(84 days)
The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is indicated for palliative treatment of colonic, duodenal or gastric outlet obstruction or strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is composed of two components: the implantable metallic stent and the delivery device. The stent is composed of implant-grade cobalt-base superalloy wire braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, and self-expanding. The stent is available in multiple sizes. Physician preference and individual patient condition and/or anatomy will determine the appropriate size chosen.
Here's an analysis of the provided text regarding the acceptance criteria and study for the WALLSTENT® Enteral Endoprosthesis, formatted to include the requested information.
Note: The provided document is a 510(k) summary for a medical device seeking an additional indication for a device that is already legally marketed. This type of submission relies heavily on the equivalence to a predicate device and often does not involve a new, large-scale clinical study for the specific expanded indication if the technological characteristics are identical.
Wallstent® Enteral Endoprosthesis - Acceptance Criteria and Study Analysis
This 510(k) submission primarily focuses on demonstrating substantial equivalence to a predicate device for an additional indication (gastric outlet obstruction or strictures). The device itself (materials, construction, processing) is identical to the predicate. Therefore, the "study" demonstrating the device meets acceptance criteria largely relies on the prior performance of the predicate device and a literature review for the new indication.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criterion (Category) | Specific Criteria (Implicit) | Reported Device Performance |
|---|---|---|
| Mechanical Strength | - Fatigue resistance (adequate in vivo lifespan) - Corrosion resistance (biocompatibility and durability) - Relative radial force (ability to effectively open and maintain lumen diameter) - Stent deformation (resistance to collapse or shape change) | "Performance testing was done on predicate devices. Tests included fatigue, corrosion resistance, relative radial force, and stent deformation testing to assure mechanical strength of the wire. The results were all within the expected ranges." Note: These tests were not repeated for this submission as the device is identical to the predicate. |
| Safety & Effectiveness | - Biocompatibility (no adverse biological reactions) - Ability to palliate obstruction/strictures - No new safety concerns compared to predicate | The device is "physically identical" to the predicate. "A search of clinical literature has found that the clinical in vivo experience of a stent within the clinical indication that we are requesting has been successful. In brief a metal stent placement within the obstructed colon permits definitive surgery to be postponed until it can be performed in a better prepared patient." "The results of the literature search and tests demonstrate that the WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is equivalent to the predicate device and is therefore safe and effective for its intended use." |
| Technological Characteristics | - Materials - Construction - Processing | "The WALLSTENT® Enteral Endoprosthesis with Unistep™M Delivery System has technological (materials, construction, processing) characteristics identical to those of the predicate WALLSTENT® device." |
2. Sample Size Used for the Test Set and Data Provenance
- Test Set (for Mechanical/Performance Data): Not explicitly stated as a "sample size" in the context of a new human clinical study. The performance testing was done on predicate devices, implying a set of devices manufactured under the same specifications. The exact number of units tested for fatigue, corrosion, etc., is not provided, but it would have been a representative sample according to recognized test standards for medical devices.
- Data Provenance: The mechanical/performance data originated from testing of the predicate devices (likely in a laboratory setting, location not specified but presumably where the manufacturer's R&D/testing is conducted).
- Clinical Data (for New Indication): The clinical evidence for the additional indication relies on a literature search. This implies aggregated data from published clinical studies, not a specific "test set" commissioned by Boston Scientific for this 510(k). Therefore, the data provenance would be global, retrospective clinical study data from various published sources.
3. Number of Experts Used to Establish the Ground Truth for the Test Set and Qualifications of Those Experts
- Mechanical/Performance Data: The "ground truth" for the mechanical tests would be established by engineering specifications and recognized test standards. The "experts" would be the engineers and quality assurance personnel conducting and interpreting these tests, qualified in mechanical engineering, materials science, and medical device testing. No specific number is provided, typical of in-house testing.
- Clinical Data (Literature Review): The "ground truth" for the clinical effectiveness in the new indication (gastric outlet obstruction) was established by the published outcomes of the studies included in the literature review. The "experts" here would be the authors and peer reviewers of those published clinical studies (likely interventional gastroenterologists, surgeons, radiologists, etc., with relevant experience). The submission itself does not indicate Boston Scientific used its own panel of experts to re-establish ground truth for the literature review; rather, they are relying on the established findings in the medical literature.
4. Adjudication Method for the Test Set
- Mechanical/Performance Data: Adjudication for mechanical tests typically involves adherence to pre-defined test protocols, acceptance criteria, and standard operating procedures. Any deviations or borderline results would be adjudicated by the engineering and quality teams, potentially with input from regulatory experts. No specific "2+1" or "3+1" method is mentioned, as this is more common for subjective clinical interpretations.
- Clinical Data (Literature Review): The "adjudication" for the literature review involved the selection and interpretation of published studies relevant to "clinical in vivo experience of a stent within the clinical indication that we are requesting." This implies a review process by the sponsor's clinical and regulatory teams. Specific adjudication methods (like expert panels re-reviewing individual patient data from the literature) are not described, which is typical for a literature-based justification in a 510(k).
5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was done
No, an MRMC comparative effectiveness study was not done. This type of study is more common for diagnostic imaging devices where reader performance is a key metric. This submission concerns an implantable therapeutic device, and the demonstration of effectiveness relies on mechanical performance and previously published clinical outcomes, not on human reader interpretation.
6. If a Standalone (i.e., algorithm only without human-in-the-loop performance) was done
This question is not applicable to the WALLSTENT® Enteral Endoprosthesis, as it is a physical medical device, not an algorithm or AI software. Therefore, no standalone algorithm performance study was done.
