(29 days)
Not Found
No
The device description and intended use focus on a physical stent and delivery system, with no mention of software, algorithms, or AI/ML capabilities. The "Mentions AI, DNN, or ML" field is explicitly marked as "Not Found".
Yes
The device is used to treat tracheobronchial strictures caused by malignant neoplasms, which is a therapeutic application.
No
The device is a prosthesis designed to maintain or increase the luminal diameter of a passage, which is a treatment function, not a diagnostic one.
No
The device description clearly states it is a physical prosthesis constructed of braided wire and a polymeric covering, which is a hardware component.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to treat tracheobronchial strictures by physically implanting a device to maintain or increase the luminal diameter. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a physical prosthesis (a stent) designed for implantation. It does not involve the examination of specimens derived from the human body (like blood, urine, tissue, etc.) to provide information for diagnosis, monitoring, or treatment.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples or providing diagnostic information based on such analysis.
IVD devices are used in vitro (outside the body) to examine specimens and provide information about a person's health. This device is used in vivo (inside the body) as a therapeutic implant.
N/A
Intended Use / Indications for Use
The WALLSTENT® Tracheobronchial Endoprosthesis is indicated for use in the treatment of tracheobronchial strictures produced by malignant neoplasms.
The WALLSTENT® Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.
The WALLSTENT® Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
The WALLSTENT® Enteral Endoprosthesis is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.
The WALLSTENT® Esophageal Prosthesis is indicated for palliative treatment of esophageal strictures produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
JCT, MUM, MOR, FGE, ESW
Device Description
The WALLSTENT® Tracheobronchial Endoprosthesis is a self-expanding prosthesis constructed of braided wire of biomedical superalloy, in some cases partially covered by a polymeric covering. Some models include a radiopaque core. The stent's purpose is to maintain or increase the luminal diameter of the passage in which it is implanted. The stent is placed by means of a delivery system, which is a coaxial tubing assembly that constrains the prosthesis until it is released in a controlled manner by retraction of the outer tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Tracheobronchial, Duodenal, Biliary, Colonic, Esophageal
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)
Not Found
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.
K980163, K980113, K964121, K964119, K961262, K954290, K940396, K934116
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.
Not Found
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
§ 878.3720 Tracheal prosthesis.
(a)
Identification. The tracheal prosthesis is a rigid, flexible, or expandable tubular device made of a silicone, metal, or polymeric material that is intended to be implanted to restore the structure and/or function of the trachea or trachealbronchial tree. It may be unbranched or contain one or two branches. The metal tracheal 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
Image /page/0/Picture/2 description: The image is a black and white seal for the Department of Health and Human Services, USA. The seal is circular and contains the words "DEPARTMENT OF HEALTH AND HUMAN SERVICES. USA" around the top half of the circle. In the center of the seal is an abstract image of an eagle with three heads.
NOV - 3 2006
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
Boston Scientific Corporation % Ms. Angela Byland Manager, Regulatory Affairs Cardiovascular Two Scimed Place Maple Grove, Minnesota 55311-1566
Re: K982184
Trade/Device Name: WALLSTENT® Tracheobronchial Endoprosthesis Regulation Number: 21 CFR 878.3720 Regulation Name: Tracheal prosthesis Regulatory Class: II Product Code: JCT, MUM, MOR, FGE, ESW Dated: June 18, 1998 Received: June 22, 1998
Dear Ms. Byland:
This letter corrects our substantially equivalent letter of July 21, 1998.
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) that do not require approval of a premarket approval (PMA). You may. therefore, market the device, subject to the general controls provisions of the Act. 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.
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
1
Page 2 - Ms. Angela Byland
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.
