(443 days)
The Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. 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 Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. 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 Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe comprises hypodermic single lumen luer-lock safety needles alone (Identified in this submission as Medline Sure-Snap Safety Needles) and a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes (identified in this submission as Medline Sure-Snap Safety Syringes).
The provided text describes a 510(k) premarket notification for the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe. This type of submission aims to demonstrate substantial equivalence to legally marketed predicate devices, rather than proving the device meets specific acceptance criteria through a clinical efficacy study. Therefore, much of the requested information regarding clinical study design (sample size, expert ground truth, MRMC studies, training set details) is not applicable or explicitly stated in this document because the regulatory pathway chosen focuses on device characteristics and bench testing.
However, based on the document, here's what can be extracted regarding acceptance criteria and the study performed, focusing on the "Performance Testing (Bench)" and "Usability Testing" sections as these are the closest to performance evaluation.
Acceptance Criteria and Device Performance (Summary based on available information)
The primary "acceptance criteria" from a regulatory perspective for this 510(k) submission is to demonstrate substantial equivalence to predicate devices. This is achieved by showing that the new device has the same intended use, similar technological characteristics, and that any differences do not raise new questions of safety or effectiveness. Performance is evaluated through a series of bench tests and a simulated clinical use study as recommended by FDA guidance.
Table of Acceptance Criteria and Reported Device Performance
Since this is a 510(k) submission based on substantial equivalence and non-clinical testing, explicit numerical "acceptance criteria" and "reported device performance" are presented as compliance with established standards and successful outcomes of specific tests, rather than clinical efficacy metrics.
| Acceptance Criterion (Implicit/Explicit) | Reported Device Performance (as demonstrated by testing) |
|---|---|
| Biocompatibility: Device materials are safe for human contact. | Compliant: Biocompatibility tests (ISO MEM Elution, ISO Intracutaneous Irritation, ISO Guinea Pig Maximization Sensitization, ISO Acute Systemic Injection, ASTM Hemolysis Assay, ISO Materials Mediated Rabbit Pyrogen, Bacterial Endotoxin Testing) were performed on both the luer-lock piston syringe and the safety needle, demonstrating compliance with ISO 10993 standards. No adverse biological reactions were reported, suggesting the materials are biocompatible. |
| Functional Performance (Syringe): Meets standards for manual hypodermic syringes and small-bore connectors. | Compliant: Performance testing for the luer-lock piston syringe was conducted in accordance with ISO 7886-1 (Sterile hypodermic syringes for single use) and ISO 80369-7 (Small-bore connectors). This implies the device met the requirements of these standards for aspirations and injections. |
| Functional Performance (Needle): Meets standards for hypodermic needles and stainless steel tubing; includes sharps injury protection. | Compliant: Performance testing for the Medline Sure-Snap Safety Needles was performed in accordance with ISO 7864 (Sterile hypodermic needles), ISO 9626 (Stainless steel needle tubing), ISO 23908 (Sharps injury protection), and ISO 80369-7 (Small-bore connectors). This implies the device met the requirements of these standards, including the functionality of the sharps protection feature. |
| Usability/Sharps Injury Prevention Feature: The needle stick prevention feature functions reliably in simulated use. | Successful Activation: A simulated clinical use study was conducted. Of the 1,000 safety needles tested (500 per safety needle type), there were no failures in the activation of the needle stick prevention feature. The pass/fail criteria for function were met, and healthcare professionals provided feedback on perceived functionality. |
| Chemical Safety: Absence of harmful chemicals (e.g., DEHP), controlled particulate matter and endotoxins. | Compliant: Phthalates testing confirmed the device is not made with DEHP. Particulate Matter Testing was in accordance with USP <788>, and Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing was in accordance with USP <85>. Results indicate chemical safety requirements were met. |
| Sterilization & Shelf Life: Sterility Assurance Level (SAL) and functionality maintained over shelf life. | Compliant: Sterilization validation based on ISO 11135 achieved an SAL of 10⁻⁶. EO and Ethylene Chlorohydrin (ECH) residuals were evaluated per ISO 10993-7. Accelerated aging studies (ASTM F1980-16) confirmed functionality and sterility are maintained throughout the shelf life duration. |
Study Details
-
Sample sizes used for the test set and the data provenance:
- Test Set (Simulated Clinical Use Study for Sharps Injury Prevention): 1,000 safety needles were tested (500 per "safety needle type" – though the document details multiple configurations, it doesn't specify if "safety needle type" refers to Sure-Snap Safety Needle vs. Sure-Snap Safety Syringe types or different gauge sizes).
