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.

Device Description

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.

AI/ML Overview

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:

Test Category	Implied Acceptance Criteria / Performance Goal
Sterilization & Shelf Life	- Sterility: Achieve a Sterility Assurance Level (SAL) of 1 x 10⁻⁶ in accordance with ISO 11135:2014. - 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 <788> for particulate matter in injections. - Phthalates: Acceptable levels of phthalates. - Bacterial Endotoxin: Meet requirements of USP <85> 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 <151>, 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.

Summary

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Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.

October 18, 2023

Medline Industries, LP Kelsey Closen Regulatory Affairs Specialist Three Lakes Drive Northfield. Illinois 60093

Re: K231907

Trade/Device Name: Medline Safety Insulin and TB Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, MEG Dated: July 21, 2023 Received: July 21, 2023

Dear Kelsey Closen:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

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Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.

For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).

Sincerely,

erely, Juliane C. Lessard -S

Juliane C. Lessard, Ph.D. Director DHT3C: Division of Drug Delivery and General Hospital Devices. and Human Factors OHT3: Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health

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Indications for Use

510(k) Number (if known) K231907

Device Name Medline Safety Insulin and TB Syringes

Indications for Use (Describe)

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.

Type of Use (Select one or both, as applicable)
	Prescription Use (Part 21 CFR 801 Subpart D)
	Over-The-Counter Use (21 CFR 801 Subpart C)

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Image /page/3/Picture/0 description: The image is the logo for Medline. The logo is set on a blue background. The word "MEDLINE" is in white, bold, sans-serif font. Above the word is a white starburst-like shape with four points.

ledline Industries. L Three Lakes Drive Northfield, IL 60093

K231907- 510(k) SUMMARY

Submitter / 510(k) Sponsor

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Contact Person

Contact Person: Kelsey Closen, Regulatory Affairs Specialist Phone: 847-949-2283 Email: KClosen@medline.com

Summary Preparation Date October 19th 2023

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline Safety Insulin and TB Syringes Common Name: Tuberculin and Insulin Safety Syringes Classification Name: Syringe, Antistick and Syringe, Piston Product Code: MEG and FMF Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 880.5860

Predicate Device

Predicate Device: K061492, Kendall Monoject® Magellan Insulin and Tuberculin Safety Syringe

Device Description

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. A white, stylized star shape is in the center, with the word "MEDLINE" in white, bold letters positioned horizontally across the star. The star shape has four points, with the top and bottom points being more elongated than the side points.

Medline Industries, LP
Three Lakes Drive
Northfield, IL 60093

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.

Indications for Use

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.

TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES
DeviceCharacteristic	Proposed Device	Predicate Device	ComparisonAnalysis
	Medline Safety Insulin and TBSyringesK231907	Kendall Monoject Magellan andTuberculin Insulin Safety SyringeK061492
Product Code	MEG and FMF	FMF	Similar-See comment #1
Regulation Number	21CFR 880.5860	21CFR 880.5860	Same
Intended Use	Insulin Syringe:The device is intended for the deliveryof U-100 insulin. The needle stickprevention feature of the device, onceactivated, guards against accidentalneedle-sticks.	Insulin Syringe:The device is intended for the deliveryof U-100 insulin. The needle stickprevention feature of the device, onceactivated, guards against accidentalneedle-sticks.	Same

