(7 days)
The Protégé® GPSTM Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.
The provided document pertains to a 510(k) premarket notification for a medical device, specifically a biliary stent. This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving safety and effectiveness through clinical trials that establish specific acceptance criteria and performance metrics in the way a PMA (Premarket Approval) submission would.
Therefore, the document does not contain the requested information regarding acceptance criteria, the study proving the device meets those criteria, sample sizes, expert qualifications, ground truth establishment, or human-in-the-loop performance.
Instead, the submission focuses on demonstrating:
- Intended Use: Palliative treatment of malignant neoplasms in the biliary tree.
- Device Description: Self-expanding nitinol stent with an open lattice design, electropolished, premounted on a delivery catheter.
- Modification: Addition of 150mm length stents in 6, 7, and 8mm diameters to the existing 6Fr 0.035'' delivery system.
- Substantial Equivalence: Claim that the modified device is substantially equivalent to a currently marketed stent and delivery system in intended use, materials, technological characteristics, and performance.
- Evidence for Equivalence: Performance testing (bench testing) supported the substantial equivalence claim.
The FDA's review confirms this substantial equivalence based on the provided information, but also imposes a specific warning and labeling requirements to mitigate potential off-label use in the vascular system.
In summary, the provided text describes a regulatory submission for a medical device based on substantial equivalence, not a study setting specific acceptance criteria and demonstrating human or AI performance against them.
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Premarket Notification (510(k)) Summary
| 510(k) Number: | K042204 |
|---|---|
| Product Name: | Protégé ® GPS™ Self-Expanding Nitinol Stent (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | ev3 Inc.4600 Nathan Lane NorthPlymouth, MN 55442 |
| Official Contact: | Glen D. SmytheSr. Regulatory Affairs SpecialistTelephone: 763-398-7391Fax: 763-398-7200 |
| Summary Preparation Date: | August 13, 2004 |
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission for a modification to the Protégé® GPS™ Self-Expanding Nitinol Stent.
The Protégé® GPS™ Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé stent is a self-expanding nitinol stent with an open lattice design. The stent is electropolished. The device is provided premounted on a delivery catheter. Upon deployment the constrained stent self-expands to conform to the duct inner luminal surface.
The modified device is substantially equivalent* to the currently marketed stent and delivery system in intended use, materials, technological characteristics and performance. A 150mm length stent in diameters of 6, 7, and 8mm has been added to the 6Fr 0.035'' delivery system. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the Protégé GPS Self-Expanding Nitinol Stent meets the requirements that are considered acceptable for the intended use.
*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 35 of the US Code.
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Image /page/1/Picture/1 description: The image shows the logo for the Department of Health & Human Services USA. The logo consists of a circular border with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" written around it. Inside the circle is a stylized image of three human profiles facing to the right, with wavy lines below them.
AUG 23 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Glen D. Smythe Sr. Regulatory Affairs Specialist ev3. Inc. 4600 Nathan Lane North PLYMOUTH MN 55442-2920
Re: K042204
Trade/Device Name: Protégé® GPS™ Self-Expanding Nitinol Stent (Biliary Indication) Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: August 13, 2004 Received: August 16, 2004
Dear Mr. Smythe:
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 and the limitations described below. 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.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device will be used for an intended use not identified in the proposed labeling and that such use could cause harm. Therefore, in accordance with Section 513(i)(1)(E) of the Act, the following limitation must appear in the Warnings section of the device's labeling:
The safety and effectiveness of this device for use in the vascular system have not been established.
Furthermore, the indication for biliary use must be prominently displayed in all labeling, including pouch, box, and carton labels, instructions for use, and other promotional materials, in close proximity to the trade name, of a similar point size, and in bold print.
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Page 2 - Mr. Glen D. Smythe
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 docs 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.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and permits your device to proceed to the market. This letter will allow you to begin marketing your device as described in your Section 510(k) premarket notification if the limitation statement described above is added to your labeling.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. Therefore, a new 510(k) is required before these limitations are modified in any way or removed from the device's labeling.
If you desire specific information about the application of other labeling requirements to your device (2) CFR Part 801), please contact the Office of Compliance at (301) 594-4616. 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.
Sincerely yours,
Donna-Bea Tillman, Ph.D.
Donna-Be Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number: K042204
Device Name: ev3 Protégé® GPSTM Self-Expanding Nitinol Stent (Biliary Indication)
FDA's Statement of the Indications For Use for device:
The Protégé® GPSTM Self-Expanding Nitinol Stent is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Edwind A. Simpson
(Division Sign-Off) Division of Reproductive, Abdominal. and Radiological Devices 510(k) Number _
§ 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.