(241 days)
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe is intended to be used only for the flushing of indwelling vascular access devices. Catalog Number 306547 10 mL BD PosiFlush™ SP Syringes are generally compatible for use with syringe pumps.
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP (also referred to as BD PosiFlush™ SP Syringe) is a three-piece, sterile, single use syringe with a 6% (luer) connector prefilled with 0.9% sodium chloride injection, USP, and sealed with a tip cap. The BD PosiFlush™ SP Syringe is provided with a sterile fluid path, which is sterilized via moist heat.
The change described in this submission is the qualification of a supplier specific formulation for stopper material for 0.9 % Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringes.
This document describes a Special 510(k) submission for a medical device called "0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SP Syringe" (K161552). The submission aims to demonstrate substantial equivalence to a previously cleared predicate device (K141311) due to a change in the supplier specific formulation for the stopper material.
I will focus on the provided information to answer your request, specifically looking for acceptance criteria and the study proving it.
Here's an analysis based on the document:
1. Table of Acceptance Criteria and Reported Device Performance:
The document broadly states that "Design Verification testing was also conducted to ensure the device met the predetermined acceptance criteria for the following tests." It lists the tests but does not provide a specific table enumerating the acceptance criteria values themselves or the quantitative performance measurements obtained for each test. Instead, it states that the device "met predetermined acceptance criteria per BD's internal specification" and "have been verified to meet the established performance criteria above."
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Biocompatibility | All tests (Cytotoxicity, Hemolysis, Acute systemic toxicity, Sub-Chronic Toxicity, Intracutaneous reactivity, Occular irritation, Partial thromboplastin Time, Sensitization, Pyrogenicity, Genotoxicity, Chemical extractable analysis) met the requirements of the FDA Guidance Use of International Standard ISO 10993-1. |
| Design Verification | Met predetermined acceptance criteria per BD's internal specification for: |
- Container Closure Integrity
- Break Out/Sustaining force
- Stopper Separation
- Leakage
- Pump Force
- Ship Test
- Dead Space
- Syringe Induced Reflux |
2. Sample Sizes Used for the Test Set and Data Provenance:
The document does not specify the sample sizes used for any of the tests (biocompatibility or design verification). It also does not mention the country of origin of the data or whether the data was retrospective or prospective. The studies were conducted by Becton, Dickinson and Company.
3. Number of Experts and Qualifications for Ground Truth:
This section is not applicable as the clearance is for a pre-filled syringe (a medical device, not an AI or diagnostic tool that requires human expert interpretation for ground truth). The "ground truth" for the performance tests would be based on established engineering and biological standards and verified by internal testing protocols.
4. Adjudication Method:
This is not applicable for the same reasons as point 3.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study:
This is not applicable as the device is a pre-filled syringe, not an AI-assisted diagnostic tool.
6. Standalone (Algorithm Only) Performance:
This is not applicable as the device is a pre-filled syringe and does not involve an algorithm.
7. Type of Ground Truth Used:
For the performance tests, the "ground truth" would be established by:
- Established industry standards and regulations (e.g., ISO 10993 for biocompatibility).
- BD's internal specifications and engineering requirements for device functionality and integrity (e.g., for leakage, break force, dead space).
8. Sample Size for the Training Set:
This is not applicable as this is not an AI/machine learning device that requires a training set.
9. How the Ground Truth for the Training Set was Established:
This is not applicable for the same reasons as point 8.
Study Proving Device Meets Acceptance Criteria:
The study that proves the device meets the acceptance criteria is detailed across two main categories:
-
Biocompatibility Testing:
- Methodology: Evaluated in accordance with FDA Guidance Use of International Standard ISO 10993-1, "Biological evaluation of medical devices - Part 1: Evaluation and testing within a risk management process," June 16, 2016.
- Tests Performed: Cytotoxicity (per ISO10993-5), Hemolysis (per ISO10993-4), Acute systemic toxicity (per ISO10993-11), Sub-Chronic Toxicity (Per ISO10993-11), Intracutaneous reactivity (per ISO10993-10), Ocular irritation (per ISO 10993-10), Partial thromboplastin Time (ISO 10993-4), Sensitization (per ISO10993-10), Pyrogenicity (per ISO 10993-11), Genotoxicity (per ISO 10993-3), and Chemical extractable analysis (per ISO 10993-18).
- Conclusion: The tests confirmed that the device met the requirements outlined in the standards, indicating it is biocompatible.
-
Design Verification Testing:
- Methodology: Conducted to ensure the device met "predetermined acceptance criteria per BD's internal specification." The specific methodologies for each test (e.g., how "Container Closure Integrity" was tested) are not detailed but would be standard industry practices for syringe manufacturing.
- Tests Performed: Container Closure Integrity, Break Out/Sustaining force, Stopper Separation, Leakage, Pump Force, Ship Test, Dead Space, Syringe Induced Reflux.
- Conclusion: The testing demonstrated that the subject device "met predetermined acceptance criteria."
Overall Conclusion from the Document:
The submission concludes that the BD PosiFlush™ SP Syringes "have been verified to meet the established performance criteria above." The results of this design verification and biocompatibility testing "demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device and demonstrated the same intended use, fundamental scientific technology and operating principles" as the predicate device, thereby proving substantial equivalence.
§ 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).