- Data Provenance: The document does not explicitly state the country of origin or whether the data was retrospective or prospective. Given it's a 510(k) submission, the studies would typically be conducted prospectively as part of the premarket submission process, and are likely to be conducted under a quality system by the manufacturer (Medline Industries, Inc. in Northfield, Illinois, USA).
-
Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- For the simulated clinical use study (usability testing), "Participating healthcare professionals assessed the function of the safety needle with a pass/fail criteria and provided feedback." The specific number of professionals or their detailed qualifications (e.g., years of experience, specific role like nurse, phlebotomist) are not specified in the document.
-
Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- The document implies a direct "pass/fail criteria" assessed by the participating healthcare professionals during the simulated clinical use study. It does not mention any formal adjudication method (like 2+1 or 3+1 consensus) for the results, suggesting a direct observation of the device's functional activation.
-
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. This is a medical device (syringe and needle) and not an AI/imaging device. Therefore, an MRMC comparative effectiveness study is not applicable and was not conducted.
-
If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical instrument, not an algorithm. Bench tests evaluate the physical properties and functional aspects of the device itself (e.g., needle sharpness, sheath activation), which could be considered a form of "standalone" performance testing for a physical object.
-
The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- For the simulated clinical use study, the "ground truth" for the device's safety feature activation was based on direct observation of its functional activation against pre-defined pass/fail criteria by "participating healthcare professionals." It's a performance truth based on observed mechanical function in a simulated setting, rather than a diagnostic truth like pathology or outcome data.
- For other performance tests (e.g., biocompatibility, functional performance under ISO standards), the "ground truth" is defined by the requirements and test methods specified in the cited international consensus standards. Compliance with these standards indicates the device performs as expected for its class.
-
The sample size for the training set:
- Not applicable. This device is not an AI/machine learning model, so there is no concept of a "training set" for an algorithm. All listed tests are for device verification/validation.
-
How the ground truth for the training set was established:
- Not applicable. As there is no training set for an AI model.
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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 and 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.
December 9, 2022
Medline Industries, Inc. Dinah Rincones Sr. Regulatory Affairs Specialist Three Lakes Drive Northfield, Illinois 60093
Re: K213054
Trade/Device Name: Medline Sure-Snap Safety Needle, Medline Sure-Snap Safety Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF, FMF, FMI, MEG Dated: September 17, 2021 Received: September 22, 2021
Dear Dinah Rincones:
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 (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 located 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.
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
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801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 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 4. Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 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,
Alan M.
Stevens -
S3
CAPT Alan M. Stevens Assistant 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
Enclosure
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Indications for Use
510(k) Number (if known) K213054
Device Name
Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe.
Indications for Use (Describe)
The Medline Sure-Snap Safety Syringe is intended for use in the aspiration of fluids for medical purposes. 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 Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. 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.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| 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 is set against a blue background. The word "MEDLINE" is in bold, white letters. A white, stylized starburst is behind the text, with the starburst's center aligned with the middle of the word "MEDLINE."
