(29 days)
The Monarch™ G-Tube is to be used as a percutaneous replacement gastrostomy tube for providing a patient with nutrition, medication and allow for decompression of the stomach through an established stoma in a human patient who is unable to consume nutrition by conventional means.
Not Found
Here's an analysis of the provided text, focusing on the request to describe acceptance criteria and a study proving device performance.
Based on the provided document, the "Capsule Monarch™, Transshaping Gastrostomy Tube" received a 510(k) clearance from the FDA. However, this document does not contain information about specific acceptance criteria or an explicit study proving the device meets those criteria.
The 510(k) clearance process focuses on demonstrating "substantial equivalence" to a legally marketed predicate device, rather than requiring a detailed clinical study with quantifiable acceptance criteria in the same way a PMA (Pre-Market Approval) Submission would.
Therefore, many of the requested fields cannot be directly extracted from this document. I will fill in what can be inferred or stated as "Not Applicable" or "Not Provided."
Acceptance Criteria and Device Performance Study for Capsule Monarch™, Transshaping Gastrostomy Tube
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Not Provided | Not Provided |
| (The 510(k) clearance process for this device relies on demonstrating substantial equivalence to a predicate device, rather than specific, quantitative performance criteria being met through a dedicated study detailed in this document. The FDA letter confirms the device is substantially equivalent for its stated indications for use.) | (The document does not contain quantitative performance data or results from a study designed to meet specific acceptance criteria.) |
2. Sample size used for the test set and the data provenance
- Sample Size: Not Provided.
- Data Provenance: Not Provided. The 510(k) clearance is based on comparison to a predicate device, and the specific data used for that comparison (if any formal test set was created) is not detailed in this letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Number of Experts: Not Provided.
- Qualifications of Experts: Not Provided.
4. Adjudication method for the test set
- Adjudication Method: Not Applicable / Not Provided. The 510(k) summary does not describe a test set or an adjudication process for ground truth.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance
- MRMC Study: No. This device is a gastrostomy tube, not an AI-assisted diagnostic tool, so an MRMC study with human readers and AI assistance is not applicable.
- Effect Size: Not Applicable.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done
- Standalone Performance Study: No. This device is a physical medical device (gastrostomy tube), not a software algorithm.
7. The type of ground truth used
- Type of Ground Truth: Not Applicable / Not Provided. The 510(k) process for this type of device typically relies on engineering and material specifications, biocompatibility testing, and comparison to a known safe and effective predicate device rather than a "ground truth" derived from expert consensus, pathology, or outcomes data in the context of diagnostic accuracy.
8. The sample size for the training set
- Sample Size: Not Applicable / Not Provided. As this is not an AI/algorithm-based device, there is no "training set" in the context of machine learning.
9. How the ground truth for the training set was established
- How Ground Truth Established: Not Applicable. (See point 8).
Summary of Information from Document:
The provided document is an FDA 510(k) clearance letter for the "Capsule Monarch™, Transshaping Gastrostomy Tube." This letter confirms that the FDA found the device to be substantially equivalent to legally marketed predicate devices for its stated Indications For Use:
- To be used as a percutaneous replacement gastrostomy tube for patients with a well-established gastrostomy tract.
- Assists in providing nutrition through an established stoma in a human patient who is unable to consume nutrition by conventional means.
- Can also deliver medication and allow for decompression of the stomach.
The core of this regulatory approval is substantial equivalence, meaning the device is as safe and effective as a predicate device already on the market, not that it underwent a specific clinical trial demonstrating performance against predefined acceptance criteria outlined in this document.
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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.
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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
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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
§ 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.