(76 days)
The IntraStent™ DoubleStrut™ LD Biliary Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree.
The IntraStent™ DoubleStrut™ LD is a balloon expandable stainless steel stent with an open cell design. The stent is provided unmounted, to be manually crimped onto an open lumen PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The provided text describes a 510(k) submission for the IntraStent™ DoubleStrut™ LD Biliary Stent, focusing on demonstrating substantial equivalence to predicate devices, rather than a study proving the device meets acceptance criteria from a clinical outcome perspective.
Here's an analysis based on the information provided, specifically addressing the requested points:
1. Table of Acceptance Criteria and Reported Device Performance
The submission does not define specific clinical acceptance criteria in terms of performance metrics (e.g., patency rates, complication rates). Instead, the "acceptance criteria" are implied as demonstrating substantial equivalence through bench tests to established predicate devices.
| Acceptance Criterion (Implied) | Reported Device Performance |
|---|---|
| Meet same performance characteristics as predicate IntraStent™ DoubleStrut™ (K991929) | Bench tests were performed to verify this. |
| Non-pyrogenic | Pyrogenicity testing performed on a lot-to-lot basis supports this claim. |
| Identical materials to predicate devices | Stated as identical to currently marketed IntraStent™ DoubleStrut™ and Cordis Corporation/Johnson & Johnson PALMAZ™ and PALMAZ-SCHATZ™ stents. |
| Identical indication for use to predicate devices | Stated as identical: "palliative treatment for malignant strictures of the biliary tree." |
| Identical technological characteristics to predicate devices | Stated as identical, providing a larger version of IntraStent™ DoubleStrut™ (9-12 mm expanded diameter), fabricated by laser-cutting 316L stainless steel hypotube. |
2. Sample Size Used for the Test Set and Data Provenance
The submission describes bench tests and pyrogenicity testing, not clinical trials with patient data.
- Test Set Sample Size: Not explicitly stated for bench tests (e.g., number of stents tested). For pyrogenicity, it's mentioned as "lot to lot basis," implying samples from manufacturing lots.
- Data Provenance: Not applicable in the context of clinical data (no country of origin or retrospective/prospective clinical data mentioned). The data provenance is from internal bench testing conducted by the manufacturer.
3. Number of Experts Used to Establish Ground Truth for the Test Set and Qualifications of Those Experts
Not applicable. The ground truth for bench tests is the engineering specification and performance of the predicate device. There is no mention of experts establishing a "ground truth" for the test set in the sense of clinical diagnoses or interpretations.
4. Adjudication Method for the Test Set
Not applicable. This concept primarily applies to human reader studies or clinical trials where expert consensus is needed to resolve discrepancies. Bench tests rely on objective physical measurements and compliance with engineering specifications.
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?
Not applicable. This is a medical device (stent), not an AI-powered diagnostic or decision-support system. Therefore, MRMC studies comparing human readers with and without AI assistance are not relevant to this submission.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) Was Done
Not applicable. This is a medical device (stent), not an algorithm or AI system.
7. The Type of Ground Truth Used
The "ground truth" for this 510(k) submission is the performance and characteristics of the legally marketed predicate devices (IntraStent™ DoubleStrut™ K991929 and Cordis Corporation PALMAZ™ and PALMAZ-SCHATZ™ stents). The testing (bench tests, pyrogenicity) aimed to demonstrate that the new device's performance aligns with these established predicates.
8. The Sample Size for the Training Set
Not applicable. This is not an AI or machine learning device requiring a training set.
9. How the Ground Truth for the Training Set Was Established
Not applicable. As above, this is not an AI or machine learning device.
Summary of the Study Proving Acceptance Criteria:
The study proving the device meets the "acceptance criteria" (understood as demonstrating substantial equivalence to predicate devices) primarily involved:
- Bench Tests: These were conducted to verify that the IntraStent™ DoubleStrut™ LD met the "same performance characteristics" as the predicate IntraStent™ DoubleStrut™ (K991929). The submission states "Performance testing (bench) further supports a substantial equivalence claim." No specific details about the types of bench tests (e.g., radial force, fatigue, crimp retention) or their results are provided in this summary.
- Pyrogenicity Testing: This was performed on a "lot to lot basis" to support the claim that the device is non-pyrogenic.
The conclusion is that "The collective evidence therefore provides assurance that the IntraStent™ meets the requirements that are considered acceptable for the intended use" by demonstrating its "identical" nature in materials, indication for use, and technological characteristics, and by showing similar performance in bench tests, to its predicate devices.
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1 2000 FEB
510(k) Summary (Page 1 of 2)
Product Name: IntraStent™ DoubleStrut™ LD Common Name: Biliary Catheter
| Submitter's Name: | IntraTherapeutics, Inc, 651 Campus DriveSt. Paul, MN 55112 |
|---|---|
| Official Contact: | Cathy YohnkSenior Clinical /Regulatory Affairs SpecialistTel. 651-697-2003 Fax 651-697-2080 |
Summary Preparation Date: August 19, 1999
This summary is provide in compliance with section 513(I)(3)(A) of the Act and summarizes the safety and effectiveness information contained in this premarket notification submission.
The product trade and common name are IntraStent™ DoubleStrut™ LD and billary The product trade and common as a Class II product classified under 21 CFR $8768.5010 as a eatherer , rospoctrory - The is a Substantial equivalence* is claimed to IntraTherapeutics, Inc. IntraStent™ DoubleStrut™ (K991929) and Cordis Corporation PALMAZ™ and Inc. Intrastein Balloon-Expandable Biliary Stent (K905720, K911581, K964688).
