(68 days)
The proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System is intended for use in the palliation of malignant neoplasms in the biliary tree.
The device description of the proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System is as follows.
- Delivery system profile in the area of stent housing is 5 F for stent diameters ranging from 5-7 mm and 6F for stent diameters ranging from 8-10 mm.
- The stent will be delivered to the lesion site via the Rapid Exchange Stent Delivery System
- Guidewire Lumen - 0.014"
- Stent delivery system useable length - 135 mm
- Stent lengths - 20, 30 and 40 mm
- Stent diameters - 5, 6, 7, 8, 9, and 10 mm
The provided document is a 510(k) summary for a medical device called the "Precise™ Rx Nitinol Stent Transhepatic Biliary System." This type of submission is for demonstrating substantial equivalence to a legally marketed predicate device, rather than proving a device meets specific acceptance criteria through a comparative effectiveness study or standalone performance evaluation.
Therefore, much of the requested information regarding acceptance criteria, specific study design details, ground truth establishment, expert involvement, and statistical measures like effect size or sample sizes for training/test sets is not available in this document. This submission focuses on demonstrating that the new device is as safe and effective as existing predicate devices through pre-clinical testing, rather than reporting on a clinical study with detailed performance metrics against predefined acceptance criteria.
However, I can extract the following information that is available:
1. Table of Acceptance Criteria and Reported Device Performance:
As this is a 510(k) submission based on substantial equivalence, there are no explicit "acceptance criteria" presented in the format of a table with specific performance metrics as would be found in a clinical trial report. Instead, the "performance" is demonstrated by showing "substantial equivalence" to predicate devices through pre-clinical testing. The document states:
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices for safety and effectiveness. | Equivalence was confirmed through pre-clinical testing. |
| (No specific quantifiable acceptance criteria are provided in the document.) | (No specific quantifiable performance data is provided in the document.) |
2. Sample size used for the test set and the data provenance:
- Sample size for test set: Not applicable/Not provided. The document refers to "pre-clinical testing" without detailing specific sample sizes for a test set. This generally refers to bench testing rather than human subject data.
- Data provenance (country of origin, retrospective/prospective): Not applicable/Not provided. Pre-clinical testing is typically laboratory-based and does not involve patient data with specific provenance.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
- Not applicable/Not provided. This type of information is relevant for clinical studies involving expert adjudication, which is not described in this 510(k) summary.
4. Adjudication method for the test set:
- Not applicable/Not provided. Adjudication methods are typically used in clinical trials to establish ground truth from expert readings, which is not described here.
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:
- No, a multi-reader multi-case comparative effectiveness study was not done. This device is a physical medical device (stent), not an AI-powered diagnostic tool.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- Not applicable. This device is a physical medical device (stent), not an algorithm.
7. The type of ground truth used:
- Not applicable/Not provided in the context of clinical outcomes. The "ground truth" for "pre-clinical testing" usually refers to engineering specifications and performance benchmarks met through laboratory tests (e.g., stent deployment characteristics, material integrity), rather than clinical outcomes or pathology.
8. The sample size for the training set:
- Not applicable/Not provided. This pertains to machine learning models, which is not relevant for this device.
9. How the ground truth for the training set was established:
- Not applicable/Not provided. This pertains to machine learning models, which is not relevant for this device.
In summary, the provided document is a 510(k) notification for a medical device (a stent) and establishes substantial equivalence through pre-clinical testing. It does not contain information about clinical acceptance criteria, detailed study designs for evaluating performance against such criteria, expert evaluations, or AI-related metrics because these are not typically required for this type of submission for this kind of device.
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SEP 1 7 2003
K032137
page 1 of 2
510(k) Summary of Safety and Effectiveness
| GeneralProvisions | The name of the device is: | |
|---|---|---|
| Proprietary Name | Common or Usual Name | |
| Precise™ Nitinol Stent TranshepaticBiliary System | Biliary Stent | |
| Name ofPredicateDevices | The predicate devices are as follows:Cordis Precise™ Nitinol Stent Transhepatic Biliary SystemSystem (510(k) # K012993 – October 5, 2001) - Cordis Corporation. Precise™ Nitinol Stent Transhepatic Biliary System(510(k) # K010445 - March 16, 2001) Cordis Corporation. SMART Control Nitinol Stent Transhepatic Biliary System (510(k) #K021898 - August 14, 2002) - Cordis Corporation. Medi-Tech Transhepatic Biliary Wallstent Endoprosthesis with MonorailDelivery system (510(k) # K012822 – October 24, 2001) – BostonScientific Corporation. Bard LUMINEXX™ 6 Fr Biliary Stent and Delivery System (510(k) #K020682 - April 02, 2002) - C.R. Bard Inc. | |
| Classification | Class II. | |
| PerformanceStandards | Performance standards have not been established by the FDA under section514 of the Food, Drug and Cosmetic Act. | |
| Indicationsfor Use | The proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System isintended for use in the palliation of malignant neoplasms in the biliary tree. |
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K032137
Page 2 of
Device
Description
The device description of the proposed Precise™ Rx Nitinol Stent
Transhepatic Biliary System is as follows.
- Delivery system profile in the area of stent housing is 5 F for stent diameters ranging from 5-7 mm and 6F for stent diameters ranging from 8-10 mm.
- The stent will be delivered to the lesion site via the Rapid Exchange Stent Delivery System
- Guidewire Lumen - 0.014"
- Stent delivery system useable length - 135 mm
- Stent lengths - 20, 30 and 40 mm
- Stent diameters - 5, 6, 7, 8, 9, and 10 mm
Biocompatibility
All materials used in the proposed Precise™ Rx Nitinol Stent
Transhepatic Biliary System are biocompatible.
The proposed Precise™ Rx Nitinol Stent Transhepatic Biliary System is Summary of substantially equivalent to the predicate devices. The equivalence was Substantial Equivalence confirmed through pre-clinical testing.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES USA" around the perimeter. Inside the circle is a stylized image of an eagle with three lines extending from its head.
Food and Drug Administratio 9200 Corporate Boulevard Rockville MD 20050
SEP 1 7 2003
Mr. Sam Mirza Manager, Regulatory Affairs Cordis Corporation 14201 N.W. 60th Avenue MIAMI LAKES FL 33014
Re: K032137
Trade/Device Name: Cordis Precise™ Rx 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: August 14, 2003 Received: August 18, 2003
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 yours,
Daniel G. Schultz, M.D.
Director Office of Device Evaluation Center for Devices and Radiological Health
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Page _ 1 of 1
510(k) Number (if known): K032137
Device Name: Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System
FDA's Statement of the Indications For Use for device:
The Cordis Precise™ Rx Nitinol Stent Transhepatic Biliary System is indicated for use in the palliation of malignant neoplasms in the biliary tree.
Prescription Use V OR (Per 21 CFR 801.109)
Over-The-Counter Use__________________________________________________________________________________________________________________________________________________________
Daniel h. Lyman
(Division Sign-Off)
(Division Sign-Off) Division of Reproductiv and Radiological De 510(k) Number
§ 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.