(17 days)
No
The device description and intended use are for a standard mechanical syringe, with no mention of AI/ML or related concepts.
No
The device is used for injecting or withdrawing fluids, which is a procedural function, not necessarily a therapeutic one. Therapeutic devices are typically those that treat or cure a disease or condition.
No
Explanation: The device is described as a syringe intended for injecting or withdrawing fluids, which is a therapeutic or delivery function, not a diagnostic one. There is no mention of it analyzing or detecting conditions.
No
The device description clearly describes a physical syringe with a barrel, plunger, and nozzle, 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 "to inject fluid into, or withdraw fluids from, the body." This describes a direct interaction with the patient's body for therapeutic or diagnostic purposes within the body, not for testing samples outside the body.
- Device Description: The description of a syringe with a barrel and plunger aligns with a device used for administering or collecting substances directly from a living organism.
- Lack of IVD Characteristics: There is no mention of analyzing samples, reagents, or any process that would be performed in vitro (outside the living organism).
IVDs are devices used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnostic, monitoring, or compatibility purposes. This syringe does not fit that description.
N/A
Intended Use / Indications for Use
The B. Braun Piston Syringes are intended to be used to inject fluid into, or withdraw fluids from, the body.
Product codes
FMF
Device Description
The B. Braun piston syringe is a 2-piece syringe consisting of a calibrated hollow barrel and a movable plunger without a plunger tip. One end of the barrel has a male connector (nozzle), which permits attachment to a female connector (hub). Both luer lock and luer slip nozzles are available, with centric and eccentric configurations.
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)
Not Found
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
K063280
NOV 17 2006
5. 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
Contact: Christine Ford, Regulatory Affairs Specialist
phone (610) 596-2367 fax (610) 266-4962 |
|-----------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | Injekt® Piston Syringe |
| COMMON OR USUAL
NAME: | Piston Syringe |
| DEVICE
CLASSIFICATION: | Piston Syringe
Class II, CFR Title 21 § 880.5860 |
| PREDICATE DEVICE: | NIPRO disposable hypodermic syringes with or without
needle (K051574) |
| DESCRIPTION: | The B. Braun piston syringe is a 2-piece syringe consisting
of a calibrated hollow barrel and a movable plunger without
a plunger tip. One end of the barrel has a male connector
(nozzle), which permits attachment to a female connector
(hub). Both luer lock and luer slip nozzles are available,
with centric and eccentric configurations. |
| INTENDED USE: | The B. Braun Piston Syringes are intended to be used to
inject fluid into, or withdraw fluids from, the body. |
| SUBSTANTIAL
EQUIVALENCE: | The B. Braun Piston Syringes have the same intended use,
operation, and similar design as the stated predicate device,
the NIPRO disposable hypodermic syringes with or
without needle (K051574). There are no differences
between the predicate and proposed devices that raise new
issues of safety and effectiveness. |
1
Image /page/1/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle. The eagle is composed of three curved lines that form the shape of the bird's body and wings. The text is in all caps and is evenly spaced around the circle.
ood and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Christine Ford Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
NOV 17 2006
Re: K063280
Trade/Device Name: B. Braun Injekt® Piston Syringes Regulation Number: 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: October 27, 2006 Received: October 31, 2006
Dear Ms. Ford:
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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
2
Page 2 - Ms. Ford
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); 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.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). 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) 443-6597 or at its Internet address http://www.fda.gov/cdrh/industry/support/index.html.
Sincerely yours.
Suite Y. Michael Omis
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
3
Indications for Use Statement 4.
Page
510(k) Number (if known): K063280
Device Name:
B. Braun Injekt® Piston Syringes
Indications For Use:
The B. Braun Injekt® piston syringes are intended to be used to inject fluid into, or withdraw fluids from, the body.
Prescription Use X (Per 21 CFR 801.109)
.
OR
Over-The-Counter Use
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Ris C. Chaym for Apu 11/7/2000
nesthesiology, General Hospital, trol, Dental Dev
) Number. Ko632jo