Segmented Esophageal Stent System

K182910 · Micro-Tech (Nanjing) Co., Ltd. · ESW · May 29, 2019 · General, Plastic Surgery

Device Facts

• Record ID: K182910
• Device Name: Segmented Esophageal Stent System
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: ESW · General, Plastic Surgery
• Decision Date: May 29, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 878.3610
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

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

Device Story

Segmented Esophageal Stent System maintains esophageal luminal patency in patients with malignant strictures and concurrent fistulas. Device consists of a self-expanding Nitinol wire frame with PTFE connecting loops, fully covered by a silicone membrane to prevent tissue ingrowth and occlude fistulas. Flanges at both ends provide migration resistance. Radiopaque bands (4 at ends, 2 at middle) facilitate fluoroscopic visualization. Stent is pre-loaded in a delivery system allowing desheathing and recapture during placement. Used by trained healthcare professionals in clinical settings. Stent conforms to esophageal curvature due to segmented structure, reducing lumen stimulation. Retrieval loop allows repositioning during initial procedure. Benefits include restored patency and fistula occlusion, improving patient quality of life.

Clinical Evidence

No clinical data. Substantial equivalence supported by bench testing, including biocompatibility (cytotoxicity, sensitization, irritation, toxicity, pyrogen, mutagenicity, muscle implant), and performance testing (visual inspection, dimension, deployment/expansion/compression force, corrosion, tensile strength, sterility, shelf life, and MR compatibility).

Technological Characteristics

Nitinol wire frame, PTFE connecting loops, silicone membrane covering. Segmented design for flexibility. Radiopaque markers. EO sterilized (SAL 10^-6). Biocompatibility per ISO 10993-1. MR compatibility per ASTM F2503, F2052, F2119, F2182, F2213. Single-use, prescription only.

Indications for Use

Indicated for patients with esophageal strictures caused by intrinsic or extrinsic malignant tumors and concurrent esophageal fistula. Prescription use only.

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

• CHOOSTENT™ Covered Esophageal Stent (K072094)

Submission Summary (Full Text)

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May 29, 2019

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

Re: K182910

> Trade/Device Name: Segmented Esophageal Stent System Regulation Number: 21 CFR§ 878.3610 Regulation Name: Esophageal Prosthesis Regulatory Class: II Product Code: ESW Dated: April 29, 2019 Received: May 2, 2019

Dear Becky Li:

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.

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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) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see

https://www.fda.gov/CombinationProducts/GuidanceRegulatoryInformation/ucm597488.html; 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 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,

For

Shani P. Haugen, Ph.D. Acting, Assistant Division 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

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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

# Indications for Use

510(k) Number (if known) K182910

Device Name Segmented Esophageal Stent System

### Indications for Use (Describe)

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

| Type of Use (Select one or both, as applicable) |
|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| <span> <span style="padding-right: 20px;"> ☒ Prescription Use (Part 21 CFR 801 Subpart D) </span> <span> ☐ Over-The-Counter Use (21 CFR 801 Subpart C) </span> </span> |

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Image /page/3/Picture/2 description: The image shows a logo with the letters "MT" in a stylized, blocky font, colored in blue. A horizontal line is placed beneath the logo. Below the line, the text "Tab 2" is written in a large, bold font. The logo appears to be a trademarked symbol, indicated by the circled 'R' symbol in the upper right corner.

# 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: K182910

#### Date of Preparation: 1.

2019-05-22

#### 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 & Regulatory Affairs Director

Tel: [phone]

Fax: [phone]

Email: [e-mail]

#### 3. ldentification of Proposed Device

### Trade Name: Segmented 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

#### ldentification of Predicate Device 4.

510(k) Number: K072094

Product Name: CHOOSTENT™ Covered Esophageal Stent

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Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are bold and appear to be interconnected, with the "M" slightly overlapping the "T". A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

510K Summary-2019-05-29 updated

Manufacturer: M. I. Tech Co., Ltd.

#### 5. Indications for Use

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

#### 6. Device Description

The stent is provided pre-loaded in the delivery system. The stent is made up of several segments. The main frame is woven by Nitinol wire, and the connecting part is PTFE connecting loop. The stent with this segmented structure can flexibly conform to the curvature of the human body lumen, thereby reducing the stimulation of the end to the lumen. Silicone membrane applied to the stent covers the complete body of the stent along both flanges, which means the segmented esophageal stent is a fully covered stent. The stent is formed with a flange at either end. The increased diameter of the stent at the stent ends helps provide resistance to migration. The covering is intended to reduce the risk of tissue ingrowth and provides a occlusion for esophageal fistulas. To aid in visibility under fluoroscopy there are 4 bands at either end of the stent and 2 bands at the middle of the stent. The stent has a retrieval loop which can be used to reposition the stent during the initial placement procedure if desired. The delivery system allows for desheathing to deploy the stent and recapturing the stent during stent deployment. 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.

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

The Segmented Esophageal Stent System incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and features the same intended use with the predicate device, namely the Esophageal Stent System manufactured by M. I. Tech Co., Ltd., under K072094.

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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional design. The letters are connected and appear to be leaning slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. The logo has a clean and modern look.

