(174 days)
FOR USE TO MAINTAIN THE PATENCY OF IN-DWELLING INTRAVENOUS VASCULAR ACCESS DEVICES (IVAD)
The Heparin I. V. Flush Syringe (the DEVICE) is a single dose, disposable, sterile, plastic prefilled syringe. The DEVICE consists of a hypodermic syringe barrel, stopper plunger, plunger rod, luer lock (LL) tip cap and Heparin Lock Flush Solution, USP (1 Unit/mL or 10 Units/mL or 100 Units/mL in 0.9% Sodium Chloride), which meets the requirements set forth in the current USP Heparin Lock Flush Solution monograph. Two different sizes (6 mL, 12 mL) of hypodermic syringes will be utilized in packaging. The hypodermic syringe is transparent. The barrel of the reservoir for the product and will be overfilled during manufacturing process. The plunger and plunger rod are the only two moving parts of the device. The flush 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 fully automated syringe filling machine utilizing non - sterile components. The components of the DEVICE (hypodermic syringe, tip cap and (Heparin Lock Flush Solution, USP) will be sterilized using steam in a terminal sterilizer after the syringe barrel is filled with Heparin Lock Flush Solution and sealed with Tip Cap and Plunger Stopper.
The acceptance criteria and study information for Medefil's Heparin I.V. Flush Syringe are described below, based on the provided 510(k) summary.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Specific Test/Requirement | Reported Device Performance |
|---|---|---|
| Physical Integrity | Dimensional Requirements (Engineering Drawings) | The DEVICE meets the requirements set forth in the engineering drawings. |
| Mechanical Performance | The DEVICE performed comparably to the substantially equivalent predicate device, not affecting safety or effectiveness. | |
| Seal Integrity (Dye Ingress Test) | Tested on terminally sterilized syringes (filled, sealed, steam sterilized). Specific results (e.g., pass/fail rates) are not provided, but the statement implies successful integrity. | |
| Seal Integrity (Microbial Ingress Test) | Performed by filling with Tryptic Soy Broth and using a vacuum method. Specific results are not provided, but the statement implies successful integrity. | |
| Biocompatibility | Biological Reactivity (In Vitro and In Vivo) | The polypropylene used in the DEVICE was found to meet the requirements of a USP Class VI plastic. |
| Cytotoxicity | Polypropylene and tip caps are not cytotoxic in nature. | |
| Sterility | Pyrogenicity (LAL Test Method for Bacterial Endotoxin) | The DEVICE shall be pyrogen free. (Implied performance is that it meets this, as it supports the claim of increased sterility assurance with terminal sterilization). |
| Chemical Stability & Compatibility | Compatibility with Heparin Lock Flush Solution (USP Monograph) | Stability testing was performed on Heparin I.V. Flush Syringes after terminal sterilization, at accelerated and real-time temperatures. This demonstrated that the new syringe material and sterilization process are compatible with the USP Heparin Lock Flush Solution. |
| Clinical Safety | Hemolysis (for 100 Units/mL concentration) | Did not result in any hemolysis, as measured by quantitating free hemoglobin in plasma and LDH levels. |
| Osmolality | No change in osmolality. | |
| Dilution of Heparin in Whole Blood Impact | The study showed that dilution of heparin in whole blood did not result in any measurable changes in various markers of hemolysis. |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the exact sample sizes used for each test. However, it indicates:
- Test Sets: "The syringes tested were filled with product, sealed, steam sterilized... for dye leak testing. The microbial ingress testing was performed by filling with Tryptic Soy Broth..." and "The polypropylene was tested for Biological Reactivity Tests In Vitro and In Vivo." Also, "The stability testing was performed on Heparin I. V. Flush Syringes..." and "Heparin I. V. Flush Syringe, 100 Units/mL did not result in any hemloysis..."
- Data Provenance: The studies were conducted by Medefil, Inc. and appear to be prospective in nature, as they involve testing of the device for its performance and safety characteristics. The document does not specify a country of origin for the data, but Medefil, Inc. is located in Glendale Heights, Illinois, USA, suggesting a domestic provenance.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable to this type of device submission. The tests performed are laboratory-based and analytical (physical, mechanical, chemical, biological reactivity, sterility, stability, clinical safety markers), not involving subjective interpretation by human experts to establish "ground truth" in the way a diagnostic imaging device might.
4. Adjudication Method for the Test Set
This information is not applicable as the tests are analytical and objective, not requiring adjudication of human interpretations.
5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study
No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is typically performed for diagnostic imaging devices where human readers interpret medical images, often with and without AI assistance, to assess the AI's impact on reader performance. This device is a pre-filled syringe (a medical device), not a diagnostic imaging AI.
6. Standalone (i.e., algorithm only without human-in-the-loop performance) Study
Yes, the studies performed for this device can be considered standalone performance assessments of the device itself (the pre-filled syringe) in meeting its design specifications and safety requirements. The device itself is not an algorithm, so "without human-in-the-loop performance" here means evaluating the physical, chemical, and biological properties of the syringe system.
7. Type of Ground Truth Used
The "ground truth" for the various tests was established by:
- Engineering Drawings: For dimensional criteria.
- Predicate Device Performance: For mechanical comparability.
- Established Test Methods and Standards:
- Dye ingress test and microbial ingress test: For seal integrity.
- USP Class VI plastic requirements: For biocompatibility of polypropylene.
- LAL test method: For pyrogenicity.
- USP monograph Heparin Lock Flush Solution: For chemical stability and compatibility.
- Quantitation of free hemoglobin, LDH levels, and osmolality measurement: For clinical safety (hemolysis).
These are objective, quantifiable measures against predefined standards or comparators.
8. Sample Size for the Training Set
This information is not applicable. The device is a physical medical device (pre-filled syringe), not an AI algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the same reason as above; there is no "training set" 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).