(242 days)
Not Found
No
The provided text describes a medical device for insulin infusion and does not mention any AI components.
Yes.
The device is used for the subcutaneous infusion of insulin, which is administered as a treatment for a medical condition (diabetes).
No
The device is an infusion set designed to deliver insulin subcutaneously. It does not perform any diagnostic function.
No
The device description clearly outlines physical components like the inserter, tube set, disconnect cover, cannula, and tubing, and details manufacturing processes like extrusion and sterilization.
No
The device is used for the direct administration of a substance (insulin) into the body, not for performing tests on samples taken from the body.
N/A
Intended Use / 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.
Product codes
FPA
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
subcutaneous
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
Not Found
Summary of Performance Studies
Bench Testing: Insertion Force and Depth, Strength of Materials, Joints, and Connectors, Tubing and Cannula Priming, 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
The different technological characteristics of the devices do not raise new questions of safety and effectiveness.
Key Metrics
Not Found
Predicate Device(s)
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.
FDA 510(k) Clearance Letter - SteadiSet Infusion Set
Page 1
U.S. Food & Drug Administration
10903 New Hampshire Avenue Doc ID # 04017.07.05
Silver Spring, MD 20993
www.fda.gov
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"
Page 2
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.
Page 3
K242692 - Kristina Nistler Page 3
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 (DICE@fda.hhs.gov) or phone (1-800-638-2041 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
Page 4
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
Form Approved: OMB No. 0910-0120
Expiration Date: 07/31/2026
See PRA Statement below.
Indications for Use
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)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services
Food and Drug Administration
Office of Chief Information Officer
Paperwork Reduction Act (PRA) Staff
PRAStaff@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
Page 5
510(k) Summary
Date: September 5, 2024
I. SUBMITTER
Address
Capillary Biomedical, Inc
2 Wrigley, Suite 100
Irvine, California 92618 USA
+1 (858-366-6900)
Contact Person
Karen Mudd, PhD
Director, Regulatory Affairs
Phone: +1 (805) 403-9454
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.
Page 6
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 |
Page 7
| 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.