(84 days)
No
The summary describes a mechanical device (stent and delivery system) and its intended use. There is no mention of AI, ML, image processing, or any software-based functionality that would suggest the use of these technologies. The performance studies focus on mechanical properties.
Yes
The device is used for the "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," which indicates it is used for treatment.
No
The device is described as an implantable metallic stent for treating obstructions or strictures, indicating a therapeutic rather than diagnostic purpose.
No
The device description explicitly states it is composed of an implantable metallic stent and a delivery device, which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use describes a device used for the palliative treatment of obstructions and strictures caused by malignant neoplasms and to relieve large bowel obstruction. This is a therapeutic intervention performed directly on the patient's anatomy.
- Device Description: The device is an implantable metallic stent and a delivery system. This is a physical device used to open up blockages within the body.
- Lack of IVD Characteristics: An IVD is a medical device used to perform tests on samples taken from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. The provided description does not mention any testing of samples or diagnostic purposes.
Therefore, the WALLSTENT® Enteral Endoprosthesis with Unistep™ Delivery System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for 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.
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.
Product codes
78 MQR
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.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
colonic, duodenal or gastric outlet, large bowel
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)
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.
Key Metrics (Sensitivity, Specificity, PPV, NPV, etc.)
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 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.”
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 Corporation |
| 5905 Nathan Lane | |
| Plymouth, MN 55442 | |
| Phone: (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
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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