(77 days)
The subject device is intended to facilitate subcutaneous infusion of fluids.
The Deltec Subcutaneous Infusion Set consists of a needle with attached wing, extension tubing and female luer.
This document is a 510(k) summary for a medical device called the "Deltec Subcutaneous Infusion Set." It seems to be for a simple, non-AI-powered device. Therefore, the questions related to AI/algorithm performance, ground truth, expert adjudication, and training/test sets are not applicable.
Here's how to address the relevant parts of your request based on the provided text:
1. A table of acceptance criteria and the reported device performance
| Acceptance Criteria (Functional Requirements) | Reported Device Performance |
|---|---|
| Tubing to needle bond strength | Met (implied by "designed to meet") |
| Luer to tubing bond strength | Met (implied by "designed to meet") |
Note: The document states the device is "designed to meet certain functional requirements related to tubing to needle and luer to tubing bond strength" but does not explicitly provide numerical acceptance criteria or specific test results. The conclusion that "the Deltec Subcutaneous Infusion Set is suitable for its intended use" implies these functional requirements were met.
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)
Not applicable. This device is a physical infusion set, not an AI/algorithm-driven device that uses a "test set" in the context of data. No clinical studies were performed.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g. radiologist with 10 years of experience)
Not applicable. This is not an AI/algorithm device requiring ground truth established by experts.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable.
5. If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
Not applicable. This is not an AI/algorithm device.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This is a physical medical device, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
Not applicable.
8. The sample size for the training set
Not applicable.
9. How the ground truth for the training set was established
Not applicable.
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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.
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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 SubcutaneousInfusion Set | Subcutaneous InfusionSet | Micro Med 42" WingedSub-Q Infusion Set | |
|---|---|---|---|
| MANUFACTURER | SIMS Deltec Inc. | SIMS Deltec Inc. | Micro Med, Inc. |
| CONFIGURATION | |||
| needle lengthneedle anglegauge | ½ inch90°27 | ¾ inch30°27 | 0.475 inch90°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.
§ 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.