	TB Syringe:The device is intended for the deliveryof Tuberculin. The needle stickprevention feature of the device, onceactivated, guards against accidentalneedle-sticks.	TB Syringe:The device is intended for the deliveryof Tuberculin. The needle stickprevention feature of the device, onceactivated, guards against accidentalneedle-sticks.
Design Features	-Manually operated safety feature toprevent accidental needle sticks.-Graduation markings	-Manually operated safety feature toprevent accidental needle sticks.-Graduation markings	Same
Mechanism ofAction	Insulin Syringe:Mechanical delivery of U-100 insulin.Needle-stick prevention feature ismannually activated by the user by afinger-tip or thumb operation.TB Syringe:Mechanical delivery of tuberculin.Needle-stick prevention feature ismanually activated by the user by afinger-tip or thumb operation	Insulin Syringe:Mechanical delivery of U-100 insulin.Needle-stick prevention feature ismannually activated by the user by afinger-tip or thumb operation.TB Syringe:Mechanical delivery of tuberculin.Needle-stick prevention feature ismanually activated by the user by afinger-tip or thumb operation	Same
Components	Sterile SyringeSingle lumen needleSafety sheild/feature	Sterile SyringeSingle lumen needleSafety sheild/feature	Same
Prescription vs.OTC	Prescription Use Only	Prescription Use Only	Same
Sterile vs. Non-Sterile	Sterile	Sterile	Same
Sterilization Method	EO	EO	Same
Shelf life	5 years	5 years	Same
Single Use vs.Reusable	Single Use	Single Use	Same
Non-pyrogenic	Yes	Yes	Same
Size Configurations	Insulin Syringes:1ml Syringe w/ Needle, 29G x 0.5in1ml Syringe w/ Needle, 30G x 5/16in1ml Syringe w/ Needle, 31G x 5/16in1ml Syringe w/ Needle, 31G x 6mm0.5ml Syringe w/ Needle, 29G x 0.5in0.5ml Syringe w/ Needle, 30G x 5/16in0.5ml Syringe w/ Needle, 31G x 5/16in0.5ml Syringe w/ Needle, 31G x 6mmTB Syringes:	Insulin Syringes:1ml Syringe w/ Needle, 29G x 0.5in1ml Syringe w/ Needle, 30G x 5/16in0.5ml Syringe w/ Needle, 29G x 0.5in0.5ml Syringe w/ Needle, 30G x 5/16in0.3ml Syringe w/ Needle, 29G x 0.5in0.3 ml Syringe w/ Needle, 30G x 5/16inTB Syringes:1 mL syringe w/ needle 25Gx5/8"(0.508mm x 1.6cm)	Different –See comment # 2Referenceagency clearedIml syringeswith needle in31G x6mm and0.5ml syringewith needle,31G x6mm(K220061)
	1 mL Tuberculin Safety Syringe withNeedle, 25Gx5/8" (0.508 x 1.6 cm)1 mL Tuberculin Safety Syringe withNeedle, 27Gx1/2" (0.356 mm x 1.3 cm)1 mL Tuberculin Safety Syringe withNeedle, 28 G x 1/2" (0.356 mm x 1.3cm	1 mL syringe w/ needle, 28 Gx1/2"(0.356mm x 1.3cm)
Lubricant	Silicone	Silicone	Same
Needle Cap Color	Insulin: OrangeTB: Red, Grey and Brown	Insulin: OrangeTB: Orange, Red, Brown and Grey	Similar - seecomment #3
Device Materials(barrel and shield)	Polypropylene and Polyethylene	Polypropylene and Polyethylene	Same

Summary of Technological Characteristics

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Image /page/5/Picture/0 description: The image features the Medline logo, which is set against a blue background. The logo consists of the word "MEDLINE" in bold, white sans-serif font, positioned to the left of a stylized white starburst symbol. The starburst is oriented vertically, with its points extending upwards and downwards. A small portion of a gray rectangle is visible in the upper right corner of the image.

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

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Image /page/6/Picture/0 description: The image is a logo for Medline. The logo consists of the word "MEDLINE" in a sans-serif font, with a white cross-like symbol behind the text. The background is a solid dark blue color. The logo is simple and clean, with a professional look.

ledline Industries. LF Three Lakes Drive Northfield. IL 60093

Discussions of differences in technological characteristics

. Comment #1 Medline also has MEG as a product code since the proposed devices make an anti-stick claim. Both of these product codes are defined by the same FDA requlation number (21 CFR 880.5860), and this difference does not impact Medline's ability to claim substantial equivalence.
Comment # 2- Reference device cleared TB syringe 1mL with needle, 27Gx ½", Insulin syringe 1mL with needle 31G x 5/16″ and 0.5ml, 31Gx5/16" (K153537). Reference device cleared 1mL syringes with needle in 31Gx 6mm (K220061). The addition of 27Gx1/2", Insulin syringe 1mL with needle 31G x 5/16 including the 1ml with needle in 31Gx6mm does not raise different questions of safety and effectiveness than the predicate device.
. Comment #3-The TB syringe cap colors are different among the proposed device and predicate device. Biocompatibility on the caps was conducted and supports that this difference does not impact the safety and effectiveness of the device to claim substantially equivalent to the predicate.

Shelf Life and Sterilization

The proposed Medline Safety Insulin and TB Syringe is terminally sterilized by Ethylene Oxide (EO). The sterilization validation for the proposed device has been conducted in accordance with ISO 11135:2014, Sterilization of Health Care Products – Ethylene Oxide – Requirements for Development, Validation, and Routine Control of a Sterilization Process for Medical Devices, to ensure a Sterility Assurance Level (SAL) of 1 x 10%. The proposed device has also been evaluated for EO and Ethylene Chlorohydrin (ECH) residuals in accordance with ISO 10993-7:2008(R)2012, Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.

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Image /page/7/Picture/0 description: The image features the logo for Medline, a healthcare company. The logo consists of the word "MEDLINE" in a bold, sans-serif font, with a stylized white cross symbol superimposed over the text. The background is a solid dark blue color, providing a strong contrast to the white text and cross.

ledline Industries. Three Lakes Drive Northfield II 60093

Additionally, in accordance with ASTM F1980-16, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices, aging studies have been conducted to verify a five-year shelf life of the subject device and ensure that its functionality and sterility are successfully maintained throughout the duration of this shelf life. For additional information on the sterilization and shelf life of the proposed device, please refer to Section 14 of this submission. Test articles also underwent transportation-testing method, ISTA-3A:2008 and underwent a drop, vibration with top load, vibration without top load and a second drop test. After distribution stimulation, the test articles were tested to ASTM F1929:2015. Resistance to Dye Penetration.

