(145 days)
Not Found
No
The device description and testing information focus on the physical properties and performance of a syringe, with no mention of AI or ML capabilities.
Yes
The device is described as being used for "general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin" and "subcutaneous injection of U-100 insulin." While the syringe itself is a delivery mechanism, the act of injecting substances like insulin (which is a therapeutic agent) or aspirating fluids from the body clearly indicates a therapeutic purpose or a procedure that is part of therapy.
No
The device is described as a syringe intended for general purpose fluid aspiration/injection, and specifically for subcutaneous injection of insulin. Its function is to administer or extract fluids, not to diagnose a condition or disease.
No
The device description clearly outlines physical components like a barrel, stopper, and plunger rod, indicating it is a hardware device (syringe).
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "general purpose fluid aspiration/injection" and "general purpose injection and aspiration of fluid from vials, ampoules and parts of the body below the surface of the skin." This describes a device used for administering or withdrawing substances directly from or into the body or containers, not for testing samples in vitro (outside the body).
- Device Description: The description details a syringe and needle assembly designed for physical manipulation of fluids. It does not mention any components or functions related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The text does not contain any keywords or phrases typically associated with IVD devices, such as "diagnostic," "assay," "test," "sample analysis," "analyte," "reagent," or "in vitro."
The device is a medical device used for administering or withdrawing fluids, which falls under a different regulatory category than IVD devices.
N/A
Intended Use / Indications for Use
The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals for general purpose injection of fluid from vials, ampoules and parts of the body below the surface of the skin. The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards accidental needle sticks during normal handling and disposal of the used needle/ syringe combination.
The BD 1mL Luer-Lok™ Insulin Syringe is intended for subcutaneous injection of U-100 insulin.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMF, FMI, FMF
Device Description
The BD 1mL Luer-Lok™ Hypodermic Syringe and BD 1mL Luer-Lok™ Insulin Syringe are three-piece sterile, single use, hypodermic syringes with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assemblies for both products are identical and consist of a lubricated styrene acrylic copolymer barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the BD 1mL Luer-Lok™ Hypodermic Syringe incorporates a scale graduated in units of milliliters, while the barrel scale of the BD 1mL Luer-Lok™ Insulin Syringe incorporates a scale graduated in units of insulin.
The BD 1mL Luer-Lok™ Hypodermic Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration or with a BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle.
The BD 1mL Luer-Lok™ Insulin Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration.
The modified BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe include a change in the barrel resin material from a polycarbonate resin to a styrene acrylic copolymer resin. The syringe performance characteristics are equivalent to the predicate device.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
parts of the body below the surface of the skin.
Indicated Patient Age Range
Not Found
Intended User / Care Setting
health care 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)
BD has performed the following non-clinical/design verification testing and the results of these tests demonstrate that the BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe performed in an equivalent manner to the predicate devices.
Performance Characteristic: Break Out Force, Sustaining Force, Dimensional Stability of Barrel, ID (inner diameter), Strip/resistance to overriding, Unscrewing torque, Barrel Scale Permanency, Sticktion. Acceptance Criteria: Equivalent to predicate.
Biocompatibility Testing:
- Cytotoxicity: Not Found
- Hemolysis: Per ISO 10993-4, Non-hemolytic
- Acute Systemic Toxicity: Per ISO 10993-11, Non-toxic
- Intracutaneous Reactivity: Per ISO 10993-10, Non-Irritant
- Sensitization: Per ISO 10993-10, Non-Sensitizer
- Material-Mediated Pyrogenicity: Per ISO 10993-11 and USP 151, Non-Pyrogenic
- LAL Endotoxin: Per USP and USP, Pass
- Genotoxicity: Per ISO 10993-3, Non-mutagenic
- Subacute/Subchronic toxicity: Per ISO 10993-11, Non-toxic
- Chemical Extractable Analysis: Per ISO 10993-18, acceptable extractables/leachables profile
- Insulin compatibility (BD 1mL Luer-Lok™ Insulin Syringe only): Pass
Clinical testing was not required for this submission.
