(19 days)
The Edwards Lifesciences LifeStent Valeo Biliary Stent Systems are indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent Valeo consists of a balloon expandable stent that is provided on an over the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible. balloon expandable stent is made by laser cutting an open lattice design into a stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site and expanded by balloon inflation. The subject device is supplied in lengths of 17/18mm, 26mm, 36 mm and diameters of 6mm, 7mm, 8mm, 9mm and 10mm.
Acceptance Criteria and Study for LifeStent Valeo Biliary Stent System
This device notification (K052132) is a 510(k) premarket notification for the LifeStent Valeo Biliary Stent System, seeking substantial equivalence to previously cleared predicate devices. The information provided focuses on demonstrating technological characteristics similar to predicate devices rather than establishing new clinical performance criteria.
Therefore, the requested details regarding a detailed table of acceptance criteria, device performance, sample sizes used for test sets, expert-established ground truth, adjudication methods, MRMC studies, standalone performance, and how ground truth for training data was established are not contained in the provided S510(k) summary.
The summary describes a traditional device clearance pathway based on substantial equivalence, relying heavily on bench testing and comparison to existing devices.
However, based on the provided text, we can infer and directly state certain aspects:
1. Table of Acceptance Criteria and Reported Device Performance:
The document does not provide a specific table of quantitative acceptance criteria with corresponding performance metrics for the LifeStent Valeo Biliary Stent System that would be directly comparable to a clinical study. Instead, the "Performance Data" section indicates:
| Acceptance Criterion (Inferred from Bench Testing) | Reported Device Performance |
|---|---|
| Deployment | Performed in a manner substantially equivalent to predicate devices |
| Dimensional Accuracy | Performed in a manner substantially equivalent to predicate devices |
| Balloon Performance | Performed in a manner substantially equivalent to predicate devices |
| Stent Deformation | Performed in a manner substantially equivalent to predicate devices |
| Tensile Testing (applicable joints of delivery system) | Performed in a manner substantially equivalent to predicate devices |
2. Sample Size Used for the Test Set and Data Provenance:
- Sample Size: Not specified. The document states "bench testing" was completed. This type of testing typically involves a number of units to demonstrate consistency and meet engineering specifications, but a formal clinical "test set" sample size for patient-level outcomes is not mentioned as this is a substantial equivalence submission relying on bench data.
- Data Provenance: The data is from "bench testing" conducted by Edwards Lifesciences LLC. The country of origin of this testing is not explicitly stated, but the company is located in Irvine, CA, USA. This is retrospective data collected for regulatory submission purposes, not prospective clinical trial data.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications:
- Not Applicable. As no clinical "test set" with human interpretation or diagnosis is described, there were no experts used to establish ground truth in this context. The "truth" for bench testing is derived from engineering specifications and measurement standards.
4. Adjudication Method for the Test Set:
- Not Applicable. No human-based adjudication process is described as there is no clinical "test set" in the context of this 510(k) summary.
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done:
- No. An MRMC study was not conducted or mentioned in this 510(k). This type of study assesses human reader performance with and without an AI algorithm, which is not relevant for a device cleared based on substantial equivalence through bench testing.
6. If a standalone (i.e., algorithm only without human-in-the-loop performance) was done:
- No. This device is a physical medical device (biliary stent system), not an AI algorithm. Therefore, "standalone" algorithm performance is not applicable.
7. The Type of Ground Truth Used:
- The "ground truth" for the performance data presented is based on engineering specifications and validated measurement methods used during bench testing (e.g., precise measurements for dimensional accuracy, material strength tests for tensile testing). This is in contrast to clinical ground truth established by experts, pathology, or outcomes data, which are not discussed here.
8. The Sample Size for the Training Set:
- Not Applicable. The device is a physical stent system, not an AI algorithm. Therefore, there is no "training set" in the context of machine learning.
9. How the Ground Truth for the Training Set was Established:
- Not Applicable. As there is no training set for an AI algorithm, this question is not relevant.
