(85 days)
No
The device description and intended use focus on a purely mechanical function of opening an anti-reflux valve for gas decompression. There is no mention of any computational or data-driven processes.
Yes
The device is used to relieve gaseous pressure in a patient's stomach, which provides patient comfort by addressing a physiological issue.
No
The device is described as a "Decompression Tube" used to relieve gaseous pressure from a patient's stomach by allowing gas to escape. Its function is therapeutic, not diagnostic.
No
The device description clearly outlines physical components made of Polyethylene and PVC tubing, indicating it is a hardware device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In vitro diagnostics are tests performed on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections. They are used to provide information for diagnosis, monitoring, or screening.
- Device Function: The AMT Decompression Tubes are used to physically relieve gas pressure from a patient's stomach by opening a valve on a feeding device. This is a mechanical action performed directly on the patient's body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a physical process of decompression, not a diagnostic test.
- Device Description: The description details the physical components and how they function to open a valve and allow gas to escape. There is no mention of analyzing biological samples.
Therefore, the AMT Decompression Tubes fall under the category of a medical device used for a therapeutic or supportive purpose, not an in vitro diagnostic device.
N/A
Intended Use / 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.
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.
Product codes
78 KGC
Device 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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
stomach
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
The AMT Decompression Tubes are as safe and effective as other predicate devices cited above.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 876.5980 Gastrointestinal tube and accessories.
(a)
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).(b)
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.
0
K980142 1 of 2
510(k) Summary
| 1. Submitter Name: | Applied Medical Technology, Inc. |
|---|---|
| 2. Address: | 15653 Neo Parkway |
| 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: |
- 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 |
| 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.
-
- 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.
1
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
2
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.