What is the FDA product code for NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE?

LJT. It is classified under 21 CFR 880.5965 as a Class 2 device in the General Hospital panel.

What is the regulatory pathway for NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE?

510(k) clearance (submission type: Traditional).

What are the predicate devices for NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE?

Kawasumi Laboratories Port Access Infusion Set; Baxter Health Care Interlink Slit Septum Injection Site.

Who can help prepare an FDA 510(k) submission like NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE?

Innolitics — a medical-device software consultancy — provides regulatory and engineering support for FDA 510(k) submissions. See https://innolitics.com/services/510ks/ or contact https://innolitics.com/contact.

NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE

Q: Who is the manufacturer of NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE?

Kawasumi Laboratories Co., Ltd. filed the 510(k) submission for NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE (K964117).

K964117 · Kawasumi Laboratories Co., Ltd. · LJT · Mar 14, 1997 · General Hospital

Device Facts

Record ID	K964117
Device Name	NON-PVC FLUID PATH PORT ACCESS INFUSION SET WITH SLIT SEPTUM INJECTION SITE
Applicant	Kawasumi Laboratories Co., Ltd.
Product Code	LJT · General Hospital
Decision Date	Mar 14, 1997
Decision	SESE
Submission Type	Traditional
Regulation	21 CFR 880.5965
Device Class	Class 2
Attributes	Therapeutic

Intended Use

THE NON-PVC PORT ACCESS INFUSION SET IS ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS.

Device Story

Sterile, single-use winged access set; consists of needle, wings, and non-PVC tubing. Used by clinicians in hospital settings to access implanted medication ports. Device punctures port septum to establish fluid path for medication delivery. Coextruded tubing prevents fluid contact with PVC. Benefits include non-reactive fluid path for safe medication administration.

Clinical Evidence

Bench testing only. Biocompatibility testing performed on body fluid-contacting materials. Device meets USP XXII Bacterial Endotoxins Test (LAL) requirements.

Technological Characteristics

Non-PVC coextruded tubing; winged needle assembly; sterile, single-use. Materials are non-reactive. No electronic or software components.

Indications for Use

Indicated for patients requiring access to implanted medication ports for the delivery of medications, including chemotherapy, in hospital settings.

Regulatory Classification

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.

Special Controls

*Classification.* Class II (special controls) Guidance Document: “Guidance on 510(k) Submissions for Implanted Infusion Ports,” FDA October 1990.

Predicate Devices

Kawasumi Laboratories Port Access Infusion Set
Baxter Health Care Interlink Slit Septum Injection Site

Related Devices

K974829 — NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SET) · Kawasumi Laboratories Co., Ltd. · Feb 12, 1998
K060580 — K-SHIELD PORT ACCESS INFUSION SET · Kawasumi Laboratories, Inc. · Jun 6, 2006
K972712 — CORE RESISTANT HUBER INFUSION SETS · Icu Medical, Inc. · Oct 1, 1997
K170881 — ISP Safety Huber Needle Infusion Set · Infusion Safety Products, Inc. · Dec 14, 2017
K990693 — FLEXNEEDLE PLUS · Act Medical, Inc. · May 14, 1999

Submission Summary (Full Text)

{0} K 96 4/17 # MAR 14 1997 510(K) SUMMARY ## 1. SUBMITTER KAWASUMI LABORATORIES, INC. 3-28-15 MINAMI-OH SHINAGAWA-KU, TOKYO 140 JAPAN PHONE: 81-3-376-1151 FAX: 81-3-376-3235 CONTACT: MR. SHOZO MORIYAMA U.S. AGENT: 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 ## 2. 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 ## 3. PREDICATE DEVICE: KAWASUMI LABORATORIES PORT ACCESS INFUSION SET AND BAXTER HEALTH CARE'S "INTERLINK" SLIT SEPTUM INJECTION SITE. ## 4. 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. ## 5. INTENDED USE: THE NON-PVC PORT ACCESS INFUSION SET IS ROUTINELY USED TO ACCESS IMPLANTED MEDICATION PORTS FOR THE DELIVERY OF MEDICATIONS. ## 6. 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. 9 {1} 7. PERFORMANCE DATA: KAWASUMI LABORATORIES HAS CONDUCTED 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. 8. 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.