(87 days)
Safelock Disposable Insulin Syringe is intended to inject U-100 insulin into the human body and aid in the prevention of accidental needle stick injuries.
Safelock Disposable Insulin Syringes are provided sterile, single use, which consist of five pieces components: (1) a syringe barrel calibrated in units of insulin (U-100) with a permanently attached single lumen needle on it, (2) a needle cap, (3) plunger and (4) protective end cap and (5) an additional safety mechanism installed at the needle end of the syringe. The devices are available in different combination of syringe volumes and needle sizes.
Here's an analysis of the provided text regarding acceptance criteria and the study that proves the device meets them, structured as requested:
Device: Safelock Disposable Insulin Syringe
1. Table of Acceptance Criteria and Reported Device Performance
The provided summary details various non-clinical tests performed according to recognized ISO and ASTM standards. The reported performance is generally stated as "met all design specifications" or "met the pre-established criteria." Specific quantitative acceptance criteria or performance metrics are largely absent from this summary but are implied by adherence to the referenced standards.
| Acceptance Criteria Category | Standard/Guidance | Reported Device Performance |
|---|---|---|
| Physical, Mechanical, and Chemical (Syringe) | ISO 8537:2007 (Clauses 5, 6.1, 6.2, 7, 8, 9.1, 9.2, 10.1, 10.2, 11.1, 11.2, 13.2, 14.1, 14.2, 14.3) | Met all design specifications (implied by adherence to ISO 8537:2007 requirements) |
| Freedom from extraneous matter | Clause 5 of ISO 8537:2007 | Met |
| Limits for acidity and alkalinity | Clause 6.1 of ISO 8537:2007 | Met |
| Limits for extractable metals | Clause 6.2 of ISO 8537:2007 | Met |
| Lubrication of syringes and needles | Clause 7 of ISO 8537:2007 | Met |
| Range of sizes | Clause 8 of ISO 8537:2007 | Met |
| Scale | Clause 9.1 of ISO 8537:2007 | Met |
| Numbering of scale | Clause 9.2 of ISO 8537:2007 | Met |
| Dimensions | Clause 10.1 of ISO 8537:2007 | Met |
| Finger grips | Clause 10.2 of ISO 8537:2007 | Met |
| Piston/plunger assembly | Clause 11.1 of ISO 8537:2007 | Met |
| Fit of piston in barrel | Clause 11.2 of ISO 8537:2007 | Met |
| Needle tubing for syringes | Clause 13.2 of ISO 8537:2007 | Met |
| Dead space | Clause 14.1 of ISO 8537:2007 | Met |
| Freedom from leakage at needle | Clause 14.2 of ISO 8537:2007 | Met |
| Liquid and air leakage past piston | Clause 14.3 of ISO 8537:2007 | Met |
| Physical, Mechanical, and Chemical (Needle) | ISO 9626:1991/AMD-1:2001 (Clauses 3-11) | Met all design specifications (implied by adherence to ISO 9626:1991 requirements) |
| Materials | Clause 3 of ISO 9626:1991/AMD-1:2001 | Met |
| Surface finish | Clause 4 of ISO 9626:1991/AMD-1:2001 | Met |
| Cleanliness | Clause 5 of ISO 9626:1991/AMD-1:2001 | Met |
| Limits for acidity and alkalinity | Clause 6 of ISO 9626:1991/AMD-1:2001 | Met |
| Size designation | Clause 7 of ISO 9626:1991/AMD-1:2001 | Met |
| Dimensions | Clause 8 of ISO 9626:1991/AMD-1:2001 | Met |
| Stiffness | Clause 9 of ISO 9626:1991/AMD-1:2001 | Met |
| Resistance to breakage | Clause 10 of ISO 9626:1991/AMD-1:2001 | Met |
| Resistance to corrosion | Clause 11 of ISO 9626:1991/AMD-1:2001 | Met |
| Sterile Barrier Packaging Testing | ASTM F88/F88M-09, ASTM F1140/F1140M-13 | Met all design specifications |
| Seal strength | ASTM F88/F88M-09 | Met |
| Internal pressure | ASTM F1140/F1140M-13 | Met |
| Sterilization and Shelf Life Testing | ISO 10993-7:2008, USP37-NF 32, | Verified claimed shelf life based on tests on accelerated aged samples |
| EO residue | ISO 10993-7:2008 | Met |
| ECH residue | ISO 10993-7:2008 | Met |
| Bacteria Endotoxin Limit | USP37-NF 32, | Met |
| Shelf Life Evaluation | Physical, Mechanical Chemical, Package and Sterility Test on accelerated aged samples | Verified claimed shelf life of the device |
| Biocompatibility | ISO 10993 series standards | Not required; materials identical to previously cleared K113091 |
| Safety Feature Testing | FDA Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature, issued on August 9, 2005 | Met pre-established criteria; force to activate and detach safety mechanism passed |
2. Sample Size Used for the Test Set and the Data Provenance
The provided text does not specify the sample size for any of the non-clinical tests (e.g., number of syringes tested for each ISO standard criterion, number of packages for ASTM, number of devices for safety feature testing).
The provenance of the data is that it was generated through non-clinical bench testing performed by the manufacturer, Jiangyin Caina Technology Co., Ltd. (located in China). The summary reports on tests performed on the "proposed device." It does not indicate retrospective or prospective in the typical sense of clinical studies, as these are lab-based evaluations.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of those Experts
This section is not applicable as the evaluation relies on direct measurement and adherence to objective standards (ISO, ASTM, USP) rather than expert interpretation of a ground truth in a clinical or image-based context. The "ground truth" is defined by the parameters and limits set forth in the referenced standards.
4. Adjudication Method for the Test Set
This section is not applicable. The tests are objective measurements against established standard criteria, not subjective assessments requiring adjudication among multiple reviewers.
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 is not applicable as the device is a medical syringe with a safety feature, not an AI-powered diagnostic or assistive technology for human readers. There is no mention of AI in this submission.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done
This is not applicable for the same reason as point 5. The device does not involve an algorithm.
7. The Type of Ground Truth Used
The ground truth for most tests is based on objective, internationally recognized performance standards (ISO, ASTM, USP) which define acceptable limits for physical, mechanical, chemical, and sterility properties. For the simulated clinical study and safety feature testing, the "ground truth" was derived from "pre-established criteria" and FDA guidance for sharps injury prevention devices, which likely includes defined force thresholds or functional performance checks.
8. The Sample Size for the Training Set
This is not applicable. The device is a physical medical device and does not involve AI or machine learning models that require a training set.
9. How the Ground Truth for the Training Set was Established
This 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).