(212 days)
The Heparin Lock Flush Solution, USP syringes are intended for use in maintaining patency of vascular access devices (VAD'S).
Heparin Lock Flush Solution, USP BD Pre-Filled Heparin Lock Flush Syringe. Product sizes/reorder numbers: The following sizes/reorder numbers of the Heparin Lock Flush Solution, USP syringes to be offered are:
| BD Cat. # | Description |
|---|---|
| 306509 | Heparin, 10u/mL, 6mL Fill In 10mL Syringe |
| 306510 | Heparin, 10u/mL, 5mL Fill In 10mL Syringe |
| 306511 | Heparin, 10u/mL, 5mL Fill In 5mL Syringe |
| 306521 | Heparin, 10u/mL, 3mL Fill In 10mL Syringe |
| 306512 | Heparin, 10u/mL, 3mL Fill In 3mL Syringe |
| 306527 | Heparin, 10u/mL, 2mL Fill In 3mL Syringe |
| 306513 | Heparin, 100u/mL, 5mL Fill In 10mL Syringe |
| 306514 | Heparin, 100u/mL, 3mL Fill In 10mL Syringe |
| 306515 | Heparin, 100u/mL, 5mL Fill In 5mL Syringe |
| 306516 | Heparin, 100u/mL, 3mL Fill In 5mL Syringe |
| 306517 | Heparin, 100u/mL, 3mL Fill In 3mL Syringe |
| 306528 | Heparin, 100u/mL, 2mL Fill In 3mL Syringe |
| 306525 | Heparin, 10u/mL, 5mL Fill In 10mL Syringe With Blunt Plastic Cannula |
| 306531 | Heparin, 100u/mL, 5mL Fill In 10mL Syringe With Blunt Plastic Cannula |
| 306529 | Heparin, 100u/mL, 5mL Fill In 5mL Syringe With Blunt Plastic Cannula |
| 306537 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 100u/mL Heparin Lock Flush Syringe), 5mL Fill In 10mL Syringe - 100u/mL Heparin |
| 306538 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 10u/mL Heparin Lock Flush Syringe), 3mL Fill In 3mL Syringe - 10u/mL Heparin |
| 306539 | SASH Kit (2 - 0.9% Sodium Chloride Syringes and 1 - 100u/mL Heparin Lock Flush Syringe), 3mL Fill In 5mL Syringe - 100u/mL Heparin |
The Heparin Lock Flush Solution, USP syringe contains sterile flush (0.9% Sodium Chloride Injection, USP and Heparin Sodium 10 and 100U/mL solution as does the predicate devices). The Heparin Lock Flush Solution, USP syringe has a sterile solution contents and fluid path as do the predicate devices. The Heparin Lock Flush Solution, USP syringe is aseptically filled as the predicate device, BD Preefil™. The Heparin Lock Flush Solution, USP syringe is a three-piece piston design as are the predicate devices, BD Preefil™and the Baxter Heparin Lock Flush syringe. The Heparin Lock Flush Solution, USP syringe barrel is molded from polypropylene as are the predicate devices, BD Preefil™and the Baxter Heparin Lock Flush syringe. The Heparin Lock Flush Solution, USP syringe has a similar package unit design as the predicate device, BD Preefil™.
This document is a 510(k) premarket notification for a medical device – specifically, a pre-filled heparin lock flush syringe. These types of regulatory submissions do not typically include studies or data proving acceptance criteria in the manner one would see for AI/ML-based diagnostic devices.
Instead, the submission focuses on demonstrating "substantial equivalence" to predicate devices already on the market. This means the manufacturer is asserting that their new device is as safe and effective as existing legally marketed devices, based on similar intended use, technology, and performance characteristics, rather than independent performance studies with acceptance criteria.
Therefore, the requested information about acceptance criteria, study details, sample sizes, ground truth establishment, expert adjudication, MRMC studies, and standalone performance is not present in the provided text.
The document states:
- Intended Use: "Heparin Lock Flush Solution, USP syringes are intended for use in maintaining patency of vascular access devices (VAD'S)."
- Equivalence Determination: The manufacturer compares their device to predicate devices based on elements like solution contents, sterility, filling process, design, and materials (e.g., "The Heparin Lock Flush Solution, USP syringe contains sterile flush... as does the predicate devices").
Because this is a substantial equivalence claim for a physical medical device, not an AI/ML algorithm, the requested study details are not applicable.
§ 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).