DAXOR MAX100 SYRINGE (MAX100)

K970419 · Daxor Corporation · FMF · Dec 22, 1997 · General Hospital

Device Facts

• Record ID: K970419
• Device Name: DAXOR MAX100 SYRINGE (MAX100)
• Applicant: Daxor Corporation
• Product Code: FMF · General Hospital
• Decision Date: Dec 22, 1997
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 880.5860
• Device Class: Class 2

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).

Device Story

Daxor Max100 Syringe is a manual fluid injection device designed for healthcare professionals. It facilitates precise measurement and delivery of fluid boluses into IV ports. The device is intended to ensure exact quantity delivery, aiding clinical procedures where volume accuracy is critical. It is not intended for direct patient injection or arterial line access. The device functions as a standard syringe mechanism for controlled fluid administration.

Clinical Evidence

No clinical data provided; bench testing only.

Technological Characteristics

Manual syringe for fluid injection. Designed for precise volume delivery into IV ports. No electronic components, software, or energy sources.

Indications for Use

Indicated for use by healthcare professionals for precise fluid bolus injection into IV ports. Not for direct patient injection or arterial line use.

Regulatory Classification

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.

Submission Summary (Full Text)

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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration
9200 Corporate Boulevard
Rockville MD 20850

DEC 22 1997

Mr. Ronald H. Baldry
Vice President for Engineering
Daxor Corporation
312 Trossachs Lane
Knoxville, Tennessee 37922-3421

Re: K970419
Trade Name: Daxor Max100 Syringe (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, Drug, 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 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 current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (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 regulation may result in regulatory action. In addition, 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

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Page 2 - Mr. Baldry

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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at [phone]. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at [phone]. 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 [phone] or [phone] 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

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08/13/97 14:01 301 594 2358 CDRH ODE 003

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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 DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)

Concurrence of CDRH, Office of Device Evaluation (ODE)

Patricia Cucente
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices
510(k) Number: K970419

Prescription Use ☑ (Per 21 CFR: 801.109)
OR
Over-The-Counter Use ☐ (Optional Format 1-2-96)