(62 days)
To assist in the placement of AMT MINI Button feeding devices by providing temporary feeding tube stability during insertion through patient stoma tract.
Not Found
I am sorry, but the provided text from the FDA 510(k) letter for the "AMT Introducer: MINI Button Delivery System" does not contain information about acceptance criteria or a study that proves the device meets such criteria.
The 510(k) letter is primarily a regulatory document confirming that the device has been determined to be "substantially equivalent" to legally marketed predicate devices. It focuses on:
- Device Identification: Trade/Device Name, Regulation Number, Regulatory Class, Product Code.
- Regulatory Determination: Stating that the device is substantially equivalent, allowing it to be marketed.
- General Controls: Reminding the applicant of ongoing regulatory compliance requirements (annual registration, listing, good manufacturing practice, labeling, etc.).
- Indications for Use: What the device is intended to be used for.
There is no mention of:
- Specific performance metrics or acceptance criteria (e.g., accuracy, precision, reliability).
- Any study data, sample sizes, data provenance, ground truth establishment, or expert involvement.
- Multi-Reader Multi-Case (MRMC) studies or standalone algorithm performance.
Therefore, I cannot fulfill your request to describe the acceptance criteria and the study that proves the device meets them based on the provided text. This type of information would typically be found in the more detailed technical sections of the 510(k) submission itself, which are not included in this letter.
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Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
OCT 2 5 2004
Mr. Chris Zantopulos Quality Assurance/Regulatory Affairs Applied Medical Technology, Inc. 15653 Neo Parkway CLEVELAND OH 44128
Re: K042300
Trade/Device Name: AMT Introducer: MINI Button Delivery System Regulation Number: 21 CFR §876.5980 Regulation Name: Gastrointestinal tubes and accessories Regulatory Class: II Product Code: 78 KNT Dated: August 20, 2004 Received: August 24, 2004
Dear Mr. Zantopulos:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave review 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 for use stated in the ences, 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 and Council Fre Act. However, you are responsible to determine that the medical devices you pro ristens or morents in the kit have either been determined as substantially equivalent under the ass we component in the arrocess (Section 510(k) of the act), or were legally on the market prior to play 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) purender your it a new 510(k) before including these components in your kit. The general you mast bacinin a new > 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. Chris Zantopulos
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Flease oc advised that I Dris issuance or or device complies with other requirements of the Act that I DA has made a determination as administered by other federal agencies. You must of any I edelar statutes and registments, including, but not limited to: registration (21 CFR Part comply with an the Fet 8 requirement (21 CFR Part 801); good manufacturing practice 807), fisming (21 OF RT Parces), quality systems (QS) regulation (21 CFR Part 820); and if requirements as set lorth in the quarty by would 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) This icher with and w you'ls cognification of substantial equivalence of your device to a legally prematication for results in a classification for your device and thus, permits your marketed proceed to the market. If you desire specific advice for your device on the labeling de vice to problem to and interest in the Office of Compliance at (301) 594-4616. Also, ETT Parcel Contract regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). regulation other general information on your responsibilities under the Act from the r out may other before, 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 Brogdon
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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f. Indications for use statement:
510(k) Number (if known): not assigned yet
Device Name: AMT Introducer: MINI Button Delivery System
Indications for Use:
To assist in the placement of AMT MINI Button feeding devices by providing temporary feeding tube stability during insertion through patient stoma tract.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-The-Counter Use (Optional Format 1-2-96)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Nancy C brogdon
510k) Nu
Applied Medical Technology, Inc. - 510(k) Submission AMT Introducer: MINI Button Delivery System Section G - Page G.7
§ 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.