(490 days)
Not Found
No
The device description and intended use are purely mechanical, and there is no mention of AI, ML, or any related concepts.
No
The device is described as a blunt syringe cannula used to pierce pre-split rubber injection sites for medication delivery, not to treat a condition itself.
No
Explanation: The device is described as a "Blunt Syringe Cannula" used with a syringe to pierce an injection site, which is a sterile access device, not a diagnostic one. Its intended use does not involve diagnosing conditions or diseases.
No
The device description clearly states it is a "Blunt Syringe Cannula," which is a physical medical device, not 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 be used with a syringe to pierce a pre-split rubber injection site." This describes a mechanical action for accessing a medical port, not a test performed on a sample taken from the human body to provide information about a physiological state or disease.
- Device Description: The description focuses on the physical design and function of a cannula for piercing a site, not on analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any components or processes typically associated with IVDs, such as reagents, assays, sample collection, or analysis of biological markers.
Therefore, this device falls under the category of a general medical device used for drug delivery or fluid transfer, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The intended use is to be used with a syringe to pierce a pre-split rubber injection site.
Product codes (comma separated list FDA assigned to the subject device)
FMF, FMI
Device Description
B. Braun Medical Inc. intends to introduce into interstate commerce the Blunt Syringe Cannula. These have the same design and performance characteristics as the InterLink Syringe Cannnula currently marketed by Becton Dickinson and covered under K920422. It is also similar to McGaw's SafeLine System covered under K913177. The intended use is to be used with a syringe to pierce a pre-split rubber injection site.
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)
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually . required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
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
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).
0
May 20, 1997
SEP 2 5 1998
II 510 (k) Summary
B. Braun Medical, Inc 824 Twelfth Avenue Bethlehem, PA 18018 (610)691-5400
Requlatory Affairs Manager Mark S. Alsberge, CONTACT:
PRODUCT NAME: Blunt Syringe Cannula
TRADE NAME: Blunt Syringe Cannula
CLASSIFICATION NAME:
General Hospital Class II,FMF, Piston Syringe 21 CFR. 880.5860
SUBSTANTIAL EQUIVALENCE, TO:
| 510 (k) number | Name | Applicant |
|---|---|---|
| K920422 | InterLink Syringe | |
| Cannula | Becton Dickinson, Inc. | |
| K913177 | SafeLine System | McGaw, Inc. |
DEVICE DESCRIPTION:
B. Braun Medical Inc. intends to introduce into interstate commerce the Blunt Syringe Cannula. These have the same design and performance characteristics as the InterLink Syringe Cannnula currently marketed by Becton Dickinson and covered under K920422. It is also similar to McGaw's SafeLine System covered under K913177. The intended use is to be used with a syringe to pierce a pre-split rubber injection site.
- The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without
1
premarket approval or reclassification. Such a determination is not intended to be applicable to patent infringement suits or any other patent matter related to this product or the technology used to manufacture the product.
MATERIAL:
B. Braun Medical certifies that the biocompatibilty tests 'recommended in the Tripartite Guidance for this category of contact duration will be completed for all the materials used in the manufacture of the device.
SUBSTANTIAL EQUIVALENCE:
The Blunt Syringe Cannula is equivalent in materials, form, and intended use to the InterLink Syringe Cannula currently marketed by Becton Dickinson, covered under K920422. There are no new issues of safety or effectiveness raised by the Blunt Syringe Cannula.
SAFETY AND EFFECTIVENESS:
All finished products are tested and must meet all required release specifications before distribution. The array of testing required for release include, but are not limited to; sterility, pyrogenicity (endotoxin/ LAL Method), physical testing, visual examination (in process and finished product).
The physical testing is defined by Quality Control Test Procedure documents. These tests are established testing procedures and parameters which conform to the product design specifications.
The testing instruction records for each of the individually . required procedures are approved, released, distributed and revised in accordance with document control GMP"s.
2
Image /page/2/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 the left side of the image. To the right of the text is a stylized graphic of an eagle or bird-like figure, composed of three curved lines that suggest movement or flight. The words "SERVICES USA" are visible above the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 25 1998
Mr. Mark S. Alsberge Regulatory Affairs Director B. Braun Medical, Incorporated 824 12th Avenue Bethlehem, Pennsylvania 18018-0027
K971924 Re: Trade Name: Blunt Syringe Cannula Regulatory Class: II Product Code: FMI Dated: August 26, 1998 Received: Auqust 31, 1998
Dear Mr. Alsberge:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਬੈ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Page 2 - Mr. Alsberge
the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally 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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.qov/cdrh/dsmamain.html",
Sincerely yours,
Susan Rumm
tw Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
1497 924 510(k) Number (if known): annula Device Name: Indications For Use: presslit SafeLine pierce To be used with rubber in iction
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Palazzo Puccerite
(Division Sign-Off) Division of Denial. Infection Control, and General Hospital Devices
510(k) Number 4971924
Prescription Use
(Per 21 CFR 801.109)
:
OR
Over-The-Counter Use
(Optional Format 1-2-96)