(260 days)
Rusch EasyCric Emergency Cricothyrotomy Set is indicated to provide emergency airway access when conventional ventilation by intubation or face mask cannot be performed.
The Rusch EasyCric Emergency Cricothyrotomy Set is a sterile, single use emergency cricothyroidotomy set available in size 5 mm. The device employs the Seldinger technique to provide an emergency artificial airway when attempts to intubate the trachea fail. Cricothyroidotomy provides faster access in emergency situations than surgical or percutaneous tracheostomy, which are time consuming procedures. The device gains access by cutting the link between the cricoid cartilage and the thyroid cartilage into the ligamentum conicum. It is available uncuffed. Components of the set include the EasyCric tube and insertion dilator, scalpel, puncture needle, syringe, guidewire, comport neckband and saline solution.
Here's an analysis of the provided text, focusing on the acceptance criteria and study information:
The document describes the Rusch EasyCric Emergency Cricothyrotomy Set and its substantial equivalence to a predicate device. The "study" in this context refers to various performance tests conducted to demonstrate that the new device meets established safety and performance standards equivalent to the predicate. This is not a clinical study involving human patients or complex diagnostic algorithms.
Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Connector bonding strength | Must be able to sustain axial force of 15 ± 1.5N without movement | Met (Implied by "Pass/fail criteria has been met") |
| Flange (neck-plate) bonding strength | Must be able to sustain axial force of 15 ± 1.5N without movement | Met (Implied by "Pass/fail criteria has been met") |
| Connector Fit Test (ring gauge test) | The connector's leading edge shall lie between the minimum and maximum diameter steps of the gauge. | Met (Implied by "Pass/fail criteria has been met") |
| Coating consistency on the tube | Smooth and even coating on the tube | Met (Implied by "Pass/fail criteria has been met") |
| Coating lubricity | Wear value of less than 150% | Met (Implied by "Pass/fail criteria has been met") |
| Visual Inspection of Saline, Scalpel and Neckband | No torn packaging or damage to the product | Met (Implied by "Pass/fail criteria has been met") |
| Guidewire testing | Smooth insertion without restriction | Met (Implied by "Pass/fail criteria has been met") |
| Biocompatibility testing | Must meet the requirements as outlined in ISO 10993-1 | Met (Implied by "Pass/fail criteria has been met" and "All patient contacting materials are in compliance with ISO 10993-1") |
Study Details:
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Sample size used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for each performance test (e.g., how many connectors were tested for bonding strength). It lists the types of tests performed.
- Data Provenance: Not specified, but these are likely laboratory-based tests conducted by the manufacturer (Teleflex Medical). No country of origin for the data or whether it's retrospective/prospective is indicated, as this typically applies to clinical or observational studies on patient data.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable. These are engineering/performance bench tests, not evaluations requiring expert medical interpretation to establish ground truth such as in diagnostic imaging studies. The "ground truth" is defined by the physical or chemical properties being measured against established standards (e.g., force, dimension, visual integrity, biocompatibility standards).
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Adjudication method for the test set:
- Not applicable in the context of expert consensus or multi-reader reviews, as these are technical performance tests against objective criteria. The pass/fail criteria for each test serves as the "adjudication."
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If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No, an MRMC comparative effectiveness study was not done. This type of study is relevant for evaluating diagnostic performance of imaging devices or algorithms with human readers, which is not the nature of this device's submission.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is a medical device (cricothyrotomy set), not an AI algorithm. Its performance is assessed through its physical and functional integrity, not through algorithmic output.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for the performance tests consists of established engineering standards, physical measurement criteria, and adherence to recognized international standards (e.g., ISO 5366-1, ISO 5356, ISO 10993-1).
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The sample size for the training set:
- Not applicable. This device does not involve a "training set" in the context of machine learning or AI models.
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How the ground truth for the training set was established:
- Not applicable, as there is no training set for this type of device.
Summary of Device Performance Study:
The "study" presented here is a series of bench and laboratory performance tests designed to demonstrate that the Rusch EasyCric Emergency Cricothyrotomy Set is substantially equivalent to a predicate device. The tests evaluate physical characteristics and safety aspects of the device components (e.g., connector strength, coating quality, biocompatibility). The acceptance criteria for these tests are derived from international standards (ISO) or internal specifications designed to ensure the device is safe and performs as intended. The document states that all pass/fail criteria were met, leading to the conclusion of substantial equivalence. This is primarily a regulatory submission focused on engineering and material performance.
§ 868.5090 Emergency airway needle.
(a)
Identification. An emergency airway needle is a device intended to puncture a patient's cricothyroid membrane to provide an emergency airway during upper airway obstruction.(b)
Classification. Class II (performance standards).