(74 days)
Not Found
No
The device description focuses on the mechanical components of a stent and delivery system, with no mention of software, algorithms, or data processing that would indicate AI/ML.
Yes
The device is indicated for palliative treatment of strictures and obstructions, which directly addresses a health condition.
No
Explanation: The device is a stent system used for palliative treatment of strictures and obstructions, which is a therapeutic purpose, not a diagnostic one.
No
The device description clearly outlines physical components including an implantable metal stent and a delivery system consisting of coaxial tubes, marker bands, and a guidewire lumen. This indicates a hardware-based medical device, not a software-only one.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- IVD Definition: In Vitro Diagnostics are medical devices used to perform tests on samples taken from the human body, such as blood, urine, or tissue, to detect diseases, conditions, or infections.
- Device Description: The description clearly states that this device is an implantable metal stent and a delivery system. It is designed to be inserted into the body to treat strictures and obstructions in the colon and gastroduodenum.
- Intended Use: The intended use is for the palliative treatment of colonic and gastroduodenal strictures and obstructions caused by malignant neoplasms. This is a therapeutic intervention performed within the body, not a diagnostic test performed on samples outside the body.
The device is a therapeutic medical device, specifically a stent system, used for internal treatment.
N/A
Intended Use / Indications for Use
The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectory in patients with malignant strictures.
The WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
Product codes (comma separated list FDA assigned to the subject device)
MQR, MUM
Device Description
The WallFlex™ Colonic Soft Stent System with Anchor Lock Delivery System and WallFlex™ Duodenal Soft Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the Anchor Lock Delivery System.
The stent is manufactured from Nitinol wires braided together to form a cylinder with a flared end. The wires are looped at both stent ends and welded at the non-flared end. The WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent will be offered in three diameters: 22 mm with a 27 mm flare, 20 mm with a 25 mm flare, and 18 mm with a 23 mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The stent sizes that are shared between the WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent are identical in all aspects of their design; the only difference is in indication.
The stent is compressed on a flexible catheter for delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during deployment. There are 3 radiopaque marker bands on the delivery system to facilitate placement; the exterior tube marker band, the deployment limit marker band, and the post deployment marker band. The exterior tube marker band is located adjacent to the leading end of the stent and the deployment limit marker band is located adjacent to the trailing end of the stent. The deployment limit marker band identifies the stent deployment limit, the point beyond which the stent cannot be reconstrained. The post deployment marker band, situated 4cm from the trailing end of the constrained stent, helps to facilitate accurate placement of the stent. The only design difference between the colonic and duodenal product offerings is how the stent is loaded onto the delivery system. The colonic stent is loaded with the flare is distal to the operator, and the duodenal stent is loaded with the flare is proximal to the operator.
The Anchor Lock stent holder is located at the trailing end of the stent and secures the stent on the delivery system to aid in reconstrainment when repositioning the stent. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in. / 0.89 mm guidewire. The device may be inserted through the working channel of a 9 French endoscope (minimum channel diameter 3.2mm scope). The WallFlex Colonic/Duodenal Soft Stent with Anchor Lock Delivery System will be offered in 230cm.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
Colon, Gastroduodenal
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 (bench) was successfully completed to establish substantial equivalence between the proposed device and the predicate device. This testing included the following: Trackability/Pushability, Marker Band Visualization, Deployment Force, Reconstrainment Force, Stent Reconstrainment Percentage, Withdrawal of Partially Deployed Stent, Deployment Accuracy, Bond Integrity, Unconstrained Stent Length, Unconstrained Stent Diameter, Flare Diameter, Stent Hoop Force (Expansion and Compression), Stent Fatigue Resistance, Stent Flexibility, Stent Corrosion Resistance, Endoscope Compatibility Device Outer Diameter, Potentiodynamic, Foreshortening, Comparative Hoop Force (Expansion and Compression).
