(85 days)
The Mediane Stopcock and Manifold are indicated to serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.
Medline Stopcock and Manifold
This document is an FDA 510(k) clearance letter for the "Medline Stopcock and Manifold." It primarily concerns the regulatory approval of a medical device and does not contain information about a clinical study with acceptance criteria and device performance data in the context of AI/ML or diagnostic performance.
Therefore, I cannot provide the requested information, which typically pertains to studies evaluating the diagnostic accuracy, sensitivity, specificity, or other performance metrics of a device, especially those involving AI/ML components.
The provided document details:
- Device Name: Medline Stopcock and Manifold
- Regulation Number and Name: 21 CFR 870.4290 (Cardiopulmonary Bypass Adaptor), 21 CFR 870.4270 (Stopcock, Manifold or Fitting)
- Regulatory Class: Class II
- Product Code: DTL
- Indications for Use: To serve as flow controls and conduit devices for IV fluid delivery to the patient's vascular system.
- 510(k) Number: K120069
- Date of Clearance: April 3, 2012
This is a traditional medical device clearance, not a submission involving the kind of performance evaluation typically described by your prompt's questions (e.g., test sets, ground truth, expert adjudication, MRMC studies, AI/ML performance, etc.).
§ 870.4290 Cardiopulmonary bypass adaptor, stopcock, manifold, or fitting.
(a)
Identification. A cardiopulmonary bypass adaptor, stopcock, manifold, or fitting is a device used in cardiovascular diagnostic, surgical, and therapeutic applications to interconnect tubing, catheters, or other devices.(b)
Classification. Class II (special controls). The device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 870.9.