Reliant Multistage Dilatation Balloon Catheter

K162226 · Micro-Tech (Nanjing) Co., Ltd. · FGE · Jan 25, 2017 · Gastroenterology, Urology

Device Facts

• Record ID: K162226
• Device Name: Reliant Multistage Dilatation Balloon Catheter
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: FGE · Gastroenterology, Urology
• Decision Date: Jan 25, 2017
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.5010
• Device Class: Class 2
• Attributes: Therapeutic

Intended Use

The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.

Device Story

The Reliant™ Multistage Dilatation Balloon Catheter is a single-use, endoscopically-delivered device designed to dilate gastrointestinal strictures. It features a balloon capable of three distinct, progressively larger diameters via controlled radial expansion. The catheter is compatible with endoscopes having a 2.8mm or greater working channel and includes a preloaded 0.035-inch guidewire. Used in clinical settings by physicians, the device is inserted endoscopically to the site of the stricture. The physician manually controls balloon inflation to achieve the desired diameter, providing mechanical dilation to open the stricture. This procedure aims to improve patient outcomes by relieving obstructions in the GI tract. The device is supplied sterile and is intended for single use.

Clinical Evidence

No clinical data. Bench testing only, including tensile strength testing between the balloon/tube and tube/junction, and biocompatibility testing (cytotoxicity, sensitization, and irritation).

Technological Characteristics

Multistage dilatation balloon catheter; double lumen tube; 0.035-inch guidewire; balloon diameters 6-20mm; working lengths 1800/2300mm; EO sterilization; single-use. Materials modified from predicate; biocompatibility confirmed per ISO standards.

Indications for Use

Indicated for adult and adolescent populations to endoscopically dilate gastrointestinal tract strictures.

Regulatory Classification

Identification

A biliary catheter and accessories is a tubular flexible device used for temporary or prolonged drainage of the biliary tract, for splinting of the bile duct during healing, or for preventing stricture of the bile duct. This generic type of device may include a bile collecting bag that is attached to the biliary catheter by a connector and fastened to the patient with a strap.

Special Controls

*Classification.* Class II (special controls). The device, when it is a bile collecting bag or a surgical biliary catheter that does not include a balloon component, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.

Predicate Devices

• Disposable Multistage Dilation Balloon Catheter (K151671)

Submission Summary (Full Text)

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Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002

January 25, 2017

Micro-Tech (Nanjing) CO., Ltd. Becky Li Quality Director NO. 10 Gaoke Third Road Nanjing, 210032 China

Re: K162226

> Trade/Device Name: Reliant™ Multistage Dilatation Balloon Catheter Regulation Number: 21 CFR§ 876.5010 Regulation Name: Biliary Catheter and Accessories Regulatory Class: II Product Code: FGE, KNO Dated: December 27, 2016 Received: December 27, 2016

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. 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 (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.

If you desire specific advice for your device on our labeling regulation (21 CFR Part 801), please contact the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. 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 the CDRH's Office of Surveillance and Biometrics/Division of Postmarket Surveillance.

You may obtain other general information on your responsibilities under the Act from the Division of Industry and Consumer Education at its toll-free number [phone] or [phone] or at its Internet address

http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm.

Sincerely.

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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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DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration

### Indications for Use

510(k) Number (if known) K162226

Device Name

Reliant(TM) Multistage Dilatation Balloon Catheter

Type of Use (Select one or both, as applicable)

Indications for Use (Describe)

The Reliant(TM) Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the gastrointestinal tract.

| <span style="font-size:12px;">☒</span> 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 the letters "MT" in a stylized, three-dimensional font on the left, with the word "MICRO-TECH" in a simple sans-serif font on the right. Below the word "MICRO-TECH" are two Chinese characters.

#### 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.

### 1. Date of Preparation: 2016-12-15

# 2. Sponsor Identification Micro-Tech (Nanjing) Co., Ltd.

No.10 Gaoke Third Road, Nanjing National Hi-Tech, Industrial Development Zone, Nanjing 210032, Jiangsu Province, PRC Establishment Registration Number: 3004837686 Contact Person: Becky Li Position: Quality Director Tel: [phone] Fax: [phone] Email: [e-mail]

### 3. Identification of Proposed Device

Product Name: Reliant™ Multistage Dilatation Balloon Catheter Common Name: Reliant™ Multistage Dilatation Balloon Catheter Regulatory Information Classification Name: 1) Catheter, Biliary, diagnostic, 2) Dilator, esophageal Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 1) 876.5010, 2) 876.3565 Review Panel: Gastroenterology/Urology

### 4. Identification of Predicate Device

510(k) Number: K151671 Product Name: Disposable Multistage Dilation Balloon Catheter Common Name: Disposable Multistage Dilation Balloon Catheter Regulatory Information Classification Name: 1) Catheter, Biliary, diagnostic, 2) Dilator, esophageal Classification: 2 Product Code: 1) FGE, 2) KNQ Regulation Number: 1) 876.5010, 2) 876.5365

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Image /page/4/Picture/1 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 text, there are two Chinese characters, also in blue.

Manufacture: Micro-Tech (Nanjing) Co., Ltd Review Panel: Gastroenterology/Urology This predicate device has not been subject to a design-related recall.

### 5. Indications for Use

The Reliant™ Multistage Dilatation Balloon Catheter is indicated for use in adult and adolescent populations to endoscopically dilate strictures of the qastrointestinal tract.

### 6. Device Description

The Reliant™ Multistage Dilatation Balloon Catheter is capable of 3 distinct and progressively larger size diameters via controlled radial expansion. Specific balloon sizes are printed on each package and hub label.

