(99 days)
Becton Dicksnson® MedSaver The syringe.
Not Found
No
The description details a standard mechanical syringe with a focus on reducing dead space. There is no mention of software, algorithms, or any computational processing that would suggest AI/ML.
No.
The device is a syringe used for administering pharmaceuticals, not for therapeutic treatment itself. It's an administration device, not a therapeutic device.
No
The device is described as a hypodermic syringe used for administering pharmaceuticals, not for diagnosing conditions.
No
The device description clearly describes a physical syringe with a piston, barrel, needle, and gasket, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to draw and administer pharmaceuticals directly to a patient, either directly or via an intravenous port. This is a direct interaction with the patient's body for therapeutic purposes.
- Device Description: The description details a standard hypodermic syringe with a permanently attached needle, designed for injecting substances into the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used outside the body to analyze samples and provide diagnostic information. This syringe is used inside the body to deliver medication.
N/A
Intended Use / Indications for Use
The product is a standard piston type hypodermic syringe. Such device will be used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use, and which the product will be specifically marketed for, the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.
Product codes
FMF
Device Description
The Ulti Care Low Dead Space syringe is substantially equivalent to the Becton Dicksnson® MedSaver The syringe. The device is intended to minimize the consumption of expensive pharmacenticals by reducing the distance between the calibrated barrel of the syringe and the needle. The devise has a permanently attached needle that eliminates the tip and hub-of a normal needle/syringe combination. This results in less waste of pharmaceutical and greater efficiency. The device will be used with any pharmaceutical that needs to be injected either transdermally or through an intravenous port. The intended device has the same technological characteristics as the presently marketed Becton Dickinson MedSaver™ using a manually operated piston type hypodemic syringe, injected molded plastic parts, a synthetic latex gasket and permanently attached stainless steel needle.
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Becton Dicksnson® MedSaver The syringe.
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 880.5860 Piston syringe.
(a)
Identification. A piston syringe is a device intended for medical purposes that consists of a calibrated hollow barrel and a movable plunger. At one end of the barrel there is a male connector (nozzle) for fitting the female connector (hub) of a hypodermic single lumen needle. The device is used to inject fluids into, or withdraw fluids from, the body.(b)
Classification. Class II (performance standards).
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MAR 2 4 2000
510(k) Numbert K994230 UltiCare Disposable Syringe
510(k) Summary
The submitter of this submission is: 1) Ulti Med Inc. 287 E. Sixth Street St. Paul, MN 55101
The contact person is: Charles W. Erickson-
On this 22nd day of March, 2000.
- The trade name of the device shall be "Ulti Care". The name of the device shall be "Low 2) Dead Space" which is also the common or usual name for this type of device.
- The Ulti Care Low Dead Space syringe is substantially equivalent to the Becton Dicksnson ਤੇ) MedSaver The syringe.
- The device is intended to minimize the consumption of expensive pharmacenticals by 4) reducing the distance between the calibrated barrel of the syringe and the needle. The devise has a permanently attached needle that eliminates the tip and hub-of a normal needle/syringe combination. This results in less waste of pharmaceutical and greater efficiency_
- The device will be used with any pharmaceutical that needs to be injected either trans ર) dermally or through an intravenous port.
- The intended device has the same technological characteristics as the presently marketed 6) Becton Dickinson MedSaver™ using a manually operated piston type hypodemic syringe, injected molded plastic parts, a synthetic latex gasket and permanently attached stainless steel needle.
1
Image /page/1/Picture/2 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo features a stylized image of an eagle with its wings spread, and the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circle around the eagle. The eagle is facing left, and its wings are curved upwards. The text is in all capital letters and is evenly spaced around the circle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 2 4 2000
Charles W. Erickson Mr. UltiMed, Inc. 287 East Sixth Street St. Paul, Minnesota 55101
K994230 Re : UltiCare Disposable Syringe Trade Name: Regulatory Class: II Product Code: FMF January 10, 2000 Dated: Received: January 14, 2000
Dear Mr. Erickson:
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, qood 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 Requlations, Title 21, Parts 800 to 895. ਕੇ 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 requlatory action. In addition, FDA may publish further announcements concerning your device in Please note: this response to your the Federal Register. premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
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MAR 2 4 2000
Page 2 - Mr. Erickson
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) 594-4690. 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 qeneral 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,
Susan Runner
A Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K994230 UltiCare Disposable Syringe
Indication For Use
The product is a standard piston type hypodermic syringe. Such device will be used to draw a quantity of pharmaceutical from its container and allow administration of the pharmaceutical directly to the patient. As an alternative use, and which the product will be specifically marketed for, the product will allow administration of the pharmaceutical to the patient via an intravenous port, heparin lock, or saline lock.
Peterson Cusack
(Division Sian-Off) Division of Dental, Infection Control. and General Hospital De 510(k) Number .
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