(494 days)
Not Found
Not Found
No
The summary describes a physical medical device (gastrostomy tube) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
No.
The device is a gastrostomy tube用于 feeding, not for treating a disease or disorder. It provides nutritional support rather than therapy.
No
Explanation: The device is a gastrostomy tube used for long-term feeding support, not for diagnosing medical conditions. It is a replacement tube for an established stoma tract.
No
The device description clearly identifies the device as a "Flexiflo® Low-Profile Balloon Gastrostomy Tube Kit and Accessories," which are physical medical devices, not software.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information about a person's health.
- Device Function: The Flexiflo Low-Profile Balloon Gastrostomy tube is a device inserted into the body to provide nutrition directly to the stomach. It is a therapeutic or supportive device, not a diagnostic one.
- Intended Use: The intended use clearly states it's for feeding patients who cannot consume an adequate diet orally. This is a functional support, not a diagnostic test.
- Lack of Diagnostic Elements: The description does not mention any analysis of biological samples, diagnostic testing, or providing information about a disease state based on in vitro analysis.
Therefore, the Flexiflo Low-Profile Balloon Gastrostomy tube falls under the category of a medical device for patient support and therapy, not an In Vitro Diagnostic.
N/A
Intended Use / Indications for Use
The Flexiflo Low-Profile Balloon Gastrostomy tube is indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning gut who require long-term feeding support. This includes patients in whom malnutrition already exists, or may result, secondary to neurologic diseases resulting in an abnormality in swallowing; tumors of the head, neck or esophagus; or upper airway diseases or oropharyngeal trauma resulting in an abnormality in swallowing. Some patients requiring chronic use of supplemental fluids are candidates for gastrostomy.
Product codes
78 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
pediatric, adult and elderly patients
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.
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Image /page/0/Picture/2 description: The image is a black and white logo for the U.S. Department of Health & Human Services. The logo features a stylized caduceus symbol, which is a staff with two snakes coiled around it. The symbol is surrounded by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" in a circular arrangement. The text is in all caps and is evenly spaced around the symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
NOV - 7 1997
Sanford W. Bigelow, Ph.D. Director, Medical Nutritional Regulatory Affairs Ross Products Division Abbott Laboratories 625 Cleveland Avenue Columbus, Ohio 43215-1724
K962554 Re: Flexiflo® Low-Profile Balloon Gastrostomy Tube Kit and Accessories Dated: September 29, 1997 Received: September 30, 1997 Regulatory class: II 21 CFR §876.5980/Product code: 78 KNT
Dear Dr. Bigelow:
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. 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 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 Druq 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 ·
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Page 2 - Sanford W. Bigelow, Ph.D.
devices under the Electronic Product Radiation Control provisions, or other Federal Laws or Regulations.
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) 594-4616. 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 Other general information on your responsibilities under the Act may 807.97). 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,
Robert R Rathbun/
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
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Ross Products Division Abbott Laboratories Premarket Notification Information
VIII. INDICATIONS FOR USE
The Flexiflo Low-Profile Balloon Gastrostomy tube is indicated for use as a replacement tube in an established stoma tract for pediatric, adult and elderly patients who cannot consume an adequate diet orally. Gastrostomy feeding may be indicated for patients with a functioning gut who require long-term feeding support. This includes patients in whom malnutrition already exists, or may result, secondary to neurologic diseases resulting in an abnormality in swallowing; tumors of the head, neck or esophagus; or upper airway diseases or oropharyngeal trauma resulting in an abnormality in swallowing. Some patients requiring chronic use of supplemental fluids are candidates for gastrostomy.
Concurrence of CDRH, Office of Device Evaluation (ODE)
Robert R. Satting/
(Division Sign-Off) Division of Reproductive, Abdominal, ENT, and Radiological Devices 11962559 510(k) Number_
Prescription Use
OR Over-The-Counter Use
(Per 21 CFR 801.109)
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