(120 days)
The Retractable Safety Syringe works like a conventional hypodermic syringe except for its ability to retract the contaminated needle inside of the syringe immediately after patient injection is activated by the syringe user. Because the contaminated needle is automatically withdrawn into the syringe user is protected from accidental needle sticks. These accidental needle sticks would occur between removing the needle from the patient and disposing of the syringe in a sharps disposable container.
For general injection use: The function of Retractable Safety Syringe is to provide a safe and reliable method of injecting fluids into or withdrawing fluids from the body. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe contains various capacity, such as 1ml, 2.5ml, 3ml, 5ml and 10ml.
For allergy use: The 1ml Retractable Safety Allergy Syringe is intended for the preparation/mixing of allergenic extracts/ prescribed substances, the manual aspiration of fluids, and for the injection of fluids into parts of the body below the surface of the skin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
For Tuberculin use: The 1ml Retractable Safety Tuberculin Syringe is intended for the delivery of Tuberculin. The Retractable Safety Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential or syringe reuse.
The proposed devices are available in various specifications, including 1ml, 2.5ml, 3ml, 5ml and 10ml. The applications of Retractable Safety Syringe include general injection, allergy and Tuberculin. General injection use is for 1ml, 2.5ml, 3ml, 5ml and 10ml, while allergy and Tuberculin uses are only for 1ml. The combinations of syringe and needle are listed in the below table.
The proposed device consists of eleven components: (1) piston, (3) barrel, (4) needle cap, (5) sealing plug, (6) slide bushing, (7) needle tube, (8) spring, (9) plunger lid, (10) barrel barb, (11) hub.
The proposed devices are provided sterile. The product is sterilized by Ethylene Oxide Gas to achieve a SAL of 10 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.
The provided text describes the 510(k) premarket notification for a Retractable Safety Syringe. It does not contain information about a study proving the device meets specific acceptance criteria in the context of AI/ML performance. Instead, it focuses on demonstrating substantial equivalence to predicate devices through non-clinical performance testing against established international standards for medical devices.
Therefore, many of the requested elements for an AI/ML-focused study acceptance criteria cannot be extracted from this document, such as sample sizes for test/training sets, data provenance, number/qualifications of experts, adjudication methods, MRMC studies, standalone performance, or ground truth types.
However, I can extract information related to the device's functional and safety performance, which are its acceptance criteria in this context, and the studies performed to demonstrate these.
Here's a breakdown of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
For medical devices like syringes, "acceptance criteria" are typically defined by regulatory standards (e.g., ISO, ASTM, USP) that specify performance requirements. The "reported device performance" is then the demonstration that the device meets these standards.
| Acceptance Criteria (Standard & Requirement) | Reported Device Performance (Compliance) |
|---|---|
| Biocompatibility: Device is not adverse to human tissue | Complies with ISO 10993-5:2009 (cytotoxicity), ISO 10993-10:2010 (irritation and delayed-type hypersensitivity), ISO 10993-11 (systemic toxicity), ASTM F756-17 (hemolytic properties), ISO 10993-4:2017 (interactions with blood) |
| Sterilization: Ethylene Oxide Sterilization Residuals | Complies with ISO 10993-7:2008 |
| Pyrogenicity: Absence of pyrogens | Complies with USP Pyrogen Test |
| Packaging Seal Integrity: Detection of seal leaks | Complies with ASTM F1929-15 (dye penetration) |
| Packaging Seal Strength: Strength of flexible barrier materials | Complies with ASTM F88/F88M-15 |
| Packaging Visual Integrity: Integrity of seals by visual inspection | Complies with ASTM F1886/F1886M-16 |
| Endotoxins: Absence of bacterial endotoxins | Complies with USP 39-NF34 Bacterial Endotoxins Test |
| Needle Requirements: Sterile hypodermic needles for single use | Complies with ISO 7864:2016 (requirements and test method) |
| Needle Tubing: Stainless steel needle tubing requirements | Complies with ISO 9626:2016 (requirements and test method) |
| Syringe Performance: Sterile hypodermic syringe for manual use | Complies with ISO 7886-1:2017 (Part 1: Syringes for manual use) |
| Sharps Injury Protection: Requirements and test methods for sharps protection features | Complies with ISO 23908:2011 (sharps protection features) |
| Particulate Matter: Absence of particulate matter in injection | Complies with USP 39-NF34 Particulate Matter in Injection |
| Safety Feature Effectiveness: Effect of safety feature in preventing sharps injuries | Complies with requirements demonstrated by a simulated clinical use study per FDA Guidance "Medical Devices with Sharps Injury Prevention Features" |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
The document mentions "non-clinical tests" and a "simulated clinical use study." However, it does not specify the exact sample sizes for these tests. The data provenance (country of origin, retrospective/prospective) is also not stated. These are typically detailed in the full test reports, which are not included in this summary.
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. This device is a physical medical device (syringe) and its performance is evaluated against engineering and biological standards, not through expert-labeled ground truth for AI/ML performance.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
Not applicable. As above, this pertains to expert review for AI/ML ground truth, which is not relevant here.
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 for AI/ML-assisted diagnostic or interpretative devices.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a manual physical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" for this device's performance is established by international and national standards (e.g., ISO, ASTM, USP) for physical and biological characteristics of syringes and needles. For the safety feature, it involves demonstration of compliance during a simulated clinical use study as per FDA guidance.
8. The sample size for the training set
Not applicable. This is for AI/ML models.
9. How the ground truth for the training set was established
Not applicable. This is for AI/ML models.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets its acceptance criteria is a comprehensive set of non-clinical performance tests conducted in accordance with recognized international and national standards. These include:
- Biocompatibility tests (ISO 10993 series, ASTM F756-17) to ensure the materials are safe for human contact.
- Sterilization and packaging integrity tests (ISO 10993-7, USP , ASTM F1929-15, ASTM F88/F88M-15, ASTM F1886/F1886M-16, USP 39-NF34 ) to confirm sterility and maintain it until use.
- Physical and functional performance tests for needles and syringes (ISO 7864:2016, ISO 9626:2016, ISO 7886-1:2017) to ensure they meet specifications for injection.
- Sharps injury prevention tests (ISO 23908:2011) to verify the effectiveness of the retractable safety feature.
- Particulate matter tests (USP 39-NF34 ) to ensure fluid cleanliness for injection.
- A simulated clinical use study to specifically evaluate the effect and effectiveness of the safety feature as per FDA guidance.
The document states that "The test results demonstrated that the proposed device complies with the following standards" for each category, indicating that the device met the acceptance criteria defined by these standards.
§ 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).