(59 days)
Not Found
No
The description focuses on the mechanical components of a stent and delivery system, with no mention of AI/ML terms or functionalities.
Yes
The device is indicated for the palliative treatment of colonic strictures caused by malignant neoplasms, which is a therapeutic purpose.
No
Explanation: The device is indicated for palliative treatment of colonic strictures, which is a treatment function, not a diagnostic one.
No
The device description clearly states it consists of an implantable metal stent and a delivery system, which are physical hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for the "palliative treatment of colonic strictures caused by malignant neoplasms." This describes a therapeutic intervention performed within the body, not a test performed on a sample taken from the body to diagnose or monitor a condition.
- Device Description: The device is an implantable metal stent and a delivery system. This is a medical device designed for placement within the colon.
- Lack of IVD Characteristics: The description does not mention any components or processes related to analyzing biological samples (blood, urine, tissue, etc.) or providing diagnostic information based on such analysis.
IVD devices are used to examine specimens derived from the human body to provide information for the diagnosis, monitoring, or treatment of a disease or condition. This device is a therapeutic device used to treat a physical obstruction.
N/A
Intended Use / Indications for Use
The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
MQR
Device Description
The proposed WallFlex™ Enteral Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is offered in two diameters: 25mm body with a 30mm flare, and 22mm body with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Colon / Colonic
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)
Comparative performance testing was performed to establish substantial equivalence between the proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System, and the predicate Ultraflex Precision Colonic Stent System, and the Wallstent Enteral Endoprothesis with Unistep Plus Delivery System. This testing included but was not limited to a dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity and MRI.
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.
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
§ 878.3610 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
Endoscopy
SECTION 10 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
Boston Scientific Corporation One Boston Scientific Place Natick, MA 01760-1537
Contact: Kathleen Morahan, RAC Regulatory Affairs Manager Date Prepared: July 30, 2004
2. Device:
Trade Name: WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System Common Name: Expandable, metal colonic stent Classification Name: Stent, colonic, metallic, expandable Product Code: MQR Classification: Class II
3. Predicate Device:
Boston Scientific Corporation's Ultraflex™ Precision™ Colonic Stent System, K030769.
Boston Scientific Corporation's Wallstent Enteral Endoprosthesis and Unistep Plus Delivery System, K000281.
4. Device Description:
The proposed WallFlex™ Enteral Stent with Anchor Lock Delivery System consists of two components: an implantable metal stent and a delivery system. The proposed stent is two components: an insplantaoffered in two diameters: 25mm body with a 30mm flare, mandracetal or over with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube.
5. Intended Use:
The proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms.
Premarket Notification, WallFlex Enteral Colonic Stent with Anchor Lock Delivery System Proprietary and Confidential Information of Boston Scientific Corporation
1
6. Technological Characteristics:
Essentially, the proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System has the same technological characteristics as the predicate devices. The proposed stent combines the design features of the Ultraflex™ Precision™ Colonic stent and the Wallstent Enteral stent, yielding a self-expanding Nitinol stent. The proposed Anchor Lock delivery consists of a coaxial tubing assembly that constrains the stent on the delivery catheter shaft until the stent is released by retracting the exterior tube, like the predicate Wallstent Unistep Plus delivery system.
7. Performance Data:
Comparative performance testing was performed to establish substantial equivalence between the proposed WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System, and the predicate Ultraflex Precision Colonic Stent System, and the Wallstent Enteral Endoprothesis with Unistep Plus Delivery System. This testing included but was not limited to a dimensional evaluation, fatigue testing, radial force comparison, deployment and reconstrainment force, bond integrity and MRI.
8. Conclusion:
Boston Scientific Corporation has demonstrated that WallFlex Enteral Colonic Stent with Anchor Lock Delivery system is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic Stent and the Wallstent Enteral Endoprosthesis with Unistep Plus Delivery System.
2
Image /page/2/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a stylized caduceus symbol, which features a staff with a snake winding around it, and three horizontal bars above it. The text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" is arranged in a circular fashion around the caduceus symbol.
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
SEP 3 0 2004
Ms. Kathleen Morahan Regulatory Affairs Manager Boston Scientific Corporation Endoscopy Division One Boston Scientific Place NATICK MA 01760
Re: K042065
K 042065
Trade/Device Name: WallFlex™ Enteral Colonic Stent and Anchor Lock Delivery System 25mm and 22mm x 90mm, -120mm, and -60mm Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: 78 MQR Dated: July 30, 2004 Received: August 12, 2004
Dear Ms. Morahan:
We have reviewed your Section 510(k) premarket notification of intent to market the device we nave teviewed your bector 310(a) fee 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 connine.cc proc to may 20, 1978, as eccordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). alle Cosmette Act (110) market the device, subject to the general controls provisions of the Act. The I ou may, therefore, market the act include requirements for annual registration, listing of general controls provisions of ractice, 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 your device is classified (600 above) a Existing major regulations affecting your device can be It may be subject to additions, Title 21, Parts 800 to 898. In addition, FDA may round in the Ood of Pressiants concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean Picase oe advised that 1 277 5 155aates or our device complies with other requirements of the Act that I DA has made a determinations administered by other Federal agencies. You must of any Federal Statues and roganders including, but not limited to: registration and listing Comply with an the Ace 3 requirements) xxxxl 801); good manufacturing practice requirements as set (21 CFR Part 607), laborning (21 CFR Part 820); and if applicable, the electronic Iorni in the quality by tions (sections 531-542 of the Act); 21 CFR 1000-1050.
3
This letter will allow you to begin marketing your device as described in your Section 510(k) This letter will allow you to begin marketing your antial equivalence of your device to a legally
premarket notification. The FDA finding of substantial equivalence of your premarket notification. The FD7A inding of substantial equivation of 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
r the regulation If you desire specific advice for your device on one of the following numbers, based on the regulation number at the top of the letter:
| 8xx. 1xxx | (301) 594-4591 |
|---|---|
| 876.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4616 |
| 884.2xxx, 3xxx, 4xxx, 5xxx, 6xxx | (301) 594-4616 |
| 892.2xxx, 3xxx, 4xxx, 5xxx | (301) 594-4654 |
| Other | (301) 594-4692 |
Additionally, for questions on the promotion and advertising of your device, please contact the Additionally, for questions on the pronocol and and the regulation entitled, "Mashranding
Office of Compliance at (301) 594-4639. Other of Compliance at (501) 594-057. Tax (207.97) you may obtain. Other general by reference to premarket notification (21 cc 1 c = 0 +7 joed from the Division of Small
information on your responsibilities under the Act may be obtained from the (800) 63 information on your responsibilities under the research its toll-free number (800) 638-2041 or
Manufacturers, International and Consumer Assiss assessed instal Manufacturers, International and Collisation in and Collectives and Collectives and manufacturers.
Sincerely yours,
Nancy C. Brogdon
Nancy C. Brogdon Director, Division of Reproductive, Abdominal and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
4
SECTION 3 INDICATIONS FOR USE
Indications for Use:
510(k) Number (if known): Fo-Be Determined 5 0420 (se
Device Name: WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System
Indications For Use:
The WallFlex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated The Wall'Iex - Encrai-Colonic strictures caused by malignant neoplasms.
Prescription Use __ X (Part 21 CFR 801 Subpart D) AND/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)
et Notification, WallFlex Enteral Colonic Stent with Anchor Lock Delivery System
mproprietary and Confidential Information of Boston Scientific Corporation
04206
(Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Devices
510(k) Number
00000:3