(172 days)
The LifeStent Biliary Endoprosthesis is intended for the palliation of malignant neoplasms in the biliary tree.
The LifeStent Biliary Endoprosthesis is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The device is a balloon expandable stent made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is designed to be manually crimped onto a PTA balloon catheter, inserted percutaneously to the diseased site, and deployed by balloon inflation. The stents are available with an expansion range of 4.0-7.0 mm at lengths of 13, 18, 26, 36, and 56 mm.
The provided document is a 510(k) summary for the LifeStent Biliary Endoprosthesis, which is a medical device. This type of document is for demonstrating substantial equivalence to a predicate device, not typically a study proving the device meets specific acceptance criteria in the way a clinical trial for a novel drug or high-risk device would. Therefore, the requested information, particularly regarding AI performance, ground truth, expert adjudication, and detailed statistical results, is not present in this type of regulatory submission for this device.
Based on the provided text, here's what can be extracted and what cannot:
1. Table of acceptance criteria and the reported device performance:
The document states that "Orbus protocols ensure that the LifeStent Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force testing, compression force testing, dimensions, expansion damage, and corrosion testing."
This implies that the "acceptance criteria" are related to achieving substantial equivalence in these in-vitro performance characteristics compared to the predicate devices. However, the exact numerical acceptance criteria (e.g., "expansion force must be within X% of predicate") and the specific reported performance values are not detailed in this summary. It only states that the device performs in a manner substantially equivalent.
| Acceptance Criteria Category | Reported Device Performance |
|---|---|
| Deployment | Substantially equivalent to predicate devices |
| Expansion Force Testing | Substantially equivalent to predicate devices |
| Compression Force Testing | Substantially equivalent to predicate devices |
| Dimensions | Substantially equivalent to predicate devices |
| Expansion Damage | Substantially equivalent to predicate devices |
| Corrosion Testing | Substantially equivalent to predicate devices |
| Material Properties | Identical to predicate devices |
| Packaging | Similar to predicate devices |
| Sterilization Methods | Similar to predicate devices |
| Intended Use | Same as predicate devices (Palliation of malignant neoplasms in biliary tree) |
2. Sample size used for the test set and the data provenance (e.g. country of origin of the data, retrospective or prospective):
This document describes in-vitro performance tests on the device itself, not a clinical study on patient data. Therefore, there is no information about patient sample sizes or data provenance in the context of clinical data. The "test set" would refer to the number of devices tested for each in-vitro parameter, which is not specified.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts:
This is irrelevant for an in-vitro device performance study. "Ground truth" in this context would be objective physical measurements of the stent's properties. No experts are mentioned for establishing ground truth on physical properties.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set:
Not applicable for in-vitro device performance testing.
5. 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 device is a physical medical implant (stent), not an AI-based diagnostic or prognostic tool. Therefore, an MRMC study and AI performance metrics are not applicable and not mentioned.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done:
Not applicable as this is not an AI algorithm.
7. The type of ground truth used (expert concensus, pathology, outcomes data, etc):
For the in-vitro performance tests, the 'ground truth' would be the objective measurements of the physical and mechanical properties of the stent, compared against established engineering and material standards, or directly against the predicate device's measured properties. No expert consensus, pathology, or outcomes data is mentioned for establishing this.
8. The sample size for the training set:
Not applicable, as this is not an AI model.
9. How the ground truth for the training set was established:
Not applicable, as this is not an AI model.
Summary of what is available from the document:
The 510(k) summary focuses on demonstrating substantial equivalence of the LifeStent Biliary Endoprosthesis to previously marketed predicate devices. This demonstration is primarily based on:
- Identical Intended Use: Palliation of malignant neoplasms in the biliary tree.
- Identical Material Properties: Made from 316L stainless steel.
- Similar Performance Properties: Assessed through in-vitro tests (deployment, expansion force, compression force, dimensions, expansion damage, corrosion testing) the summary claims the device performs in a manner substantially equivalent to predicates.
- Similar Packaging and Sterilization Methods.
