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THE IV ADD-ON FILTER ADMINISTRATION SET USED TO ATTACH TO A NON FILTERED IV ADMINISTRATION SET FOR THE PURPOSE OF FILTERING SOLUTION DURING INTRAVASCULAR ADMINISTRATION. THE DEVICE MAY INCLUDE A NEELE FREE VALVE INJECTION SITE WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES.

Device Description

A STERILE, SINGLE USE ADD-ON FILTER ADMINISTRATION SET USED TO SERVE AS A CONDUIT FOR THE FILTRATION OF IV FLUID FROM A CONTAINER TO A PATIENT'S VASCULAR SYSTEM THROUGH A NEEDLE OR CATHETER INSERTED INTO A VEIN. THE DEVICE MAY INCLUDE A NEELELESS ACCESS CONECTOR WHICH ELIMINATES THE USE OF NEEDLES TO ACCESS THE SET DURING IV ADMINISTRATION AND AIDS IN THE PREVENTION OF NEELDESTICK INJURIES. THE FILTER PORE SIZE WILL BE .22 OR 1.2 MICRON WITH AN EFFECTIVE FILTRATION RATE (EFA) OF 10 CM2.

AI/ML Overview

This document is a 510(k) summary for a medical device called the "IV Add-on Filter Administration Set with and without Y Connect or Needleless Access Connector" by Kawasumi Laboratories. It is a premarket notification to the FDA to demonstrate substantial equivalence to a legally marketed predicate device.

Here's an analysis of the provided information regarding acceptance criteria and supporting studies:

1. Table of Acceptance Criteria and Reported Device Performance

Acceptance Criteria	Reported Device Performance
Biocompatibility: Device materials in contact with body fluids must be suitable for intended use.	Kawasumi Laboratories conducted biocompatibility tests on body fluid contacting material portions of the device. The conclusion states: "THE DEVICE MEETS ALL BIOCOMPATIBILITY AND PYROGENICITY TEST REQUIREMENTS."
Pyrogenicity: Device must be non-pyrogenic.	The conclusion states: "THE DEVICE MEETS ALL BIOCOMPATIBILITY AND PYROGENICITY TEST REQUIREMENTS."
Filtration Effectiveness: Filter pore size of .22 or 1.2 micron with an Effective Filtration Rate (EFA) of 10 CM2, capable of filtering out particles larger than the specified pore size in IV solution.	The device's description states it has a filter pore size of .22 or 1.2 micron with an EFA of 10 CM². The significant performance characteristics state: "Both devices filter out particles in an IV line administering a solution when those particles are larger than the...22 micron or 1.2 micron pore size of the specific filter chosen." This indicates the new device performs similarly to the predicate device in filtration.
Safety and Performance (Substantial Equivalence): As safe as the predicate device and performs as well as the predicate device.	The conclusion states: "Therefore, it is as safe as the predicate device and performs as well as the predicate device." The FDA's letter confirms substantial equivalence to legally marketed predicate devices.

2. Sample Size Used for the Test Set and Data Provenance

Sample Size: The document does not specify a distinct "test set" sample size for the biocompatibility or pyrogenicity tests. It generically states that tests were "conducted on the body fluid contacting material portions of the device."
Data Provenance: Not explicitly stated. However, given that Kawasumi Laboratories is based in Japan (with a US office), the testing could have been conducted in Japan or by a contract lab. The document does not specify if the data is retrospective or prospective, but testing for a new device would typically involve prospective data generation.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and Their Qualifications

This information is not provided in the document. The tests performed (biocompatibility, pyrogenicity, and filtration effectiveness) are laboratory-based and typically follow standardized protocols. Expert "ground truth" establishment in the sense of clinical interpretation (e.g., by radiologists) is not applicable to the type of device and performance characteristics being evaluated here.

4. Adjudication Method for the Test Set

Not applicable. The tests performed are objective laboratory measurements (e.g., chemical analysis for biocompatibility, sterility/endotoxin testing for pyrogenicity, physical measurements for filtration). There is no "adjudication method" in the context of human interpretation of a test set.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done

No, an MRMC comparative effectiveness study was not done. This type of study (comparing human readers' performance with and without AI assistance) is relevant for diagnostic imaging devices or other software that aids human interpretation. This document is for an IV administration set with a filter, which is a physical medical device, not a diagnostic AI system.

6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done

No, a standalone performance study was not done. This concept is also applicable to AI algorithms. This device is a physical filter, not an algorithm.

7. The Type of Ground Truth Used

The "ground truth" used for this device's evaluation is based on standardized laboratory test results for biocompatibility, pyrogenicity, and physical performance characteristics (filtration efficiency, pore size).
- For biocompatibility: Adherence to relevant biocompatibility standards (e.g., ISO 10993 series).
- For pyrogenicity: Absence of pyrogens as per Pharmacopoeial standards.
- For filtration: Physical testing to confirm pore size and effective filtration area and its ability to remove particles.

8. The Sample Size for the Training Set

Not applicable. This device is a physical medical device. It does not use Machine Learning or AI, and therefore does not have a "training set" in the computational sense. The testing performed is to demonstrate the physical and chemical properties of the device.

9. How the Ground Truth for the Training Set Was Established

Not applicable. As stated above, there is no training set for this device.

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