(223 days)
78 KNT
Not Found
No
The summary describes a physical medical device (gastrostomy tube) and does not mention any software, algorithms, or AI/ML terms.
Yes
The device is described as assisting in providing nutrition, delivering medication, and allowing for decompression of the stomach in patients unable to consume nutrition conventionally. These functions are therapeutic as they treat or manage a patient's condition.
No
Explanation: The device is a replacement gastrostomy tube used for delivering nutrition and medication, and for stomach decompression. It does not perform any diagnostic functions.
No
The intended use describes a physical device (gastrostomy tube) used for delivering nutrition and medication, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used to deliver nutrition and medication directly into the stomach of a patient through an established stoma. This is a therapeutic or supportive medical device used in vivo (within the living body).
- Lack of IVD Characteristics: The description does not mention any of the typical characteristics of an IVD, such as:
- Analyzing samples (blood, urine, tissue, etc.)
- Providing information about a patient's health status, diagnosis, or disease state based on the analysis of samples.
- Reagents, calibrators, or controls used for testing.
IVDs are used to perform tests on samples taken from the body to provide diagnostic or other health-related information. This device is used on the body to provide direct support and treatment.
N/A
Intended Use / Indications for Use
The Pre-Loaded Replacement G-Tube Device is to be used as a percutaneous 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 Pre-Loaded Replacement G-Tube Device can also deliver medication and allow for decompression of the stomach.
Product codes
78 KNT
Device Description
Pre-Loaded Replacement G-Tube Device
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
Not Found
Key Metrics
Not Found
Predicate Device(s)
Not Found
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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes entwined around it. The symbol is enclosed in a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. The text is written in all capital letters.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB - 9 1998
Thomas W. Parkinson Leader - Quality Assurance/Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway Cleveland, Ohio 44128
Re : K972478 AMT Pre-Loaded Replacement Gastrostomy Tube Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT Dated: December 18, 1997 Received: December 19, 1997
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 However, you are responsible to determine that the medical devices you use Act. 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 regulation (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. 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 Regulations.
1
Page - 2 - Mr. Thomas W. Parkinson
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 the 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/dsmamain.html".
Sincerely yours,
Rolar R. Sathing)
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
2
SECTION - I
1.5. - INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Device Name: ___ Pre-Loaded Replacement G-Tube Device
Indications For Use:
The Pre-Loaded Replacement G-Tube Device is to be used as a percutaneous 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 Pre-Loaded Replacement G-Tube 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)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | ||
|---|---|---|
| Robert D. Sathing/ | ||
| (Division Sign-Off) | ||
| Division of Reproductive, Abdominal, ENT, | ||
| and Radiological Devices | ||
| 510(k) Number | K972478 | |
| Prescription Use | ||
| (Per 21 CFR 801.109) | OR | Over-The-Counter Use |
| (Optional Format 1-2-96) |
Applied Medical Technology, Inc. - 510(k) Submission Pre-Loaded Replacement G-Tube Device ・ Section I - Page 1.12.