The results of non-clinical testing demonstrate that the proposed WallFlex Colonic/Duodenal Soft Stent System with Anchor Lock Delivery System is considered equivalent to the commercially available device and therefore safe and effective for its intended use.
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
Image /page/0/Picture/0 description: The image contains the logos of the Department of Health and Human Services and the Food and Drug Administration (FDA). The Department of Health and Human Services logo is on the left, and the FDA logo is on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. Food & Drug Administration" in blue text.
April 17, 2020
Boston Scientific Corporation Catherine Sanford Senior Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, Massachusetts 01752
Re: K200257
Trade/Device Name: WallFlex Colonic Soft Stent System with Anchor Lock Delivery System, WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: MQR, MUM Dated: February 27, 2020 Received: February 28, 2020
Dear Catherine Sanford:
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. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. 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. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
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
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Daniel Walter Assistant Director DHT3A: Division of Renal, Gastrointestinal, Obesity and Transplant Devices OHT3: Office of Gastrorenal, ObGyn, General Hospital and Urology Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration
Form Approved: OMB No. 0910-0120 Expiration Date: 06/30/2020 See PRA Statement below.
Indications for Use
510(k) Number (if known)
Device Name
WallFlex Colonic Soft Stent System with Anchor Lock Delivery System WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System
Indications for Use (Describe)
The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System is indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectory in patients with malignant strictures.
The WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
Type of Use (Select one or both, as applicable)
X Prescription Use (Part 21 CFR 801 Subpart D)
Over-The-Counter Use (21 CFR 801 Subpart C)
CONTINUE ON A SEPARATE PAGE IF NEEDED.
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FORM FDA 3881 (7/17)
Page 1 of 1
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Page 28 of 157
3
1. Submitter
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Catherine Sanford Sr. Regulatory Affairs Specialist Telephone: (508) 683-4498 E-mail: Catherine.sanford@bsci.com
Date Prepared: January 31st, 2020
2. Proposed Devices
| Trade Name: | WallFlex Colonic Soft Stent System with Anchor Lock Delivery
System, |
|----------------------------|----------------------------------------------------------------------------|
| Common Name: | Expandable, metallic colonic stent |
| Product Code: | MQR, |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 878.3610 |
| Trade Name: | WallFlex Duodenal Soft Stent System with Anchor Lock Delivery
System |
| Common Name: | Expandable, metallic duodenal stent |
| Product Code: | MUM |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 878.3610 |
| 3. Predicate Devices | |
| Trade Name: | WallFlex Enteral Colonic Stent System with Anchor Lock
Delivery System |
| Manufacturer: | Boston Scientific Corporation |
| Clearance Number: | K061877 |
| Common Name: | Expandable, metallic colonic stent |
| Product Code: | MQR |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 878.3610 |
| Trade Name: | WallFlex Enteral Duodenal Stent System with Anchor Lock
Delivery System |
| Manufacturer: | Boston Scientific Corporation |
| Clearance Number: | K062750 |
| Common Name: | Expandable, metallic duodenal stent |
Page 29 of 157
4
| Product Code: | MUM |
|---|---|
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 878.3610 |
| Trade Name: | Evolution Duodenal Stent System – Uncovered, Evolution Colonic |
| Stent System - Uncovered | |
| Manufacturer: | Cook Ireland Ltd. |
| Clearance Number: | K163468 |
| Common Name: | Expandable, metallic duodenal stent |
| Product Code: | MUM, MQR |
| Device Class and Panel: | Class II, Gastroenterology/Urology |
| Classification Regulation: | 21 CFR 878.3610 |
4. Device Description
The WallFlex™ Colonic Soft Stent System with Anchor Lock Delivery System and WallFlex™ Duodenal Soft Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the Anchor Lock Delivery System.
