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K Number
K964117
Device Name
NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
Manufacturer
KAWASUMI LABORATORIES CO., LTD.
Date Cleared
1997-03-14

(150 days)

Product Code
LJT
Regulation Number
880.5965
Type
Traditional
Panel
General Hospital
Reference & Predicate Devices
N/A
Predicate For
N/A
AI/MLSaMDIVD (In Vitro Diagnostic)TherapeuticDiagnosticis PCCP AuthorizedThirdpartyExpeditedreview
Intended Use

ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.

Device Description

A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.

AI/ML Overview

The provided text does not contain information about acceptance criteria and a study proving a device meets them in the context of AI/ML performance evaluation. The document describes a medical device (KAWASUMI LABORATORIES NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE) and its performance data relates to biocompatibility and pyrogenicity tests, not AI/ML model performance.

Therefore, I cannot populate the table or answer the questions related to AI/ML study design, sample sizes, expert ground truth, or adjudication methods based on the provided text.

The only relevant information that can be extracted is about the performance data for the described medical device:

Acceptance Criteria and Device Performance (Biocompatibility/Pyrogenicity)

Acceptance CriteriaReported Device Performance
Biocompatibility Tests (on body fluid contacting material portions)Device is suitable for its intended use.
Limulus Amebocyte Lysate ("LAL") Test (described at "(85) BACTERIAL ENDOTOXINS TEST", USP XXII, PP 1493-1495)The device meets the LAL test.

The text explicitly states: "The device meets all biocompatibility and pyrogenicity test requirements."

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K 964117

MAR

  1. SUBMITTER

U.S. AGENT:

KAWASUMI LABORATORIES, INC. 3-28-15 MINAMI-OHI SHINAGAWA-KU, TOKYO 140 JAPAN PHONE: 81-3-376-1151 81-3-376-3235 FAX: CONTACT: MR. SHOZO MORIYAMA

KAWASUMI LABORATORIES AMERICA, INC 5100 W. KENNEDY BLVD., SUITE 455 TAMPA, FL 33609 PHONE: (813) 282-3733 FAX: (813) 282-3544 CONTACT: MR. JACK PAVLO

  1. NAME OF DEVICE: KAWASUMI LABORATORIES NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE

COMMON NAME: WINGED ACCESS SET

CLASSIFICATION: UNCLASSIFIED

    1. PREDICATE DEVICE: KAWASUMI LABORATORIES PORT ACCESS INFUSION SET AND BAXTER HEALTH CARE'S "INTERLINK" SLIT SEPTUM INJECTION SITE.
    1. DESCRIPTION OF THE DEVICE: A NON-PVC PORT ACCESS INFUSION SET IS A STERILE, SINGLE USE DEVICE WITH A NEEDLE, WING, NON-PVC I.D. TUBING AND NON-PVC COMPONENTS USED FOR ACCESSING IMPLANTED MEDICATION PORTS.
    • BASIC CONCEPT: A DEVICE USED FOR ACCESSING AN IMPLANTED MEDICATION PORT BY PUNCTURING THE SEPTUM OF THE MEDICATION PORT USED FOR THE DELIVERY OF MEDICATION. FLUID ADMINISTRATION THROUGH THE NON-PVC FLUID PATH PORT ACCESS INFUSION SET ARE THOSE GENERALLY USED IN HOSPITALS AND FOR CHEMOTHERAPY.
    • SIGNIFICANT PERFORMANCE CHARACTERISTICS: THERE ARE NO NEW PERFORMANCE CHARACTERISTICS OF THIS DEVICE COMPARED TO SUBSTANTIALLY EQUIVALENT DEVICES MARKETED FOR SALE IN INTERSTATE COMMERCE. BOTH DELIVER FLUID TO THE VASCULAR SYSTEM THROUGH A NON-REACTIVE MATERIAL.
  • THE NON-PVC PORT ACCESS INFUSION SET IS 5. INTENDED USE: ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.
    1. TECHNOLOGICAL CHARACTERISTICS: THERE ARE NO TECHNOLOGICAL CHARACTERISTICS OF THIS DEVICE TO SUBSTANTIALLY EQUIVALENT DEVICES INCLUDING KAWASUMI AND BAXTER SETS BEING MARKETED FOR SALE IN INTERSTATE COMMERCE. THIS DEVICE USES A COEXTRUDED TUBE WHICH DOES NOT EXPOSE THE FLUID DELIVERED INTRAVASCULARY TO PVC.

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KAWASUMI LABORATORIES HAS CONDUCTED 7. PERFORMANCE DATA: BIOCOMPATIBILITY TESTS ON THE BODY FLUID CONTACTING MATERIAL PORTIONS OF THE DEVICE, AND KL BELIEVES THE BIOCOMPATIBILITY DATA SHOW THE DEVICE IS SUITABLE FOR ITS INTENDED USE.

THE DEVICE MEETS THE LIMULUS AMEBOCYTE LYSATE ("LAL") TEST DESCRIBED AT "(85) BACTERIAL ENDOTOXINS TEST", USP XXII, PP 1493-1495.

    1. CONCLUSIONS: THE DEVICE MEETS ALL BIOCOMPATIBILITY AND PYROGENICITY TEST REQUIREMENTS. THEREFORE, IT IS AS SAFE AS THE PREDICATE DEVICE AND PERFORMS AS WELL AS THE PREDICATE DEVICE.

§ 880.5965 Subcutaneous, implanted, intravascular infusion port and catheter.

(a)
Identification. A subcutaneous, implanted, intravascular infusion port and catheter is a device that consists of a subcutaneous, implanted reservoir that connects to a long-term intravascular catheter. The device allows for repeated access to the vascular system for the infusion of fluids and medications and the sampling of blood. The device consists of a portal body with a resealable septum and outlet made of metal, plastic, or combination of these materials and a long-term intravascular catheter is either preattached to the port or attached to the port at the time of device placement. The device is available in various profiles and sizes and can be of a single or multiple lumen design.(b)
Classification. Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.