Esophageal Stent System

K172813 · Micro-Tech (Nanjing) Co., Ltd. · ESW · May 18, 2018 · General, Plastic Surgery

Device Facts

• Record ID: K172813
• Device Name: Esophageal Stent System
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: May 18, 2018
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Esophageal Stent System consists of self-expanding nitinol wire stent pre-loaded in introduction system; silicone membrane covers stent body and flanges to reduce tissue ingrowth and seal fistulas. Used in clinical setting by trained healthcare professionals. Stent features flange ends for migration resistance and lasso loop for repositioning during initial placement. Delivery system uses outer tube to constrain stent; handle allows desheathing for deployment and resheathing for repositioning. Fluoroscopic visibility provided by four bands at each end. Device is sterile, single-use, prescription-only. Provides mechanical support to maintain luminal patency and seal fistulas, potentially improving patient swallowing and quality of life.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing including biocompatibility (ISO 10993-1), visual inspection, dimension testing, deployment/expansion/compression force testing, corrosion testing, tensile strength, sterility, shelf life, and MR compatibility (ASTM F2503, F2052, F2119, F2182, F2213).

Technological Characteristics

Materials: Nitinol (stent), Silicone (membrane), PTFE and Pebax (introduction system). Self-expanding metal stent with flange design. Dimensions: 18-22mm diameter, 60-150mm length. Delivery system: 6.7mm OD, 650mm working length. Sterilization: Sterile. Connectivity: None. Software: None. MR conditional per ASTM F2503, F2052, F2119, F2182, F2213.

Indications for Use

Indicated for maintaining esophageal luminal patency in patients with esophageal strictures caused by intrinsic and/or extrinsic malignant tumors and for occlusion of concurrent esophageal fistula.

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 Covered Stent System (K091510)

Submission Summary (Full Text)

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June 21, 2018

Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality and Regulatory Affairs Director No.10 Gaoke Third Road Nanjing, Jiangsu 210032 China

Re: K172813 Trade/Device Name: Esophageal Stent System Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: April 13, 2018 Received: April 17, 2018

Dear Becky Li:

This letter corrects our substantially equivalent letter of May 18, 2018.

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. 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.

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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 803); good manufacturing practice requirements as set forth in the quality systems (QS) regulation (21 CFR Part 820); 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/6 description: The image shows the FDA logo on the left side. On the right side of the image, the text "Jeffrey W" is present, followed by the date "2018.06.2" and the time zone "-04'00'". The text is in a simple, sans-serif font and is aligned to the left.

Jeffrey W. Cooper -S 2018.06.21 16:26:16

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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# Indications for Use

Form Approved: OMB No. 0910-0120 Expiration Date: January 31, 2017 See PRA Statement below.

510(k) Number (if known)

K172813

Device Name Esophageal Stent System

Indications for Use (Describe)

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

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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Image /page/3/Picture/1 description: The image shows the logo for Micro-Tech. The logo consists of a blue 3D block letter "M" and "T" on the left, followed by the text "MICRO-TECH" in blue. There is a horizontal line under the text "MICRO-TECH". Below the line, there are two Chinese characters in blue.

510K Summary

# 510K Summary

This 510(k) Summary of 510(k) safety and effectiveness information is being submitted in accordance with requirements of SMDA 1990 and Title 21, CFR Section 807.92.

The assigned 510(k) Number: K172813

# 1. Date of Preparation: 05/22/2018

# 2. Sponsor Identification

Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone,

Nanjing, Jiangsu Province, PRC

# Establishment Registration Number: 3004837686

Contact Person: Becky Li

Position: Quality & RA Director

Tel: [phone]

Fax: [phone]

Email: [e-mail]

# 3. Identification of Proposed Device

Trade Name: Esophageal Stent System

Common Name: Prosthesis, Esophageal

# Regulatory Information

Classification Name: Esophageal Prosthesis

Classification: 2

Product Code: ESW

Regulation Number: 878.3610

Review Panel: Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image shows a logo for MICRO-TECH. The logo consists of a blue 3D block letter "M" and "T" on the left, followed by the text "MICRO-TECH" in blue on the right. Below the text, there are two Chinese characters in blue.

