(28 days)
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Not Found
No
The summary describes a physical feeding tube and does not mention any software, algorithms, or AI/ML capabilities.
No
The Corflo cuBBy LPGD is a device for administering feeding solutions and gastric drainage, which are supportive care functions rather than direct treatment or prevention of a disease/condition.
No
Explanation: The device is described as allowing for the administration of feeding solutions and gastric drainage, which are therapeutic and supportive functions, not diagnostic.
No
The device description clearly identifies the device as a "Low Profile Gastrostomy Device (LPGD)", which is a physical medical device (a feeding tube). The intended use also describes a physical action ("administration of feeding solutions directly into the stomach"). There is no mention of software as the primary or sole component.
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 administering feeding solutions and gastric drainage directly into the stomach. This is a therapeutic and supportive function, not a diagnostic one.
- Device Description: The description is of a gastrostomy device, which is a medical device used for feeding and drainage, not for performing tests on samples taken from the body.
- Lack of IVD Indicators: There is no mention of analyzing samples (like blood, urine, tissue, etc.) or providing diagnostic information about a patient's condition.
IVD devices are specifically designed to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. This device does not fit that description.
N/A
Intended Use / Indications for Use
The Corflo® cuBBy ™ LPGD is designed to allow for the administration of feeding solutions directly into the stomach of patients who are unable to take oral feedings but whose alimentary tracts are otherwise intact. It may also be used for gastric drainage with the aid of a decompression tube.
Product codes
78 KNT
Device Description
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Mentions image processing
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Mentions AI, DNN, or ML
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Input Imaging Modality
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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
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Summary of Performance Studies
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Key Metrics
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Predicate Device(s)
Not Found
Reference Device(s)
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Predetermined Change Control Plan (PCCP) - All Relevant Information
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§ 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
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 0 1999
Stephanie Wasielewski Director of Regulatory Affairs/Quality Corpak MedSystems 100 Chaddick Drive Wheeling, IL 60090
Re: K990127 Corflo cuBBy™ Low Profile Gastrostomy Device (LPGD) Dated: January 11, 1999 Received: January 13, 1999 Regulatory Class: II 21 CFR 876.5980/Procode: 78 KNT
Dear Ms. Wasielewski:
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 proo 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, 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 (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, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in requlatory 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 531 through 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 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 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 requlation 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,
Capt. Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
1
INDICATIONS for USE STATEMENT
510(k)
Number
Device Name
Indications for Use
Corflo® cuBBy ™ LPGD
The Corflo cuBBy LPGD is designed to allow for the
administration of feeding solutions directly into the stomach
of patients who are unable to take oral feedings but whose
alimentary tracts are otherwise intact. It may also be used
for gastric drainage with the aid of a decompression tube.
PLEASE DO NOT WRITE BELOW THIS LINE
Concurrence of CDRH, Office of Device Evaluation (ODE)
| Prescription Use
| (Per 21CFR 801.109) | Over-The-Counter Use |
|---|---|
| ----------------------------------------- | ---------------------- |
or
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
and Radiological. . . . . . . . . .
510(k) Number K96127