Agile Esophageal Stent System

K180144 · Boston Scientific Corporation · ESW · Sep 21, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K180144
• Device Name: Agile Esophageal Stent System
• Applicant: Boston Scientific Corporation
• Product Code: ESW · General, Plastic Surgery
• Decision Date: Sep 21, 2018
• 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

Agile Esophageal Stent System is a self-expanding, braided nitinol stent used to maintain esophageal luminal patency in malignant strictures and fistulas; device is MR conditional. Stent is preloaded in a coaxial delivery system compatible with therapeutic gastroscope working channels (min 3.7mm). Physician performs endoscopic placement under direct visualization; delivery system includes radiopaque markers for fluoroscopic guidance and visual markers on the handle for endoscopic positioning. Suture at stent flares allows for repositioning during initial deployment. Stent is fully or partially covered with silicone. Device provides mechanical support to the esophageal wall to prevent occlusion; benefits include restored luminal patency and improved patient quality of life.

Clinical Evidence

No clinical data. Substantial equivalence is supported by extensive bench testing, including biocompatibility (cytotoxicity, sensitization, systemic toxicity, genotoxicity, implantation), and mechanical performance testing (deployment/reconstrainment, tensile strength, corrosion, fatigue, and comparative hoop expansion/compression force).

Technological Characteristics

Self-expanding braided nitinol stent; silicone covering (fully or partially covered). Coaxial delivery system with radiopaque and visual markers. MR conditional. Dimensions: 14mm-23mm diameter, 59mm-150mm length. Sterile, single-use. No software or electronic components.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and concurrent esophageal fistulas requiring maintenance of esophageal luminal patency.

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

• Wallflex Esophageal Fully & Partially Covered Stent System (K091510/ K073266)
• Taewoong Niti-S Esophageal TTS Stent (K123205)
• Merit Alimaxx-ES Esophageal Stent (K080838)

Reference Devices

• Ultraflex Esophageal NG Stent System (K091816)

Submission Summary (Full Text)

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September 21, 2018

Boston Scientific Corporation Kayla Mackey Regulatory Affairs Specialist II 100 Boston Scientific Way Marlborough, Massachusetts 01752

Re: K180144

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: August 22, 2018 Received: August 23, 2018

Dear Kayla Mackey:

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

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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/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.htm); 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 http://www.fda.gov/MedicalDevices/Safety/ReportaProblem/default.htm.

For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice

(https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/) and CDRH Learn (http://www.fda.gov/Training/CDRHLearn). 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 (http://www.fda.gov/DICE) for more information or contact DICE by email ([e-mail]) or phone [phone] or 301-796-7100).

Sincerely,

Image /page/1/Picture/7 description: The image shows the FDA logo on the left side. On the right side of the image, there is text that says "Jeffrey W" followed by "2018.09" and then "-04'00'". The FDA logo is a stylized version of the letters FDA.

Jeffrey W. Cooper -S 2018.09.21 15:47:15

for Benjamin R. Fisher, Ph.D. Director Division of Reproductive, Gastro-Renal, and Urological Devices Office of Device Evaluation Center for Devices and Radiological Health

Enclosure

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| Form Approved: OMB No. 0910-0120 | |
|----------------------------------|--|
| Expiration Date: 06/30/2020 | |
| See PRA Statement below. | |

| 510(k) Number (if known) | Unknown K180144 |
|--------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Device Name | Agile Esophageal Stent System |
| Indications for Use (Describe) | 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. |

| Type of Use (Select one or both, as applicable) | |
|-----------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------|
| <span style="text-decoration: underline;">Prescription Use (Part 21 CFR 801 Subpart D)</span> | <span style="text-decoration: underline;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> |

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FORM FDA 3881 (7/17)

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## SECTION 5: 510(K) SUMMARY

# 1. Submitter:

Boston Scientific Corporation 100 Boston Scientific Way Marlborough, MA 01752

Kayla Mackey Regulatory Affairs Specialist II Telephone: [phone] Fax: [phone]

Date Prepared: January 16, 2018

# 2. Device:

| Trade Name: | Agile™ Esophageal Stent System |
|----------------------|--------------------------------|
| Classification Name: | Esophageal Prosthesis |
| Regulation Number: | 21 CFR 878.3610 |
| Product Code: | ESW |
| Classification: | Class II |

## 3. Predicate Device(s):

| Trade Name: | Wallflex Esophageal Fully &<br>Partially Covered Stent System |
|----------------------|---------------------------------------------------------------|
| 510(k) Number: | K091510/ K073266 |
| Classification Name: | Esophageal Prosthesis |
| Regulation Number: | 21 CFR 878.3610 |
| Product Code: | ESW |
| Classification: | Class II |
| Trade Name: | Taewoong Niti-S Esophageal TTS<br>Stent |
| 510(k) Number: | K123205 |
| Classification Name: | Esophageal Prosthesis |
| Regulation Number: | 21 CFR 878.3610 |
| Product Code: | ESW |
| Classification: | Class II |
| Trade Name: | Merit Alimaxx-ES Esophageal<br>Stent |
| 510(k) Number: | K080838 |

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Classification Name: Regulation Number: Product Code: Classification:

Esophageal Prosthesis 21 CFR 878.3610 ESW Class II

#### Reference Device:

Trade Name: 510(k) Number: Classification Name: Regulation Number: Product Code: Classification:

Ultraflex Esophageal NG Stent System K091816 Esophageal Prosthesis 21 CFR 878.3610 ESW Class II

## 4. Device Description:

The Agile™ Esophageal Stent System is intended for the endoscopic placement of the selfexpanding nitinol stent for maintaining luminal patency in esophageal strictures. The flexible Agile Stent and through-the scope Delivery System allow for stent placement through direct visualization. The Agile™ Esophageal Stent System is supplied sterile.

