(322 days)
INT Vacuum Locking Syringe is intended for use only by physicians for adult patients to inject fluids into, or withdraw fluids from the body. It can also be used in cases where a Vacuum Syringe is preferred (e.g., thrombus, abscess fluid, bile, urine, etc.)
The INT Vacuum Locking Syringe is used to inject or withdraw fluids from the body. It can also be used in cases where a vacuum syringe is preferred (e.g., thrombus, abscess fluid, bile, urine etc.). The Syringe consists of graduation lines, zero line, luer connector, nozzle lumen, seals, barrel, plunger, push-button, barrel flanges, locking column, locking piece and fiducial line. When the Syringe is used, it can be divided into two situations: normal suction in normal state and vacuum suction in locked state. Vacuum Locking Syringe is placed in a soft blister box which is composed of Tyvek 2FS and PE. The proposed device is sterilized by EO and intended for single use. The packaging form is sealed packaging and guarantees that the product is sterile until opening. The packaging can ensure the sterilized finished device during its shelf life of 3 years.
The provided text is a 510(k) summary for a medical device (INT Vacuum Locking Syringe) seeking FDA clearance. It describes non-clinical testing performed to establish substantial equivalence to a predicate device. However, it explicitly states "No clinical study is included in this submission."
Therefore, I cannot provide information regarding:
- Multi-reader multi-case (MRMC) comparative effectiveness study
- Effect size of human readers improving with AI vs. without AI assistance
- Standalone (algorithm only without human-in-the-loop performance) study
I can, however, extract information about the non-clinical acceptance criteria and testing that was performed.
Here's the breakdown of the information that can be extracted:
1. A table of acceptance criteria and the reported device performance:
The document describes non-clinical performance testing conducted on the subject device against recognized standards. It states: "Results of the testing demonstrate that the subject device met the acceptance criteria sufficient for its intended use." However, the specific quantitative acceptance criteria and the exact reported performance values (e.g., specific force in N, leakage volume) are not detailed in this summary. The summary only lists the items tested and the methodology/standards used.
| Item Tested | Methodology/Standard | Reported Device Performance (as stated in document) |
|---|---|---|
| Appearance | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Graduated scale | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Barrel | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Luer connector | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Nozzle lumen | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Force to operate the piston | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Freedom from air and liquid leakage past plunger stopper | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Tolerance on graduated capacity | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Dead space | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Push-button distance | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Matching of seals and plunger | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Matching of barrel and Piston | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Tensile strength | ISO 7886-1:2017, ISO 80369-7:2021 | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Particulate Matter | USP Particulate Matter in Injections | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Titration acidity or alkalinity | In-house standards | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Limits for extractable metals | In-house standards | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Reducing (oxidizable) matter | In-house standards | Met acceptance criteria sufficient for its intended use. (Specific criteria and values not detailed) |
| Biocompatibility (Cytotoxicity, Sensitization, Intracutaneous Toxicity, Acute Systemic Toxicity, Pyrogen, In Vitro Hemolytic Properties) | FDA's biocompatibility guidance, "Use of International Standard ISO 10993-1..." | All tests performed and passed. |
| Sterile Barrier Packaging (Visual inspection, Seal strength, Dye penetration, Durability of markings) | ASTM F1886/F1886M-16, ASTM F88/F88-15, ASTM F1929-15, ISO 20417:2021 | Test result showed that the device package can maintain its integrity. |
| Sterilization (EO residue, ECH residue, Bacteria Endotoxin Limit) | ISO 10993-7:2008, USP | Met acceptance criteria. |
| Shelf-Life Evaluation (Physical, Mechanical, Chemical, Package Tests) | Stability studies including accelerated aging | Verified the claimed shelf life of 3 years. |
2. Sample size used for the test set and the data provenance:
The document mentions "non-clinical bench performance testing was conducted on the subject device" and lists various tests. However, it does not specify the sample sizes used for any of these tests.
Regarding data provenance, the testing was performed by the manufacturer, Shanghai Kindly Medical Instruments Co., Ltd., based in China, as part of their 510(k) submission. This is retrospective testing done to support the premarket notification.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not applicable as the document explicitly states "No clinical study is included in this submission" and the testing described is non-clinical bench testing. Ground truth for clinical studies typically involves expert assessment of patient data.
4. Adjudication method for the test set:
This information is not applicable as it pertains to clinical studies and expert consensus, which were not part of this submission.
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:
No, a multi-reader, multi-case comparative effectiveness study was not done. The document explicitly states "No clinical study is included in this submission." The device is a physical medical instrument (syringe), not an AI-powered diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
No, a standalone study (in the context of AI algorithm performance) was not done. The device is a physical syringe, and the testing described is bench performance testing for a medical instrument, not a software algorithm.
7. The type of ground truth used:
For the non-clinical performance and biocompatibility testing, the "ground truth" is defined by the acceptance criteria specified within the referenced international standards (e.g., ISO 7886-1, ISO 80369-7, ISO 10993-1, ASTM standards, USP standards) and the manufacturer's own in-house standards. Compliance with these established technical specifications and biological safety requirements serves as the ground truth for device performance and safety.
8. The sample size for the training set:
This information is not applicable as there is no "training set" in the context of this device and the non-clinical testing performed. This usually refers to machine learning models, which are not involved here.
9. How the ground truth for the training set was established:
This information is not applicable for the same reason as point 8.
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).