(63 days)
Not Found
No
The device description and performance studies focus on the mechanical and material properties of a standard hypodermic syringe, with no mention of AI or ML.
No
A therapeutic device directly treats or cures a disease or condition. This device's intended use is for "general aspiration and injection of fluids," which describes a delivery or collection mechanism, not a treatment itself. The act of "injection" can be part of a therapy (delivering medication), but the syringe itself is not the therapeutic agent.
No
The device is described as a hypodermic syringe intended for general aspiration and injection of fluids, which are therapeutic and procedural uses, not diagnostic.
No
The device description explicitly states it consists of physical components: a graduated barrel, plunger rod, and needle/hub assembly. The performance studies also focus on physical characteristics and material properties, not software functionality.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "general aspiration and injection of fluids." This describes a direct interaction with the patient's body for administering or withdrawing substances.
- Device Description: The description details a syringe with a needle, barrel, and plunger rod. This is a device designed for physical manipulation of fluids within or from the body.
- Lack of IVD Characteristics: An IVD device is used to examine specimens derived from the human body (like blood, urine, tissue) in vitro (outside the body) to provide information for diagnosis, monitoring, or screening. This description does not mention any such use or analysis of bodily specimens.
- Performance Studies: The performance studies focus on the physical and biological properties of the syringe and needle (functional performance, biocompatibility), not on the analysis of biological samples.
The BD Hypodermic Syringe is a medical device used for direct patient care, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
BD Hypodermic Syringe is intended for general aspiration and injection of fluids.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The BD Hypodermic Syringe operates on the same fundamental scientific technology as the predicate cleared under K980580. The subject device consists of a: graduated barrel, plunger rod and needle/hub assembly. The device is offered with an attached 27G x 16mm cannula integrated with a 1mL syringe barrel capacity. The subject device is offered in self-contained (with a plunger cap) configuration. It is a single-use disposable device that is provided sterile. The BD Hypodermic Syringe is non-toxic and non-pyrogenic.
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)
Non-Clinical Test Summary: The subject device has similar technological characteristics as the predicate device cleared in K980580. BD has validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included functional performance per ISO 7886-1:2017, ISO 7864:2016, and ISO 9626:2016. Material changes were evaluated in accordance with ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process.
Functional Performance Testing:
- ISO 7886-1: 2017 Sterile hypodermic syringes for single use Part 1: Syringes for . manual use
- ISO 7864: 2016 Sterile hypodermic needles for single use Requirements and test . methods
- ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices . - Requirements and test methods
Biocompatibility Testing: BD Hypodermic Syringe is categorized as an externally communicating device, involving direct contact with tissue for a prolonged contact duration (>24 hours to 30 days). A series of biological test were performed in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process with the following endpoints:
- Cytotoxicity
- . Sensitization
- . Irritation or Intracutaneous reactivity
- . Acute systemic toxicity
- . Material mediated pyrogenicity
- . Subacute/Subchronic toxicity
- . Indirect hemolysis
- . USP
All material modifications met the requirements per ISO 10993-1:2018. Results of testing demonstrated the BD Hypodermic Syringe met requirements for its intended use and is as safe and effective as its predicate devices.
Clinical Test Summary: Not Applicable.
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 and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA acronym followed by the full name of the agency on the right. The Department of Health & Human Services logo is a stylized depiction of an eagle. The FDA acronym and the agency's full name are in blue.
January 25, 2021 Becton Dickinson and Company Charlton Foo Staff Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K203453
Trade/Device Name: BD Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: November 19, 2020 Received: November 23, 2020
Dear Charlton Foo:
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 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for
1
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 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,
Rumi Young Acting 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
Submission Number (if known)
Device Name
BD Hypodermic Syringe
Indications for Use (Describe)
BD Hypodermic Syringe is intended for general aspiration and injection of fluids.
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
510(k) Summary
| Submitted By: | Charlton Foo | |
|---|---|---|
| Staff Regulatory Affairs Specialist | ||
| Becton Dickinson and Company | ||
| 1 Becton Drive | ||
| Franklin Lakes, NJ 07417 | ||
| Tel: 201 847 6869 | ||
| Fax: 201 847 5307 | ||
| Date Prepared: | January 21, 2021 | |
| Device Name: | Trade Name: | BD Hypodermic Syringe |
| Common Name: | Hypodermic Syringe | |
| Classification: | Class II device; 21 CFR 880.5860, | |
| (Syringe, Piston) | ||
| Product Code: | FMF (Piston Syringe) |
Legally marketed predicate device to which substantial equivalence is being claimed: K980580: Becton Dickinson Syringes
Reason for Submission:
- . Expansion of syringe portfolio for general aspiration and injection of fluids in a 16mm needle length and thin wall configuration for the proposed syringe
- . Material modifications
- Packaging Changes .
Device Description:
The BD Hypodermic Syringe operates on the same fundamental scientific technology as the predicate cleared under K980580. The subject device consists of a: graduated barrel, plunger rod and needle/hub assembly. The device is offered with an attached 27G x 16mm cannula integrated with a 1mL syringe barrel capacity. The subject device is offered in self-contained (with a plunger cap) configuration. It is a single-use disposable device that is provided sterile. The BD Hypodermic Syringe is non-toxic and non-pyrogenic.
