(49 days)
The BD OneCath™ midline catheter is inserted into a patient's vascular system for short-term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids. This intravascular catheter may be used for any patient population with consideration given to adequacy of vascular anatomy and appropriateness of procedure.
The BD OneCath midline products are similar in design to other midline catheters. The catheter tubing is a radiopaque, polyurethane material that is inserted into the vascular system via a catheter introducer.
The provided documentation (K042862) describes the BD OneCath™ Midline Catheter. However, it does not include detailed acceptance criteria or a study that proves the device meets specific performance criteria in the way typically expected for an AI/ML medical device. This submission is for a traditional medical device (catheter) and focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing.
Therefore, for aspects related to AI/ML device performance, such as sample size for test sets, number of experts for ground truth, adjudication methods, MRMC studies, standalone performance, training set details, and ground truth establishment for training, the information is not applicable or not provided in this document.
Here's the information that can be extracted or inferred from the document:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Biocompatibility: Meet regulatory standards for materials in contact with the human body. | Biocompatibility testing of the new polyurethane tubing was conducted. (Conclusion: Substantially equivalent to predicate, implying acceptable biocompatibility). |
| Physical Performance: Equivalent or superior to predicate in areas of potential failure (e.g., pull strength, junction security). | Physical testing on areas of potential failure (such as pull strength and the security of junctions between the extension tubing and molded parts) were conducted. |
| The polyurethane used for the BD OneCath product has improved radiopacity, resistance to alcohol, and flex endurance than the polyurethane used for the current L-Cath midline catheter. (Implies performance meets or exceeds predicate). | |
| Functional Equivalence: Perform intended functions (sample blood, monitor blood pressure, administer fluids) for short-term use. | The device is intended for peripheral use to sample blood, monitor blood pressure, or administer fluids, for short-term use (less than 30 days). The nonclinical tests concluded "The BD OneCath midline catheter is substantially equivalent to the BD L-Cath midline catheter" for these intended uses. |
| Material Properties: Improved radiopacity, alcohol resistance, and flex endurance. | The polyurethane used for the BD OneCath product has improved radiopacity, resistance to alcohol, and flex endurance than the polyurethane used for the current L-Cath midline catheter. (This describes the improved characteristics, implying these were target criteria and were met.) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Sample Size for Test Set: Not specified. The document refers to "biocompatibility testing" and "physical testing" but does not detail the number of units or samples tested for each.
- Data Provenance: Not specified. These are non-clinical (laboratory/bench) tests conducted by the manufacturer, Becton Dickinson.
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 a physical medical device (catheter), not an AI/ML diagnostic or image analysis tool. Ground truth is established through laboratory measurements and established biocompatibility standards, not expert interpretation of outputs.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not Applicable. Ground truth is based on objective laboratory measurements and standardized test results rather than expert adjudication.
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
- No. This is not an AI/ML device, and no MRMC study was conducted or is relevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- No. This is not an AI/ML device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- The ground truth for the non-clinical tests would be based on objective laboratory measurements (e.g., tensile strength, elongation, burst pressure, material composition analysis, radiopacity measurements) and established industry standards for biocompatibility (e.g., ISO 10993 series). Performance measurements would be compared against defined specifications or the performance of the predicate device.
8. The sample size for the training set
- Not Applicable. This is not an AI/ML device; there is no "training set."
9. How the ground truth for the training set was established
- Not Applicable. As there is no training set for an AI/ML model, there is no ground truth established for it.
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).