This letter will allow you to continue marketing your device as described in your Section 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 regulation (21 CFR Part 801), please contact the Office of Compliance at (240) 276-0115. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR 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 (240) 276-3150 or at its Internet address http://www.fda.gov/cdrh/dsma/dsmamain.html
Sincerely yours,
Mark N. Melkerson Director Division of General, Restorative and Neurological Devices Office of Device Evaluation Center for Devices and Radiological Health
2
Indications for Use Statement
| 510(k) Number
| (if known) | K982184 |
|---|---|
| Device Name | WALLSTENT® Tracheobronchial Endoprosthesis |
| Indications For Use | The WALLSTENT® Tracheobronchial Endoprosthesis is |
| indicated for use in the treatment of tracheobronchial | |
| strictures produced by malignant neoplasms. |
Prescription Use:_ X (Per 21 CFR §801 Subpart D) OR
Over-The-Counter Use: (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE - CONTINUE ON ANOTHER PAGE IF NEEDED)
Concurrence of CDRH, Office of Device Evaluation (ODE)
Hulu Lumm
Division of General, Restorative, and Neurological Devices
510(k) Number K982184
3
510(k) Number (if known):
Device Name: WALLSTENT® Enteral Endoprosthesis
Indications For Use:
The WALLSTENT® Enteral Endoprosthesis is indicated for palliation of duodenal strictures caused by malignant neoplasms.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
| Concurrence of CDRH/Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, | |
| and Neurological Devices | Page 1 of _______ |
| 510(k) Number | K982184 |
4
510(k) Number (if known):_____________________________________________________________________________________________________________________________________________________
Device Name:
Indications For Use:
The WALLSTENT® Endoprosthesis is indicated for use in the treatment of biliary strictures produced by malignant neoplasms.
Prescription Use X (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _____________ (21 CFR 801 Subpart C)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) Division of General, Restorative, and Neurological Devices | Page 1 of _______ |
| 510(k) Number | K982184 |
5
510(k) Number (if known):
Device Name: _________________________________________________________________________________________________________________________________________________________________
Indications For Use:
The WALLSTENT® Enteral Endoprosthesis is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.
Prescription Use × (Part 21 CFR 801 Subpart D) AND/OR
Over-The-Counter Use _________________________________________________________________________________________________________________________________________________________ (21 CFR 801 Subpart C)
| Concurrence of CDRH, Office of Device Evaluation (ODE) | |
|---|---|
| (Division Sign-Off) | |
| Division of General, Restorative, and Neurological Devices | |
| Page 1 of | |
| 510(k) Number | K982184 |
6
510(k) Number (if known):
Device Name: WALLSTENT® Esophageal Endoprosthesis
Indications For Use:
The WALLSTENT® Esophageal Prosthesis is indicated for palliative treatment of esophageal strictures produced by malignant neoplasms.
Prescription Use × (Part 21 CFR 801 Subpart D)
AND/OR
Over-The-Counter Use (21 CFR 801 Subpart C)
Concurrence of CDRH Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of General, Restorative
and Neurological Devices do not remove this line
510(k) Number K982184 0. Page 1 of _
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982184 p. 1 of 3
Image /page/7/Picture/1 description: The image shows the words "Boston Scientific" stacked on top of each other. The words are in a bold, serif font. The word "Boston" is on the top line, and the word "Scientific" is on the bottom line. The text is black and the background is white.
