(283 days)
Not Found
No
The device description and performance studies indicate a standard mechanical syringe with no mention of AI/ML capabilities or related data/training sets.
No.
A therapeutic device is one that treats a disease or condition. This device is used to deliver a substance (insulin) that treats a disease, but the device itself does not provide therapy.
No
The device is an insulin syringe used for the subcutaneous injection of insulin, which is a therapeutic function rather than a diagnostic one.
No
The device description clearly states it is a plastic syringe with a barrel, plunger rod, and needle/hub assembly, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "subcutaneous injection of U-100 insulins." This describes a device used to administer a substance directly into the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe, a tool for injection, not a device for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information. The device's function is purely mechanical for drug delivery.
IVD devices are used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The subject BD Insulin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose of U 100 insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. The BD Insulin Syringes are sterile, single use, and non-pyrogenic. These devices operate on the principles of a piston syringe. The BD Insulin Syringe with 6mm length cannula have a sub-brand name of BD Veo™ Insulin Syringe.
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
Not Found
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)
Bench functional performance: Testing was conducted according to ISO 8537:2016 Sterile single-use syringes, with or without needle, for insulin, and ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. This testing included Air Leakage, Cannula Pull Force, Hub Pull Force, Hub Pull Force, Liquid Leakage, Needle Break-Off Force, Penetration Force, Scale Print Permanency, Shield Pull Force, Syringe Filling Force, Syringe Injection Force (Force to Expel Water), Volumetric Accuracy, Dead Space and Corrosion Resistance.
Biocompatibility testing: Testing was conducted according to relevant sections of ISO 10993:2019 Biological evaluation of medical devices. This testing included Cytotoxicity, Sensitization (GP Max), Sensitization, Intracutaneous Reactivity, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Hemocompatibility, and Genotoxicity (Bacterial and Mammalian). The medical device is classified as: externally communicating, blood path indirect, with prolonged contact duration.
Additional Testing: ASTM F2148: 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA), ISO 11137-1:2006/Amd 2013(E) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. ISO 11137-2:2013(E) Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose, ISO 11137-3: 2017(E) Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control, and ISO 11737-1:2018(E) Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products .
Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use and is as safe and effective as its predicate device.
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 shows the logo of the U.S. Food & Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
October 21, 2019 Becton Dickinson and Company Meriam Youssef Senior Manager Regulatory Affairs 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K190054
Trade/Device Name: BD Insulin Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: September 19, 2019 Received: September 23, 2019
Dear Meriam Youssef:
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 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 (OS) 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 mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
For 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) K190054
Device Name BD Insulin Syringe
| Indications for Use (Describe) | Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins |
|---|---|
| -------------------------------- | --------------------------------------------------------------------------------------------- |
| 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."
3
K190054 510(k) Summary
| Submitted By: | Meriam Youssef
Sr. Manager Regulatory Affairs, BD Medical- Diabetes Care
1 Becton Drive
Franklin Lakes, NJ 07417
Tel: 201 847 6557
Fax: 201 847 5307 | | | |
|----------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------|--|--|
| Date Prepared: | September 19, 2019 | | | |
| Device Name: | Trade Name: | BD Insulin Syringe™ | | |
| | Common Name: | Syringe, Piston | | |
| | Regulation Name: | Piston syringe | | |
| | Regulation: | 21 CFR 880.5860 | | |
| | Product Code: | FMF | | |
Legally marketed predicate device to which substantial equivalence is being claimed:
- BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the . BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle (K170386)
Device Description:
The subject BD Insulin Syringes are a plastic syringe designed for subcutaneous injection of a desired dose of U 100 insulin. The BD Insulin Syringe consists of a graduated barrel, plunger rod and needle/hub assembly. The BD Insulin Syringes are sterile, single use, and non-pyrogenic. These devices operate on the principles of a piston syringe. The BD Insulin Syringe with 6mm length cannula have a sub-brand name of BD Veo™ Insulin Syringe.
