(111 days)
The Disposable Endobronchial Blocker Tube is intended to differentially intubate a patient's bronchus in order to isolate the left or right lung for procedures that require one-lung ventilation. The 5Fr Endobronchial Blocked for infants populations; The 7Fr Endobronchial Blocker Tube is indicated for children populations; The 9Fr Endobronchial Blocker Tube is indicated for adults use only.
Patient Population: Patients requiring one lung isolation. Environment of Use: Hospitals-OR and ICU.
The Disposable Endobronchial Blocker Tube is used to isolate the left or right lung of a patient for surgery, one lung ventilation or one lung anesthesia. It is composed of blocker catheter, cuff, three-way connector, tube connector, one-way valve (with a pilot balloon) and multifunctional adaptor.
The blocker catheter has a flexible angled tip which can be easily placed into desired bronchus. It also contains a polyurethane cuff at its distal tip to create an effective seal within the inner bronchial wall and minimize potential trauma to the bronchus. The proximal end of the blocker catheter is bonded with a one-way valve and a pilot balloon assembly. This pilot balloon assembly facilitates inflation of the distal balloon and maintains inflation until it is released. The distance markings on the blocker catheter indicate how far the blocker has been advanced.
The multi-functional adaptor can be used by connecting a blocker tube to various endotracheal tubes and anesthetic circuits.
The Disposable Endobronchial Blocker Tube is available in three models: 5Fr, 7Fr and 9Fr. The device is composed of biologically safe materials. It is supplied sterile and intended for single use only.
The provided text describes a 510(k) premarket notification for a Disposable Endobronchial Blocker Tube. This type of submission focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than proving novel effectiveness. Therefore, the information typically requested in your prompt regarding artificial intelligence (AI) device performance, ground truth establishment, expert adjudication, multi-reader multi-case studies, and standalone algorithm performance is not applicable to this medical device submission.
The "study" described in the document is a series of non-clinical, functional and biocompatibility tests intended to show that the new device performs similarly and safely compared to the predicate device, not necessarily to prove a specific clinical efficacy or diagnostic accuracy.
Here's the breakdown of the information that is available based on your request, with an explanation for the parts that are not applicable:
1. A table of acceptance criteria and the reported device performance
The document states: "Testing datas and results are included in this submission, and demonstrated that the Disposable Endobronchial Blocker Tube meets all the pre-determined testing and acceptance criteria." However, the specific acceptance criteria and the detailed reported Device performance values are not explicitly listed in the provided text. The document lists the types of tests performed:
| Test Type | Description / Compliance |
|---|---|
| Dimensions | Met pre-determined criteria (details not provided) |
| Cuff Resting Diameter | Met pre-determined criteria (details not provided) |
| Cuff herniation | Met pre-determined criteria (details not provided) |
| Cuff seal | Met pre-determined criteria (details not provided) |
| Bond strength | Met pre-determined criteria (details not provided) |
| Liquid leakage of one way valve | Met pre-determined criteria (details not provided) |
| Air leakage of one way valve | Met pre-determined criteria (details not provided) |
| Seal test | Met pre-determined criteria (details not provided) |
| Biocompatibility | Met ISO 10993-1, ISO 10993-5 (Cytotoxicity), ISO 10993-10 (Irritation & Sensitization) acceptance criteria (results not detailed) |
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document does not specify the sample sizes used for the non-clinical tests (e.g., how many blocker tubes were tested for dimensions, cuff seal, etc.), nor does it mention data provenance as it's not a clinical study involving patient data.
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)
This is not applicable. The "ground truth" equivalent for a physical device like this is its compliance with engineering specifications and biocompatibility standards, not clinical diagnostic accuracy assessed by human experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. Adjudication methods are typically relevant for clinical studies or AI performance evaluations where human expert consensus is needed.
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
This is not applicable. The device is a physical medical instrument, not an AI diagnostic or assistance tool. Therefore, MRMC studies and AI effect sizes are irrelevant to this submission. The submission explicitly states: "Clinical and animal testing were not performed for Disposable Endobronchial Blocker Tube as part of the premarket Notification requirements for this 510(k) submission and the subject of this premarket submission, Disposable Endobronchial Blocker Tube, did not require clinical and animal studies to support substantial equivalence."
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable, as it is not an AI algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" for this medical device's performance is adherence to established engineering specifications, performance standards (like ISO 5361:2016 for anesthetic and respiratory equipment), and biocompatibility guidelines (ISO 10993 series).
8. The sample size for the training set
This is not applicable. There is no AI model or "training set" for this physical device.
9. How the ground truth for the training set was established
This is not applicable.
§ 868.5740 Tracheal/bronchial differential ventilation tube.
(a)
Identification. A tracheal/bronchial differential ventilation tube is a device used to isolate the left or the right lung of a patient for anesthesia or pulmonary function testing.(b)
Classification. Class II (performance standards).