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510(k) Data Aggregation
(263 days)
The Revivator resuscitator is intended for pulmonary resuscitation.
The adult resuscitator is for people with a body weight of more than 30 kg (66 lbs)
The child resuscitator is for children with a body weight between 7 and 30 kg (15-66 lbs)
The infant resuscitator is for infants with a body weight up to 7 kg (15 lbs)
A resuscitator is a device using positive pressure to inflate the lungs of an unconscious person who is not breathing, in order to keep him oxygenated and alive. The manual resuscitators basically consist of a mask and a large hand-squeezed plastic bulb using ambient air, or supplemental oxygen. The air and oxygen flows into the resuscitator bag. And compressing the bag, the patient is ventilated. In order not to apply a high pressure to the patient's airways, the resuscitators include a pressure-limiting valve.
1. Acceptance Criteria and Reported Device Performance
The device, "Revivator" manual resuscitator, claims substantial equivalence to predicate devices based on compliance with the ISO 10651-4:2002 standard for lung ventilators. The acceptance criteria are derived from this standard. The reported device performance is compared against these criteria and the performance of predicate devices.
| Acceptance Criteria (ISO 10651-4:2002) | Revivator Performance (Adult, Child, Infant) | Predicate Device Performance (Ambu & Mercury Medical Resuscitators) |
|---|---|---|
| Pressure-limiting valve for <10 kg body weight: Not higher than 4.5 kPa (45 cm H2O) | Child/Infant: 4.5 kPa (45 cm H2O) | Child/Infant: 4.0 kPa (Ambu); 4.0 ± 0.5 kPa (Mercury Med) |
| Pressure-limiting valve for >10 kg body weight: Not higher than 6 kPa (60 cm H2O) (if included, optional) | Adult: 6 kPa (60 cm H2O) | Adult: 4.0 kPa (Ambu Spur II); Optional for small adults (Mercury Med) |
| Max. tidal volume for <10 kg body weight: At least 150 mL | Infant: 200 mL | Meets standard |
| Max. tidal volume for 10-40 kg body weight: At least 450 mL | Child: 500 mL | Meets standard |
| Max. tidal volume for >40 kg body weight: At least 600 mL | Adult: 1000 mL | Meets standard |
| Delivered oxygen concentration (with O2 source) : At least 85% (V/V) (with attachment) | Without reservoir: 39-88% O2 (at 2-15 L/min O2 flow); With reservoir: 98-100% O2 (at 2-15 L/min O2 flow) | Claimed to meet standard (reservoir volume contributes) |
| Apparatus dead space: Shall not exceed 5 mL + 10 % of the minimum delivered volume | Lower than 7 mL | Between 5 and 7 mL |
| Expiratory resistance: Shall not exceed 5 cm H2O | 0.09 cm H2O (at 5 L/min); 1.76 cm H2O (at 50 L/min) | Values much lower than admissible |
| Inspiratory resistance: Shall not exceed 5 cm H2O below atmospheric pressure | 0.37 cm H2O (at 5 L/min); 3.48 cm H2O (at 50 L/min) | Values much lower than admissible (Ambu Spur II adult/pediatric 5 cm H2O at 50 L/min) |
| Patient connectors: 22/15 mm | 22mm male / 15mm female | In conformity (Ambu) |
| Expiratory connectors: 30 mm male | 30mm male (PEEP/AGSS) | In conformity (Ambu) |
| Bag refill valve connectors: 32 mm female conical | 32 mm female | In conformity (Predicate devices) |
| Storage temperatures: -40°C to +60°C (with 40%-95% r.h.) | -40°C to +70°C | All resuscitators meet; Revivator & Ambu reusable can store at 70°C |
| Operating temperatures: -18°C to +50°C (with 40%-95% r.h.) | -20°C to +60°C | All resuscitators meet; Revivator & Ambu reusable can operate at -20°C |
| Dismantling & reassembly: Functional test after reassembly | Includes functional test in labeling | Includes functional test in labeling |
| Patient Valve function after contamination with vomitus: In conformity with standard | In conformity with standard | In conformity with standard |
| Drop test: In conformity with standard | In conformity with standard | In conformity with standard |
| Immersion in water: In conformity with standard | In conformity with standard | In conformity with standard |
| End-expiratory pressure: If > 0.2 kPa, value in instructions; pressure gradient < 0.6 kPa | Not an increase in pressure gradient at end of expiration at 30 L/min | Expected to be lower than 0.2 kPa |
2. Sample Size and Data Provenance
The provided document describes a device comparison study for market clearance (510(k) submission) against predicate devices and an international standard (ISO 10651-4:2002). This type of submission generally relies on bench testing and engineering analysis rather than clinical trials with human subjects.
- Test Set Sample Size: The document does not explicitly state a "sample size" in terms of number of devices for specific tests. Instead, it refers to the device models (Adult, Child, Infant for both REVIVATOR PLUS and REVIVATOR RES-Q) and the inherent design specifications of these models. The testing implicitly covers these models to ensure compliance with the stated ISO standard.
- Data Provenance: The data provenance is from bench testing conducted to evaluate compliance with ISO 10651-4:2002. The company, HERSILL, S.L., is located in Móstoles, Madrid, Spain, suggesting the testing was performed in Spain or by a contracted laboratory. The nature of the comparison is retrospective in the sense that the device's characteristics are compared against established standards and existing predicate devices' specifications, rather than a prospective clinical study.
3. Number of Experts and Qualifications
The document does not mention the use of experts to establish a "ground truth" for a test set in the way one might for an AI diagnostic device. Instead, the "ground truth" is the ISO 10651-4:2002 standard itself and the specifications of the legally marketed predicate devices. The individuals involved in the testing would be qualified engineers and technicians proficient in medical device testing and quality assurance, likely with expertise in respiratory devices and relevant ISO standards.
4. Adjudication Method
Not applicable. This is a technical performance comparison against a standard and predicate devices, not a clinical study requiring expert adjudication of cases.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No. This document describes a 510(k) submission for a manual resuscitator, which involves demonstrating substantial equivalence through technical performance comparisons, not comparative effectiveness studies with human readers or AI assistance.
6. Standalone Performance Study (Algorithm Only)
The device is a manual resuscitator, a physical medical device. It does not involve an algorithm or software requiring a standalone "algorithm only" performance study in the context of AI. The performance metrics reported are for the physical device itself.
7. Type of Ground Truth Used
The ground truth used for this study is:
- International Standard Compliance: Primarily, the requirements and specifications outlined in ISO 10651-4:2002: Lung ventilators - Part 4: Particular requirements for operator-powered resuscitators.
- Predicate Device Specifications: The technical characteristics and performance data of previously cleared manual resuscitators (Ambu and Mercury Medical resuscitators).
8. Sample Size for the Training Set
Not applicable. This is not a machine learning or AI-based device, so there is no concept of a "training set" in the context of device performance evaluation described here.
9. How Ground Truth for the Training Set Was Established
Not applicable, as there is no training set mentioned or implied for this mechanical device.
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