(88 days)
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple lengths, (20, 30, 70, 80, 80, s premounted on an 80 or 135 cm working length 6F, 0.018" (or 0.014") over-the-wire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Biocompatibility testing meets "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents" (2/98) | Biocompatibility testing meets FDA's "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents" (2/98). |
| Bench tests of performance characteristics on the 6 Fr system to the same specifications as the 7 Fr system, demonstrating equivalency in performance. | Bench tests of performance characteristics were performed on the 6 Fr system to the same specifications as the 7 Fr system, demonstrating equivalency in performance. |
| Substantial equivalence to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 7 Fr system, (K003040) in intended use, materials, technological characteristics and performance. | The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 6 Fr system, is substantially equivalent to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 7 Fr system, (K003040) in intended use, materials, technological characteristics and performance. |
2. Sample Size Used for the Test Set and Data Provenance
The provided summary does not specify a separate "test set" in the context of clinical trials or data-driven performance. The performance evaluation primarily relies on:
- Bench testing for the 6 Fr system.
- Comparison to the previously cleared 7 Fr system (K003040).
Therefore, there is no information on sample size or data provenance (country of origin, retrospective/prospective) for a distinct clinical test set. The evaluation is based on device characteristics and equivalence to a predicate device.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications
This information is not applicable as the provided document describes a 510(k) submission primarily based on substantial equivalence and bench testing, rather than a clinical study requiring expert-established ground truth for a test set.
4. Adjudication Method for the Test Set
This information is not applicable for the reasons stated in point 3.
5. If a Multi Reader Multi Case (MRMC) Comparative Effectiveness Study Was Done, and Effect Size
No, an MRMC comparative effectiveness study was not conducted or reported in this 510(k) summary. The submission focuses on device characteristics and substantial equivalence.
6. If a Standalone (i.e. algorithm only without human-in-the-loop performance) Was Done
This question is not applicable as the device is a physical medical device (a stent and delivery system), not an algorithm or AI software. There is no "standalone" performance for an algorithm.
7. The Type of Ground Truth Used
The "ground truth" in this context is the performance of the predicate device, the 7 Fr Protégé™ stent system (K003040), which was previously cleared by the FDA based on its own evidence of safety and effectiveness. The current submission establishes that the 6 Fr system is substantially equivalent to this predicate.
8. The Sample Size for the Training Set
This information is not applicable. The device is a physical medical device, not an AI or machine learning algorithm that requires a "training set."
9. How the Ground Truth for the Training Set Was Established
This information is not applicable for the reasons stated in point 8.
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SEP = 7 2001
Premarket Notification (510(k)) Summary
| 510(k) Number: | K011806 |
|---|---|
| Product Name: | Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) |
| Common Name: | biliary stent |
| Class: | Class II, 21 CFR 876.5010 |
| Submitter's Name: | Sulzer IntraTherapeutics Inc.651 Campus DriveSt. Paul, MN 55112 |
| Official Contact: | Maria BrittleSr. Reg/Clin/Training AssociateTelephone: 651-697-2018Fax: 651-697-4808 |
| Summary Preparation Date: | June 7, 2001 |
This summary is provided in compliance with section 513(I)(3)(A) of the Act and summarizes 1 his summal y is provided in compution contained in this premarket notification submission for a 6 Fr delivery catheter with added feature. Substantial equivalence is claimed to the 7 Fr Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology.
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
The Protégé™ stent is a self-expanding nitinol (nickel-titanium alloy) stent provided in multiple I he f rooge - stein to a 60, 70 and 80 mm) and diameters (6, 7, 8 and 9 mm). The stent is lengths, (20, 30, 70, 80, 80, s premounted on an 80 or 135 cm working length 6F, 0.018" (or 0.014") over-the-wire delivery catheter designed for transhepatic access. Upon deployment, the stent achieves its predetermined diameter and exerts a constant, gentle outward force to establish patency in the biliary ducts. The disposable StarPort Delivery Technology system is comprised of an inner and outer sheath, which are locked together with a safety lock.
Biocompatibility testing meets FDA's "Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents" (2/98). Bench tests of performance characteristics were performed on the 6 Fr system to the same specifications as the 7 Fr system, demonstrating equivalency in performance.
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 6 Fr system, is substantially equivalent to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, 7 Fr system, (K003040) in intended use, materials, technological characteristics and performance.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle with three lines representing its wings.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
7 2001 SEP
Ms. Maria E. Brittle Regulatory Affairs Manager Sulzer IntraTherapeutics, Inc. 651 Campus Drive ST. PAUL MN 55112
Re:
Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication), 6 Fr delivery catheter Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: June 7, 2001 Received: June 11, 2001
Dear Ms. Brittle:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 - Ms. Maria E. Brittle
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 corply 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 above is added to your labeling, as described.
Please note that the above labeling limitations are required by Section 513(i)(1)(E) of the Act. I tease note and alo a c 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 (21 CFR Part 801 and additionally Part 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. 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"(21 CFR Part 807.97). 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.
Thing Phung
Bernard B atland, M.D., Ph.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K011806
Device Name: Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication), 6 Fr delivery catheter
FDA's Statement of the Indications For Use for device:
The Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication) is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Nancy C. Brogdon
(Division Sign-Off) Division of Reproductiv Ahdomin and Radiological Devic 510(k) Number _
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use_
§ 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.