510(k) SUMMARY [AS REQUIRED BY 21CFR807.92(c)]
Submitter / 510(k) Sponsor
Dinah Rincones Sr. Regulatory Affairs Specialist Medline Industries, LP. Three Lakes Drive Northfield, IL 60093 Phone: 847-949-2687 Email: Drincones@medline.com
Summary Preparation Date
September 17, 2021
Type of 510(k) Submission Traditional
Device Name / Classification
| • Device Common Name | Piston Syringe with Safety Hypodermic SingleLumen Needle, Safety Hypodermic Single LumenNeedle |
|---|---|
| • Proprietary Name | Medline Sure-Snap Safety Needle and MedlineSure-Snap Safety Syringe |
| • Class | Class II |
| • Review Panel | General Hospital |
| • Regulation Number | 21 CFR 880.5860 |
| • Classification Product Code | FMF (Piston Syringe) |
| • Subsequent Product Codes | FMI (Hypodermic Single Lumen Needle)MEG (Antistick Syringe) |
Predicate Device
Primary Predicate Device: Syringe with Safety Needle, Safety Needle (K193526). Secondary Predicate Device: BD Eclipse Hypodermic Needle (K161170).
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Image /page/4/Picture/0 description: The image shows the Medline logo. The logo is set against a blue background. The word "MEDLINE" is written in white, with a stylized star symbol above it. The star symbol has four points, resembling a compass rose.
Device Description
The Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe comprises hypodermic single lumen luer-lock safety needles alone (Identified in this submission as Medline Sure-Snap Safety Needles) and a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes (identified in this submission as Medline Sure-Snap Safety Syringes).
Medline Sure-Snap Safety Needles
The Medline Sure-Snap Safety Needle consists of a permanently attached metal single lumen hypodermic needle that is sharpened at one end and at the other end ioined to a female connector (Needle Hub) designed to mate with a male connector (nozzle) of a luer-lock piston syringe. It also comprises a safety shield to minimize risk of accidental needle stick. The safety shield is a mechanism that covers the needlepoint after use and should be activated immediately following the injection. It can be activated by centering the thumb or forefinger on the textured finger pad and pushing the safety cover forward over the needle until you hear or feel it lock. A hard surface can also be used to push-up against. The small hook located on the back wall of the safety sheath locks the needle into place once it is activated; this prevents the needle from being "un-activated."
The Medline Sure-Snap Safety Needles are offered in a variety of gauge sizes (18-30 gauge) and needle lengths (½''- 112°). The needle hub and the safety needle sheath is color-coded to the appropriate gauge needle per ISO 6009. The Medline Sure-Snap Safety Needle should only be used with luer-lock syringes. This product is single use, provided sterile and will be available in the following design configurations:
| Medline ModelNumber | Description | NeedleGauge | NeedleLength | Safety NeedleSheath/NeedleHub Color |
|---|---|---|---|---|
| SSN100187 | NEEDLE,HYPODERM,SAFETY,18GX1.5 | 18G | 1.5in | Pink |
| SSN100185 | NEEDLE,HYPODERM,SAFETY,18GX1 | 18G | 1in | Pink |
| SSN100195 | NEEDLE,HYPODERM,SAFETY,19GX1 | 19G | 1in | Cream |
| SSN100205 | NEEDLE,HYPODERM,SAFETY,20GX1 | 20G | 1in | Yellow |
| SSN100207 | NEEDLE,HYPODERM,SAFETY,20GX1.5 | 20G | 1.5in | Yellow |
| SSN100215 | NEEDLE,HYPODERM,SAFETY,21GX1 | 21G | 1in | Green |
| SSN100217 | NEEDLE,HYPODERM,SAFETY,21GX1.5 | 21G | 1.5in | Green |
| SSN100225 | NEEDLE,HYPODERM,SAFETY,22GX1 | 22G | 1in | Black |
| SSN100227 | NEEDLE,HYPODERM,SAFETY, 22GX1.5 | 22G | 1.5in | Black |
| SSN100235 | NEEDLE,HYPODERM,SAFETY, 23GX1 | 23G | 1in | Blue |
| SSN100237 | NEEDLE,HYPODERM,SAFETY, 23GX1.5 | 23G | 1.5in | Blue |
| SSN100255 | NEEDLE,HYPODERM,SAFETY, 25GX1 | 25G | 1in | Orange |
| SSN100257 | NEEDLE,HYPODERM,SAFETY, 25GX1.5 | 25G | 1.5in | Orange |
Table 1: Medline Sure-Snap Safety Needle Configurations
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Image /page/5/Picture/0 description: The image features the Medline logo against a blue background. The logo consists of the word "MEDLINE" in a bold, sans-serif font, positioned to the left of a white, stylized starburst symbol. The starburst has four points, with the top and bottom points being longer than the side points, creating a dynamic and eye-catching design.
