(72 days)
Not Found
Not Found
No
The provided text describes a simple medical device (an IV extension set) and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is described as an "extension set to be used as an extension to the Intravascular administration set," connecting it to a catheter or needle. Its primary function is to facilitate the delivery of substances, not to treat or diagnose a medical condition directly.
No
This device is described as an "extension set to be used as an extension to the Intravascular administration set," connecting to a catheter or needle for fluid administration. Its purpose is to facilitate the delivery of substances, not to diagnose a condition or disease.
No
The intended use describes a physical medical device (an extension set for IV administration) and does not mention any software component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the intravascular administration of substances into a vessel. This is a direct interaction with the patient's circulatory system.
- IVD Definition: In Vitro Diagnostics are devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They do not directly interact with the patient's internal systems in the way this extension set does.
The description of the device's function (connecting administration sets to catheters/needles inserted into vessels) is consistent with a medical device used for patient treatment or monitoring, not for analyzing samples outside the body.
N/A
Intended Use / Indications for Use
An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.
Product codes
FPA
Device Description
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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
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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
§ 880.5440 Intravascular administration set.
(a)
Identification. An intravascular administration set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into a vein. The device may include the needle or catheter, tubing, a flow regulator, a drip chamber, an infusion line filter, an I.V. set stopcock, fluid delivery tubing, connectors between parts of the set, a side tube with a cap to serve as an injection site, and a hollow spike to penetrate and connect the tubing to an I.V. bag or other infusion fluid container.(b)
Classification. Class II (special controls). The special control for pharmacy compounding systems within this classification is the FDA guidance document entitled “Class II Special Controls Guidance Document: Pharmacy Compounding Systems; Final Guidance for Industry and FDA Reviewers.” Pharmacy compounding systems classified within the intravascular administration set are exempt from the premarket notification procedures in subpart E of this part and subject to the limitations in § 880.9.
0
Image /page/0/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States of America. The seal features a stylized eagle with its wings spread, symbolizing protection and service. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle, indicating the department's name and national affiliation. The seal is presented in black and white.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 8 1998
Venetec International, Incorporated C/O Ms. Grace Holland Requlatory Consultant Promedica 3722 Avenue Sausalito Irvine, California 92606
K980992 Re :
Statluck® IV Extension Sets with Needleless Trade Name: Access Devices Requlatory Class: II Product Code: FPA Dated: March 17, 1998 Received: March 17, 1998
Dear Ms. Holland:
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 legally marketed predicate 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 requlations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਰ substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, 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
1
Page 2 - Ms. Holland
through 542 of the Act for devices under the Electronic Product Radiation 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 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"(21CFR 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/dsma/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Directdr Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
2
Page 1 of 1
K 980992 510(k) Number (if known): __
IV Extension Sets with Needleless Access Devices Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
An extension set to be used as an extension to the Intravascular administration set to be assul in the IV extension set will connect the administration set to a catheter or needle inserted into a vessel. The IV IV administration bet to a calleless access devices to protect the users from needle stick injuries.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE IN ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use (Per 21 CFR 801.109)
OR
Over The-Counter Use ... .......
(Optional Format 1-2-96)
Date of Application - Mach 17, 1998 Revised on May 22, 1998
Patrizio Cusande
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number
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