DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
K012147 · Zevex, Inc. · KNT · Nov 2, 2001 · Gastroenterology, Urology
Device Facts
Record ID
K012147
Device Name
DEVICE MODIFICATION OF ENTERAL FEEDING SETS FOR GRAVITY AND PUMP USE
Applicant
Zevex, Inc.
Product Code
KNT · Gastroenterology, Urology
Decision Date
Nov 2, 2001
Decision
SESE
Submission Type
Special
Regulation
21 CFR 876.5980
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a controlled rate. These enteral feeding sets interface with the patient's feeding tube and may use gravity or an enteral feeding pump to dispense feeding solution. The devices may include a spike to connect to a pre-filled container.
Device Story
Enteral feeding sets facilitate delivery of liquid nutrients to patients via feeding tubes; sets connect to pre-filled containers via spike; operation via gravity or external enteral feeding pump. Modifications include 'Slip Loc' enteral adapter design, new USP Class VI base materials, and integrated anti-free-flow fitting for pump models. Anti-free-flow fitting automatically prevents flow when set is removed from pump. Used in clinical or home settings; operated by healthcare professionals or caregivers. Output is controlled flow of nutritional solution to patient. Benefits include accurate nutrient delivery and prevention of free-flow incidents.
Clinical Evidence
Bench testing only. Testing included volumetric accuracy, blow-by pressure of the anti-free-flow fitting, bond strength between components, and cytotoxicity testing for biocompatibility of new materials.
Technological Characteristics
Materials: USP Class VI polymers. Components: 'Slip Loc' enteral adapter, anti-free-flow fitting, tubing, spike. Connectivity: None (mechanical). Sterilization: Non-sterile. Operation: Gravity or pump-assisted flow control.
Indications for Use
Indicated for patients requiring enteral nutrition delivery via feeding tube, utilizing either gravity-fed or pump-assisted administration of liquid nutrients.
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.
Enteral Feeding Sets for Gravity and Pump Use (K862489)
Submission Summary (Full Text)
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K012147
Page 1 of 2
NOV 2 2001
## 510(K) SUMMARY FOR K012147
ZEVEX
INCORPORATED
10/03/2001
Submitter ZEVEX, Inc. 4314 ZEVEX Park Lane Salt Lake City, UT 84123 (801) 264-1001 Contact: Susan Schmidt
Trade Name: ZEVEX, Inc, Enteral Feeding Sets for Gravity and Pump Use Common Name: Enteral Feeding Sets for Gravity and Pump Use Classification Name: Tubes, Gastrointestinal (and Accessories)
#### K954735 Infusion pump, enteral, external Predicates: (disposable sets were included as accessories) K862489 Enteral Feeding Sets for Gravity and Pump Use
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a The devices in this product failing sets interface with the patient's feeding tube and may use controlled rate. Theose literal rooms dispense feeding solution. The devices may include a use gravity of an onterarresting paint on a spike to connect to a pre-filled container.
## Summary of Device Comparision:
| New Device Models: | |
|--------------------------------------------------|-----------|
| Spike Pump Set | S0010 |
| Spike Pump Set with Anti Free Flow Fitting | 2L8018-AF |
| 500 ml Bag Pump Set | S0500 |
| 500 ml Bag Pump Set with Anti Free Flow Fitting | 2L0500-AF |
| 1200 ml Bag Pump Set | S1200 |
| 1200 ml Bag Pump Set with Anti Free Flow Fitting | 2L8020-AF |
| 1200 ml Bag Gravity Set | 2L8001 |
| 300 ml Intermittent Feeding Gravity Set | 2L8050 |
| | |
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Image /page/1/Picture/1 description: The image shows the logo for ZEVEX INCORPORATED. The word "ZEVEX" is in large, bold, black letters. Below it, the word "INCORPORATED" is in smaller, black letters.