The FDA's review confirms this substantial equivalence, allowing the device to be marketed, with specific labeling limitations regarding its use in the vascular system. The document pertains to a physical device approval, not an AI or software device, hence many of the requested criteria are not relevant or discussed.
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K023121
page 1 of 2
510(k) Summary
| 1. | Submitter: | Orbus Medical Technologies, Inc5363 NW 35th AveFort Lauderdale, Florida 33309Phone: (954) 730-0711Fax: (954) 730-7601 |
|---|---|---|
| 2. | Contact: | Jim ClossickDirector of Quality Assurance and Regulatory Affairs |
| 3. | Date Prepared: | September 18, 2002 |
| 4. | Device Trade Name: | LifeStent Biliary Endoprosthesis |
| 5. | Device Common Name: | Biliary stent |
| 6. | Device Classification: | Biliary Catheter (78 FGE) |
| 7. | Predicate Devices: | Orbus R Stent (LifeStent) Biliary EndoprosthesisIntraTherapeutics Intrastent Biliary EndoprosthesisIntraTherapeutics Intrastent DoubleStrut Biliary EndoprosthesisIntraTherapeutics Intrastent DoubleStrut XS Biliary EndoprosthesisCordis Palmaz Balloon Expandable Stent |
8. Description:
The LifeStent Biliary Endoprosthesis is a permanently implanted device used to maintain patency of a major bile duct obstructed by tissue of an impinging tumor. The device is a balloon expandable stent made by laser cutting an open lattice design into a 316L stainless steel tube. The stent is designed to be manually crimped onto a PTA balloon catheter, inserted percutaneously to the diseased site, and deployed by balloon inflation. The stents are available with an expansion range of 4.0-7.0 mm at lengths of 13, 18, 26, 36, and 56 mm.
Intended Use: 9.
The LifeStent Biliary Endoprosthesis is intended for the palliation of malignant neoplasms in the biliary tree.
10. Technological Characteristics:
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.
Performance Data: 11.
Orbus protocols ensure that the LifeStent Biliary Endoprosthesis performs in a manner substantially equivalent to the predicate devices during in vitro tests such as deployment, expansion force testing, compression force testing, dimensions, expansion damage, and corrosion testing.
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12. Conclusion
Since the LifeStent Biliary Endoprosthesis 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).
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510(k) Number (if known):_K023121
Device Name: Orbus LifeStent Biliary Endoprosthesis
FDA's Statement of the Indications For Use for device:
The Orbus LifeStent Biliary Endoprosthesis is indicated for use for the palliation of malignant neoplasms in the biliary tree.
Perscription Use (Per 21 CFR 801.109) OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
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Image /page/3/Picture/2 description: The image shows the address of the Food and Drug Administration. The address is 9200 Corporate Boulevard, Rockville MD 20850. The text is in black font and is aligned to the left.
MAR 1 0 2003
Mr. Jim Clossick Director of Quality Assurance and Regulatory Affairs Orbus Medical Technologies 5363 NW 35th Avenue FT LAUDERDALE FL 33309
Re: K023121
Trade/Device Name: LifeStent™ Biliary Endoprosthesis Regulation Number: 21 CFR $876.5010 Regulation Name: Biliary catheter and accessories Regulatory Class: II Product Code: 78 FGE Dated: February 12, 2003 Received: February 14, 2003
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 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.
Image /page/3/Picture/12 description: The image is a black and white seal for the Department of Health & Human Services - USA. The seal is circular with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" around the perimeter. In the center of the seal is a stylized image of an eagle with its wings spread.
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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 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 (OS) regulation (21 CFR Part 820); and if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050. 9
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,
David C. Sabol, MD
Daniel G. Schultz, M.D. Director Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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510(k) Number (if known): K023121
Device Name: Orbus LifeStent Biliary Endoprosthesis
FDA's Statement of the Indications For Use for device:
The Orbus LifeStent Biliary Endoprosthesis is indicated for use for the palliation of malignant neoplasms in the biliary tree.
Perscription Use √
(Per 21 CFR 801.109)
OR
Over-the-Counter Use _________________________________________________________________________________________________________________________________________________________
Nancy C broydon
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devi 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.