(225 days)
The Safety Insulin Syringe is a sterile, single use and non-reusable syringe intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse.
The Safety Insulin Syringe is a sterile, single use and non-reusable syringe with a permanently attached needle, which is intended for injection of U-100 insulin into the body, while reducing the risk of sharps injuries and the potential for insulin syringe reuse. The proposed device is available in 0.3ml, 0.5ml, 1ml volumes with a 26G-34G gauge needle. The safety feature will be manually activated to cover the needle immediately after use to minimize risk of accidental needle sticks.
The provided text describes a 510(k) premarket notification for a medical device, the "Safety Insulin Syringe," not an AI/ML medical device. Therefore, the information required to populate the fields related to AI/ML acceptance criteria and study design (such as training sets, test sets, expert adjudication, MRMC studies, etc.) is not present in the document.
The document focuses on demonstrating substantial equivalence to a predicate device through non-clinical testing of the physical, chemical, and performance characteristics of the syringe itself, as well as its safety features.
However, I can extract the acceptance criteria and performance data that are relevant to this type of medical device submission.
Here's a summary based on the provided text, focusing on the available information:
Acceptance Criteria and Device Performance (for a non-AI/ML medical device)
The device, a "Safety Insulin Syringe," is evaluated based on its physical, chemical, and safety performance. The acceptance criteria are typically compliance with recognized international standards and demonstration of specific functional parameters.
| Acceptance Criteria Category | Specific Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Needle Performance | Compliance with ISO 9626 (Stainless steel needle tubing for the manufacture of medical devices - Requirements and methods) and ISO 7864:2016 (Sterile hypodermic needles for single use - Requirements and test methods). | Device demonstrated to be in conformance with ISO 9626 and ISO 7864:2016. |
| Syringe Performance | Compliance with ISO 8537:2016 (Sterile single-use syringes, with or without needle, for insulin). | Device demonstrated to be in conformance with ISO 8537:2016. |
| Safety Feature Performance | Compliance with ISO 23908-First edition: Sharps Injury Protection - Requirements and Test Methods - Sharps protection features for single-use hypodermic needles. Specific parameters: |
- Force to activate the safety mechanism: less than 5N.
- Force that the safety mechanism is destroyed (resist force): greater than 20N. | The safety feature performance test for the proposed device was evaluated, and the test result conforms to requirements of ISO 23908:2011 standards.
- "The force to activate the safety mechanism is less than 5N" was met.
- "The force that the safety mechanism is destroyed is greater than 20N" was met. |
| Biocompatibility | Compliance with ISO 10993-1 for Externally Communicating Device, Blood Path Indirect, Prolonged Contact (>24 hours to 30 days). Testing includes: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, Subacute Systemic Toxicity. | Biocompatibility evaluated and results comply with ISO 10993 requirements. Specific tests conducted were: Cytotoxicity, Sensitization, Irritation or intracutaneous reactivity, Acute systemic toxicity, Pyrogenicity, Hemocompatibility, and Subacute Systemic Toxicity. |
| Particulate Matter | Compliance with USP . | Testing performed and results not explicitly stated but implied to be compliant through lack of identified issue. |
| Sterilization & Residues | Validation of sterilization per ISO 11135. Compliance with ISO 10993-7:2008 for EO and ECH (Ethylene Chlorohydrin) residue limits. Compliance with USP for Bacterial Endotoxin Limit. | Sterilization method validated per ISO 11135. Device found to be compliant with ISO 10993-7:2008 for EO and ECH residue and USP for Bacterial Endotoxin Limit. |
| Shelf Life & Packaging Integrity | Shelf life of 5 years. Evaluation using physical, mechanical, chemical, and package tests on aging samples (validated using ASTM F1980-16 for accelerated aging). Simulated Transportation Test (ASTM D4169-16). Sterile Barrier Packaging Testing: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), Dye Penetration (ASTM F1929-15). | 5-year shelf life determined based on stability studies including accelerated aging. Simulated transportation test conducted according to ASTM D4169-16. Sterile barrier packaging tests performed: Visual Inspection (ASTM F1886 / F1886M-16), Seal Strength (ASTM F88/F88M-15), and Dye Penetration (ASTM F1929-15) – all implied to be compliant. |
| Simulated Clinical Use (for Sharps Injury Prevention) | Evaluation of the safety mechanism according to FDA Guidance, "Guidance for Industry and FDA Staff: Medical Device with Sharps Injury Prevention Feature" (August 9, 2005) and ISO 23908. Pre-established criteria for safe and effective activation and protection. | A simulated clinical use study was performed on 500 device samples. The results demonstrated that the proposed device met the pre-established criteria. |
Since this is not an AI/ML device, the following points are not applicable and are listed as "N/A":
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Sample size used for the test set and the data provenance:
- Test Set Sample Size: N/A (for AI/ML test sets). For simulated clinical use of the physical device, 500 device samples were used.
- Data Provenance: N/A (for AI/ML test sets, as no image/data input is being classified). The physical device performance testing was performed by the manufacturer, Berpu Medical Technology Co., Ltd. (China). The tests are non-clinical (laboratory/bench testing) and simulate real-world use.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: N/A (no ground truth based on expert review of data is established for this type of device).
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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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: N/A.
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If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): N/A (for AI/ML ground truth). The "ground truth" for this medical device is adherence to physical/performance standards (e.g., ISO, ASTM, USP) and functional testing parameters for its mechanical safety features.
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The sample size for the training set: N/A.
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How the ground truth for the training set was established: N/A.
§ 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).