FDA 510(k) Search - By Innolitics (SaMD and AI Experts)

The K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector intended use is for the access of peripheral veins for blood collection. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.

The K-Shield Small Vein Infusion Set with Antineedle Stick Protector intended use is for the access of peripheral veins for solution infusion. The antineedle stick protector is an integral, active safety device intended to minimize accidental needle stick injuries when used to shield the needle.

Device Description

The K-Shield Small Vein Infusion Set with Antineedle Stick Protector and the K-Shield Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector are sterile, single use devices commonly used to access a patient's veins for blood collection or solution infusion. Both devices are comprised of a needle and wing assembly with tubing and a female luer connector. The Multisample Luer Connector is used to transfer blood from the Winged Collection Set to a vacuum tube. Both devices incorporate an integral antineedle stick protector used to prevent accidental needlestick injuries.

AI/ML Overview

The provided document details a 510(k) premarket notification for a medical device (Kawasumi Laboratories Small Vein Infusion Set with Antineedle Stick Protector and Winged Collection Set with Multisample Luer Adapter and Antineedle Stick Protector). This is for a device modification summary, not an AI/ML device, and therefore the provided document does not contain information typically associated with AI/ML model evaluations such as:

Acceptance criteria and reported device performance in terms of AI metrics (e.g., sensitivity, specificity, accuracy).
Sample sizes for test sets in an AI context (e.g., number of images, patient cases).
Data provenance for AI/ML training/test sets.
Number and qualifications of experts for ground truth establishment for AI/ML.
Adjudication methods for AI/ML ground truth.
Multi-reader multi-case (MRMC) comparative effectiveness studies for AI.
Standalone performance for an AI algorithm.
Type of ground truth (beyond product testing results).
Training set sample size for an AI model.
How ground truth for a training set was established for an AI model.

Instead, the document focuses on the mechanical and functional performance of a medical device (a winged collection set and small vein infusion set with an antineedle stick protector) and its substantial equivalence to predicate devices.

Based on the provided text, here is an analysis of the acceptance criteria and study for this physical medical device:

1. Table of Acceptance Criteria and Reported Device Performance

Test	Acceptance Criteria (Implied)	Reported Device Performance
Kawasumi Internal Test: Wing Activation	Pass	PASS
Kawasumi Internal Test: Wing Deactivation	Pass	PASS
Kawasumi Internal Test: Defeat Locking Mechanism	Pass	PASS
Simulated Use Study: Prevention of Needle Sticks	No needle sticks occurred	No needle sticks occurred
Simulated Use Study: User Feedback	No problems indicated	No problems indicated

Note: The document implicitly defines "PASS" as meeting the acceptance criteria for the internal tests. For the simulated use study, the stated "successful" outcome and specific results serve as the performance and meet the implied acceptance criteria.

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

Test Set: Not explicitly stated as a numerical sample size. The "simulated clinical observations" involved a "simulated use study," but the number of participants or simulated uses is not provided.
Data Provenance: The tests were "Kawasumi Internal Test" and "Simulated Clinical Observations" conducted by Kawasumi Laboratories, indicating an internal, prospective study environment for the modification assessment. The country of origin for the data is Japan (Kawasumi Laboratories, Inc. is based in Tokyo) for the internal tests, and potentially the US for the simulated use study (Kawasumi Laboratories America, Inc. is in Tampa, FL), though this is not explicitly stated.

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

There were no "experts" in the sense of medical professionals establishing a diagnostic ground truth for an AI/ML model. The "ground truth" here is the physical performance and safety features of the device, assessed through internal engineering tests and a simulated use study. The "ground truth" was established by the test results themselves as outlined in the table above.

4. Adjudication Method for the Test Set

Not applicable as this is not an AI/ML model evaluation requiring expert consensus or adjudication. The internal tests have objective Pass/Fail criteria, and the simulated use study collected observations directly.

5. 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

Not applicable. This is not an AI/ML device. The study involves a physical medical device and its safety features.

6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is not an AI/ML algorithm.

7. The Type of Ground Truth Used

The ground truth used was based on:

Objective measurements and outcomes from internal engineering tests (e.g., verifying wing activation, deactivation, and defeat locking mechanism).
Direct observation of events during a simulated clinical use study (e.g., absence of needle sticks).
User feedback collected via questionnaires during the simulated use study.

8. The Sample Size for the Training Set

Not applicable. This is not an AI/ML device, so there is no "training set." The device was modified and then tested.

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

Not applicable, as there is no training set for an AI/ML model. The "ground truth" for the device's design and intended function was established through engineering specifications, previous predicate device performance, and the modifications made.

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K Number

K030385

Device Name

IV ADD-ON FILTER ADMINISTRATION SET WITH AND WITHOUT Y CONNECT OR NEEDLELESS ACCESS CONNECTOR

Manufacturer

KAWASUMI LABORATORIES AMERICA, INC.

Date Cleared

2003-04-15

(69 days)

Product Code

Regulation Number

Type

Panel

Reference & Predicate Devices

N/A

Intended Use

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