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The Insulin Syringes are intended for subcutaneous injection of U100 insulin or U40 insulin.

The Insulin Syringes are 0.3 mL, 0.5 mL, or 1.0 mL synnges designed for subcutaneous injection of a desired dose of insulin. The Insulin Syringes consist of a graduated barrel, plunger rod and needle/hub assembly. It is available in various needle gauge sizes (25G, 26G, 27G, 28G, 29G, 30G and 31G) and various needle lengths (6mm). The Insulin Syringes are sterile, single use, and non-toxic. These devices operate on the principles of a piston syringe.

The provided document is an FDA 510(k) premarket notification for "Insulin Syringes," which are medical devices, not AI/ML-driven software with specific acceptance criteria related to a test set, expert ground truth, or MRMC studies. The document describes a traditional medical device (insulin syringes) and its substantial equivalence to previously cleared predicate devices.

Therefore, the requested information regarding acceptance criteria, study design (test set, ground truth, expert adjudication, MRMC, standalone performance, training set details) for an AI/ML device is not available in this document. The document primarily focuses on:

• Device Description: Physical characteristics (volume, needle gauge/length, materials), intended use (subcutaneous injection of U100/U40 insulin).
• Modifications: Updates to packaging options and syringe sizes compared to the predicate.
• Substantial Equivalence Justification: Comparison of indications for use, technological characteristics (design, materials, sterilization) with predicate devices.
• Performance Testing: References to ISO standards for sterile single-use syringes, hypodermic syringes, stainless steel needle tubing, hypodermic needles, and sterilization validation (e.g., ISO 8537, ISO 7886-1, ISO 9626, ISO 7864, ISO 11135, ASTM F1980-16). These are standard tests for physical and functional properties of syringes, not AI/ML performance metrics.

The "Performance Testing" section refers to engineering and manufacturing standards for physical device performance, not for the performance of an algorithm or software. There are no mentions of AI/ML, image data, diagnostic accuracy, or human reader studies.

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The Syringe with Safety Needle is intended for use in the aspiration of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The Safety Needle is intended for use with a luer lock syringe for aspiration and injection of fluids for medical purpose. After withdrawal of the needle from the body, the attached needle safety shield can be manually activated to cover the needle immediately after use to minimize risk of accidental needle stick.

The proposed devices are provided in two types of configurations; one type is a syringe with safety needle contained in a sterility maintenance package, the other is one safety needle contained in a sterility maintenance package.

The Syringe with Safety Needle is available in various combination of syringe volume and needle size. The proposed device is operated manually. The liquid is aspiration into the syringe by pulling the plunger manually and injected into the body by pushing the plunger manually. When the needle is pulled out from the body, push the safety shield to cover the needle.

The proposed devices are sterilized by Ethylene Oxide Gas to achieve a SAL of 10-6 and supplied sterility maintenance package which could maintain the sterility of the device during the shelf life of five years.

The provided document is a 510(k) premarket notification for a medical device (Syringe with Safety Needle, Safety Needle). It primarily demonstrates substantial equivalence to a predicate device rather than presenting a de novo study proving a device meets specific clinical acceptance criteria through a novel study design. Therefore, much of the requested information regarding clinical study setup (sample size, ground truth, expert opinions, MRMC studies) is not applicable to this type of submission.

The document focuses on non-clinical performance data and a simulated clinical study for the safety mechanism.

Here's a breakdown of the available information based on your request:

1. Table of Acceptance Criteria & Reported Device Performance

The acceptance criteria are generally based on compliance with international and ASTM standards (e.g., ISO 10993 series for biocompatibility, ISO 7864 for hypodermic needles, ISO 7886-1 for syringes, ISO 23908 for sharps injury protection, ASTM standards for packaging integrity). The reported device performance is stated as meeting these standards. Specific numerical acceptance criteria or performance metrics for each test are not explicitly detailed in a single table, but rather implied by the statement "The test results demonstrated that the proposed device complies with the following standards" and "The test results show that the device meets the requirements of related standards."

Non-Clinical Acceptance Criteria (Implied by Standards Compliance):

2. Sample size used for the test set and the data provenance

• Non-Clinical/Bench Testing: The document states "Non clinical tests were conducted to verify that the proposed device met all design specifications" and "Physical. Mechanical, Chemical testing listed in following table were performed on the proposed device." Specific sample sizes for each non-clinical test (e.g., biocompatibility lot sizes, mechanical test numbers) are not provided in this summary.
• Simulated Clinical Study: "A simulated clinical study was performed... to evaluate the safety mechanism of the proposed device." Similarly, the specific sample size for this simulated study is not provided.
• Data Provenance: The manufacturer is Jiangsu Caina Medical Co., Ltd in China. The testing was conducted internally or by contract labs consistent with international standards. The document does not specify country of origin for any "data" beyond the manufacturer's location. The studies are by nature prospective (testing the new device).

3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts

• This information is not applicable as there was no clinical study involving expert interpretation of patient data to establish ground truth. The "ground truth" for the non-clinical tests is adherence to established international and ASTM standards.
• For the "Simulated Clinical Study," the ground truth would be objectively measured performance against the safety mechanism's functional requirements as per FDA guidance and ISO 23908:2011. No human expert interpretation with ground truth labels is mentioned.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

• Not applicable. There was no clinical study with human readers/interpreters requiring adjudication of results.

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 physical medical instrument (syringe/needle), not an AI-enabled diagnostic device. No MRMC study was performed.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

• Not applicable. This is a physical medical device, not an algorithm.

7. The type of ground truth used (expert concensus, pathology, outcomes data, etc)

• The "ground truth" for this submission are the performance specifications and acceptance criteria outlined in recognized industrial and medical device standards (ISO, ASTM, USP), as well as relevant FDA guidance documents for sharps injury prevention. For the simulated clinical study, the ground truth was the objective performance of the safety mechanism against pre-established criteria based on these standards and guidance.

8. The sample size for the training set

• Not applicable. This is not a machine learning/AI device, so there is no concept of a "training set."

9. How the ground truth for the training set was established

• Not applicable. (See point 8).

Summary of what the document does provide regarding acceptance:

The acceptance of this device for 510(k) clearance is primarily based on:

1. Demonstration of Substantial Equivalence (SE) to a legally marketed predicate device (K170651 for "Sterile Disposable Syringe with Safety Needle" and "Sterile Disposable Safety Needle"). The "Indications for Use" are shown to be the same.
2. Compliance with recognized consensus standards (listed on page 12-14) for biocompatibility, sterility, physical/mechanical performance, packaging, and sharps injury prevention.
3. Non-clinical testing results affirming that the proposed device performs comparably to the predicate device and meets the performance requirements of applicable standards.
4. A Simulated Clinical Study (details not provided beyond its existence and outcome) to evaluate the safety mechanism's compliance with FDA guidance and ISO 23908:2011, demonstrating it "met the pre-established criteria."
5. A Safety Feature Test comparing the proposed device to the predicate, showing "the test data of the proposed device is very close to the test data of the predicate device."

No human clinical trials or complex multi-reader studies were required or conducted, as indicated by "No clinical study is included in this submission."

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