(216 days)
The KING LTS is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration oonlour vehilation is considered to have a low risk of aspiration of stomach contents.
Tube with two attached, inflatable balloons. Ventilation openings between the balloons. Can be sterilized in an autoclave. Proximal ISO Standard 15mm connector for attachment to breathing circuit. Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream. Connected to a Breathing Circuit. Inserted blindly. Seals the esophagus. Cuffs are inflated with one inflation port. Instructions that patient should have fasted before using the product. Latex free product.
Here's a breakdown of the acceptance criteria and study information based on the provided text, recognizing this is a 510(k) premarket notification for a Class I device seeking substantial equivalence, not a detailed clinical trial report.
Acceptance Criteria and Reported Device Performance
The provided document describes a 510(k) submission seeking substantial equivalence to a predicate device (King Systems Corporation KLT Oropharyngeal Airway, 510(k) #K021634). For devices seeking substantial equivalence, the "acceptance criteria" are generally that the new device performs as well as or similarly to the predicate device, especially regarding performance characteristics relevant to its intended use and safety. The study provided here is primarily a comparison to the predicate device, demonstrating that the design and certain performance characteristics are "substantially equivalent."
Table of Acceptance Criteria and Reported Device Performance
Since this is a substantial equivalence submission, the acceptance criteria are implicit: the new device's characteristics should match or be demonstrably similar to the predicate device. The "reported device performance" is the comparison data presented.
| Characteristic | Acceptance Criteria (from predicate) | KING LTSTM (New Device) Performance | Comparison |
|---|---|---|---|
| Intended Use | Ventilation during anesthesia during procedures of short duration. An oropharyngeal airway is a device inserted through the mouth to provide a patent airway. | Same as predicate (Yes) | Meets criteria by being identical. |
| Design | Tube with two attached, inflatable balloons | Yes | Meets criteria by being identical. |
| Ventilation openings between the balloons | Yes | Yes | Meets criteria by being identical. |
| Can be sterilized in an autoclave | Yes | Yes | Meets criteria by being identical. |
| Proximal ISO Standard 15mm connector for attachment to breathing circuit | Yes | Yes | Meets criteria by being identical. |
| Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream | Yes | Identical to materials in predicate device | Meets criteria by being identical. |
| Summary of Features: Connected to a Breathing Circuit | Yes | Yes | Meets criteria by being identical. |
| Internal Volume (dead space) (ml)* | 9.0 | 8.7 | Difference: 0.3 ml. The submission implies this is proportionally, approximately equal. |
| Resistance cmH2O @ 30 L/min* | 1.3 | 1.6 | Difference: 0.3 cmH2O. The submission implies this is proportionally, approximately equal. |
| Weight (gm)* | 32.2 | 51.3 | Difference: 19.1 gm. This is a noticeable difference, but for a Class I device and the context of substantial equivalence, it's likely deemed acceptable if it doesn't impact safety or effectiveness. |
| Prescription use only? | Yes | Yes | Meets criteria by being identical. |
| Inserted blindly? | Yes | Yes | Meets criteria by being identical. |
| Enters the trachea? | No | No | Meets criteria by being identical. |
| Seals the esophagus? | Yes | Yes | Meets criteria by being identical. |
| Cuffs are inflated with one inflation port? | Yes | Yes | Meets criteria by being identical. |
| Instructions that patient should have fasted before using the product? | Yes | Yes | Meets criteria by being identical. |
| Latex free product | Yes | Yes | Meets criteria by being identical. |
| Product classification | CAE | CAE | Meets criteria by being identical. |
| *Comparison values are for Size 4. |
Study Information
The provided document is a 510(k) premarket notification for a Class I device establishing substantial equivalence to an existing predicate device. This type of submission, especially for Class I devices, typically relies on demonstrated comparability through engineering testing and material analysis rather than extensive human clinical trials.
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Sample size used for the test set and the data provenance:
- The "test set" in this context refers to the specific device characteristics measured for the KING LTS™ (new device) and compared to the KING LT™ (predicate device).
- Specific sample sizes for the measurements of internal volume, resistance, and weight are not explicitly stated (e.g., "n=X devices were tested for resistance"). However, the comparison is made on "Size 4 for both the KING LTS™ and the KING LT™," implying that at least one unit of each size 4 device was used for these measurements. It's likely that a small number of devices were tested per characteristic to ensure consistency.
- Data Provenance: The data appears to be from internal manufacturer testing ("Manufacturer's tests have shown the device to successfully withstand fifty or more cleaning and autoclave sterilization cycles."). The country of origin for the new product is Germany ("Product manufactured in Germany is new to U.S. market.").
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- This question is not applicable to this type of 510(k) submission. "Ground truth" for diagnostic or AI devices is typically established by multiple experts. For this device (an oropharyngeal airway), the "truth" is established by direct measurement of physical and performance characteristics, and by clinical consensus on its intended use and safety profile, which are aligned with the predicate. No expert panels for ground truth determination are described.
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Adjudication method for the test set:
- Not applicable. There is no expert adjudication described for the physical and performance measurements reported.
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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:
- Not applicable. This is not an AI-powered diagnostic device, and therefore, no MRMC study or AI assistance evaluation was conducted or described.
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If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This is not an AI algorithm.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
- The "ground truth" for this device's performance is based on engineering measurements and specifications (e.g., internal volume, resistance, weight, material composition, sterilization capabilities) and alignment with established medical device standards (e.g., ISO 5356-1, ASTM F1242-96) and regulatory classifications (CAE - 21 CFR 868.5110). Clinical "ground truth" is implied by its similarity to an already legally marketed and accepted predicate device with a known safety and effectiveness profile.
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The sample size for the training set:
- Not applicable. This is not a machine learning or AI device that requires a training set.
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How the ground truth for the training set was established:
- Not applicable. As this is not an AI device, there is no training set or ground truth for such a set.
§ 868.5110 Oropharyngeal airway.
(a)
Identification. An oropharyngeal airway is a device inserted into a patient's pharynx through the mouth to provide a patent airway.(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.