| Medline ModelNumber | Description | NeedleGauge | NeedleLength | Safety NeedleSheath/NeedleHub Color |
|---|---|---|---|---|
| SSN100253 | NEEDLE,HYPODERM,SAFETY, 25GX5/8 | 25G | 5/8in | Orange |
| SSN100276 | NEEDLE,HYPODERM,SAFETY, 27GX1.25 | 27G | 1.25in | Grey |
| SSN100273 | NEEDLE,HYPODERM,SAFETY, 27GX5/8 | 27G | 5/8in | Grey |
| SSN100272 | NEEDLE,HYPODERM,SAFETY, 27GX0.5 | 27G | 0.5in | Grey |
| SSN100302 | NEEDLE,HYPODERM,SAFETY, 30GX0.5 | 30G | 0.5in | Yellow |
Medline Sure-Snap Safety Syringe
The Medline Sure-Snap Safety Syringes are a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes. The Medline Sure-Snap Safety Syringes are sterile, non-pyrogenic, single use devices intended to be used to inject fluids into or withdraw fluids from the body.
The Medline Sure-Snap Safety Syringes will be available in the following design configurations:
| Medline ModelNumber | Description | NeedleGauge | NeedleLength | Safety NeedleSheath/NeedleHub Color | SyringeVolume |
|---|---|---|---|---|---|
| SSN101235F | SYR W/NDLE,SAFETY,23GX1, 1ML | 23G | 1in | Blue | 1mL |
| SSN101255F | SYR W/NDLE,SAFETY,25GX1, 1ML | 25G | 1in | Orange | 1mL |
| SSN101272F | SYR W/NDLE,SAFETY,27GX0.5, 1ML | 27G | 0.5in | Grey | 1mL |
| SSN103205 | SYR W/NDLE,SAFETY,20GX1,3ML | 20G | 1in | Yellow | 3mL |
| SSN103207 | SYR W/NDLE,SAFETY,20GX1.5, 3ML | 20G | 1.5in | Yellow | 3mL |
| SSN103217 | SYR W/NDLE, SAFETY,21GX1.5, 3ML | 21G | 1.5in | Green | 3mL |
| SSN103215 | SYR W/NDLE,SAFETY,21GX1,3ML | 21G | 1in | Green | 3mL |
| SSN103227 | SYR W/NDLE,SAFETY,22GX1.5, 3ML | 22G | 1.5in | Black | 3mL |
| SSN103225 | SYR W/NDLE,SAFETY,22GX1,3ML | 22G | 1in | Black | 3mL |
| SSN103235 | SYR W/NDLE,SAFETY,23GX1,3ML | 23G | 1in | Blue | 3mL |
| SSN103255 | SYR W/NDLE,SAFETY,25GX1,3ML | 25G | 1in | Orange | 3mL |
| SSN103253 | SYR W/NDLE,SAFETY,25GX5/8, 3ML | 25G | 5/8in | Orange | 3mL |
| SSN105217 | SYR W/NDLE,SAFETY,21GX1.5, 5ML | 21G | 1.5in | Green | 5mL |
| SSN110227 | SYR W/NDLE,SAFETY,22GX1.5, 10ML | 22G | 1.5in | Black | 10mL |
| SSN110207 | SYR W/NDLE,SAFETY,20GX1.5, 10ML | 20G | 1.5in | Yellow | 10mL |
| SSN110217 | SYR W/NDLE,SAFETY,21GX1.5, 10ML | 21G | 1.5in | Green | 10mL |
Table 2: Medline Sure-Snap Safety Syringe Configurations
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Image /page/6/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, positioned to the left of a stylized white cross. The background is a solid dark blue color, providing a strong contrast to the white elements of the logo.
