(80 days)
The Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter is used in the diagnosis of diffuse lung disease by allowing collection of bronchoalveolar lavage (BAL) specimens from deep within the lung. The use of a bronchoscope is not necessary. This catheter is used in adult intubated patients.
Sterile, single use, catheter kit for performing non-bronchoscopic Brochoalveolar Lavage (BAL) in adult patients undergoing mechanical ventilation. (also known as mini-BAL)
The document provided is a 510(k) summary for a medical device called the "Kimberly-Clark* KimVent* BAL Cath* Bronchial Aspirate Sampling Catheter." This type of submission is for demonstrating substantial equivalence to a predicate device, rather than proving efficacy through clinical trials with specific performance criteria for AI/ML systems.
Therefore, much of the requested information (such as AI/ML specific metrics, expert adjudication, MRMC studies, training set details, etc.) is not applicable and cannot be extracted from this document, as the device is a physical catheter, not an AI/ML system.
However, I can provide the available information regarding the device's acceptance criteria and how it was proven to meet them, based on the provided text.
Here's a summary of the available information:
1. Acceptance Criteria and Reported Device Performance
The device is a physical catheter, and its performance was evaluated through bench testing against established standards, not through specific clinical performance metrics like sensitivity or specificity typically associated with AI/ML systems.
| Acceptance Criteria Category | Reported Device Performance (Summary of Testing) |
|---|---|
| Physical Performance | Demonstrates substantial equivalence to the predicate device (BAL Cath* K923487). |
| Standard Conformance | Conforms to applicable sections of: |
- ISO 594-2:1998 (Conical fittings with a 6 % (Luer) taper for syringes, needles and certain other medical equipment — Part 2: Lock fittings)
- ISO 10993-5:2009 (Biological evaluation of medical devices — Part 5: Tests for in vitro cytotoxicity)
- ISO 10993-7:2008 (Biological evaluation of medical devices — Part 7: Ethylene oxide sterilization residuals)
- ISO 10993-10:2010 (Biological evaluation of medical devices — Part 10: Tests for irritation and skin sensitization)
- ISO 11135-1:2007 (Sterilization of health care products — Ethylene oxide — Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices)
- ISO 5356-1:2004 (Anaesthetic and respiratory equipment — Conical connectors — Part 1: Cones and sockets) |
| Overall Outcome | All results of testing met acceptance criteria. |
2. Sample size used for the test set and the data provenance
Not applicable for a physical device being evaluated through bench testing. The "test set" here refers to the samples or units of the physical device subjected to the bench tests. The document does not specify the number of units tested.
Data provenance (country of origin, retrospective/prospective) is also not applicable as this is not a study involving human data or AI/ML model evaluation.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
Not applicable. Ground truth, in the context of AI/ML, refers to validated classifications or outcomes. For a physical device's performance, the "ground truth" is typically defined by the objective measurements and pass/fail criteria specified by the benchmarking standards (e.g., specific force, flow rate, or biocompatibility limits). These are set by the standard-setting bodies, not by human experts adjudicating individual cases.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable for physical device testing against technical standards.
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 device is a physical catheter, not an AI/ML system, and no human reader studies with or without AI assistance were conducted or are relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is not an algorithm. The "standalone performance" refers to the device's ability to meet the specified physical and material criteria through bench testing, as summarized in Section 1.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
For this physical device, the "ground truth" for proving acceptance criteria was based on objective measurements and conformance to established international standards (ISO standards listed above) for physical properties, biocompatibility, and sterilization.
8. The sample size for the training set
Not applicable. This is a physical device, not an AI/ML model that requires training data.
9. How the ground truth for the training set was established
Not applicable. No training set was used.
§ 868.6810 Tracheobronchial suction catheter.
(a)
Identification. A tracheobronchial suction catheter is a device used to aspirate liquids or semisolids from a patient's upper airway.(b)
Classification. Class 1 (general controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 868.9.