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

Intended 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

May 9, 2025

Capillary Biomedical, LLC.
Karen Mudd
Director, Regulatory Affairs
2 Wrigley, Suite 100
Irvine, California 92618

Re: K242692
Trade/Device Name: SteadiSet Infusion Set
Regulation Number: 21 CFR 880.5440
Regulation Name: Intravascular Administration Set
Regulatory Class: Class II
Product Code: FPA
Dated: March 31, 2025
Received: March 31, 2025

Dear Karen Mudd:

We have reviewed your section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate 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 (the Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database available at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.

If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.

Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device"

U.S. Food & Drug Administration
10903 New Hampshire Avenue
Silver Spring, MD 20993
www.fda.gov

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K242692 - Kristina Nistler
Page 2

(https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).

Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review, the QS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).

Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801 and Part 809); medical device reporting (reporting of medical device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reporting-combination-products); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.

All medical devices, including Class I and unclassified devices and combination product device constituent parts are required to be in compliance with the final Unique Device Identification System rule ("UDI Rule"). The UDI Rule requires, among other things, that a device bear a unique device identifier (UDI) on its label and package (21 CFR 801.20(a)) unless an exception or alternative applies (21 CFR 801.20(b)) and that the dates on the device label be formatted in accordance with 21 CFR 801.18. The UDI Rule (21 CFR 830.300(a) and 830.320(b)) also requires that certain information be submitted to the Global Unique Device Identification Database (GUDID) (21 CFR Part 830 Subpart E). For additional information on these requirements, please see the UDI System webpage at https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system.

Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-devices/medical-device-safety/medical-device-reporting-mdr-how-report-medical-device-problems.

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K242692 - Kristina Nistler
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For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Joshua Balsam -S

Joshua M. Balsam, Ph.D.
Branch Chief
Division of Chemistry and
Toxicology Devices
OHT7: Office of In Vitro Diagnostics
Office of Product Evaluation and Quality
Center for Devices and Radiological Health

Enclosure

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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Indications for Use
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.

Submission Number (if known)
K242692

Device Name
SteadiSet Infusion Set

Indications for Use (Describe)
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.

Type of Use (Select one or both, as applicable)
☑ Prescription Use (Part 21 CFR 801 Subpart D)
☐ Over-The-Counter Use (21 CFR 801 Subpart C)

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510(k) Summary

Date: September 5, 2024

I. SUBMITTER

Address
Capillary Biomedical, Inc
2 Wrigley, Suite 100
Irvine, California 92618 USA
[phone])

Contact Person
Karen Mudd, PhD
Director, Regulatory Affairs
Phone: [phone]

II. DEVICE

Proprietary / Trade Name
SteadiSet Infusion Set

Common Name
Infusion Set

Classification Name
Intravascular administration set

Classification Regulation
21 CFR 880.5440

Regulatory Class
Class II

Product Code
FPA

III. PREDICATE DEVICE

Predicate Device
K061374, AutoSoft™ 30 Infusion Set

IV. DEVICE BRIEF DESCRIPTION

The subject device, Capillary Biomedical, Inc. SteadiSet Infusion Set, 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.

V. 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.

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VI. COMPARISON OF TECHNOLOGICAL CHARACTERISTICS WITH THE PREDICATE DEVICE

| Item | Predicate Device K061374 | Subject Device |
| --- | --- | --- |
| Product Code | FPA | Same |
| Regulation Number | 21 CFR 880.5440 | Same |
| Indication for Use/Intended Use | The AutoSoft™ 30 infusion set is indicated for the subcutaneous infusion of insulin administered by an external pump. The infusion set is indicated for single use | Same |
| Use Type | Single Use | Same |
| Time of Use | 3 days | Same |
| Compatible Devices | Tandem cartridges featuring the t:lock™ connector | Same |
| Sterilization | Ethylene Oxide (ETO) | Same |
| Material Composition | | |
| Metallic Components | Yes | Same |
| PVC Plasticizers | No | Same |
| Additives | Colorant Pigments | Same |
| Cannula Material | Teflon Cannula | Polyether amide TPE & Stainless-Steel coil Cannula |
| Physical Specifications | | |
| Dimensions | ID 0.38mm | Same |
| | OD 1.50mm | Same |
| | Tube Length 23 and 43 inches | Tube Length 5, 23, 32, and 43 inches |
| | Cannula Length 13mm | Same |
| Priming Volume | ≤0.2 mL | Same |
| End Configuration | Distal Connector Needle | Distal Hub Connector |
| | Proximal Reservoir Connector | Same |
| Connector Type | Distal Cannula housing click-in | Distal Rotational hub connector |
| | Proximal t:lock reservoir connector | Same |
| Tubing Color | No colorant Clear/transparent | Same |

VII. NON-CLINICAL PERFORMANCE DATA

| Performance Characteristic | Testing Performed |
| --- | --- |
| Bench Testing | Insertion Force and Depth |
| | Strength of Materials, Joints, and Connectors |
| | Tubing and Cannula Priming |

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| | Tubing Elongation |
| --- | --- |
| | Functional Performance |
| | Tandem Pump Compatibility |
| | Corrosion Testing |
| Usability/Human Factors | Simulated-Use Human Factors Validation |
| Biocompatibility | Cytotoxicity |
| | Sensitization |
| | Irritation |
| | Acute Systemic Toxicity |
| | Material Mediated Pyrogenicity |
| | Subacute Toxicity |
| | Genotoxicity |
| | Implantation |
| | Sub-chronic Toxicity |
| Sterilization and Shipping | Sterility Assurance Level 10^{-6} |
| | Shipping, Shelf-Life, and Aging |

## VIII. SUBSTANTIAL EQUIVALENCE DISCUSSION SUMMARY

Guidance document, The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)] July 28, 2014, was consulted in determining substantial equivalence between the subject and predicate device.

The predicate device is legally marketed. The predicate device labeling has been reviewed and is consistent with IFU statements for the subject device. The devices have the same intended use. As shown in comparison table above, the design, materials, energy source and other features of the devices have been reviewed. There are differences noted between the two devices, indicating that the devices do not have the same technological characteristics as defined in section 513(i)(1)(B) of the FD&C Act and 21 CFR 807.100(b)(2)(ii)(A). The different technological characteristics of the devices do not raise new questions of safety and effectiveness.

## IX. CONCLUSIONS

Per the comparison and analysis above, the subject device is determined to be substantially equivalent (SE) to the predicate device.