The Agile™ Stent is a flexible. MR conditional, self-expanding, braided nitinol stent. The proximal and distal ends of the stent have a flare which is larger in diameter than the stent body. The stent wires at each end of the flare are looped. A suture is threaded within the looped ends of both the proximal and distal stent flares to aid in repositioning during initial placement. The proposed Agile Stent is both fully and partially covered in a silicone covering.

The Agile™ Stent comes preloaded and constrained in the delivery system. The delivery system consists of two coaxial shafts compatible with a minimum 3.7mm working channel of a therapeutic gastroscope. The exterior tube is used to constrain the stent before deployment and to reconstrain the stent after partial deployment. The delivery system has radiopaque and visual markers to aid the user in accurate stent placement. There are three visual markers on the delivery system handle to aid in the placement of the stent under endoscopic visualization and four radiopaque markers on the interior of the delivery system to aid in placement of the stent under fluoroscopic visualization.

| Table 5-1: Agile Partially Covered Stent Sizes | | | |
|------------------------------------------------|----------------|--------------|----------------|
| UPN | Stent Size | | |
| | Stent Diameter | Stent Length | Flare Diameter |
| M00517200 | 14mm | 62 mm | 19mm |
| M00517210 | 14mm | 102 mm | 19mm |
| M00517220 | 14mm | 119 mm | 19mm |
| M00517230 | 14mm | 148 mm | 19mm |
| M00517240 | 18mm | 59 mm | 23mm |
| M00517250 | 18mm | 97 mm | 23mm |
| M00517260 | 18mm | 119 mm | 23mm |
| M00517270 | 18mm | 149 mm | 23mm |

#### Proposed Model Configurations:

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| Table 5-1: Agile Partially Covered Stent Sizes | | | |
|------------------------------------------------|----------------|--------------|----------------|
| UPN | Stent Size | | |
| | Stent Diameter | Stent Length | Flare Diameter |
| M00517280 | 23mm | 62 mm | 28mm |
| M00517290 | 23mm | 101 mm | 28mm |
| M00517300 | 23mm | 120 mm | 28mm |
| M00517310 | 23mm | 150 mm | 28mm |

| Table 5-2: Agile Fully Covered Stent Sizes | | | |
|--------------------------------------------|----------------|--------------|----------------|
| UPN | Stent Size | | |
| | Stent Diameter | Stent Length | Flare Diameter |
| M00517400 | 14mm | 62 mm | 19mm |
| M00517410 | 14mm | 102 mm | 19mm |
| M00517420 | 14mm | 119 mm | 19mm |
| M00517430 | 14mm | 148 mm | 19mm |
| M00517440 | 18mm | 59 mm | 23mm |
| M00517450 | 18mm | 97 mm | 23mm |
| M00517460 | 18mm | 119 mm | 23mm |
| M00517470 | 18mm | 149 mm | 23mm |
| M00517480 | 23mm | 62 mm | 28mm |
| M00517490 | 23mm | 101 mm | 28mm |
| M00517500 | 23mm | 120mm | 28mm |
| M00517510 | 23mm | 150mm | 28mm |

### 5. Indications for 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.

### 6. Technological Characteristics

The intended use of the proposed Agile™ Esophageal Stent System is identical to the predicate Wallflex Esophageal Fully and Partially Covered Stent System. Taewoong Niti-S TTS Esophageal Stent, and Merit Alimaxx-ES Esophageal Stent.

The proposed Agile™ Esophageal Stent Delivery system is similiar to the predicate Taewoong Niti-S TTS Esophageal delivery system in overall length and working length, outer diameter, method of placement, and guidewire compatibility.

The proposed Agile™ Esophageal Stent is similar to the predicate Wallflex Esophageal Fully and Partially Covered Stents, Taewoong Niti-S TTS Esophageal Stents, and Merit Alimaxx-ES Esophageal Stents in terms of performance, stent diameter, and stent length. The

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stent materials are similar between the proposed Agile Esophageal Stent System and the predicate Wallflex Esophageal Fully and Partially Covered Stents.

