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.

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.

AI/ML Overview

The provided FDA 510(k) Clearance Letter for the SteadiSet Infusion Set does not contain the information requested regarding acceptance criteria and the study that proves the device meets those criteria. This document primarily focuses on demonstrating substantial equivalence to a predicate device based on similar design, materials, and intended use, rather than presenting detailed performance study results against specific acceptance criteria.

The "Non-Clinical Performance Data" section lists various tests performed (e.g., Insertion Force and Depth, Strength of Materials, Biocompatibility, Sterility), but it does not provide:

Specific acceptance criteria values for each test (e.g., "Insertion force must be less than X N").
Reported device performance values (e.g., "Observed insertion force was Y N").
Details about the study methodology for these performance characteristics (e.g., sample size, ground truth establishment, expert involvement).

Therefore, I cannot fulfill most of the request based solely on the provided text. The questions asking about sample sizes, data provenance, number of experts, adjudication methods, MRMC studies, standalone algorithm performance, and ground truth establishment (especially for training sets) are all related to robust clinical or non-clinical performance studies that are not described in this clearance letter.

This type of FDA letter confirms clearance based on a submission, but the detailed study reports themselves are typically much more extensive and are not usually part of the publicly available clearance letter.

Here's a breakdown of what can be inferred or stated based on the provided document, and what is missing:

1. A table of acceptance criteria and the reported device performance

Cannot be provided definitively from this document. The document lists types of tests performed (e.g., "Insertion Force and Depth", "Strength of Materials, Joints, and Connectors"), but it does not specify the quantitative acceptance criteria for these tests nor the measured performance values of the SteadiSet Infusion Set against those criteria. For example, it lists "Insertion Force and Depth" as a test, but doesn't say "Acceptance Criteria: Insertion Force < 10 N, Observed: 8 N".

2. Sample sized used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective)

Cannot be provided from this document. The document does not specify sample sizes for any of the listed "Non-Clinical Performance Data" tests. It also does not mention data provenance details like country of origin or whether studies were retrospective or prospective, as these are typically detailed in the full submission, not the clearance letter.

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/Cannot be provided from this document. This information is typically relevant for AI/ML device studies involving human interpretation (e.g., radiologists for imaging diagnostics). For an infusion set, "ground truth" would be established by bench testing methodologies, physical measurements, and chemical analyses against established standards and specifications, not by human expert consensus or clinical interpretation in the same way. The document does not mention any expert panels or their qualifications for establishing ground truth for the device's technical performance.

4. Adjudication method (e.g. 2+1, 3+1, none) for the test set

Not applicable/Cannot be provided from this document. Similar to point 3, adjudication methods (like 2+1, 3+1 consensus) are typically used for medical image interpretation or clinical outcomes where human judgment needs to be reconciled. For bench tests of an infusion set, performance is measured objectively, and "adjudication" in this sense is not relevant.

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. MRMC studies are specific to AI/ML devices, particularly in medical imaging (e.g., CAD systems assisting radiologists). This is an infusion set, not an AI diagnostic device. Therefore, no MRMC study would have been performed or reported here.

6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done

Not applicable. This is an infusion set, not an AI algorithm. There is no "standalone algorithm performance" to assess.

7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)

Inferred based on the device type: For an infusion set, "ground truth" for the listed "Non-Clinical Performance Data" would be based on:
- Benchtop measurements against engineering specifications: For characteristics like Insertion Force, Tubing Elongation, Priming Volume.
- Validated chemical/biological assays: For Biocompatibility (Cytotoxicity, Sensitization, Irritation, etc.), Sterility.
- Standardized functional tests: For Functional Performance, Tandem Pump Compatibility, Corrosion Testing.
- Simulated-use protocols: For Usability/Human Factors.
- These are based on established standards (e.g., ISO, ASTM, FDA guidance) for medical device evaluation.

8. The sample size for the training set

Not applicable/Cannot be provided from this document. The concept of a "training set" is relevant for AI/ML models. This is a physical medical device. Manufacturing processes involve quality control, but not "training sets" in the AI sense.

9. How the ground truth for the training set was established

Not applicable/Cannot be provided from this document. As "training set" doesn't apply to this physical device, neither does the establishment of its ground truth.

In Summary:

The provided FDA 510(k) clearance letter serves as confirmation that the FDA has found the SteadiSet Infusion Set to be "substantially equivalent" to a legally marketed predicate device (K061374, AutoSoft™ 30 Infusion Set). This determination is based on the information provided in the original 510(k) submission, which would have included detailed reports of the non-clinical performance data and how the device met specific performance criteria. However, the clearance letter itself does not contain the granular data requested about acceptance criteria, detailed study parameters, sample sizes, or ground truth establishment methodologies with quantified results.

Summary

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.

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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
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"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 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

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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.

Regulation Number and Section

§ 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.