(53 days)
Not Found
No
The device description and performance studies focus on the physical components and functional performance of a syringe, with no mention of AI or ML technologies.
No
The device is a hypodermic syringe for general purpose fluid aspiration/injection, which is used for diagnostic or delivery purposes, not for treating a disease or condition itself.
No
Explanation: The device is a syringe intended for general purpose fluid aspiration/injection, which directly describes a therapeutic or interventional function, not a diagnostic one.
No
The device description clearly describes a physical syringe with a barrel, stopper, and plunger rod, and mentions materials and sterilization methods, indicating it is a hardware device.
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 device used to physically move fluids into or out of the body, not to perform tests on samples taken from the body.
- Device Description: The description details a syringe with a barrel, stopper, and plunger rod. This is consistent with a device for fluid delivery or withdrawal, not for analyzing biological samples.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. There is no mention of reagents, test strips, or any components typically associated with IVD devices.
IVD devices are specifically designed to perform tests on biological samples (like blood, urine, tissue) outside of the body to diagnose conditions, monitor health, or determine compatibility. This syringe is a tool for administering or withdrawing fluids directly from or into the body.
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 modified BD Single Use, Hypodermic Syringe is a three-piece single use, hypodermic syringe with a 6% (Luer) connector in 1ml Luer Slip, 3ml and 5ml Luer Lok and Luer Slip syringe sizes. The syringe assembly consists of a plastic barrel with a graduated scale, a synthetic rubber stopper, and a plastic plunger rod. The changes to the modified device from the predicate include a new synthetic stopper material and a new silicone based stopper lubricant formulation. The syringe performance characteristics are equivalent to the predicate device. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The modified BD Single Use, Hypodermic Syringe are provided sterile, by either EO or an Irradiation sterilization method, in a syringe only configuration or with a pre-attached or side-by-side hypodermic needle.
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)
Design Verification tests were performed based on the risk analysis performed, and the results of these tests demonstrate that the BD Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended.
Design Verification testing included the following:
- Functional Testing:
- Sustaining Force: Determination of forces required to operate plunger ISO 7886-1 - Annex G. Acceptance Criteria: Per ISO 7886-1.
- Break-Out Force: Determination of forces required to operate plunger ISO 7886-1 - Annex G. Acceptance Criteria: Per ISO 7886-1.
- Pump Sticktion / Force: Determination of forces required to move the piston ISO 7886-2 - Annex C. Acceptance Criteria: Per ISO 7886-2.
- Stopper Seal: Water Leakage Test ISO 7886-1 - Annex D. Acceptance Criteria: Per ISO 7886-1.
- Autoclavability: Water Leakage Test ISO 7886-1 - Annex D After Syringe autoclave for 15mins at 270°F. Acceptance Criteria: Per ISO 7886-1.
- Chemical Testing (Extractables):
- Zinc: ISO 7886-1. Acceptance Criteria: Per ISO 7886-1.
- Lead, Tin, Iron: ISO 7886-1. Acceptance Criteria: Per ISO 7886-1.
- Cadmium: ISO 7886-1. Acceptance Criteria: Per ISO 7886-1.
- pH shift: ISO 7886-1. Acceptance Criteria: Per ISO 7886-1.
- Biocompatibility Testing:
- Cytotoxicity: ISO10993-5:1999. Acceptance Criteria: Non-Toxic.
- Hemolysis: ISO10993-4:2002/A:2006. Acceptance Criteria: Non-Toxic.
- Acute Systemic Toxicity: ISO10993-11:2006. Acceptance Criteria: Non-Toxic.
- Intracutaneous Reactivity: ISO10993-10:2002/A1:2006. Acceptance Criteria: Non-Irritant.
- Murine Local Lymph Node Assay: ISO10993-10:2002/A1:2006. Acceptance Criteria: Non-Sensitizer.
- Pyrogenicity: ISO10993-11:2006. Acceptance Criteria: Non-Pyrogenic.
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
510(K) Summary of Safety and Effectiveness
MAY 13 2011
KU0771
Date Prepared: 16 March 2011
Submitted By: 1.
John Roberts Regulatory Affairs Specialist BD Medical - Medical Surgical Systems 1 Becton Drive Franklin Lakes, NJ 07417 201 847 5473 Tel: 201 847 5307 Fax:
2. Device Name:
BD Single Use, Hypodermic Syringe Trade Name: Common Name: Piston Syringe Classification Name: Syringe, Piston Class II, 21 CFR 880.5860 Classificiation:
Predicate Device: 3.
Becton Dickinson Single Use Hypodermic Syringe Trade Name: Becton, Dickinson and Company Manufacturer: 510(k) Number: K980987
4. Device Description:
The modified BD Single Use, Hypodermic Syringe is a three-piece single use, hypodermic syringe with a 6% (Luer) connector in 1ml Luer Slip, 3ml and 5ml Luer Lok and Luer Slip syringe sizes. The syringe assembly consists of a plastic barrel with a graduated scale, a synthetic rubber stopper, and a plastic plunger rod. The changes to the modified device from the predicate include a new synthetic stopper material and a new silicone based stopper lubricant formulation. The syringe performance characteristics are equivalent to the predicate device. The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
The modified BD Single Use, Hypodermic Syringe are provided sterile, by either EO or an Irradiation sterilization method, in a syringe only configuration or with a pre-attached or side-by-side hypodermic needle.
