(413 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 capabilities.
No
This device is a syringe for fluid aspiration/injection, which is a delivery mechanism, not a therapeutic device.
No
A hypodermic syringe is used for fluid aspiration/injection, which are interventional procedures, not diagnostic ones. Diagnostic devices are used to identify or detect a disease or condition.
No
The device description clearly details a physical, three-piece hypodermic syringe made of materials like polypropylene and synthetic rubber, and the performance studies focus on physical characteristics and biocompatibility, not software validation.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "for general purpose fluid aspiration/injection." This describes a physical action of moving fluids, not a diagnostic test performed in vitro (outside the body) on biological samples.
- Device Description: The description details the physical components and function of a syringe for aspirating and injecting fluids. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: The document does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of specific analytes (markers, substances)
- Diagnostic interpretation of results
- Use in a laboratory setting for diagnostic testing
The device is clearly intended for direct use on a patient for administering or withdrawing fluids, which is a therapeutic or procedural function, not a diagnostic one.
N/A
Intended Use / Indications for Use
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
Product codes (comma separated list FDA assigned to the subject device)
FMF
Device Description
The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 3ml, 5ml and 10ml Luer-Lok syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. The syringe assembly consists of a lubricated polypropylene 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 syringe barrel incorporates a male 6% (Luer) connector which is connectable to a compatible female 6% (Luer) connector. The modified BD Single Use, Hypodermic Syringe includes a new resin material in the barrel of the syringe. 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
Not Found
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 based on the risk analysis conducted and the results of these tests demonstrate that the BD Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate device.
- Break Out Force
- Sustaining Force
- Flange Bend Force
- Dimensional Stability of Barrel ID (inner diameter)
- Barrel Scale Permanency
- Barrel Impact Test
- ISO 7886 and ISO 594 Leakage Testing
The device is sterilized using a gamma irradiation process and was validated per ISO 11137-2:2013.
In addition, a biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process. Based on the evaluation, the following biological tests were conducted:
- Cytotoxicity (Per ISO 10993-5, Non-cytotoxic)
- 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)
- Pyrogenicity (Per ISO 10993-11 and USP , Non-Pyrogenic)
- Acidity/Alkalinity/ Extractable Metals (Per ISO 7886-1, met acceptance criteria)
- Chemical Extractables Analysis (Per ISO 10993-18, no toxicologically significant differences in extractables profiles.)
Per the design control requirements specified in 21 CFR 820.30. the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.
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.
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 & 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 23, 2018
Becton, Dickinson and Company Victoria Morrow Sr. Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, New Jersey 07417
Re: K172670
Trade/Device Name: BD Single Use, Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: Class II Product Code: FMF Dated: February 2, 2018 Received: February 5, 2018
Dear Victoria Morrow:
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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice
(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/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 -S
Tina Kiang, Ph.D. for 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)
Device Name BD Single Use, Hypodermic Syringe
Indications for Use (Describe)
The BD Single Use, 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)
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3
Image /page/3/Picture/0 description: The image shows the logo for BD, a global medical technology company. The logo consists of two parts: a circular orange symbol on the left and the letters "BD" in blue on the right. The orange symbol features a stylized sun-like design with rays emanating from a central point, while the letters "BD" are bold and slightly rounded.
