(388 days)
For the flushing and assessing the patency of indwelling catheters and venipuncture devices which are designed for intermittent injection therapy, blood sampling, or fluid and nutritional therapy.
The proposed Flush Syringe pre-filled with 0.9% Sodium Chloride will be composed of a medical grade plastic syringe and 0.9% Sodium Chloride for the purpose of flushing and assessing the patency of indwelling catheters and venipuncture devices
This document is a 510(k) Premarket Notification for a Flush Syringe with 0.9% Sodium Chloride. It seeks to demonstrate substantial equivalence to previously cleared predicate devices.
Based on the provided text, the device in question is a medical device (a pre-filled syringe with saline), not an AI/ML powered device. Therefore, the concepts of "acceptance criteria" and "study that proves the device meets the acceptance criteria" in the context of AI/ML performance (e.g., accuracy, sensitivity, specificity, F1 score) are not applicable here.
The document discusses "substantial equivalence" based on technological characteristics and intended use, comparing the new device to existing predicate devices. The "study" here refers to the documentation and testing performed to demonstrate that the new device is as safe and effective as the predicate devices, rather than a performance study of an algorithm.
Here's a breakdown of the information relevant to a non-AI/ML medical device submission, structured to answer your questions as much as possible given the context:
1. Table of Acceptance Criteria and Reported Device Performance
For non-AI/ML medical devices like this flush syringe, "acceptance criteria" and "device performance" are typically related to:
- Physical and chemical characteristics: Sterility, composition of saline, syringe materials, plunger function, integrity.
- Functional performance: Ability to flush and assess patency without leakage or material incompatibility.
- Biocompatibility: Materials used are safe for medical contact.
The document does not explicitly list a table of acceptance criteria with specific quantitative targets and results for the flush syringe's performance attributes in the provided sections. Instead, it relies on demonstrating substantial equivalence to predicate devices.
What is implied:
| Acceptance Criteria Category | Implicit Criterion (based on substantial equivalence) | Reported Device Performance (implied) |
|---|---|---|
| Intended Use | Same as predicate devices | "To flush or assess the patency of indwelling catheters and venipuncture devices" - Met |
| Technological Characteristics | Similar to predicate devices | "Technology and operating principles are the same for both devices." - Met |
| Material/Design (Differences) | Differences (sterilization, plunger tip) do not raise new safety/effectiveness questions | Information provided in 510(k) "supports claim for substantial equivalence." - Met |
| Sterility | Must be sterile (implied for medical device) | New sterilization method used, assumed to meet sterility standards (details not provided here) - Met |
| Functionality (e.g., no leaks) | Perform effectively without unintended side effects | Not explicitly detailed here, but presumed to be equivalent to predicates - Met |
The 510(k) process is about demonstrating that the new device is as safe and effective as a legally marketed predicate device, rather than proving performance against novel, pre-defined quantitative metrics similar to those for AI models. The "study" is the entire 510(k) submission itself, which provides data and justification for substantial equivalence.
2. Sample Size Used for the Test Set and Data Provenance
This information is not provided in the given text. For a physical device like a syringe, "test set" would refer to the number of syringes subjected to various physical, chemical, and sterility tests. The provenance (country of origin, retrospective/prospective) of such test data is also not specified, though it would typically be derived from manufacturer-conducted studies.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts
This concept is not applicable to this type of device submission. "Ground truth" established by experts is primarily relevant to diagnostic or interpretative AI/ML systems where human judgment is being replicated or assisted. For a flush syringe, the "ground truth" is typically defined by objective physical, chemical, and biological tests (e.g., pH readings, bacterial cultures, material compatibility tests) against established engineering and medical standards.
4. Adjudication Method for the Test Set
This concept is not applicable to this type of device submission. Adjudication methods (like 2+1 or 3+1) are used to resolve disagreements among human experts when establishing ground truth for diagnostic decisions, which is not the case for a physical medical device like a flush syringe.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. These studies are typically performed for diagnostic imaging devices or software where multiple readers (e.g., radiologists) interpret cases (e.g., medical images) to assess the impact of a new technology (e.g., AI assistance) on their diagnostic performance. This is not relevant for a pre-filled saline syringe.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
No, a standalone performance study was not done. This concept refers to the performance of an AI algorithm independent of human interaction. Since the device is a physical syringe and not an AI algorithm, this question is not applicable.
7. The Type of Ground Truth Used
As discussed in point 3, the concept of "ground truth" in the AI/ML sense is not applicable. For this device, "ground truth" would be established through:
- Objective physical and chemical tests: Ensuring the 0.9% Sodium Chloride solution is accurate, maintaining pH, integrity of the syringe components, ease of plunger movement, etc.
- Sterility testing: Ensuring the product is sterile.
- Biocompatibility testing: Ensuring the materials are safe for patient contact.
- Functional testing: Ensuring the syringe can effectively flush without leakage or particulate generation.
- Compliance with recognized standards: Adherence to ISO standards, USP monographs, etc.
The document implicitly refers to these types of "truths" by stating the device has "similarities" in technology and operating principles to predicate devices and that differences "do not raise new questions of safety or effectiveness."
8. The Sample Size for the Training Set
Not applicable. This device does not use an AI/ML algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no AI/ML training set, there is no ground truth to establish for it in this context.
§ 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).