The proposal device is substantially equivalent to the currently marketed devices, CHOOSTENT™ covered esophageal stent, K072094.

The following table is the technological comparison between the proposed device and predicate device CHOOSTENT™ covered esophageal stent (K072094).

Table 2 Technological comparison between the proposed device and predicate device

| ITEM | Proposed Device<br>Segmented<br>Esophageal Stent<br>System | Predicate Device<br>(K072094)<br>CHOOSTENTTM covered<br>esophageal stent | Remark |
|----------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------|
| Product Code | ESW | ESW | Same |
| Regulation No. | 878.3610 | 878.3610 | Same |
| Class | 2 | 2 | Same |
| Configuration | Stent and delivery<br>system | Stent and delivery system | Same |
| Indications for<br>Use | Segmented<br>Esophageal Stent<br>System is intended<br>for maintaining<br>esophageal luminal<br>patency in<br>esophageal strictures<br>caused by intrinsic,<br>or extrinsic malignant<br>tumors only, and<br>occlusion of<br>concurrent<br>esophageal fistula. | The CHOOSTENTTM<br>covered esophageal stent<br>is intended for<br>maintaining esophageal<br>luminal patency in<br>esophageal strictures<br>caused by intrinsic and or<br>extrinsic malignant<br>tumors only and<br>occlusion of concurrent<br>esophageal fistula. | Same |
| Single Use | Yes | Yes | Same |
| Diameter of<br>Stent (mm) | 18,20,22 | 18 | Different |
| Length of<br>Stent (mm) | 60, 80, 100, 120, 140 | 80, 110, 140, 170 | Different |
| Maximum OD<br>(D) of Delivery<br>System (mm) | 6.7 | 6.0 | Different |
| Working<br>Length (mm) | 650 | 700 | Different |
| ITEM | Proposed Device<br>Segmented<br>Esophageal Stent<br>System | Predicate Device<br>(K072094)<br>CHOOSTENT™ covered<br>esophageal stent | Remark |
| Covering | Fully Covered | Fully Covered | Same |
| Shelf life | 2 years | 3 years | Different |
| Packaging | EO sterilized pouch<br>with one device per<br>pouch | EO sterilized pouch with<br>one device per pouch | Same |
| Biocompatibility | Conform to ISO<br>10993-1 | Conform to ISO 10993-1 | Same |
| Sterilization | EO Sterilized,<br>SAL:10-6 | EO Sterilized, SAL:10-6 | Same |
| MRI<br>information | Comply with ASTM F<br>2503, ASTM F 2052,<br>ASTM F2119, ASTM<br>F2182, ASTM F2213 | Comply with ASTM F<br>2503, ASTM F 2052,<br>ASTM F2119, ASTM<br>F2182, ASTM F2213 | Same |
| Labeling | Conform to 21 CFR<br>part 801 | Conform to 21 CFR part<br>801 | Same |

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Image /page/6/Picture/1 description: The image shows a blue and white logo with the letters "MT" in a stylized, three-dimensional design. The "M" is formed by two angled lines that meet at a point, and the "T" is a vertical line with a horizontal line across the top. The logo has a three-dimensional effect, with the letters appearing to be raised and angled slightly. A circled "R" symbol is located in the upper right corner of the logo, indicating that it is a registered trademark.

510K Summary-2019-05-29 updated

#### 8. Performance Data

The Segmented 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", ISO 11135 'Sterilization of Health Care Products-Ethylene Oxide-Part 1:Requirements for Development, Validation, and Routine Control of Sterilization Processes for Medical Devices', and FDA's biocompatibility guidance, Use of International Standard ISO-10993-7, "Biological Evaluation of Medical Devices7: Ethylene Oxide Sterilization Residuals', the following tests were conducted:

### Stent Biocompatibility Testing:

- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity

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Image /page/7/Picture/1 description: The image shows a blue logo with the letters 'MT' stacked on top of each other in a stylized, three-dimensional font. The 'M' is on the bottom and the 'T' is on the top. The logo has a registered trademark symbol '®' in the upper right corner. The logo appears to be for a company or organization with the initials 'MT'.

- Pyrogen ●
- Salmonella Reverse Mutation Test
- In Vitro Mammalian Cell Gene Mutation Test
- Muscle Implant

### Delivery System Biocompatibility Testing:

- Vitro Cytotoxicity
- Skin Sensitization
- Irritation
- Acute Systemic Toxicity

The device specific guidance document was consulted in preparing this premarket submission, VIII Performance testing-Bench of 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
- ゃ Dimension Testing
- ゃ Deployment Force Testing
- ゃ Expansion Force Testing
- ゃ Compression Force Testing
- ゃ Corrosion Testing
- や Tensile Strength Testing
- や Sterility Testing
- ゃ Shelf Life Testing
- ゃ MR Compatibility Testing

The testing performed demonstrated that the proposed device and predicate device are equivalent.

#### 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

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Image /page/8/Picture/1 description: The image shows a blue logo with the letters 'MT' in a stylized, three-dimensional design. The letters are connected and appear to be angled slightly, giving the logo a dynamic look. A small 'R' in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo.

510K Summary-2019-05-29 updated

performance testing, the Segmented 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 CHOOSTENT™ Covered Esophageal Stent (K072094).