K980145 · Applied Medical Technology, Inc. · KGC · Apr 10, 1998 · Gastroenterology, Urology
Device Facts
Record ID
K980145
Device Name
AMT DECOMPRESSION TUBES
Applicant
Applied Medical Technology, Inc.
Product Code
KGC · Gastroenterology, Urology
Decision Date
Apr 10, 1998
Decision
SESE
Submission Type
Traditional
Regulation
21 CFR 876.5980
Device Class
Class 2
Attributes
Therapeutic
Indications for Use
The AMT Decompression Tubes are intended to be used with the AMT Button, AMT One Step Button, AMT Replacement Button, Microvasive One Step Button, Microvasive Button, Microvasive Replacement Button, (along with similar gastro button feeding devices distributed by Bard, Circon, Surgitek and others). The AMT Decompression Tubes allow gaseous decompression of patients using the Button by opening internal anti-reflux valve, thus allowing gas to escape giving comfort to the patient.
Device Story
Device consists of injection-molded polyethylene decompression tube attached to 12-inch PVC tubing with 16 French connector; available in various diameters and lengths (straight or right-angle). Used in clinical or home settings by patients or caregivers. Operation involves inserting tube into gastrointestinal button feeding port; mechanical action opens button's internal anti-reflux valve. Allows stomach gas to escape, relieving pressure and providing patient comfort. Disposable, non-sterile, single-user device.
Clinical Evidence
No clinical data; bench testing only.
Technological Characteristics
Materials: Polyethylene (decompression component), PVC (tubing). Form factor: 12-inch tubing with 16 French connector; various French sizes and lengths. Principle: Mechanical insertion to actuate anti-reflux valve. Non-sterile, single-user, disposable.
Indications for Use
Indicated for patients using gastrointestinal button feeding devices (e.g., AMT, Bard, Surgitek, Microvasive) to allow gaseous stomach decompression by opening the device's internal anti-reflux valve.
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.
One Step Button and Replacement Button Decompression Tubes (Microvasive/Boston Scientific Corp.)
One Step Button Decompression Tubes (C.R. Bard)
Submission Summary (Full Text)
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K980142 1 of 2
## 510(k) Summary
| 1. Submitter Name: | Applied Medical Technology, Inc. |
|-----------------------------------------------------------------------|--------------------------------------------------------|
| 2. Address: | 15653 Neo Parkway<br>Cleveland, OH 44128 USA |
| 3. Telephone: | 216-475-5577 |
| 4. FAX: | 216-475-5575 |
| 5. Contact Person: | Tom Parkinson - Quality Assurance / Regulatory Affairs |
| 6. Date of preparation: | January 13, 1998 |
| 7. Device Trade or Proprietary Name: | AMT Decompression Tubes |
| 8. Device Common Name: | Decompression Tubes |
| 9. Device Classification Name: | Gastrointestinal Tube Accessories (78KGC) |
| 10. Substantial Equivalency is claimed against the following devices: | |
1. Applied Medical Technology, Inc. - Decompression Tubes - K920894
APR 10 1998
| 1. Applied Medical Technology, Inc. - | Decompression Tubes - K920894 |
|------------------------------------------|---------------------------------------------------------------|
| 2. Microvasive/Boston Scientific Corp. - | One Step Button and Replacement Button<br>Decompression Tubes |
| 3. C.R.Bard - | One Step Button Decompression Tubes |
#### 11. Device of Description:
Decompression device attached to a 12" piece of PVC tubing with a 16 French connector on the other end. The Decompression part is injection molded of Polyethylene in various diameters (French sizes) and Lengths (in cm), either right angle or straight. The proper length is determined by the length of the gastrointestinal button (ie: One Step Button, AMT Button) placed in the patient. By inserting the decompression tube, the gastrointestinal button's internal anti reflux valve is opened, allowing a pathway for patient stomach gasses to escape (decompression). The devices are sold in various sizes, packaged individually with Directions For Use, non-sterile, single user, and disposable.
### 12. Intended Use:
The AMT Decompression Tubes are intended to be used with the AMT Button, AMT One Step Button, AMT Replacement Button, Microvasive One Step Button, Microvasive Button, Microvasive Replacement Button, (along with similar gastro button feeding devices distributed by Bard, Circon, Surgitek and others). The AMT Decompression Tubes allow gaseous decompression of patients using the Button by opening internal anti-reflux valve, thus allowing gas to escape giving comfort to the patient.
### 13. Safety and Effectiveness of the device: The AMT Decompression Tubes are as safe and effective as other predicate devices cited above.
- 14. Summary comparing technological characteristics with other predicate devices: The AMT Decompression tubes are identical in design and manufacture, using the same materials and processes used in 510(k) K920894 of Applied Medical Technology, Inc.
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Image /page/1/Picture/0 description: The image shows a logo for the Department of Health & Human Services. The logo features the department's name in a circular arrangement on the left side. To the right of the text is a stylized symbol consisting of three overlapping human profiles. The profiles are depicted in a simple, abstract manner, with flowing lines suggesting movement or connection.
### DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Thomas W. Parkinson Leader - Quality Assurance / Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, OH 44128
Re: K980145
AMT Decompression Tube Dated: January 13, 1998 Received: January 15, 1998 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KGC
APR 1 0 1998
Dear Mr. Parkinson:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to 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). 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 (Premarket Approval), 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 895. A substantially equivaliation assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (OS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
This letter will allow you to begin marketing your derice 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 and additionally 809.10 for in vitro. diagnostic devices), please contact the Office of Compliance at (301) 594-4613. 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 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers Assistance at its toll-free number (800) 638-2041 or (301) 443-6597 or at its Internet address "http://www.fda.gov/cdrh/dsmaldsmamain.html".
Sincerely yours.
Willian Yin, Ph.D.
Director, Division of Reproductive, Abdominal, Ear, Nose and Throat and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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K 480145
## SECTION - I
# I.5. - INDICATIONS FOR USE STATEMENT
The AMT Decompression Tubes are used to allow decompression of gasses from a patient's stomach when the patient is using an AMT Button, AMT One Step Button, BARD Button, Surgitek One Step Button, Microvasive One Step Button, AMT Replacement Buttons, or other similar button feeding device that has an anti-reflux valve incorporated. By inserting the proper size decompression tube into the button feeding port, the decompression tube will open the anti-reflux valve, allowing patient stomach decompression without damaging the anti-reflux valve. Opening the anti-reflux valve relieves gaseous pressure in the patient's stomach by allowing the gas to escape through the decompression tube providing comfort to the patient. Other uses are not recommended.
Robert D. Ratting/
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological Devices
510(k) Number K980145
Prescription Use
(Per 21 CFR 801.109)
Over-the-Counter Use.
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.