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.
K941562, K021475, K161170, K024112
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/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which is a staff with two snakes coiled around it. The caduceus is positioned to the right of the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA", which is arranged in a circular fashion around the logo.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
December 19, 2016
Becton, Dickinson and Company Murtaza Rana Senior Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K162081
Trade/Device Name: BD 1ml Luer-Lok™ Hypodermic Syringe BD 1 mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle BD 1ml Luer-Lok™ Insulin Syringe
Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF, FMF, FMI Dated: November 17, 2016 Received: November 18, 2016
Dear Murtaza Rana:
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. 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.
1
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 devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely,
Image /page/1/Picture/8 description: The image contains a signature and the name "Tina Kiang". There is also a dash followed by the number 5 below the name. The signature is complex and illegible.
Tina Kiang, Ph.D. Acting Director Division of Anesthesiology. General Hospital, Respiratory, Infection Control, and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K162081
Device Name
BD 1mL Luer-Lok™ Hypodermic Syringe
Indications for Use (Describe)
The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
3
Indications for Use
510(k) Number (if known) K162081
Device Name
BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle
Indications for Use (Describe)
The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals for general purpose injection of fluid from vials, ampoules and parts of the body below the surface of the skin.
The BD Eclipse™ Hypodermic Needle contains a mechanism that covers the needlepoint after use. In the activated position the needle cover guards accidental needle sticks during normal handling and disposal of the used needle/ syringe combination.
| 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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
Indications for Use
510(k) Number (if known) K162081
Device Name BD 1mL Luer-Lok™ Insulin Syringe
Indications for Use (Describe)
The BD 1mL Luer-Lok™ Insulin Syringe is intended for subcutaneous injection of U-100 insulin.
Type of Use (Select one or both, as applicable)
| Prescription Use (Part 21 CFR 801 Subpart D)
|X | Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
5
510(k) Summary – K162081
| Submitted By: | Murtaza Rana
Senior Regulatory Affairs Specialist
Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Phone: (201)847-6980
Fax: (201)847-5307 | |
|--------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Date Prepared: | December 15, 2016 | |
| Subject Devices: | Trade Name:
Common Name:
Classification:
Product Code: | BD 1mL Luer-Lok™ Hypodermic Syringe
Piston Syringe
Class II device, 21 CFR §880.5860, Piston Syringe
FMF (Syringe, Piston) |
| | Trade Name: | BD 1mL Luer-Lok™ Hypodermic Syringe with BD
Hypodermic Needle or BD Eclipse™ Hypodermic
Needle |
| | Common Name:
Classification:
Product Code: | Piston Syringe, Hypodermic Needle
Class II, 21 CFR §880.5860, Piston Syringe
FMF (Syringe, Piston), FMI (Needle, Hypodermic,
Single Lumen) |
| | Trade Name:
Common Name:
Classification:
Product Code: | BD 1mL Luer-Lok™ Insulin Syringe
Piston Syringe
Class II device, 21 CFR §880.5860, Piston Syringe
FMF (Syringe, Piston) |
| Predicate Devices: | Trade Name:
510(k) Reference:
Common Name:
Classification:
Product Code: | BD 1mL Luer-Lok™ Hypodermic Syringe
K941562
Piston Syringe
Class II device, 21 CFR §880.5860, Piston Syringe
FMF (Syringe, Piston) |
| | Trade Name:
510(k) Reference:
Common Name:
Classification:
Product Code: | BD Hypodermic Needle
K021475
Hypodermic Needle
Class II, 21 CFR §880.5570, Hypodermic Single Lumen
