(130 days)
Not Found
Not Found
No
The device description is a simple saline flush syringe, and there are no mentions of AI, ML, or related concepts in the provided summary.
No
The device is described as a "Normal Saline I.V. Flush Syringe" used to "maintain patency of in-dwelling intravenous access devices." This indicates it's used for maintenance and prevention, rather than for treating a specific disease or condition, which is characteristic of therapeutic devices.
No
This device, a normal saline IV flush syringe, is intended to maintain the patency of intravenous access devices. Its function is to prevent blockages, not to gather information about a patient's health status or diagnose a condition.
No
The device description explicitly states "Normal Saline I. V. Flush Syringe," which is a physical medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)". This describes a direct interaction with a patient's circulatory system to keep a medical device open, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a "Normal Saline I. V. Flush Syringe". This is a medical device used for flushing IV lines, not for performing diagnostic tests.
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Testing of biological samples (blood, urine, tissue, etc.)
- Detection or measurement of analytes
- Diagnosis, monitoring, or screening of diseases or conditions
Therefore, this device falls under the category of a general medical device used for patient care, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)
Product codes
FOZ
Device Description
Normal Saline I.V. Flush Syringe
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): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Not Found
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 880.5200 Intravascular catheter.
(a)
Identification. An intravascular catheter is a device that consists of a slender tube and any necessary connecting fittings and that is inserted into the patient's vascular system for short term use (less than 30 days) to sample blood, monitor blood pressure, or administer fluids intravenously. The device may be constructed of metal, rubber, plastic, or a combination of these materials.(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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, with three stylized lines forming the body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 2 5 2000
Mr. Pradeep Aqqarwal President - CEO Medefil, Incorporated 492 Lunt Avenue 60193 Schaumburq, Illinois
Re: K993515 Normal Saline I.V. Flush Syringe Trade Name: Requlatory Class: II Product Code: FOZ Dated: February 3, 2000 February 4, 2000 Received:
Dear Mr. Aggarwal:
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 requlations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. ਸ 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
1
Page 2 - Mr. Aggarwal
the Federal Register. Please note: this response to your premarket notification submission does not 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.fdaggov/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
Medefil, Inc. October 1999 Sterile Normal Saline I. V. Flush Syringe Indications For Use
of Page
510(k) Number (if known):
Normal Saline I. V. Flush Syringe Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
FOR USE TO MAINTAIN PATENCY OF IN-DWELLING INTRAVENOUS ACCESS DEVICES (IVAD)
(PLEASE DO NOT WRITE BELOW THIS LINE – CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription use ✓
(Per 21 CFR 801,109)
or
ver-the-counter use --
(Optional Format 3-10-98)
Paltase Cacceniti
Division Sign-Off) Division of Dental, Infection Control, and General Hospital D 510(k) Number
000020