SteadiSet Infusion Set

K242692 · Capillary Biomedical, LLC · FPA · May 9, 2025 · General Hospital

Device Facts

• Record ID: K242692
• Device Name: SteadiSet Infusion Set
• Applicant: Capillary Biomedical, LLC
• Product Code: FPA · General Hospital
• Decision Date: May 9, 2025
• Decision: SESE
• Submission Type: Abbreviated
• Regulation: 21 CFR 880.5440
• Device Class: Class 2
• Attributes: Therapeutic

Indications for Use

The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use. Rx - For Prescription Use Only SteadiSet infusion set is neither intended nor indicated for use with blood, blood products, or intravenous infusion (IV). Replace the infusion set and tubing every 2-3 days per your healthcare professional's instructions. SteadiSet Infusion Set is a single-use device and should be disposed of immediately after use. Do not clean, re-sterilize, or re-use the set. This may cause damage to the set and may lead to infection, site irritation, or inaccurate delivery. SteadiSet is not indicated for use in an MRI environment or during radiation therapy. Remove the infusion set prior to MRI or radiation therapy. The SteadiSet infusion set with t:lock tubing connector should only be used with Tandem cartridges featuring the t:lock connector.

Device Story

Sterile, single-use intravascular administration set; delivers insulin from external pump reservoir to subcutaneous tissue via soft cannula. Components: inserter, tube set, disconnect cover. Inserter housing with buttons facilitates 35-degree cannula insertion; cannula consists of soft polyether amide TPE extruded over stainless-steel coil. Tube set connects reservoir to hub; features t:lock connector for compatibility with specific Tandem cartridges. Used by patients in home or clinical settings; operated by patient or caregiver. Device provides insulin pathway; disconnect cover allows temporary separation from hub. Benefits: enables continuous subcutaneous insulin delivery; reduces site irritation/infection risk through single-use design. Healthcare provider prescribes device; patient manages daily infusion and site rotation every 2-3 days.

Clinical Evidence

No clinical data. Evidence consists of bench testing, including mechanical integrity (cannula pull, hub/tubing pull, tubing elongation), performance testing (mass flow rate, pressure leak, priming, insertion force/depth), usability/human factors validation, biocompatibility (ISO 10993 series), sterilization validation (SAL 10^-6), and shipping/shelf-life/aging studies.

Technological Characteristics

Materials: Polyether amide TPE and stainless-steel coil cannula. Sterilization: Ethylene Oxide (ETO). Connectivity: Mechanical t:lock connector for Tandem cartridges. Dimensions: Tubing lengths 5, 23, 32, 43 inches. Insertion: 35 ± 5-degree angle. Standards: ISO 80369-6, ISO 8536-4, ISO 10993 series, ASTM F2096, F1886, F88, F1980, D4169, D4332, F2503, ISO 15223-1, ISO 20417.

Indications for Use

Indicated for subcutaneous insulin infusion via external pump in patients requiring insulin therapy. Single-use only. Contraindicated for blood/blood products, IV use, MRI environments, and radiation therapy.

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

• AutoSoft™ 30 infusion set (K061374)

Submission Summary (Full Text)

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FDA

U.S. FOOD & DRUG

ADMINISTRATION

# 510(k) SUBSTANTIAL EQUIVALENCE DETERMINATION DECISION SUMMARY

## I Background Information:

A 510(k) Number

K242692

B Applicant

Capillary Biomedical, LLC

C Proprietary and Established Names

SteadiSet Infusion Set

D Regulatory Information

| Product Code(s) | Classification | Regulation Section | Panel |
| --- | --- | --- | --- |
| FPA | II | 21 CFR 880.5440 – Intravascular administration set | General Hospital |

E Purpose for Submission:

New Device

## II Intended Use/Indications for Use:

A Intended Use(s):

See Indications for Use below.

B Indication(s) for Use:

The SteadiSet Infusion Set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use.

