(385 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and standard performance of a syringe, with no mention of AI or ML capabilities.
No
The device is a general-purpose syringe used for fluid aspiration/injection, which is a diagnostic or procedural tool, not a device used to treat or cure a disease or condition.
No
The device is a syringe for fluid aspiration/injection, which directly performs a medical action (injecting or withdrawing fluids from the body) rather than diagnosing a condition.
No
The device description clearly outlines physical components (luer lock tip, barrel, plunger rod, stopper) and the performance studies focus on biocompatibility and bench testing of these physical attributes, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general purpose fluid aspiration/ injection." This describes a device used to physically move fluids into or out of the body.
- Device Description: The description details a syringe used for injecting or withdrawing fluids from the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. IVDs typically involve testing or analyzing biological samples (blood, urine, tissue, etc.) outside of the body.
The device described is a general-purpose medical device used for administering or withdrawing fluids directly from a patient.
N/A
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.
Product codes
FMF
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
healthcare professionals
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Summary of Non-Clinical Testing:
Biocompatibility Testing: 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. Performed tests: ISO 10993-5:2009 (In Vitro Cytotoxicity), ISO 10993-10:2010 (Irritation and Skin Sensitization), ISO 10993-11:2017 (Systemic Toxicity), ISO 10093-4 and ASTM F756-17 (Hemolysis Assay), USP 151 (Material Mediated Pyrogenicity).
Performance Testing (Bench): Conducted for compliance with 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): Not applicable. No animal testing was performed.
Performance Testing (Clinical): Not applicable. No clinical testing was performed.
Other Testing:
Particulate Matter Testing in accordance with USP Particulate Matter in Injections.
Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP Bacterial Endotoxin Testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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).
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
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).
1
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
2
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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3
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
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.
4
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 Lock | ||
| Graduated Barrel | |||
| 3 parts: Piston, Barrel, Stopper | Luer Slip or Luer Lock | ||
| Graduated Barrel | |||
| 3 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 = Synthetic | ||
| Rubber |
- Plunger =
Polypropylene - Lubricant = Silicone
Oil
Luer Lock tip to
ISO 80369-7
Syringe to ISO
7886-1 | - Stopper =
thermoplastic
elastomer - Plunger =
Polypropylene - Lubricant = Silicone
Oil
Syringe to ISO 7886-1
and 7886-2 | impact the safety or
performance of the device
per testing.
Different -
Medline Luer Lock
Syringes are also
designed to ISO
80369-7. This does not
impact the safety or
performance of the device |
| Volume | 3mL
5mL
10mL
20mL
30mL
60mL | 3mL
20mL | performance of the device
Different -
Medline Luer Lock
Syringes are available in
additional configurations,
the additional
configurations do not
cause any additional risks
or concerns based on
performance 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 syringe
as well as discharge the fluid
for both manual and pump
driven operation. | Three-piece piston syringe.
Plunger is used to fill syringe as
well as discharge the fluid for
both manual and pump driven
operation. | Same |
| Lubricant Composition | Silicone Oil | Silicone Oil | Same |
| Barrel Transparency | Clear | Clear | Same |
| Physical and
Mechanical | ISO 7886-1 | ISO 7886-1
ISO 7886-2 | Same |
| Biocompatibility | ISO 10993 | ISO 10993 | Same |
| Labeling | Complied with 21 CFR
part | Complied with 21 CFR part | Same |
5
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
6
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.
7
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 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.