#### 510(K) SUMMARY FOR K012147 (continued)
| Model | Comparison Criteria | Modified Device | Predicate Device |
|----------------------------------------------------|--------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------|
| All | Enteral Adapter | 'Slip Loc' design<br>New Base Material, USP Class VI | Original design<br>Original Base Material,<br>USP Class VI |
| All | Cap, Enteral Adapter | Designed to fit 'slip loc' enteral adapter<br>Same Base Material | Designed to fit original enteral adapter<br>Same Base Material |
| All anti free flow models | Pump Fitting | Anti Free Flow Fitting<br>New Base Material, USP Class VI | Pinch Clip Occluder anti free flow device<br>Original Base Material, USP Class VI |
| 500 ml Bags,<br>300 ml intermittent<br>gravity set | Bag Assembly | Smaller surface area<br>Same material | 1200 ml (larger surface area)<br>Same material |
| All | All other components | Same | Same |
| All | Intended Use | Same | Same |
| All | Biocompatibility of<br>final product | Only material changes are 'slip loc' enteral adapter and anti free flow fitting. Both new materials are USP Class VI and colorants are approved by FDA for food grade applications. | Original materials were USP class VI. |
| All | Sterilization | Not sterile | K954735 disposable sets are<br>not sterile |
| All | Labeling | Added additional pump and gravity set use information<br>Added anti free flow information<br>(where applicable) | Referenced pump procedures |
The anti free flow device, in the new models, consists of a tubing fitting which has been modified to include an anti free flow feature, which automatically prevents flow when the set is removed from the pump. Testing included a volumetric accuracy test, a test to check the blow by pressure of the anti free flow fitting, a bond test to check the bond strength between components, and a cytotoxicity test to check the biocompatibility of the new materials. The test results indicated that the modifications have not reduced the safety or effectiveness of the product or created new issues regarding safety or effectiveness.
44
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Image /page/2/Picture/1 description: The image is a black and white logo for the Department of Health & Human Services - USA. The logo is circular in shape, with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter of the circle. In the center of the circle is a stylized image of three birds in flight, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
# NOV 0 2 2001
Ms. Susan P. Schmidt Regulatory Affairs Manager ZEVEX®, Inc. 4314 ZEVEX Park Lane SALT LAKE CITY UT 84123 Re: K012147
Trade/Device Name: ZEVEX® Enteral Feeding Sets for Gravity and Pump Use Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II
Product Code: 78 KNT Dated: October 3, 2001 Received: October 4, 2001
Dear Ms. Schmidt:
We have reviewed your Section 510(k) premarket notification of intent to market the indicati we have reviewed your Section 910(x) premailer is substantially equivalent (for the indications referenced above and nave decembed the actived predicate devices marketed in interstate for use stated in the encrosule) to regally manced producal Device Amendments, or to commerce prior to May 20, 1970, the chance with the provisions of the Federal Food, Drug, devices that have been recassified in accordance with as persuisions of the Act. The and Cosment Act (Act) that to not require subject to the general controls provisions of the Act. The You may, therefore, market the device, subject to uirements for annual registration, listing of the and general controls provisions of the rict mercise requirement of the management misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), ( If your device is classified (SCC above) and entines regulations affecting your device can be
it may be subject to additional controls. Existing major regulations affectives it may be subject to additional controls. Little 21, Parts 800 to 898. In addition, FDA may found in the Code of Fouch Regarments your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Please be advised that FDA s issuated of a but cevice complies with other requirements of the Act
that FDA has made a determination that your device complies - You must that FDA has made a decommanding and regulations administered by other Federal and light or any Federal Statutes and regulations and limited to: registration and listing comply with all the Act 3 requirements, meaths; good manufacturing practice requirements as set
(21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing the ologtrop (21 CFR Part 807), labornig (21 CFR Part 820); and if applicable, the electronic forth in the quality systems (QD) regulations (sections 531-542 of the Act); 21 CFR 1000-1050.
product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000
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Page 2
This letter will allow you to begin marketing your device as described in your 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 11 you don't the Office of Compliance at one of the following numbers, based on the regulation number at the top of this letter:
| 8xx.1xxx | (301) 594-4591 |
|----------------------------------|----------------|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). Other general information on of responsibilities under the Act may be obtained from the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html.
Sincerely yours,
Nancy C Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K012147
Page_12of_23
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Enteral Feeding Sets for Gravity and Pump Use Device Name:_
Indications For Use:
NOV 0 2 2001
The devices in this product family are used to dispense liquid nutrients (feeding solution) at a The devices in this product family are assures with the patient's feeding tube and user controlled rate. These enteral feeding pump to dispense feeding solution. The devices may inay use gravity of an enteral revealing polution and/or a spike to connect to a pre-filled container.
(Please do not WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C. Broadon
(Division Sign-Om
Division of Reproductive, Abdominal,
and Radiological Devices K012147
510(k) Number
(Optional Format 3-10-98)
*Prescription Use* ✓
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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.
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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).
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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.
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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.
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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.
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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.
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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.
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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.
