(443 days)
Not Found
No
The device description and intended use focus on mechanical safety features and do not mention any computational or data-driven capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
No
The device is described as a safety syringe and safety needle for aspiration and injection of fluids, which are tools for medical procedures, but they do not directly provide therapy or therapeutic effect. Their primary function is fluid delivery/collection and needle-stick prevention.
No.
Explanation: The device is intended for the aspiration and injection of fluids, and includes a safety feature to prevent needle sticks. It is used for medical procedures, but not for diagnosing diseases or conditions.
No
The device description clearly states it comprises physical components like hypodermic needles and syringes, which are hardware. There is no mention of software as the primary or sole component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "aspiration and injection of fluids for medical purposes" and for minimizing "risk of accidental needle stick." This describes a device used for administering or withdrawing substances directly from the body, not for testing samples in vitro (outside the body).
- Device Description: The description details hypodermic needles and syringes, which are tools for accessing the body, not for performing diagnostic tests on samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples, detecting analytes, or providing diagnostic information based on testing.
IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device's function is purely related to the physical act of aspiration and injection.
N/A
Intended Use / Indications for Use
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.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI, MEG
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).
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
trained madical 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)
Biocompatibility Testing:
Performed on the luer-lock piston syringe and Medline Sure-Snap Safety Needle 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 Biological Evaluation of the Medical Devices – Part 1: Evaluation of Testing within a Risk Management Process.
Tests performed: ISO MEM Elution, ISO Intracutaneous Irritation Test, ISO Guinea Pig Maximization Sensitization Test, ISO Acute Systemic Injection Test, ASTM Hemolysis Assay, ISO Materials Mediated Rabbit Pyrogen, Bacterial Endotoxin Testing and Validation.
Functional Performance Testing:
For luer lock piston syringe: ISO 7886-1, ISO 80369-7:2016.
For Medline Sure-Snap Safety Needles: ISO 7864, ISO 9626, ISO 23908, ISO 80369-7:2016.
Usability Testing:
A human factors study was conducted, specifically a simulated clinical use test, to assess the usability and function of the needle stick prevention feature.
Sample Size: 1,000 safety needles tested (500 per safety needle type).
Results: 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 Particulate Matter in Injections.
Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP Bacterial Endotoxin Testing.
Sterilization and Shelf Life:
Sterilized by Ethylene Oxide (EO) in accordance with ISO 11135:2014, achieving a Sterility Assurance Level (SAL) of 10-6.
Evaluated for EO and Ethylene Chlorohydrin (ECH) residuals in accordance with ISO 10993-7:2008.
Aging studies (shelf life) conducted in accordance with ASTM F1980-16.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
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 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
1
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
2
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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3
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 Single
Lumen Needle, Safety Hypodermic Single Lumen
Needle |
|-------------------------------|--------------------------------------------------------------------------------------------------------|
| • Proprietary Name | Medline Sure-Snap Safety Needle and Medline
Sure-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 Model
Number | Description | Needle
Gauge | Needle
Length | Safety Needle
Sheath/Needle
Hub 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 Model
Number | Description | Needle
Gauge | Needle
Length | Safety Needle
Sheath/Needle
Hub 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 Model
Number | Description | Needle
Gauge | Needle
Length | Safety Needle
Sheath/Needle
Hub Color | Syringe
Volume |
|-------------------------|---------------------------------|-----------------|------------------|---------------------------------------------|-------------------|
| 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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Image /page/7/Picture/0 description: The image is a square logo for Medline. The logo has a blue background with the word "MEDLINE" in white, sans-serif font in the upper left corner. A white, stylized star shape is behind the text. The star shape has four points, with the top and bottom points being longer than the side points. There is a gray bar at the top of the image.