| Syringe size (mL) | Bevel | Cannula length (mm) | Gauge (G) |
|---|---|---|---|
| 0.3mL | 3 | 12.7mm | 29G |
| 0.3mL | 3 | 12.7mm | 30G |
| 0.3mL | 3 | 8mm | 29G |
| 0.3mL | 3 | 8mm | 31G |
| 0.3mL | 3 | 6mm | 31G |
| 0.5mL | 3 | 12.7mm | 28G |
| 0.5mL | 3 | 12.7mm | 29G |
| 0.5mL | 3 | 12.7mm | 30G |
| 0.5mL | 3 | 8mm | 31G |
| 0.5mL | 3 | 6mm | 31G |
| 1mL | 3 | 16mm | 27G |
| 1mL | 3 | 12.7mm | 28G |
| 1mL | 3 | 12.7mm | 29G |
| 1mL | 3 | 12.7mm | 30G |
| 1mL | 3 | 8mm | 30G |
| 1mL | 3 | 8mm | 31G |
| 1mL | 3 | 6mm | 31G |
| 1mL | 3 | 16mm | 27G |
The BD Insulin Syringes are offered in the following sizes:
4
Indications for Use:
Becton Dickinson insulin syringes are intended for subcutaneous injection of U-100 insulins.
Differences in Indications for use: The indications for use are the same as the predicate.
Substantial Equivalence Discussion:
| Predicate Device | Comparison | ||
|---|---|---|---|
| General Information | |||
| Feature | Subject Device: | ||
| BD Insulin Syringe | BD Ultra-Fine™ Insulin | ||
| Syringe, BD Ultra-Fine™ | |||
| II Insulin Syringe, BD | |||
| Insulin Syringes with the | |||
| BD Ultra-Fine™ needle | |||
| and BD Insulin Syringes | |||
| with Micro-Fine™ IV | |||
| Needle | |||
| 510(k) Number | K190054 | K170386 | N/A |
| Device Classification | Syringe Piston | Same | Same |
| Regulation Number | 880.586 | Same | Same |
| Product Code | FMF | Same | Same |
| Indications of Use | Becton Dickinson insulin | ||
| syringes are intended for | |||
| subcutaneous injection of | |||
| U 100 insulins | Becton Dickinson insulin | ||
| syringes are intended for | |||
| subcutaneous injection of | |||
| U-100 insulins. | Same | ||
| Specific Drug Use | U-100 Insulin | Same | Same |
| Capacity | 1mL, | ||
| 0.5mL, | |||
| 0.3mL | 1mL | The subject device | |
| includes a 0.5mL and | |||
| 0.3ml model. | |||
| Bevel | 3 | 3 | Dimensional |
| modifications to | |||
| primary bevel of | |||
| cannula | |||
| Cannula Gauge Size(s) | 27G, 28G, 29G, 30G, 31G | 27G, 28G, 29G, 30G, 31G | Same |
| Nozzle Tip Type | Snap fit needle hub for | ||
| 0.3mL and 0.5mL designs | |||
| for permanently | |||
| attached needles | |||
| Integral barrel for 1mL | |||
| design for | |||
| permanently attached | Integral barrel for 1mL | ||
| design for | |||
| permanently attached | |||
| needles | Introduction of one glue | ||
| well design for 1mL | |||
| barrel configuration | |||
| Scale Markings | needles | ||
| 1 unit increments and ½ | |||
| unit increments (0.3mL) | |||
| 1 unit increments (0.5mL) | |||
| 2 units increments (1mL) | 2 units increments | ||
| (1mL) | Addition of ½ unit scale | ||
| mark increments | |||
| General Information | |||
| Feature | Subject Device: | Predicate Device | Comparison |
| General Information | |||
| Feature | Subject Device: | ||
| BD Insulin Syringe | BD Ultra-Fine™ Insulin | ||
| Syringe, BD Ultra-Fine™ | |||
| II Insulin Syringe, BD | |||
| Insulin Syringes with the | |||
| BD Ultra-Fine™ needle | |||
| and BD Insulin Syringes | |||
| with Micro-Fine™ IV | |||
| Needle | |||
| Packaging Configuration | Polybag for self-contained | ||
| syringe and blister pack | |||
| (multiple blister packs per | |||
| perforated sheet) offerings | Polybag for self-contained | ||
| syringe and blister pack | |||
| (individual blister pack) | |||
| offerings | Addition of retention | ||
| ring to 1mL | |||
| self-contained insulin | |||
| syringe | |||
| Multiple blister packs | |||
| per perforated sheet | |||
| Cannula Length Size(s) | 6mm, 8mm, 12.7mm, | ||
| 16mm | 6mm, 8mm, 12.7mm, | ||
| 16mm | Same | ||
| Cannula (Needle) material | 304 Stainless Steel | 304 Stainless Steel | Same |
| Cannula (Needle) shield | |||
| material and Cap (for | |||
| plunger rod) material | Polyethylene | Polyethylene | Modification to the co- |
| monomer of | |||
| polyethylene material | |||
| Cannula cover color | Orange | Orange | Same |
| Lubricant | Medical Grade Silicone | Medical Grade Silicone | Modification to |
