(32 days)
Not Found
Not Found
No
The summary describes a mechanical administration set and accessories for fluid delivery, with no mention of AI/ML capabilities or data processing.
No
The device is an administration set and accessories designed to deliver fluids, but it does not directly treat or diagnose a medical condition.
No
The device is an administration set and accessories designed for fluid delivery using infusion pumps, not for diagnosing medical conditions.
No
The device description clearly outlines physical components like administration sets, reservoirs, security shells, and valves, indicating it is a hardware-based medical device.
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 a flexible remote bag with female luer connector" using infusion pumps. This describes a device used for administering fluids into the body, not for testing samples from the body to diagnose conditions.
- Device Description: The description focuses on the components and function of an administration set for delivering fluids, including reservoirs, security shells, and an antisiphon valve. This aligns with the function of an infusion set.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), detecting analytes, or providing diagnostic information.
IVD devices are specifically designed to be used in vitro (outside the body) to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is clearly in vivo (within the body) administration of fluids.
N/A
Intended Use / Indications for Use
"The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector."
Product codes (comma separated list FDA assigned to the subject device)
FPA
Device Description
The purpose of this submission is to offer an additional CADD® Administration Set that can be used with three new accessories; i.e. a 250 ml Flexible Medication Reservoir, a Modified Security Shell, and a Security Shell Adapter; for the delivery of fluids with SIMS Deltec CADD® ambulatory infusion pumps. The Modified Security Shell and Security Shell Adapter provide a "locked" compartment for the 250 ml Flexible Medication Reservoir to deter unauthorized access to its contents. An add-on antisiphon valve is included with the set. This valve 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)
Functional Testing: Biocompatibility testing was conducted on the set's fluid path components.
Clinical Studies: Clinical studies were not deemed necessary regarding the CADD® Administration Set and Accessories due to their similarity in materials, design and function to other SIMS Deltec products and the Sabratek Set and Accessories.
Conclusions Drawn from the Studies: The results of the testing indicated that the fluid path materials used in the CADD® Administration Set and Accessories are biocompatible. Therefore, these products 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.
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
2/12/99
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS
CADD® Administration Set and Accessories
January 6, 1999
GENERAL INFORMATION I.
| 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 and Accessories |
| Proprietary Name: | CADD® Administration Set
CADD® 250 ml Flexible Medication Reservoir
Modified Security Shell
Security Shell Adapter |
| Equivalence Device
Comparison: | CADD® Administration Set
(manufactured by SIMS Deltec, Inc.)
SabrasetTM 560500-100 Administration Set with 100 ml
Bag and Cassette
(manufactured by Sabratek) |
II. DEVICE DESCRIPTION
The purpose of this submission is to offer an additional CADD® Administration Set that can be used with three new accessories; i.e. a 250 ml Flexible Medication Reservoir, a Modified Security Shell, and a Security Shell Adapter; for the delivery of fluids with SIMS Deltec CADD® ambulatory infusion pumps. The Modified Security Shell and Security Shell Adapter provide a "locked" compartment for the 250 ml Flexible Medication Reservoir to deter unauthorized access to its contents. An add-on antisiphon valve is included with the set. This valve is designed to protect against unregulated gravity infusion that can result from an improperly attached reservoir.
1
ロ. INTENDED USE OF DEVICE
The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector.
DEVICE COMPARISON IV.
| | SIMS Deltec CADD® | Sabratek Sabraset™
560500-100 | |
|----------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------|
| | Administration Set with
Accessories | Administration Set with
100 ml Bag & Cassette | SIMS Deltec CADD®
Administration Set |
| INTENDED USE | The CADD® Admin-
istration Set is designed to
be used with Deltec
CADD® Pumps to allow
fluid delivery from a
flexible remote bag with
female luer connector. | For use with the Sabratek
6060 Homerun® pump. | The CADD® Admin-
istration Set is designed to
be used with a variety of
Deltec CADD® Pumps to
allow fluid delivery from a
remote bag. |
| CAN BE USED WITH
REMOTE FLEXIBLE
RESERVOIR | YES | YES | YES |
| CAN BE USED WITH
AN ENCLOSURE AND
REMOTE FLEXIBLE
RESERVOIR TO
LIMIT ACCESS TO
MEDICATION | YES
(Modified Security Shell,
Security Shell Adapter,
and 250 ml Flexible
Medication Reservoir)
Subject of this submission. | YES | YES |
| FREE FLOW
PROTECTION
MECHANISM | YES
(Add-on anti-siphon
valve) | UNKNOWN | YES
(Add-on anti-siphon
valve) |
| DIMENSIONS
(NOMINAL) | | | |
| LENGTH | 69 in. | 56 in. | 77 in. |
| TUBING I.D. | 0.040 in. | UNKNOWN | 0.040 in. |
| TUBING O.D. | 0.105 in. | UNKNOWN | 0.105 in. |
| PRIMING VOLUME | 2 ml | 3 ml | 2.3 ml |
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510(k) Summary of Safety and Effectiveness Page 3 of 3
V. SUMMARY OF STUDIES
Functional Testing A.
Biocompatibility testing was conducted on the set's fluid path components.
Clinical Studies B.
Clinical studies were not deemed necessary regarding the CADD® Administration Set and Accessories due to their similarity in materials, design and function to other SIMS Deltec products and the Sabratek Set and Accessories.
C. Conclusions Drawn from the Studies
The results of the testing indicated that the fluid path materials used in the CADD® Administration Set and Accessories are biocompatible. Therefore, these products 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 circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" arranged around the top half. Inside the circle is an abstract symbol resembling an eagle or a stylized human figure, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 2 1999
Mr. Edward W. Numainville Vice President, Regulatory Affairs and Quality Systems SIMS Deltec, Incorporated 1265 Grey Fox Road St. Paul, Minnesota 55112
Re : K990083 Trade Name: CADD® Administration Set, and Accessories Regulatory Class: II Product Code: FPA Dated: January 6, 1999 Received: January 11, 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 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 (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. ਰੈ 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 Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of
4
Page 2 - Mr. Numainville
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 marketed produces or mits 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
Directør 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: CADD Administration Set with Accessories
Indications for Use:
"The CADD® Administration Set is designed to be used with Deltec CADD® Pumps to allow fluid delivery from a flexible remote bag with female luer connector."
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use V (Per 21 CFR 801.109) OR
Over-The Counter Use _________________
Palacios Crescenti
(Division Sign-Off)
Division of Dental, Infection Control, and General Hospital Devices 510(k) Number _