(31 days)
The S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The device description of the proposed S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System is as follows.
7 French stent delivery system profile;
Stent material – Nickel Titanium alloy and tantalum micromarkers;
Expanded stent diameters, 8, 9, and 10 mm;
Stent lengths 40, 60, and 80 mm;
Stent delivery system usable length 190 cm; and
Guidewire lumen 0.035".
The provided document does not contain information about acceptance criteria or a study that proves the device meets specific acceptance criteria in the manner typically associated with clinical performance studies for diagnostic or AI-based devices.
Instead, this document is a 510(k) summary for a medical device (S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System) seeking marketing clearance from the FDA. The "study" mentioned is a "pre-clinical testing" conducted to demonstrate substantial equivalence to predicate devices, not a clinical effectiveness study with performance metrics as requested in the prompt.
Here's a breakdown based on the available information, highlighting what is not present:
1. Table of acceptance criteria and reported device performance:
This information is not provided in the document. The document describes the device and its intended use, and states that substantial equivalence was confirmed through pre-clinical testing, but it does not specify any quantitative acceptance criteria or performance metrics (like sensitivity, specificity, accuracy, etc.) for the device itself.
2. Sample size used for the test set and data provenance:
This information is not provided. The document only mentions "pre-clinical testing" without detailing the nature of this testing, the sample size, or data provenance.
3. Number of experts used to establish the ground truth for the test set and their qualifications:
This information is not provided. As no clinical or expert-reviewed test set is described, there's no mention of experts or their qualifications.
4. Adjudication method for the test set:
This information is not provided. No adjudication method is mentioned.
5. If a multi-reader multi-case (MRMC) comparative effectiveness study was done, and its effect size:
An MRMC study was not mentioned or conducted. The device is a physical stent, not an AI or diagnostic tool that would typically involve human readers.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
A standalone performance study of an algorithm was not done. This device is a medical stent, not an algorithm.
7. The type of ground truth used:
This information is not provided. Given the nature of a stent approval through substantial equivalence, the "ground truth" would likely relate to material properties, mechanical performance, and biological compatibility, rather than clinical outcomes or expert consensus in the diagnostic sense. The document refers to "pre-clinical testing" which would assess these physical and biological characteristics.
8. The sample size for the training set:
This information is not provided. Training sets are relevant for AI/ML models, not for a physical device like a stent.
9. How the ground truth for the training set was established:
This information is not provided.
Summary of the study that proves the device meets the acceptance criteria (based on the document):
The document states that the S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System is substantially equivalent to predicate devices, and this equivalence was confirmed through pre-clinical testing.
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Predicate Devices:
- Cordis S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System (510(k) # K003365 – November 22, 2000)
- Cordis S.M.A.R.T.™ Control Nitinol Stent Transhepatic Biliary System (510(k) # K021898 – August 14, 2002)
- SMART Nitinol stent Transhepatic Biliary System (Enhanced Radiopacity) (510(k) # K001843 – July 20, 2000)
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Nature of the "Study" / Justification: The primary "study" is the pre-clinical testing which demonstrated the substantial equivalence of the new device to the already-cleared predicate devices. This type of submission relies on showing that the new device has the same intended use, technological characteristics (or differences that do not raise new questions of safety or effectiveness), and performs as safely and effectively as the predicate devices. The document highlights various technical specifications of the device (e.g., 7 French stent delivery system profile, stent material, expanded stent diameters, stent lengths, usable length, guidewire lumen) and states all materials are biocompatible, which would be assessed in such pre-clinical tests.
In essence, this 510(k) is about demonstrating substantial equivalence through non-clinical means (pre-clinical testing), not about meeting specific clinical performance acceptance criteria in a trial setting.
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MAR 1 () 2003
K030409
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 | |
|---|---|---|
| S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System | Biliary Stent |
| Name of Predicate Devices | The device is substantially equivalent to: |
|---|---|
| Cordis S.M.A.R.T.TM Nitinol Stent Endoscopic Biliary System (510(k) # K003365 – November 22, 2000) - Cordis Corporation.Cordis S.M.A.R.T.TM Control Nitinol Stent Transhepatic Biliary System (510(k) # K021898 – August 14, 2002) - Cordis CorporationSMART Nitinol stent Transhepatic Biliary System (Enhanced Radiopacity) (510(k) # K001843 – July 20, 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 S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree. |
| Device Description | The device description of the proposed S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System is as follows. 7 French stent delivery system profile;Stent material – Nickel Titanium alloy and tantalum micromarkers;Expanded stent diameters, 8, 9, and 10 mm;Stent lengths 40, 60, and 80 mm;Stent delivery system usable length 190 cm; andGuidewire lumen 0.035". |
| Biocompatibility | All materials used in the S.M.A.R.T. TM Nitinol Stent Endoscopic Biliary System are biocompatible. |
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K030409
page 2 of 2
The S.M.A.R.T.TM Nitinol Stent Endoscopic Biliary System is substantially Summary of equivalent to the predicate devices. The equivalence was confirmed through Substantial Equivalence pre-clinical testing.
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Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes representing the department's mission. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAR 1 0 2003
Mr. Sam Mirza Manager Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue MIAMI LAKES FL 33014
Re: K030409
Trade/Device Name: S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 6, 2003 Received: February 7, 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.
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 - Mr. Sam Mirza
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.
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): _K030409
Device Name: Cordis S.M.A.R.T.101 Nitinol Stent Endoscopic Biliary System
FDA's Statement of the Indications For Use for device:
The Cordis S.M.A.R.T.™ Nitinol Stent Endoscopic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Perscription Use (Per 21 CFR 801.109)
OR
Over-the-Counter Use ---------------------------------------------------------------------------------------------------------------------------------------------------------
Thiel K. Lysem
(Division Sign-Off)
Division in Reproductive, Abdominal, and Radiological Devices
510(k) Number K030409
§ 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.