Indications for Use
The Medline Sure-Snap Safety Syringe is intended for use in the aspiration and injection of fluids for medical purposes. 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 Medline Sure-Snap Safety Needle is intended for use with a luer-lock syringe for aspiration and injection of fluids for medical purposes. 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.
Summary of Technological Characteristics
Refer to Table 3 on the next page.
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Table 3: Comparison of the Proposed Device with the Predicate Device
| DeviceCharacteristic | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remarks(Comparison with the PrimaryPredicate Device) |
|---|---|---|---|---|
| ProductName | Medline Sure-Snap SafetyNeedle and Medline Sure-Snap Safety Syringe | Syringe with Safety Needle,Safety Needle | BD Eclipse HypodermicNeedle | N/A |
| 510(k)Reference | K213054 | K193526 | K161170 | N/A |
| ProductOwner | Medline Industries, Inc. | Jiangsu Caina Medical Co.,Ltd | Becton, Dickinson andCompany | N/A |
| Product Code | Classification Product Code:• FMF (Piston Syringe)Subsequent Product Codes:• FMI (Hypodermic SingleLumen Needle)• MEG (Antistick Syringe) | Classification Product Code:• FMF (Piston Syringe)Subsequent Product Codes:• FMI (Hypodermic SingleLumen Needle)• MEG (Antistick Syringe) | FMI: Needle, Hypodermic,Single Lumen | SAME |
| RegulationNumber | 21 CFR 880.586021 CFR 880.5570 | 21 CFR 880.586021 CFR 880.5570 | 21 CFR §880.5570 | SAME |
| DeviceDescription | Safety needle alone and acombination of a pistonsyringe with a safety needle. | Safety needle alone and acombination of a pistonsyringe with a safety needle. | Safety Needle alone | SAME |
| Indicationsfor Use | Safety NeedleThe Medline Sure-SnapSafety Needle is intended foruse with a luer-lock syringefor aspiration and injection offluids for medical purposes.After withdrawal of theneedle from the body, theattached needle safety shieldcan be manually activated tocover the needle immediatelyafter use to minimize risk ofaccidental needle stick. | Safety NeedleThe Safety Needle is intendedfor use with a luer-locksyringe for aspiration andinjection of fluids for medicalpurpose. After withdrawal ofthe needle from the body, theattached needle safety shieldcan be manually activated tocover the needle immediatelyafter use to minimize risk ofaccidental needle stick. | Safety NeedleThe BD Eclipse HypodermicNeedle is used for general-purpose injection andaspiration of fluid from vials,ampoules and parts of thebody below the surface of theskin. The BD EclipseHypodermic Needle iscompatible for use withstandard luer-lock syringes.The BD Eclipse HypodermicNeedle contains a mechanismthat covers the needlepointafter use. In the activatedposition the needle coverguards against accidentalneedle sticks during normalhandling and disposal of theused needle/ syringecombination. | SAME |
| Syringe with Safety NeedleThe Medline Sure-SnapSafety Syringe is intended foruse in the aspiration andinjection of fluids for medicalpurposes. After withdrawal ofthe needle from the body, theattached needle safety shieldcan be manually activated tocover the needle immediatelyafter use to minimize risk ofaccidental needle stick. | Syringe with Safety NeedleThe Syringe with SafetyNeedle is intended for use inthe aspiration and injection offluids for medical purposes.After withdrawal of theneedle from the body, theattached needle safety shieldcan be manually activated tocover the needle immediatelyafter use to minimize risk ofaccidental needle stick. | N/A | SAME | |
