(21 days)
The LUMINEXX™ Endoscopic Biliary Stent is indicated for use in the palliative treatment of patients with malignant biliary strictures.
The LUMINEXX™ Endoscopic Biliary Stent is a stenting system designed to maintain the patency of biliary ducts obstructed by malignant biliary strictures. The device includes the self-expanding LUMINEXX™ Biliary stent pre-loaded on a delivery system. The 7.5F delivery system is compatible with a 3.2 mm endoscope working channel and accepts a 0.35" guidewire. The stent is available in 8 and 10 mm diameters, and 40, 60, 80, and 100 mm lengths. The working length of the delivery system is 190 cm. The LUMINEXX™ Endoscopic Biliary Stent is a metal mesh stent constructed of nitinol. Tantalum spoons on each end of the stent provide enhanced radiopacity. The stent is self-expanding and is packaged pre-mounted on a disposable delivery system.
- Table of Acceptance Criteria and Reported Device Performance:
The provided document describes a 510(k) premarket notification for the LUMINEXX™ Endoscopic Biliary Stent, seeking "substantial equivalence" to a predicate device. In this context, "acceptance criteria" and "reported device performance" are framed around demonstrating that the new device meets the same performance requirements and is as safe and effective as the predicate.
| Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|
| Meets performance requirements of the predicate device. | "Design verification data demonstrated that the LUMINEXX™ Endoscopic Biliary Stent meets the same performance requirements..." |
| Is as safe as the predicate device. | "...and is as safe and effective as the predicate device." |
| Is as effective as the predicate device. | "...and is as safe and effective as the predicate device." |
| Compatibility with a 3.2 mm endoscope working channel. | "The 7.5F delivery system is compatible with a 3.2 mm endoscope working channel..." |
| Accept 0.35" guidewire. | "...and accepts a 0.35" guidewire." |
| Available in specified diameters (8, 10 mm) and lengths (40, 60, 80, 100 mm). | "The stent is available in 8 and 10 mm diameters, and 40, 60, 80, and 100 mm lengths." |
| Delivery system working length of 190 cm. | "The working length of the delivery system is 190 cm." |
| Constructed of nitinol (metal for self-expansion). | "The LUMINEXX™ Endoscopic Biliary Stent is a metal mesh stent constructed of nitinol." |
| Enhanced radiopacity (e.g., with tantalum spoons). | "Tantalum spoons on each end of the stent provide enhanced radiopacity." |
| Self-expanding. | "The stent is self-expanding..." |
| Packaged pre-mounted on a disposable delivery system. | "...and is packaged pre-mounted on a disposable delivery system." |
| Indicated for palliative treatment of malignant biliary strictures. | "The LUMINEXX™ Endoscopic Biliary Stent is indicated for use in the palliative treatment of patients with malignant biliary strictures." (This is the intended use, not a performance metric per se, but validated through substantial equivalence.) |
- Sample size used for the test set and the data provenance:
The provided document does not specify a "test set" in the context of clinical data for the LUMINEXX™ Endoscopic Biliary Stent. The submission is a 510(k) which relies on demonstrating substantial equivalence to a predicate device rather than conducting new clinical trials with patient data. The "Performance Data" section states, "Design verification data demonstrated that the LUMINEXX™ Endoscopic Biliary Stent meets the same performance requirements and is as safe and effective as the predicate device." This likely refers to bench testing, engineering verification, and perhaps animal testing, rather than human clinical trials. Therefore, information on sample size and data provenance (country, retrospective/prospective) related to a clinical test set is not provided.
- Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This information is not provided. As discussed above, the submission relies on design verification and substantial equivalence to a predicate device, not on a clinical test set requiring expert-established ground truth.
- Adjudication method (e.g., 2+1, 3+1, none) for the test set:
This information is not provided. There is no mention of a clinical test set or any adjudication process.
- 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 information is not provided. The LUMINEXX™ Endoscopic Biliary Stent is a physical medical device (a stent and delivery system), not an AI algorithm or a diagnostic tool that would involve human readers or MRMC studies.
- If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
This information is not applicable and not provided. The LUMINEXX™ Endoscopic Biliary Stent is a physical medical device, not an algorithm.
