The intended use for the SmartSite Valve and sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle. This new indication will allow the SmartSite Valve and qualified sets to also be used with low pressure power injectors for which the maximum pressure setting is 325 psi. When used with a power injector, the SmartSite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for up to 325 psi.
Device Story
SmartSite Needle Free Valve Administration Sets facilitate IV fluid, medication, and blood product delivery. The device features a needle-free valve allowing clinicians to add medications to primary infusion lines without needles. The system is used in healthcare facilities, home care, and medical transport. This notification adds an indication for use with low-pressure power injectors (up to 325 psi). When used with power injectors, the valve must be secured via luer lock to compatible, pressure-rated components. The device design, materials, and operation remain unchanged from the predicate. The valve provides a closed system for fluid access, reducing needle-stick risks for healthcare providers and facilitating safe, efficient medication administration.
Clinical Evidence
Bench testing only. No clinical data provided.
Technological Characteristics
Needle-free valve administration set. Materials and design are identical to the predicate device (K960280). Compatible with luer lock connections. Rated for low-pressure power injection up to 325 psi.
Indications for Use
Indicated for use in professional healthcare environments, home care, and medical transport for the delivery of fluids, medications, blood, and blood products via infusion systems. Compatible with low-pressure power injectors up to 325 psi.
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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#### JUL 26 2006 SUMMARY OF SAFETY AND EFFECTIVENESS
# Cardinal Health 303, Inc. DBA Cardinal Health, Alaris® Products
#### SmartSite Valve Sets with Additional Indication
#### SUBMITTER INFORMATION
| A. | Company Name: | Cardinal Health, Alaris® Products | |
|----|--------------------------------|-----------------------------------------------------|--|
| B. | Company Address: | 10221 Wateridge Circle<br>San Diego, CA 92121-2733 | |
| C. | Company Phone:<br>Company Fax: | (858) 458-7830<br>(858) 458-6114 | |
| D. | Contact Person: | Stacy L. Lewis<br>Sr. Regulatory Affairs Specialist | |
| E. | Date Summary Prepared: | May 5, 2006 | |
| | ICE IDENTIFICATION | | |
| A. | Generic Device Name: | Administration Set | |
| B. | Trade/Proprietary Name: | SmartSite Needle Free Valve<br>Administration Sets | |
| C. | Classification: | Class II | |
| D. | Product Code: | FPA, Intravascular Administration Set | |
### DEVICE DESCRIPTION
DEVI
As originally submitted, the SmartSite Administration Sets (K960280) are intended to be used for IV administration of drugs and fluids, and the specific purpose for the SmartSite Valve is to allow the user to add drugs and fluids into the primary line without the use of a needle. This Traditional 510(k) Premarket Notification will add a new indication for the SmartSite Valve and qualified extension sets to allow use with low pressure devices up to 325psi. When used with a low pressure power injector, the SmartSite Valve must be secured to other devices with a luer lock connection and the other devices must also be rated for up to 325 psi. This new indication will require no changes to the current device design, materials, manufacturing processes, method of operation or basic scientific technology.
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## SUMMARY OF SAFETY AND EFFECTIVENESS Cardinal Health, Alaris Products SmartSite Valve Sets with Additional Indication Page 2 of 2
#### SUBSTANTIAL EQUIVALENCE
The Cardinal Health, Alaris Products SmartSite Valve Sets with Additional Indication is of comparable type and is substantially equivalent to the following predicate device:
| Predicate Device | Manufacturer | 510(k) No. | Date Cleared |
|----------------------------------|-------------------------------------|------------|---------------|
| SmartSite Administration<br>Sets | Cardinal Health, Alaris<br>Products | K960280 | April 4, 1996 |
#### INTENDED USE
The intended use for the SmartSite Valve and sets is to allow IV fluid delivery of a wide range of fluids. The needle free valve allows the user to add medication into the primary line without the use of a needle. This new indication will allow the SmartSite Valve and qualified sets to also be used with low pressure power injectors for which the maximum pressure setting is 325 psi. When used with a power injector, the SmartSite Valve must be secured to other devices with a luer lock connection; other devices must also be rated for up to 325 psi.
#### TECHNOLOGICAL CHARACTERISTICS
A comparison of the technological characteristics of the Cardinal Health, Alaris Products SmartSite Valve Administration Sets with Additional Indication and the predicate devices has been performed. The results of this comparison demonstrate that the SmartSite Valve Sets with Additional Indication is equivalent to the marketed predicate device in technological characteristics.
#### PERFORMANCE DATA
The performance data indicate that the Cardinal Health, Alaris Products SmartSite Sets with Additional Indication meets specified requirements and is substantially equivalent to the predicate device.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUL 26 2006
Ms. Stacy L. Lewis Sr. Regulatory Affairs Specialist Cardinal Health, Alaris® Products 10221 Wateridge Circle San Diego, California 92121-2733
Re: K061285
Trade/Device Name: SmartSite Needle Free Valve Administration Sets Regulation Number: 21 CFR 880.5440 Regulation Name: Intravascular Administration Set Regulatory Class: II Product Code: FPA Dated: May 6, 2006 Reccived: May 8, 2006
Dear Ms. Lewis:
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 Mcdical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (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. 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.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to such 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.
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Page 2 - Ms. Lewis
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); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801). please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (240) 276-3150 or at its Internet address http://www.fda.gov/cdrlv/industry/support/index.html.
Sincerely yours.
Chris Van Pelt
Chiu Lin, Ph.D. Director Division of Anesthesiology, General Hospital, Infection Control and Dental Devices Office of Device Evaluation Center for Devices and Radiological Health
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# INDICATIONS FOR USE
510(k) Number:
K061285 (To Be Assigned By FDA)
Device Trade Name:
SmartSite Needle Free Valve Administration Sets
Indications For Use:
The SmartSite Needle Free Valve Administration Sets are intended for use in today's growing professional healthcare environment including healthcare facilities, home care, and medical transport that utilize infusion systems for the delivery of fluids, medications, blood and blood products. The SmartSite valve allows the user to add medication into the primary line without the use of a needle. The SmartSite valve may also be used with low pressure power injectors rated for a maximum setting of 325psi.
Prescription Use OR X (Per 21 CFR 801.109)
Over-The-Counter Use
PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Cintron L.h<
nesiology, General Hospr.
K66225
00024
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.