Needle
FMI (Needle, Hypodermic, Single Lumen) |
| | Trade Name:
510(k) Reference:
Common Name:
Classification:
Product Code: | BD Eclipse™ Hypodermic Needle
K161170
Hypodermic Needle
Class II, 21 CFR §880.5570, Hypodermic Single Lumen
Needle
FMI (Needle, Hypodermic, Single Lumen) |
| Trade Name: | BD 1mL Luer-Lok TM Insulin Syringe | |
| 510(k) Reference: | K024112 | |
| Common Name: | Piston Syringe | |
| Classification: | Class II device, 21 CFR §880.5860, Piston Syringe | |
| Product Code: | FMF (Syringe, Piston) | |
6
Device Description
The BD 1mL Luer-Lok™ Hypodermic Syringe and BD 1mL Luer-Lok™ Insulin Syringe are three-piece sterile, single use, hypodermic syringes with male 6% (Luer) conical lock fittings, which are connectable to a compatible female 6% (Luer) connector. The syringe assemblies for both products are identical and consist of a lubricated styrene acrylic copolymer barrel with a graduated scale, a lubricated synthetic rubber stopper and a polypropylene plunger rod. The plunger rod is pulled back to aspirate fluids or depressed to inject or expel fluids. The barrel scale of the BD 1mL Luer-Lok™ Hypodermic Syringe incorporates a scale graduated in units of milliliters, while the barrel scale of the BD 1mL Luer-Lok™ Insulin Syringe incorporates a scale graduated in units of insulin.
The BD 1mL Luer-Lok™ Hypodermic Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration or with a BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle.
The BD 1mL Luer-Lok™ Insulin Syringe is provided sterile by an irradiation sterilization method in a syringe only configuration.
The modified BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe include a change in the barrel resin material from a polycarbonate resin to a styrene acrylic copolymer resin. The syringe performance characteristics are equivalent to the predicate device.
Indications for Use/Intended Use
The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle is intended for use by health care professionals 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 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.
The BD 1mL Luer-Lok™ Insulin Syringe is intended for subcutaneous injection of U-100 insulin.
7
Technological Characteristics
The subject BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe are equivalent to that of the predicate BD 1mL Luer-Lok™ Hypodermic Syringe, BD Hypodermic Needle, BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe in intended use, materials and performance characteristics.
| Element of Comparison | Subject Device | Predicate Device | Element of Comparison | Subject Device | Predicate Device | Predicate Device | Predicate Device | ||
|---|---|---|---|---|---|---|---|---|---|
| 510(k) Reference: | K162081 | K941562 | 510(k) Reference: | K162081 | K941562 | K021475 | K161170 | ||
| Indications for Use/Intended Use | The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | The BD 1mL Luer-Lok™ Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | Indications for Use/Intended Use | The BD 1mL Luer-LoK™ | |||||
| Hypodermic Syringe with BD | |||||||||
| Hypodermic Needle or BD | |||||||||
| Eclipse™ Hypodermic | |||||||||
| Needle is intended for use by | |||||||||
| health care professionals 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 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. | The BD 1mL Luer-Lok™
Hypodermic Syringe is
intended for use by health
care professionals for general
purpose fluid
aspiration/injection. | The BD Hypodermic Needle
is intended 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
intended 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. | |
| Syringe materials | Barrel | Styrene acrylic copolymer | Polycarbonate | | Barrel | Styrene acrylic copolymer | Polycarbonate | N/A | N/A |
| | Barrel Lubricant | Silicone | Silicone | Syringe
materials | Barrel Lubricant | Silicone | Silicone | N/A | N/A |
| | Plunger Rod | Polypropylene | Polypropylene | | Plunger Rod | Polypropylene | Polypropylene | N/A | N/A |
