(416 days)
The multiple-lumen catheter permits venous access to the central circulation. The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.
Quad-Lumen Central Venous Catheter
I am sorry, but the provided text is a 510(k) clearance letter from the FDA for a medical device (ARROWgard Blue™ Quad-Lumen Central Venous Catheter). This document does not contain information about acceptance criteria, device performance, results of a study, sample sizes, expert qualifications, or ground truth establishment.
Therefore, I cannot fulfill your request for the specific information regarding a study and acceptance criteria based on this input. It primarily deals with the regulatory clearance process and substantial equivalence, not the detailed technical and clinical validation study results.
{0}------------------------------------------------
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" arranged around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas D. Nickel Vice President, Regulatory Affairs and Quality Assurance Arrow International, Incorporated 3000 Bernville Road Reading, Pennsylvania 19605
AUG 21 1997
K962577 Re : ARROWgard Blue™ Quad-Lumen Central Venous Trade Name: Catheter Requlatory Class: II Product Code: FOZ September 24, 1996 Dated: Received: September 30, 1996
Dear Mr. Nickel:
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 (the Act). You may, therefore, market the device, subject to the general controls provisions However, you are responsible to determine that the of Act. medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were on the market prior to May 28, 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unfinished) and further process (e.g., sterilize) you must submit a new 510(k) before including these components in your kit. The general controls provisions 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 additional controls. Existing major regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Good
{1}------------------------------------------------
Page 2 - Mr. Nickel
Manufacturing Practice for Medical Devices: General (GMP) regulation (21 CFR Part 820) and that, through periodic GMP inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in .... the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
FDA notes that your device will contain sutures for which you have provided evidence that the suture characteristics are not altered by the sterilization process used for the device. However, you should be aware of the following additional information regarding the inclusion of a suture as a component of your device:
- The labeling, packaging and method of sterilization of 1. the suture cannot be changed without prior notification, review and clearance by FDA.
- The supplier of the sutures used in your device cannot be 2. changed without prior notification, review and clearance by FDA.
In addition, we have determined that your device kit contains the following components which are subject to regulation as drugs :
- Povidone-Iodine swabsticks, 1.
- Povidone-Iodine ointment, 1 qm., and 2.
- Lidocaine hydrochloride, 5 ml., 1%, ampule. 3.
Our substantially equivalent determination does not apply to the drug components of your device. We recommend you first contact the Center for Drug Evaluation and Research before marketing your device with the drug components. For information on applicable Agency requirements for marketing these drugs, we suggest you contact:
Director, Division of Drug Labeling Compliance (HFD-310) Center for Drug Evaluation and Research Food and Druq Administration 5600 Fishers Lane Rockville, Maryland 20857 (301) 594-0063
{2}------------------------------------------------
Page 3 - Mr. Nickel
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 legally 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 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4639. 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 requlation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). 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 at (301) 443-6597.
Sincerely yours,
Timothy A. Ulatowski
Timot A. Ulatowski Acting Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{3}------------------------------------------------
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Quad-Lumen Central Venous Catheter Device Name:__________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The multiple-lumen catheter permits venous access to the central circulation.
The Arrow antiseptic surface catheter is intended to help provide protection against catheter related infections. The catheter is not intended to be used as a treatment for existing infections nor is it indicated for longterm use.
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off) Division of Dental, Infection Contr and General Hospital Devices
510(k) Number _K962577
'rescription Use r 21 CFR 801.109)
OR
Over-The-Counter Use
(Opuonal Formal 1-2-96)
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(b)
Classification. Class II (performance standards).