(46 days)
The APA Oxy Blade™ is a multi-functional, single-use, disposable larynoscope blade intended to assist in direct and indirect laryngoscopy and to facilitate and aid in tracheal intubation in routine and difficult airways in adult patients. The APA Oxy Blade™ incorporates an oxygen tube adaptor and tubing to provide supplemental oxygen to the patient while undergoing endotracheal intubation.
The APA Oxy Blade is a laryngoscope blade intended to be used with the Venner Medical APA™ Video Laryngoscope. The APA Oxy Blade is a standard MacIntosh laryngoscope blade with the addition of an oxygen tube adaptor/holder and tubing to provide supplemental oxygen to the patient when using the Venner APA Video Laryngoscope. The Venner APA Video Laryngoscope, like other rigid laryngoscopes, provides a clear view of the upper airway (trachea/airway) and aids in the placement of an endotracheal tube for intubation.
The provided text describes the 510(k) premarket notification for the APA Oxy Blade, a rigid laryngoscope. This document focuses on demonstrating substantial equivalence to existing predicate devices, rather than proving the device meets specific acceptance criteria in the manner of a clinical trial or algorithm performance study.
Therefore, many of the requested elements (e.g., sample sizes for test sets, number of experts for ground truth, MRMC studies, training set details) are not applicable as this submission is for a Class I medical device, which typically relies on comparisons to predicates and engineering/performance verification for regulatory clearance, not extensive clinical performance studies or AI algorithm validation.
Here's a breakdown of the available information:
1. A table of acceptance criteria and the reported device performance:
The document outlines performance data categories and successful outcomes, which effectively serve as the acceptance criteria and reported performance.
| Acceptance Criterion (Category within performance testing) | Reported Device Performance (Result) |
|---|---|
| Packaging Integrity | Suitable and intact (visual inspection, pouch seal strength, dye penetration testing passed; devices and pouches passed all tests). |
| Biocompatibility (Cytotoxicity) | Pass (non-toxic per ISO 10993-5:2009, ISO 10993-12:2012) |
| Biocompatibility (Intracutaneous Reactivity) | Pass (non-irritating per ISO 10993-10:2010) |
| Biocompatibility (Guinea Pig Maximum Sensitization) | Pass (non-sensitizing per ISO 10993-10:2010, ISO 10993-12:2012) |
| Biocompatibility (Acute Systemic Toxicity) | Pass (non-toxic per ISO 10993-11:2017) |
| Dimensional Specifications | Met for both MAC 3 and MAC 4 sizes. |
| Functional Testing (Anti-fog) | All blades successfully passed with no fogging observed. |
| Functional Testing (Flow Rate) | All devices successfully passed and met the acceptance criterion of > 15 L/min. |
| Mechanical Testing (Diffuser and tube pull test) | All devices successfully met the acceptance criteria. |
| Mechanical Testing (Tube coupling and tube pull test) | All devices successfully met the acceptance criteria. |
| Mechanical Testing (Simulation tensile test (blade to adaptor to diffuser)) | All devices successfully met the acceptance criteria. |
| Mechanical Testing (Air-leak testing) | All devices successfully met the acceptance criteria. |
2. Sample sizes used for the test set and the data provenance:
- Sample Size: The document does not explicitly state the numerical sample size for each test (e.g., "n=X blades were tested"). Instead, it uses phrases like "The results from testing were provided," "all devices and pouches passed the tests," "All blades successfully passed," and "All devices successfully met the acceptance criteria." This implies that a sufficient number of samples were tested to demonstrate conformity, as per standard engineering verification practices for medical devices of this class.
- Data Provenance: The tests are described as "Performance testing was performed to characterize the APA Oxy Blade," indicating that these were prospective engineering and bench tests conducted specifically for this submission. The country of origin of the testing data is not specified, but the applicant, Venner Medical (Singapore) Pte Ltd, is based in Singapore.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not Applicable. This device is a physical medical instrument (laryngoscope blade) and its performance is evaluated through engineering and biocompatibility testing, not through expert-reviewed "ground truth" like in an AI/diagnostic study. The "ground truth" here is objective measurement against engineering specifications and biological safety standards.
4. Adjudication method for the test set:
- Not Applicable. As per point 3, this is not an expert-driven diagnostic study requiring adjudication. The tests involve objective measurements (e.g., dimensions, flow rate, pull strength, visual inspection for fogging/leaks, lab results for biocompatibility).
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done:
- No. This type of study is typically performed to evaluate the diagnostic performance of software or imaging devices, often involving human readers. The APA Oxy Blade is a physical instrument, and its clearance relies on substantial equivalence and bench testing, not MRMC studies.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- No. This device does not involve an algorithm. The "standalone performance" is demonstrated through the various engineering and biocompatibility tests described (e.g., flow rate, anti-fogging, mechanical strength, material safety).
7. The type of ground truth used:
- The "ground truth" for this device's performance is established by engineering specifications, standardized test methods (e.g., ISO standards for biocompatibility), and pre-defined acceptance criteria for physical and functional properties. For example, "acceptance criterion of > 15 L/min" for flow testing.
8. The sample size for the training set:
- Not Applicable. This is not a machine learning or AI device that requires a "training set."
9. How the ground truth for the training set was established:
- Not Applicable. As per point 8.
§ 868.5540 Rigid laryngoscope.
(a)
Identification. A rigid laryngoscope is a device used to examine and visualize a patient's upper airway and aid placement of a tracheal tube.(b)
Classification. Class I (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 868.9