(109 days)
Not Found
No
The summary describes a mechanical stent system and its delivery mechanism, with no mention of software, algorithms, or data processing that would indicate the use of AI or ML.
Yes
The device is indicated for "palliative treatment" of obstructions and strictures and to "relieve large bowel obstructions," all of which are therapeutic actions.
No
Explanation: The device is a stent system used for the palliative treatment of strictures and obstructions caused by malignant neoplasms. Its purpose is to treat the condition, not to diagnose it.
No
The device description explicitly states that the system consists of two components: an implantable metal stent and an anchor lock delivery system, both of which are hardware components.
Based on the provided information, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use clearly describes a device used for the palliative treatment of colonic and gastroduodenal strictures and obstructions caused by malignant neoplasms. This is a therapeutic intervention performed directly on the patient's body.
- Device Description: The device is an implantable metal stent and a delivery system. This is a physical device designed to be placed within the body to open up a blockage.
- 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, etc.) to provide information for diagnosis, monitoring, or treatment.
IVD devices are used in vitro (outside the body) to analyze samples and provide diagnostic information. This device is used in vivo (inside the body) for therapeutic purposes.
N/A
Intended Use / Indications for Use
The WallFlex Colonic 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 colectomy in patients with malignant strictures.
The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
Product codes
MQR, MUM
Device Description
The WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the anchor lock delivery system.
The proposed stent is manufactured of Nitinol. The stent will be offered in two diameters, 22mm with a 27mm flare and 25mm with a 30mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The WallFlex Duodenal Stent will only be offered in the 22mm/27mm stent diameter (all lengths) preloaded on the 230cm Anchor Lock Delivery System. The WallFlex Colonic Stent will be offered in the 22mm/27mm and 25mm/30mm diameters (all lengths) preloaded on the 230cm or 135cm Anchor Lock Delivery System. The 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, gastroduodenal, 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 (study type, sample size, AUC, MRMC, standalone performance, key results)
Bench Testing:
The proposed WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System successfully passed all pre-defined product specifications for the tests performed. Below is a summary of the tests performed to show the proposed device satisfied all design verification requirements. In addition, potentiodynamic testing and foreshortening was performed to address recent FDA guidance and to further support substantial equivalence. The results of this testing are passing.
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.”
0
Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA text logo on the right. The FDA text logo is in blue and includes the letters "FDA" followed by "U.S. FOOD & DRUG ADMINISTRATION".
September 28, 2020
Boston Scientific Corporation Catherine Sanford Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, MA 01752
Re: K201159
Trade/Device Name: WallFlex Colonic Stent System with Anchor Lock Delivery System WallFlex Duodenal Stent System with Anchor Lock Delivery System Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal prosthesis Regulatory Class: II Product Code: MQR, MUM
Dear Catherine Sanford:
The Food and Drug Administration (FDA) is sending this letter to notify you of an administrative change related to your previous substantial equivalence (SE) determination letter dated July 17, 2020. Specifically, FDA is updating this SE Letter, Indications for Use, and 510(k) trade names, which did match, as an administrative correction.
Please note that the 510(k) submission was not re-reviewed. For questions regarding this letter please contact Glenn Bell, (301) 796-6531, Glenn.Bell(@fda.hhs.gov.
Sincerely,
Joyce Whang
for Glenn B. Bell, Ph.D. 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
1
Image /page/1/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.
August 17, 2020
Boston Scientific Corporation Catherine Sanford Senior Regulatory Affairs Specialist 100 Boston Scientific Way Marlborough, Massachusetts 01752
Re: K201159
Trade/Device Name: WallFlex Colonic 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: July 16, 2020 Received: July 17, 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 requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part
2
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 (QS) 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 medical devices and radiation-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).
Sincerelv.
Daniel G. Walter Jr -S
Daniel G. Walter, Jr. 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 Ouality Center for Devices and Radiological Health
Enclosure
3
Indications for Use
510(k) Number (if known) K201159
Device Name
WallFlex Colonic Stent System with Anchor Lock Delivery System WallFlex Duodenal Stent System with Anchor Lock Delivery System
Indications for Use (Describe)
The WallFlex Colonic 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 colectomy in patients with malignant strictures.
