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The Medline Safety Insulin Syringe is intended for the delivery of U-100 insulin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Medline TB (Tuberculin) Syringe is intended for the delivery of tuberculin. The needle stick prevention feature of the device, once activated, guards against accidental needle-sticks.

The Medline Safety Insulin Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for delivery of U-100 Insulin. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver insulin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense insulin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The Medline Safety Insulin Syringe barrel contains major and minor graduated ink markings and will be available in a 1 ml (100 units), and 0.5 ml (50 units) syringe volumes with three different needle gauge sizes.

The Medline TB Syringe is a sterile, single-use device, intended for prescription-use only, and is labeled for Tuberculin use. The proposed device consists of the following components: (1) a syringe barrel with a permanently attached single lumen needle; (2) a plunger; (3) a needle cap; and (4) a manually operated safety feature (i.e. shield) at the needle end of the syringe. The proposed device functions by mechanical action to deliver tuberculin. The syringe consists of a plunger that fits within the syringe barrel. The plunger can be linearly pulled and pushed along the inside of the barrel, allowing the syringe to take in and dispense tuberculin through the needle. The segmented safety shield is designed to be extended over the needle and locked. Activation is performed by a manual operation by extending the shield to cover the needle. Once activated, the safety shield is securely and permanently locked with a twisting motion. The syringe barrel contains graduated markings, with major graduation markings every 0.05mL and minor graduation markings every 0.01mL. The Medline TB Syringe will be available in a 1 mL syringe volume with three different needle sizes.

This document, a 510(k) premarket notification, describes the "Medline Safety Insulin and TB Syringes" and aims to demonstrate their substantial equivalence to a predicate device, the "Kendall Monoject® Magellan Insulin and Tuberculin Safety Syringe." It is not a document describing an AI/ML powered device, therefore the information requested in the prompt relating to AI models and ground truth generation (training set, test set, expert adjudication, MRMC studies, standalone performance, etc.) is not applicable to this submission.

The acceptance criteria and study proving the device meets them relate to the physical and biological performance of the syringes, particularly their safety features and material compatibility.

Here's a breakdown of the acceptance criteria and performance testing:

1. Table of Acceptance Criteria and Reported Device Performance

The submission does not present a formal table of quantitative acceptance criteria alongside specific numerical performance results. Instead, it lists the types of non-clinical tests conducted and states that "The results of these tests have demonstrated the overall safety of the proposed device and its effectiveness in accordance with relevant test methods, and ultimately support a substantial equivalence determination." This implies that the device met the standards and requirements of the cited ISO, ASTM, and USP standards.

The categories of testing and implied performance goals are:

• Residuals: EO and Ethylene Chlorohydrin (ECH) residuals within acceptable limits per ISO 10993-7:2008(R)2012.
• Shelf Life: Maintain functionality and sterility for 5 years as demonstrated by accelerated aging studies per ASTM F1980-16.
• Transportation Testing: Device integrity maintained after simulated transport (ISTA-3A:2008 – drop, vibration with top load, vibration without top load, second drop test).
• Package Integrity: No dye penetration after distribution stimulation per ASTM F1929:2015. |
  | Chemical Safety Testing | - Particulate Matter: Meet requirements of USP for particulate matter in injections.
• Phthalates: Acceptable levels of phthalates.
• Bacterial Endotoxin: Meet requirements of USP and Limulus Amebocyte Lysate (LAL) testing for bacterial endotoxins. |
  | Functional Performance Testing | - Visual Appearance: Pass visual inspection per ASTM F1886:2016 for seal integrity.
• Package Integrity: Pass seal leak detection per ASTM F1929-15.
• Seal Strength: Meet strength requirements per ASTM F88-21.
• Syringe Performance (Insulin): Meet requirements of ISO 8537:2016 for sterile single-use syringes for insulin.
• Sharps Injury Protection: Meet requirements and test methods of ISO 23908:2011 for sharps protection features.
• Needle Requirements: Meet requirements of ISO 7864:2016 for sterile hypodermic needles for single use.
• Needle Tubing: Meet requirements of ISO 9626:2016 for stainless steel needle tubing.
• Manual Syringe Use: Meet requirements of ISO 7886-1:2017 for sterile hypodermic syringes for manual use. |
  | Usability Testing | - Demonstrate effective sharps injury prevention features in simulated clinical use, in accordance with FDA guidance "Medical Devices with Sharps Injury Prevention Features." |
  | Biocompatibility Testing | - Cytotoxicity: No in vitro cytotoxicity (ISO 10993-5:2009).
• Sensitization: No sensitization (ISO 10993-10:2010).
• Irritation: No irritation (ISO 10993-10:2010).
• Acute Systemic Toxicity: No acute systemic toxicity (ISO 10993-11:2017).
• Hemolysis: Acceptable hemolytic properties (ASTM F756-17, ISO 10993-4:2017).
• Material-Mediated Pyrogenicity: No pyrogenic response (USP , ISO 10993-11:2017).
• Subacute/Subchronic Toxicity: No subacute/subchronic toxicity (ISO 10993-11:2017).
• Complement Activation: Acceptable complement activation (ISO 10993-4:2017).
• Partial Thromboplastin Time: Acceptable effect on PTT (ISO 10993-4:2017).
• Platelet and Leukocyte Counts: Acceptable effect on platelet and leukocyte counts (ISO 10993-4:2017). |

2. Sample Size for Test Set and Data Provenance

The document does not specify exact sample sizes for each test. Instead, it refers to industry standards (ISO, ASTM, USP) which typically prescribe minimum sample sizes for specific tests. The provenance of the data is not explicitly stated in terms of country or retrospective/prospective, but these are standard non-clinical laboratory tests performed on manufactured devices.

3. Number of Experts Used to Establish Ground Truth for Test Set and Qualifications

This is not applicable to this type of device submission. The "ground truth" for these tests are the established parameters and performance requirements defined by the international and national standards (ISO, ASTM, USP). The "experts" would be the qualified personnel performing the testing in compliance with these validated methods.

4. Adjudication Method for the Test Set

Not applicable. Testing results are generally objective measurements against established pass/fail criteria from the standards.

5. Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study

Not applicable. This device is a mechanical syringe, not an AI-assisted diagnostic tool.

6. Standalone (Algorithm Only) Performance

Not applicable. This device is a mechanical syringe.

7. The Type of Ground Truth Used

The "ground truth" for this device is based on:

• International and National Standards: ISO (International Organization for Standardization), ASTM (American Society for Testing and Materials), and USP (United States Pharmacopeia) define the performance and safety requirements.
• Predicate Device Equivalence: The primary objective is to demonstrate that the new device performs as safely and effectively as the legally marketed predicate device (Kendall Monoject® Magellan Insulin and Tuberculin Safety Syringe).
• Biocompatibility Standards: Guidelines from ANSI/AAMI/ISO 10993-1 ensure the materials are safe for biological contact.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device.

9. How the Ground Truth for the Training Set was Established

Not applicable. This is not an AI/ML device.

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