The IntraStent™ DoubleStrut™ LD is a balloon expandable stainless steel stent with an I ne intrablem - Dozetter is provided unmounted, to be manually crimped onto a open natiliant PTA balloon catheter for biliary stent expansion of choice by the physician. Upon balloon inflation the crimped stent expands to conform to the duct inner luminal surface and retains the expanded state upon balloon deflation.
The intended use is "as a palliative treatment for malignant neoplasms in the biliary tree".
Summary of technological characteristics: The IntraStent™ DoubleStrut™ LD provides a larger version the IntraStent™ DoubleStrut™ (K991929), allowing an expanded diameter of 9-12 mm. The IntraStent™ devices are balloon expandable stents fabricated by cutting an engineered series of slots/apertures into a 316L stainless steel hypotube. The cuts are made with a laser. The IntraStent™ devices are cleaned, electro-polished, packaged in a double sterile barrier and sterilized. The IntraStent™ devices are ethylene oxide sterilized and are provided unmounted.
Page 1/2
*This document uses the term "substantial equivalence" as intended in 21 CFR 807.87, and not as defined in Title 36 of the US Code.
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Page 2/2
510K Summary (Page 2 of 2)
The IntraStent™ devices incorporate the use of manual compression using one's thumbs and forefingers to compress the stent onto the delivery balloon catheter.
Bench tests were performed to verify that the IntraStent™ DoubleStrut™ LD met the same performance characteristics as the predicate IntraStent™ DoubleStrut™ (K991929). Pyrogenicity testing performed on a lot to lot basis supports the nonpyrogenic claim.
The IntraStent™ is substantially equivalent to the currently marketed IntraStent™ DoubleStrut™ and the Cordis Corporation/Johnson & Johnson PALMAZ™, and PALMAZ-SCHATZ™ Balloon-Expandable Biliary Stents as a palliative treatment for malignant strictures of the biliary tree. As demonstrated the IntraStent™ LD is identical in materials, indication for use, and technological characteristics. Performance testing (bench) further supports a substantial equivalence claim. The collective evidence therefore provides assurance that the IntraStent™ meets the requirements that are considered acceptable for the intended use.
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DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Image /page/2/Picture/2 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo features a stylized depiction of an eagle or bird with three wing-like shapes, symbolizing health and human services. The bird is encircled by the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". The logo is simple and uses a black and white color scheme.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
1 2000 FEB
Ms. Cathy Yohnk MS. Cathy Tomas
Senior Clinical Research / Regulatory Affairs Associate IntraTherapeutics, Inc. 651 Campus Drive St. Paul, Minnesota 55112
K993904 Re:
IntraStent™ DoubleStrut™ LD Biliary Stent Regulatory Class: II 21 CFR 876.5010 Product Code: 78 FGE Dated: December 30, 1999 Received: January 3, 2000
Dear Ms. Yohnk:
We have reviewed your Section 510(k) notification of intent to market the device referenced We have reviewed your Section >10(K) notineans of the mixalent (for the indications for use above and we have determined the evece is sedicate devices marketed in interstate commerce
s the enclosure) to legally marketed producate devices marketed in interstation stated in the enclosure) to legally marketed president of the Medicents, or to devices that
prior to May 28, 1976, the enactment date of the Medical Food. Drug, and prior to May 28, 1970, the chacinent date of the Federal Food, Drug, and Cosmetic Act (Act). You may, therefore, market the device, subject to the general controls provisions Cosmetic Act (Act). You may, merciolo, market the general controls provisions of the provisions of the Act and the immanious sessinous of devices, good manufacturing practice, Act merade roquinst misbranding and adulteration.
The Office of Device Evaluation has determined that there is a reasonable likelihood that this were w The Office of Device Evanuation his detectimized in the proposed labeling and that such used device with be used for an intended ass nocession 513(i)(1)(E) of the Act, the following Could Cause namn: "Therefore 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, r untilerinore, the indication for othialy as and other promotional materials, in merading pourity to the trade name, of a similar point size, and in bold print.
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Page 2 – Ms. Cathy Yohnk
If your device is classified (see above) into either class II (Special Controls) or class III (Premarket Approval), it may be subject to such additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 895. A substantially equivalent determination assumes compliance with the Current Good Manufacturing Practice requirements, as set forth in the Quality System Regulation (QS) for Medical Devices: General regulation (21 CFR Part 820) and that, through periodic QS inspections, the Food and Drug Administration (FDA) will verify such assumptions. Failure to comply with the GMP regulation may result in regulatory action. In addition, I'DA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission docs not affect any obligation you might have under sections 531 through 542 of the Act for devices under the Electronic Product Radiation Control provisions, or other Federal laws or regulations.
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 510(k) premarket notification if the limitation statement above is added to your labeling, as described.
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 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compliance at (301) 594-4616. Additionally, for questions on the promotion and advertising of your device, please contact the Office of Compliance at (301) 594-4639. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 807.97). Other general information on your responsibilities under the Act may be obtained from the Division of Small Manufacturers 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 W. Katz
David W. Feigal, Jr. M.D., M.P.H. Acting 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): K993904
Device Name: IntraStent™ DoubleStrut™ LD Biliary Stent
FDA's Statement of the Indications For Use for device:
The IntraStent™ DoubleStrut™ LD Biliary Stent is indicated as a palliative treatment for malignant neoplasms in the biliary tree.
Prescription Use X OR (Per 21 CFR 801.109)
Over-The-Counter Use
(Division Sign-Off)
Division of Reproductive, Abdominal, ENT,
Division of Repreductive. Abdominal, ENT, and Radiological Devic 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.