(196 days)
The KING LT-D is intended for use in adult patients (in excess of 25 kg) for controlled ventilation during anesthesia for procedures that are short in duration and when the patient is considered to have a low risk of aspiration of stomach contents.
Each device is constructed of medical grade elastomeric and thermoplastic materials. All fittings conform to ISO 5356-1/1996: Anesthetic and Respiratory Equipment - Conical Connectors; Part 1 Cones and Sockets. The device incorporates the following components or features:
- . Bi-directional gas flow through a ventilation channel.
- Inflatable bladders to assist in maintenance of placement and in sealing the . airway from the stomach and from the atmosphere
- . Indicators for proper placement permanently printed on the tube
- A rigid plastic connector complying with ISO standards for the 15mm connection . to the patient end of a breathing circuit.
This document describes a premarket notification (510(k)) for the KING LT-D Disposable Oropharyngeal Airway, not an AI device. Therefore, many of the requested criteria (e.g., sample sizes for test/training sets, expert ground truth, MRMC studies, standalone performance, software validation) are not applicable.
The document focuses on demonstrating substantial equivalence to a predicate device for a disposable version of an existing product. The acceptance criteria are related to material properties, design conformity, and intended use, rather than performance metrics of an AI algorithm.
1. A table of acceptance criteria and the reported device performance
| Characteristic | Acceptance Criteria (based on predicate) | KING LT-D Performance (reported) |
|---|---|---|
| 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. | Yes | Yes |
| Design: Tube with two attached, inflatable balloons | Yes | Yes |
| Ventilation openings between the balloons | Yes | Yes |
| Sterile device indicated for single patient use. | No (for predicate) | Yes |
| ISO Standard 15 mm proximal connector for attachment to breathing circuit | Yes | Yes |
| Medical grade polymers or approved materials for all components in contact with the anesthesia gas stream. | Yes | Yes |
| Connected to a Breathing Circuit | Yes | Yes |
| 11.5 mm internal diameter | Yes | Yes |
| Weight (gm) | 32.2 (predicate) | 32.1 |
| Prescription use only? | Yes | Yes |
| Inserted blindly? | Yes | Yes |
| Enters the trachea? | No | No |
| Seals the esophagus? | Yes | Yes |
| Cuffs are inflated with one inflation port? | Yes | Yes |
| Instructions that patient should have fasted before using the product? | Yes | Yes |
| Latex free product | Yes | Yes |
| Product classification | CAF (predicate) | CAE |
| Materials in conformity with voluntary standards (ISO 5356-1/1996, ASTM F1242-96, EN30993/ISO 10993) | Utilized in whole or in part | Yes (stated in text) |
| Biocompatibility | Equivalent to other medical devices | Yes (stated in text) |
| All verification and validation activities demonstrated that the predetermined acceptance criteria were met. | Yes | Yes (stated in text) |
| Conformance with design control procedure requirements as specified in 21 CFR 820.30 | Yes | Yes (stated in text) |
Study Proving Acceptance Criteria:
The study proving the device meets the acceptance criteria is a premarket notification (510(k)) submission demonstrating substantial equivalence to a legally marketed predicate device (King Systems Corporation KLT Oropharyngeal Airway, 510(k) #K021634).
The acceptance criteria are primarily met by:
- Direct comparison of characteristics (e.g., intended use, design, dimensions, materials, sterile status) to the predicate device.
- Compliance with recognized standards: ISO 5356-1/1996-12-15, ASTM F1242-96, and EN30993/ISO 10993 for biocompatibility.
- Risk analysis and verification/validation activities: The document states that "the designated individual(s) performed all verification and validation activities and the results of the activities demonstrated that the predetermined acceptance criteria were met."
- Conformance with design control procedures as per 21 CFR 820.30.
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This is a medical device submission based on substantial equivalence to a predicate, not a study involving a test set of data in the context of an AI/software device. The product is manufactured in Malaysia.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This device is not software driven and does not involve AI or the establishment of ground truth by experts in the sense of diagnostic accuracy studies.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. There is no test set or adjudication process described for this device.
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
Not applicable. This is not an AI-assisted device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an AI algorithm. The document explicitly states: "This device is not software driven. Software validation and verification is not applicable."
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable in the context of an AI device. For this medical device, the "ground truth" or basis for acceptance is primarily the characteristics and performance of the legally marketed predicate device and compliance with established international and ASTM standards for design, materials, and intended use.
8. The sample size for the training set
Not applicable. This is a medical device, not an AI model requiring a training set.
9. How the ground truth for the training set was established
Not applicable, as there is no training set for this type of device.
§ 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.