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.
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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.
K242692 - Page 3 of 6
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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
K242692 - Page 4 of 6
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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
K242692 - Page 5 of 6
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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.
Two short videos show you everything — or skip straight to the written tutorial if you'd rather read. You can reopen this any time from the Tutorial button in the top bar.
Part 1 — Search, results, and everyday workflows 16 min
Part 2 — Embeddings: the galaxy map 3 min
1. Search: exact and fuzzy
Type a phrase like "coronary artery calcification" into the search box. You get two kinds of results. Exact results match the literal phrase — prefix searches work ("coronary artery calcificati") but suffix searches do not. Fuzzy results match on the meaning and intent of your phrase rather than the exact words, and are sorted by relevance score. Hover over the Exact or Fuzzy badge on any row to see exactly why it matched.
Use the checkboxes above the results to narrow: SaMD keeps only software-only devices, AI / ML keeps only devices with AI.
Exact vs. fuzzy search: what's the difference?
Exact matches on the literal phrase (prefix search works, suffix does not). Fuzzy matches on the meaning and intent of the phrase rather than the exact words. Hover over the badge on any row to see why it matched.
You search "coronary artery calcification" and want only software devices with AI. What two filters do you apply?
Narrow by SaMD (software-only devices), then narrow by AI/ML (devices with AI).
2. The results table
Scroll right in the results table. The intended use is extracted for you — no need to open the PDF. The device story gives a high-level snapshot of what the device does and how it's used. The AI Performance sub-table shows each output name, acceptance criteria, observed values, and development/test dataset descriptions — the same format Innolitics uses for regulatory strategy outputs, and the fastest high-level fingerprint of an AI device. It is AI-generated but has been very reliable in practice.
Where do you find a device's intended use without opening the PDF?
Scroll right in the search results table. The intended use column is extracted for you; no need to dig into the 510(k) summary PDF.
What does the AI Performance sub-table show, and why is it useful?
Output name, acceptance criteria, observed values, development dataset description, and test dataset description. It's the same format we use for regulatory strategy output and Fast 510(k) input, and the fastest high-level fingerprint of an AI device. AI-generated but reliable in practice.
3. Judging fuzzy relevance
Fuzzy results trail off in relevance as you scroll. Use three signals to decide how far down to go: the fuzzy badge explanations, the intended use column, and whether your target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, you're past the relevant zone. A top hit with a low score (~0.4) and a stretched explanation is a hint the closest predicates are far away — the project may be headed for De Novo. Note the fuzzy search is a pattern match: it doesn't handle negation ("not") well, and hardware devices can appear — filter by SaMD/AI ML to cut them.
How do you judge how far down fuzzy search results to go?
Use the relevancy signals: the fuzzy badge explanations, the intended use column, and whether the target output (e.g., Cobb angle) still appears in the AI Performance sub-table. Once it stops appearing, results are trailing off in relevancy.
4. Device detail page: chat and citations
Click a device name to open its detail page: device facts on the left, a chat window on the right. Ask something like "Describe the training data". The answer carries little citation bubbles — click one to jump to the highlighted passage in the source PDF, so you can verify every AI answer against the document. There's also a Download PDF button for sharing.
How do you verify an AI chat answer on the device detail page?
Click the citation bubbles to jump to the relevant highlight in the source document.
Reading rule for every project: how many summaries do you read in full?
At least the three most relevant 510(k) or De Novo summaries, in full. After that, use targeted chat questions to confirm your memory quickly. The tool supports this professional habit — it doesn't replace it.
5. Side-by-side comparison
Select multiple rows in the results table (aim for under ~10), then open the PDF Viewer tab. Ask one question — it goes to all selected devices in parallel, each with citations. This is the fastest way to compare and contrast devices: training data, PCCP scope, how they handled adding new scanners, and so on.
What does the side-by-side PDF viewer mode do?
Select multiple devices, open the PDF viewer tab, and ask one question (e.g., "Describe the training data"). It queries all selected devices simultaneously with citations, so you can compare and contrast quickly.
6. Collections
With rows selected, go to the Collections tab and create a labeled collection (e.g., "Cobb Angle Project"). Reload that selection any time — before a client call, pull up the collection and ask questions across all of its devices at once.
How do you save a set of selected devices for later use?
Select the rows, go to the Collections tab, and create a labeled collection (e.g., "Cobb Angle Project"). You can reload the selection anytime and carry it into the PDF viewer and other tabs that support selections.
7. Product codes and the regulations tree
Click a product code in the results to jump to it in the regulations tree — identification text, sibling product codes, and devices you can open in a PDF viewer on the right. Click a regulation number to see its identification, special controls, and related product codes. You can also search by product code or regulation number at the top of the tree. Always read the special controls if any exist for your device — it broadens your search and sharpens pre-kickoff research.
What can you do from the regulations tree view?
Browse product codes and regulation numbers, read the identification text and special controls, browse sibling product codes, open device PDFs on the right, and search by product code or regulation number at the top of the tree.
8. Chart view
Click Show Chart and segment by regulation number (or product code) to see which regulations dominate your result set. Clicking a regulation takes you into the regulations tree. Great for spotting that most matches are, say, hardware laparoscopic devices — a cue to go back and filter.
How do you see which regulations dominate a search result set?
Click "Show Chart" and segment by Regulation Number. Clicking a regulation takes you to the regulations tree.
9. The predicate graph
Open the Predicates tab for a family-tree view of predicate relationships. Click a node to trace its parents and children; selections from search carry over pre-selected. Commonly predicated devices are worth reading — a lot of people predicated them for a reason. The visual lineage is also handy on client calls, e.g. to show how a predicate family evolved and justify why your predicate still holds.
In the predicate graph, why are commonly predicated devices worth reading?
A lot of people predicated them for a reason. Clicking a node traces parents and children, and selections from search carry over pre-selected.
10. Embeddings: the galaxy map
The Embeddings tab plots every matching document in a 2-D "galaxy map" where semantically similar devices cluster together. Hover or click clusters to explore, and let AI label the clusters for you. Embeddings beat product codes for grouping: two devices can carry different product codes (LLZ vs. QIH) yet do the same thing — the embedding captures the meaning of the intended use and device story. This is also exactly how retrieval-augmented generation (RAG) works under the hood, and it makes a great visual on client calls.
Try it yourself
Head to the search page and work through a few of these AI/ML fuzzy searches to build intuition: perivascular fat on CT · aortic valve calcification opportunistic screening on noncontrast CT · breast cancer prediction on digital pathology slides · autism detection · gestational age prediction · a hearing aid that can also detect a pulse · foundation model based analysis of ECG · large language models · penetration test. Watch how the relevance scores, intended use, and AI Performance tables tell you when results stop being meaningful.