# 7. Biocompatibility Analysis

The following biocompatibility tests have been completed for the proposed Agile Esophageal Fully Covered Stent System.

| Table 5-3 Summary of Agile Esophageal Fully Covered Stent Biocompatibility Testing | | | |
|------------------------------------------------------------------------------------|---------|--|--|
| Test | Results | | |
| MEM Elution Cytotoxicity/Part 5 | Pass | | |
| Sub-acute (Subchronic)/Part 11/ Intravenous Toxicity | Pass | | |
| Guinea Pig Maximization Sensitization/Part 10 | Pass | | |
| Intracutaneous Reactivity/Part 10 | Pass | | |
| Sub-acute (Subchronic)/Part 11/ Intraperitoneal Toxicity | Pass | | |
| Materials Mediated Rabbit Pyrogen/Part 11 | Pass | | |
| Ames Mutagenicity/ Part 3 | Pass | | |
| Acute Systemic Injection/Part 11 | Pass | | |
| Mouse Lymphoma / Part 3 | Pass | | |
| Analytical Testing/ Part 18 (NVR; GCMS; LC-MS; ICPMS;<br>HS-GC-MS) | Pass | | |
| Implantation (Intramuscular)/ Part 6<br>(4weeks) | Pass | | |
| Implantation (Intramuscular)/ Part 6<br>(13 weeks) | Pass | | |

| Test | Results |
|-----------------------------------------------|---------|
| MEM Elution Cytotoxicity/Part 5 | Pass |
| Intracutaneous Reactivity/Part 10 | Pass |
| Guinea Pig Maximization Sensitization/Part 10 | Pass |
| Analytical testing | Pass |

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Ultraflex Esophageal NG Stent System (K091816) was used as a reference device to support the biocompatibility of the Agile Esophageal Partially Covered Stent. The following biocompatibility tests have been leveraged from Ultraflex Esophgeal NG Stent System (K091816).

| Table 5-5 Summary of Ultraflex Esophageal NG Stent System Biocompatibility Testing | | |
|------------------------------------------------------------------------------------|---------|--|
| Test | Results | |
| Cytotoxicity | Pass | |
| Sensitization | Pass | |
| Intracutaneous Reactivity | Pass | |
| Systemic Toxicity- Acute Systemic Toxicity | Pass | |
| Subacute Toxicity- Intravenous | Pass | |
| Subacute Toxicity- Intraperitoneal | Pass | |
| Genotoxicity- Ames Assay | Pass | |
| Mouse Lymphoma | Pass | |
| Mouse Lymphoma / Part 3 | Pass | |
| Implantation (12 weeks) | Pass | |
| USP Physiochemical | Pass | |

### 8. Performance Data

The proposed Agile™ Esophageal Stent System successfully passed all pre-defined product specifications for the tests performed. Below is a summary of the tests performed on the Agile Esophageal Stent System:

| Table 5-6 Summary of Bench Tests and Results | | |
|----------------------------------------------|--------------------------------------------|------------------------|
| No. | Test | Results<br>(Pass/Fail) |
| 1 | Guidewire Passage | Pass |
| 2 | Trackability/Pushability | Pass |
| 3 | Deployment and Reconstrainment | Pass |
| 4 | Delivery System Removal | Pass |
| 5 | Immediate Stent Opening | Pass |
| 6 | Delivery System Withdrawal | Pass |
| 7 | Stent Hoop Expansion and Compression Force | Pass |
| 8 | Delivery System Working Length | Pass |
| 9 | Delivery System Outer Diameter | Pass |
| 10 | Visual Transition Zone Length | Pass |
| 11 | Stent Foreshortening | Pass |
| 12 | Final Unconstrained Stent Length | Pass |
| 13 | Stent Flare Length | Pass |

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| 14 | Non-Covered Length (Partially Covered Codes Only) | Pass |
|----|------------------------------------------------------|------|
| 15 | Stent Covering Length (Partially Covered Codes Only) | Pass |
| 16 | Stent Diameter | Pass |
| 17 | Flare Diameter | Pass |
| 18 | Tip to Inner Member Bond Tensile | Pass |
| 19 | Inner Jacket to Handle Assembly Tensile | Pass |
| 20 | Reconstrainment Band to Inner Jacket Tensile | Pass |
| 21 | Exterior Tube to Handle Bond Tensile | Pass |
| 22 | Inner Jacket to Inner Member Bond Tensile | Pass |
| 23 | Exterior Tube Transition Zone Tensile | Pass |
| 24 | Suture Pull Strength Test | Pass |
| 25 | Corrosion Testing | Pass |
| 26 | Fatigue Testing | Pass |
| 27 | Deployment Accuracy | Pass |
| 28 | Magnetic Resonance Testing | Pass |

| Table 5-7 Summary of the Comparative Bench Tests | |
|--------------------------------------------------|------------------------------------------|
| No. | Test |
| 29 | Stent Hoop Expansion & Compression Force |

## 9. Comparative Bench Testing

Comparative bench testing was conducted on the Agile Esophageal Stent System and its substantially equivalent predicate device. The comparative testing demonstrated that the Stent Hoop Expansion and Compression Force of the Agile Esophageal Stents falls within the range of the currently marketed predicates for the propose stent diameters.

### Conclusion:

The information Boston Scientific provided in this submission demonstrates that the proposed Agile Esophageal Stent System is substantially equivalent to the currently cleared predicate devices thru the design and performance characteristics and indication for use.