(321 days)
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Not Found
No
The provided text does not contain any keywords or descriptions related to AI or ML technology. The device description is focused on fluid injection and quantity control.
No
The device is described as being used for "fluid injection" where the quantity of the injected fluid bolus is known exactly, indicating it is a tool for administering substances rather than directly treating a disease or condition itself. Therapeutic devices treat or alleviate symptoms of a disease, injury, or disability. This device facilitates a procedure but isn't itself a treatment.
No
Explanation: The device is described as being used for "fluid injection" where the quantity of the injected fluid is known. This indicates a therapeutic or procedural function, not a diagnostic one. Diagnostic devices typically identify, monitor, or detect medical conditions or disease.
No
The description explicitly states the device is for "fluid injection," which inherently involves hardware (e.g., a syringe, pump, or other injection mechanism) to deliver the fluid. A software-only device would typically process data or provide information, not directly perform a physical action like injection.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "fluid injection" into IV ports. This is a direct medical intervention on a patient, not a test performed on a sample taken from the body (which is the definition of an in vitro diagnostic).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Providing diagnostic information about a patient's health status
- Using reagents or assays
The device appears to be a medical device used for administering fluids, likely a type of syringe or infusion device with a focus on precise volume control.
N/A
Intended Use / Indications for Use
This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly.
This device will be used to inject into IV ports (not directly into the patient or into arterial lines).
Product codes
FMF
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
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Intended User / Care Setting
health care professionals
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Not Found
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).
0
Image /page/0/Picture/1 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized image of a human figure with three faces in profile, resembling a bird in flight. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES · USA" is arranged in a circular pattern around the image.
.. . .
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 2 2 1997
Mr. Ronald H. Baldry Vice President for Engineering Daxor Corporation 312 Trossachs Lane Knoxville, Tennessee 37922-3421
K970419 Re: Trade Name: Daxor Max100 Syrinqe (Max100) Regulatory Class: II Product Code: FMF Dated: October 31, 1997 Received: November 4, 1997
Dear Mr. Baldry:
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, Druq, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions of the Act. 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 such additional controls. Existing major regulations affectinq 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (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 requlation may result in requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531
1
Page 2 - Mr. Baldry
through 542 of the Act for devices under the Electronic enroagh Siz Control provisions, or other Federal laws or requlations.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA findinq 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 regulation (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
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 Directbr Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Page / of /
510(k) Number: K970419
Device Name: Daxor Max100 Syringe
Indications for Use:
This device is intended for use by health care professionals for fluid injection, where it is important to ensure that the quantity of the injected fluid bolus is known exactly.
This device will be used to inject into IV ports (not directly into the patient or into arterial lines).
(PLEASE I O NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pelacio Crecents
Prescriptior Use_ (Per 21 CFI : 801.109)
OR
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
(Optional Format 1-2-96)