(64 days)
Not Found
No
The device description and performance studies focus on the physical and functional characteristics of a standard hypodermic syringe, with no mention of AI or ML capabilities.
No
The device is a general-purpose fluid aspiration/injection tool, not classified as therapeutic. Its function is to facilitate the delivery or removal of substances, rather than providing direct therapeutic treatment.
No
The device is described as a hypodermic syringe for general purpose fluid aspiration/injection, which relates to treatment or administration, not diagnosis. There is no mention of it being used to identify, detect, or monitor a disease or condition.
No
The device description clearly outlines a physical, hardware-based medical device (syringe) and makes no mention of any software component.
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 into or out of the body, 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 fluid handling. It does not mention any components or processes related to analyzing biological samples for diagnostic purposes.
- Lack of IVD Indicators: There is no mention of analyzing blood, urine, tissue, or any other biological sample for the purpose of diagnosing a disease or condition. The device is used on the patient for fluid management, not on a sample from the patient for analysis.
IVD devices are specifically designed to perform tests on biological samples to provide information for diagnosis, monitoring, or screening. This syringe is a tool for administering or withdrawing fluids from a patient, which is a therapeutic or procedural action, 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
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 1ml Luer Slip. 3ml. 10ml and 20ml 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 plastic barrel with a graduated scale, a lubricated synthetic rubber stopper and a plastic plunger rod. The plunger rod is pulled along the inside of the barrel to aspirate fluids and pushed along the inside of the barrel 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 BD Single Use, Hypodermic Syringe are provided sterile (EtO) in a syringe only configuration or with a hypodermic needle. 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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
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 features the department's name in a circular arrangement around a symbol. The symbol is a stylized representation of a human figure, with three faces overlapping to create a sense of depth and connection. The logo is simple, yet recognizable, and represents the department's mission to protect the health of all Americans.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
September 2, 2015
Becton, Dickinson and Company Murtaza Rana Regulatory Affairs Specialist 1 Becton Drive Franklin Lakes, NJ 07417
Re: K151766
Trade/Device Name: BD Single Use, Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: June 25, 2015 Received: June 30, 2015
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.
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
1
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 (reporting of medical device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (QS) 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/Resourcesfor You/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 yours.
Erin I. Keith -S
Erin I. Keith, M.S. Director Division of Anesthesiology, General Hospital, Respiratory, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known) K151766
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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510(k) Summary
| Submitted By: | Murtaza Rana |
|---|---|
| Regulatory Affairs Specialist | |
| Becton, Dickinson and Company | |
| 1 Becton Drive | |
| Franklin Lakes, NJ 07417 | |
| Phone: (201)847-6980 | |
| Fax: (201)847-5307 | |
| Date Prepared: | August 3, 2015 |
| Device: | |
| Trade Name: BD Single Use, Hypodermic Syringe | |
| Common Name: Piston Syringe | |
| Classification: Class II device, 21 CFR §880.5860, | |
| Piston Syringe | |
| Product Code: FMF (Syringe, Piston) | |
| Predicate Device: | K980987 |
| BD Single Use, Hypodermic Syringe |
Device Description
The BD Single Use, Hypodermic Syringe is a three-piece, sterile, single use hypodermic syringe with a 6% (Luer) male connector in 1ml Luer Slip. 3ml. 10ml and 20ml 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 plastic barrel with a graduated scale, a lubricated synthetic rubber stopper and a plastic plunger rod. The plunger rod is pulled along the inside of the barrel to aspirate fluids and pushed along the inside of the barrel 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 BD Single Use, Hypodermic Syringe are provided sterile (EtO) in a syringe only configuration or with a hypodermic needle. 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.
Intended 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 is equivalent to that of the predicate BD Single Use, Hypodermic Syringe in intended use, materials and performance characteristics.
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| 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 | ||
| Rubber | Rubber | |
| Stopper | ||
| Silicone | Silicone | |
| Lubricant | ||
| Sterilization Method | Ethylene Oxide | Ethylene Oxide |
| SAL | $10^{-6}$ | $10^{-6}$ |
| Shelf Life | 5 Years | 5 Years |
Non-Clinical Testing
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.
| Performance Characteristic | Acceptance Criteria | |
|---|---|---|
| Functional Testing | Break Out Force | Equivalence to Predicate |
| Sustaining Force | Equivalence to Predicate | |
| Flange Bend Force | Equivalence to Predicate | |
| Dimensional Stability of | ||
| Barrel ID (inner | ||
| diameter) | Equivalence to Predicate | |
| Barrel Scale Permanency | Equivalence to Predicate | |
| Barrel Impact Test | Equivalence to Predicate | |
| Biocompatibility | ||
| Testing | Cytotoxicity | |
| Hemolysis | Per ISO10993-4, Non-toxic | |
| Acute Systemic Toxicity | Per ISO10993-11, Non-toxic | |
| Intracutaneous Reactivity | Per ISO10993-10, Non-Irritant | |
| Sensitization | Per ISO10993-10, Non-Sensitizer | |
| Pyrogenicity | Per ISO 10993-11 and USP 151, Non-Pyrogenic | |
| Chemical Extractable | ||
| Analysis | Per ISO 10993-18, acceptable level of | |
| extracts. |
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Clinical Testing
Clinical testing was not required for this submission.
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.
Conclusion
The BD Single Use, Hypodermic Syringe has been verified to meet the established performance criteria above. The results of the non-clinical/design verification testing demonstrate that the BD Single Use, Hypodermic Syringe performs as intended and performs as well as the legally marketed predicate device.