Agile Esophageal Stent System

K233837 · Boston Scientific Corporation · ESW · Apr 4, 2024 · General, Plastic Surgery

Device Facts

• Record ID: K233837
• Device Name: Agile Esophageal Stent System
• Applicant: Boston Scientific Corporation
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Apr 4, 2024
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Agile Esophageal 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.

Device Story

The Agile Esophageal Stent System is a self-expanding metal stent designed to maintain esophageal patency. It is available in partially or fully silicone-covered configurations with diameters of 14mm, 18mm, and 23mm. The device is pre-loaded onto a delivery system (10.5Fr or 18.5Fr) that accommodates a guidewire. It is used by clinicians in a clinical setting to treat malignant esophageal strictures and fistulas. The stent provides mechanical support to the esophageal wall, preventing collapse or occlusion, thereby facilitating patient nutrition and symptom relief.

Clinical Evidence

No clinical data provided. Substantial equivalence is based on the device being identical to the predicate devices in intended use, indications, technical characteristics, performance, and materials.

Technological Characteristics

Self-expanding metal stent; partially or fully silicone-covered; 14mm, 18mm, and 23mm diameters; 10.5Fr or 18.5Fr delivery systems; guidewire compatible (0.035" or 0.038").

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors and for the occlusion of concurrent esophageal fistulas.

Regulatory Classification

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.

Special Controls

The special control for this device is FDA's “Guidance for the Content of Premarket Notification Submissions for Esophageal and Tracheal Prostheses.”

Predicate Devices

• Agile Esophageal Stent System (K180144)
• Agile Esophageal OTW Stent System (K211960)

Submission Summary (Full Text)

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April 4, 2024

Boston Scientific Corporation Alexis Erazo Principal Regulatory Affairs Specialist 100 Boston Scientific Wav Marlborough, Massachusetts 01752

## Re: K233837

Trade/Device Name: Agile Esophageal Stent System Regulation Number: 21 CFR 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: Class II Product Code: ESW Dated: March 4, 2024 Received: March 5, 2024

## Dear Alexis Erazo:

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).

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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 ([e-mail]) or phone [phone] or 301-796-7100).

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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

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# Indications for Use

510(k) Number (if known) K233837

Device Name Agile Esophageal Stent System

Indications for Use (Describe)

The Agile Esophageal Stent System is intended for maintaining esophageal strictures caused by intrinsic and/or extrinsic malignant tumors, and occlusion of concurrent esophageal fistulas.

| Type of Use (Select one or both, as applicable) |
|-------------------------------------------------------------------------------------|
| <span style="font-size:100%;">☑</span> Prescription Use (Part 21 CFR 801 Subpart D) |
| <span style="font-size:100%;">☐</span> Over-The-Counter Use (21 CFR 801 Subpart C) |

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| | | | | K233837 - Page 1 of 2 | | |
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| 510(k) #: K233837 | | 510(k) Summary | | Prepared on: 2024-03-05 | | |
| Contact Details | | | | 21 CFR 807.92(a)(1) | | |
| Applicant Name | | Boston Scientific Corporation | | | | |
| Applicant Address | | 100 Boston Scientific Way Marlborough MA 01752 United States | | | | |
| Applicant Contact Telephone | | 508.382.0365 | | | | |
| Applicant Contact | | Ms. Alexis Erazo | | | | |
| Applicant Contact Email | | [e-mail] | | | | |
| Device Name | | | | 21 CFR 807.92(a)(2) | | |
| Device Trade Name | | Agile 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 | | |
| K180144 | | Agile Esophageal Stent System | | ESW | | |
| K211960 | | Agile Esophageal OTW Stent System | | ESW | | |
| Device Description Summary | | | 21 CFR 807.92(a)(4) | | | |
| The Agile Esophageal Stent System consists of a self-expanding esophageal metal stent and a delivery system. The Agile Esophageal<br>Stent is available partially or fully covered with silicone covering and in three diameter sizes: 14mm, 18mm and 23mm. The 14mm and<br>18mm diameter stents are pre-loaded on a 10.5Fr delivery system and the 23mm diameter stent is pre-loaded on an 18.5Fr delivery<br>system. The 10.5Fr delivery system has a single central lumen to accommodate a 0.035" (0.89 mm) guidewire. The 18.5Fr delivery system<br>has a single central lumen to accommodate a 0.038" (0.97mm) guidewire. | | | | | | |
| Intended Use/Indications for Use | | | | 21 CFR 807.92(a)(5) | | |
| The Agile Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic<br>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 Agile™ Esophageal Stent System device are identical to the predicate device. | | | | | | |
| Technological Comparison | | | | | 21 CFR 807.92(a)(6) | |

The proposed Agile™ Esophageal Stent System device is identical to the in design, material, chemical composition, fundamental technology, principle of operation, sterilization, packaging, shelf-life and manufacturing process.

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#### Non-Clinical and/or Clinical Tests Summary & Conclusions 21 CFR 807.92(b)

Boston Scientific Corporation has demonstrated that the proposed Agile™ Esophageal Stent System are substantially equivalent to the previously cleared and currently marketed predicate Agile™ Esophageal Stent System (K180144 and K211960).

The proposed Agile Esophageal Stent System are identical to the predicate Agile Esophageal Stent System (K180144 and K211960) 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 Agile™ Esophageal Stent System demonstrates the devices are substantially equivalent.

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)]."