- The type of ground truth used (expert consensus, pathology, outcomes data, etc.):
Given the nature of a 510(k) for a physical medical device like a stent, the "ground truth" for demonstrating performance and safety would typically come from:
- Engineering specifications and test methodologies: For mechanical properties, material compatibility, deployment characteristics, radiopacity, and dimensional accuracy.
- Predicate device data and scientific literature: To establish the acceptable performance and safety profile in a clinical setting.
- The document explicitly mentions "Design verification data," which would rely on engineering measurements and tests against predefined specifications and comparison with the predicate device's established performance.
There is no mention of expert consensus, pathology, or outcomes data being used as "ground truth" for a de novo independent assessment of this specific device's clinical performance in the provided text.
- The sample size for the training set:
This information is not provided and not applicable. The LUMINEXX™ Endoscopic Biliary Stent is a physical medical device, not a machine learning algorithm that requires a "training set."
- How the ground truth for the training set was established:
This information is not provided and not applicable. As stated above, this is a physical medical device, not an AI algorithm.
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K031186
page 1 of 2
MAY - 6 2003
BARD ENDOSCOPIC TECHNOLOGIES
J.H. Bard mo 129 Cancora Road P.O. Box 7031 Bilanda, MA 01821-703 978-663-8989
510(k) SUMMARY OF SAFETY AND EFFECTIVENESS INFORMATION
- Submitter Information: A.
| Submitter's Name: | C.R. Bard, Inc.,Bard Endoscopic Technologies Division |
|---|---|
| Submitter's Address: | 129 Concord Road,Billerica MA 01821-7031 |
(978) 262-4878
Contact Person: Thomas Hirte
Contact Person's Telephone Number: (978) 262-4867
Contact Person's FAX Number:
-
B. Device Name:
LUMINEXX™ Endoscopic Biliary Stent -
C. Predicate Devices:
Bard® memotherm® Endoscopic Biliary Stent
Device Description: D.
The LUMINEXX™ Endoscopic Biliary Stent is a stenting system designed to maintain the patency of biliary ducts obstructed by malignant biliary strictures. The device includes the self-expanding LUMINEXX™ Biliary stent pre-loaded on a delivery system. The 7.5F delivery system is compatible with a 3.2 mm endoscope working channel and accepts a 0.35" guidewire. The stent is available in 8 and 10 mm diameters, and 40, 60, 80, and 100 mm lengths. The working length of the delivery system is 190 cm.
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K031/186
page 2 of 2
BANK
· BARD ENDOSCOPIC TECHNOLOGIES
Per Doncern Boar 0 Box 2631 Bilenca, MA 01821-7031 978-663-3999
E Intended Use:
The LUMINEXX™ Endoscopic Biliary Stent is indicated for use in the palliative treatment of patients with malignant biliary strictures.
-
F. Technological Characteristics Summary
The LUMINEXX™ Endoscopic Biliary Stent is a metal mesh stent constructed of nitinol. Tantalum spoons on each end of the stent provide enhanced radiopacity. The stent is self-expanding and is packaged pre-mounted on a disposable delivery system. ... . -
Performance Data: G.
Design verification data demonstrated that the LUMINEXXTM Endoscopic Biliary Stent meets the same performance requirements and is as safe and effective as the predicate device.
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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 features a stylized eagle or bird-like symbol with three curved lines representing its wings or feathers. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular pattern around the bird symbol.
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Thomas Hirte, P.E. Senior Regulatory Affairs Specialist Bard Endoscopic Technologies C. R. Bard, Inc. 129 Concord Road P.O. Box 7031 Billerica, Massachusetts 01821-7031
Re: K031186
Trade/Device Name: LUMINEXX™ Endoscopic Biliary Stent Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: April 14, 2003 Received: April 15, 2003
Dear Mr. Hirte:
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.
MAY - 6 2003
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Page 2 -- Mr. Thomas Hirte
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 yours,
Daniel G. Schultz, M.D.
Paniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page 1 of 1
510(k) Number (if known): K031186
Device Name: Bard LUMINEXXTM Endoscopic Biliary Stent
FDA's Statement of the Indications For Use for device:
The LUMNEXX™ Endoscopic Biliary Stent is indicated for use in the palliative treatment of patients with malignant biliary strictures.
Prescription Use レ (Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Daniel A. Kramer
(Division Sign-Off) Division Reproductive, Abdominal, and Radion gical 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.