(35 days)
Not Found
No
The summary describes a mechanical stent and delivery system with no mention of AI or ML capabilities.
Yes
The device is described as "maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula," which directly addresses the treatment of a medical condition.
No
The device is an esophageal stent system used for maintaining luminal patency and occluding fistulas, which are treatment functions, not diagnostic ones.
No
The device description clearly outlines physical components including a self-expanding metal stent, a silicone polymer covering, a suture, and a coaxial tube delivery system. This indicates it is a hardware-based medical device, not software-only.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is to maintain esophageal luminal patency in patients with esophageal strictures and fistulas. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is a self-expanding metal stent and a delivery system. This is a medical device designed for implantation or placement within the body.
- Lack of IVD Characteristics: IVD devices are used to examine specimens derived from the human body (like blood, urine, tissue) to provide information for diagnosis, monitoring, or screening. This device does not involve the analysis of such specimens.
Therefore, the WallFlex Esophageal Fully Covered Stent System is a therapeutic medical device, not an in vitro diagnostic device.
N/A
Intended Use / Indications for Use
The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
Product codes
ESW
Device Description
The proposed WallFlex Esophageal Fully Covered Stent System consists of a selfexpanding metal stent and a delivery system. The proposed stent is manufactured from a metallic radiopaque material that is formed into a cylindrical mesh. It is fully covered with a silicone polymer. A suture is threaded through the proximal end of the stent and is intended to aid in removal during the initial stent placement procedure, to be used in the event of incorrect placement. The delivery system is a coaxial tube design. The exterior tube is used to constrain the stent before deployment and reconstrain the stent, if desired, after partial deployment. The exterior tube has a clear section so that the contrained stent is visible. The interior tube has a single central lumen to accommodate a 0.038" guidewire.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
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)
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
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.”
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SECTION 5 510(k) SUMMARY
510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752 Telephone: 508-683-4454 Fax: 508-683-5939
Contact: Marybeth Gamber Manager, Regulatory Affairs Date Prepared: May 21, 2009
2. Device:
Trade Name: WallFlex Esophageal Fully Covered Stent System Classification Name: Prosthesis, Esophageal Regulation Number: 21 CFR 878.3610 Product Code: ESW Classification: Class II
3. Predicate Device:
WallFlex Esophageal Partially Covered Stent System K073266 Manufactured by Boston Scientific, Inc.
ALIMAXX-E Esophageal Stent System Manufactured by Alveolus, Inc
4. Device Description:
The proposed WallFlex Esophageal Fully Covered Stent System consists of a selfexpanding metal stent and a delivery system. The proposed stent is manufactured from a metallic radiopaque material that is formed into a cylindrical mesh. It is fully covered with a silicone polymer. A suture is threaded through the proximal end of the stent and is intended to aid in removal during the initial stent placement procedure, to be used in the event of incorrect placement. The delivery system is a coaxial tube design. The exterior tube is used to constrain the stent before deployment and reconstrain the stent, if desired, after partial deployment. The exterior tube has a clear section so that the contrained stent is visible. The interior tube has a single central lumen to accommodate a 0.038" guidewire.
5. Intended Use:
The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by instrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
6. Technological Characteristics:
The proposed WallFlex Esophageal Fully Covered Stent System is similar in design. materials, and manufacturing processes to the predicate devices, the WallFlex Esophageal
JUN 26 2009
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K091570
pg 2 of 2
Partially Covered Stent System (K073266) and the ALIMAXX-E Esophageal Stent System (K051621, K080838).
7. Performance Data:
In-vitro testing has been performed and all components, subassemblies, and/or full devices met the required specifications for the completed tests.
8. Conclusion:
Boston Scientific Corporation has demonstrated that the proposed WallFlex Esophageal Fully Covered Stent System is substantially equivalent to the currently marketed WallFlex Esophageal Partially Covered Stent System (K073266) and the ALIMAXX-E Esophageal Stent System (K051621, K080838).
2
Image /page/2/Picture/0 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular seal with the text "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA" arranged around the perimeter. Inside the circle is a stylized symbol resembling three overlapping human figures or abstract shapes, oriented diagonally.
DEPARTMENT OF HEALTH & HUMAN SERVICES
Public Health Service
Food and Drug Administration 9200 Corporate Boulevard Rockville MD 20850
JUN 26 2009
Ms. Marybeth Gamber Manager II, Regulatory Affairs Boston Scientific Corporation 100 Boston Scientific Way Endoscopy Division, M11 MARLBOROUGH MA 01752
Re: K091510
Trade/Device Name: WallFlex Esophageal Fully Covered Stent System Regulation Number: 21 CFR §878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: ESW Dated: May 21, 2009 Received: May 27, 2009
Dear Ms. Gamber:
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 (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); medical device reporting of medical
3
device-related adverse events) (21 CFR 803); 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.
If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please go to http://www.fda.gov/AboutFDA/CentersOffices/CDRHOffices/ucm115809.html for the Center for Devices and Radiological Health's (CDRH's) Office of Compliance. Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to http://www.fda.gov/cdrh/mdr/ for the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.
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/industry/support/index.html.
Sincerely yours,
Janine M. Morris Acting Director, Division of Reproductive, Abdominal, and Radiological Devices Office of Device Evaluation Center for Devices and Radiological Health
Enclosure
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SECTION 4 INDICATIONS FOR USE STATEMENT
510(k) Number (if known):
Device Name:
Indications for Use:
This application
WallFlex Esophageal Fully Covered Stent System
The WallFlex Esophageal Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistula.
091510
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)
until (Division Sign-Off) Division of Reproductive, Abdominal, and Radiological Device
510(k) Number