(55 days)
The LifeStent NT35 Biliary Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree.
The LifeStent NT35 consist of a self-expanding stent that is provided loaded into 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, selfexpanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 20mm, 30mm, 60mm, 80mm and 90mm and diameters of 9mm and 10mm.
The provided document is a 510(k) Summary for the LifeStent NT35 Biliary Stent System. It details the device, its intended use, and substantial equivalence to a predicate device, but does not contain information about acceptance criteria or a study proving the device meets those criteria.
The document states:
- Performance Data: "Edwards Lifesciences completed bench testing such as deployment testing, dimensional testing, compression force testing, expansion force testing, stent deformation testing as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate device cited in item 7 above."
This indicates that bench testing was performed to demonstrate substantial equivalence to a predicate device (LifeStent NT18 Self-Expanding Biliary Stent System). However, it does not provide:
- A table of acceptance criteria and the reported device performance.
- Sample sizes used for the test set or their data provenance.
- Number or qualifications of experts used to establish ground truth.
- Adjudication method for the test set.
- Information about a multi-reader multi-case (MRMC) comparative effectiveness study.
- Details about a standalone algorithm performance study. (This is a medical device, not an AI/algorithm-driven device, so this type of study is not applicable here.)
- The type of ground truth used. (Not applicable for a physical device bench test.)
- Sample size for the training set. (Not applicable for a physical device bench test.)
- How ground truth for the training set was established. (Not applicable for a physical device bench test.)
In summary, the provided text does not contain the specific information requested regarding acceptance criteria and detailed study results for the LifeStent NT35 to demonstrate meeting those criteria. The submission relies on demonstrating substantial equivalence through bench testing against a predicate device.
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Image /page/0/Picture/1 description: The image shows the Edwards Lifesciences logo and the date DEC 2 3 2004. The logo is a stylized "E" inside a square. The text "Edwards Lifesciences" is to the right of the logo. The date is above the text.
CONFIDE May not be reproduced withou
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:
October 28, 2004
4. Device Trade Name:
LifeStent NT35 Biliary Stent System
5. Device Common Name:
Biliary Stent
6. Device Classification Name:
Biliary Catheter (78 FGE), Class II
7. Predicate Devices:
LifeStent NT18 Self-Expanding Biliary Stent System (K024303)
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Kovacs page 202 a
Image /page/1/Picture/1 description: The image shows the logo for Edwards Lifesciences. The logo consists of a square graphic on the left and the text "Edwards Lifesciences" on the right. The text is in a serif font and is underlined.
CONFIDENTIAL
May not be reproduced without written permission from
Edwards Lifesciences
510(k) Summary (continued)
8. Device Description:
The LifeStent NT35 consist of a self-expanding stent that is provided loaded into 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, selfexpanding stent is made by laser cutting an open lattice design into a nitinol tube. The subject device is supplied in lengths of 20mm, 30mm, 60mm, 80mm and 90mm and diameters of 9mm and 10mm.
9. Intended Use:
The LifeStent NT35 Biliary Stent System is 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, compression force testing, expansion force testing, stent deformation testing as well as tensile strength testing on applicable joints of the delivery system. The results indicate that the system performed in a manner substantially equivalent to the predicate device cited in item 7 above.
12. Conclusion:
Since the LifeStent NT35 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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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 circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is an abstract symbol resembling an eagle or bird in flight, composed of three curved lines.
Public Health Service
DEC 2 3 2004
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Kevin Drisko Sr. Regulatory Manager Edwards Lifescience L.L.C. One Edwards Way IRVINE CA 92614
Re: K042985 Trade/Device Name: LifeStent NT 35 Biliary Stent System Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: December 2, 2004 Received: December 3, 2004
Dear Mr. Drisko:
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 or 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.
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.
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Page 2 – Mr. Kevin Drisko
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,
Mustin M.D. for
Donna-Bea Tillman, Ph Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Indications for Use
510(k) Number (if known): K042985
Device Name: LifeStent NT35 Biliary Stent System
FDA's Statement of the Indications For Use for device:
The LifeStent NT35 Stent System is indicated for use in the palliation of malignant strictures (neoplasms) in the biliary tree
| Prescription Use |
|---|
| (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)
Pond G. Span
Abdominalj,
6105
KE 42985
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.