(54 days)
No
The document describes a standard administration set for fluid delivery, focusing on a filter change and functional/biocompatibility testing. There is no mention of AI, ML, image processing, or any other technology typically associated with AI/ML.
No
The device is an administration set for delivering fluid from an IV bag, not a therapeutic device itself.
No
The device is an administration set used for fluid delivery from an IV bag, not for diagnosing medical conditions.
No
The device description clearly lists physical components such as a bag spike, tubing, housing, filter, clamps, and connectors, indicating it is a hardware device.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use/Indications for Use: The description clearly states the device is designed for "fluid delivery from an IV bag" using a pump. This is a function related to administering substances to a patient, not analyzing samples from the body to diagnose a condition.
- Device Description: The components listed (bag spike, tubing, filter, connectors, etc.) are typical of intravenous administration sets, not devices used for in vitro testing.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
The device is an administration set used for delivering fluids intravenously, which falls under the category of medical devices used for treatment or support, not diagnosis.
N/A
Intended Use / Indications for Use
The CADD-Prizm High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.
The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag.
Product codes
FPA
Device Description
The purpose of this submission is to offer an alternate 1.2 μ Filter for manufacturing standardization and use with the current SIMS Deltec Administration Sets. The Administration Sets are made up of the following components: bag spike, tubing, housing, 1.2 μ filter, tubing clamp, injection site (found on the CADD-Prizm® High Volume Administration Set only), male luer connector with protective cap, and antisiphon valve.
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 specification testing was performed on the alternate filter when used with the anti-siphon valve.
Biocompatibility testing was conducted.
Clinical studies were not deemed necessary regarding the new Administration Sets due to their similarity in materials, design and function to current commercially available SIMS Deltec Administration Sets.
The results of the testing indicated that the filter functions according to specification and the set meets the biocompatibility requirements. Therefore, the Administration Sets are considered acceptable for human use.
Key Metrics
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.
0
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CADD-Prizm® High Volume Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve
CADD® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve
April 15, 1999
I. GENERAL INFORMATION
| Applicant's Name and Address: | SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 | | |
|--------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--|--|
| Contact Person: | Edward W. Numainville
Vice President, Regulatory Affairs and
Quality Systems | | |
| Common/Usual Name: | Administration Set | | |
| Proprietary Name: | CADD-Prizm® High Volume Administration Set
with 1.2 $\mu$ Filter and Add-on Anti-siphon Valve
CADD® Administration Set with 1.2 $\mu$ Filter and
Add-on Anti-siphon Valve
Hereafter, collectively referred to as
"Administration Sets". | | |
| Equivalence Device Comparison: | CADD-Prizm® High Volume Administration Set
with 1.2 $\mu$ Filter and Add-on Anti-siphon Valve
CADD® Administration Set with 1.2 $\mu$ Filter and
Add-on Anti-siphon Valve | | |
II. DEVICE DESCRIPTION
The purpose of this submission is to offer an alternate 1.2 µ Filter for manufacturing standardization and use with the current SIMS Deltec Administration Sets. The Administration Sets are made up of the following components: bag spike, tubing, housing, 1.2 µ filter, tubing clamp, injection site (found on the CADD-Prizm® High Volume Administration Set only), male luer connector with protective cap, and antisiphon valve.
1
INTENDED USE OF THE DEVICE III.
The CADD-Prizm High Volume Administration Set is designed for use with the CADD-Prizm® pump to allow fluid delivery from an IV bag.
The CADD® Administration Set is designed to be used with a variety of CADD® pumps to allow fluid delivery from an IV bag.
IV. DEVICE COMPARISON
| | CADD-Prizm High
Volume Administration
Set with 1.2 µ Filter and
Add-on Anti-siphon Valve | CADD-Prizm® High
Volume Administration
Set with 1.2 µ Filter and
Add-on Anti-siphon Valve | CADD® Administration
Set with 1.2 µ Filter and
Add-on Anti-siphon Valve | CADD® Administration
Set with 1.2 µ Filter and
Add-on Anti-siphon Valve |
|-------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. |
| 510(K) NUMBER | Subject Device | K943310 | Subject Device | K933390
K954870 |
| INDICATIONS FOR
USE | The CADD-Prizm® High
Volume Administration Set
is designed for use with the
CADD-Prizm® pump to
allow fluid delivery from
an IV bag. | The CADD-Prizm® High
Volume Administration Set
is designed for use with the
CADD-Prizm® pump to
allow fluid delivery from
an IV bag. | The CADD®
Administration Set is
designed to be used with a
variety of CADD® pumps
to allow fluid delivery from
an IV bag. | The CADD®
Administration Set is
designed to be used with a
variety of CADD® pumps
to allow fluid delivery from
an IV bag. |
| DIMENSIONS
(Nominal) | | | | |
| LENGTH | 120 in. | 120 in. | 94 in. | 94 in. |
| I.D. | 0.100 | 0.100 | 0.060 in. (coiled tubing) | 0.060 in. (coiled tubing) |
| O.D. | 0.164 | 0.164 | 0.105 in. (coiled tubing) | 0.105 in. (coiled tubing) |
| FILTER | YES | YES | YES | YES |
| ANTI-SIPHON
VALVE | YES | YES | YES | YES |
V. SUMMARY OF STUDIES
A. Functional Testing
Functional specification testing was performed on the alternate filter when used with the anti-siphon valve.
Biocompatibility testing was conducted.
2
Clinical Studies B.
Clinical studies were not deemed necessary regarding the new Administration Sets due to their similarity in materials, design and function to current commercially available SIMS Deltec Administration Sets.
Conclusions Drawn from the Studies C.
The results of the testing indicated that the filter functions according to specification and the set meets the biocompatibility requirements. Therefore, the Administration Sets are considered acceptable for human use.
3
Image /page/3/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with three heads.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 9 1999
Mr. Edward W. Numainville Vice President Regulatory Affairs and Quality Systems SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
Re : K991301 Trade Name: CADD-Prizm® High Volume Administration Set with 1.2 μ Filter and Add-on Anti-siphon Valve Requlatory Class: II Product Code: FPA Dated: April 15, 1999 Received: April 16, 1999
Dear Mr. Numainville:
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 regulations affecting your device can be found in the Code of Federal Requlations, Title 21, Parts 800 to 895. ਸ substantially equivalent determination assumes compliance with the Good Manufacturing Practice for Medical Devices: General (GMP) regulation (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 regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
4
Page 2 - Mr. Numainville
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 asborizon in four and 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 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 one royalation" (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.fdag.gov/cdrh/dsmamain.html".
Sincerely yours
Timothy A. Ulatowski
Timothy A. Ulatowski Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radioloqical Health
Enclosure
5
K991301
510(k) Number (if known):
Device Name: CADD-Prizm® High Volume Administration Set with 1.2 u Filter and Add-on Anti-siphon Valve
Indications for Use:
"The CADD-Prizm® 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)
Palanca Cassonte
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _ 1199
) Prescription Use (Per 21 CFR 801.109) Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
6
510(k) Number (if known): _
Device Name: CADD® Administration Set with 1.2 u Filter and Add-on Anti-siphon Valve
Indications for Use:
"The CADD® Administration Set is designed to be used with a variety of CADD® pumps 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)
Patricia Cuende
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________ 49
Prescription Use _____________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
OR
Over-The Counter Use