Medline Luer Lock Syringes are Rx, sterile, non-pyrogenic, single use syringes intended to inject fluids into or withdraw fluids from, the body. The syringe consists of a luer lock tip, graduated barrel, a plunger rod and stopper. The barrel has gradient markings (mL) and the male luer lock tip allows the user to attach to a hypodermic needle or administration line. The plunger is pulled back to aspirate fluids or depressed to inject or expel fluids. Medline Luer Lock Syringes are available in 3mL, 5mL, 20mL, 30mL and 60mL.

AI/ML Overview

The document describes the Medline Luer Lock Syringes, which are sterile, non-pyrogenic, single-use syringes intended for general purpose fluid aspiration/injection by healthcare professionals for manual use. The device's substantial equivalence to a predicate device (BD Plastipak Syringe, K182589) was established through non-clinical performance testing and biocompatibility assessments, rather than clinical studies or those involving AI.

Here's the breakdown of the information requested, based on the provided text:

1. Table of Acceptance Criteria and Reported Device Performance

Test Name	Acceptance Criteria (Standard Reference)	Reported Device Performance (Compliance)
Biocompatibility	ISO 10993-1, ISO 10993-5, ISO 10993-10, ISO 10993-11, ISO 10093-4, ASTM F756-17	Testing performed in accordance with FDA guidance and standards, indicating compliance (implied by 510(k) clearance)
Performance (Syringe)	ISO 7886-1:2017 (Sterile hypodermic syringes for single use - Part 1)	Testing performed for compliance with this standard, indicating compliance (implied by 510(k) clearance)
Performance (Connectors)	ISO 80369-7:2016 (Small-Bore Connectors for Liquids and Gasses - Part 7)	Testing performed for compliance with this standard, indicating compliance (implied by 510(k) clearance)
Particulate Matter	USP <788> Particulate Matter in Injections	Testing performed in accordance with USP <788>, indicating compliance (implied by 510(k) clearance)
Bacterial Endotoxin	USP Bacterial Endotoxin Testing (Limulus Amebocyte Lysate (LAL))	Testing performed in accordance with USP Bacterial Endotoxin Testing, indicating compliance (implied by 510(k) clearance)
Shelf Life	N/A (Comparison to predicate, 5 years)	5 years shelf life (same as predicate)
Sterility Assurance Level	$10^{-6}$	$10^{-6}$ (same as predicate)

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

The document does not specify the exact sample sizes for each test mentioned (e.g., number of syringes tested for flow rate, leakage, etc.). It only states that "Performance testing on the Medline Luer Lock Syringes was conducted for compliance with the below standards."

Regarding data provenance, the studies are non-clinical (bench testing and biocompatibility), so "country of origin of the data" and "retrospective or prospective" are not applicable in the typical sense of clinical or real-world data studies. The testing was conducted internally or by contracted labs to demonstrate compliance with international standards.

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. The evaluations are based on established engineering standards (e.g., ISO, USP) and laboratory testing protocols, not expert consensus on ground truth in a diagnostic or interpretive sense.

4. Adjudication method for the test set

This information is not applicable. Adjudication methods like 2+1 or 3+1 are typically used for establishing ground truth in studies involving human interpretation (e.g., medical imaging), which is not the case for device performance testing against defined engineering standards.

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

No, a multi-reader multi-case (MRMC) comparative effectiveness study was not done. This type of study is relevant for evaluating the impact of AI on human diagnostic performance, which is not applicable to a piston syringe.

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

No, a standalone (algorithm only) performance evaluation was not done. This is also relevant for AI/software devices, not for a physical medical device like a syringe.

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

The "ground truth" used for this device is based on established international and national engineering standards (e.g., ISO 7886-1, ISO 80369-7), biocompatibility guidelines (ISO 10993), and pharmacopeial monographs (USP). Compliance with these standards defines the acceptable performance and safety criteria for the device.

8. The sample size for the training set

This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a training set.

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

This information is not applicable, as there is no training set for this device.

Summary

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February 16, 2024

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

Re: K230235

Trade/Device Name: Medline Luer Lock Syringes Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 13, 2024 Received: February 14, 2024

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 (OS) 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 QS 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 mediation-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, Shruti N. Mistry -S

Shruti Mistry Assistant Director Division of Drug Delivery and General Hospital Devices, and Human Factors 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) K230235

Device Name Medline Luer Lock Syringes

Indications for Use (Describe)

Medline Luer-Lock Syringes are intended for use by healthcare professionals for general purpose fluid aspiration/ injection. Intended for manual use.

X 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 shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white, stylized cross. The background is a solid blue color. The logo is simple and clean, and the colors are contrasting.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

K230235 510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]

Submitter / 510(k) Sponsor

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Registration Number: 1417592

Contact Person

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

Summary Preparation Date February 16th 2024

Type of 510(k) Submission Traditional

Device Name / Classification

Trade Name: Medline Luer Lock Syringes Common Name: Piston Syringe Classification Name: Syringe, Piston Product Code: FMF Classification Panel: General Hospital Regulatory Class: II Regulation Number: 21 CFR 880.5860

Predicate Device

BD Plastipak Syringe, K182589

Device Description

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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, sans-serif font, stacked on top of a white starburst-like shape. The background is a solid dark blue color. The logo is simple and modern, and the colors are clean and professional.

Medline Industries, LP Three Lakes Drive Northfield, IL 60093

Indications for Use

Medline Luer-Lock Syringes are intended for use by healthcare professionals for general purpose fluid aspiration/ injection. Intended for manual use.