The stent is manufactured from Nitinol wires braided together to form a cylinder with a flared end. The wires are looped at both stent ends and welded at the non-flared end. The WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent will be offered in three diameters: 22 mm with a 27 mm flare, 20 mm with a 25 mm flare, and 18 mm with a 23 mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The stent sizes that are shared between the WallFlex Colonic Soft Stent and the WallFlex Duodenal Soft Stent are identical in all aspects of their design; the only difference is in indication.
The stent is compressed on a flexible catheter for delivery system consists in part of coaxial tubes. The exterior tube serves to constrain the stent until retracted during deployment. There are 3 radiopaque marker bands on the delivery system to facilitate placement; the exterior tube marker band, the deployment limit marker band, and the post deployment marker band. The exterior tube marker band is located adjacent to the leading end of the stent and the deployment limit marker band is located adjacent to the trailing end of the stent. The deployment limit marker band identifies the stent deployment limit, the point beyond which the stent cannot be reconstrained. The post deployment marker band, situated 4cm from the trailing end of the constrained stent, helps to facilitate accurate placement of the stent. The only design difference between the colonic and duodenal product offerings is how the stent is loaded onto the delivery system. The colonic stent is loaded with the flare is distal to the operator, and the duodenal stent is loaded with the flare is proximal to the operator.
The Anchor Lock stent holder is located at the trailing end of the stent and secures the stent on the delivery system to aid in reconstrainment when repositioning the stent. The interior tube of the coaxial system contains a central lumen that accommodates a 0.035 in. / 0.89 mm guidewire. The device may be inserted through the working channel of a 9 French endoscope (minimum
5
channel diameter 3.2mm scope). The WallFlex Colonic/Duodenal Soft Stent with Anchor Lock Delivery System will be offered in 230cm.
5. Indications for Use
The WallFlex Colonic Soft Stent System with Anchor Lock Delivery System are indicated for palliative treatment of colonic strictures caused by malignant neoplasms and to relieve large bowel obstructions prior to colectomy in patients with malignant strictures.
The WallFlex Duodenal Soft Stent System with Anchor Lock Delivery System are indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
6. Technological Characteristics
The proposed WallFlex™ Colonic Soft Stent System with Anchor Lock Delivery System and WallFlex™ Duodenal Soft Stent System with Anchor Lock Delivery System share the same intended use, indications for use, and fundamental scientific technology as the predicate WallFlex Enteral Colonic/Duodenal Stent with Anchor Lock Delivery System cleared via K061877 and K062750 respectively. The only design difference between the colonic and duodenal product offerings is how the stent is loaded onto the delivery system. The proposed device and the predicate device share nearly identical technological characteristics, with the exception of wire diameter, loop design of stent ends, and delivery system diameter.
7. Performance Data
Performance testing (bench) was successfully completed to establish substantial equivalence between the proposed device and the predicate device. This testing included the following:
- Trackability/Pushability
- Marker Band Visualization
- Deployment Force ●
- Reconstrainment Force ●
- Stent Reconstrainment Percentage ●
- o Withdrawal of Partially Deployed Stent
- Deployment Accuracy
- Bond Integrity ●
- Unconstrained Stent Length
- Unconstrained Stent Diameter
- Flare Diameter
- o Stent Hoop Force (Expansion and Compression)
- Stent Fatigue Resistance
- o Stent Flexibility
- o Stent Corrosion Resistance
- Endoscope Compatibility Device Outer Diameter ●
- Potentiodynamic ●
- Foreshortening
- Comparative Hoop Force (Expansion and Compression) o
6
The results of non-clinical testing demonstrate that the proposed WallFlex Colonic/Duodenal Soft Stent System with Anchor Lock Delivery System is considered equivalent to the commercially available device and therefore safe and effective for its intended use.
8. Conclusion
The information provided by Boston Scientific Corporation in this submission demonstrates that the proposed WallFlex Colonic/Duodenal Soft Stent System with Anchor Lock Delivery System is substantially equivalent to the currently cleared WallFlex Enteral Colonic/Duodenal Stent System with Anchor Lock Delivery System (K061877, K062750).