4
Intended Use:
BD Hypodermic Syringe is intended for general aspiration and injection of fluids.
The intended use of the subject device remains the same as the predicate device K980580 Becton Dickinson Syringes.
Comparison with Predicate Device:
The subject device has the same fundamental scientific technology as the predicate, which operate on the principles of a piston syringe. The modifications of the subject device consist of design, performance, and material. The purpose of this submission is to market the BD Hypodermic Syringe device. The table below provides a side-by-side comparison of the subject device compared to its predicate.
| General
Information
Feature | Subject Device:
BD Hypodermic Syringe | Predicate Device:
Becton Dickinson Syringes
(K980580) | Comparison |
|-----------------------------------|--------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------|-------------------------------------------|
| Classification | 11 | 11 | Same |
| Product Code | FMF | FMF | Same |
| Regulation
Number | 880.5860 | 880.5860 | Same |
| Intended Use | BD Hypodermic Syringe is
intended for general
aspiration and injection of
fluids. | These syringes are intended
for general purpose fluid
aspiration/ injection and
insulin injection. | Same |
| Gauge | 27G | 28G, 27G, 26G | Same |
| Needle Length | 16mm | 12.7mm and 9.5mm | Addition of
16mm length |
| Needle wall
thickness | Regular Wall and Thin Wall | Regular Wall | Addition of Thin
Wall
Configuration |
| Needle Shield
Color | Gray | Gray (27G) | Same |
| Bevel | 3 Bevel | 3 Bevel | Same |
| Barrel Size | 1mL | 1mL and 0.5mL | Same |
| Maximum Dead
Space | 0.01mL | 0.07mL | Reduction in
maximum dead
space |
| Scale Mark | Millimeters (mL) | Millimeters (mL) | Same |
| Single Use Only | Yes | Yes | Same |
5
| General
Information
Feature | Subject Device:
BD Hypodermic Syringe | Predicate Device:
Becton Dickinson Syringes
(K980580) | Comparison |
|-----------------------------------|-----------------------------------------------------|-------------------------------------------------------------|--------------------------------|
| Packaging
Configuration | Self-Contained configuration | Self-contained, Blister pack
and Tray configuration | Same |
| Sterile (10-6) | Yes | Yes | Same |
| Sterilization
Method | Gamma | Gamma | Same |
| Shelf Life | 5 years | 5 years | Same |
| Non-Pyrogenic | Yes | Yes | Same |
| Component Materials | | | |
| Needle | Stainless Steel | Stainless Steel | Same |
| Needle Shield | Polyethylene | Polyethylene / Polypropylene | Same |
| Needle Lubrication | Medical Grade Silicone | Medical Grade Silicone | Same |
| Plunger Rod | Polystyrene | Polypropylene | New plunger
material |
| Plunger Tip | Polyisoprene Rubber and
Styrene Butadiene Rubber | Polyisoprene Rubber | Additional
stopper material |
| Plunger Cap | Polyethylene | Polyethylene | Same |
| Barrel | Polypropylene | Polypropylene | Same |
| Hub | Polypropylene | Polypropylene | Same |
Testing:
Non-Clinical Test Summary
The subject device has similar technological characteristics as the predicate device cleared in K980580. BD has validated the design of the subject device as part of its design control process in accordance with the Quality System Regulation. This testing included functional performance per ISO 7886-1:2017, ISO 7864:2016, and ISO 9626:2016. Material changes were evaluated in accordance with ISO 10993-1:2018: Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process.
Functional Performance Testing
- ISO 7886-1: 2017 Sterile hypodermic syringes for single use Part 1: Syringes for . manual use
- ISO 7864: 2016 Sterile hypodermic needles for single use Requirements and test . methods
6
- ISO 9626: 2016 Stainless steel needle tubing for the manufacture of medical devices . - Requirements and test methods
Biocompatibility Testing
BD Hypodermic Syringe is categorized as an externally communicating device, involving direct contact with tissue for a prolonged contact duration (>24 hours to 30 days). A series of biological test were performed in accordance with ISO 10993-1:2018 Biological Evaluation of Medical Devices – Part 1: Evaluation and testing within a risk management process with the following endpoints:
- Cytotoxicity ●
- . Sensitization
- . Irritation or Intracutaneous reactivity
- . Acute systemic toxicity
- . Material mediated pyrogenicity
- . Subacute/Subchronic toxicity
- . Indirect hemolysis
- . USP
All material modifications met the requirements per ISO 10993-1:2018. Results of testing demonstrated the BD Hypodermic Syringe met requirements for its intended use and is as safe and effective as its predicate devices.
Clinical Test Summary Not Applicable.
Conclusion:
The modifications to the design, dimensions and materials of the subject device met the requirements of the FDA recognized consensus standards. The differences between the predicate and the subject device do not raise any new or different questions of safety or effectiveness.
The BD Hypodermic Syringe is substantially equivalent to the predicate device cleared under K980580 with respect to the indications for use, target populations, treatment method, use environment and technological characteristics.