(160 days)
Not Found
No
The device description and lack of mentions of AI/ML, image processing, or performance studies related to algorithmic analysis strongly suggest this is a mechanical medical device without AI/ML components.
No
Explanation: A therapeutic device is used to treat or prevent disease. The V2 Injection Site is designed to provide needle-free access for IVs and extension sets, which is a functional accessory for medical procedures, not a treatment in itself.
No
Explanation: The device, the V2 Injection Site, is described as providing needle-free access on I.V. and Extension Sets. Its function is to facilitate drug delivery or fluid administration, not to diagnose a disease or condition.
No
The device description clearly describes a physical medical device (injection site) and makes no mention of software as a component or the primary function.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The text explicitly states "Not Found" for this section, which is a key indicator for IVD devices. IVDs have specific intended uses related to diagnosing diseases or conditions.
- Device Description: The description clearly states the device is an "Injection Site" designed for "needle-free access on I.V. and Extension Sets." This describes a device used for administering fluids or medications intravenously, not for testing biological samples in vitro.
- Lack of IVD-related information: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting specific analytes (proteins, DNA, antibodies, etc.)
- Providing diagnostic information
The device described is an accessory for intravenous fluid administration, which falls under a different regulatory category than IVDs.
N/A
Intended Use / Indications for Use
Not Found
Product codes
FPA
Device Description
In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the V2 Injection Site. The V2 Injection Site is designed to provide needle-free access on I.V. and Extension Sets as an alternative to latex injection sites or other needle-free access systems. It may be accessed with standard male luer connectors and requires no special accessory devices.
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
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
II 510(k) Summary of Safety and Effectiveness in Accordance with SMDA'90
B. Braun Medical, Inc November 21, 1995 824 Twelfth Avenue Bethlehem, PA 18018 (610) 691-5400
1 1 5 1 5 1
CONTACT: Mark S. Alsberge, Regulatory Affairs Manager
PRODUCT NAME: V2 Injection Site
Intravascular Administration Set TRADE NAME:
CLASSIFICATION NAME:
General Hospital Class II, 80 FPA, Intravascular Administration Set 21 CFR -880.5860
SUBSTANTIAL EQUIVALENCE' TO:
| 510(k) number | Name | Applicant |
|---|---|---|
| K942988 | Filtered Extension | |
| Sets | B. Braun of America |
DEVICE DESCRIPTION:
In accordance with section 510 (k) for the Federal Food, Drug, and Cosmetic Act, B. Braun Medical, Inc. intends to introduce into interstate commerce the V2 Injection Site. The V2 Injection Site is designed to provide needle-free access on I.V. and Extension Sets as an alternative to latex injection sites or other needle-free access systems. It may be accessed with standard male luer connectors and requires no special accessory devices.
The term "substantially equivalent" as use herein is intended to be a determination of substantial equivalence from an FDA -regulatory point of view under the Federal Food, Drug, and Cosmetic Act and relates to the fact that the product can be marketed without premarket approval or reclassification. These products may be considered distinct from a patent point of view. The term "substantially equivalent" is not applicable to and does not diminish any patent claims related to this product or the technology used to manufacture the product.
1
MATERIAL:
The V2 Injection Site is composed of materials that have been tested in accordance with Tripartite Guidance for Plastics and determined to be suitable for the intended use of this product.
SUBSTANTIAL EQUIVALENCE:
The V2 Injection Site is equivalent in materials, form, and intended use to Filtered Extension Sets currently marketed by B. Braun of America. There are no new issues of safety or effectiveness raised by the V2 Injection Site.
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: 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.