(30 days)
The Cordis S.M.A.R.T. ™ .018" Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The Cordis S.M.A.R.T. ™ .018" Nitinol Stent Transhepatic Biliary System is a system consisting of a self-expanding, open mesh, nitinol stent preloaded onto a sheathed delivery catheter. The delivery system is designed to deliver the stent to the stricture site via transhepatic access. Once positioned at the stricture site, the sheath is withdrawn and the stent is released. Upon release, the stent expands and conforms to the inner lumen of the biliary duct.
The provided text is a 510(k) submission for a medical device (Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System) seeking clearance from the FDA. This type of submission is focused on demonstrating substantial equivalence to a previously legally marketed device, rather than proving efficacy through clinical trials with specific acceptance criteria and performance metrics as would be seen for AI/ML-based devices.
Therefore, the information requested in the prompt (acceptance criteria, study details, sample sizes, ground truth, expert qualifications, etc.) is not present in this document because it is not relevant to a 510(k) submission for this type of device. The clearance is based on pre-clinical testing demonstrating equivalence to the predicate device, not on specific clinical performance metrics.
Specifically, the document states:
- "The Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing."
A 510(k) for a stent, especially one from 1999, would typically involve:
- Mechanical and material testing: Demonstrating strength, fatigue resistance, corrosion resistance, and other physical properties of the stent are equivalent to or better than the predicate.
- Biocompatibility testing: As mentioned, "All materials used... are biocompatible." This involves standard ISO 10993 tests.
- Delivery system performance: Evaluation of the catheter's ability to navigate, deploy, and retrieve (if applicable) the stent.
- Dimensional equivalency: Ensuring the stent and delivery system dimensions are comparable to the predicate.
Therefore, I cannot provide the requested information for acceptance criteria and the study that proves the device meets them because the provided text describes a 510(k) premarket notification for a physical medical device (a stent) and does not contain the details of an AI/ML study, performance metrics, or clinical acceptance criteria as would be needed for software or AI/ML evaluations.
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Attachment 4
Summary of Safety and Effectiveness
| GeneralProvisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Cordis S.M.A.R.T. TM .018" Nitinol StentTranshepatic Biliary System | Biliary Stent | |
| Name ofPredicateDevices | The device is substantially equivalent to:• Cordis S.M.A.R.T. TM Nitinol Stent Transhepatic Biliary System | |
| Classification | Class II. | |
| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act. | |
| Indications forUse | The Cordis S.M.A.R.T. TM .018" Nitinol Stent Transhepatic BiliarySystem is intended for use in the palliation of malignant neoplasms in thebiliary tree. | |
| DeviceDescription | The Cordis S.M.A.R.T. TM .018" Nitinol Stent Transhepatic BiliarySystem is a system consisting of a self-expanding, open mesh, nitinol stentpreloaded onto a sheathed delivery catheter. The delivery system is designedto deliver the stent to the stricture site via transhepatic access. Oncepositioned at the stricture site, the sheath is withdrawn and the stent isreleased. Upon release, the stent expands and conforms to the inner lumen ofthe biliary duct. | |
| Biocompatibility | All materials used in the Cordis S.M.A.R.T. TM .018" Nitinol StentTranshepatic Biliary System are biocompatible. |
Continued on next page
Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System Special 510(k) October, 1999
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Summary of Substantial Equivalence
The Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System is substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing.
Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System Special 510(k) October, 1999
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Image /page/2/Picture/1 description: The image is a circular logo for the U.S. Department of Health and Human Services. The logo features a stylized eagle with outstretched wings, symbolizing the department's mission to protect the health of all Americans. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES-USA" are arranged in a circular pattern around the eagle. The logo is simple, clean, and easily recognizable.
NOV 28 1999
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Elena S. Jugo, R.A.C. Manager, Regulatory Affairs Cordis Corporation P.O. Box 025700 Miami, FL 33102-5700
Re: K993646
Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: October 28, 1999 Received: October 29, 1999
Dear Ms. Jugo:
We have reviewed your Section 510(k) notification of intent to market the device referenced we have roviewed your becally be is substantially equivalent (for the indications for use above into we nave acterine as a 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 Costisions of the Act and the limitations described below. The general controls provisions of the provisions of the 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 - Ms. Elema S. Jugo
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 affecting your device can be found 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 comply with the GMP regulation 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 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 W. Frye
David W. Feigal Ar., M.D. Acting 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): K993646
Device Name: Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System
FDA's Statement of the Indications For Use for device:
The Cordis S.M.A.R.T.™ .018" Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
David A. Segner
(Division Sign-Off) Division of Reproductive, Abdominal, B and Radiological Devi 510(k) Number
Prescription Use OR
(Per 21 CFR 801.109)
Over-The-Counter Use
§ 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.