(337 days)
The S.M.A.R.T. ® RE-FLEX™ Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Not Found
This document is an FDA 510(k) clearance letter for a medical device called "The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System". It confirms that the device is substantially equivalent to legally marketed predicate devices.
However, this document does not contain the detailed information necessary to describe acceptance criteria or a study proving the device meets those criteria, as typically found in clinical trial reports or detailed premarket submission documents.
The provided text is an FDA clearance letter, which is a regulatory decision document. It states that the device is substantially equivalent and can be marketed, but does not explain the data leading to that conclusion in the format requested.
Therefore, I cannot populate the table or answer most of the questions based on the input provided. The document primarily focuses on regulatory approval, labeling requirements, and general controls, not on the specifics of performance testing or clinical study results.
Here's what can be extracted and what cannot:
1. A table of acceptance criteria and the reported device performance
- Cannot be provided. This document does not specify acceptance criteria (e.g., specific clinical endpoints, success rates, patency rates) or detailed performance results in a quantitative manner.
2. Sample size used for the test set and the data provenance (e.g., country of origin of the data, retrospective or prospective)
- Cannot be provided. This information is not present in the FDA clearance letter.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts (e.g., radiologist with 10 years of experience)
- Not applicable/Cannot be provided. This type of detail is relevant for studies involving human interpretation (e.g., medical imaging AI), not typically for a self-expanding stent device in this context where "ground truth" would be related to clinical outcomes or device functionality established through different types of studies (e.g., mechanical testing, animal studies, human clinical trials). The document mentions no such experts or ground truth establishment.
4. Adjudication method (e.g., 2+1, 3+1, none) for the test set
- Not applicable/Cannot be provided. Similar to point 3, this is for studies involving human interpretation.
5. 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/Cannot be provided. This type of study relates to AI-assisted diagnostic or interpretative devices. The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent System is a physical interventional device, not an AI diagnostic tool.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This pertains to AI algorithms.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Cannot be provided. The document does not describe the types of data (e.g., clinical trial results, pathology) that would have established the ground truth for the performance claims in the actual submission to the FDA.
8. The sample size for the training set
- Not applicable/Cannot be provided. This applies to machine learning models, not to a physical medical device like a stent.
9. How the ground truth for the training set was established
- Not applicable/Cannot be provided. This applies to machine learning models.
In summary: The provided FDA 510(k) clearance letter serves as proof of regulatory approval based on substantial equivalence, but it is not the study report itself. The detailed clinical or performance study data (including acceptance criteria, sample sizes, and specific results) that informed this FDA decision would be found in the actual 510(k) submission and associated technical reports, which are not included in this extract.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-002
March 12, 2014
Cordis Corporation % Kim Fonda Regulatory Affairs Project Manager 6500 Paseo Padre Parkway FREMONT CA 94555
Re: K130981
Trade/Device Name: The S.M.A.R.T. RE-FLEX™ Biliary Self Expanding Stent
System
Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: February 7, 2014 Received: February 10, 2014
Dear Kim Fonda,
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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you; however, that device labeling must be truthful and not misleading.
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.
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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.
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.
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.
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); medical device reporting (reporting of medical device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Small Manufacturers, International and Consumer Assistance at its toll-free number (800) 638 2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to
http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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Page 3 – Ms. Kim Fonda
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) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.
Sincerely yours,
Christy L. Foreman -S
Christy Foreman Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K13098
Device Name: S.M.A.R.T. ® RE-FLEX™ Biliary Self Expanding Stent System
FDA's Statement of the Indications for Use for device:
The S.M.A.R.T. ® RE-FLEX™ Biliary Self Expanding Stent System is indicated for use in the palliation of malignant strictures in the biliary tree.
Over-The-Counter Use Prescription Use _ X AND/OR (Part 21 CFR 801 Subpart D) (21 CFR 801 Subpart C)
Herbert P. Lerner =S 2014.03.04 15:14:12 -05'00'
§ 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.