Summary of Technological Characteristics TABLE 1: COMPARISON OF PROPOSED AND PREDICATE DEVICES

Device Characteristic	Proposed Device	Predicate Device	Comparison Analysis
Product Name	Medline Luer Lock Syringe	BD Plastipak Syringe	N/A
510(k) Reference	K230235	K182589	N/A
Product Owner	Medline Industries, LP	Becton, Dickinson and Company	N/A
Product Code	FMF	FMF	Same
Intended Use / Indications for Use	Medline Luer-Lock Syringes are intended for use by healthcare professionals for general purpose fluid aspiration/ injection. Intended for manual use.	The BD Plastipak™ Syringe is intended for single use by health care professionals for general purpose fluid aspiration/injection	Same
Mode of Action	Intended for manual use	Intended for manual use and use with power driven syringe pumps	Different - Medline syringe will be used for manual use. This does not raise new question of safety and effectiveness.
Regulation Number	21 CFR 880.5860	21 CFR 880.5860	Same
Syringe Type	Piston Syringe	Piston Syringe	Same
Design Features	Luer LockGraduated Barrel3 parts: Piston, Barrel, Stopper	Luer Slip or Luer LockGraduated Barrel3 parts: Piston, Barrel, Stopper	Different- Medline Luer Lock Syringe will not be offered in Luer Slip
Nozzle/Tip Type	Luer Lock, ISO 80369-7	Luer Lock, ISO 80369-7	Same
Barrel Markings Specs	Graduated Scale	Graduate Scale	Same
Gradation Legibility	Bold Markings	Bold Markings	Same
Material	Barrel = Polypropylene	Barrel = Polypropylene	Different - The raw material of the Stopper varies slight between the proposed and predicate device. This does not
Design Standards	- Stopper = SyntheticRubber- Plunger =Polypropylene- Lubricant = SiliconeOilLuer Lock tip toISO 80369-7Syringe to ISO7886-1	- Stopper =thermoplasticelastomer- Plunger =Polypropylene- Lubricant = SiliconeOilSyringe to ISO 7886-1and 7886-2	impact the safety orperformance of the deviceper testing.Different -Medline Luer LockSyringes are alsodesigned to ISO80369-7. This does notimpact the safety orperformance of the device
Volume	3mL5mL10mL20mL30mL60mL	3mL20mL	performance of the deviceDifferent -Medline Luer LockSyringes are available inadditional configurations,the additionalconfigurations do notcause any additional risksor concerns based onperformance testing
Prescription vs. OTC	Rx	Rx	Same
Shelf Life	5 years	5 years	Same
Sterilization Method	EO	EO	Same
Sterile vs. Non-Sterile	Sterile	Sterile	Same
SAL	$10^{-6}$	$10^{-6}$	Same
Disposable vs. Non-Disposable	Disposable	Disposable	Same
Single Use vs. Reusable	Single Use	Single Use	Same
Operational Principles	Three-piece piston syringe.Plunger is used to fill syringeas well as discharge the fluidfor both manual and pumpdriven operation.	Three-piece piston syringe.Plunger is used to fill syringe aswell as discharge the fluid forboth manual and pump drivenoperation.	Same
Lubricant Composition	Silicone Oil	Silicone Oil	Same
Barrel Transparency	Clear	Clear	Same
Physical andMechanical	ISO 7886-1	ISO 7886-1ISO 7886-2	Same
Biocompatibility	ISO 10993	ISO 10993	Same
Labeling	Complied with 21 CFRpart	Complied with 21 CFR part	Same

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Image /page/5/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in a sans-serif font, with the letters arranged horizontally. The word is white and is placed on a blue background. A white starburst symbol is behind the word "MEDLINE".

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 white, bold, sans-serif font, stacked on top of a white symbol that resembles a stylized cross or a compass rose. The background is a solid dark blue color. The logo is simple and clean, with a focus on the company name and a recognizable symbol.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

Summary of Non-Clinical Testing

Biocompatibility Testing

The biocompatibility evaluation for the Medline Luer Lock Syringes was conducted in accordance with FDA guidance document, Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing", ISO 10993-1 Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process. "

The following biocompatibility testing was performed:

ISO 10993-5:2009 Biological Evaluation of Medical Devices Part 5: Tests for In Vitro Cytotoxicity ●
. ISO 10993-10:2010 Biological Evaluation of Medical Devices - Part 10: Tests for Irritation and Skin Sensitization
ISO 10993-11:2017 Biological Evaluation of Medical Devices Part 11: Tests for Systemic Toxicity .
ISO 10093-4 and ASTM F756-17 Hemolysis Assay ●
USP 151 Material Mediated Pyrogenicity ●

Performance Testing (Bench)

Performance testing on the Medline Luer Lock Syringes was conducted for compliance with the below standards:

ISO 7886-1:2017 Sterile hypodermic syringes for single use Part 1: Syringes for manual Use ●
ISO 80369-7: 2016 Small-Bore Connectors For Liquids and Gasses in Healthcare applications ● Part 7: Connectors for intravascular or hypodermic applications

Performance Testing (Animal)

This section does not apply. No animal testing was performed.

Performance Testing (Clinical)

This section does not apply. No clinical testing was performed.

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Image /page/7/Picture/0 description: The image is a logo for Medline. The logo is white text on a blue square background. The text "MEDLINE" is in a sans-serif font. There is a white abstract symbol that looks like a plus sign that is vertically oriented behind the text.

Medline Industries, LP Three Lakes Drive Northfield. IL 60093

Other Testing

The following additional testing was performed:

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

Summary of Clinical Testing

Not applicable.

Conclusion

In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification, Medline Industries, Inc. concludes that the Medline Luer Lock Syringes are as safe and as effective for their intended use as the predicate device BD Plastipak Syringe, K182589.

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).