(56 days)
Not Found
No
The document describes a simple medical device (extension sets for infusion pumps) and does not mention any AI or ML components or functionalities.
No
The device is an extension set used for the administration of fluids or medications, not a therapeutic device itself. Its function is to facilitate the delivery of therapy, not to provide therapy.
No
The device is an extension set for administering fluids or medications with infusion pumps, not for diagnosing conditions.
No
The device description clearly describes physical components like tubing, filters, and valves, indicating it is a hardware device, not software-only.
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 CADD pumps. This is a therapeutic or drug delivery function, not a diagnostic one.
- Device Description: The description focuses on the physical components and their function in delivering fluids/medications, such as tubing, filters, and valves. There is no mention of analyzing samples from the body to diagnose a condition.
- Lack of IVD Indicators: The text does not contain any of the typical indicators of an IVD, such as:
- Analyzing biological samples (blood, urine, tissue, etc.)
- Detecting or measuring substances in samples
- Providing information for diagnosis, monitoring, or screening of diseases
The device is an accessory for drug delivery pumps, designed to facilitate the administration of medications or fluids into a patient's body.
N/A
Intended Use / Indications for Use
" The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps. "
"The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump."
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
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)
A. Functional Testing
Functional testing performed on the sets to establish their operating parameters.
Biocompatibility testing was conducted on the set components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the Extension Sets with Microbore Tubing due to their similarity in materials, design and function to current SIMS Deltec commercially available extension sets.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification and the materials used in the sets are biocompatible. Therefore, these sets are 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
DEC 1 7 1997
Extension Sets with Microbore Tubing
October 20, 1997
GENERAL INFORMATION L
| 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. (612) 628-7166 |
| Common/Usual Name: | Extension Set |
| Proprietary Name: | Extension Set with Microbore Tubing |
| Equivalence Device
Comparison: | Extension Set with Anti-Siphon Valve
(manufactured by SIMS Deltec, Inc.)
Micro-Volume Extension Set with 0.22 µ Filter
(manufactured by Baxter Healthcare Corp.) |
II. DEVICE DESCRIPTION
The purpose of this submission is to offer an alternative, as a matter of customer preference, to the current commercially available SIMS Deltec Extension Sets. The Extension Sets have been modified to include microbore tubing for use in microinfusions and a new compatible female luer on two of the sets. A 0.2 micron filter has been included on two of the sets and is an air eliminating filter similar to the filter on the Baxter Extension Set. An anti-siphon valve is included on one of the sets and is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
1
INTENDED USE OF DEVICE Ш.
The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for use with the CADD-Micro® pump.
The Extension Set with Anti-Siphon Valve must be used with the MEDICATION CASSETTE™ reservoir to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
| | Extension Set with
microbore tubing | Extension Set with
microbore tubing and
0.2 μ filter | Extension Set with
microbore tubing, 0.2
μ filter, and anti-
siphon valve | Extension Set with
anti-siphon valve
K942046 | Micro-Volume
Extension Set with
0.22 μ Filter
K811463 |
|-------------------------|---------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------|
| MANUFACTURER | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | SIMS Deltec, Inc. | Baxter Healthcare
Corporation |
| INTENDED USE | The Extension Set with
microbore tubing
attaches to the Micro
Medication Reservoir for
use with the CADD-
Micro® pump. | The Extension Set with
microbore tubing
attaches to the Micro
Medication Reservoir for
use with the CADD-
Micro® pump. | The Extension Set with
Anti-Siphon Valve must
be used with the
MEDICA-TION
CASSETTE™ reservoir
to protect against
unregulated gravity
infusion that can result
from an improperly
attached reservoir. | The Extension Set with
Anti-Siphon Valve is an
accessory for fluid
delivery devices. It is
design-ed to protect
against unregulated
gravity infusion from
improperly attached
administration sets used
with mechanical infusion
pumps in vulnerable
patients. | |
| DIMENSIONS
(Nominal) | | | | | |
| LENGTH | 45 inches | 60 inches | 60 inches | 4 inches or 60 inches | 60 inches |
| TUBING LD. | 0.020 inches | 0.020 inches | 0.020 inches | 0.040 inches | |
| TUBING O.D. | 0.088 inches | 0.088 inches | 0.088 inches | 0.105 inches | |
| FILTER | NO | YES | YES | NO | YES |
| ANTI-SIPHON
VALVE | NO | NO | YES | YES | NO |
IV. DEVICE COMPARISON
2
SUMMARY OF STUDIES V.
A. Functional Testing
Functional testing performed on the sets to establish their operating parameters.
Biocompatibility testing was conducted on the set components.
B. Clinical Studies
Clinical studies were not deemed necessary regarding the Extension Sets with Microbore Tubing due to their similarity in materials, design and function to current SIMS Deltec commercially available extension sets.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the Extension Sets with Microbore Tubing function according to specification and the materials used in the sets are biocompatible. Therefore, these 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 stylized caduceus symbol, which is a staff with two snakes coiled around it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 17 1997
Mr. Edward W. Numainville Mr. Baward W. Ramatillatory Affairs and Quality Systems Sims Deltec, Incorporated 1265 Grey Fox Road 55112 St. Paul, Minnesota
K974013 Re : Extension Set with Microbore Tubing, Trade Name: Extension Set with Microbore Tubing and 0.2 µ Filter Requlatory Class: II Product Code: FPA Dated: October 20, 1997 Received: October 22, 1997
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. ਜੋ substantially equivalent determination assumes compliance with the current Good Manufacturing Practice requirement, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic (OS) inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP requlation may result in regulatory In addition, FDA may publish further announcements action. concerning your device in the Federal Register. Please note: this response to your premarket notification submission does
4
Page 2 - Mr. Numainville
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 requlations.
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 regulation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4618. 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 gener 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.qov/cdrh/dsmamain.html".
Sincerely yours,
Timothy A. Ulatowski
Timot hy A. Ulatowski Director Division of Dental, Infection Control and General Hospital Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
5
510(k) Number (if known):
Device Name: Extension Set with Microbore Tubing, 0.2 u Filter, and Anti-Siphon Valve
Indications for Use:
" The Extension Set with Anti-Siphon Valve attaches to the MEDICATION CASSETTE™ reservoir for the administration of fluids or medications with CADD® pumps. "
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Litera Cucente
(Division Sign-Off) Division of Dental, Infection Control, and General Flospital Devices 510(k) Number ________________________________________________________________________________________________________________________________________________________________
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The Counter Use _________________________________________________________________________________________________________________________________________________________
6
. . . . . . . .
510(k) Number (if known):
Device Name: Extension Set with Microbore Tubing, or Extension Set with Microbore Tubing and 0.2 u Filter
Indications for Use:
"The Extension Set with microbore tubing attaches to the Micro Medication Reservoir for the administration of fluids or medications with the CADD-Micro® pump."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Fabian Cusati
(Division Sign-Off) Division of Dental, Infection Control, and General Hospital B r : ^/k) Number _
Prescription Use レ (Per 21 CFR 801.109)
OR
Over-The Counter Use -------