(79 days)
Not Found
No
The device description and intended use focus on a mechanical gastrostomy tube replacement. There is no mention of AI, ML, image processing, or data analysis that would indicate the use of such technologies.
Yes
The device is used to deliver nutrition and medication directly into the stomach and allows for decompression, which are all therapeutic interventions for patients unable to consume nutrition by conventional means.
No
The device is described as a replacement gastrostomy device for providing nutrition, medication, and stomach decompression, not for diagnosing medical conditions.
No
The device description clearly outlines physical components made of silicone and barium, indicating it is a hardware medical device, not software-only.
Based on the provided information, the AMT Button Replacement Gastrostomy 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 Button Replacement Gastrostomy Device is a medical device used to deliver nutrition and medication directly into the stomach through an established stoma. It is a physical device inserted into the body, not a test performed on a sample outside the body.
- Intended Use: The intended use clearly describes a method of delivering substances into the body, not analyzing samples from the body.
Therefore, the AMT Button Replacement Gastrostomy Device falls under the category of a medical device used for direct patient care and treatment, not an in vitro diagnostic.
N/A
Intended Use / Indications for Use
The AMT Button is intended to be used as a replacement gastrostomy feeding device. Other uses are not recommended.
The AMT Button Replacement Gastrostomy Device is to be used as a replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The AMT Button Replacement Gastrostomy Device can also deliver medication and allow for decompression of the stomach.
Product codes (comma separated list FDA assigned to the subject device)
78 KNT
Device Description
AMT Button is injection molded of Silicone. The Dome is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The Anti-Reflux Valve is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The device is sold in various sizes. Size is determined by the Physician or Professional Health Giver (dependant on length of existing stoma tract). The AMT Button is packaged in a kit which includes Directions For Use, Obturator Rod, Patient Care Kit, Stoma Measuring Device. The AMT Button Replacement Gastrostomy Device is sterile, single user, and disposable. The Patient Care Kit and Stoma Measuring Device are Non-Sterile and packaged for single user, 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
Physician or Professional Health Giver
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)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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
16980305 1- 68 1
APR 16 1998
| 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 22, 1998 |
| 7. Device Trade or Proprietary Name: | AMT Button |
| 8. Device Common Name: | AMT Button Gastrostomy Feeding Device |
| 9. Device Classification Name: | Gastrointestinal Tube and Accessories (78KGC) |
| 10. Substantial Equivalency is claimed against the following devices: |
510(k) Summary
| 1. Applied Medical Technology, Inc. - | AMT Button - K843392 |
|---|---|
| 2. Microvasive/Boston Scientific Corp. - | Button and Replacement Button |
| 3. C.R.Bard - | Button and Replacement Button |
11. Device of Description:
AMT Button is injection molded of Silicone. The Dome is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The Anti-Reflux Valve is injected molded from Silicone and Barium mixed for radiopaic detection if desired and is glued (with silicone) to the body of the Button. The device is sold in various sizes. Size is determined by the Physician or Professional Health Giver (dependant on length of existing stoma tract). The AMT Button is packaged in a kit which includes Directions For Use, Obturator Rod, Patient Care Kit, Stoma Measuring Device. The AMT Button Replacement Gastrostomy Device is sterile, single user, and disposable. The Patient Care Kit and Stoma Measuring Device are Non-Sterile and packaged for single user, disposable.
12. Intended Use:
The AMT Button is intended to be used as a replacement gastrostomy feeding device. Other uses are not recommended.
13. Safety and Effectiveness of the device:
The AMT Button is as safe and effective as other predicate devices cited above.
14. Summary comparing technological characteristics with other predicate devices:
The AMT Button identical in design and manufacture, using the same materials and processes used in 510(k) K843392 of Applied Medical Technology, Inc.
AMT Button U.S. Patent No .: 4,863,438
Applied Medical Technology, Inc. - 510(k) Submission AMT Button Replacement Gastrostomy Device Section H - Page H.2.
1
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is an abstract symbol that resembles a stylized human figure or head in profile, with three overlapping shapes suggesting multiple faces or layers. The symbol is rendered in black, contrasting with the white background of the seal.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
APR 1 6 1998
Mr. Thomas W. Parkinson · Leader - Quality Assurance / Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, Ohio 44128
Re: K980305 AMT Button Replacement Gastrostomy Device Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dated: January 22, 1998 Received: January 27, 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 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). 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., unfinished) 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, and labeling, and prohibitions against misbranding and adulteration.
If your device is classified (see above) into either class II (Special Controls) or class III (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 equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General requlation (21 CFR Part 820) and that, through periodic QS inspections, FDA will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, the Food and Drug Administration (FDA) may publish further announcements concerning your device in the Federal Register.
2
Page 2 - Mr. Thomas W. Parkinson
Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Requlations.
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 leqally 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 the labeling requlation (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/dsma/dsmamain.html".
Sincerely yours,
Robert R Ratting/
Lillian 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
3
SECTION - I
11480 XV3
INDICATIONS FOR USE STATEMENT
510(k) Number (if known): _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
.. . . . . . .
The AMT Button Replacement Gastrostomy Device is to be used as a replacement gastrostomy tube for a patient with a well established gastrostomy tract. This device will assist in providing nutrition directly into the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means. The AMT Button Replacement Gastrostomy Device can also deliver medication and allow for decompression of the stomach.
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
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Concurrence of CDRH, Office of Device Evaluation (ODE)
| Division Sign-Off | |
|---|---|
| Division of Reproductive, Abdominal, ENT, and Radiological Devices | |
| 510(k) Number | K980305 |
| Prescription Use | (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
|---|---|---|---|
| ------------------ | ------------------------------------------ | ---- | ---------------------- |
(Optional Format 1-2-96)
Applied Medical Technology, Inc. - 510(k) Submission
AMT Button Replacement Gastrostomy Device Section 1 - Page 1.10.