#### 4. Identification of Predicate Device

510(k) Number: K091510

Product Name: WallFlex Esophageal Fully Covered Stent System

### 5. Indications for Use

Esophageal Stent System is intended for maintaining esophageal luminal patency in esophageal strictures caused by intrinsic and/or extrinsic malignant tumors only, and occlusion of concurrent esophageal fistula.

### 6. Device Description

The Esophageal Stent System consists of a self-expanding metal stent and a stent introduction system. The stent is provided pre-loaded in the introduction system. The handle allows for desheathing to deploy the stent and resheathing recapturing the stent during stent deployment. The stent is woven from nitinol wire. The stent is formed with a flange at either end. The increased diameter of the stent ends helps provide resistance to migration. A silicone membrane applied to the stent covers the complete body of the stent along with part or fully of both flanges. The covering is intended to reduce the risk of tissue ingrowth and provides a seal for esophageal fistulas. To aid in visibility under fluoroscopy there are four bands at either end of the stent. The stent has a lasso loop which can be used to reposition the stent during the initial placement procedure if desired. The device is supplied sterile, intended for single use only and is available for prescription use only. Use of this device is restricted to a trained healthcare professional.

The detail dimension information of the proposed device is as follows:

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Image /page/5/Picture/1 description: The image contains the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the word "MICRO-TECH" written in a simple font to the right of the letters. Below the word "MICRO-TECH" are two Chinese characters.

510K Summary

| No | Model | Diameter<br>of Stent<br>(D) | Diameter<br>of Stent<br>(D1,D2) | Length<br>of<br>Stent<br>(L) | Length<br>of<br>Stent<br>(LO) | Maximum<br>OD<br>(D) of<br>Delivery<br>System | Working<br>Length<br>(L) | Covering |
|----|------------------|-----------------------------|---------------------------------|------------------------------|-------------------------------|-----------------------------------------------|--------------------------|----------------------|
| 1 | NST01-222-18.060 | 18 | 23 | 060 | 030 | 6.7 | 650 | Partially<br>Covered |
| 2 | NST01-222-18.080 | 18 | 23 | 080 | 050 | 6.7 | 650 | Partially<br>Covered |
| 3 | NST01-222-18.100 | 18 | 23 | 100 | 070 | 6.7 | 650 | Partially<br>Covered |