| OperatingPrinciple | Safety NeedleThe Medline Sure-SnapSafety Needles are devicesthat are composed of ahypodermic needle with a onepiece hub/adapter andpivoting cover that isconnected to the hub. Thedevice consists of amechanism that covers theneedle point after use. | Safety NeedleThe Safety Needles aredevices that are composed ofa typical hypodermic needlewith a one piece hub/adapterand pivoting cover that isconnected to the adapter. Thedevice consists of amechanism that covers theneedle point after use. | Safety NeedleBD Eclipse HypodermicNeedles are devices that arecomposed of a typicalhypodermic needle with a onepiece hub/adapter andpivoting cover that isconnected to the adapter. Thedevice consists of amechanism that covers theneedle point after use. | SAME |
| SyringeThe Medline Sure-SnapSafety Syringe is a luer-lockpiston syringe for manual usewith safety needle. | SyringeThe Syringe with SafetyNeedle is a luer-lock pistonsyringe for manual use withsafety needle. | N/A | SAME | |
| DesignFeatures | Safety NeedleComponents: Needle hub,needle tube/cannula,lubricant, safety shield,needle cap.Specifications:• Needle length: 0.5in – 1.5in• Needle Gauge Range: 18G-30G (18G, 19G, 20G, 21G,22G, 23G, 25G, 27G, 30G).• Bevel: Regular, short,intradermal.• Luer-lock connector.• Needle hub color: per ISO6009 | Safety NeedleComponents: Needle hub,needle tube/cannula,lubricant, Safety shield,needle cap.Specifications:• Needle length: 0.5in – 1.5in• Needle Gauge Range: 16G-31G (16G, 18G, 19G, 20G,21G, 22G, 23G, 25G, 26G,27G, 28G, 29G, 30G, 31G)• Luer-lock connector.• Needle hub color: per ISO6009 | Safety NeedleComponents: Needle hub,needle tube/cannula,lubricant, Safety shield,needle cap.Specifications:• Needle length: 0.5in – 1.5in• Needle Gauge: 18G-30G• Bevel: Regular, short,intradermal.• Luer-lock connector.• Needle hub color: per ISO6009 | SIMILARThe subjectdevice needlegauge (G) arewithin the rangeof the predicateneedle Gcleared. |
| SyringeComponents: Barrel, plunger, gasket.Connector: Luer-Lock.Volume: 1, 3, 5, 10mL. | SyringeComponents: Barrel, plunger, gasket.Connector: Luer-Lock.Volume: 1, 3, 5, 10, 20, 30, 60mL. | N/A | SIMILARThe subject device piston syringe volume is within the range of the predicate device piston syringe volume cleared. | |
| NeedleExternal communicating coming in contact with circulating blood for a contact period for less than 24 hours. | NeedleExternal communicating coming in contact with circulating blood for a contact period for less than 24 hours. | NeedleExternal communicating coming in contact with circulating blood for a contact period for less than 24 hours. | SAME | |
| Contact Typeand Duration | SyringeExternal communicating device coming in contact with blood path indirect for a contact period less than 24hrs. | SyringeExternal communicating device coming in contact with blood path indirect for a contact period less than 24hrs. | N/A | SAME |
| Sterile vs.Non-Sterile | EO Sterilized | EO Sterilized | EO Sterilized | SAME |
| Sterilization/SAL Level | Per ISO 11135 / SAL 10-6 | Per ISO 11135 / SAL 10-6 | Per ISO 11135 / SAL 10-6 | SAME |
| Disposable vs.Non-Disposable | Disposable | Disposable | Disposable | SAME |
| Single Use vs.Reusable | Single Use | Single Use | Single Use | SAME |
| Non-pyrogenic | Yes | Yes | Yes | SAME |
| Prescriptionvs. OTC | Rx | Rx | Rx | SAME |
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Image /page/8/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square. To the right of the word is a white starburst symbol, with four points extending outward from the center.
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Image /page/9/Picture/0 description: The image features the logo of Medline, a healthcare company. The logo consists of the word "MEDLINE" in bold, sans-serif font, positioned to the left of a stylized starburst or cross-like symbol. The starburst is white, and the background is a solid, dark blue color. The logo is simple, clean, and easily recognizable.
Discussion of Similarities and Differences
Medline believes that the technological differences between the subject and predicate device do not raise new questions of safety and effectiveness.
Does the New Device Have the Same Intended Use?
