iiSure Infusion Set

K261530 · Deka Research and Development · FPA · Jun 3, 2026 · General Hospital

Device Facts

• Record ID: K261530
• Device Name: iiSure Infusion Set
• Applicant: Deka Research and Development
• Product Code: FPA · General Hospital
• Decision Date: Jun 3, 2026
• Decision: SESE
• Submission Type: Special
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic, Pediatric

Indications for Use

The iiSure Infusion Set is indicated for the subcutaneous infusion of insulin, administered by an external pump. The infusion set is indicated for use with adult and pediatric users weighing greater than 10 kg. The infusion set is indicated for single-use.

Device Story

Sterile, single-use subcutaneous infusion set; establishes sealed fluid path from external portable insulin pump to patient. Components include 6 mm, 90° soft polypropylene cannula; preloaded mechanical inserter; tubing (23-inch or 3.5-inch configurations); Luer connector. Inserter features automatic needle retraction after insertion. Used in clinical or home settings by patients or caregivers. Patient prepares site, uses inserter to place cannula in subcutaneous tissue (abdomen, leg, buttocks, hips, arms, or back), and connects to pump. Enables continuous insulin delivery; tubing allows disconnection/reconnection. Benefits include reliable insulin administration and extended wear duration (up to 96 hours).

Clinical Evidence

No clinical data or animal studies were required. Substantial equivalence supported by bench testing, including insulin compatibility testing (96-hour duration) and performance testing for shipping, storage, sterile barrier integrity, and device functionality for the extended 2-year shelf life.

Technological Characteristics

Sterile, single-use subcutaneous infusion set. Cannula: 6 mm, 90°, polypropylene. Tubing: 23-inch or 3.5-inch lengths, Luer lock connection. Inserter: Mechanical, preloaded, automatic needle retraction. Biocompatibility: ISO 10993-1 compliant. Sterilization: Ethylene Oxide (EO), SAL 10^-6. Wear duration: 96 hours. Shelf life: 2 years.

Indications for Use

Indicated for subcutaneous insulin infusion via external pump in adult and pediatric patients weighing >10 kg. Single-use only.

Regulatory Classification

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.

Special Controls

*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.

Predicate Devices

• iiSure Infusion Set (K261530 - original clearance)

Submission Summary (Full Text)

{0}

FDA

U.S. FOOD & DRUG

ADMINISTRATION

# SPECIAL 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K261530

B Applicant

Deka Research and Development

C Proprietary and Established Names

iiSure Infusion Set

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| FPA | Intravascular administration set | 880.5440 | General Hospital |

## II Review Summary:

This 510(k) submission contains information/data on modifications made to the submitter's own CLASS II device requiring 510(k). The following items are present and acceptable.

1. The name and 510(k) number of the SUBMITTER'S previously cleared device. (For a preamendments device, a statement to this effect has been provided.)
2. Submitter's statement that the INDICATIONS FOR USE/INTENDED USE of the modified device as described in its labeling HAS NOT CHANGED along with the proposed labeling which includes instructions for use, package labeling, and, if available, advertisements or promotional materials (labeling changes are permitted as long as they do not affect the intended use).
3. A description of the device MODIFICATION(S), including clearly labeled diagrams, engineering drawings, photographs, user's and/or service manuals in sufficient detail to demonstrate that the FUNDAMENTAL SCIENTIFIC TECHNOLOGY of the modified device has not changed. This change was for updating the device name, adding a 3.5-

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

{1}

K261530 - Page 2 of 2

inch tubing set configuration, extending the duration of use from 72 to 96 hours, extending the shelf life, and minor modifications to the materials used in the finished device.

4. Comparison Information (i.e., similarities and differences) to the submitter's legally marketed predicate device including, labeling, intended use, and physical characteristics.

5. A Design Control Activities Summary which includes:

a) Identification of Risk Analysis method(s) used to assess the impact of the modification on the device and its components, and the results of the analysis.

b) Based on the Risk Analysis, an identification of the verification and/or validation activities required, including methods or tests used and acceptance criteria to be applied.

The labeling for this modified subject device has been reviewed to verify that the indication/intended use for the device is unaffected by the modification. In addition, the submitter's description of the particular modification(s) and the comparative information between the modified and unmodified devices demonstrate that the fundamental scientific technology has not changed. The submitter has provided the design control information as specified in The New 510(k) Paradigm and on this basis, I recommend the device be determined substantially equivalent to the previously cleared (or their preamendment) device.