(165 days)
The Safety Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the skin. The Safety sheath of Syringe is designed to aid in the prevention of needle stick injuries and reduce the potential of syringe reuse.
The Disposable Syringe with permanently attached needle is intended for use by health care professionals for general purpose aspiration of fluid from vials, ampoules and liquid injection below the surface of the skin.
The proposed Syringes include Disposable Syringe with permanently attached needle and a Safety Syringe with permanently attached needle. The Disposable Syringe with permanently attached needle have one kind of product configuration, and the Safety Syringe with permanently attached needle has two kinds of product configurations. The proposed syringes are available in different combination of syringe volumes and/or needle sizes, and the syringe is sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterile in packaging to maintain the sterility of the device during the shelf life of three years.
This is a 510(k) premarket notification for a medical device (Safety Syringe with permanently attached needle; Disposable Syringe with permanently attached needle), not an AI/ML powered device. Therefore, the common acceptance criteria and study designs applicable to AI/ML devices, such as those involving human readers, effect sizes, specific ground truth methods, and training/test set sample sizes for AI model development, are not relevant to this document.
The document describes performance testing for substantial equivalence to predicate devices, which focuses on various engineering and biocompatibility standards.
Here's the relevant information about the acceptance criteria and study (non-clinical) that proves the device meets them:
1. Table of Acceptance Criteria and Reported Device Performance:
The document doesn't present acceptance criteria and performance in a direct "acceptance criteria vs. reported performance" table for all aspects. Instead, it refers to compliance with established international standards for medical devices. The "reported device performance" is implicitly that the device complies with these standards where listed.
| Acceptance Criteria (Standard Compliance) | Reported Device Performance |
|---|---|
| Biocompatibility: | |
| ISO 10993-5: 2009 (Cytotoxicity) | Performed, conforms |
| ISO 10993-10: 2010 (Skin sensitization, Intracutaneous reactivity) | Performed, conforms |
| ISO 10993-4: 2017 (Hemolysis) | Performed, conforms |
| ISO 10993-11: 2017 (Acute systemic toxicity, Pyrogenicity) | Performed, conforms |
| USP (Particulate matter) | Performed, conforms |
| Sterilization & Shelf Life: | |
| ISO 11135 (EO Sterilization) | Validated |
| USP42-NF37 (Bacteria Endotoxin Limit) | Carried out |
| ISO 10993-7:2008 (EO residue, ECH residue) | Performed, conforms |
| ASTM F1980-16 (Aging Test for Shelf Life) | Performed, determines 3-year shelf life |
| ASTM F88/F88M-15 (Seal strength) | Performed, packaging acceptable |
| ASTM F 1929-2015 (Blue Dye Penetration) | Performed, packaging acceptable |
| ASTM F 1886/ F 1886M-16 (Seal Integrity Visual Inspection) | Performed, packaging acceptable |
| Performance Testing: | |
| ISO 7886-1: 2017 (Sterile hypodermic syringes for manual use) | Performed, conforms |
| ISO 7886-4: 2018 (Syringes with re-use prevention feature) | Performed, conforms |
| ISO 7864: 2016 (Sterile hypodermic needles) | Performed, conforms |
| ISO 9626:2016 (Stainless Steel Needle Tubing) | Performed, conforms |
| ISO 23908: 2011 (Sharps injury protection) | Performed, conforms |
2. Sample Size Used for the Test Set and Data Provenance:
The document does not specify the exact sample sizes for each of the non-clinical tests mentioned. The "tests" are laboratory-based and generally involve a specified number of samples needed to demonstrate compliance with the relevant ISO or ASTM standards. Data provenance is not described in terms of country of origin as it's not clinical data, but rather laboratory test results. All tests are non-clinical (laboratory-based).
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of those Experts:
Not applicable. These are non-clinical, laboratory-based tests for physical and material properties, not clinical evaluations requiring expert interpretation for ground truth.
4. Adjudication Method for the Test Set:
Not applicable for non-clinical laboratory testing. Results are typically objectively measured against standard specifications.
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 device is a manual medical device, not an AI-powered system that would involve human readers or AI assistance.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable. This device is a manual medical device, not an AI algorithm.
7. The type of ground truth used:
For this device, "ground truth" is defined by the objective specifications and acceptance criteria outlined in the referenced international standards (ISO, ASTM, USP). For example:
- Biocompatibility: The "ground truth" is the acceptable range of biological response according to ISO 10993 standards.
- Sterilization: The "ground truth" is a Sterility Assurance Level (SAL) of 10^-6, verified by methods validated to ISO 11135.
- Physical Performance: The "ground truth" is the specific functional and dimensional requirements set forth in standards like ISO 7886-1 or ISO 9626.
There is no "expert consensus" or "pathology" in the traditional sense for these types of mechanical and material tests.
8. The sample size for the training set:
Not applicable. This is not an AI/ML device; there is no training set.
9. How the ground truth for the training set was established:
Not applicable. There is no training set for this type of 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).