C Special Conditions for Use Statement(s):

Rx - For Prescription Use Only

SteadiSet infusion set is neither intended nor indicated for use with blood, blood products, or intravenous infusion (IV).

Food and Drug Administration

10903 New Hampshire Avenue

Silver Spring, MD 20993-0002

www.fda.gov

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Replace the infusion set and tubing every 2-3 days per your healthcare professional's instructions.

SteadiSet Infusion Set is a single-use device and should be disposed of immediately after use. Do not clean, re-sterilize, or re-use the set. This may cause damage to the set and may lead to infection, site irritation, or inaccurate delivery.

SteadiSet is not indicated for use in an MRI environment or during radiation therapy. Remove the infusion set prior to MRI or radiation therapy.

The SteadiSet infusion set with t:lock tubing connector should only be used with Tandem cartridges featuring the t:lock connector.

## III Device Description

The device is a sterile, non-pyrogenic, intravascular administration set device used to administer insulin from a reservoir cartridge to a patient subcutaneously through a cannula. The infusion set administers insulin by means of a compatible external pump. The infusion set consists of an inserter, tube set, and disconnect cover. The inserter consists of a housing, insertion buttons, an infusion set hub (with cannula) and adhesive patch with protective liner. The inserter facilitates insertion of the cannula subcutaneously. The cannula is a soft medical-grade polymer extruded over a stainless-steel coil.

The tube set provides the insulin pathway between the hub's indwelling cannula and an external insulin pump cartridge. The tube set consists of infusion set tubing with a reservoir connector (proximal end) and hub connector (distal end). The disconnect cover can be connected to the hub to provide cover when the infusion set tubing is disconnected from the hub.

The device is sterilized by Ethylene Oxide (ETO) and is a single-patient, single-use device to be used for up to 3 days.

## IV Substantial Equivalence Information:

A Predicate Device Name(s):

AutoSoft™ 30 infusion set

B Predicate 510(k) Number(s):

K061374

C Comparison with Predicate(s):

| Device & Predicate Device(s): | K061374 | K242692 |
| --- | --- | --- |

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| Device Trade Name | AutoSoft™ 30 Infusion Set | SteadiSet Infusion Set |
| --- | --- | --- |
| General Device Characteristic Similarities | | |
| Intended Use/Indications For Use | Subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use. | Same |
| Time of Use | 3 days | Same |
| Compatible Devices | Tandem cartridges featuring the t:lock™ connector | Same |
| Sterilization | Ethylene Oxide (ETO) | Same |
| General Device Characteristic Differences | | |
| Cannula Material | Teflon Cannula | Polyether amide TPE & Stainless-Steel coil Cannula |
| Tube Length | 23 and 43 inches | 5, 23, 32, and 43 inches |
| End configuration | Distal Connector Needle | Distal Hub Connector |
| Connect type | Distal Cannula housing click-in | Distal Rotational hub connector |
| Insertion Angel | 30 degrees | 35 ± 5-degrees |
| Cannula Material | Polytetrafluoroethylene (Teflon) | Polyether amide TPE & |

V Standards/Guidance Documents Referenced:

ISO 80369-6, First Edition 2016-03-15 - Small bore connectors for liquids and gases in healthcare applications – Part 6: Connectors for neuraxial applications

ISO 8536-4, Sixth edition 2019-09 Infusion equipment for medical use – Part 4: Infusion sets for single use, gravity feed.

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ASTM F2096-11, Standard Test Method for Detecting Gross Leaks in Packaging by Internal Pressurization (Bubble Test)

ASTM F1886/F1886M-16, Standard Test Method for Determining Integrity of Seals for Flexible Packaging by Visual Inspection

ASTM F88/F88M-23, Standard Test Method for Seal Strength of Flexible Barrier Materials

ASTM F1980-21, Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices

ASTM D4169-22, Standard Practice for Performance Testing of Shipping Containers and Systems

ASTM D4332-22, Standard Practice for Conditioning Containers, Packages, or Packaging Components for Testing

ISO 10993-1 Fifth edition 2018-08, Biological evaluation of medical devices – Part 1: Evaluation and testing within a risk management process.

