(26 days)
Not Found
No
The device description and performance studies focus on the physical characteristics and sterilization of a standard hypodermic syringe, with no mention of AI or ML.
No.
The device is a syringe intended for general purpose aspiration and injection of fluids, not for treating a disease or condition.
No
The device is a hypodermic syringe, an instrument used for aspiration and injection of fluids, which are procedures, and not for diagnosing a condition or disease.
No
The device description clearly outlines physical components such as a barrel, stopper, plunger rod, and needle, indicating it is a hardware device, not software-only.
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 aspiration and injection of fluids." This describes a physical action performed on a patient (injecting or withdrawing fluids), not a test performed on a sample outside the body to diagnose a condition.
- Device Description: The description details a syringe and needle, which are tools for administering or withdrawing substances from a living organism. It does not describe components or processes used for analyzing biological samples in a laboratory setting.
- Lack of IVD Characteristics: The document does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring specific analytes
- Providing diagnostic information about a patient's health status
- Reagents, calibrators, or controls
In summary, the BD Emerald™ Single Use, Hypodermic Syringe is a medical device used for direct patient care (injection and aspiration), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The BD Emerald™ Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.
Product codes
FMF
Device Description
The BD Emerald™ Single Use, Hypodermic Syringe is a three-piece sterile, single use, hypodermic syringe with a 6% Luer taper tip that is provided in the following syringe sizes: 2ml, 3ml, 3ml, and 10ml. All sizes will be available with either a Luer Slip or Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination.
The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a resin stopper, and a polypropylene plunger rod. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The needle assembly consists of a lubricated stainless steel needle attached to a polypropylene hub with epoxy.
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)
The results of Design Verification tests demonstrate that the BD Emerald™ Single Use. Hypodermic Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended.
The BD Emerald™ Single Use Hypodermic Syringe have been designed and successfully tested to meet the applicable requirements outlined in ISO 7886-1. Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use. The needles that may be included with the syringe meet the applicable requirements outlined in ISO 7864, Sterile Hypodermic Needles for Single Use and ISO 9626, Stainless Steel Needle Tubing for the Manufacture of Medical Devices.
The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a Risk Management Process.
The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 11135-1, Sterilization of Healthcare Products - Ethylene Oxide Sterilization Process for Medical Devices.
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 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
510(K) Summary of Safety and Effectiveness
· NOV 2 8 201
2113741
Submitted By:
Kara McKee. Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 Tel: 201 847 3247 Fax: 201 847 5307
Device Name:
| Trade Name: | BD Emerald™ Single Use Hypodermic Syringe |
|---|---|
| Common Name: | Piston Syringe |
| Classification Name: | Syringe, Piston |
| Classification: | Class II, 21 CFR 880.5860. |
Predicate Device:
| Trade Name(s): | Becton Dickinson Single Use Hypodermic Syringe |
|---|---|
| Manufacturer: | Becton, Dickinson and Company |
| 510(k) Number(s): | K980987 and K110771 |
Device Description:
The BD Emerald™ Single Use, Hypodermic Syringe is a three-piece sterile, single use, hypodermic syringe with a 6% Luer taper tip that is provided in the following syringe sizes: 2ml, 3ml, 3ml, and 10ml. All sizes will be available with either a Luer Slip or Luer Lock tip and may be packaged as a syringe only, or syringe and needle combination.
The syringe assembly consists of a lubricated polypropylene barrel with a graduated scale, a resin stopper, and a polypropylene plunger rod. The polypropylene syringe barrel incorporates a male 6% (Luer) connector, and is connectable to a compatible female 6% (Luer) connector. The needle assembly consists of a lubricated stainless steel needle attached to a polypropylene hub with epoxy.
Intended Use:
The BD Emerald™ Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.
1
page 2 of 3
Technological Characteristics:
The principle device of this 510(k) premarket notification is the result of material; design, and labeling changes to the predicate devices (K980987 and K110771) which were conducted in accordance with Ouality System Regulations, 21 CFR 820.
The BD Emerald™ Single Use Hypodermic Syringe is Substantially Equivalent to the predicate devices, given that both the principle and predicate devices:
- have the same intended use
- operate under the same operating principle
- meet the requirements for manual use as defined by ISO 7886-1
- have materials that comply with ISO 10993 as applicable to the intended use of the device
- are sterilized to a Sterility Assurance Level (SAL) of 10-6
- demonstrate equivalent performance during design verification testing.
Testing:
The results of Design Verification tests demonstrate that the BD Emerald™ Single Use. Hypodermic Syringe performed in an equivalent manner to the predicate devices and is safe and effective when used as intended.
Performance Testing:
The BD Emerald™ Single Use Hypodermic Syringe have been designed and successfully tested to meet the applicable requirements outlined in ISO 7886-1. Sterile Hypodermic Syringes for Single Use - Part 1: Syringes for Manual Use. The needles that may be included with the syringe meet the applicable requirements outlined in ISO 7864, Sterile Hypodermic Needles for Single Use and ISO 9626, Stainless Steel Needle Tubing for the Manufacture of Medical Devices.
Biocompatibility Testing:
The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 10993-1, Biological Evaluation of Medical Devices Part 1: Evaluation and testing within a Risk Management Process.
Sterilization and Shelf-life Testing:
The BD Emerald™ Single Use Hypodermic Syringe and needles have been designed and successfully tested to meet the applicable requirements outlined in ISO 11135-1, Sterilization of Healthcare Products - Ethylene Oxide Sterilization Process for Medical Devices.
2
8.
The vast similarities of the BD Emerald™ Single Use Hypodermic Syringe to the predicate devices support the substantial equivalence in intended use, function and basic composition. The testing to voluntary standards provides additional evidence that the BD Emerald™ Single Use Hypodermic Syringe is substantially equivalent to the predicate devices in terms of safety, efficacy and performance.
111324
The differences between the BD Emerald™ Single Use Hypodermic Syringe and the predicate devices do not raise new issues of safety or effectiveness. . . . . . .
.
3
Image /page/3/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The logo is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Ms. Kara McKee Regulatory Affairs Specialist Becton Dickinson 1 Beckton Drive Franklin Lakes, New Jersey 07417
NOV 2 8 2011
Re: K113241
Trade/Device Name: BD Emerald™ Single Use Hypodermic Syringe Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: November 1, 2011 Received: November 2, 2011
Dear Ms. McKee:
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.
4
Page 2 - Ms. McKee
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 (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 go to http://www.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices /ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. 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 Small Manufacturers, International and Consumer Assistance 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.
Sincerely vours.
Anthony V. Walker
Anthony D. Watson, B.S., M.S., M.B.A. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
Indications for Use Statement
510(k) Number (if known): K | 3241
BD Emerald™, Single Use, Hypodermic Syringe Device Name:
Indications for Use:
The BD Emerald™ Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose aspiration and injection of fluids.
Prescription Use Over-The-Counter Use X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C) (Please DO NOT WRITE BELOW THIS LINE - Continue on Another PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
of Page
Robert Chayra 11/30/4
(Division Sign-Off) Division of Anesthesiology, General Hospital Infection Control, Dental Devices
`510(k) Number: