AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.
Device Story
AQUARIUS™ Extension Feeding Set is a single-patient-use accessory for gastric feeding devices. It consists of a hollow tube with a funnel at one end for connection to a nutrition source and a connector at the other end for attachment to a gastrostomy button or similar gastric feeding device. The device incorporates safety connectors designed to prevent accidental misconnection between enteral and intravenous (IV) systems. The device is used in clinical or home settings by patients or caregivers to extend the reach of feeding tubes. By ensuring secure, non-luer compatible connections, it reduces the risk of medication or nutrition delivery errors, thereby enhancing patient safety during enteral feeding.
Clinical Evidence
No clinical data. Bench testing only. Biocompatibility testing (cytotoxicity, irritation, sensitization) per ISO 10993-5 and ISO 10993-10 confirmed toxicological safety. Performance testing included tensile strength, flow rate, and leakage tests. Mechanical testing per ISO 80369-1, Annex B and AAMI/ANSI ID54 verified non-compatibility with female luer connectors and intravenous sets.
Technological Characteristics
Device consists of a hollow tube, funnel, and connector. Tube and funnel are made of flexible medical-grade Polyurethane (PUR); connector is made of acrylonitrile butadiene styrene. Designed for enteral feeding with safety connectors to prevent IV misconnection. Complies with ISO 80369-1 and AAMI/ANSI ID54 for connector safety. Single-patient use.
Indications for Use
Indicated for use as an extension set for gastric feeding devices (e.g., AQUARIUS™ G-button) to facilitate enteral nutrition delivery while mitigating the risk of accidental IV-enteral system misconnections.
Regulatory Classification
Identification
A gastrointestinal tube and accessories is a device that consists of flexible or semi-rigid tubing used for instilling fluids into, withdrawing fluids from, splinting, or suppressing bleeding of the alimentary tract. This device may incorporate an integral inflatable balloon for retention or hemostasis. This generic type of device includes the hemostatic bag, irrigation and aspiration catheter (gastric, colonic, etc.), rectal catheter, sterile infant gavage set, gastrointestinal string and tubes to locate internal bleeding, double lumen tube for intestinal decompression or intubation, feeding tube, gastroenterostomy tube, Levine tube, nasogastric tube, single lumen tube with mercury weight balloon for intestinal intubation or decompression, and gastro-urological irrigation tray (for gastrological use).
Special Controls
*Classification.* (1) Class II (special controls). The barium enema retention catheter and tip with or without a bag that is a gastrointestinal tube and accessory or a gastronomy tube holder accessory is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I (general controls) for the dissolvable nasogastric feed tube guide for the nasogastric tube. The class I device is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to § 876.9.
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## JUL 2 8 2014
#### Premarket Notification Summary under 21 CFR § 807.92
- a) Type of 510(k) submission: Special
- b) Common name: Feeding Extension Set
- c) Device trade name: AQUARIUS™ Extension Feeding set
- d) Classification Panel: 21 CFR 876.5980
- e) Classification Name: Gastrointestinal tube and accessories
- f) Class: Il
- g) Product code: KNT
- h) Unmodified/ Predicate device: 510(k) K132686
- i} 510(k) submitter/holder: Degania Silicone Ltd
- j) FDA Registration Number: 8030107
- k) Contact person: Zoya Lee, Regulatory Affairs, e-mail: zoya@ds-il.com, fax: +972 4 675 5155, tel: +972 4 6755122
- l) Device Description: The Aquarius™ Extension Feeding Set comprise from the hollow Tube with Connector and Funnel at the ends. The Funnel connects to delivery source of nutrition and the Connector connects to a gastric feeding device. The Aquarius™ Extension Feeding Set is compatible with Aquarius™ Gastrostomy Button (G-Button) and any castric feeding device with Mc-Key™ connection ring. A device is for single patient use only.
- m) Indication of Use. AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system ..
- n) Technological Characteristic. AQUARIUS™ Extension Feeding Set is a substantially equivalent to the unmodified/ predicate device. The only difference between modified and unmodified/ predicate device is in constructive material of the tube and funnel of the device. The hollow tube and funnel of modified device are made of flexible medical grade Polyurethane (PUR) and not from PVC; connector is made from the same acrylonitrile butadiene styrene. No any change in Intention of Use, product design, specification, functional performance, labels and Instruction Of Use.
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- o) Non- clinical Summary. Non- clinical verification of AQUARIUS™ Extension Feeding Set was conducted through biocompatibility and performance functionality testing. The results of Cytotoxicity, Irritation and Sensitization studies according to the standards ISO 10993-5 & ISO 10993-10 have demonstrated the toxicological safety of the proposed devices. The results of the tensile strength, flow rate, and leakage test have demonstrated the compliance with the performance and functionality specification of the device. The results of the mechanical tests according to ISO 80369-1, Annex B and AAMI/ANSI ID54 have demonstrated noncompatibility of the proposed device with female luer connectors and other intravenous sets.
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Image /page/2/Picture/1 description: The image shows the logo for the Department of Health and Human Services (USA). The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - (USA)" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002
July 28, 2014
Degania Silicone, Ltd. % Zoya Lee Regulatory Affairs Kibbutz Degania Bet Emek Havarden 1513000 lsraci
Re: K141631
> Trade/Device Name: AQUARIUSTM Extension Feeding Set Regulation Number: 21 CFRS 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 2 9. 2014 Received: July 1. 2014
Dear Zoya Lee.
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 (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. However, you are responsible to determine that the medical devices you use as components in the kit have either been determined as substantially equivalent under the premarket notification process (Section 510(k) of the act), or were legally on the market prior to May 28. 1976, the enactment date of the Medical Device Amendments. Please note: If you purchase your device components in bulk (i.e., unlinished) and further process (e.g.. sterilize) you must submit a new 510(k) before including these components in your kit. 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 HI (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be
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Page 2 - Zoya Lee
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.
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); medical device reporting (reporting of medical devicerelated adverse events) (21 CFR 803); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act): 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safcty/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address
http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerelv yours,
# Benjamin R. Fisher -S
Benjamin R. Fisher. Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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#### DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
#### Indications for Use
510(k) Number (if known) K141631
Device Name
AQUARIUS™ Extension Feeding Set
#### Indications for Use (Describe)
nocations to Ose (Describe)
AQUARIUS™ Extension Feeding Set is intended for use as an extension set for AQUARIUS™ G-button/ or other gastric feeding device, incorporating safety connectors which help mitigate the risk of accidental connection of an IV system to the enteral system, or the enteral system to IV system.
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)
### PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON A SEPARATE PAGE IF NEEDED.
| FOR FDA USE ONLY |
|------------------------------------------------------------------------------|
| Concurrence of Center for Devices and Radiological Health (CDRH) (Signature) |
# Benjamin R. Fisher -S 2014.07.28 16:37:16 -04'00'
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The burden time for this collection of information is estimated to average 79 hours per response, including the The builden inte for this concenter of internation to ocess, gather and maintain the data needed and complete time to rolledions, or information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
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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.
