(88 days)
Not Found
None
No
The summary describes a basic medical device (needle and syringe) with no mention of AI/ML, image processing, or data analysis capabilities.
No
The device is described as being used for the "infusion of drug, collecting solution or blood" and acts as a "fluid pathway." While drugs can be therapeutic, the device itself is a delivery mechanism and not a therapeutic agent.
No
Explanation: The device description states its purpose is for infusion of drugs, collecting solutions or blood, and for continuous drug infusion, serving as a fluid pathway. These are therapeutic or collection functions, not diagnostic ones.
No
The 510(k) summary describes physical medical devices (Needle and Syringe) used for infusion and collection, not software.
Based on the provided information, the JMS Needle and JMS Syringe are not IVD (In Vitro Diagnostic) devices.
Here's why:
- IVD devices are used to examine specimens taken from the human body. They are used in vitro (in glass, or outside the body) to diagnose diseases or other conditions.
- The intended use of the JMS Needle and Syringe is for infusion of drugs, collecting solutions or blood directly into or from the patient's body. This is an in vivo (in the living body) application.
The description clearly states the devices are inserted into the patient's body to create a fluid pathway or for infusion/collection. This is the opposite of how IVD devices are used.
N/A
Intended Use / Indications 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.
Product codes
FMI
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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Anatomical Site
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Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies
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Key Metrics
Not Found
Predicate Device(s)
Not Found
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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).
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