(19 days)
LifeStent SDS Biliary Endoprosthesis
No
The device description and performance studies focus on the mechanical properties and delivery system of a stent, with no mention of AI or ML.
Yes
The device is a stent used for palliation of malignant neoplasms in the biliary tree, which is a therapeutic intervention.
No
The device is a stent used for palliation of malignant neoplasms in the biliary tree, which is a treatment rather than a diagnostic function.
No
The device description clearly states it is a physical stent made of stainless steel and a balloon catheter delivery system, which are hardware components.
Based on the provided information, the Orbus LifeStent XL SDS Biliary Endoprosthesis is not an IVD (In Vitro Diagnostic) device.
Here's why:
- IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information about a person's health. The LifeStent XL SDS Biliary Endoprosthesis is a permanently implanted device used to maintain the patency of a bile duct. It is a therapeutic device, not a diagnostic one.
- The description clearly states it is a "permanently implanted device" and is "inserted percutaneously to the diseased site." This describes an in-vivo (within the living body) application, not an in-vitro (in glass, outside the body) diagnostic test.
- The intended use is for "palliation of malignant neoplasms in the biliary tree," which is a treatment goal, not a diagnostic one.
Therefore, the Orbus LifeStent XL SDS Biliary Endoprosthesis is a medical device, but it falls under the category of therapeutic or interventional devices, not in vitro diagnostics.
N/A
Intended Use / Indications for Use
The LifeStent XL SDS Billary Endoprosthesis are intended for the palliation of malignant neoplasms in the biliary tree.
Product codes (comma separated list FDA assigned to the subject device)
78 FGE
Device Description
The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is I ne Enehein AL SDD Dipercutaneous transluminal angioplasty (PTA) balloon catheter which acts as the 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 316L 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 systems are available with expanded diameter of 100mm at stent lengths of 17, 27, 37mm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
biliary tree
major bile duct
Indicated Patient Age Range
Not Found
Intended User / Care Setting
Not Found
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies (study type, sample size, AUC, MRMC, standalone performance, key results)
Orbus protocols ensure that the LifeStent XL SDS Biliary Endoprosthesis perform in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s): If the device was cleared using the 510(k) pathway, identify the Predicate Device(s) K/DEN number used to claim substantial equivalence and list them here in a comma separated list exactly as they appear in the text. List the primary predicate first in the list.
LifeStent SDS Biliary Endoprosthesis
Reference Device(s): Identify the Reference Device(s) K/DEN number and list them here in a comma separated list exactly as they appear in the text.
Predetermined Change Control Plan (PCCP) - All Relevant Information for the subject device only (e.g. presence / absence, what scope was granted / cleared under the PCCP, any restrictions, etc).
Not Found
§ 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.
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MAY 1 0 2004
K041032
Page 1 of 2
| 1. | Submitter: | Orbus Medical Technologies, Inc
5363 NW 35th Ave
Fort Lauderdale, Florida 33309
Phone: (954) 730-0711
Fax: (954) 730-7601 |
|----|------------------------|---------------------------------------------------------------------------------------------------------------------------------------|
| 2. | Contact: | Jim Clossick
Director of Quality Assurance and Regulatory Affairs |
| 3. | Date Prepared: | 3/1/04 |
| 4. | Device Trade Name: | LifeStent XL SDS Biliary Endoprosthesis |
| 5. | Device Common Name: | Biliary stent |
| 6. | Device Classification: | Biliary Catheter (78 FGE) |
| 7. | Predicate Devices: | LifeStent SDS Biliary Endoprosthesis |
510(k) Statement
Description: 8.
The LifeStent XL SDS Biliary Endoprosthesis consists of a balloon expandable stent which is I ne Enehein AL SDD Dipercutaneous transluminal angioplasty (PTA) balloon catheter which acts as the 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 316L 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 systems are available with expanded diameter of 100mm at stent lengths of 17, 27, 37mm.
Intended Use: 9.
The LifeStent XL SDS Billary Endoprosthesis are intended for the palliation of malignant neoplasms in the biliary tree.
Technological Characteristics: 10.
Comparisons of the new and predicate devices were designed to show that the technical characteristics such as materials, performance properties, biocompatibility, method of sterilization, and packaging are identical or substantially equivalent.
1
Performance Data: 11.
Orbus protocols ensure that the LifeStent XL SDS Biliary Endoprosthesis perform in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force, compression force, dimensions, corrosion susceptibility, visual appearance, balloon performance, expansion damage, and balloon tensile strength.
Conclusion 12.
Since the LifeStent XL SDS Biliary Endoprosthesis, comprised of the Ø 8-12 mm LifeStent (K023121) and the Opti-Plast XT catheter (K941706), has the same intended use, identical material properties, similar performance properties, packaging, and sterilization methods, it may be considered substantially equivalent to the predicate devices cited in (7). These devices are a line extension to the LifeStent XL 8 and 9mm Biliary Endoprosthesis previously cleared per K040550.
2
Image /page/2/Picture/1 description: The image shows a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. Inside the circle is a stylized image of an eagle with its wings spread. The eagle is facing to the right and has three wavy lines below it.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
MAY 1 0 2004
Mr. Jim Clossick Director of Quality Assurance and Regulatory Affairs Orbus Medical Technologies 5363 NW 35th Avenue Fort Lauderdale, Florida 33309
Re: K041032
Trade/Device Name: Orbus LifeStent XL SDS Biliary Endoprosthesis Regulation Number: 21 CFR §876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: April 19, 2004 Received: April 21, 2004
Dear Mr. Clossick:
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 cnactment 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.
3
Page 2 - Mr. Jim Clossick
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 I lease or acresed 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 The I Dr. Initime of vablar your device and permits your device to proceed to the market. This resure in a classis. In a base in 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 (2) 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,
Phillips
Tillman, Ph.D. Donna-Acting Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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Page_ 1 of 1
510(k) Number: K041032
Device Name: Orbus LifeStent XL SDS Biliary Endoprosthesis
FDA's Statement of the Indications For Use for device:
The Orbus LifeStent XL SDS Biliary Endoprosthesis is indicated for the palliation of malignant neoplasms in the biliary tree.
Prescription Use
(Per 21 CFR 801.109) √
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
David A. Logsdon
(Division Sign-Off)
(Division of Reproductive, Abdominal, and Roon of Reproductive
and Radiological Devices 510(k) Number