(30 days)
The MIC-KEY Low Profile Gastrostomy Tube is designed as a replacement gastrostomy tube for use in a mature gastric stoma when a low profile device would benefit the patient.
Gastrostomy tubes are indicated for patients with inability to swallow, other neurological disorders, and other conditions for which tube feeding would benefit the patient in the judgment of the physician.
MIC-KEY® Low Profile Gastrostomy Tube
The provided document is a 510(k) premarket notification letter from the FDA for a medical device called the "MIC-KEY® Low Profile Gastrostomy Tube." This letter approves the device based on its substantial equivalence to a legally marketed predicate device.
It is important to understand that this document describes a regulatory approval process based on equivalence, not a study performing specific acceptance criteria for a novel AI/software device. This document does not contain information about:
- Acceptance criteria in the context of device performance metrics (like sensitivity, specificity, AUC).
- A study proving the device meets acceptance criteria in the way an AI/software device would.
- Sample sizes for test or training sets, data provenance, ground truth establishment, expert qualifications, or adjudication methods for performance evaluation.
- Multi-reader multi-case (MRMC) comparative effectiveness studies or standalone algorithm performance.
Therefore, I cannot fill out the requested table and provide the detailed information about a "study that proves the device meets the acceptance criteria" because this document does not contain that type of information. It's a regulatory approval notice for a physical medical device.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
DEC 1 0 2004
Mr. S. McMillan Regulatory Affairs Kimberly-Clark Health Care Ballard Medical Products 12050 Lone Peak Parkway DRAPER UT 84020
Re: K043114
Trade/Device Name: MIC-KEY® Low Profile Gastrostomy Tube Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tube and accessories Regulatory Class: II Product Code: 78 KNT Dated: November 8, 2004 Received: November 10, 2004
Dear Mr. McMillan:
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. S. McMillan
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); Iisting (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 applicable, the electronic 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) remarket 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, 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 Tou may 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,
David A. Lynn
N
DE
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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INDICATIONS FOR USE STATEMENT
510(k) Number:
Device Name: MIC-KEY® Low Profile Gastrostomy Tube
Indications for Use: The MIC-KEY Low Profile Gastrostomy Tube is designed as a replacement gastrostomy tube for use in a mature gastric stoma when a low profile device would benefit the patient.
Gastrostomy tubes are indicated for patients with inability to swallow, other neurological disorders, and other conditions for which tube feeding would benefit the patient in the judgment of the physician. .
(PLEASE DO NOT WRITE BELOW THIS LINE. CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
PRESCRIPTION USE______________________________________________________________________________________________________________________________________________________________
OVER-THE-COUNTER USE_ OR
David A. Logann
ti-fision or coproductive, Abdominal, - Radiological Devic ു പ്രത്യേകത്തിലെ
November 8, 2004
CONFIDENTIAL
§ 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.