(69 days)
The Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringes are intended for maintenance of patency of vascular access devices only.
Heparin Lock Flush Solution, USP, BD PosiFlush™ Heparin Lock Flush Syringe (also referred to as BD PosiFlush" Heparin Lock Flush Syringe) is provided in either 10 or 100 Units/mL concentrations in 0.9% Sodium Chloride Injection, USP packaged in a plastic, disposable, single use syringe. The syringe is a three-piece, single use syringe with a 6% (luer) connector prefilled with Heparin Lock Flush Solution, and sealed with a tip cap. The BD PosiFlush"" Heparin Lock Flush Syringe is provided in a 3mL or 5mL size configuration. The BD PosiFlush™ Heparin Lock Flush Syringe is provided with a sterile fluid path, sterilized via moist heat. The solution is delivered through the vascular access device to maintain catheter patency and is not to be used for anticoagulation therapy.
The change described in this submission is to qualify a new stopper material used in the BD PosiFlush " Heparin Lock Flush Syringe.
The provided document is a 510(k) Premarket Notification for a medical device, specifically the BD PosiFlush Heparin Lock Flush Syringe. The purpose of this document is to demonstrate that the new device is substantially equivalent to a previously cleared predicate device, rather than to establish new performance criteria for a novel device or an AI/ML algorithm.
Therefore, the concepts of "acceptance criteria," "study proving the device meets the acceptance criteria," "sample size for test set," "data provenance," "number of experts for ground truth," "adjudication method," "MRMC comparative effectiveness study," "standalone performance," "type of ground truth," "sample size for training set," and "how ground truth for training set was established" as they relate to AI/ML device validation are not applicable to this document.
This document describes a change to an existing device (qualifying a new stopper material) and relies on design verification testing and biocompatibility testing to demonstrate that the modified device remains substantially equivalent to the predicate device and does not affect the safety and efficacy.
Key information provided in the document relevant to device validation (though not in the context of AI/ML performance):
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Acceptance Criteria & Reported Performance:
- The document 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 of acceptance criteria values or the reported performance data for each test. It only states that the device "met predetermined acceptance criteria per BD's internal specification" and "results of design verification testing demonstrate that the modifications made to the subject device do not affect the safety and efficacy of the device."
- Tests Conducted:
- Container Closure Integrity
- Break Loose/Break Out/Sustaining force
- Stopper Separation
- Leakage
- Pump Force
- Ship Test
- Dead Space
- Syringe Induced Reflux
- Biocompatibility testing was conducted in accordance with ISO 10993-1, including: Cytotoxicity, Hemolysis, Acute systemic toxicity, Sub-Chronic Toxicity, Intracutaneous reactivity, Ocular irritation, Partial thromboplastin Time, Sensitization, Pvrogenicity, Genotoxicity, and Chemical extractable analysis. The document states "Biocompatibility evaluation was conducted..." and implies successful completion, but does not provide specific acceptance criteria or reported results.
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Sample Size and Data Provenance: Not applicable in the context of an AI/ML test set. The document refers to "design verification testing" and "biocompatibility testing" which would have involved a certain number of manufactured units, but the sample sizes for these tests are not explicitly stated in this summary.
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Ground Truth Experts/Adjudication Method/MRMC/Standalone Performance/Type of Ground Truth/Training Set Details: These concepts are entirely irrelevant to this type of device submission, which is for a physical medical device with a material change, not an AI/ML diagnostic or therapeutic algorithm. The "ground truth" for a device like this would be established through established physical and chemical testing standards, not expert consensus on medical images or outcomes data in the sense of AI/ML.
In summary, the provided document does not contain the information required to answer the questions as they are framed for an AI/ML device. It focuses on the substantial equivalence of a physical medical device after a material change.
§ 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).