(488 days)
Not Found
Not Found
No
The description focuses on the mechanical safety features of a needle and infusion set, with no mention of AI or ML terms or functionalities.
No
The device is used to administer fluids, drugs, and for blood sampling, and its safety features are designed to prevent needlestick injuries. Its primary function is a delivery and collection mechanism, not directly a therapeutic one.
No
The device is described as an "infusion set" used for administering fluids, drugs, and blood sampling, and for preventing needlestick injuries. Its function is to deliver or withdraw substances, not to diagnose a condition.
No
The device description clearly describes a physical medical device (infusion set, needle, plastic cone) used for accessing vascular ports and preventing needlestick injuries. There is no mention of software as the primary or sole component.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to access surgically implanted vascular ports for administering fluids, drugs, and blood sampling. This is a direct interaction with the patient's circulatory system for therapeutic and diagnostic purposes in vivo (within the living body).
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are performed in vitro (outside the living body).
The Marquette Medical Safety Huber Infusion Set is a medical device used for accessing the body, not for analyzing samples taken from the body.
N/A
Intended Use / Indications for Use
The Marquette Medical Safety Huber Infusion Set is a safety IV administration set used to access surgically implanted vascular ports. The Medical Safety Huber Needle is used to administer fluids or drugs and blood sampling. The Marquette Medical Safety Huber Infusion Set facilitates safe removal of the needle by encapsulating the needle within a telescoping plastic cone to help prevent needlestick injuries when using the device for vascular port access.
Product codes
FPA, LJT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
vascular ports
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
Not Found
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 is a black and white circular seal. The seal contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the border of the circle. Inside the circle is a stylized image of an eagle or other bird with three wing-like shapes extending from its body.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP - 8 2003
Marquette Medical, Incorporated C/O Mr. E.J. Smith Smith & Associates P.O. Box 4341 Crofton, Maryland 21114
Re: K021471
Trade/Device Name: Marquette Huber Trap Safety Infusion Set Huber Needle Regulation Number: 880.5440, 880.5965 Regulation Name: Intravascular Administration Set Subcutaneous, Implanted Intravascular Infusion Port and Catheter Regulatory Class: II Product Code: FPA, LJT Dated: July 25, 2003 Received: July 28, 2003
Dear Mr. Smith:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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 (PMA), 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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
1
Page 2 - Mr. Smith
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 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), please contact the Office of Compliance at (301) 594-4618. Also, please note the regulation entitled. "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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.
Susan Runner, DDS, MA
Runner, DDS. N Susan Interim Director Division of Anesthesiology, General Hospital Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
510(k) Number:
Device Name:
Classification Panel:
Indications for Use:
The Marquette Medical Safety Huber Infusion Set is a safety IV administration set used to access surgically implanted vascular ports. The Medical Safety Huber Needle is used to administer fluids or drugs and blood sampling. The Marquette Medical Safety Huber Infusion Set facilitates safe removal of the needle by encapsulating the needle within a telescoping plastic cone to help prevent needlestick injuries when using the device for vascular port access.
Palture Cucenite
(Division Sign-Off) Division of Anesthesiology, General Hospital, Infection Control, Dental Devices
510(k) Number:________________________________________________________________________________________________________________________________________________________________
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use:
Over-the-Counter Use: --------------------------------------------------------------------------------------------------------------------------------------------------------