7. The Type of Ground Truth Used
- For Mechanical Performance: Engineering specifications and established test standards.
- For Clinical Effectiveness (New Indication): Outcomes data derived from the published clinical literature regarding the use of similar stents (and the predicate stent) for the palliative treatment of malignant obstructions/strictures. This implicitly includes expert consensus from the medical community as reflected in published research.
8. The Sample Size for the Training Set
No specific "training set" in the context of machine learning or AI is mentioned because this device is a physical product, not dependent on an algorithm trained on data. The device's design is based on established engineering principles and prior experience with the predicate device.
9. How the Ground Truth for the Training Set Was Established
Not applicable, as there is no "training set" in the context of an algorithm. For the design and engineering principles, the "ground truth" is established through materials science, biomechanical engineering, and clinical experience gained from previous versions of the device (the predicate).
{0}------------------------------------------------
JUN 2 2 1999
Wallstent® Enteral Endoprosthesis
0005
91056
510(k) Summary for The WALLSTENT® Enteral Endoprosthesis
| Date Prepared: | March 29, 1999 |
|---|---|
| Sponsor: | Boston Scientific Corporation5905 Nathan LanePlymouth, MN 55442Phone: (612)550-5500 |
| Contact: | Daniel J. Dillon(508)-650-8751 |
Enteral Endoprosthesis with UnistepTM Device Proprietary Name: WALLSTENT® Delivery System
Classification: Class III
Equivalent Devices: WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System, K954290 and K980113
Device Description:
The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is composed of two components: the implantable metallic stent and the delivery device. The stent is composed of implant-grade cobalt-base superalloy wire braided in a tubular mesh configuration. The design configuration results in a stent that is flexible, compliant, and self-expanding. The stent is available in multiple sizes. Physician preference and individual patient condition and/or anatomy will determine the appropriate size chosen.
Intended Use:
This device is intended for palliative treatment of colonic, duodenal or gastric outlet obstruction or strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures. It is physically identical to the predicate WALLSTENT® Enteral Endoprosthesis with UnistepTM Delivery System, which is indicated for palliative treatment of colonic and duodenal strictures produced by malignant neoplasms. The device described in this submission differs only in the additional indication.
Technological Characteristics:
Enteral Endoprosthesis with Unistep™M Delivery System has The WALLSTENT® technological (materials, construction, processing) characteristics identical to those of the
{1}------------------------------------------------
Wallstent® Enteral Endoprosthesis
predicate WALLSTENT® device. These devices allow for self expanding deployment using dynamic radial force to gently and firmly expand the lumen diameter. The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System will be used to open a pathway through a restricted lumen. The predicate devices achieve the same end result.
A search of clinical literature has found that the clinical in vivo experience of a stent within the clinical indication that we are requesting has been successful. In brief a metal stent placement within the obstructed colon permits definitive surgery to be postponed until it can be performed in a better prepared patient.
Performance testing was done on predicate devices. Tests included fatigue, corrosion resistance, relative radial force, and stent deformation testing to assure mechanical strength of the wire. The results were all within the expected ranges. Because this is a request for an additional indication and introduces no new materials, designs, or processes, these tests were not repeated.
The results of the literature search and tests demonstrate that the WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is equivalent to the predicate device and is therefore safe and effective for its intended use.
{2}------------------------------------------------
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Mr. Daniel J. Dillon Regulatory Affairs Project Manager Boston Scientific Corporation Microvasive Endoscopy One Boston Scientific Place Natick, MA 01760-1537
Re: Kaaloee
WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System Dated: March 29, 1999 Received: March 30, 1999 Regulatory Class: III 21 CFR §878.3610/Procode: 78 MQR
Dear Mr. Dillon:
We have reviewed your Section 510(k) notification of intent to market the device referenced above and we 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. The general controls of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration.
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 regult in regulatory action. In addition, FDA may publish further announcements concerning your device in the Federal Register. Please note: this response to your premarket notification submission does 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.
This letter will allow you to begin marketing your device as described in your 510(k) premarket notification. The FDA finding of substantial equivalence of your device to a legally marketed predicate device results in a classification for your device and thus, permits your device to proceed to the market.
If you desire specific advice for your device on our labeling requlation (21 CFR Part 801 and additionally 809.10 for in vitro diagnostic devices), please contact the Office of Compilance at (301) 594-4613. 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.
CAPT Daniel O. Schultz, M.D.
CAPT Daniel G. Schultz, M.D. Acting Director, Division of Reproductive, Abdominal, Ear, Nose and Throat, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
Image /page/2/Picture/14 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo is a circular emblem with the department's name encircling a stylized symbol. The symbol resembles a bird in flight, composed of three curved lines that converge to form the body and wings. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES • USA" is arranged around the upper half of the circle.
JUN 2 2 1999
{3}------------------------------------------------
Page 1 of 1
991057 510(k) Number (if known):
Device Name: WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System
Indication for Use:
The WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is indicated for palliative treatment of colonic, duodenal or gastric outlet obstruction or strictures caused by malignant neoplasms, and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED
============================================================================================================================================================================= Concurrence of CDRH, Office of Device Evaluation (ODE)
Prescription Use Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (Per 21 CFR 801.109)
(Division Sign-Off) Division of Reproductive, Abdominal, ENT and Radiological Dev 510(k) Number
§ 878.3610 Esophageal prosthesis.
(a)
Identification. An esophageal prosthesis is a rigid, flexible, or expandable tubular device made of a plastic, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the esophagus. The metal esophageal prosthesis may be uncovered or covered with a polymeric material. This device may also include a device delivery system.(b)
Classification. Class II. The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”