(122 days)
There are no K/DEN numbers listed in the "Predicate Device(s)" section of the provided text.
Not Found
No
The device description and other sections do not mention any AI or ML capabilities. The device is a simple mechanical component for IV administration.
No.
The device facilitates the administration of solutions and drugs, but it does not directly treat or diagnose a disease or condition. It is an accessory to the intravenous administration process.
No
This device is an I.V. extension line assembly used to facilitate the administration of solutions and drugs, not to diagnose medical conditions.
No
The device description clearly describes a physical medical device (I.V. Extension Line Assembly with Stopcock) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to facilitate the administration of intravenous fluids and drugs to a patient. This is a direct interaction with the patient's circulatory system for therapeutic purposes.
- Device Description: The description details a physical device used to connect to an IV supply and a patient, providing length and additional ports for fluid administration. It does not describe any components or processes for analyzing biological samples in vitro (outside the body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in biological samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions based on sample analysis.
The device is clearly intended for direct patient care and the delivery of substances into the body, which falls under the category of medical devices used for treatment or administration, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
Not Found
Product codes
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Device Description
The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are adminstered intraveneously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet.
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
This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the logo for BIOMEDIX inc. The logo is in black and white and features the company name in a bold, sans-serif font. Below the company name is the tagline "quality medical products" in a smaller font. The logo is simple and professional, and it conveys the company's focus on quality medical products.
EP 16 1698
| TO: | Food and Drug Administration
Center for Devices and Radiological Health ( HFZ-401 )
9200 Corporate Blvd.
Rockville, MD 20850 |
|----------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| FROM: | Daniel J. Dyar, President |
| DATE: | May 17, 1996 (Revised June 11, 1996) |
| SUBJECT: | 510 K Summary |
| TRADE NAME: | I.V. Extension with Stopcock. |
| COMMON NAME: | I.V. Extension |
| CLASSIFICATION NAME: | [ 880.5440 ] Intravascular Administration Set |
SUBSTANTIALLY EQUIVALENT TO:
Biomedix, Inc. claims substantial equivalence regarding this design of the I.V. Extension Line Assembly with Stopcock as follows:
Products currently on the market include:
Baxter PHARMASEAL K52 NOVEX Three-Way Stopcock with Extension Tube. ( Sterile, For Single Use Only, Capacity 2.3 mL, Length 50.8 cm. Blue Protector covers Male Adapter. )
Medex Extension Set - 12" Extension with"Y" Injection Site.
McGaw - G0719 I.V. Extension Set, Female and Needle Adapter, Vol. 3 mL., Length 21" G0726 I.V. Extension Set with (2) Injection Sites, Vol. 6 mL., Length 33" G0716 I.V. Extension Set with (2) Injection Sites with check valve and flashtube., Vol. 6 mL., Length 34" PAGE 15
1
510 K SUMMARY ( CONTINUED )
| COMPONENT | BIOMEDIX | BAXTER K52 | MEDEX
EXTENSION SET |
|-------------|-----------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------|---------------------------------------|
| Stopcock | All 3 ports include
both threaded and /
or slip luer
connections. | ( 1 ) Port has
removeable needle
injection site. ( 2 )
remaining ports have
slip luer conn. only. | ( 1 ) Y - Port for
Sharps Devices. |
| Capacity | 3.75 ml. | 2.3 ml. | N/A |
| Tubing | .114 +/- .002" I.D. | .088-.090" I.D. | N/A |
| Connections | Choice of Needle or
Blunt Cannula Y-
Site with Male Slip
Luer Connector. | Male Slip Luer
Connector Only. | Male Slip Luer
Connector Only. |
DESIGN COMPARISONS:
The Biomedix design allows injection of solutions directly at the Patient I.V. Catheter. A slip-type clamp on the tubing portion of the I.V. Extension Line allows the line to be shutoff preventing backflow and/or dilution of administered fluids away from the patient.
DESCRIPTION:
The I.V. Extension Line Assembly with Stopcock is attached to the Primary I.V. to facilitate two advantages. One, is to add extra length between the I.V. Supply and the Patient. A second, is to provide additional supply ports for the administration of alternate solutions and special drugs that are adminstered intraveneously. A four-way stopcock offers selection of the fluid types and sources. Biomedix is offering two models, one with a standard Needle-Type Injection Site at the Outlet and a second with a Blunt Cannula (Needleless) Type Injection Site at the outlet.
INTENDED USE: This product would be used by Nurses and Paramedics in prehospital, emergency room and field situations.
2
510 K SUMMARY ( CONTINUED )
SUMMARY OF DEVICE COMPARISONS:
Basic constuction of both Biomedix and Competitive Products of this type are of commercially available components. Biomedix already employs a process and construction similiar to this in their existing Selec-3 Primary I.V. Set.
Sincerely,
David J. Barron
Daniel J. Dyar President Biomedix, Inc.
PAGE 16a