(50 days)
KAWASUMI LABORATORIES PORT ACCESS INFUSION SET, PRN NONCOR PORT INFUSION SET
No
The summary describes a simple mechanical infusion set and makes no mention of AI, ML, or any related technologies.
No.
The device (infusion set) is used to deliver fluids for diagnosis or treatment, but it does not directly treat a disease; it's a delivery mechanism.
No
The device is an infusion set used to deliver fluids and medications, which can aid in diagnosis or treatment, but the device itself does not perform diagnostic functions. It's a tool for administration, not for information gathering about a patient's condition for diagnostic purposes.
No
The device description clearly states it is a "NON-PVC PORT ACCESS INFUSION SET" with physical components like a needle, tubing, and other non-PVC components, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states "INFUSION OF FLUIDS... TO AID IN THE DIAGNOSIS OR TREATMENT OF DISEASE OR OTHER CONDITIONS." This describes a device used for delivering substances into the body for therapeutic or diagnostic purposes, not for examining specimens in vitro (outside the body).
- Device Description: The description details a physical device used for accessing implanted ports and infusing fluids. This aligns with a medical device used for direct patient care, not for laboratory testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological specimens, reagents, or any other activities typically associated with in vitro diagnostics.
Therefore, this device is a medical device used for infusion, not an IVD.
N/A
Intended Use / Indications for Use
INFUSION OF FLUIDS, INCLUDING THOSE CONTAINING MEDICATIONS, FROM A CONTAINER TO A PORT IMPLANTED IN, OR OTHERWISE ATTACHED TO, A PATIENT TO AID IN THE DIAGNOSIS OR TREATMENT OF DISEASE OR OTHER CONDITIONS.
Product codes
LJT
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.
A DEVICE USED FOR ACCESSING AN IMPLANTED BASIC CONCEPT: 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
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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.
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
KAWASUMI LABORATORIES PORT ACCESS INFUSION SET, PRN NONCOR PORT INFUSION SET
Reference Device(s)
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
FEB 1 2 1998
510(K) SUMMARY
SUBMITTER 1.
U.S. AGENT:
KAWASUMI LABORATORIES, INC. 3-28-15 MINAMİ-ÖHİ SHINAGAWA-KU, TOKYO 140 JAPAN PHONE: 81-3-376-1151 81-3-376-3235 FAX: CONTACT: MR. SHUJI SUWA
KAWASUMI LABORATORIES AMERIČA, INC 5905 C HAMPTON OAKS PARKWAY TAMPA, FL 33610 PHONE: FAX CONTACT: MR. JACK PAVLO
- NAME OF DEVICE: KAWASUMI LABORATORIES NON-PVC FLUID PATH PORT ACCESS INFUSION SET (WITH AND WITHOUT INJECTION SITE)
COMMON NAME: WINGED ACCESS SET
CLASSIFICATION: UNCLASSIFIED
-
- PREDICATE DEVICES: KAWASUMI LABORATORIES PORT ACCESS INFUSION SET AND THE PRN NONCOR PORT INFUSION SET
-
- 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.
- A DEVICE USED FOR ACCESSING AN IMPLANTED BASIC CONCEPT: 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 WHEN COMPARED TO SUBSTANTIALLY EQUIVALENT DEVICES MARKETED FOR SALE IN INTERSTATE COMMERCE. BOTH DELIVER FLUIDS 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.
-
- TECHNOLOGICAL CHARACTERISTICS: NO NEW TECHNOLOGICAL CHARACTERISTICS OF THIS DEVICE EXIST WHEN COMPARED TO SUBSTANTIALLY EQUIVALENT DEVICES INCLUDING KAWASUMI AND PRN SETS BEING MARKETED FOR SALE IN INTERSTATE COMMERCE. THIS DEVICE USES A COEXTRUDED TUBE WHICH DOES NOT EXPOSE THE FLUID DELIVERED INTRAVASCULARLY TO PVC.
1
-
- 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.
- 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.
-
- 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.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized eagle with its wings spread, and the words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged in a circular pattern around the eagle. The logo is black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1998
Kawasumi Laboratories, Incorporated C/O Donald R. Stone McKenna and Cuneo, L.L.P. 1575 Eye Street, N.W.......... Washington, DC 20005
K974829 Re : Non-PVC Fluid Path Port Access Infusion Set Trade Name: with and without Injection Site Regulatory Class: Unclassified Product Code: LJT Dated: November 10, 1997 December 24, 1997 Received:
Dear Mr. Stone:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions The general controls provisions of the Act of the Act. include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts_800_to_895. A. - - - -----substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (QS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements Please note: concerning your device in the Federal Register. this response to your premarket notification submission does not affect any obligation you might have under sections 531
3
Page 2 - Mr. Stone
through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your device as described in your 510 (k) premarket notification. The FDA finding of substantial equivalence of your device to a leqally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timo Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
EXHIBIT B1.
INDICATIONS FOR USE
NON-PVC FLUID PATH PORT ACCESS INFUSION DEVICE NAME: WITH AND WITHOUT INJECTION SITE
INDICATIONS FOR USE:
INFUSION OF FLUIDS, INCLUDING THOSE CONTAINING MEDICATIONS, FROM A CONTAINER TO A PORT IMPLANTED IN, OR OTHERWISE ATTACHED TO, A PATIENT TO AID IN THE DIAGNOSIS OR TREATMENT OF DISEASE OR OTHER CONDITIONS.
Patricia Caversata
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital 510(k) Number
Prescription Use
(Per 21 CFR 801.109)