(50 days)
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.
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.
Here's an analysis of the provided text regarding the acceptance criteria and study for the device K974829:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility requirements | Device meets all biocompatibility test requirements. |
| Pyrogenicity requirements | Device meets all pyrogenicity test requirements. |
| Limulus Amebocyte Lysate ("LAL") Test (USP XXII) | Device meets the LAL test described at "(85) Bacterial Endotoxins Test", USP XXII, pp 1493-1495. |
2. Sample Size Used for the Test Set and Data Provenance
The provided text does not contain information regarding the sample size used for the test set or the data provenance (e.g., country of origin, retrospective or prospective). The document only mentions that Kawasumi Laboratories "conducted biocompatibility tests on the body fluid contacting material portions of the device."
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
The provided text does not contain information regarding the number of experts used to establish ground truth or their qualifications. The studies mentioned are laboratory tests (biocompatibility, LAL) and do not appear to involve expert-driven ground truth establishment in a clinical context.
4. Adjudication Method for the Test Set
The provided text does not contain information regarding an adjudication method. The tests described are objective laboratory tests.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted. The document focuses on demonstrating substantial equivalence to a predicate device based on material characteristics and basic safety tests, not on improving human reader performance.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Study Was Done
The device is an "Infusion Set," which is a physical medical device, not an algorithm or AI system. Therefore, a standalone algorithm study is not applicable and was not performed.
7. The Type of Ground Truth Used
The ground truth for the device's performance was established through objective laboratory tests, specifically:
- Biocompatibility tests: These typically involve in-vitro and sometimes in-vivo toxicology assessments against established ISO standards or similar guidelines.
- Pyrogenicity testing: This refers to the LAL test, which is a standardized method to detect bacterial endotoxins.
8. The Sample Size for the Training Set
The provided text does not contain information regarding a training set sample size. As the device is not an AI/ML algorithm, the concept of a "training set" is not applicable in this context.
9. How the Ground Truth for the Training Set Was Established
As the device is not an AI/ML algorithm, the concept of a "training set" and establishing ground truth for it is not applicable. The "ground truth" for the device's safety and performance was established through the aforementioned laboratory tests on the device materials.
{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)
§ 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.