(150 days)
KAWASUMI LABORATORIES PORT ACCESS INFUSION SET AND BAXTER HEALTH CARE'S "INTERLINK" SLIT SEPTUM INJECTION SITE.
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No
The summary describes a standard medical device for accessing implanted ports and does not mention any AI or ML components or functionalities.
No
This device is an infusion set used to access implanted medication ports for drug delivery, acting as a conduit rather than providing direct therapeutic action itself.
No
Explanation: The device is described as "ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS," indicating its function is for medication delivery, not diagnosis. There is no mention of it being used to identify or analyze a medical condition.
No
The device description clearly states it is a "NON-PVC PORT ACCESS INFUSION SET" with physical components like a needle, wing, and tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS." This describes a device used for administering substances into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description details a physical device with a needle, tubing, and components for accessing ports. This aligns with a medical device used for infusion, not a diagnostic test.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to perform tests on samples taken from the human body to provide information for diagnosis, monitoring, or screening. This device's function is purely for delivering medication.
N/A
Intended Use / Indications for Use
ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.
Product codes
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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.
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.
Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
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Intended User / Care Setting
HOSPITALS
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
KAWASUMI LABORATORIES PORT ACCESS INFUSION SET AND BAXTER HEALTH CARE'S "INTERLINK" SLIT SEPTUM INJECTION SITE.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
K 964117
MAR
- 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
- 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
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- PREDICATE DEVICE: KAWASUMI LABORATORIES PORT ACCESS INFUSION SET AND BAXTER HEALTH CARE'S "INTERLINK" SLIT SEPTUM INJECTION SITE.
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- 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.
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- 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.
1
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.
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- 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.