510(k) Summary
| Submitter's
Name and
Address | Boston Scientific Corporation
One Scimed Place
Maple Grove, MN 55311 | | | |
|------------------------------------|----------------------------------------------------------------------------------------------------------------------|-----------------------------------------|-----------------------------------------|--------------------------------------------|
| Contact Name
and Information | Angela Byland
Manager, Regulatory Affairs
Phone: 763-494-2887
Fax: 763-494-2981
e-mail: bylanda@bsci.com | | | |
| Original Date
Prepared | July 13, 1998 | | | |
| Date Prepared | July 14, 2006 | | | |
| Proprietary
Name(s) | WALLSTENT®
Tracheo-
bronchial
Endoprosthesis | WALLSTENT®
Enteral
Endoprosthesis | WALLSTENT®
Biliary
Endoprosthesis | WALLSTENT®
Esophageal
Endoprosthesis |
| Common Name | Tracheal
Endoprosthesis | Esophageal
Endoprosthesis | Biliary Stent | Esophageal
Endoprosthesis |
| Product Code | JCT | MUM and
MQR | FGE | ESW |
| Classification of
Device | Class III
21 CFR Part
878.3720 | Class III
21 CFR Part
878.3610 | Class II
21 CFR Part
876.5010 | Class III
21 CFR Part
878.3610 |
8
lc982184 p.20t'3
| Predicate Device | |||
|---|---|---|---|
| 1 | WALLSTENT® | ||
| Tracheobronchial | |||
| Endoprosthesis | |||
| (12-30 mm) | K980163 | March 13, 1998 | |
| 2 | WALLSTENT® | ||
| Enteral | |||
| Endoprosthesis | |||
| (Duodenal) | K980113 | April 3, 1998 | |
| 3 | WALLSTENT® | ||
| Tracheobronchial | |||
| Endoprosthesis | |||
| (5-10 mm) | K964121 | December 4, 1996 | |
| 4 | WALLSTENT® | ||
| Biliary (8-10 mm) | |||
| (Endoscopic and | |||
| Transhepatic) | K964119 | April 28, 1997 | |
| 5 | WALLSTENT® | ||
| Biliary (12 mm) | |||
| (Endoscopic and | |||
| Transhepatic) | K961262 | May 16, 1996 | |
| 6 | WALLSTENT® | ||
| Enteral | |||
| Endoprosthesis | K954290 | July 10, 1996 | |
| 7 | WALLSTENT® | ||
| Esophageal | K940396 | October 2, 1994 | |
| 8 | WALLSTENT® | ||
| Tracheobronchial | |||
| Prosthesis | K934116 | June 2, 1994 | |
| Device | |||
| Description | The WALLSTENT® Tracheobronchial Endoprosthesis is a self- | ||
| expanding prosthesis constructed of braided wire of biomedical | |||
| superalloy, in some cases partially covered by a polymeric covering. | |||
| Some models include a radiopaque core. The stent's purpose is to | |||
| maintain or increase the luminal diameter of the passage in which it is | |||
| implanted. | |||
| The stent is placed by means of a delivery system, which is a coaxial | |||
| tubing assembly that constrains the prosthesis until it is released in a | |||
| controlled manner by retraction of the outer tube. |
:
1
9
K982184 p. 3 of 3
| Indications for
Use | 1. | The WALLSTENT® Tracheobronchial
Endoprosthesis is indicated for use in the treatment
of tracheobronchial strictures produced by malignant
neoplasms. |
|----------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------|
| | 2. | Palliative treatment of colonic and duodenal
strictures caused by malignant neoplasms. |
| | 3. | The WALLSTENT® Tracheobronchial
Endoprosthesis is indicated for use in the treatment
of tracheobronchial strictures produced by malignant
neoplasms. |
| | 4. | Treatment of biliary strictures produced by malignant
neoplasms. |
| | 5. | Treatment of biliary strictures produced by malignant
neoplasms. |
| | 6. | Palliative treatment of colonic strictures caused by
malignant neoplasms. |
| | 7. | Treatment of esophageal strictures and
tracheoesophageal fistulas produced by malignant
neoplasms. |
| | 8. | The WALLSTENT® Tracheobronchial
Endoprosthesis is indicated for use in the treatment
of tracheobronchial strictures produced by malignant
neoplasms. |
| Technological
Characteristics | This premarket notification deals solely with addition of a
claim to MRI safety. The design of the product is
unchanged. | |
| Conclusion | The devices are unchanged and there are no changes to
safety and efficacy.
The purpose of this 510(k) notification is to present
information supporting a labeling change indicating a level
of MRI compatibility consistent with current and proposed
practices. | |