| | Stopper | Polyisoprene Rubber | Polyisoprene Rubber | | Stopper | Polyisoprene Rubber | Polyisoprene Rubber | N/A | N/A |
| | Stopper Lubricant | Silicone | Silicone | | Stopper
Lubricant | Silicone | Silicone | N/A | N/A |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | | | | | | | |
| SAL | 10-6 | 10-6 | | | | | | | |
| Shelf Life | 5 Years | 5 Years | | | | | | | |
BD 1mL Luer-Lok™ Hypodermic Syringe:
8
BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle:
9
| Element of Comparison | Subject Device | Predicate Device | Predicate Device | Predicate Device |
|---|---|---|---|---|
| Needle Length | 1/2 in. - 1 in. | N/A | 1/2 in. - 1 in. | 1/2 in. - 1 in. |
| Needle Gauge | 20G – 30G | N/A | 18G - 30G | 18G – 30G |
| SAL | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ | $10^{-6}$ |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | Gamma Irradiation | EtO |
| Shelf Life | 5 Years | 5 Years | 5 Years | 5 Years |
BD 1mL Luer-Lok™ Insulin Syringe:
| Element of Comparison | Subject Device | Predicate Device | |
|---|---|---|---|
| 510(k) Reference: | K162081 | K024112 | |
| Indications for Use/Intended Use | The BD 1mL Luer-Lok™ Insulin | ||
| Syringe is intended for subcutaneous | |||
| injection of U-100 insulin. | The BD 1mL Luer-Lok™ Insulin | ||
| Syringe is intended for subcutaneous | |||
| injection of insulin. | |||
| Syringe | |||
| materials | Barrel | Styrene acrylic copolymer | Polycarbonate |
| Barrel Lubricant | Silicone | Silicone | |
| Plunger Rod | Polypropylene | Polypropylene | |
| Stopper | Polyisoprene Rubber | Polyisoprene Rubber | |
| Stopper Lubricant | Silicone | Silicone | |
| Sterilization Method | Gamma Irradiation | Gamma Irradiation | |
| SAL | 10-6 | 10-6 | |
| Shelf Life | 5 Years | 5 Years |
10
Non-Clinical Testing
BD has performed the following non-clinical/design verification testing and the results of these tests demonstrate that the BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe performed in an equivalent manner to the predicate devices.
| Performance Characteristic | Acceptance Criteria | |
|---|---|---|
| Break Out Force | Equivalent to predicate | |
| Functional Testing | Sustaining Force | Equivalent to predicate |
| Dimensional Stability of Barrel | Equivalent to predicate | |
| ID (inner diameter) | Equivalent to predicate | |
| Strip/resistance to overriding | Equivalent to predicate | |
| Unscrewing torque | Equivalent to predicate | |
| Barrel Scale Permanency | Equivalent to predicate | |
| Sticktion | Equivalent to predicate | |
| Biocompatibility | ||
| Testing | Cytotoxicity | |
| Hemolysis | Per ISO 10993-4, Non-hemolytic | |
| Acute Systemic Toxicity | Per ISO 10993-11, Non-toxic | |
| Intracutaneous Reactivity | Per ISO 10993-10, Non-Irritant | |
| Sensitization | Per ISO 10993-10, Non-Sensitizer | |
| Material-Mediated | ||
| Pyrogenicity | Per ISO 10993-11 and USP 151, Non-Pyrogenic | |
| LAL Endotoxin | Per USP and USP, Pass | |
| Genotoxicity | Per ISO 10993-3, Non-mutagenic | |
| Subacute/Subchronic toxicity | Per ISO 10993-11, Non-toxic | |
| Chemical Extractable Analysis | Per ISO 10993-18, acceptable extractables/leachables profile | |
| Insulin compatibility (BD 1mL | ||
| Luer-Lok™ Insulin Syringe | ||
| only) | Pass |
Clinical Testing
Clinical testing was not required for this submission.
Substantial Equivalence
The BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe are substantially equivalent to the predicate devices in intended use, operating principle, technology, design, materials and performance.
Conclusion
The BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe have been verified to meet the established performance criteria above. The non-clinical/design verification testing demonstrate that the BD 1mL Luer-Lok™ Hypodermic Syringe, BD 1mL Luer-Lok™ Hypodermic Syringe with BD Hypodermic Needle or BD Eclipse™ Hypodermic Needle and BD 1mL Luer-Lok™ Insulin Syringe perform as intended and perform as well as the legally marketed predicate devices and are therefore substantially equivalent.