(34 days)
The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm is intended for use in the palliation of malignant neoplasms in the biliary tree.
7 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters 6, 7, 8, 9, and10 mm; . Stent lengths: 20, 40, 60, and 80 mm; ● Stent delivery system usable length 40 cm; and . Guidewire lumen 0.035".
The provided text describes a 510(k) submission for the Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm. This type of submission focuses on demonstrating substantial equivalence to a legally marketed predicate device rather than conducting new clinical trials to establish de novo performance or acceptance criteria.
Therefore, the document does NOT contain information on:
- Acceptance criteria and reported device performance in a table format, as this is typically established through clinical performance studies.
- Sample size and data provenance for a test set.
- Number of experts and their qualifications for establishing ground truth.
- Adjudication method.
- Multi-Reader Multi-Case (MRMC) comparative effectiveness study or its effect size.
- Standalone algorithm performance.
- Type of ground truth used.
- Sample size for the training set.
- How ground truth for the training set was established.
Instead, the document states:
1. Acceptance Criteria and Study:
- Acceptance Criteria: Not explicitly stated as a set of performance metrics. The underlying "acceptance criteria" for a 510(k) submission is demonstrating substantial equivalence to a predicate device.
- Study Proving Equivalence: The document states, "The Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm is substantially equivalent to the predicate device. The equivalence was confirmed through pre-clinical testing."
Summary of Device Performance (as demonstrated by substantial equivalence):
The device is considered to perform equivalently to the predicate device Cordis SMART™ Nitinol Stent Transhepatic Biliary System (510(k) # K001843 - July 18, 2000) for its intended use.
Detailed Breakdown of what is NOT available from the provided text:
Due to the nature of a 510(k) submission, particularly for a Biliary Stent, the provided text focuses on demonstrating substantial equivalence, not on establishing novel performance metrics through a clinical study with detailed acceptance criteria and expert-adjudicated ground truth.
- A table of acceptance criteria and the reported device performance: Not provided. The submission relies on pre-clinical testing to confirm substantial equivalence to a predicate device, rather than establishing new performance metrics.
- Sample size used for the test set and the data provenance: Not applicable or provided, as there is no mention of a clinical test set in the context of efficacy or diagnostic performance. The substantial equivalence was confirmed via pre-clinical testing, which would involve laboratory or bench tests, not patient data in the sense of a clinical test set.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts: Not applicable or provided. Ground truth in this context (for a medical device like a stent) would typically refer to outcomes in clinical trials, which are not detailed here. The "ground truth" for the 510(k) is the established safety and effectiveness of the predicate device.
- Adjudication method for the test set: Not applicable or provided.
- 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. This device is a stent, not an AI-powered diagnostic tool requiring human reader studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done: Not applicable. This device is a stent, not a software algorithm.
- The type of ground truth used: For a device like a stent, "ground truth" for regulatory purposes typically relates to objective measures of safety (e.g., biocompatibility, mechanical integrity) and performance (e.g., ability to expand and maintain patency). These were assessed via pre-clinical testing for substantial equivalence. The "intended use" (palliation of malignant neoplasms in the biliary tree) implies clinical outcomes, but no clinical study results are presented here.
- The sample size for the training set: Not applicable. There is no mention of an algorithm or training set.
- How the ground truth for the training set was established: Not applicable.
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2-11-02 510(k) Summary of Safety and Effectiveness 020052 The name of the device is: General Provisions Common or Usual Name Proprietary Name Biliary Stent Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm The device is substantially equivalent to: Name of Cordis SMART™ Nitinol Stent Transhepatic Biliary System (510(k) # Predicate ● K001843 - July 18, 2000). Devices Class II. Classification Performance standards have not been established by the FDA under section Performance 514 of the Food, Drug and Cosmetic Act. Standards The Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm Indications is intended for use in the palliation of malignant neoplasms in the biliary tree. for Use The device description of the proposed Cordis SMART™ Nitinol Stent Device Transhepatic Biliary System - 40 cm is as follows. Description 7 French stent delivery system profile; . Stent material - Nickel Titanium alloy and tantalum . micromarkers; Expanded stent diameters 6, 7, 8, 9, and10 mm; . Stent lengths: 20, 40, 60, and 80 mm; ● Stent delivery system usable length 40 cm; and . Guidewire lumen 0.035". . All materials used in the Cordis SMART™ Nitinol Stent Transhepatic Biocompatibility Biliary System - 40 cm are biocompatible. The Cordis SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm Summary of is substantially equivalent to the predicate device. The equivalence was Substantial Equivalence confirmed through pre-clinical testing. SMART™ Nitinol Stent Transhepatic Biliary System - 40 cm Special 510(k) January 4, 2002
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
FEB 1 1 2002
Mr. Sam Mirza Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue Miami Lakes, Florida 33014
Re: K020052
Trade/Device Name: Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic
Biliary System - 40 cm Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: January 4, 2002 Received: January 8, 2002
Dear Mr. Mirza:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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 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 Part 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 Part 807.97). Other general information on your responsibilities under the Act may be obtained 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 vours.
Bernard land, M.D., Ph.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K020052
Device Name: Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm
FDA's Statement of the Indications For Use for device:
The Cordis S.M.A.R.T.™ Nitinol Stent Transhepatic Biliary System - 40 cm is intended for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use OR
(Per 21 CFR 801.109)
Over-The-Counter Use
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§ 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.