(77 days)
Not Found
None
No
The summary describes a simple mechanical infusion set with no mention of AI or ML capabilities, image processing, or performance metrics typically associated with AI/ML devices.
No.
The device facilitates fluid infusion but does not directly treat a disease or medical condition.
No
Explanation: The device is intended to facilitate subcutaneous infusion of fluids, which is a treatment delivery function, not a diagnostic one.
No
The device description explicitly states it consists of physical components: a needle, wing, extension tubing, and female luer. This indicates it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "to facilitate subcutaneous infusion of fluids." This describes a device used to deliver substances into the body, not to test samples from the body.
- Device Description: The description of a needle, tubing, and luer is consistent with a device for administering fluids, not for performing diagnostic tests on biological samples.
- Lack of IVD Characteristics: There is no mention of analyzing biological samples (blood, urine, tissue, etc.), reagents, or any process related to diagnosing a condition based on in vitro testing.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device's function is purely for delivery of fluids into the body.
N/A
Intended Use / Indications for Use
The subject device is intended to facilitate subcutaneous infusion of fluids.
Product codes
Not Found
Device Description
The Deltec Subcutaneous Infusion Set consists of a needle with attached wing, extension tubing and female luer.
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
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Summary of Performance Studies
Functional Testing: The subject device is designed to meet certain functional requirements related to tubing to needle and luer to tubing bond strength.
Clinical Studies: Not deemed necessary.
Key Metrics
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Predicate Device(s)
Not Found
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 Date Prepared: May 20, 1996
I. GENERAL INFORMATION
OCT 1 8 1996
| Applicant's name and address: | SIMS Deltec, Inc. |
|---|---|
| 1265 Grey Fox Road | |
| St. Paul, MN 55112 |
David H. Short Manager, Regulatory Affairs (612)628-7214
II. PRODUCT INFORMATION
Contact:
| Common/Usual Name: | Subcutaneous Infusion Set |
|---|---|
| Classification Name: | Infusion Set |
| Proprietary Name: | Deltec Subcutaneous Infusion Set |
III. EQUIVALENCE DEVICE COMPARISON
SIMS Deltec's Subcutaneous Infusion Set and Micro Med's 42" Winged Sub-Q Infusion Set.
IV. DEVICE DESCRIPTION
The Deltec Subcutaneous Infusion Set consists of a needle with attached wing, extension tubing and female luer.
1
Image /page/1/Picture/0 description: The image contains a series of dark, abstract shapes against a white background. The shapes appear to be randomly distributed and vary in size and form. The shapes are simple and lack any distinct features. The image has a high contrast between the dark shapes and the white background.
510(k) Summary of Safety and Effectiveness Date Prepared: May 20, 1996
IV. DEVICE COMPARISON
Provided in Table 1 is a feature comparison of commercially available subcutaneous infusion sets.
| | Deltec Subcutaneous
Infusion Set | Subcutaneous Infusion
Set | Micro Med 42" Winged
Sub-Q Infusion Set |
|----------------------------------------|-------------------------------------|------------------------------|--------------------------------------------|
| MANUFACTURER | SIMS Deltec Inc. | SIMS Deltec Inc. | Micro Med, Inc. |
| CONFIGURATION | | | |
| needle length
needle angle
gauge | ½ inch
90°
27 | ¾ inch
30°
27 | 0.475 inch
90°
27 |
| tubing length | 42 inches | 30 inches | 42 inches |
| winged needle | yes | yes | yes |
Table 1. Comparison Chart
V. INTENDED USE
The subject device is intended to facilitate subcutaneous infusion of fluids.
SUMMARY OF STUDIES VI.
A. Functional Testing
The subject device is designed to meet certain functional requirements related to tubing to needle and luer to tubing bond strength.
B. Clinical Studies
Clinical studies were not deemed necessary.
VII. CONCLUSION
Based upon the information provided above, the Deltec Subcutaneous Infusion Set is suitable for its intended use.