Yes, the subject device and predicate device have the same intended use: To be used 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.
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Image /page/10/Picture/0 description: The image shows the Medline logo. The logo consists of the word "MEDLINE" in white, set against a blue square background. To the right of the text is a white symbol that resembles a stylized cross or starburst. The logo is simple, clean, and easily recognizable.
Does the New Device Have Technological Characteristics that Raise New Types of Safety and Effectiveness Ouestions?
No, the proposed device does not have any new technological characteristics that raise any new safety and/or effectiveness questions. Both device comprise hypodermic single lumen luer-lock safety needles alone and a combination of hypodermic single lumen luer-lock safety needles with luer-lock piston syringes. The predicate and subject device are comprised of the same components: Luer-lock piston syringe and luer-lock safety needles comprised of needle tube/cannula, lubricant, needle cap, and a needle stick prevention feature, (i.e. safety shield) intended to be manually operated/activated in order to prevent accidental needle sticks. Additionally, both devices have similar dimensions. The subject device and the predicate device are both offered in 0.5in - 1.5in needle length range; and similar needle gauge (G) range. While the subject device is offered in18G-30G needle gauge range, the predicate device is offered in a needle gauge range of 16G-31G. However, the subject device needle gauge offered is within the predicates' needle gauge range cleared. In addition, both devices are color-coded per ISO 6009.
Does Descriptive or Performance Information Demonstrate Equivalence?
Yes, the similarities between the proposed device and the predicate device include: design features, intended use, function, and performance specifications. The proposed device is subject to the same performance testing as the predicate, which is based on the same FDA-recognized consensus standards applicable to a device of this type. Both devices also include a needle sick prevention feature. Activation of the safety feature on the proposed and predicate device is achieved by centering the thumb or forefinger on the textured finger pad and pushing the safety cover forward over the needle until you hear or feel it lock. A hard surface can also be used to push-up against. The small hook located on the back wall of the safety sheath locks the needle into place once it is activated; this prevents the needle from being "unactivated." As recommended in the FDA guidance document. Medical Devices with Sharps Injurv Prevention Features, a simulated clinical use study was conducted on the proposed device in order to specifically assess the function of the needle stick prevention feature. Both the predicate and subject device are also intended for prescription-use only and are only intended to be used by trained madical professionals.
Summary of Testing and Supporting Information
Testing was conducted to demonstrate substantial equivalence of Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe to the predicate device.
A summary of testing is presented below with more information provided in the applicable sections.
Biocompatibility Testing
The biological evaluation for the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe was conducted in accordance with FDA guidance document, "Use of International Standard ISO 10993, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing" and ISO 10993-1
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Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process.
The following biocompatibility tests were performed on the luer-lock piston syringe (used in the Medline Sure-Snap Safety Syringe):
Biocompatibility Testing Performed:
- ISO MEM Elution per ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests . for in vitro Cytotoxicity.
- ISO Intracutaneous Irritation Test per ISO 10993-10: 2010 Biological Evaluation of Medical ● Devices-Part 10: Test for Irritation and Skin Sensitization.
- ISO Guinea Pig Maximization Sensitization Test per ISO 10993-10: 2010 Biological Evaluation of ● Medical Devices-Part 10: Test for Irritation and Skin Sensitization.
- ISO Acute Systemic Injection Test per ISO 10993-11: 2017 Biological Evaluation of Medical ● Devices Part 11: Tests for Systemic Toxicity.
- ASTM Hemolysis Assay per ISO 10993-4:2017. Biological Evaluation of Medical Devices. Part 4 - Selection of Tests for Interaction with Blood.
- ISO Materials Mediated Rabbit Pyrogen per ISO 10993-11:2017. Biological Evaluation of Medical ● Devices, Part 11: Tests for Systemic Toxicity.
- . Bacterial Endotoxin Testing and Validation.
The following biocompatibility tests were performed on the Medline Sure-Snap Safety Needle:
Biocompatibility Testing Performed:
- ISO MEM Elution per ISO 10993-5:2009 Biological Evaluation of Medical Devices-Part 5: Tests . for in vitro Cytotoxicity.
