(15 days)
Not Found
No
The device description and intended use focus on standard components of intravascular administration sets and extension sets, with no mention of AI or ML capabilities.
No
The device is used to administer fluids, not to treat a disease or condition. While essential for certain medical interventions, it serves as a delivery system rather than providing therapy itself.
No
The device is used to administer fluids to a patient's vascular system, which is a therapeutic function, not a diagnostic one. It does not mention any capabilities for detecting, monitoring, or analyzing physiological parameters or conditions.
No
The device description explicitly lists numerous physical components (bag spike, drip chamber, tubing, luer connectors, etc.) which are hardware, not software.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostic devices are used to examine specimens taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This testing happens outside the body (in vitro).
- Device Function: The description clearly states the device is used to "administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein." This is a device used for direct administration of substances into the body, not for testing samples taken from the body.
- Intended Use: The intended use is for administering fluids, not for performing diagnostic tests on patient samples.
- Device Components: The components listed (bag spike, drip chamber, tubing, luer connectors, etc.) are all consistent with devices used for fluid administration, not for in vitro diagnostic testing.
Therefore, based on the provided information, the Intravascular Administration Set and Extension Set is a medical device used for fluid administration, not an In Vitro Diagnostic device.
N/A
Intended Use / Indications for Use
The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componentry that aid in the prevention of accidental needle sticks.
Product codes
FPA
Device Description
The Intravascular Administration Set and Extension Set is components commonly found on intravascular administration sets. Intravascular administration sets consists of various components such as: bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors and bag hanger. Extension sets consist of various parts such as: luer connector, tubing, clamp, check valve flow controller, Y-site, injection port, needleless injection port, stopcock, filter, and manifold. For custom applications, a customer may request a certain length, priming volume and componentry. So. the set and actual components will vary with customer specifications.
Components will be assembled into standard configurations specified by the customer and packaged.
Types of components that may be contained in a set include: Bag Spike, Drip Chamber, Burette, Tubing, Clamp, Flow Controller, Injection Site, Needleless Injection Site, Filter, Flash Bulb, Luer, Bag Hanger, Check Valve, Y-site, Stopcock, Manifold.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
patient's vascular system through a needle or catheter inserted into the patient's artery or vein.
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)
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.
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Image /page/0/Picture/1 description: The image shows a handwritten text that appears to be a combination of letters and numbers. The text reads "kpsi499" in a slightly stylized or cursive font. The characters are bold and dark, contrasting with the white background.
510(k) Summary of Safety and Effectiveness
The following section is included as required by the Safe Medical Device Act (SMDA) of 1990.
| Name: | Medegen Medical Manufacturing Services |
|---|---|
| Address: | 930 Wanamaker Ave. |
| Ontario, CA 91761 | |
| CONTACT PERSON: | SALVADORE F. PALOMARES, RAC |
510(k) Summary of Safety and Effectiveness
This summary of 510(k) safety and effectiveness information is being submitted in accordance with the requirements of SMDA 1990 and 21 CFR 807.92.
The assigned 510(k) number is:
| Trade Name: | Intravascular Administration Set and Extension Set |
|---|---|
| Common Name: | Intravascular Administration Set |
| Classification Name: | Same |
| Equivalent Devices: | |
|---|---|
| Manufacturer: | Kipp Group |
| Name: | Intravascular Administration Set |
| 510(k) #: | K991932 |
Device Description:
The Intravascular Administration Set and Extension Set is components commonly found on intravascular administration sets. Intravascular administration sets consists of various components such as: bag spike, drip chamber, burette, tubing, Y-site, clamp, flow controller, check valve injection site, needleless injection site, stopcock, manifold, filter, flash bulb, luer connectors and bag hanger. Extension sets consist of various parts such as: luer connector, tubing, clamp, check valve flow controller, Y-site, injection port, needleless injection port, stopcock, filter, and manifold. For custom applications, a customer may request a certain length, priming volume and componentry. So. the set and actual components will vary with customer specifications.
Components will be assembled into standard configurations specified by the customer and packaged.
| Bag Spike | Clamp | Filter | Check Valve |
|---|---|---|---|
| Drip Chamber | Flow Controller | Flash Bulb | Y-site |
| Burette | Injection Site | Luer | Stopcock |
| Tubing | Needleless Injection Site | Bag Hanger | Manifold |
Types of components that may be contained in a set include:
Intended Use:
The Intravascular Administration Set and Extension Set is a device used to administer fluids from a container to a patient's vascular system through a needle or catheter inserted into the patient's artery or vein. The Intravascular Administration Set and Extension Set may incorporate componently that aid in the prevention of accidental needle sticks.
Biocompatibility:
The materials used to manufacture the Intravascular Administration Set and Extension Set are used in legally marketed devices under comparable conditions of use.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health and Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" arranged around the perimeter. Inside the circle is a stylized graphic of a human figure, represented by three curved lines, symbolizing health and well-being.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 2 2 2005
Medegen Medical Manufacturing Services C/O Mr. Mark Job Responsible Third Party Official Regulatory Technology Services, LLC 1394 25th Street, NW Buffalo, Minnesota 55313
Re: K051499
Trade/Device Name: Intravascular Administration Set and Extension Set Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: June 4, 2005 Received: June 7, 2005 :
Dear Mr. Job:
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 (1 will), it inche 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 Eederal Register.
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Page 2 - Mr. Job
Please be advised that FDA's issuance of a substantial equivalence determination does not Please be auvrsed that I Dr. b lookines on that your device complies with other requirements Incall that 1127 mas mace a autes and regulations administered by other Federal agencies. of the Act of ally I oderal barates and systements, including, but not limited to: registration 1 ou indisting (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice allo listing (21 CFR Part 007), labelity systems (QS) regulation (21 CFR Part 820); and if requirements as set form in at at 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) This letter will anow you to begal finding of substantial equivalence of your device to a premarket notification - 11 - 11 - 11 - 11 - 12 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 - 11 your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), If you desire specific at not to for your at (240) 276-0115. 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 may obtain 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/industry/support/index.html.
Sincerely yours,
Chien-Lin Liu, Ph.D.
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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