| 4 | NST01-222-18.120 | 18 | 23 | 120 | 090 | 6.7 | 650 | Partially<br>Covered |
| 5 | NST01-222-18.140 | 18 | 23 | 140 | 110 | 6.7 | 650 | Partially<br>Covered |
| 6 | NST01-222-18.150 | 18 | 23 | 150 | 120 | 6.7 | 650 | Partially<br>Covered |
| 7 | NST01-222-20.060 | 20 | 25 | 060 | 030 | 6.7 | 650 | Partially<br>Covered |
| 8 | NST01-222-20.080 | 20 | 25 | 080 | 050 | 6.7 | 650 | Partially<br>Covered |
| 9 | NST01-222-20.100 | 20 | 25 | 100 | 070 | 6.7 | 650 | Partially<br>Covered |
| 10 | NST01-222-20.120 | 20 | 25 | 120 | 090 | 6.7 | 650 | Partially<br>Covered |
| 11 | NST01-222-20.140 | 20 | 25 | 140 | 110 | 6.7 | 650 | Partially<br>Covered |
| 12 | NST01-222-20.150 | 20 | 25 | 150 | 120 | 6.7 | 650 | Partially<br>Covered |
| 13 | NST01-222-22.060 | 22 | 27 | 060 | 030 | 6.7 | 650 | Partially<br>Covered |
| 14 | NST01-222-22.080 | 22 | 27 | 080 | 050 | 6.7 | 650 | Partially<br>Covered |
| 15 | NST01-222-22.100 | 22 | 27 | 100 | 070 | 6.7 | 650 | Partially<br>Covered |
| 16 | NST01-222-22.120 | 22 | 27 | 120 | 090 | 6.7 | 650 | Partially<br>Covered |
| 17 | NST01-222-22.140 | 22 | 27 | 140 | 110 | 6.7 | 650 | Partially<br>Covered |
| 18 | NST01-222-22.150 | 22 | 27 | 150 | 120 | 6.7 | 650 | Partially<br>Covered |
| | | | | | | 510K Summary | | |
| 19 | NST01-224-18.060 | 18 | 23 | 060 | 030 | 6.7 | 650 | Fully Covered |
| 20 | NST01-224-18.080 | 18 | 23 | 080 | 050 | 6.7 | 650 | Fully Covered |
| 21 | NST01-224-18.100 | 18 | 23 | 100 | 070 | 6.7 | 650 | Fully Covered |
| 22 | NST01-224-18.120 | 18 | 23 | 120 | 090 | 6.7 | 650 | Fully Covered |
| 23 | NST01-224-18.140 | 18 | 23 | 140 | 110 | 6.7 | 650 | Fully Covered |
| 24 | NST01-224-18.150 | 18 | 23 | 150 | 120 | 6.7 | 650 | Fully Covered |
| 25 | NST01-224-20.060 | 20 | 25 | 060 | 030 | 6.7 | 650 | Fully Covered |
| 26 | NST01-224-20.080 | 20 | 25 | 080 | 050 | 6.7 | 650 | Fully Covered |
| 27 | NST01-224-20.100 | 20 | 25 | 100 | 070 | 6.7 | 650 | Fully Covered |
| 28 | NST01-224-20.120 | 20 | 25 | 120 | 090 | 6.7 | 650 | Fully Covered |
| 29 | NST01-224-20.140 | 20 | 25 | 140 | 110 | 6.7 | 650 | Fully Covered |
| 30 | NST01-224-20.150 | 20 | 25 | 150 | 120 | 6.7 | 650 | Fully Covered |
| 31 | NST01-224-22.060 | 22 | 27 | 060 | 030 | 6.7 | 650 | Fully Covered |
| 32 | NST01-224-22.080 | 22 | 27 | 080 | 050 | 6.7 | 650 | Fully Covered |
| 33 | NST01-224-22.100 | 22 | 27 | 100 | 070 | 6.7 | 650 | Fully Covered |
| 34 | NST01-224-22.120 | 22 | 27 | 120 | 090 | 6.7 | 650 | Fully Covered |
| 35 | NST01-224-22.140 | 22 | 27 | 140 | 110 | 6.7 | 650 | Fully Covered |
| 36 | NST01-224-22.150 | 22 | 27 | 150 | 120 | 6.7 | 650 | Fully covered |

