(86 days)
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for use in maintaining the patency of vascular access devices (VAD's)
10 usp units/mL and 100 usp units/mL in 3ml fill in 3ml syringe with 10ml diameter and 5ml fill in 5ml syringe with 10ml diameter
The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe uses a single use disposable Hypodermic syringe, identical to the Predicate Device (K003553), filled with USP Heparin Lock Flush Solution. The Modified Device has a sterile fluid path with an SAL of 10°.
The Modified Device, the subject of this 510(k), the Heparin Lock Flush Solution, USP -BD PosiFlush Heparin Lock Flush Syringe has been modified to achieve terminal sterilization (SAL of 1066) via steam autoclave.
The Modified Device is manufactured of similiar materials and has the same intended use as the Predicate Devices.
This submission (K090680) describes a medical device, the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe. It is important to note that this is a physical medical device (a pre-filled syringe with heparin solution) and not an AI/ML powered device. As such, the typical acceptance criteria and study designs associated with AI/ML systems (such as sample sizes for training/test sets, expert adjudication, MRMC studies, and ground truth establishment methods for observational data) are not applicable here.
Instead, the submission focuses on demonstrating substantial equivalence to previously approved predicate devices based on design verification tests for safety and effectiveness of the physical product, its materials, intended use, and manufacturing process.
Here's the information parsed from the provided text, adapted for a physical medical device:
1. Table of Acceptance Criteria and Reported Device Performance
Since this is a physical device submission focused on substantial equivalence, the "acceptance criteria" are implied by the performance of the predicate device and the design verification tests. The "reported device performance" refers to the results of these tests and the overall assessment of equivalence.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Intended Use Equivalence: Maintain patency of vascular access devices (VAD's) for specific concentrations and fill volumes. | The Modified Device has the same intended use as the Predicate Devices: "maintaining the patency of vascular access devices (VADs)" with specified concentrations (10 usp units/mL and 100 usp units/mL) and fill volumes (3ml in 3ml syringe, 5ml in 5ml syringe). |
| Material Equivalence: Manufactured from similar materials to predicate. | The Modified Device is "manufactured of similar materials" to the Predicate Devices. |
| Sterility Assurance Level (SAL): Achieves terminal sterilization at SAL of 10⁻⁶. | The Modified Device has been modified to achieve terminal sterilization (SAL of 10⁻⁶) via steam autoclave. The predicate device K003553 also uses a hypodermic syringe with a sterile fluid path with an SAL of 10⁻⁶ (stated for the predicate in section 4, though the modified device's SAL is confirmed in section 6). |
| Safety and Effectiveness Equivalence relative to predicate devices. | "Design Verification tests were performed based on the risk analysis performed and results of these tests demonstrate that the Heparin Lock Flush Solution, USP - BD PosiFlush™ Heparin Lock Flush Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended." |
2. Sample Size Used for the Test Set and Data Provenance
- Sample Size: The document does not specify a numerical sample size for "design verification tests." These tests are typically laboratory-based and may involve multiple units of the device to confirm manufacturing quality, material compatibility, and performance characteristics (e.g., flow rate, integrity, sterility).
- Data Provenance: The data would be derived from internal testing conducted by Becton, Dickinson and Company. It is "prospective" in the sense that the tests were performed specifically for this 510(k) submission on the newly designed/modified device. The country of origin of the data is the USA (where BD Medical Surgical is located).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This concept is not directly applicable to this type of device submission. The "ground truth" for a physical device like a pre-filled syringe is established through objective engineering and chemical testing standards, manufacturing processes, and regulatory requirements (e.g., USP monographs for the heparin solution, ISO standards for syringes, sterility testing protocols). Experts would be involved in designing and executing these tests, and interpreting the results against established standards, rather than establishing a "ground truth" through consensus on observational data.
4. Adjudication Method for the Test Set
Not applicable. Adjudication methods (like 2+1, 3+1) are used for resolving disagreements among multiple human readers interpreting subjective data (e.g., medical images). For physical device testing, the results are typically objective measurements against a defined standard.
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 is a physical device, not an AI/ML system.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a physical device, not an algorithm.
7. The Type of Ground Truth Used
The ground truth used for this device would be a combination of:
- Established Standards: USP (United States Pharmacopeia) monographs for Heparin Lock Flush Solution, standards for syringe manufacturing, and sterility testing protocols.
- Predicate Device Performance: The performance characteristics and safety profile of the legally marketed predicate devices (K011967, K003553, K013556) serve as a de facto "ground truth" for what is considered safe and effective in this device class.
- Risk Analysis: A documented risk analysis would have guided the design verification tests to ensure all potential risks were mitigated and tested.
8. The Sample Size for the Training Set
Not applicable. This is a physical device, not an AI/ML system, so there is no "training set."
9. How the Ground Truth for the Training Set Was Established
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).