(74 days)
No
The summary describes a mechanical stent and delivery system with no mention of AI or ML components or functionalities.
Yes
The device is used for palliative treatment and to relieve large bowel obstruction, which are therapeutic actions.
No
The device is a stent delivery system indicated for palliative treatment of colonic strictures and relieving large bowel obstruction, which are therapeutic rather than diagnostic purposes.
No
The device description clearly states it consists of an implantable metal stent and a delivery system, which are physical hardware components, not software.
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 and to relieve large bowel obstruction. This is a therapeutic intervention performed in vivo (within the body).
- Device Description: The device is an implantable metal stent and a delivery system. This is a medical device designed to be placed inside the body.
- Lack of IVD Characteristics: There is no mention of the device being used to examine specimens derived from the human body (like blood, urine, tissue samples, etc.) to provide information for diagnosis, monitoring, or compatibility testing.
IVD devices are used in vitro (outside the body) to analyze biological samples. This device is clearly designed for in vivo use.
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 and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
Product codes
MOR, MQR
Device Description
The proposed Wallflex Enteral Stent with Anchor Lock Delivery System consists of 2 components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and offered in two diameters, a 25mm body with a 30mm flare, and a 22mm body with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery system 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
colonic strictures, 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
As this is a request for an expanded indication and introduces no new materials or design changes the performance testing presented in K042065 was not repeated.
Key Metrics
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
Endoscopy
SECTION 5 510(K) SUMMARY
510(K) SUMMARY
1. Submitter:
SEP 1 5 2006
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01545 Telephone: 508-683-4347 Fax: 508-683-5939
Contact: Elena Bickoff Regulatory Affairs Specialist Date Prepared: June 30, 2006
2. Device:
Trade Name: Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System Common Name: Expandable, metallic colonic stent Classification Name: Stent, colonic, metallic, expandable Regulation Number: 878.3610 Product Code: MOR Classification: Class II
3. Predicate Device(s):
- A Boston Scientific Corporation's Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System. K042065
- A Boston Scientific Corporation's Ultraflex™ Precision™ Colonic Stent System, K060323
- A Boston Scientific Corporation's Wallstent® Enteral Prosthesis, K000281
All above predicates are class II devices per 21 CFR 878.3610
4. Device Description:
The proposed Wallflex Enteral Stent with Anchor Lock Delivery System consists of 2 components: an implantable metal stent and a delivery system. The proposed stent is manufactured of Nitinol and offered in two diameters, a 25mm body with a 30mm flare, and a 22mm body with a 27mm flare. Each diameter is offered in three lengths, 6cm, 9cm, and 12cm. The proposed Anchor Lock delivery system 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.
Premarket Notification, Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System
1
Endoscopy
5. Intended Use:
The Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstruction prior to colectomy in patients with malignant strictures.
6. Technological Characteristics:
The proposed Wallflex Enteral Colonic Stent with Anchor Lock Delivery System has the identical technological characteristics as the currently marketed Wallflex Enteral Colonic Stent with Anchor Lock Delivery System (K042065).
7. Performance Data:
As this is a request for an expanded indication and introduces no new materials or design changes the performance testing presented in K042065 was not repeated.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed Wallflex Enteral Colonic stent is substantially equivalent to Boston Scientific Corporation's currently marketed Ultraflex™ Precision™ Colonic stent and Wallstent® Enteral stent. The proposed delivery system is substantially equivalent to the Wallflex Anchor Lock delivery system.
2
Image /page/2/Picture/1 description: The image shows the logo for the Department of Health & Human Services (HHS). The logo consists of a circular seal with the words "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized image of an eagle or bird-like figure with three curved lines representing its wings or body.
Food and Drug Administration 9200 Corporate Blvd. Rockville MD 20850
SEP 15-2006
Ms. Elena Bickoff Regulatory Affairs Specialist Boston Scientific Corporation 100 Boston Scientific Way MARLBOROUGH MA 01752
Re: K061877
Trade/Device Name: Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System Model numbers M00565040, -5050, -5060, -5070, -5080, -5090, -5100, -5110, -5120, -5130, -5140 and -5150 Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MQR Dated: June 30, 2006 Received: July 3, 2006
Dear Ms. Bickoff:
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 application (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 (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 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Image /page/2/Picture/10 description: The image shows a circular logo with the text "FDA Centennial" and the years "1906-2006" at the top. The letters "FDA" are prominently displayed in the center of the logo. The text "Centennial" is written in a cursive font below the letters "FDA". The logo is surrounded by a circular border with additional text.
nd Promoting Public
3
Page 2 -
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 if 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 liating (21 CFR Part 807); labeling (21 CFR Part 801); good manufacturing practice requirements as set 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 begin 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, permitts 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 one of the following numbers, based on the regulation number at the top of this letter:
| 21 CFR 876.xxx | (Gastroenterology/Renal/Urology) | 240-276-0115 |
|---|---|---|
| 21 CFR 884.xxx | (Obstetrics/Gynecology) | 240-276-0115 |
| 21 CFR 894.xxx | (Radiology) | 240-276-0120 |
| Other | 240-276-0100 |
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/edrh/industry/support/index.html.
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 4 INDICATIONS FOR USE STATEMENT
Indications for Use:
510(k) Number (if known): To Be Determined K041877
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 for palliative treatment of colonic strictures caused by malignant neoplasms and than elieve large bowel obstruction prior to colectomy in patients with malignant strictures .
Prescription Use X AND/OR (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 807 Subpart C)
(PLEASE DO NOT WRITE BELOW THIS LINE-CONTINUE ON ANOTHER PAGE IF NEEDED)
Ra-C.Phll
Concurrence of CDRH, Office of Device Evaluation (ODE)
(Division Sign-Off)
Division of Reproductive. Abdominal,
and Radiological Devices
510(k) Number K061877
Premarket Notification, Wallflex™ Enteral Colonic Stent with Anchor Lock Delivery System
000009