# Table 1 Dimension information of proposed device (Unit: mm)

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4/8

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510K Summary

### 7. Comparison of Technological Characteristics with a Predicate Device

The Esophageal Stent System incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Boston Scientific Corporation Predicate Device, WallFlex Esophageal Fully Covered Stent System, under K091510.

The proposal device is substantially equivalent to the currently marketed devices, WallFlex Esophageal Fully Covered Stent System, K091510 cleared June 26, 2009.

The following table is the technological comparison between the proposed device and predicate device WallFlex Esophageal Fully Covered Stent System (K091510).

| ITEM | Proposed Device<br>Esophageal Stent System | Predicate Device (K091510)<br>WallFlex Esophageal Fully<br>Covered Stent System | Remark |
|-------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------|
| Diameter of Stent (mm) | 18,20,22 | 18,23 | One more different<br>diameter than<br>predicate device. More<br>diameter could provide<br>more choices. |
| Length of Stent (mm) | 60, 80, 100, 120, 140, 150 | 103, 123, 153<br>105, 125, 155 | More short lengths<br>than predicate device.<br>More length can<br>provide more choices<br>for users |
| Maximum OD (D) of<br>Delivery System (mm) | 6.7 | 6.17 | Different but similar |
| Working Length (mm) | 650 | 780 | Different working<br>length, but similar |
| Image: Logo | | | 510K Summary |
| Covering | Partially Covered, Fully<br>Covered | Fully Covered | The proposed device<br>includes partially<br>covered and fully<br>covered. The<br>predicate device only<br>has fully covered. |
| Main Stent material | Nitinol, Silicone | Nitinol, Silicone | Same |
| Main Introduction system<br>materials | PTFE, Pebax | PTFE, Pebax | Same |
| Indications for Use | Esophageal Stent System<br>is intended for maintaining<br>esophageal luminal patency<br>in esophageal strictures<br>caused by intrinsic and/or<br>extrinsic malignant tumors<br>only, and occlusion of<br>concurrent esophageal<br>fistula. | The WallFlex Esophageal<br>Fully Covered Stent System<br>is intended for maintaining<br>esophageal luminal patency<br>in esophageal strictures<br>caused by instrinsic and/or<br>extrinsic malignant tumors,<br>and occlusion of concurrent<br>esophageal fistula. | Same |
| Stent function | maintaining esophageal<br>luminal patency in<br>esophageal strictures | maintaining esophageal<br>luminal patency in<br>esophageal strictures | Same |
| Shelf life | 2 years | 1.5 years | Different, longer shelf<br>life than predicate<br>device |
| Principle of operation | The proposed device<br>consists of the stent and<br>delivery system. The outer<br>tube of the delivery system<br>serves to constrain the<br>stent before deployment<br>and reposition the stent, if<br>desired, after partial<br>deployment. Loosen the<br>safe lock, then withdraw the<br>front handle to deploy the<br>stent. Take the opposite<br>action to reposition the<br>stent | The proposed device<br>consists of the stent and<br>delivery system. The outer<br>tube of the delivery system<br>serves to constrain the stent<br>before deployment and<br>reposition the stent, if<br>desired, after partial<br>deployment. Loosen the<br>safe lock, then withdraw the<br>front handle to deploy the<br>stent. Take the opposite<br>action to reposition the stent | Same |
| Single Use | Yes | | |
| MRI information | Comply with ASTM F 2503,<br>ASTM F 2052, ASTM<br>F2119, ASTM F2182,<br>ASTM F2213 | Comply with ASTM F 2503,<br>ASTM F 2052, ASTM<br>F2119, ASTM F2182, ASTM<br>F2213 | MR conditional<br>scanning parameters<br>are different |

Table 2 Technological comparison between the proposed device and predicate device

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Image /page/8/Picture/1 description: The image contains the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue font on the left side of the image. To the right of the letters is the text "MICRO-TECH" in a similar blue font. Below the text "MICRO-TECH" are two Chinese characters.

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Image /page/9/Picture/2 description: The image contains the logo for Micro-Tech. The logo consists of a blue stylized "MT" symbol on the left, followed by the text "MICRO-TECH" in blue. Below the company name are two Chinese characters, also in blue. The logo appears to be for a technology-related company.

### 8. Performance Data

The biocompatibility evaluation for the Esophageal Stent System was conducted in accordance with ISO 10993-1: 2009 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing within a Risk Management Process" and FDA's biocompatibility guidance, Use of International Standard ISO-10993-1, "Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" (June 16, 2016), the following tests were conducted:

### Biocompatibility Testing on Stent:

- Cytotoxicity
- Sensitization
- Intracutaneous Reactivity
- Acute Systemic Toxicity
- Material-mediated Pyrogenicity
- Salmonella Reverse Mutation
- Implantation
- Toxicological Risk Assessment based on Chemical Characterization

# Biocompatibility Testing on Introduction System:

- Cytotoxicity
- Sensitization
- Irritation

The device specific guidance document was consulted in preparing this premarket submission, Guidance for the content of premarket notifications for esophageal and tracheal prostheses issued April 28th 1998, the following tests were conducted for the subject device:

- ゃ Visual Inspection

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Image /page/10/Picture/1 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, blue, three-dimensional font on the left. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font, also in blue. Below the text "MICRO-TECH" are two Chinese characters.

- や Dimension Testing
- ゃ Deployment Force Testing
- Expansion Force Testing ゃ
- ゃ Compression Force Testing
- や Corrosion Testing
- や Tensile Strength Testing
- や Sterility Testing
- ゃ Shelf Life Testing
- や MR Compatibility Testing

#### 9. Clinical Test Conclusion

No clinical study is included in this submission.

#### 10. Substantially Equivalent (SE) Conclusion

Based on the indications for use, technological characteristics, and safety and performance testing, the Esophageal Stent System has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the WallFlex Esophageal Fully Covered Stent System(K091510).