(147 days)
The GI Supply Biliary Stent is a disposable single-use device intended for use to temporarily by-pass obstructions in the biliary tree and allow drainage into the duodenum.
The GI Supply Biliary Stent is a disposable single-use device.
The provided FDA document is a 510(k) clearance letter for the GI Supply Biliary Stent. This type of document does not typically contain detailed information about the acceptance criteria, study design, or performance metrics that would be associated with a diagnostic AI/ML device.
The 510(k) process for a device like a biliary stent primarily focuses on demonstrating substantial equivalence to a legally marketed predicate device, often through bench testing (physical and mechanical properties), biocompatibility, and sometimes limited animal or human clinical data to assess safety and performance in a non-inferiority context. It does not involve AI model development or the detailed validation studies you've asked about for AI-driven diagnostics.
Therefore, I cannot extract the requested information from the provided text. The document confirms that the device is a biliary stent, intended for temporarily bypassing obstructions in the biliary tree and allowing drainage into the duodenum. There is no mention of AI, machine learning, image analysis, or diagnostic functions within this document.
If you have a document pertaining to an AI/ML diagnostic device, please provide that, and I would be happy to analyze it for the requested details.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus, which is a symbol of medicine, with three horizontal lines representing the branches of government. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 2 4 2003
GI Supply c/o Mr. Rob Whalen Regulatory Consultant MYCOSCIENCE INC. 25 Village Hill Road WILLINGTON CT 06279
Re: K031360
Trade/Device Name: GI Supply Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: July 31, 2003 Received: August 4, 2003
Dear Mr. Whalen:
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) that do not require approval of a premarket approval application (PMA). 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 (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.
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 and 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 applicable, the electronic product radiation control provisions (sections 531-542 of the Act); 21 CFR 1000-1050.
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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 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), please contact the Office of Compliance at one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. Ixxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
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 regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97) you may obtain. Other general information on your responsibilities under the Act may be obtained 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
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 8.2
Intended Use Statement
510k INDICATION FOR USE STATEMENT
510(k) Number (if known):
K03/1360
- Device Name: GI Supply Biliary Stent
Applicant Name: GI Supply division of Chek-Med Systems Inc.
The GI Supply Biliary Stent is a disposable single-use device Indication for Use: intended for use to temporarily by-pass obstructions in the biliary tree and allow drainage into the duodenum.
GI Supply/Chek-Med Signature:
Date: 4-28-03
Frank Carter - CEO
David G. Lygum.
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device 510(k) Number.
Prescription Use
(Per 21 CFR 801.109)
§ 876.5010 Biliary catheter and accessories.
(a)
Identification. A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.(b)
Classification. Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.