(301 days)
The RX Herculink® Elite™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
The modified RX Herculink Elite Biliary Stent System includes:
- . A balloon expandable L605 cobalt chromium alloy stent pre-mounted on the balloon of a rapid exchange (RX) stent delivery system;
- Two radiopaque markers located underneath the balloon which identify the stent . position and fluoroscopically mark the working length of the balloon;
- . Proximal shaft markers to aid with delivery catheter position, relative to a biliary guiding catheter tip;
- A third marker located approximately 30 cm from the center of the balloon that aids in locating the guide wire exit lumen and facilitating catheter removal and exchange.
The delivery system can be utilized to optimize the stent wall apposition post stent deployment.
Here's an analysis of the provided text regarding the acceptance criteria and the study that proves the device meets them:
Device: RX Herculink® Elite™ Biliary Stent System
510(k) Number: K063481
Date Prepared: 11/09/2006 (for original 510k summary)
1. Table of Acceptance Criteria and Reported Device Performance
| Test | Acceptance Criteria | Reported Device Performance |
|---|---|---|
| Foreshortening, Uniformity of Expansion | Met the acceptance criteria. | Pass |
| Balloon Rated Burst Pressure (RBP) | Rupture met the acceptance criteria. Labeling 25% above RBP, 17 ATM met the acceptance criteria. | Pass |
| Inflation/ Deflation | Acceptance criteria for the inflation and deflation times were met. | Pass |
| Tensile Strength | The acceptance criterion for the catheter soft tip was met. | Pass |
| Deployment: Accuracy of stent placement, Low pullback resistance of a deflated balloon, Capable of safely removing the delivery system | The acceptance criteria for deployments were met. | Pass |
| Overall test device performance rating: Was the function of the test article clinically acceptable for its intended use? | Clinically acceptable for its intended use. | Pass |
2. Sample Size Used for the Test Set and Data Provenance
The document does not explicitly state the sample sizes used for each specific in-vitro bench test (e.g., number of stents or balloons tested for foreshortening, RBP, etc.). It only mentions "results of the in vitro bench tests and analyses" in the Performance Data section.
The provenance of the data is in-vitro bench testing, meaning tests were conducted in a laboratory setting, not on human or animal subjects. Therefore, there is no country of origin for clinical data or retrospective/prospective classification in this context.
3. Number of Experts Used to Establish Ground Truth and Qualifications
This information is not provided in the document. The acceptance criteria for the in-vitro tests appear to be based on engineering specifications and performance standards relevant to the device's function, rather than requiring expert consensus on a "ground truth" derived from patient data.
4. Adjudication Method for the Test Set
Adjudication methods (like 2+1, 3+1) are typically used in studies involving human interpretation or clinical endpoints. Since the performance evaluation here is based on in-vitro bench testing against predefined technical specifications, an adjudication method is not applicable and therefore not mentioned. The "Pass" results indicate the device met the established engineering acceptance criteria for each test.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study Was Done
No, an MRMC comparative effectiveness study was not done. This type of study involves multiple human readers interpreting medical images or data, often with and without AI assistance, to measure diagnostic accuracy or effectiveness. The current submission is for a physical medical device (biliary stent system) and its performance was evaluated through physical and mechanical bench tests, not clinical image interpretation.
6. If a Standalone (Algorithm Only Without Human-in-the-Loop Performance) Was Done
No, a standalone (algorithm only) performance study was not done. This type of study is relevant for AI/ML-based diagnostic or analytical algorithms. The device in question is a physical medical device, and its performance was assessed through in-vitro bench testing of its mechanical and functional properties.
7. The Type of Ground Truth Used
The "ground truth" for this device's evaluation is based on engineering specifications and predefined performance standards for medical device components. For example:
- Foreshortening, Uniformity of Expansion: Mechanical tolerance limits.
- Balloon Rated Burst Pressure (RBP): Industry standards and regulatory requirements for balloon integrity under pressure.
- Inflation/Deflation: Time limits established for safe and effective deployment/retrieval.
- Tensile Strength: Minimum strength requirements for material integrity.
- Deployment: Functional requirements for accurate placement, ease of use, and safe removal.
8. The Sample Size for the Training Set
Not applicable. This submission describes the testing of a physical medical device. It does not involve any machine learning algorithms or AI, and therefore, there is no "training set."
9. How the Ground Truth for the Training Set Was Established
Not applicable. As there is no training set (no AI/ML algorithm involved), the establishment of ground truth for a training set is irrelevant to this device submission.
