(23 days)
Not Found
Not Found
No
The device description focuses on a mechanical free flow protection component (FlowStop) and does not mention any computational or learning capabilities.
No
The device is an administration set designed to deliver fluid from an IV bag, which is a component used in the therapy but not a therapeutic device itself. Its primary function is fluid delivery and safety mechanisms related to that delivery, not directly diagnosing, preventing, monitoring, treating, or alleviating disease.
No
The device description indicates it is an administration set for fluid delivery with a pump, focusing on preventing free flow. This is a therapeutic/delivery function, not a diagnostic one.
No
The device description clearly details a physical administration set with a mechanical component (FlowStop) designed to occlude a tube. This is a hardware 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 to "allow fluid delivery from an IV bag" using a pump. This describes a device used for administering fluids to a patient, not for testing samples from a patient to diagnose or monitor a condition.
- Device Description: The description focuses on the mechanical components for fluid delivery and safety features related to the pump connection. There is no mention of reagents, samples (like blood, urine, etc.), or any process for analyzing biological specimens.
- Performance Studies: The performance studies described are "Functional Testing" and "Biocompatibility testing," which are typical for devices that come into contact with the body or fluids being administered to the body, not for diagnostic tests.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device clearly falls outside of that definition.
N/A
Intended Use / Indications for Use
"The CADD® High-Volume Administration Set is designed for use with the CADD-Prizm pump to allow fluid delivery from an IV bag."
Product codes
FPA
Device Description
The CADD® High-Volume Administration Sets with FlowStop is a modification to the current CADD® High-Volume Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. FlowStop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.
The FlowStop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the "CLIP" must be removed to activate the FlowStop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the FlowStop in the open position.
The Add-on Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the FlowStop.
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
Functional Testing: In-vitro testing was conducted on the CADD® High-Volume Administration Set with FlowStop. Biocompatibility testing was performed on the new FlowStop components.
Clinical Studies: Clinical studies were not deemed necessary regarding the CADD® High-Volume Administration Set with FlowStop due to their similarity in materials, design and function to the current CADD® High-Volume Administration Sets and the GemStar™ Pump Set.
Key Results: The results of the testing indicated that the CADD® High-Volume Administration Set with FlowStop function according to specifications and the materials used in the device are biocompatible. Therefore, the product is considered acceptable for human use.
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
K03/361
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CADD® High-Volume Administration Set with FlowStop
April 29, 2003
MAY 2 3 2003
I. GENERAL INFORMATION
| Applicant's Name and Address: | Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|--------------------------------|----------------------------------------------------------------|
| Contact Person: | Lisa J. Stone
Manager, Regulatory Affairs |
| Common/Usual Name: | Administration Set |
| Proprietary Name: | CADD® High-Volume Administration Sets with
FlowStop |
| Equivalence Device Comparison: | CADD® High-Volume Administration Sets and
GemStar™ Pump Set |
II. DEVICE DESCRIPTION
The CADD® High-Volume Administration Sets with FlowStop is a modification to the current CADD® High-Volume Administration Sets. The sets will incorporate a set-based free flow protection component (i.e. FlowStop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump.
The FlowStop will be located on the set housing, which is attached to the pump. The set will be provided to the user in an open state. Before the set can be attached to the pump, the "CLIP" must be removed to activate the FlowStop. However, after attaching the set to the pump, the user can still remove the set from the pump and prime it by holding the FlowStop in the open position.
The Add-on Anti-siphon Valve, which is included with current sets will not be provided with the new sets. This valve is no longer necessary because of the addition of the FlowStop.
ш. INTENDED USE OF THE DEVICE
The CADD® High-Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.
1
IV. DEVICE COMPARISON
The CADD® High-Volume Administration Sets with FlowStop is similar in design, function, and intended use to the current CADD® High-Volume Administration Sets. These sets are identical except for the addition of the FlowStop and the removal of the anti-siphon valve.
The sets will incorporate a set-based free flow protection component (i.e. FlowStop) that is designed to occlude the tube if the set is accidentally placed onto the pump incorrectly or becomes detached from the pump. This is similar to the flow stop on the GemStar™ Pump Set.
V. SUMMARY OF STUDIES
A. Functional Testing
In-vitro testing was conducted on the CADD® High-Volume Administration Set with FlowStop.
Biocompatibility testing was performed on the new FlowStop components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the CADD® High-Volume Administration Set with FlowStop due to their similarity in materials, design and function to the current CADD® High-Volume Administration Sets and the GemStar™ Pump Set.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the CADD® High-Volume Administration Set with FlowStop function according to specifications and the materials used in the device are biocompatible. Therefore, the product is considered acceptable for human use.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of three human profiles facing right, arranged in a stacked formation. The profiles are rendered in black and appear to be connected, forming a unified shape. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged in a circular fashion around the graphic.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 2 3 2003
Ms. Lisa Stone Manager, Regulatory Affairs Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
『Re: K031361
Trade/Device Name: CADD® High-Volume Administration Set with FlowStop Regulation Number: 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: April 29, 2003 Received: May 8, 2003
Dear Ms. Stone:
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.
3
Page 2 - Ms. Stone:
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 (QS) 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 vour 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 vours,
Susan Burns
Susan Runner, DDS, MA Interim 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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K03/361
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CADD® High-Volume Administration Set with FlowStop
Indications for Use:
્રિક
"The CADD® High-Volume Administration Set is designed for use with the CADD-Prizm pump to allow fluid delivery from an IV bag."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Pitacca Cucente
(Division Sign-Off) Division of Anesthesiology. General Hospital, Infection Control, Dental Devices
510(k) Number. K031361
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use