న్. Intended Use:
The BD Single Use, Hypodermic Syringe is intended for use by health care professionals for general purpose fluid aspiration/injection.
1
Technological Characteristics: 6.
The principal device of this 510(k) premarket notification is the result of a design change to the predicate device (K980987) conducted in accordance with Quality System Regulations, 21 CFR 820. The BD Single Use, Hypodermic Syringe is Substantially Equivalent to the predicate device, given that:
- a) The BD Single Use, Hypodermic Syringe has the same intended use as the predicate device
- b) The BD Single Use, Hypodermic Syringe operates under the same operating principle as the predicate device
- c) The BD Single Use, Hypodermic Syringe barrel and plunger rod use an identical design and identical materials as the predicate device
- d) The BD Single Use, Hypodermic Syringe and the predicate device meet the requirements for manual use and use with power-driven pumps as defined by ISO 7886-1 and ISO 7886-2 respectively.
- e) The BD Single Use, Hypodermic Syringe and the predicate device component materials comply with ISO 10993 as applicable to the intended use of the device
- The BD Single Use, Hypodermic Syringe and the predicate device are sterilized to an f) SAL of 10-6 via an EtO or Irradiation sterilization process
- g) The BD Single Use, Hypodermic Syringe are assembled and packaged at the same manufacturing location utilizing the same equipment as the predicate device
- h) The BD Single Use, Hypodermic Syringe demonstrated equivalent performance to the predicate device during design verification testing.
6. Performance:
Design Verification tests were performed based on the risk analysis performed, and the results of these tests demonstrate that the BD Single Use, Hypodermic Syringe performed in an equivalent manner to the predicate device and is safe and effective when used as intended.
Design Verification testing included the following:
000011
2
| Performance Characteristic | Test Performed | Acceptance Criteria |
|---|---|---|
| Functional Testing | ||
| Sustaining Force | Determination of forces required | |
| to operate plunger | ||
| ISO 7886-1 - Annex G | Per ISO 7886-1 | |
| Break-Out Force | Determination of forces required | |
| to operate plunger | ||
| ISO 7886-1 - Annex G | Per ISO 7886-1 | |
| Pump Sticktion / Force | Determination of forces required | |
| to move the piston | ||
| ISO 7886-2 - Annex C | Per ISO 7886-2 | |
| Stopper Seal | Water Leakage Test | |
| ISO 7886-1 - Annex D | Per ISO 7886-1 | |
| Autoclavability | Water Leakage Test | |
| ISO 7886-1 - Annex D | ||
| After Syringe autoclave for | ||
| 15mins at 270°F | Per ISO 7886-1 | |
| Chemical Testing (Extractables) | ||
| Zinc | ISO 7886-1 | Per ISO 7886-1 |
| Lead, Tin, Iron | ISO 7886-1 | Per ISO 7886-1 |
| Cadmium | ISO 7886-1 | Per ISO 7886-1 |
| pH shift | ISO 7886-1 | Per ISO 7886-1 |
Biocompatibility Testing
.
! |
. "".
.. /
| Cytotoxicity | ISO10993-5:1999 | Non-Toxic |
|---|---|---|
| Hemolysis | ISO10993-4:2002/A:2006 | Non-Toxic |
| Acute Systemic Toxicity | ISO10993-11:2006 | Non-Toxic |
| Intracutaneous Reactivity | ISO10993-10:2002/A1:2006 | Non-Irritant |
| Murine Local Lymph Node | ||
| Assay | ISO10993-10:2002/A1:2006 | Non-Sensitizer |
| Pyrogenicity | ISO10993-11:2006 | Non-Pyrogenic |
3
Image /page/3/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three tail feathers, representing the three levels of government: federal, state, and local. The eagle is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
Mr. John Roberts Regulatory Affairs Specialist Becton, Dickinson and Company BD Medicalsurgical 1 Becton Drive MC237 Franklin Lakes, New Jersey 07417
MAY 1 3 2011
Re: K110771
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: April 19, 2011 Received: April 21, 2011
Dear Mr. Roberts:
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- Mr. Roberts
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/ResourcesforYou/Industry/default.htm.
Sincerely vours.
Wh for
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): 长儿1077 |
BD Single Use, Hypodermic Syringe Device Name:
Indications for Use:
The BD Single Use, Hypodermic Syringe is intended for use by health care professionls for general purpose fluid aspiration/injection.
Prescription Use X Over-The-Counter Use 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)
Page | of |
Rilis C. Chapman 5/12/11
(Division Sign-Off)
יח vision of Anesthesiology, General Hospital intection Control, Dental Devices
:.0(k) Number: K110771