(505 days)
No
The device description and performance studies focus on the physical characteristics and mechanical performance of a nitinol stent and its delivery system, with no mention of AI or ML.
Yes.
The device is intended for the "palliation of malignant neoplasms in the biliary tree" and "palliation of malignant strictures in the biliary tree," which are therapeutic purposes.
No
Explanation: The device is a "S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System" intended for the palliation of malignant neoplasms in the biliary tree. Its function is to provide palliation, which means alleviating symptoms or reducing the severity of a disease, rather than diagnosing it. The description focuses on its physical characteristics as a stent and its placement, not on any diagnostic capabilities.
No
The device description clearly outlines physical components made of Nickel Titanium alloy and tantalum, a delivery system, and specifies dimensions and sterilization methods, indicating it is a physical 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 the "palliation of malignant neoplasms in the biliary tree" and "palliation of malignant strictures in the biliary tree." This describes a therapeutic intervention performed within the body to treat a condition.
- Device Description: The description details a physical stent and its delivery system, designed to be implanted in the biliary tree.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for treatment.
N/A
Intended Use / Indications for Use
The S.M.A.R.T. Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The S.M.A.R.T. " Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree.
Product codes
FGE
Device Description
The device description of the proposed S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is as follows. 6 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters: 6, 7 and 8 mm; . Stent lengths: 120 and 150 mm; . Stent delivery system usable length: 120 cm; and . Guidewire lumen 0.035" ● The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only.
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
Prescription Use
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)
The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate devices. The substantial equivalence to the predicate devices has been demonstrated via data collected from non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct).
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
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
K062798 Pj. lot 2
Cordis Corporation, a Johnson & Johnson Company S.M.A.R.T. Nitinol Stent Transhepatic Biliary System
FEB -- 6 2008
510(k) Summary of Safety and Effectiveness
General The name of the device is: Provisions Proprietary Name Common or Usual Name S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary Stent (incl. Biliary System Accessories) The device is substantially equivalent to: Name of Cordis S.M.A.R.T.® CONTROL™ Nitinol Stent Transhepatic Biliary Predicate . Devices System (510(k) # K032457) Cordis S.M.A.R.T.® Nitinol Stent Transhepatic Biliary System . (510(k) # K003336) Cordis PRECISE™ Nitinol Stent Transhepatic Biliary System (510(k) � #K010445) ● ev3 Protégé EverFlex Self-Expanding Nitinol Stent (510(k)#K060057) Classification Class II. Performance Performance standards have not been established by the FDA under section Standards 514 of the Food, Drug and Cosmetic Act. The contents of this 510(k) premarket notification have been prepared based upon the FDA's Guidance for the Content of Premarket Notifications for Metal Expandable Biliary Stents (February 5, 1998). The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is intended for Indication for Use use in the palliation of malignant neoplasms in the biliary tree.
1
K062798 page 22 a
510(k) Premarket Notification
Cordis Corporation, a Johnson & Johnson Company S.M.A.R.T. Nitinol Stent Transhepatic Biliary System
The device description of the proposed S.M.A.R.T. ® Nitinol Stent Device Description Transhepatic Biliary System is as follows. 6 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters: 6, 7 and 8 mm; . Stent lengths: 120 and 150 mm; . Stent delivery system usable length: 120 cm; and . Guidewire lumen 0.035" ● The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is provided sterile (via Ethylene Oxide sterilization) and is intended for single use only. Biocompatibility All materials used in the S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System are biocompatible. The S.M.A.R.T. ® Nitinol Stent Transhepatic Biliary System is substantially Summary of Substantial equivalent to the predicate devices. The substantial equivalence to the Equivalence predicate devices has been demonstrated via data collected from non-clinical in-vitro bench testing and animal testing (stent placement in a biliary duct).
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with outstretched wings. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" are arranged in a circular pattern around the bird symbol.
Food and Druq Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 6 2008
Ms. Elena S. Jugo Regulatory Affairs Manager Cordis Corporation 14201 NW 60m Avenue MIAMI LAKES FL 33014
Re: K062798
Trade/Device Name: S.M.A.R.T. Nitinol Stent Transhepatic Biliary System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: January 18, 2008 Received: January 22, 2008
Dear Ms. Jugo:
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.
3
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.
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 (21 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,
onna-Bea Tillman, Ph.D., M.P.H. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K062798
Device Name: S.M.A.R.T. Nitinol Stent Transhepatic Biliary System
FDA's Statement of the Indications for Use for device:
The S.M.A.R.T. " Nitinol Stent Transhepatic Biliary System is intended for palliation of malignant strictures in the biliary tree.
Prescription Use
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Hulut lemen
(Division Sign-Off) Division of Reproductive, Abdominal and Radiological Devices 510(k) Number