Table 3: Comparison of the Proposed Device with the Predicate Device
| Device
Characteristic | Subject Device | Primary Predicate Device | Secondary Predicate Device | Remarks
(Comparison with the Primary
Predicate Device) |
|--------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------|
| Product
Name | Medline Sure-Snap Safety
Needle and Medline Sure-
Snap Safety Syringe | Syringe with Safety Needle,
Safety Needle | BD Eclipse Hypodermic
Needle | N/A |
| 510(k)
Reference | K213054 | K193526 | K161170 | N/A |
| Product
Owner | Medline Industries, Inc. | Jiangsu Caina Medical Co.,
Ltd | Becton, Dickinson and
Company | N/A |
| Product Code | Classification Product Code:
• FMF (Piston Syringe)
Subsequent Product Codes:
• FMI (Hypodermic Single
Lumen Needle)
• MEG (Antistick Syringe) | Classification Product Code:
• FMF (Piston Syringe)
Subsequent Product Codes:
• FMI (Hypodermic Single
Lumen Needle)
• MEG (Antistick Syringe) | FMI: Needle, Hypodermic,
Single Lumen | SAME |
| Regulation
Number | 21 CFR 880.5860
21 CFR 880.5570 | 21 CFR 880.5860
21 CFR 880.5570 | 21 CFR §880.5570 | SAME |
| Device
Description | Safety needle alone and a
combination of a piston
syringe with a safety needle. | Safety needle alone and a
combination of a piston
syringe with a safety needle. | Safety Needle alone | SAME |
| Indications
for Use | Safety Needle
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. | Safety Needle
The Safety Needle is intended
for use with a luer-lock
syringe 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. | Safety Needle
The BD Eclipse Hypodermic
Needle is used for general-
purpose injection and
aspiration of fluid from vials,
ampoules and parts of the
body below the surface of the
skin. The BD Eclipse
Hypodermic Needle is
compatible for use with
standard luer-lock syringes.
The BD Eclipse Hypodermic
Needle contains a mechanism
that covers the needlepoint
after use. In the activated
position the needle cover
guards against accidental
needle sticks during normal
handling and disposal of the
used needle/ syringe
combination. | SAME |
| | Syringe with Safety Needle
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. | Syringe with Safety Needle
The Syringe with Safety
Needle 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. | N/A | SAME |
| Operating
Principle | Safety Needle
The Medline Sure-Snap
Safety Needles are devices
that are composed of a
hypodermic needle with a one
piece hub/adapter and
pivoting cover that is
connected to the hub. The
device consists of a
mechanism that covers the
needle point after use. | Safety Needle
The Safety Needles are
devices that are composed of
a typical hypodermic needle
with a one piece hub/adapter
and pivoting cover that is
connected to the adapter. The
device consists of a
mechanism that covers the
needle point after use. | Safety Needle
BD Eclipse Hypodermic
Needles are devices that are
composed of a typical
hypodermic needle with a one
piece hub/adapter and
pivoting cover that is
connected to the adapter. The
device consists of a
mechanism that covers the
needle point after use. | SAME |
| | Syringe
The Medline Sure-Snap
Safety Syringe is a luer-lock
piston syringe for manual use
with safety needle. | Syringe
The Syringe with Safety
Needle is a luer-lock piston
syringe for manual use with
safety needle. | N/A | SAME |
| Design
Features | Safety Needle
Components: 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 ISO
6009 | Safety Needle
Components: 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 ISO
6009 | Safety Needle
Components: 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 ISO
6009 | SIMILAR
The subject
device needle
gauge (G) are
within the range
of the predicate
needle G
cleared. |
| | Syringe
Components: Barrel, plunger, gasket.
Connector: Luer-Lock.
Volume: 1, 3, 5, 10mL. | Syringe
Components: Barrel, plunger, gasket.
Connector: Luer-Lock.
Volume: 1, 3, 5, 10, 20, 30, 60mL. | N/A | SIMILAR
The subject device piston syringe volume is within the range of the predicate device piston syringe volume cleared. |
| | Needle
External communicating coming in contact with circulating blood for a contact period for less than 24 hours. | Needle
External communicating coming in contact with circulating blood for a contact period for less than 24 hours. | Needle
External communicating coming in contact with circulating blood for a contact period for less than 24 hours. | SAME |
| Contact Type
and Duration | Syringe
External communicating device coming in contact with blood path indirect for a contact period less than 24hrs. | Syringe
External 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 |
| Prescription
vs. OTC | Rx | Rx | Rx | SAME |
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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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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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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 Particulate Matter in Injections. ●
- Limulus Amebocyte Lysate (LAL) Bacterial Endotoxin Testing in accordance with USP ● 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).