult & Pediatric sizes provided |
| Patient Connector (22mm outside/15mm inside) | 22 mm (outside) / 15 mm (inside) Patient Connector | |
| Expiratory Connector (30mm) | 30 mm Expiratory Connector | |
| Performance Characteristics | Resuscitator Volume | Pediatric: 635 ml; Adult: 1475 ml |
| Stroke Volume (one hand) | Pediatric: 450 ml; Adult: 700 ml | |
| Stroke Volume (two hands) | Pediatric: NA; Adult: 1475 ml | |
| Usability with ambient air and/or supplementary oxygen | Can be used with ambient air and/or supplementary oxygen | |
| Pressure Limiting Valve | 40 cmH2O / 4.0 kPa, and port for attachment of manometer | |
| Substantial Equivalence | Equivalence to listed predicate devices for intended use, operation, and technological characteristics | Concluded to be substantially equivalent to K910040, K053140 (Adult) and K914187, K053142 (Pediatric) |
2. Sample size used for the test set and the data provenance
The provided 510(k) summary does not specify the exact sample sizes used for each individual test (e.g., biocompatibility testing involved multiple tests as listed but the number of samples tested for each is not detailed). The testing falls under bench testing, meaning the data provenance is from laboratory tests of the device itself rather than patient data. Therefore, there is no information on country of origin for patient data or whether it was retrospective or prospective, as no clinical data was used.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This information is not applicable as the device's acceptance criteria and performance data are based on bench testing against recognized standards and comparative characteristics of predicate devices, not on expert-established ground truth from clinical cases. There were no experts involved in establishing ground truth for a "test set" in the context of clinical or diagnostic performance. Expertise would have been involved in the design and execution of the bench tests and the interpretation of results against engineering and biological safety standards, but these individuals are not described as "experts" used to establish a ground truth for a test set in the way one would for an AI diagnostic device.
4. Adjudication method for the test set
This information is not applicable as the determination of whether the device meets acceptance criteria is based on objective measurements and compliance with established standards during bench testing, not on adjudicated clinical outcomes or interpretations.
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
No MRMC comparative effectiveness study was done. The 510(k) summary explicitly states: "No clinical tests are performed." This device is a manual resuscitator, not an AI-assisted diagnostic tool, so the concept of human readers improving with or without AI assistance is irrelevant here.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual resuscitator, a physical medical device operated by CPR-trained personnel, not an algorithm. Therefore, "standalone algorithm performance" is not a relevant concept for this product.
7. The type of ground truth used
The "ground truth" for this device's performance is established through conformance to recognized consensus standards (ISO 10651-4, ISO 5356-1, ISO 10993-1, AAMI TIR 12, AAMI TIR 30) and the measured physical and performance characteristics of the device, which are then compared to those of legally marketed predicate devices. This is a form of benchmarking and standard compliance.
8. The sample size for the training set
Not applicable. A "training set" typically refers to data used to train machine learning models. As this is a physical medical device without AI components, there is no training set in this context.
9. How the ground truth for the training set was established
Not applicable for the reasons stated in point 8.
§ 868.5915 Manual emergency ventilator.
(a)
Identification. A manual emergency ventilator is a device, usually incorporating a bag and valve, intended to provide emergency respiratory support by means of a face mask or a tube inserted into a patient's airway.(b)
Classification. Class II (performance standards).