(57 days)
Not Found
No
The description focuses on mechanical components and their function, with no mention of AI or ML terms or capabilities.
No
The device is an administration set (tubing, filter, and valves) for an IV pump, not a therapeutic device itself. It facilitates the delivery of fluids, but does not provide therapy.
No
The device is an administration set for delivering nutritional and other solutions intravenously, not for diagnosing medical conditions.
No
The device description clearly lists physical components like a bag spike, tubing, filter, and valves, indicating it is a hardware device.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "administration of nutritional and other solutions or fluids intravenously from an IV bag." This describes a device used for delivering substances into the body, not for testing samples from the body to diagnose a condition.
- Device Description: The components listed (bag spike, tubing, filter, valve, etc.) are all parts of a system for delivering fluids intravenously. There are no components described that would be used for analyzing biological samples.
- Lack of IVD Characteristics: The description does not mention any analysis of biological samples (blood, urine, tissue, etc.), detection of analytes, or diagnostic purposes.
Therefore, this device falls under the category of a medical device used for therapeutic or supportive purposes (infusion), not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
"The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag."
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The purpose of this submission is to offer an alternate CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve. The set is made up of the following components: bag spike, tubing, set plate, 1.2 u filter, tubing clamp, injection site, male luer connector with protective cap, and anti-siphon valve. The anti-siphon valve is designed to protect against unregulated gravity infusion that can result from an improperly attached set plate to the CADD-TPN® Ambulatory Infusion Pump.
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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Functional Testing: Functional specification testing was performed on the alternate filter and antisiphon valve.
Biocompatibility testing was conducted.
Clinical studies were not deemed necessary regarding the new set due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets.
Conclusions Drawn from the Studies: The results of the testing indicated that the filter functions according to specification and the set meets the biocompatibility requirements. Therefore, the CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve is considered acceptable for human use.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve
April 9, 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
Tel. (651) 628-7166 |
| Common/Usual Name: | Administration Set |
| Proprietary Name: | CADD-TPN® Administration Set with 1.2 μ
Filter and Add-on Anti-siphon Valve |
| Equivalence Device Comparison: | CADD-TPN® Administration Set with 1.2 μ
Filter
CADD® Extension Set with Anti-siphon Valve
CADD® Administration Set with TOTM
Plasticized Tubing |
II. DEVICE DESCRIPTION
The purpose of this submission is to offer an alternate CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve. The set is made up of the following components: bag spike, tubing, set plate, 1.2 u filter, tubing clamp, injection site, male luer connector with protective cap, and anti-siphon valve. The anti-siphon valve is designed to protect against unregulated gravity infusion that can result from an improperly attached set plate to the CADD-TPN® Ambulatory Infusion Pump.
III. INTENDED USE OF THE DEVICE
The CADD-TPN® Administration Set is designed for use with the CADD-TPN® pump for the administration of nutritional and other solutions or fluids intravenously from an IV bag.
1
DEVICE COMPARISON IV.
| | CADD-TPN®
Administration Set
with 1.2 µ Filter and
Add-on Anti-siphon
Valve | CADD-TPN®
Administration Set
with 1.2 µ Filter | CADD® Extension Set
with Anti-siphon
Valve | CADD®
Administration Set
with TOTM
Plasticized Tubing |
|-------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. |
| 510(K) NUMBER | Subject Device | K902374 | K942046 | K933390 |
| INDICATIONS FOR
USE | The CADD-TPN®
Administration Set is
designed for use with
the CADD-TPN® pump
for the administration
of nutritional and other
solutions or fluids
intravenously from an
IV bag. | The CADD-TPN®
Administration Set is
designed for use with
the CADD-TPN® pump
for the administration
of nutritional and other
solutions or fluids
intravenously from an
IV bag. | For use with the
MEDICATION
CASSETTE™
Reservoir. | The CADD®
Administration Set is
designed to be used
with a variety of Deltec
CADD® Pumps to
allow fluid delivery
from a remote bag. |
| DIMENSIONS
(Nominal) | | | | |
| LENGTH | 114 in. | 100 in. | 30, 45, or 60 in. | 77 in. |
| I.D. | 0.100 in. | 0.100 in. | 0.039 in. | 0.100 in. |
| O.D. | 0.164 in. | 0.164 in. | 0.106 in | 0.164 in. |
| FILTER | YES | YES | NO | NO |
| ANTI-SIPHON
VALVE | YES | NO | YES | YES |
V. SUMMARY OF STUDIES
Functional Testing A.
Functional specification testing was performed on the alternate filter and antisiphon valve.
Biocompatibility testing was conducted.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the new set due to its similarity in materials, design and function to current commercially available CADD® Administration Sets and Extension Sets.
2
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 CADD-TPN® Administration Set with 1.2 µ Filter and Add-on Anti-siphon Valve is 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 features the department's name encircling a stylized eagle emblem. The text reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a circular arrangement. The eagle is depicted with three stylized lines forming its body and wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
ਰ 1999 JUN
Mr. Edward W. Numainville Vice President Regulatory Affairs and Quality Systems SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
Re : K991255 Trade Name: CADD-TPN® Administration Set with 1.2 μ Filter and Add-on Anti-siphon Valve Regulatory Class: II Product Code: FPA Dated: April 9, 1999 Received: April 13, 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, qood 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 Regulations, Title 21, Parts 800 to 895. ਬੇ 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 requlation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Reqister.
4
Paqe 2 - Mr. Numainville
this response to your premarket notification Please note: rease 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 described in your sie wir privalence 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
premarket notification" (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.fdaygov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Director Division of Dental, Infection Control, and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
K 991255
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: CADD-TPN® Administration Set with 1.2 u Filter and Add-on Anti-siphon Valve
Indications for Use:
"The CADD-TPN® Administration Set is designed for use with the CADD-TPN® "The CADD-1111" "Xunimistration of nutritional and other solutions or fluids intravenously 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)
| Prescription Use
| (Per 21 CFR 801.109) | ✓ |
|---|---|
| ------------------------------------------ | --------------------------------------------------- |
OR
| (Division Sign-Off) | |
|---|---|
| --------------------- | -- |
Over-The Counter UseDivision of Dental, Infection Control, and General Hospital I 510(k) Number ..