(123 days)
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringes are intended to be used only for the flushing of indwelling vascular access devices.
The 0.9% Sodium Chloride Injection, USP, BD PosiFlush" SF 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 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe is sterilized via moist heat and provided externally sterile for use on a sterile field.
Here's an analysis of the provided text regarding the acceptance criteria and study for the 0.9% Sodium Chloride Injection, USP, BD PosiFlush™ SF Syringe:
This document is a 510(k) summary for a medical device that claims substantial equivalence to a predicate device, rather than a study proving the device meets novel acceptance criteria through a comparison against a primary ground truth. It focuses on demonstrating that the subject device (with new packaging) performs identically to the predicate device, which has already been deemed safe and effective.
Therefore, many of the typical questions asked for an AI/diagnostic study (like sample size for test set, number of experts for ground truth, MRMC study, standalone performance, training set details) are not applicable to this type of submission. This is a submission for a modification to an existing device (packaging change), where the primary goal is to show that the modified device maintains the performance characteristics of the original device.
1. Table of Acceptance Criteria and Reported Device Performance
The acceptance criteria are implicitly defined by the performance of the predicate device (K121050). The reported device performance for the subject device is consistently "Identical to predicate" or "Equivalent to predicate".
| Performance Characteristic | Acceptance Criteria (Predicate Device K121050) | Reported Device Performance (Subject Device) |
|---|---|---|
| Functional Testing | ||
| Container Closure Integrity | No dye in solution; No leakage in luer well or tip threads; No leakage past stopper ribs; No dye between stopper ribs | Identical to predicate |
| Break Loose Force | No leakage beyond stopper ribs | Identical to predicate |
| Break Out Force | Acceptable forces required to remove plunger rod | Identical to predicate |
| Sustaining Force | Consistent plunger rod forces | Identical to predicate |
| Pump Force (10ml/hr) | 20N | Identical to predicate |
| Pump Force (1ml/hr) | 13N | Identical to predicate |
| Pump Force (0.1ml/hr) | 9N | Identical to predicate |
| Dead Space / Expelled Volume | Equivalent to labeled volume on barrel | Identical to predicate |
| Syringe Induced Reflux | 0 average reflux when connected to a 4 Fr catheter | Identical to predicate |
| Package Integrity | Per ISO 11607 | Equivalent to predicate |
| Package Stability | Per ISO 11607 | Equivalent to predicate |
| Sodium Chloride Injection, USP Testing | ||
| Bacterial Endotoxin | Per USP | Identical to predicate |
| Particulate Matter | Per USP | Identical to predicate |
| Assay of NaCl | Per USP | Identical to predicate |
| Heavy Metals | Per USP | Identical to predicate |
| Iron | Per USP | Identical to predicate |
| UV/vis | Per USP | Identical to predicate |
| pH | Per USP | Identical to predicate |
| Biocompatibility Testing | ||
| Cytotoxicity | Per ISO10993-5:1999, Non-Toxic | Identical to predicate |
| Hemolysis | Per ISO10993-4:2002/A:2006, Non-Toxic | Identical to predicate |
| Acute Systemic Toxicity | Per ISO10993-11:2006, Non-Toxic | Identical to predicate |
| Intracutaneous Reactivity | Per ISO10993-10:2002/A1:2006, Non-Irritant | Identical to predicate |
| Sensitization | Per ISO10993-10:2002/A1:2006, Non-Sensitizer | Identical to predicate |
| Bacterial Mutagenicity | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| In Vitro Mouse Lymphoma | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| Mouse Embryo Assay | Per ISO10993-3, Non-Mutagenic | Identical to predicate |
| Occular Irritation | Per ISO10993-10:2002/A1:2006, Non-Irritant | Identical to predicate |
| Rabbit Pyrogen | Per ISO10993-11:2006, Non-Pyrogenic | Identical to predicate |
| Subchronic Intracutaneous Toxicity | Per ISO10993-11:2006, Non-Toxic | Identical to predicate |
| Chemical Extractables Analysis | LC/DAD/MS & GC/MS, No significant extractables | Identical to predicate |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
This information is not provided in the document. The document states that "Performance Testing conducted to support substantial equivalence." It details the types of tests performed (Functional, Chemical, Biocompatibility) but does not specify the sample sizes for these tests or the data provenance. These tests would typically be laboratory-based rather than involving patient data.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
This is not applicable as this is not a study requiring expert interpretation of results for ground truth establishment. The performance criteria are objective measurements as per recognized standards (e.g., USP, ISO).
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
This is not applicable. The tests performed are objective, quantitative or qualitative measurements against established specifications/standards, not subjective assessments requiring adjudication.
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
This is not applicable. This device is a pre-filled saline syringe, not an AI-powered diagnostic or assistive tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable. This device is a manual medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" or acceptance criteria for this medical device are based on:
- Established standards and regulations: e.g., USP (United States Pharmacopeia) for chemical properties and bacterial endotoxin, ISO (International Organization for Standardization) for biocompatibility and package integrity.
- Performance of the predicate device: The subject device is designed to perform "Identical to predicate" or "Equivalent to predicate" in all tested characteristics. The predicate device's performance already demonstrates its safety and effectiveness.
8. The sample size for the training set
This is not applicable. This is a physical medical device, not an AI/machine learning algorithm that requires a training set.
9. How the ground truth for the training set was established
This is not applicable. As above, no training set is relevant for this type of device.
§ 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).