(88 days)
JMS Needle is intended to be used for infusion of drug, collecting solution or blood. Insert the Needle to patient's body and use it as a fluid pathway which connects inside and outside of the body. JMS Syringe is intended to be used for infusion of solution or collecting blood connecting JMS Needle. It is also used for continuous drug infusion put in Syringe Pump. JMS Needle and JMS Syringe must be discarded after one time use.
Not Found
This document is an FDA 510(k) clearance letter for the JMS Needle and JMS Syringe. It states that the devices are substantially equivalent to previously marketed devices. However, this document does not contain any information about acceptance criteria or a study proving the device meets acceptance criteria.
Therefore, I cannot provide the requested information. The document primarily focuses on regulatory approval based on substantial equivalence, not on performance studies with specific acceptance criteria.
{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 stylized eagle or bird symbol, with three curved lines representing the bird's body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the bird symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 31 1999
Mr. Keisuke Uratomi Corporate Quality Assurance and Regulatory Affairs JMS Co., LTD 12-17 Kako-Machi, Naka-Ku Hiroshima 730 JAPAN
Re : K991904 Modification of JMS Needles and JMS Syringes Trade Name: Requlatory Class: II Product Code: FMI Dated: June 1, 1999 Received: June 4, 1999
Dear Mr. Uratomi:
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 Good Manufacturing Practice for Medical Devices: General (GMP) requlation (21 CFR Part 820) and that, through periodic GMP inspections, the Food and Drug Administration (FDA) will Verify such assumptions. Failure to comply with the GMP requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register.
{1}------------------------------------------------
Page 2 - Mr. Uratomi
this response to your premarket notification Please note: ricuse note. Chiro 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.
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 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4692. 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 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 (301) 443-6597 or at its internet address "http://www.fda.gov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
{2}------------------------------------------------
INDICATION FOR USE
510(k) Number (if known) : 长991904
Device Name : JMS Needle and JMS Syringe
Indication for Use : JMS Needle is intended to be used for infusion of drug, collecting solution or blood. Insert the Needle to patient's body and use it as a fluid pathway which connects inside and outside of the body. JMS Syringe is intended to be used for infusion of solution or collecting blood connecting JMS Needle. It is also used for continuous drug infusion put in Syringe Pump.
JMS Needle and JMS Syringe must be discarded after one time use.
Patricia Cuccereto
((Jivision Sign-Off) Division Orgh-Off)
Division of Dental, Infection Control,
and General Hospital, Devisor and Control, and General Hospital Infection 510(k) Number -
(PLEASE NOT WRITE THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED.)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use _
or
Over - The - Counter Use_
(Per 21 CFR 801.109)
(Optional Format 1-2-96
§ 880.5570 Hypodermic single lumen needle.
(a)
Identification. A hypodermic single lumen needle is a device intended to inject fluids into, or withdraw fluids from, parts of the body below the surface of the skin. The device consists of a metal tube that is sharpened at one end and at the other end joined to a female connector (hub) designed to mate with a male connector (nozzle) of a piston syringe or an intravascular administration set.(b)
Classification. Class II (performance standards).