(13 days)
The devices are intended for use when central venous catheterization or intravenous therapy for the administration of fluids, medications and/or nutritional therapy is prescribed. The use of the device for these indications is less than 30 days.
Single or double lumen intravenous catheters. Devices will be assembled in a kit that includes components that are either legally marketed; exempt from premarket requirements; or "grandfathered".
This 510(k) summary describes a medical device, the Keystone Medical Peripherally Inserted Central Catheter (PICC), and asserts its substantial equivalence to a predicate device (Medical Components, Inc. K#953811). The submission is for a device that is identical to the predicate device, with the only difference being the branding (Keystone Medical name and logo).
Therefore, the submission does not include any new studies or acceptance criteria for device performance as it relies entirely on the substantial equivalence to the predicate device, which had previous non-clinical (bench) testing. There are no clinical tests performed for this 510(k) submission.
Here's a breakdown of why the requested information cannot be provided from the given document:
- 1. A table of acceptance criteria and the reported device performance: Not provided. The submission states that non-clinical (bench) testing was completed for the predicate device (K#953811) and was included with this 510(k). However, the specific acceptance criteria and detailed performance results are not attached or described in this summary.
- 2. Sample size used for the test set and the data provenance: Not applicable. No new studies were performed.
- 3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. No new studies were performed.
- 4. Adjudication method for the test set: Not applicable. No new studies were performed.
- 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 medical device (catheter), not an AI-driven diagnostic tool.
- 6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a physical medical device.
- 7. The type of ground truth used: Not applicable for new studies. For the predicate device, it would have been physical/mechanical testing data (e.g., tensile strength, flow rates).
- 8. The sample size for the training set: Not applicable. No new studies were performed, and it's a physical device, not an AI model requiring a training set.
- 9. How the ground truth for the training set was established: Not applicable.
In summary, this 510(k) relies on the previous approval of an identical predicate device. The provided text explicitly states that "Clinical testing was not completed" and "Non clinical (bench) testing was completed to support K#953811, and was included with this 510(k) submission." Therefore, the specific details of performance and acceptance criteria for this particular submission are not described beyond the claim of substantial equivalence to the predicate.
§ 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).