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AUG 2 4 2005
KC52132
Page 1 of 2
510(k) Summary
1. Submitter's Name and Address:
Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614
2. Contact:
Kevin Drisko Sr. Regulatory Manager Edwards Lifesciences LLC One Edwards Way Irvine, CA 92614 Phone: 949-250-2416 FAX: 949-250-3630 E-Mail: kevin_drisko@edwards.com
3. Date Prepared:
August 4, 2005
4. Device Trade Name:
LifeStent Valeo Biliary Stent System
5. Device Common Name:
Biliary Stent
6. Device Classification Name:
Biliary Catheter (78 FGE), Class II
7. Predicate Devices:
LifeStent SDS/XL SDS Billary Stent Systems (K023308, K033212, K040550, K041032) LifeStent Turbo Biliary Stent System (K050627)
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K052132
Page 2 of 2
510(k) Summary (continued)
8. Device Description:
The LifeStent Valeo consists of a balloon expandable stent that is provided on an over the-wire catheter that acts as a delivery system. The stent is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The flexible. balloon expandable stent is made by laser cutting an open lattice design into a stainless steel tube. The stent is supplied mounted onto a PTA balloon catheter, inserted percutaneously to the diseased site and expanded by balloon inflation. The subject device is supplied in lengths of 17/18mm, 26mm, 36 mm and diameters of 6mm, 7mm, 8mm, 9mm and 10mm.
9. Intended Use:
The LifeStent Biliary Stent Systems are indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
10. Technological Characteristics:
Comparisons of the subject and predicate devices show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.
11. Performance Data:
Edwards Lifesciences completed bench testing such as deployment testing, dimensional testing, balloon performance testing, stent deformation testing as well as tensile testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate devices cited in item 7 above.
12. Conclusion:
Since the LifeStent Valeo has the same intended use, similar materials, similar performance properties, packaging and sterilization methods, it may be considered substantially equivalent to the predicate device cited in item 7 above.
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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 consists of a stylized eagle with three stripes forming its body and two wavy lines below, representing water. The eagle is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA".
Public Health Service
.. ...
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
AUG 2 4 2005
Mr. Kevin Drisko Senior Manager, Regulatory Affairs Edwards Lifesciences LLC One Edwards Way IRVINE CA 92614
Re: K052132
K032132
Trade/Device Name: Edwards Lifesciences LifeStent Valeo Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: FGE Dated: August 4, 2005 Received: August 11, 2005
Dear Mr. Drisko:
We have reviewed your Section 510(k) premarket notification of intent to market the device indicati We have reviewed your section 510(x) promained is substantially equivalent (for the indications for referenced above and nave decommiou the are devices marketed in interstate commence
use stated in the enclosure) to legally marketed predicate and anyance ante devices that use stated in the enclosure) to regally maneted pressed Device Amendments, or to devices that the encond Carmer of Carmer of Carmer of Carmer of Carmer of Carmer of Carmer of prior to May 26, 1976, inc chacinent and of the Federal Food, Drug, and Cosmetic have been reclassified in accordance with the previsions to the general controls provisions of the Act (Act). You may, ulciclore, market me accessor controls provisions of the Act include Act and the innuallons described below. "The general over the practice, labeling, and prohibitions against misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this device The Office of Device Evaluation has decifical in the proposed labeling and that such use could cause will be used for an intended use not rechance 113(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 Furnermore, the indication for omary ass france, and other promotional materials, in close pouch, box, and catter lasse, of a similar point size, and in bold print.
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Page 2 - Mr. Kevin Drisko
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it If your device is classifica (seculove) the ting major regulations affecting your device and be found may be subject to additions, 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 Prease be advised that FDA s issumed of a sassamming of the requirements of the Act or any FDA hia statutes and regulations administered by other Federal agencies. You must comply with all Federal statutes and regulations administered by one registration and listing (21 CFR Part 807); the Act s requirements, merading, but not miring practice requirements as set forth in the quality labeling (21 CFR 1 art 801); good management of any from the electronic product radiation Systems (QB) regulation (Ls 531-542 of the Act); 21 CFR 1000-1050.
The FDA finding of substantial equivalence of your device to a legally marketed predicate device The FDA Initing Of substantial equivalerice and permits your device to proceed to the market. This results in a classification for 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. Please note that the above mooning manufactions 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 If you desire specific information about the Office of Compliance at (301) 594-4616. Also, please note (21 CFR Fart 801), prease contact in Offication' compremarket notification'' (21 CFR Part 807.97). Ine regulation other general information on your responsibilities under the Act from the Division I ou may obtain other golleral nifonal, 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,
Nancy C. brogdon for
Donna-Bea Tillman, Ph. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page__________________________________________________________________________________________________________________________________________________________________________
510(k) Number: K052132
Device Name: Edwards Lifesciences LifeStent Valeo Biliary Stent System
FDA's Statement of the Indications For Use for device:
The Edwards Lifesciences LifeStent Valeo Biliary Stent Systems are indicated for use in the The Edwards Ellebolen strictures (neoplasms) in the biliary tree.
Prescription Use V (Per 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Nancy C. Boydon
(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.