(113 days)
Not Found
No
The device description and intended use are purely mechanical filtration, with no mention of AI/ML terms or functionalities.
No.
The device is described as a filter intended to remove particulates from drug solutions before administration, rather than treating a disease or condition itself.
No
The device is described as a filter intended to remove particulates from drug solutions prior to patient administration, not to diagnose a medical condition.
No
The device description clearly outlines physical components (female luer taper, filter assembly, nylon filter, bottom cover, male luer taper) and their mechanical function (filtering particulates). There is no mention of software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to filter particulates from drug solutions prior to patient administration. This is a physical process applied to a substance that will be introduced into the body, not a test performed on a sample taken from the body to diagnose a condition or provide information about a physiological state.
- Device Description: The description details a filter assembly designed to remove physical particles from a liquid. It does not describe any components or processes related to analyzing biological samples or detecting specific substances within those samples.
- 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 analytes (proteins, DNA, chemicals, etc.)
- Providing diagnostic information
- Mentioning any form of testing or analysis of a patient sample
The B. Braun 0.2 micron Filter is a medical device used in the preparation of medications for administration, not a diagnostic tool.
N/A
Intended Use / Indications for Use
The B. Braun 0.2 micron Filter is intended to filter particulates from drug solutions when attached to a syringe prior to patient administration.
Product codes
FMF
Device Description
The B. Braun 0.2 micron Filter consists of a female luer taper, a filter assembly which contains a 0.2 micron nylon filter, a bottom cover and a male luer taper. A syringe is intended to be attached to the female luer taper end of the filter. A drug solution may then be drawn through the filter into the syringe. The filter is then removed and the resulting filtered solution may be used for patient administration. Conversely, the syringe may be filled with a drug solution prior to attachment of the filter. The filter is intended to retain particulates when the drug solution is expelled. Currently, drug compatibility testing has been completed for use of the filter with acetylcholine chloride solutions. Use of the filter with other solutions has not been tested.
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
JAN 24 2006
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7.0 510(k) Summary
| SUBMITTER: | B. Braun Medical Inc.
901 Marcon Boulevard
Allentown, PA 18109-9341
(610) 596-2367
Contact: Christine Ford, Regulatory Affairs Specialist |
|--------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| DEVICE NAME: | B. Braun 0.2 micron filter |
| COMMON OR USUAL NAME: | 0.2 micron filter |
| DEVICE CLASSIFICATION: | Class II per Code of Federal Regulation, Title 21,
§880.5860, Piston Syringe, product code FMF . |
| PREDICATE DEVICE: | B. Braun PTFE Syringe Filter, K952918 |
| DESCRIPTION: | The B. Braun 0.2 micron Filter consists of a female luer taper, a filter assembly which contains a 0.2 micron nylon filter, a bottom cover and a male luer taper. A syringe is intended to be attached to the female luer taper end of the filter. A drug solution may then be drawn through the filter into the syringe. The filter is then removed and the resulting filtered solution may be used for patient administration. Conversely, the syringe may be filled with a drug solution prior to attachment of the filter. The filter is intended to retain particulates when the drug solution is expelled. Currently, drug compatibility testing has been completed for use of the filter with acetylcholine chloride solutions. Use of the filter with other solutions has not been tested. |
| INTENDED USE: | The B. Braun 0.2 micron Filter is intended to filter particulates from drug solutions when attached to a syringe prior to patient administration. |
| SUBSTANTIAL EQUIVALENCE: | The B. Braun 0.2 micron Filter has the same intended use, operation and function as stated for the B. Braun PTFE Syringe Filter (K952918). There are no differences that raise new issues of safety and effectiveness. |
1
Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo features a stylized eagle with three lines forming its wings and a wavy line representing water below. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JAN 2 4 2006
Ms. Christine Ford Regulatory Affairs Specialist B. Braun Medical, Incorporated 901 Marcon Boulevard Allentown, Pennsylvania 18109-9341
Re: K052773
Trade/Device Name: B. Braun 0.2 Micron Filter Regulation Number: 21 CFR 880.5860 Regulation Name: Piston Syringe Regulatory Class: II Product Code: FMF Dated: January 10, 2006 Received: January 12, 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 vour device in the Federal Register.
2
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,
Cles
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
K05277 3
2.0 Indications for Use Statement
| Page | 1 of 1 |
|---|---|
| ------ | -------- |
| 510(k) Number (if known): | |
|---|---|
| Device Name: | B. Braun 0.2 micron Filter |
Indications For Use: The B. Braun 0.2 micron Filter is intended to filter particulates from drug solutions when attached to a syringe prior to patient administration.
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
OR
Concurrence of CDRH, Office of Device Evaluation (ODE)
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