(45 days)
When the endotracheal or tracheostomy pilot tube no longer maintains cuff inflation pressure, the needle of the BE 409 Pilot Tube Repair Kit is inserted into the cut pilot tube. The cuff can then be re-inflated in the usual manner. Such a repair can deter the need to replace the entire endotracheal or tracheostomy tube because of a damaged pilot tube.
This device is intended for sale by or on the order of a physician.
The BE 409 Pilot Tube Repair Kit is intended for single patient use.
The BE 409 Pilot Tube Repair Kit will quickly and effectively restore the integrity of a pilot tube line when the regular pilot tube is accidentally cut or when the inflation port is cracked and does not maintain cuff pressure. This assembly will help prevent the need for costly and potentially dangerous tube replacement. The pilot tube connector will fit the pilot line of tubes 0.032 inch Inside Diameter - 0.050 inch Inside Diameter.
The BE 409 consists of a swaged needle with molded tab, a length of micro-bore tubing and a catheter with Luer-Lock fitting. A 10cc/mL syringe is now included in the package.
The provided text describes a Special 510(k) submission for the BE 409 Pilot Tube Repair Kit, primarily concerning the addition of a 10cc syringe and an updated instruction sheet. This submission does not contain information about a study proving device performance against acceptance criteria in the way one would typically expect for a new diagnostic or AI-driven device.
Here's an analysis based on the provided text, highlighting what's missing in relation to your request:
1. Table of Acceptance Criteria and Reported Device Performance:
- Acceptance Criteria: The document does not explicitly state quantitative acceptance criteria (e.g., specific thresholds for cuff inflation pressure restoration, repair success rates, or durability). The purpose of this 510(k) is an addition to an already approved device, not a new device requiring extensive performance validation from scratch. The implied acceptance criterion is that the device, with the added syringe, continues to effectively restore the integrity of a pilot tube line and maintain cuff inflation pressure.
- Reported Device Performance: The document merely states "Performance: Use of a BE 409 Pilot Tube Repair Kit assists a health professional in safely repairing an endotracheal or tracheostomy tube that no longer maintains cuff inflation pressure due to a leaky pilot line, thus reducing the need to re-intubate the patient." This is a descriptive statement of its function and intended benefit, not a report of quantitative performance data from a study.
2. Sample Size Used for the Test Set and Data Provenance:
- No test set or study is described. Therefore, information on sample size and data provenance is absent.
3. Number of Experts Used to Establish Ground Truth and Qualifications:
- Not applicable. Since no performance study is described, there's no mention of experts establishing ground truth.
4. Adjudication Method:
- Not applicable. No study or ground truth establishment process is detailed.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
- No such study was done. This device is a mechanical repair kit, not an AI-driven medical imaging or diagnostic tool where MRMC studies would be relevant.
6. Standalone Performance Study:
- No standalone performance study is explicitly described. The 510(k) focuses on the mechanical function of the repair kit and the addition of a syringe. The underlying performance of the repair mechanism was presumably established during the original K973755 approval in December 1997. The current submission relies on the established function of the device.
7. Type of Ground Truth Used:
- Not applicable. No performance study to establish ground truth is mentioned in this document. The "ground truth" for this device's function would likely be its ability to physically seal a pilot tube and allow cuff inflation, which would have been validated through mechanical testing or benchtop studies during the original device approval.
8. Sample Size for the Training Set:
- Not applicable. This is a mechanical device, not an AI or machine learning algorithm requiring a training set.
9. How the Ground Truth for the Training Set Was Established:
- Not applicable. As above, this is a mechanical device.
Summary of Device and 510(k) Focus:
The BE 409 Pilot Tube Repair Kit is a non-AI medical device used to repair pilot tubes of endotracheal or tracheostomy tubes. The K113644 510(k) submission is a "Special 510(k)" primarily for two modifications:
- Adding a 10cc syringe to the kit.
- Updating the User Instruction sheet.
Given the nature of these changes, the FDA's review would focus on ensuring these modifications do not negatively impact the safety or effectiveness of the already cleared device. The submission explicitly states, "No changes are being made to the device, thus no Predicate Device is listed in this summary," further indicating that the core functionality of the repair kit itself is not being re-evaluated for performance. The "performance" section describes the intended function and benefit rather than presenting new study data on its effectiveness.
§ 868.5750 Inflatable tracheal tube cuff.
(a)
Identification. An inflatable tracheal tube cuff is a device used to provide an airtight seal between a tracheal tube and a patient's trachea.(b)
Classification. Class II (performance standards).