(69 days)
Not Found
Not Found
No
The device description and intended use describe a passive fluid administration set with a filter and valve, with no mention of computational or adaptive capabilities.
No
This device is an administration set and extension set for pumps used to administer fluids or medications, not a device that itself provides therapy.
No
The device is an administration set used for delivering fluids or medications, not for diagnosing conditions.
No
The device description clearly indicates physical components like an extension set, filter, and anti-siphon valve, which are hardware.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly states the device is for the "administration of fluids or medications" with specific infusion pumps. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical components (filter, anti-siphon valve) and their function in controlling fluid flow during administration. There is no mention of analyzing samples from the human body to provide diagnostic information.
- Lack of IVD Characteristics: The text does not mention any of the typical characteristics of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in those samples
- Providing information for diagnosis, monitoring, or screening of diseases or conditions.
The device is an accessory for infusion pumps used in patient treatment, not for in vitro diagnostic testing.
N/A
Intended Use / Indications for Use
The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps.
The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.
Product codes (comma separated list FDA assigned to the subject device)
EPA
Device Description
The purpose of this submission is to offer an alternate 0.2u filter, as a matter of customer preference, for use with the SIMS Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2u Filter and Anti-Siphon Valve. The 0.2u filter is similar to the filter on the Abbott Laboratories' Filter Set with 0.22u Filter. An integral anti-siphon valve is included and is designed to protect against unregulated gravity infusion that may result from an improperly attached reservoir.
Mentions image processing
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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)
Not Found
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.
Not Found
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
K980 583
APR 27 1998 510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
APR 2 7 1998 510(k) SUMMARY OF SAFETY AND with
Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve February 12, 1998
GENERAL INFORMATION I.
| Applicant's Name
and Address: | SIMS Deltec, Inc.
1265 Grey Fox Road
St. Paul, MN 55112 |
|-----------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Contact Person: | David H. Short
Director, Regulatory and Clinical Affairs
Tel. (612) 628-7214 |
| Common/Usual Name: | Extension Set Administration Set |
| Proprietary Name: | Extension Set with 0.2µ Filter and Anti-Siphon Valve
CADD® Administration Set with 0.2µ Filter and Anti-
Siphon Valve |
| Equivalence Device
Comparison: | Extension Set with Anti-Siphon Valve
(manufactured by SIMS Deltec, Inc.)
CADD® Administration Set with 0.2µ Filter
and Anti-Siphon Valve
(manufactured by SIMS Deltec, Inc.)
Filter Set with 0.22µ Filter, y-Injection Site and
OPTION-LOK®
(manufactured by ABBOTT LABORATORIES) |
II. DEVICE DESCRIPTION
The purpose of this submission is to offer an alternate 0.2u filter, as a matter of customer preference, for use with the SIMS Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2u Filter and Anti-Siphon Valve. The 0.2u filter is similar to the filter on the Abbott Laboratories' Filter Set with 0.22u Filter. An integral anti-siphon valve is included and is designed to protect against unregulated gravity infusion that may result from an improperly attached reservoir.
1
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
Alternate 0.2u Filter for use with Deltec Extension Set with Anti-Siphon Valve and CADD® Administration Set with 0.2μ Filter and Anti-Siphon Valve February 12, 1998
INTENDED USE OF DEVICE III.
The Extension Set with 0.2u filter and anti-siphon valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps.
The CADD® Administration Set with 0.2u filter and anti-siphon valve is intended for use with CADD-1®, CADD-PCA®, CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications.
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 eagle with three lines forming its body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 2 7 1998
Mr. David H. Short 'Director, Regulatory and Clinical Affairs SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
Re : K980583 Extension Set with 0.2μ Filter and Anti-Trade Name: Siphon Valve CADD® II Requlatory Class: Product Code: EPA Dated: February 13, 1998 February 17, 1998 Received:
Dear Mr. Short:
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 Regulations, Title 21, Parts 800 to 895. A 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 requlatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
3
Page 2 - Mr. Short
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 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 requlation (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.fda.gov/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
4
Kg80583
510(k) Number (if known):
Device Name: CADD® Administration Set with 0.2µ Filter and Anti-Siphon Valve
Indications for Use:
"The CADD® Administration Set with 0.2µ filter and anti-siphon valve is intended for "The ORDD® Administration Des (CADD-PLUS®, CADD-Prizm® pumps for the administration of fluids or medications."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Patricia Caserite
on of Denni, Infection O and General Frispital Devices
510(k) Number K980583
Prescription Use
OR
Over-The Counter Use
(Per 21 CFR 801:109) --