(160 days)
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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.
This document is a 510(k) summary for a medical device called the "V2 Injection Site." It aims to demonstrate substantial equivalence to a previously cleared device. However, the provided text does not contain the detailed information necessary to answer the questions about acceptance criteria and a study proving the device meets those criteria.
Here's why and what information is missing for each point:
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A table of acceptance criteria and the reported device performance:
- Missing: The document states "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)." However, it does not list the specific acceptance criteria (e.g., tensile strength values, leak rates, flow rates, visual defect limits) or the actual performance results of the V2 Injection Site against these criteria.
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Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
- Missing: The document mentions "physical testing" and "visual examination" but provides no details about the sample sizes used for these tests, the methodology (e.g., how many units were tested), or the data provenance.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience):
- Missing: This information is completely absent. The device is an "Intravascular Administration Set" component, not an imaging or diagnostic device that typically relies on expert interpretation for ground truth. Its testing would likely involve engineering and materials experts for performance metrics, not clinical experts establishing a "ground truth" in the diagnostic sense.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set:
- Missing: This is not relevant for the type of device and testing described. Adjudication methods are typically used when there's subjective assessment involved (e.g., radiologists reviewing images) to resolve disagreements. Device performance tests for an injection site would be objective measurements.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance:
- Missing: This device is not an AI-powered diagnostic tool, so an MRMC study is not applicable.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
- Missing: This is not an algorithm-based device. Performance would be assessed through physical and material tests, not algorithm performance.
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The type of ground truth used (expert concensus, pathology, outcomes data, etc):
- Missing: For this device, "ground truth" would likely be defined by engineering specifications and material standards (e.g., ISO, ASTM standards, internal design specifications for dimensions, material properties, sterility, flow rates, leak integrity). The document refers to "Quality Control Test Procedure documents" and "product design specifications," which would define this "ground truth" against which physical tests are measured.
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The sample size for the training set:
- Missing: This device does not use a "training set" in the context of machine learning. Its design and manufacturing are based on established engineering principles and materials science.
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How the ground truth for the training set was established:
- Missing: This is not applicable, as there is no training set for this type of device.
In summary, the provided text is a regulatory summary focused on demonstrating "substantial equivalence" of a new device (V2 Injection Site) to an existing one, primarily based on materials, form, and intended use. It describes the intent to perform testing and adherence to general quality control principles but lacks the specific data, acceptance criteria, methodologies, and clinical study details that would be required to answer the requested questions.
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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
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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 ExtensionSets | 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.
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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.
§ 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.