ISO 10993-2 Third edition 2022-11, Biological evaluation of medical devices – Part 2: Animal welfare

ISO 10993-3 Third edition 2014-10-1, Biological evaluation of medical devices – Part 3: Tests for genotoxicity, carcinogenicity, and reproductive toxicity

ISO 10993-5 Third edition 2009-06-01, Biological evaluation of medical devices – Part 5: Tests for in vitro cytotoxicity

ISO 10993-6 Third edition 2016-12-01, Biological evaluation of medical devices – Part 6: Tests for local effects after implantation

ISO 10993-10 Fourth edition 2021-11, Biological evaluation of medical devices – Part 10: Tests for skin sensitization

ISO 10993-11 Third edition 2017-09, Biological evaluation of medical devices – Part 11: Tests for systemic toxicity

ISO 10993-12 Fourth Edition 2012-07-01, Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

ISO 10993-12 Fifth edition 2021-01, Biological evaluation of medical devices – Part 12: Sample preparation and reference materials

ISO 10993-17 Second Edition 2023-09, Biological evaluation of medical devices – Part 17: Toxicological risk assessment of medical device constituents

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ISO 10993-18 Second edition 2020-01 Amendment 1 2022-05

Biological evaluation of medical devices - Part 18: Chemical characterization of medical device materials within a risk management process [Including Amendment 1 (2022)]

ISO/TS 10993-19 Second edition 2020-03, Biological evaluation of medical devices – Part 19: Physico-chemical, morphological, and topographical characterization of materials

ISO 10993-23 First edition 2021-01, Biological evaluation of medical devices - Part 23: Tests for irritation

ISO/TR 10993-33 First, Biological evaluation of medical devices – Part 33: Guidance on Partial

ISO TS 21726 First edition 2019-02, Biological evaluation of medical devices – Application of the threshold of toxicological concern (TTC) for assessing biocompatibility of medical device constituents.

ASTM F2503-23, Standard Practice for Marking Medical Devices and Other Items for Safety in the Magnetic Resonance Environment

ISO 15223-1 Fourth edition 2021-07, Medical devices – Symbols to be used with information to be supplied by the manufacturer – Part 1: General requirements.

ISO 20417 First edition 2021-04 Corrected version 2021-12 Medical devices – information to be supplied by the manufacturer.

## VI Performance Characteristics:

### A. Analytical Performance

N/A

### B. Other Supportive Instrument Performance Characteristics Data

The following additional tests were conducted:

1. Functional tests

- Mechanical Integrity:
- Cannula Pull
- Hub Connector and Tubing Pull
- Tubing Elongation
- T:lock and Tubing Pull Force

- Performance Tests:
- Mass Flow Rate
- Pressure Leak.
- Tubing and Cannula Priming

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- Insertion Force and Depth

2. Usability/Human Factors
- Simulated-Use Human Factors Validation

3. Biocompatibility
- Cytotoxicity
- Sensitization
- Irritation
- Acute Systemic Toxicity
- Material Mediated Pyrogenicity
- Subacute Toxicity
- Genotoxicity
- Implantation
- Sub-chronic Toxicity

4. Sterilization and Shipping
- Sterility Assurance Level 10-6
- Shipping, Shelf-Life, and Aging Transportation Tests

5. Compatibility Tests
- Drug and Device Compatibility

6. Shelf-Life and Aging Testing

7. Packaging
- Free-fall drop, package sterile barrier testing, and climatic stressing and shipping testing

VII Proposed Labeling:

The labeling supports the finding of substantial equivalence for this device.

VIII Conclusion:

The submitted information in this premarket notification is complete and supports a substantial equivalence decision.