The WallFlex Duodenal 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) |
|---|
| ☑ Prescription Use (Part 21 CFR 801 Subpart D) |
| ☐ Over-The-Counter Use (21 CFR 801 Subpart C) |
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510(k) SUMMARY
1. Submitter:
Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752
Contact: Catherine Sanford Senior Regulatory Affairs Specialist Telephone: 508-683-4498 E-mail: Catherine.sanford@bsci.com
Date Prepared: April 29th, 2020
2. Proposed Device:
Trade Name: Wallflex Colonic Stent System with Anchor Lock Delivery System Classification Name: Expandable, metallic colonic stent Regulation Number: 21 CFR 878.3610 Product Code: MQR Classification and Panel: Class II, Gastroenterology/Urology
Trade Name: Wallflex Duodenal Stent System with Anchor Lock Delivery System Classification Name: Expandable, metallic duodenal stent Regulation Number: 21 CFR 878.3610 Product Code: MUM Classification and Panel: Class II, Gastroenterology/Urology
3. Predicate Device:
Trade Name: Wallflex Enteral Colonic Stent with Anchor Lock Delivery System Submitter / 510(k) Holder: Boston Scientific Clearance Number: K061877 Classification Name: Expandable, metallic colonic stent Regulation Number: 21 CFR 878.3610 Product Code: MQR Classification and Panel: Class II, Gastroenterology/Urology
Trade Name: Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System Submitter / 510(k) Holder: Boston Scientific Clearance Number: K062750
5
Classification Name: Expandable, metallic duodenal stent
Regulation Number: 21 CFR 878.3610 Product Code: MUM Classification and Panel: Class II, Gastroenterology/Urology
4. Device Description:
The WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System each consist of two components: the implantable metal stent and the anchor lock delivery system.
The proposed stent is manufactured of Nitinol. The stent will be offered in two diameters, 22mm with a 27mm flare and 25mm with a 30mm flare. Each diameter will be available in three lengths, 6cm, 9cm, and 12cm. The WallFlex Duodenal Stent will only be offered in the 22mm/27mm stent diameter (all lengths) preloaded on the 230cm Anchor Lock Delivery System. The WallFlex Colonic Stent will be offered in the 22mm/27mm and 25mm/30mm diameters (all lengths) preloaded on the 230cm or 135cm Anchor Lock Delivery System. The 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.
5. Indications for Use:
The WallFlex Colonic 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 colectomy in patients with malignant strictures.
The WallFlex Duodenal Stent System with Anchor Lock Delivery System is indicated for the palliative treatment of gastroduodenal obstructions produced by malignant neoplasms.
The proposed Indications for Use are identical to the predicate devices Indications for Use.
Technological Characteristics 6.
The only change introduced in this submission is to the surface finish of the nitinol wire. There is no impact to the technological characteristics as a result of this change as demonstrated by the biocompatibility testing (Section 15) and performance testing (Section 18).
7. Performance Data
Bench Testing:
The proposed WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System successfully passed all pre-defined product specifications for the tests performed. Below is a summary of the tests performed to show the proposed device satisfied all design verification requirements. In addition,
6
| Section | Test | Results (Pass/ Fail) |
|---|---|---|
| 18.1 | Deployment Force | Pass |
| 18.2 | Reconstrainment Force | Pass |
| 18.3 | Unconstrained Stent Length | Pass |
| 18.4 | Unconstrained Stent Diameter | Pass |
| 18.5 | Flare Diameter | Pass |
| 18.6 | Stent Hoop Force (Compression and Expansion) | Pass |
| 18.7 | Stent Fatigue Resistance | Pass |
| 18.8 | Stent Flexibility | Pass |
| 18.9 | Stent Corrosion Resistance | Pass |
potentiodynamic testing and foreshortening was performed to address recent FDA guidance and to further support substantial equivalence. The results of this testing are passing.
8. Conclusion
The information provided by Boston Scientific Corporation in this submission demonstrates that the proposed WallFlex Colonic Stent System with Anchor Lock Delivery System and WallFlex Duodenal Stent System with Anchor Lock Delivery System are substantially equivalent to the currently cleared Wallflex Enteral Colonic Stent with Anchor Lock Delivery System and Wallflex Enteral Duodenal Stent with Anchor Lock Delivery System (K061877, K062750).