(56 days)
Not Found
Not Found
No
The summary describes a simple medical device (gastrostomy button) and contains no mention of AI, ML, image processing, or performance studies related to algorithmic analysis.
Yes
The device is used for feeding, administration of medication, and gastric decompression, which are all therapeutic interventions for health conditions.
No
Explanation: The device is a replacement gastrostomy tube used for feeding, medication administration, and gastric decompression, which are therapeutic and supportive functions, not diagnostic.
No
The device is a physical gastrostomy button, which is a hardware medical device, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for feeding, medication administration, and gastric decompression through a gastrostomy tract. This is a direct interaction with the patient's body for therapeutic and supportive purposes.
- IVD Definition: In Vitro Diagnostics are medical devices used to examine specimens taken from the human body (like blood, urine, tissue) to provide information about a person's health. They are used outside the body (in vitro).
The Degania Silicone Gastrostomy Button is a device that is inserted into the body for direct patient care, which is the opposite of an IVD.
N/A
Intended Use / Indications for Use
Degania Silicone Gastrostomy Button is a replacement gastrostomy tube indicated for long term use in a well established gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.
Product codes
KNT
Device Description
Not Found
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Not Found
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
DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized depiction of an eagle with three lines representing its wings or feathers. The eagle is positioned above a wavy line, which could symbolize water or a horizon. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the eagle symbol.
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Room -WO66-G609 Silver Spring, MD 20993-0002
SEP -5 2012
Ms. Zoya Lee Regulatory Affairs Specialist Degania Silicone, Ltd. KEBBUTZ DEGANIA BET EMEK HAYARDER 15130 ISRAEL
Re: K122030
Trade/Device Name: Degania Silicone Gastrostomy Button Regulation Number: 21 CFR& 876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: KNT Dated: June 25, 2012 Received: July 11, 2012
Dear Ms. Lee:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and 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) that do not require approval of a premarket approval application (PMA). 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's requirements, including, but not limited to registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical
1
Page 2-
device-related adverse events) (21 CFR 803); good manufacturing practice requirements as set de rice-relation daverse overily (2 regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please n you door!e oper.fda.gov/AboutFDA/CentersOffices/CDRH/CDRHOffices/ucm115809.htm for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part note the regalations regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
You may obtain other general information on your responsibilities under the Act from the Four may obtain other greational and Consumer Assistance at its toll-free number (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/Resourcesfor You/Industry/default.htm.
Sincerély wours,
Sincerely yours,
Benjamin R. Evanko
Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
Image /page/2/Picture/0 description: The image shows a logo for a certified QMS (Quality Management System) by The Standards Institution of Israel. The logo is in the shape of a triangle with rounded corners. Inside the triangle is a circle with the text "SI ISO 9001: 2000" written on it. The text "CERTIFIED QMS" is written around the circle. The text "THE STANDARDS INSTITUTION OF ISRAEL" is written below the triangle.
Image /page/2/Picture/1 description: The image contains the words "Degania Silicone" in a stylized font. The word "Degania" is in white letters on a black background. The word "Silicone" is in black letters with a white outline on a white background.
Degania Silicone Ltd. Degania Bet 15130, Israel, Tel: 972-4-6750533, Fax: 972-4-6709182 E-mail: ds@ds-il.com Website: www.ds-il.com
2. Indications for Use
K122030 510(k) Number:
Device Name: Degania Silicone Gastrostomy Button
Indications for Use: Degania Silicone Gastrostomy Button is a replacement gastrostomy tube indicated for long term use in a well established gastrostomy tract for feeding and/or administration of medication. May be used for gastric decompression.
Prescription Use ONLY (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE OF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Document No : | Traditional 510(k) submission | Page 4 of 27 |
|---|---|---|
| Version: 0 | GASTROSTOMY BUTTON | Degania Silicone, Ltd |
Hulbert Lum
ision Sign-Off) n of Reproductive, Gastro-Renal, ar ical Devices 510(k) Number