| lubricant formulation | |||
| carrier solvent | |||
| Cannula bonding | |||
| adhesive (UV cured) | UV Cured Adhesive | UV Cured Adhesive | New 0.3mL & 0.5mL |
| UV Cured Adhesive | |||
| Scale marking ink | Solvent based Markem | ||
| black colored ink | Solvent based Markem | ||
| black colored ink | Same | ||
| Plunger rod material | Polystyrene | Polystyrene | Remove colorant |
| additive from the | |||
| plunger rod component | |||
| Plunger tip (stopper) | |||
| material | Rubber stopper | Rubber stopper | Same |
| Barrel and Hub Material | Polypropylene | Polypropylene | New material |
| formulation of | |||
| polypropylene | |||
| Single Use Only | YES | YES | Same |
| Non-Pyrogenic | YES | YES | Same |
| Sterile (10-6) | YES | YES | Same |
5
6
Discussion:
Apart from the above mentioned modifications to the design and materials, there are no technological differences between the subject and the predicate devices. The design modifications were assessed through performance testing per ISO 8537 and ISO 9626. The material changes were evaluated per ISO 10993-1.
The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.
Non-Clinical Testing:
Following BD's Quality System processes, required testing was conducted to validate the cumulative modifications made to the subject devices.
Substantial Equivalence is being supported with full performance testing the current BD Insulin Syringe devices currently marketed.
Bench functional performance
- Testing was conducted according to ISO 8537:2016 Sterile single-use syringes, with or without needle, ● for insulin, and ISO 9626:2016 Stainless steel needle tubing for the manufacture of medical devices. This testing included Air Leakage, Cannula Pull Force, Hub Pull Force, Hub Pull Force, Liquid Leakage, Needle Break-Off Force, Penetration Force, Scale Print Permanency, Shield Pull Force, Syringe Filling Force, Syringe Injection Force (Force to Expel Water), Volumetric Accuracy, Dead Space and Corrosion Resistance.
Biocompatibility testing
- Testing was conducted according to relevant sections of ISO 10993:2019 Biological evaluation of ● medical devices. This testing included Cytotoxicity, Sensitization (GP Max), Sensitization, Intracutaneous Reactivity, Irritation, Acute Systemic Toxicity, Material Mediated Pyrogenicity, Subacute/Subchronic Toxicity, Hemocompatibility, and Genotoxicity (Bacterial and Mammalian). The medical device is classified as: externally communicating, blood path indirect, with prolonged contact duration.
Additional Testing:
- ASTM F2148: 2013 Standard Practice for Evaluation of Delayed Contact Hypersensitivity Using the Murine Local Lymph Node Assay (LLNA), ISO 11137-1:2006/Amd 2013(E) Sterilization of health care products - Radiation - Part 1: Requirements for development, validation and routine control of a sterilization process for medical devices. ISO 11137-2:2013(E) Sterilization of health care products -Radiation - Part 2: Establishing the sterilization dose, ISO 11137-3: 2017(E) Sterilization of health care products - Radiation - Part 3: Guidance on dosimetric aspects of development, validation and routine control, and ISO 11737-1:2018(E) Sterilization of health care products - Microbiological methods - Part 1: Determination of a population of microorganisms on products .
Results of testing demonstrated the BD Insulin Syringes met requirements for its intended use and is as safe and effective as its predicate device.
Clinical Testing:
Not Applicable
Conclusion:
The modifications to the design, dimensions, and materials of the subject device met the standards. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.
The BD Insulin Syringes are substantially equivalent to the BD Ultra-Fine™ Insulin Syringe, BD Ultra-Fine™ II Insulin Syringe, BD Insulin Syringes with the BD Ultra-Fine™ needle and BD Insulin Syringes with Micro-Fine™ IV Needle cleared under K170386 with respect to the indications for use, target populations, treatment method, use environment and technological characteristics.