(30 days)
Not Found
No
The summary describes a physical medical device (a stent and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
Explanation: The device is a stent intended for palliative treatment of malignant neoplasms, indicating a therapeutic purpose.
No
The device is described as a "palliative treatment of malignant neoplasms," indicating it is used for treatment, not diagnosis. It is a stent designed to establish patency in biliary ducts.
No
The device description clearly details a physical stent made of nitinol and a delivery catheter, indicating it is a hardware medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "as a palliative treatment of malignant neoplasms in the biliary tree." This describes a therapeutic intervention performed within the body, not a test performed on a sample taken from the body to diagnose a condition.
- Device Description: The device is a stent, which is an implantable medical device used to open and maintain the patency of a lumen (in this case, the biliary ducts). This is a treatment device, not a diagnostic device.
- Lack of IVD characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) to provide diagnostic information.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device is used for direct treatment within the body.
N/A
Intended Use / Indications for Use
The Protégé™ Self-expanding Nitinol Stent with StarPort™ Delivery Technology is intended as a palliative treatment of malignant neoplasms in the biliary tree.
Product codes
78 FGE
Device Description
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Not Found
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.
0
| 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 Drive | |
| St. Paul, MN 55112 | |
| Official Contact: | Marcia R. Ellis |
| Regulatory Affairs Associate | |
| Telephone: 651-697-4807 | |
| Fax: 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.
1
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.
2
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
3
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_