(137 days)
Not Found
No
The summary describes a mechanical device (stent and delivery system) and does not mention any software, algorithms, or data processing that would indicate the use of AI/ML. The focus is on the physical characteristics and equivalence to predicate devices.
Yes
The device is intended for "maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only" and for "occlusion of concurrent esophageal fistula," which are therapeutic interventions.
No
The device is a stent system used to maintain esophageal luminal patency and occlude fistulas, which are therapeutic actions, not diagnostic ones.
No
The device description clearly states it is a "self-expanding metallic stent" and a "flexible delivery system," indicating it is a physical medical device, not software.
No, 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 provide information about a person's health.
- Device Description and Intended Use: The provided information clearly describes a self-expanding metallic stent intended for maintaining esophageal luminal patency and occlusion of concurrent esophageal fistula. This is a device that is implanted or placed within the body to provide structural support and/or block openings.
- Lack of IVD Characteristics: There is no mention of the device being used to test samples, analyze biological markers, or provide diagnostic information based on laboratory analysis.
Therefore, based on the provided information, this device is a therapeutic medical device used for treatment, not an in vitro diagnostic device used for diagnosis.
N/A
Intended Use / Indications for Use
The Ultraflex Esophageal NG Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. The Ultraflex Esophageal NG Covered Stent System is also indicated for occlusion of concurrent esophageal fistula.
The WallFlex Esophageal Partially Covered and Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
Product codes
ESW
Device Description
The Ultraflex Esophageal NG Stent System allows placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery system preloaded with an expandable with or without a cover. The WallFlex Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
Not Found
Input Imaging Modality
Not Found
Anatomical Site
esophagus
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
The substantial equivalence of the subject device was determined as per the FDA guidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]."
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
Image /page/0/Picture/0 description: The image shows 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 logo on the right. The FDA logo is a blue square with the letters "FDA" in white, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue.
April 29, 2024
Boston Scientific Yanine Garcia-Quezada Principal Regulatory Affairs Specialist 300 Boston Scientific Wav Marlborough, Massachusetts 01752
Re: K233939
Trade/Device Name: Ultraflex Esophageal NG Stent System; WallFlex Esophageal Stent System Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: January 29, 2024 Received: January 30, 2024
Dear Yanine Garcia-Quezada:
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 (the 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 available 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.
Additional information about changes that may require a new premarket notification are provided in the FDA guidance documents entitled "Deciding When to Submit a 510(k) for a Change to an Existing Device" (https://www.fda.gov/media/99812/download) and "Deciding When to Submit a 510(k) for a Software Change to an Existing Device" (https://www.fda.gov/media/99785/download).
1
Your device is also subject to, among other requirements, the Quality System (QS) regulation (21 CFR Part 820), which includes, but is not limited to, 21 CFR 820.30, Design controls; 21 CFR 820.90, Nonconforming product; and 21 CFR 820.100, Corrective and preventive action. Please note that regardless of whether a change requires premarket review. the OS regulation requires device manufacturers to review and approve changes to device design and production (21 CFR 820.30 and 21 CFR 820.70) and document changes and approvals in the device master record (21 CFR 820.181).
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 device-related adverse events) (21 CFR Part 803) for devices or postmarketing safety reporting (21 CFR Part 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 Part 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR Parts 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR 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).
2
Sincerely,
Shanil P. Haugen -S
Shanil P. Haugen, Ph.D. 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
3
Indications for Use
510(k) Number (if known) K233939
Device Name Ultraflex Esophageal NG Stent System WallFlex Esophageal Stent System
Indications for Use (Describe)
The Ultraflex Esophageal NG Stent is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. The Ultraflex Esophageal NG Covered Stent System is also indicated for occlusion of concurrent esophageal fistula.
The WallFlex Esophageal Partially Covered and Fully Covered Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.
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) |
CONTINUE ON A SEPARATE PAGE IF NEEDED.
This section applies only to requirements of the Paperwork Reduction Act of 1995.
DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.
The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to:
Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff(@fda.hhs.gov
"An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number."
4
510(k) Summary
21 CFR 807.92(a)(1)
Prepared on: 2023-12-14
Contact Details
21 CFR 807.92(a)(1)
| Applicant Name | Boston Scientific | |
|---|---|---|
| Applicant Address | 300 Boston Scientific Way Marlborough MA 01752 United States | |
| Applicant Contact Telephone | 508-382-0240 | |
| Applicant Contact | Yanine Garcia-Quezada | |
| Applicant Contact Email | yanine.garcia-quezada@bsci.com | |
| Device Name | 21 CFR 807.92(a)(2) | |
| Device Trade Name | Ultraflex™ Esophageal NG Stent System | |
| WallFlex™ Esophageal Stent System | ||
| Common Name | Esophageal prosthesis | |
| Classification Name | Prosthesis, Esophageal | |
| Regulation Number | 878.3610 | |
| Product Code | ESW | |
| Legally Marketed Predicate Devices 21 CFR 807.92(a)(3) | ||
| Predicate # | Predicate Trade Name (Primary Predicate is listed first) | Product Code |
| K130004 | Ultraflex Esophageal NG Stent System | ESW |
| K091510 | WallFlex Esophageal Stent System | ESW |
| Device Description Summary 21 CFR 807.92(a)(4) |
The Ultraflex Esophageal NG Stent System allows placement of a self-expanding metallic stent within the esophagus. The systems consist of a flexible delivery system preloaded with an expandable with or without a cover. The WallFlex Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system.
Intended Use/Indications for Use
21 CFR 807.92(a)(5)
The Ultraflex Esophageal NG Stent System is intended for maintaining esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only. The Ultraflex Esophageal NG Covered Stent System is also indicated for occlusion of concurrent esophageal fistula.
The WallFlex Esophageal Partially 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 fistulas.
Indications for Use Comparison
21 CFR 807.92(a)(5)
The indications for use of the proposed Ultraflex™ Esophageal NG Stent System and WallFlex™ Esophageal Stent System devices are identical to their respective predicate devices.
5
Technological Comparison
21 CFR 807.92(a)(6)
The proposed Ultraflex Esophageal Stent System and WallFlex Esophageal Stent System devices are identical to the predicate device in design, material, chemical composition, fundamental technology, principle of operation, sterilization, packaging, shelf-life and manufacturing process.
Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)
Boston Scientific Corporation has demonstrated that the proposed Ultraflex Esophageal Stent System and WallFlex Esophageal Stent System are substantially equivalent to the previously cleared and currently marketed predicate Ultraflex Esophageal Stent System (K130004) and WallFlex Esophageal Stent System (K091510), respectively.
The proposed Ultraflex Esophageal Stent System and WallFlex Esophageal Stent System are identical to the predicate Ultraflex Esophageal Stent System (K13004) and WallFlex Esophageal Stent System (K091510) in intended use, indications for use, classification, principles of operation, technical characteristics, performance, and materials. The labeling changes do not raise different questions of safety and effectiveness. The testing performed on the proposed Ultraflex Esophageal Stent System and WallFlex Esophageal Stent System demonstrates the devices are substantially equivalent.
The substantial equivalence of the subject device was determined as per the FDA quidance document, "The 510(k) Program: Evaluating Substantial Equivalence in Premarket Notifications [510(k)]."