(61 days)
Not Found
No
The 510(k) summary describes a physical medical device (a stent and delivery system) and its intended use. There is no mention of software, algorithms, image processing, AI, ML, or any data-driven components that would indicate the presence of AI/ML technology. The focus is on the material, dimensions, and delivery mechanism of the stent.
Yes
The device is intended for the palliation of malignant neoplasms in the biliary tree, which is a therapeutic intervention aimed at alleviating symptoms and improving quality of life.
No
The device is a stent system used for palliation of malignant neoplasms in the biliary tree, which is a treatment, not a diagnostic, function.
No
The device description clearly outlines physical components such as a stent delivery system, stent material (Nickel Titanium alloy and tantalum micromarkers), stent dimensions, and a proximal deployment handle, indicating it is a hardware device.
No, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is "palliation of malignant neoplasms in the biliary tree." This describes a therapeutic intervention (placing a stent to relieve obstruction), not a diagnostic test performed on samples taken from the body.
- Device Description: The description details a physical implantable device (a stent) and its delivery system. This is characteristic of a medical device used for treatment, not a diagnostic test.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (like blood, urine, tissue, etc.) to provide diagnostic information.
IVDs are devices intended to be used in vitro for the examination of specimens derived from the human body solely or principally for the purpose of providing information concerning a physiological or pathological state, or congenital abnormality, or to monitor therapeutic measures. This device does not fit that description.
N/A
Intended Use / Indications for Use
The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The device description of the proposed SMART™ Control™ 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 9, and 10 mm; Stent lengths: 100 mm; Stent delivery system usable length 80 and 120 cm; and Guidewire lumen 0.035". Proximal Deployment handle
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)
The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is Summary of Substantial substantially equivalent to the predicate devices. The equivalence was Equivalence confirmed through pre-clinical testing.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
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.
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JUN 1 6 2003
K031197
page 1 of 2
510(k) Summary of Safety and Effectiveness
| General Provisions | The name of the device is: |
|---|---|
| -------------------- | ---------------------------- |
| Proprietary Name | Common or Usual Name | |
|---|---|---|
| SMART™ Control™ Nitinol Stent | ||
| Transhepatic Biliary System | Biliary Stent |
| Name of
Predicate
Devices | The device is substantially equivalent to:
Cordis SMART™ Control™ Nitinol Stent Transhepatic Biliary System (510(k) # K021898 – August 14, 2001) - Cordis Corporation.Cordis SMART™ Control™ Nitinol Stent Transhepatic Biliary System (510(k) # K023217 - October 25, 2000) – Cordis Corporation. |
|---------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Classification | Class II. |
| Performance
Standards | Performance standards have not been established by the FDA under section 514 of the Food, Drug and Cosmetic Act. |
| Indications
for Use | The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree. |
| Device
Description | The device description of the proposed SMART™ Control™ 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 9, and 10 mmStent lengths: 100 mm;Stent delivery system usable length 80 and 120 cm; andGuidewire lumen 0.035".Proximal Deployment handle |
| Biocompatibility | All materials used in the SMART™ Control™ Nitinol Stent Transhepatic Biliary System are biocompatible. |
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K031197
page 2 of 2
The SMART™ Control™ Nitinol Stent Transhepatic Biliary System is Summary of Substantial substantially equivalent to the predicate devices. The equivalence was Equivalence confirmed through pre-clinical testing.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUM." around the left side. To the right of the text is a stylized image of three human profiles facing right, arranged in a stacked formation.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 1 6 2003
Mr. Sam Mirza Manager Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue MIAMI LAKES FL 33014
Re: K031197
Trade/Device Name: S.M.A.R.T.™ Control ™ Nitinol Stent Transhepatic Biliary System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: May 23, 2003 Received: May 27, 2003
Dear Mr. Mirza:
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.
3
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.
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,
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known):_K031197
Device Name: Cordis S.M.A.R.T.M Control™ Nitinol Stent Transhepatic Biliary System
FDA's Statement of the Indications For Use for device:
The Cordis S.M.A.R.T.TM Control™ Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Daniel A. Lyman
(Division Sign-Off)
ivision of Reproductive, Abdominal, and Radiological Devices 510(k) Number