510(k) Summary (21 CFR §807.92)
BD Single Use, Hypodermic Syringe
| Submitter
Information | Submitter Name:
Submitter Address:
Contact Person:
Email Address:
Phone Number:
Fax Number:
Date of Preparation: | Becton, Dickinson and Company
1 Becton Drive
Franklin Lakes, NJ 07417
Victoria Morrow
Sr. Regulatory Affairs Specialist
Victoria_morrow@bd.com
Phone: (201) 847-6626
Fax: (201) 847-5307
October 23, 2018 | |
|----------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|
| Subject Device | Trade Name:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Single Use, Hypodermic Syringe
Piston Syringe
21 CFR §880.5860
Piston Syringe
Class II device
FMF (Syringe, Piston)
General Hospital | |
| Predicate Device | Trade Name:
510(k) Reference:
Common Name:
Regulation Number:
Regulation Name:
Regulatory Class:
Product Code:
Classification Panel: | BD Single Use, Hypodermic Syringe
K980987
Piston Syringe
21 CFR §880.5860
Piston Syringe
Class II device
FMF (Syringe, Piston)
General Hospital | |
| Device
Description | The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use
hypodermic syringe with a 6% (Luer) male connector in 3ml, 5ml and 10ml Luer-Lok
syringe sizes. The BD Single Use, Hypodermic Syringe is intended for use by
health care professionals for general purpose fluid aspiration/injection. The syringe
assembly consists of a lubricated polypropylene 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
syringe barrel incorporates a male 6% (Luer) connector which is connectable to a
compatible female 6% (Luer) connector. The modified BD Single Use, Hypodermic
Syringe includes a new resin material in the barrel of the syringe. The syringe
performance characteristics are equivalent to the predicate device. | | |
| Indications for
Use | | The BD Single Use, Hypodermic Syringe is intended for use by health care
professionals for general purpose fluid aspiration/injection. | |
| Technological
Characteristics | | The subject BD Single Use, Hypodermic Syringe, which uses a new polyproplyene
barrel resin is equivalent to that of the predicate BD Single Use, Hypodermic
Syringe in intended use, materials and performance characteristics. | |
4
| Element of Comparison | Subject Device | Predicate Device | |
|---|---|---|---|
| Indications for Use/Intended Use | The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection. | |
| Syringe materials | Barrel | Polypropylene | Polypropylene |
| Barrel | Silicone | Silicone | |
| Lubricant | |||
| Plunger Rod | Polypropylene | Polypropylene | |
| Stopper | Polyisoprene Rubber | Polyisoprene Rubber | |
| Stopper | Silicone | Silicone | |
| Lubricant | |||
| Sterilization Method | Gamma Irradiation | ||
| E-beam | Gamma Irradiation | ||
| E-beam | |||
| SAL | 10-6 | 10-6 | |
| Shelf Life | 5 Years | 5 Years |
Performance Tests
BD has performed the following non-clinical/design verification testing based on the risk analysis conducted and the results of these tests demonstrate that the BD Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate device.
- Break Out Force ●
- Sustaining Force ●
- Flange Bend Force ●
- Dimensional Stability of Barrel ID (inner diameter) ●
- . Barrel Scale Permanency
- Barrel Impact Test
- ISO 7886 and ISO 594 Leakage Testing ●
The device is sterilized using a gamma irradiation process and was validated per ISO 11137-2:2013.
In addition, a biocompatibility evaluation was conducted on the subject device per ISO 10993-1:2009, Biological Evaluation of Medical Devices-Part 1: Evaluation and Testing Within a Risk Management Process. Based on the evaluation, the following biological tests were conducted:
- Cytotoxicity (Per ISO 10993-5, Non-cytotoxic) ●
- 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) ●
- Pyrogenicity (Per ISO 10993-11 and USP , Non-Pyrogenic) ●
- Acidity/Alkalinity/ Extractable Metals (Per ISO 7886-1, met acceptance ● criteria)
- . Chemical Extractables Analysis (Per ISO 10993-18, no toxicologically significant differences in extractables profiles.)
Per the design control requirements specified in 21 CFR 820.30. the subject device met all predetermined acceptance criteria for the above-listed performance tests, demonstrating substantial equivalence to the predicate device.
5
| Clinical Testing | Clinical testing was not required for this submission |
|---|---|
| Summary of | |
| Substantial | |
| Equivalence | The BD Single Use, Hypodermic Syringe is substantially equivalent to the predicate |
| device in intended use, principles of operation, technology, design, materials and | |
| performance. |