- ISO Intracutaneous Irritation Test per ISO 10993-10: 2010 Biological Evaluation of Medical ● Devices-Part 10: Test for Irritation and Skin Sensitization.
- ISO Guinea Pig Maximization Sensitization Test per ISO 10993-10: 2010 Biological Evaluation of ● Medical Devices-Part 10: Test for Irritation and Skin Sensitization.
- ISO Acute Systemic Injection Test per ISO 10993-11: 2017 Biological Evaluation of Medical ● Devices Part 11: Tests for Systemic Toxicity.
- ASTM Hemolysis Assay per ISO 10993-4:2017. Biological Evaluation of Medical Devices. Part 4 ● - Selection of Tests for Interaction with Blood.
- ISO Materials Mediated Rabbit Pyrogen per ISO 10993-11:2017. Biological Evaluation of Medical ● Devices, Part 11: Tests for Systemic Toxicity.
- Bacterial Endotoxin Testing and Validation.
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Image /page/12/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, positioned to the left of a stylized white cross. The background is a solid dark blue color, providing a strong contrast to the white elements of the logo.
Performance Testing (Bench)
Non-clinical verification of the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe has been conducted to evaluate the safety, performance and functionality of the proposed device.
Functional Performance Testing
The performance testing for the luer lock piston syringe (used in the Medline Sure-Snap Safety Syringe) has been conducted in accordance with following standards:
- ISO 7886-1 Second edition 2017-05 Sterile hypodermic syringes for single use - Part 1: Syringes for manual use.
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications ● - Part 7: Connectors for intravascular or hypodermic applications
The performance testing for the Medline Sure-Snap Safety Needles has been performed in accordance with following standards:
- . ISO 7864 Fourth edition 2016-08-01 Sterile hypodermic needles for single use -Requirements and test methods.
- ISO 9626 Second edition 2016-08-01 Stainless steel needle tubing for the manufacture of ● medical devices - Requirements and test methods.
- ISO 23908 First edition 2011-06-11 Sharps injury protection Requirements and test ● methods - Sharps protection features for single-use hypodermic needles, introducers for catheters and needles used for blood sampling.
- ISO 80369-7:2016 Small-bore connectors for liquids and gases in healthcare applications ● - Part 7: Connectors for intravascular or hypodermic applications.
Usability Testing
A human factors study to evaluate the usability of the subject device was additionally conducted. Specifically, a simulated clinical use test was done to assess the usability and function of the needle stick prevention feature as recommended in the FDA guidance document, Medical Devices with Sharps Injury Prevention Features. Participating healthcare professionals assessed the function of the safety needle with a pass/fail criteria and provided feedback on the perceived functionality of the proposed device. Of the 1,000 safety needles tested (500 per safety needle type), there were no failures.
Chemical Safety Testing
- Phthalates testing to support the device is not made with DEHP. ●
- Particulate Matter Testing in accordance with USP <788> Particulate Matter in Injections. ●
- Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP ● <85> Bacterial Endotoxin Testing.
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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.
Sterilization and Shelf Life
The Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe is terminally sterilized by Ethylene Oxide (EO) and its sterilization validation 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 the EO achieves a Sterility Assurance Level (SAL) of 10". The proposed device was also evaluated for EO and Ethylene Chlorohydrin (ECH) residuals in accordance with ISO 10993-7:2008 Biological Evaluation of Medical Devices – Part 7: Ethylene Oxide Sterilization Residuals.
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 ensure the functionality and sterility of the proposed device are successfully maintained throughout the duration of its shelf life.
Conclusion
In accordance with 21 CFR Part 807, and based on the information provided in this premarket notification. Medline Industries, LP. concludes that the Medline Sure-Snap Safety Needle and Medline Sure-Snap Safety Syringe is as safe and as effective for its intended use as the predicate devices: Syringe with Safety Needle, Safety Needle (K193526) and BD Eclipse Hypodermic Needle (K161170).
§ 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).