(85 days)
Indicated for use in palliation of malignant neoplasms in the biliary tree.
The Cook® Formula 418™ Biliary Stent System is indicated for use in palliation of malignant neoplasms in the biliary tree.
The Formula 418 Biliary Stent is a balloon-expandable, stainless steel stent which is premounted on the delivery system. The stent will be available in diameters of 5 and 6 mm and lengths of 12, 16, 20, 24 and 30 mm. This device will be supplied sterile and is intended for one-time use.
This document describes the Cook® Formula 418™ Biliary Stent System. The information provided focuses on its substantial equivalence to predicate devices and the performance tests conducted.
1. Table of Acceptance Criteria and Reported Device Performance
The provided text does not explicitly define specific numerical "acceptance criteria" with pass/fail thresholds for each test. Instead, it states that the tests were performed "to assure reliable design and performance under the specified testing parameters" and the results "provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent."
Therefore, the table below lists the tests conducted and paraphrases the general outcome as reported in the document. Specific quantitative values for "reported device performance" are not available in the provided text.
| Test Type | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Expansion Force Testing | Device expands as intended and maintains structural integrity. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Compression Force Testing | Device withstands compression and maintains structural integrity. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Dimensional Testing | Device dimensions meet specifications. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Balloon Burst Testing | Balloon performs as intended without premature bursting. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
| Deployment Testing | Device deploys successfully and as intended. | "The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent." |
2. Sample Size Used for the Test Set and Data Provenance
The document does not specify the sample sizes used for any of the tests (Expansion Force, Compression Force, Dimensional, Balloon Burst, Deployment Testing). It also does not explicitly state the data provenance (e.g., country of origin, retrospective or prospective) for these tests. However, given this is a 510(k) submission to the FDA, it is implied the data was generated in a controlled, prospective manner to support regulatory approval, likely within a U.S. or international compliance framework.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This document does not describe the use of human experts to establish "ground truth" for the performance tests. The tests conducted appear to be bench-top, engineering-based performance evaluations of the physical device characteristics, rather than diagnostic or clinical performance evaluations requiring expert interpretation.
4. Adjudication Method for the Test Set
Not applicable. As noted above, the tests are physical performance evaluations, not diagnostic assessments requiring adjudication.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done
No, a Multi-Reader Multi-Case (MRMC) comparative effectiveness study was not done or described in the provided documentation for this device. The submission focuses on demonstrating substantial equivalence to predicate devices based on design, materials, and performance testing, not on comparative clinical effectiveness with human readers.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was Done
Not applicable. The Cook® Formula 418™ Biliary Stent System is a physical medical device (stent and delivery system), not an algorithm or AI software. Therefore, the concept of "standalone performance" for an algorithm is not relevant here.
7. The Type of Ground Truth Used
The "ground truth" for these performance tests would be the established engineering specifications, design requirements, and recognized industry standards for biliary stents. For example:
- For dimensional testing, the ground truth would be the device's design specifications.
- For force testing, the ground truth would be functional requirements for expansion and compression within the biliary tree.
- For balloon burst testing, the ground truth would be the expected pressure resistance and burst pressure characteristics.
8. The Sample Size for the Training Set
Not applicable. This device is a physical medical device, not an AI/ML algorithm that requires a "training set" of data.
9. How the Ground Truth for the Training Set was Established
Not applicable. As this is not an AI/ML algorithm, there is no "training set" or corresponding ground truth establishment in that context.
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Cook® Formula 418™ Biliary Stent System D.C. #K051785 Request for Additional Information
DEC 9 2005
510(k) Summary
Submitted By:
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way, PO Box 489 Bloomington, IN 47402 812-339-2235 November 9, 2005
Device:
| Trade Name: | Cook® Formula 418™ Biliary Stent System |
|---|---|
| Proposed Classification: | Catheter, Biliary Diagnostic |
| FGE (21 CFR§876.5010) |
Indications for Use
Indicated for use in palliation of malignant neoplasms in the biliary tree.
Predicate Devices:
The Formula 418 Biliary Stent is similar in terms of intended use, principles of operation, materials of construction and technological characteristics to predicate devices reviewed as devices for palliation of malignant neoplasms in the biliary tree.
Device Description:
The Formula 418 Biliary Stent is a balloon-expandable, stainless steel stent which is premounted on the delivery system. The stent will be available in diameters of 5 and 6 mm and lengths of 12, 16, 20, 24 and 30 mm. This device will be supplied sterile and is intended for one-time use.
Substantial Equivalence:
The Formula 418 Biliary Stent is similar to many devices in commercial distribution for palliation of malignant neoplasms in the Biliary tree. These devices include the Formula 418™ Biliary Stent System (D.C. #K051785), Bridge FX (Bridge Assurant) Stent Delivery System (D.C. #K011817) stent, the Palmaz Genesis Transhepatic Biliary Stent (D.C. #K021345) and the Lifestent LP SDS Biliary Endoprosthesis (D.C. #K023248).
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Cook® Formula 418™ Biliary Stent System D.C. #K051785 Request for Additional Information
The similar indications for use, principles of operation, technological characteristics and performance testing results of the Formula 418 Biliary Stent as compared to the predicate devices support a determination of substantial equivalency.
Test Data:
The Formula 418 Biliary Stent was subjected to the following tests to assure reliable design and performance under the specified testing parameters. These tests were comprised of:
- Expansion Force Testing 1.
- Compression Force Testing 2.
- Dimensional Testing 3.
- Balloon Burst Testing র্ধা
- Deployment Testing 5.
The results of these tests provide reasonable assurance that the device has been designed and tested to assure conformance to the requirements for its use as a biliary stent.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird-like figure with three curved lines forming its body and wings. The logo is surrounded by a circular border containing the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" in a sans-serif font.
Public Health Service
DEC - 9 2005
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Karen Bradburn, RAC Senior Regulatory Affairs Specialist Cook Incorporated 750 Daniels Way P.O. Box 489 BLOOMINGTON IN 47402-0489
Re: K052539
Trade/Device Name: Cook® Formula 418™ Biliary Stent System Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: November 9, 2005 Received: November 10, 2005
Dear Ms. Bradburn:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave roviewed your becamined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate for use stated in the encreativent of the enactment date of the Medical Device Amendments, or to conninered pror to may 20, 1978, ac excordance with the provisions of the Federal Food, Drug, devices that have been roof our any, therefore, market the device, subject to the general controls and Cosment Friel (110). " Le limitations described below. The general controls provisions of the provisions of the for and the and al 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 doneo win be about to wor with Section 513(i)(1)(E) of the Act, 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, i attremore), 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. Karen Bradburn
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); 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 information about the application of other labeling requirements to your device (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. 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,
Wustam MD for
Dorma-Bea Tillman, Ph.D., M.P.A. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K052539
Device Name: Cook® Formula 418™ Biliary Stent System
FDA's Indications For Use:
The Cook® Formula 418™ Biliary Stent System is indicated for use in palliation of malignant neoplasms in the biliary tree.
Prescription Use X
AND/OR
Over-The-Counter Use
(Part 21 CFR 801 Subpart D)
(21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Daniel la Logeman
(Division Sign-Off)
Division of Reproductive, Abdominal, and Radiological Devices 510(k) Number_
Page 1 of 1
§ 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.