(130 days)
The Sterile Hypodermic Safety Syringes for Single Use is intended to be used for medical purpose to inject fluids into or withdraw fluids from the body. After injection, the anti-needlestick feature is manually activated to aid in the prevention of accidental needle stick injuries.
The proposed devices are for single use only, which are comprised of syringes and needles with various specifications. The proposed devices are available in a variety combination of needle sizes and syringe volumes. All specifications of proposed devices subject to the same design. The proposed devices are intended for manual use only.
The provided text describes the 510(k) summary for the "Sterile Hypodermic Safety Syringes for Single Use". This document focuses on demonstrating substantial equivalence to a predicate device, rather than defining and proving acceptance criteria for a novel AI device or a device requiring extensive clinical trials to establish effectiveness.
Therefore, many of the requested elements for an AI or complex medical device study (such as MRMC studies, training set details, expert ground truth adjudication) are not applicable or described in this document. The study described is primarily non-clinical verification and a simulated clinical study for the safety mechanism.
Here's a breakdown of the information that is available in the document, framed as closely as possible to your request, and identifying where information is not present:
Acceptance Criteria and Device Performance for Sterile Hypodermic Safety Syringes
The device in question is a "Sterile Hypodermic Safety Syringes for Single Use". The study presented is a 510(k) submission to demonstrate substantial equivalence to a legally marketed predicate device (K072739), not to establish novel acceptance criteria for a new type of functionality (like AI performance).
The "acceptance criteria" are derived from recognized international standards and FDA guidance for this class of medical device (syringes). The "reported device performance" refers to the results of testing performed against these standards.
1. Table of Acceptance Criteria and Reported Device Performance
The document lists various tests conducted with reference to specific ISO and ASTM standards. The reported device performance is generally stated as "met all design specifications" or "demonstrated substantial equivalence" with the predicate device.
| Test Category | Acceptance Criteria (Standard Reference) | Reported Device Performance |
|---|---|---|
| Physical, Mechanical, and Chemical Tests (Needle) | ||
| Materials | Clause 3 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Surface finish | Clause 4 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Cleanliness | Clause 5 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Acidity and alkalinity | Clause 6 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Size designation | Clause 7 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Dimensions | Clause 8 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Stiffness | Clause 9 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Resistance to breakage | Clause 10 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Resistance to corrosion | Clause 11 of ISO 9626:1991/AMD-1:2001 | Met specifications |
| Physical, Mechanical, and Chemical Tests (Syringe) | ||
| Cleanliness | Clause 5 of ISO 7886:1993 | Met specifications |
| Acidity or alkalinity | Clause 6 of ISO 7886:1993 | Met specifications |
| Extractable metals | Clause 7 of ISO 7886:1993 | Met specifications |
| Lubricant | Clause 8 of ISO 7886:1993 | Met specifications |
| Tolerance on graduated capacity | Clause 9 of ISO 7886:1993 | Met specifications |
| Graduated scale | Clause 10 of ISO 7886:1993 | Met specifications |
| Barrel | Clause 11 of ISO 7886:1993 | Met specifications |
| Piston/plunger assembly | Clause 12 of ISO 7886:1993 | Met specifications |
| Nozzle | Clause 13 of ISO 7886:1993 | Met specifications |
| Performance | Clause 14 of ISO 7886:1993 | Met specifications |
| Luer Connectors (Needle Hub) | ||
| Dimension Gauging | Clause 4.1 of ISO 594-2:1998 | Met specifications |
| Liquid leakage | Clause 4.2 of ISO 594-2:1998 | Met specifications |
| Air leakage | Clause 4.3 of ISO 594-2:1998 | Met specifications |
| Separation force | Clause 4.4 of ISO 594-2:1998 | Met specifications |
| Unscrewing torque | Clause 4.5 of ISO 594-2:1998 | Met specifications |
| Ease of assembly | Clause 4.6 of ISO 594-2:1998 | Met specifications |
| Resistance to overriding | Clause 4.7 of ISO 594-2:1998 | Met specifications |
| Stress cracking | Clause 3 of ISO 594-1:1986, Clause 4.1-4.5 of ISO 594-1:1986 | Met specifications |
| Sterile Barrier Packaging | ||
| Seal strength | ASTM F88/F88-09 | Met specifications |
| Internal pressure | ASTM F1140/F1140M-13 | Met specifications |
| Sterilization and Shelf Life | ||
| EO residue | ISO 10993-7:2008 | Met specifications |
| ECH residue | ISO 10993-7:2008 | Met specifications |
| Sterility test | ISO 11737-2: 2009 | Met specifications |
| Bacteria Endotoxin Limit | USP 36-NF 31 | Met specifications |
| Shelf Life Evaluation | Physical, Mechanical, Chemical, Package & Sterility Tests on real-time aging samples | Verified claimed shelf life |
| Biocompatibility | ISO 10993 standards | No cytotoxicity, no intracutaneous reactivity, no skin sensitization, no systemic toxicity, no hemolysis, no pyrogen |
| Simulated Clinical Study | FDA Guidance: Medical Device with Sharps Injury Prevention Feature, August 9, 2005 | Met pre-established criteria |
| Safety Feature Test | Comparison to predicate device | Did not show a significant difference from predicate device |
2. Sample size used for the test set and the data provenance
The document specifies that "Non clinical tests were conducted to verify that the proposed device met all design specifications". Specific sample sizes for each test are not provided in this summary. The data provenance is from JiangXi HongDa Medical Equipment Group Ltd. in Nanchang City, Jiangxi Province, China, indicating the testing was performed by the manufacturer, likely in China. The studies are non-clinical, meaning they involve laboratory or bench testing of the device itself, rather than human subjects.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This point is not applicable. For a device like a safety syringe, "ground truth" as requested (e.g., related to disease diagnosis or outcome based on expert consensus) is not established by medical experts for the performance tests listed. The "ground truth" for the non-clinical tests is the performance against the specified engineering and material standards.
4. Adjudication method for the test set
This point is not applicable. No adjudication by experts is described for these non-clinical performance and safety tests. The results are quantitative measurements against predefined standards.
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
This point is not applicable. The device is a sterile hypodermic safety syringe, not an AI-assisted diagnostic or therapeutic device. Therefore, no MRMC study, human reader improvement, or AI component is involved.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This point is not applicable as the device is not an algorithm or AI system. Its performance relates to its physical and mechanical properties and its safety mechanism.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The ground truth used for the non-clinical tests is based on the objective measurements and results obtained when testing the device against the specified physical, mechanical, chemical, and biological criteria defined in the referenced ISO and ASTM international standards, as well as FDA guidance. For the simulated clinical study and safety feature test, the "ground truth" refers to meeting the pre-established criteria specified in the FDA guidance and demonstrating functional equivalence to the predicate device, respectively.
8. The sample size for the training set
This point is not applicable. This device does not involve a "training set" in the context of machine learning or AI.
9. How the ground truth for the training set was established
This point is not applicable as there is no "training set" for this device.
§ 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).