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p66/nt-2
2007
RX Herculink ® Elite™ Biliary Stent System K063481 510(k) Amendment
Appendix C - 510(k) SUMMARY
The 510(k) Summary is submitted in accordance with 21 CFR Part 807, Section 807.92
| Submitter's Name: | Abbott Vascular(351931722) | SEP 14 |
|---|---|---|
| Submitter's Address: | 3200 Lakeside DriveSanta Clara, CA 95054 | |
| Telephone: | 951-914-2292 | |
| Fax: | 951-914-1069 | |
| Contact Person: | Nadine Smith, Regulatory Affairs Associate | |
| Date Prepared: | 11/09/2006 | |
| Device Trade Name: | RX Herculink® Elite™ Biliary Stent System | |
| Device Common Name: | Biliary Stent | |
| Device Classification: | Class II |
Summary of Substantial Equivalence:
The modified RX Herculink Elite™ Biliary Stent System is substantially equivalent to the original RX Herculink Elite Biliary Stent System (K053454, cleared 3/6/2006) and RX Herculink Plus Biliary Stent System (K010684, cleared 4/12/2001). Changes made to the original RX Herculink Elite Biliary Stent System focused primarily on the delivery system.
Device Description:
The modified RX Herculink Elite Biliary Stent System includes:
- . A balloon expandable L605 cobalt chromium alloy stent pre-mounted on the balloon of a rapid exchange (RX) stent delivery system;
- Two radiopaque markers located underneath the balloon which identify the stent . position and fluoroscopically mark the working length of the balloon;
- . Proximal shaft markers to aid with delivery catheter position, relative to a biliary guiding catheter tip;
- � A third marker located approximately 30 cm from the center of the balloon that aids in locating the guide wire exit lumen and facilitating catheter removal and exchange.
The delivery system can be utilized to optimize the stent wall apposition post stent deployment.
Summary of Changes to Previously Cleared Device
- The balloon fold configuration for 5.5 and 6.0 mm balloons was changed from . Tri-fold (3) to Quad-fold (4)
- The RX Herculink Plus balloon folding process was applied to 4.0 6.0mm . balloon diameters as appropriate.
- Added Balloon Press to 5.0 7.0mm balloon diameters .
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K.No.2451 page No.2.
RX Herculink ® Elite™ Biliary Stent System K063481 510(k) Amendment
- . Added Balloon Heat Set to all balloon sizes from 4.0-7.0mm balloon diameters
- Added a 100% in process inspection using a USON Sprint Dry Leak Tester. I .
Intended Use:
The intended use for the modified device has not changed as a result of the modifications.
The RX Herculink Elite Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Performance Data:
The results of the in vitro bench tests and analyses and biocompatibility testing demonstrated the safety and effectiveness of the modified RX Herculink Elite Biliary Stent System.
Verification and Validation (V & V) Tests:
Verification and Validation testing was performed as relevant to the modifications to the RX Herculink Elite Biliary Stent System as follows:
| Test | Results |
|---|---|
| Foreshortening, Uniformity of Expansion | PassForeshortening and Uniformity ofExpansion met the acceptance criteria. |
| Balloon Rated Burst Pressure (RBP) | PassThe balloon rupture met the acceptancecriteria. Labeling 25% above RBP, 17ATM met the acceptance criteria. |
| Inflation/ Deflation | PassAcceptance criteria for the inflation anddeflation times were met. |
| Tensile Strength | PassThe acceptance criterion for the cathetersoft tip was met. |
| DeploymentAccuracy of stent placement Low pullback resistance of a deflated balloon Capable of safely removing the delivery system | PassThe acceptance criteria for deploymentswere met.Comparison Rating - Equal |
| Overall test device performance rating.Was the function of the test article clinicallyacceptable for its intended use? | Pass |
Table 11 - V&V Summary
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Image /page/2/Picture/1 description: The image shows the seal of the Department of Health & Human Services (HHS) of the United States. The seal features a stylized eagle with three stripes on its wing, representing the three branches of government. The words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" are arranged in a circular pattern around the eagle.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 1 4 2007
Ms. Nadine Smith Regulatory Affairs Associate Abbott Vascular Vascular Solutions 3200 Lakeside Drive SANTA CLARA CA 95054-2807
Re: K063481
Trade/Device Name: RX Herculink® Elite™ Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: April 4, 2007 Received: April 5, 2007
Dear Ms. Smith:
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. Nadine Smith
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 described above is added to your labeling.
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), please contact the Office of Compliance at (301) 594-4616. 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 vours.
for
Donna-Bea Tillman, Ph.D., M.P.H. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_1_of 1
510(k) Number: K063481
Device Name: RX Herculink® Elite™ Biliary Stent System
FDA's Statement of the Indications For Use for device:
:
The RX Herculink® Elite™ Biliary Stent System is intended for palliation of malignant strictures in the biliary tree.
Prescription Use __
(Per 21 CFR 801.109)
OR
Over-the-Counter Use __
(Division Sign-Off)
Division of Reproductive, Abdominal,
and Radiological Devices
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.