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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.

Device Description

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.

AI/ML Overview

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 <788>.	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 <85> 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 <85> 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":

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.
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).
Adjudication method (e.g. 2+1, 3+1, none) for the test set: N/A.
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.
If a standalone (i.e. algorithm only without human-in-the loop performance) was done: N/A.
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.
The sample size for the training set: N/A.
How the ground truth for the training set was established: N/A.

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