The Reliant™ Multistage Dilatation Balloon Catheter is designed to pass through a 2.8mm or greater working channel of an endoscope. It will also accept a 0.035 in (0.89 mm) guidewire through its guidewire lumen. This catheter comes packaged with a 0.035 in (0.89mm) guidewire preloaded in the guidewire lumen. The guidewire is about 20cm longer than the balloon catheter with the excess length extending from single lumen tube.

The guidewire locking device is attached to the guidewire hub of the catheter. The locking device will be packaged in locked.

#### 7. Comparison of Technological Characteristics

The Reliant™ Multistage Dilatation Balloon Catheter incorporates substantially equivalent device design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device.

| Item | Proposed Device | Predicate Device<br>(K151671) | Comparison<br>on |
|------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|
| Product Code | 1) FGE, 2) KNQ | 1) FGE, 2) KNQ | Same |
| Regulation No. | 1) 876.5010, 2)<br>876.5365 | 1) 876.5010, 2)<br>876.5365 | Same |
| Class | 2 | 2 | Same |
| Supplied Sterile | Yes | Yes | Same |
| Balloon Diameter (mm) | 6-7-8, 8-9-10, 10-11-12,<br>12-13.5-15, 15-16.5-18,<br>18-19-20 | 6-7-8, 8-9-10, 10-11-12,<br>12-13.5-15, 15-16.5-18,<br>18-19-20 | Same |
| Item | Proposed Device | Predicate Device<br>(K151671) | 510K Summary<br>Comparis<br>on |
| Balloon length (mm) | 30, 55, 80. | 30, 55, 80. | Same |
| Rated pressure(atm) | 3-6-10, 3-5.5-9,<br>3-5-8,3-4.5-8,3-4.5-7,3-4<br>.5-6 | 3-6-10, 3-5.5-9,<br>3-5-8,3-4.5-8,3-4.5-7,3-4<br>.5-6 | Same |
| Working Length (mm) | 1800, 2300 | 1800, 2300 | Same |
| Indications for Use | The ReliantTM<br>Multistage Dilitation<br>Balloon Catheter is<br>indicated for use in adult<br>and adolescent<br>populations to<br>endoscopically dilate<br>strictures of the<br>gastrointestinal tract. | The Disposable<br>Multistage Dilation<br>Balloon Catheter is<br>indicated for use in adult<br>and adolescent<br>populations to<br>endoscopically dilate<br>strictures of the<br>gastrointestinal tract. | Same |
| Configuration | Tip, balloon, marker<br>band, handle junction,<br>and guidewire. | Tip, balloon, marker<br>band, handle junction,<br>and guidewire. | Same |
| Single Use | Yes | Yes | Same |
| Packaging | Single-use EO sterilized<br>pouch with one device<br>per pouch | Single-use EO sterilized<br>pouch with one device<br>per pouch | Same |
| Shelf Life | Three years (36 months) | Three years (36 months) | Same |
| Tensile Strength between<br>Balloon and Double<br>Lumen Tube(N) | $67.11\pm2.16$ | $78.11\pm9.59$ | Similar |
| Tensile Strength between<br>Double Lumen Tube and<br>Junction(N) | $109.99\pm2.12$ | $94.67\pm3.54$ | Similar |
| Biocompatibility-Cytotoxicity | The test article<br>extracts had not a<br>cytotoxic potential.<br>Neither SC extracts nor<br>CSO extracts of the<br>test article had | The test article<br>extracts had not a<br>cytotoxic potential.<br>Neither SC extracts nor<br>CSO extracts of the<br>test article had | Same |
| Biocompatibility-Sensitization | evidence of causing<br>sensitization in the<br>guinea pig. | evidence of causing<br>sensitization in the<br>guinea pig. | Same |
| Item | Proposed Device | Predicate Device<br>(K151671) | Comparison<br>on |
| Biocompatibility-Irritation | The test article<br>extracts have no<br>animal intracutaneous<br>reactivity as compared<br>to the control. | The test article<br>extracts have no<br>animal intracutaneous<br>reactivity as compared<br>to the control. | Same |

#### Comparison to Predicate Devices:

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Image /page/5/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of a blue, stylized "MT" on the left, followed by the text "MICRO-TECH" in blue. Below the text "MICRO-TECH" are two Chinese characters, also in blue.

510K Summary

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Image /page/6/Picture/0 description: The image shows the logo for Micro-Tech. The logo consists of the letters "MT" in a stylized, three-dimensional blue font on the left. To the right of the letters, the words "MICRO-TECH" are written in a simple, sans-serif font, also in blue. Below the words "MICRO-TECH", there are two Chinese characters.

510K Summary

## 8. Performance Data

The modifications that were made include:

- Double lumen tube is modified due to change the tubing material.
- The product name is changed slightly.

Comparison to Predicate Devices K151671, the material of double lumen tube is changed, according by FMEA, all necessary verification and validation tests have been performed for the Reliant™ Multistage Dilatation Balloon Catheter to assure substantial equivalence to the predicate device.

- Tensile Strength between Balloon and Double Lumen Tube
- Tensile Strength between Double Lumen Tube and Junction
- Biocompatibility Test

#### 9. Clinical Test Conclusion

No clinical study is included in this submission.

### 10. Substantially Equivalent (SE) Conclusion

Based on the indications for use and technological characteristics, substantially equivalent to the predicate device, the Reliant™ Multistage Dilatation Balloon Catheter is considered to be substantially equivalent to the Predicate Device (K151671 Disposable Multistage Dilation Balloon Catheter).