(29 days)
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Not Found
No
The 510(k) summary describes a replacement gastrostomy tube and contains no mention of AI, ML, image processing, or any other technology typically associated with AI/ML in medical devices.
Yes
The device is used to provide nutrition and medication and allow for decompression of the stomach, which are therapeutic interventions.
No
The device is described as a replacement gastrostomy tube for providing nutrition, medication, and decompression, which are therapeutic and supportive functions, not diagnostic.
No
The intended use describes a physical gastrostomy tube, which is a hardware device. There is no mention of software in the provided text.
Based on the provided information, the Monarch™ G-Tube is not an In Vitro Diagnostic (IVD) device.
Here's why:
- Intended Use: The intended use clearly states that the device is used for providing nutrition, medication, and decompression through an established stoma in a human patient. This involves direct interaction with the patient's body for therapeutic and supportive purposes.
- Anatomical Site: The anatomical sites mentioned are the gastrostomy tract and stomach, which are internal parts of the human 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 based on in vitro analysis.
- Using reagents or other substances to perform tests outside the body.
IVDs are devices used to examine specimens derived from the human body to provide information for diagnostic, monitoring, or compatibility purposes. The Monarch™ G-Tube is a medical device used for direct patient care and support, not for in vitro analysis of samples.
N/A
Intended Use / Indications for Use
The Monarch TM G-Tube 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 through an established stoma in a human patient who is unable to consume nutrition by conventional means. The Monarch TM G-Tube can also deliver medication and allow for decompression of the stomach.
Product codes
78 KNT
Device Description
Capsule Monarch™, Transshaping Gastrostomy Tube
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
gastrostomy tract, stomach
Indicated Patient Age Range
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Intended User / Care Setting
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Description of the training set, sample size, data source, and annotation protocol
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Description of the test set, sample size, data source, and annotation protocol
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Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
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Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
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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.
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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.
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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).
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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
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is circular and contains the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the circle is an abstract image of an eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC - 2 2004
Mr. Derek Williams Engineering Manager/Project Lead Engineer Applied Medical Technology, Inc. 15653 Neo Parkway CLEVELAND OH 44128-3150
Re: K043027
Trade/Device Name: Capsule Monarch™, Transshaping Gastrostomy Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: October 29, 2004 Received: November 3, 2004
Dear Mr. Williams:
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). 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 (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.
1
Page 2 - Mr. Derek Williams
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 (21 CFR Part 807); listing (21 CFR Part 807), labeling (21 CFR Part 801); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); and if requirements as bet ronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally prerieted 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, please contact the Office of Compliance at (240)276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). You may obtain other general information on your responsibilities under the Act from the Division of Small Manufacturers, International and Consumer 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,
$$
Nancy C. Brogdon
Director, Division of Reproductive,
Abdominal, and Radiological Devices
Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
2
SECTION - D
b. - INDICATIONS FOR USE STATEMENT
510(k) Number (if known): ____________________________________________________________________________________________________________________________________________________
Capsule Monarch™, Transshaping Gastrostomy Tube Trade Name: Frace Name:
Indications For Use (as shown in labeling):
The Monarch™ G-Tube is to be used as a percutaneous replacement gastrostomy tube for The Moharon - O-Fubo 15 to be assurostomy tract. This device will assist in providing a patient with a well established gas are through an established stoma in a human patient who is unable to consume nutrition by conventional means. The Monarch TM G-Tube 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)
David Simpson
(Division Sign-O Division of Reproductive. Abdo and Radiological Devices 510(k) Number ver-The-Counter Use Prescription Use AND/OR (21 CFR 801 Subpart C) (Part 21 CFR 801 Subpart D)
Applied Medical Technology, Inc. -510(k) Submission Capsule Monarch Section D - Page D.2