(88 days)
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)
The Heparin Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic pre-filled syringe. The DEVICE consists of a hypodermic syringe with a hypodermic barrel, stopper plunger, plunger rod, tip cap and Heparin Lock Flush Solution USP. Heparin I. V. Flush Syringe is manufactured in three different concentrations - 1 Unit/mL; 10 Units/mL and 100 Units/mL. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in manufacturing. The DEVICE will be marketed in the following dosage forms:
1 mL fill in 6 mL Syringe LL
2 mL fill in 6 mL Syringe LL
2.5 mL fill in 6 mL Syringe LL
3 mL fill in 6 mL Syringe LL
3 mL fill in 12 mL Syringe LL
5 mL fill in 6 mL Syringe LL
5 mL fill in 12 mL Syringe LL
10 mL fill in 12 mL Syringe LL
The barrel of the syringe is the reservoir for the product. It shall be overfilled during repackaging as per Pharmacopoeial Forum, Volume 26, Number 2: page 471. Plunger and plunger rod are the two moving parts of the DEVICE. The solution is delivered by pressing down on the plunger rod, resulting in the expulsion of the fluid from the luer tip.
The DEVICE will be filled using aseptic technique utilizing pre-sterilized components in a Class 100 environment. The sterile components of the DEVICE (hypodermic syringe, tip cap, Heparin Sodium Injection and 0.9% Sodium Chloride Injection, USP) will be purchased from qualified vendors.
The DEVICE is used to maintain patency of in-dwelling intravenous access devices (IVAD). The solution is delivered by pressing down on the plunger rod. resulting in the expulsion of the fluid from the luer tip.
This document is a 510(k) summary for Medefil's Heparin Flush Syringe, submitted to the FDA in 2002. It outlines the device's description, intended use, and claims of substantial equivalence to a predicate device.
Here's an analysis of the provided text in relation to your request about acceptance criteria and a study proving device conformance:
The provided document is not about an AI/ML-driven medical device or a diagnostic system that would typically have the kind of "acceptance criteria" and "study" you're asking for (e.g., sensitivity, specificity, clinical outcome studies).
This document describes a physical medical device (a pre-filled syringe with Heparin flush solution) and a 510(k) submission, which is a premarket submission made to the FDA to demonstrate that the new device is as safe and effective, or "substantially equivalent," to a legally marketed predicate device.
Therefore, many of your requested points regarding acceptance criteria, study design for AI, expert numbers, ground truth, etc., do not apply to this type of device and submission.
However, I can extract information relevant to "acceptance criteria" in the context of a physical medical device and how its performance is "proven" for a 510(k) submission:
1. A table of acceptance criteria and the reported device performance
In the context of this physical device and a 510(k) substantial equivalence submission, "acceptance criteria" are not reported as specific clinical performance metrics (like sensitivity/specificity for a diagnostic). Instead, the acceptance criteria are implicitly that the modified device is substantially equivalent to the predicate device in terms of safety and effectiveness, and that its changes do not raise new questions of safety or effectiveness.
The document demonstrates this by comparing various attributes of the new device to the predicate device.
| Acceptance Criterion (Implicit for 510(k) Substantial Equivalence) | Reported Device Performance (Comparison to Predicate) |
|---|---|
| Intended Use Equivalence | The DEVICE has the same intended use: to maintain patency of in-dwelling intravenous access devices (IVAD). |
| Solution Equivalence | Both have the same pre-filled solution: Heparin Lock Flush Solution, USP. |
| Principle of Operation Equivalence | Both function under the same principle of operation including independent moving parts like stopper and plunger rods. |
| Nozzle Compatibility | Both nozzle tips are compatible with female luer fitting. |
| Biocompatibility & Chemical Compatibility of Materials | Both fluid container materials are biocompatible and chemically compatible with heparin lock flush solution. The fluid container material is same for both devices: polypropylene. |
| Sterility & Pyrogen-Free Status | Both have a sterile, pyrogen free heparin lock flush solution and fluid path. The DEVICE shall be pyrogen free per the LAL test method for bacterial endotoxin. |
| Lubricant Material | Both devices use silicone as a lubricant. |
| Fluid Expulsion Mechanism | The fluid is expelled out of the syringe barrel of both devices by pressing on the plunger for a hypodermic syringe. |
| Filling Technique | Both devices are filled using aseptic technique. The DEVICE will be filled using aseptic technique utilizing pre-sterilized components in a Class 100 environment. |
| Safety/Effectiveness of Differences | Dead space: DEVICE has more dead space than the predicate, but this is implicitly deemed not to adversely affect safety/efficacy for this 510(k). |
| Concentrations: DEVICE offered in 1, 10, 100 U/mL vs. predicate in 10, 100 U/mL. | |
| Barrel Size: DEVICE 6mL, 12mL vs. predicate 3mL. | |
| Barrel Diameter: DEVICE has a larger diameter (advantageous for pediatrics due to lower infusion pressure). | |
| Manufacturing: DEVICE uses fully automated vs. semi-automated (decreases contamination opportunity). All presented as not adversely affecting safety/efficacy. |
Regarding the other points, as they are largely inapplicable to this type of device and submission, here's why, or how they might be interpreted in a non-AI context:
2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
- Not applicable for an AI device. For a physical device like this, "data" often refers to engineering tests (e.g., LAL test for pyrogenicity mentioned), material compatibility studies, or sterility validations. The document provides no details on sample sizes for such tests, nor their provenance, which are usually part of the underlying design and manufacturing validation, not typically summarized in this specific 510(k) document unless specifically requested or if it's the core focus of the submission.
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)
- Not applicable. There is no "ground truth" in the diagnostic sense here. The "truth" is established by adherence to USP standards for the Heparin solution, validated manufacturing processes, and accepted engineering principles for medical devices.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. No expert adjudication process is detailed or expected for this type of device.
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 medical device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This is a physical medical device.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
- Not applicable in the diagnostic sense. The "ground truth" for this device's safety and efficacy relies on adherence to pharmaceutical standards (USP for Heparin solution, pyrogenicity testing), material science (biocompatibility, chemical compatibility), mechanical engineering (plunger function, luer compatibility), and manufacturing quality control (aseptic technique, Class 100 environment).
8. The sample size for the training set
- Not applicable. There is no AI model or algorithm being "trained" for this device.
9. How the ground truth for the training set was established
- Not applicable. There is no AI model or algorithm being "trained" for this device.
In summary: The provided document is a 510(k) submission for a modified pre-filled Heparin flush syringe. The "acceptance criteria" and "proof" of meeting them are primarily demonstrated through a detailed comparison to a legally marketed predicate device, asserting "substantial equivalence" based on similar intended use, solution, principle of operation, materials, and manufacturing practices, with differences explicitly addressed as not adversely affecting safety or effectiveness. The detailed requirements for AI/ML performance studies you listed are not relevant here.
§ 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).