(122 days)
The WallFlex Biliary RX Uncovered Stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
The proposed WallFlex™ Biliary RX Uncovered Stent System consists of a selfexpanding metal stent and a delivery catheter. The proposed stent consists of Platinum cored Nitinol wires wound together to form a cylinder with both proximal and distal flares. The proposed stent is mounted onto a sheath delivery system. The groposed delivery system is a coaxial tubing assembly that constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
The provided document describes a 510(k) premarket notification for the WallFlex™ Biliary RX Uncovered Stent System, where the device is demonstrated to be substantially equivalent to previously marketed predicate devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to demonstrating substantial equivalence based on comparative performance testing against predicate devices, rather than a clinical study with specific performance metrics for a novel AI device.
Here's an analysis of the available information:
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria | Reported Device Performance |
|---|---|
| Substantial equivalence to predicate devices (Wallstent Biliary Endoprosthesis (K000308, K993232, K982184, K964119, K925406) and Wallstent RX Biliary Endoprosthesis (K012752, K030107)) in technological characteristics. | The proposed WallFlex™ Biliary RX Uncovered Stent System has similar technological characteristics to the currently marketed Wallstent Biliary Endoprosthesis and Wallstent RX Biliary Endoprosthesis. |
| Performance equivalent to predicate devices in specified tests. | Comparative performance testing was completed, which included but was not limited to: Dimensional evaluation Radial force Deployment and reconstrainment force Bond integrity (The document explicitly states that these tests were performed to establish substantial equivalence with predicate devices.) |
| Indicated for the palliative treatment of biliary strictures produced by malignant neoplasms. | The device is indicated for this use. (This is an intended use statement, not a performance metric from a study demonstrating efficacy against acceptance criteria.) |
2. Sample Size Used for the Test Set and Data Provenance
This document does not describe a clinical study with a "test set" in the sense of patient data. The "testing" referred to is comparative performance testing of the device itself (e.g., mechanical properties) in a laboratory setting, not on human subjects. Therefore, information about patient sample size, data provenance, or retrospective/prospective nature is not applicable here.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
This information is not applicable as the study described is not a clinical study involving the establishment of ground truth by medical experts.
4. Adjudication Method (e.g., 2+1, 3+1, none) for the Test Set
This information is not applicable as there is no "test set" in the context of clinical data requiring expert adjudication.
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
This document does not describe a multi-reader multi-case (MRMC) comparative effectiveness study, nor does it involve AI assistance. The device is a physical medical device (stent), not an AI algorithm.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
This information is not applicable as the device is a physical medical device, not an AI algorithm.
7. The Type of Ground Truth Used (expert consensus, pathology, outcomes data, etc.)
The "ground truth" in this context refers to the established functional and safety characteristics of the predicate devices. The WallFlex™ Biliary RX Uncovered Stent System demonstrated that its performance in various engineering tests was "substantially equivalent" to these established predicates. There is no mention of "expert consensus, pathology, or outcomes data" being used as ground truth for a clinical evaluation of this specific device's efficacy.
8. The Sample Size for the Training Set
This information is not applicable as the document describes engineering/performance testing of a physical device, not the training of an AI algorithm based on data.
9. How the Ground Truth for the Training Set Was Established
This information is not applicable as the document describes engineering/performance testing of a physical device, not the training of an AI algorithm.
Summary of Device Acceptance and Study Type:
The acceptance criteria for the WallFlex™ Biliary RX Uncovered Stent System, as presented in the 510(k) summary, are primarily based on demonstrating substantial equivalence to existing, legally marketed predicate devices. The study conducted to meet these criteria was comparative performance testing in a laboratory setting, focusing on engineering and material characteristics rather than clinical performance or AI algorithm validation.
The testing included:
- Dimensional evaluation
- Radial force
- Deployment and reconstrainment force
- Bond integrity
These tests were performed to show that the new device performs similarly to the predicate devices, thereby establishing its substantial equivalence for its intended use in the palliative treatment of biliary strictures produced by malignant neoplasms. There is no information in the provided text about clinical trials, human subject data, or AI performance metrics.
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Boston Scientific Corporation August 7, 2006
KD61231
21 of 2
SECTION 5 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01760 Telephone: 508-683-4356 Fax: 508-683-5939
Contact: Allyson Barford, RAC Regulatory Affairs Specialist Date Prepared: August 7, 2006
2. Device:
Trade Name: WallFlex™ Biliary RX Uncovered Stent System Common Name: Biliary Stent Classification Name: Biliary Catheter and Accessories Regulation Number: 876.5010 Product Code: FGE Classification: Class II
3. Predicate Device:
Boston Scientific Corporation's Wallstent Biliary Endoprosthesis, K000308, K993232, K982184, K964119 and K925406
Boston Scientific Corporation's Wallstent RX Biliary Endoprosthesis, K012752 and K030107
The predicate devices are class II devices per 21 CFR 876.5010
4. Device Description:
The proposed WallFlex™ Biliary RX Uncovered Stent System consists of a selfexpanding metal stent and a delivery catheter. The proposed stent consists of Platinum cored Nitinol wires wound together to form a cylinder with both proximal and distal flares. The proposed stent is mounted onto a sheath delivery system. The groposed delivery system is a coaxial tubing assembly that constrains the stent onto the delivery catheter shaft until the stent is released by retracting the exterior tube.
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5. Intended Use:
The proposed WallFlex Biliary RX Uncovered Stent System is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplated 1.
6. Technological Characteristics:
The proposed WallFlex Biliary RX Uncovered Stent System has similar technological characteristics to the currently marketed Wallstent Biliary Endoprosthesis (K000308, K993232, K982184, K964119 and K925406) and Wallstent RX Biliary Endoprosthesis (K012752 and K030107).
7. Performance Data:
Comparative performance testing was completed to establish substantial equivalence between the proposed WallFlex™ Biliary RX Uncovered Stent System and the predicate devices. This testing included but was not limited to dimensional evaluation, radial force, deployment and reconstrainment force and bond integrity.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed WallFlex Biliary RX Uncovered Stent System is substantially equivalent to Boston Scientific Corporation's currently marketed Wallstent RX Biliary Endoprosthesis and Wallstent Boildy Endoprosthesis.
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Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health and Human Services. The logo consists of a stylized eagle with three lines representing its body and wings. The eagle is facing right. The text "DEPARTMENT OF HEALTH AND HUMAN SERVICES - USA" is arranged in a circular pattern around the eagle.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Ms. Allyson Barford, R.A.C. Regulatory Affairs Specialist Boston Scientific Corporation Endoscopy 100 Boston Scientific Way MARLBOROUGH MA 01752
SEP - 1 2006
Re: K061231
Trade/Device Name: WallFlexTM Biliary RX Uncovered Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 7, 2006 Received: August 8, 2006
Dear Ms. Barford:
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.
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. Allyson Barford
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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html. .
Sincerely yours,
Donna-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: K061231
Device Name: WallFlex™ Biliary RX Uncovered Stent System
FDA's Statement of the Indications for Use for the device:
The WallFlex Biliary RX Uncovered Stent system is indicated for use in the palliative treatment of biliary strictures produced by malignant neoplasms.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use (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)
David Ch. Loymm
(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.