Summary of Non-Clinical Performance Testing

Non-clinical verification of the Medline Safety Insulin and TB Syringes has been conducted to evaluate its safety, performance, and functionality. 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. Particularly, the following was conducted to adequately demonstrate the effectiveness of the proposed device in accordance with relevant test methods cited below:

Chemical Safety Testing

Particulate Matter Testing in accordance with USP <788> Particulate Matter in Injections ●
Phthalate Testing .
Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP <85> ● Bacterial Endotoxin Testing

Functional Performance Testing

. Visual Appearance Testing in accordance with ASTM F1886:2016 Standard Test Method For Determining Integrity Of Seals For Flexible Packaging By Visual Inspection
Package Integrity Testing in accordance with ASTM F1929-15 Standard Test Method for Detecting Seal Leaks in Porous Medical Packaging by Dye Penetration
Seal Strength Testing in accordance with ASTM F88-21 Test Method for Seal Strength of Flexible ● Barrier Materials
ISO 8537:2016 Sterile Single-Use Syringes, With or Without Needles, for Insulin ●
ISO 23908:2011 Sharps Injury Protection Reguirements and Test Methods Sharps Protection ● Features for Single Use Hypodermic Needles, Introducers for Catheters and Needles Uses for Blood Sampling
ISO 7864:2016 Sterile Hypodermic Needles for Single Use Requirements and Test Methods ●
ISO 9626:2016 Stainless Steel Needle Tubing for the Manufacturing of Medical Devices -● Requirements and Test Methods
. ISO 7886-1:2017 Sterile Hypodermic Syringes for Single Use – Part 1: Syringes for Manual Use

Usability Testing

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Image /page/8/Picture/0 description: The image shows the Medline logo, which features the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized starburst or cross shape. The background is a solid, dark blue color. A small portion of a gray bar is visible on the right side of the image, partially obscuring the blue background.

ledline Industries

In accordance with the FDA guidance document Medical Devices with Sharps Injury Prevention Features, a simulated clinical use (i.e. usability) testing was conducted using the Medline Safety Insulin and TB Syringes.

Biocompatibility Testing

The biocompatibility evaluation for the Medline Safety Insulin and TB Syringes was conducted in accordance with ANSI/AAMI/ISO 10993-1:2018 Biological Evaluation of Medical Devices - Part 1: Evaluation and Testing within a Risk Management Process, as recognized by FDA. The proposed device is classified as an externally communicating with prolonged, indirect blood contact. Final biocompatibility test protocols and reports are available for the Agency's review in Appendix D.

Cytotoxicity in accordance with ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests for in vitro Cytotoxicity
. Sensitization in accordance with ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Test for Irritation and Skin Sensitization
Irritation in accordance with ISO 10993-10:2010 Biological Evaluation of Medical Devices-Part 10: Tests for Irritation and Skin Sensitization
. Acute Systemic Toxicity in accordance with ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
. Hemolysis Assay in accordance with ASTM F756-17 Standard Practice for Assessment of Hemolytic Properties of Materials and ISO 10993-Part 4:2017 Biological Evaluation of Medical Devices-Part 4: Selection of Tests for Interactions with Blood
Material-Mediated Pyrogenicity in accordance with USP <151> Rabbit Pyrogen Test as ● recommended in ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
Subacute/ Subchronic Toxicity in accordance with ISO 10993-11:2017 Biological Evaluation of Medical Devices-Part 11: Tests for Systemic Toxicity
Complement Activation in accordance with ISO 10993-4: 2017 Biological Evaluation of Medical . Devices-Part 4: Selection of Tests for Interactions with Blood.
Partial Thromboplastin Time in accordance with ISO 10993-4 Biological Evaluation of Medical . Devices-Part 4: Selection of Tests for Interactions with Blood.
Platelet and Leukocyte Counts in accordance with ISO 10993-4:2017 Standard Biological ● Evaluation of Medical Devices, Part 4 – Selection of Tests for Interaction with Blood.

Summary of Clinical Testing

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Image /page/9/Picture/0 description: The image shows the Medline logo. The logo is set against a blue square background. The word "MEDLINE" is in bold, white letters. A white star-like symbol is behind the word "MEDLINE".

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Not applicable.

Conclusion

The difference between the predicate and the subject device do not raise any new or different questions of safety or effectiveness. The Medline Safety Insulin and TB Syringes are substantially equivalent to the Kendall Monoject Magellan Insulin and Tuberculin Safety Syringe with respect to the indications for use, target populations, treatment method, and technological characteristics.

Regulation Number and Section

§ 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).