(30 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, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8, 9 and 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire 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.
The provided text is a 510(k) summary for a medical device called "Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication)". It describes a modification to an already marketed device. This kind of document is a premarket notification to the FDA, demonstrating substantial equivalence to a predicate device.
It is crucial to understand that 510(k) submissions, especially for devices like stents, typically do not include studies with "acceptance criteria" and "reported device performance" in the way one would describe a novel AI/software medical device (SaMD) study.
For a physical device like a stent, substantial equivalence is usually shown through:
- Bench testing: In-vitro mechanical and material property tests to ensure the modified device performs similarly to the predicate and meets design specifications (e.g., radial force, fatigue resistance, corrosion resistance).
- Biocompatibility testing: To ensure the materials are safe for use in the human body.
- Animal studies: To demonstrate performance in a living system, often focusing on deployment, patency, and tissue response.
- Clinical data (if available and necessary): Sometimes, a 510(k) might reference or provide limited clinical data, but often substantial equivalence for a modification can be established without new clinical trials.
The provided text focuses on the description of the modification and the FDA's determination of substantial equivalence based on the submission. It does not contain the detailed study results of mechanical tests, animal studies, or clinical studies. Therefore, much of the requested information about acceptance criteria, sample sizes, ground truth establishment, expert adjudication, or MRMC/standalone studies for AI performance is not applicable to this type of document or device.
This document confirms the device is substantially equivalent to a predicate device based on "intended use, materials, technological characteristics and performance." The modifications are described as:
- A stent retainer feature to enhance smoothness of deployment.
- Additional ports for enhanced contrast injection.
- A new 10mm stent diameter.
Based on the provided text, here is why most of your requested information cannot be found or is not directly applicable in the context of an AI/SaMD study:
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A table of acceptance criteria and the reported device performance: This document does not contain this information in the context of AI performance metrics (e.g., sensitivity, specificity). For a physical stent, acceptance criteria would relate to mechanical properties, material integrity, and functionality, which are not detailed here.
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Sample size used for the test set and the data provenance: Not applicable. There is no "test set" in the context of AI validation described.
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Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable. Ground truth for an AI assessment is not relevant here.
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Adjudication method (e.g. 2+1, 3+1, none) for the test set: Not applicable.
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If a multi reader multi case (MRMC) comparative effectiveness study was done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance: Not applicable. This is a physical stent, not an AI software.
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If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable.
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The type of ground truth used (expert consensus, pathology, outcomes data, etc): Not applicable in the AI context. For a stent, "ground truth" often relates to successful deployment, patency demonstrated through imaging, and clinical outcomes, but these are not detailed in this summary.
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The sample size for the training set: Not applicable. There is no AI training set.
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How the ground truth for the training set was established: Not applicable.
In summary: The provided document is for a physical medical device (a stent) seeking 510(k) clearance based on substantial equivalence, not for an AI/software medical device. Therefore, the questions related to AI study design and metrics are not addressed in this document.
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| 510(k) Number: | K012347 |
|---|---|
| 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: | Marcia R. EllisRegulatory Affairs AssociateTelephone: 651-697-4807Fax: 651-697-4808 |
| Summary Preparation Date: | July 23, 2001 |
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™ 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 lengths, (20, 30, 40, 50, 60, 70 and 80 mm) and diameters (6, 7, 8, 9 and 10 mm). The stent is electropolished. The stent is premounted on an 80 or 120 cm working length, 0.035" over-thewire 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.
The modified Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology, is substantially equivalent to the currently marketed Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology (K003040) in intended use, materials, technological characteristics and performance. A stent retainer feature has been added to enhance the smoothness of deployment and additional ports for enhanced contrast injection. Additionally, a 10 mm stent diameter has been added to further expand the product offering.
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Image /page/1/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circle with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol that resembles an eagle or bird in flight, composed of three curved lines.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 3 2001
Ms. Marcia R. Ellis Regulatory Affairs Associate Sulzer IntraTherapeutics, Inc. 651 Campus Drive ST. PAUL MN 55112
K012347 Re:
Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication), 10 mm Stent Diameter Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: July 23, 2001 Received: July 24, 2001
Dear Ms. Ellis:
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. Marcia R. Ellis
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations (1 renariot ripproval), in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to inspootions, the Food and on may result in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 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. 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 (21 CFR Part 801 and additionally 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 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,
Bert Ehgartner
Bernard E. Statland, M.D., Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K012347
Device Name: Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology (Biliary Indication), 10 mm Stent Diameter
FDA's Statement of the Indications For Use for device:
The Protégé™ Self-Expanding Nitinol Stent with StarPort™ Delivery Technology The Frotege --- Sen-Expanding Nitinalive treatment of malignant neoplasms in the biliary tree.
Prescription Use_V OR (Per 21 CFR 801.109)
Over-The-Counter Use
Harvey broadin
(Division Sign-Off) (Division of Reproductive, Abde and Radiological Devices 510(k) Number
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.