Embrella Endoscopic Distal Attachment

K190030 · Micro-Tech (Nanjing) Co., Ltd. · FED · Mar 5, 2019 · Gastroenterology, Urology

Device Facts

• Record ID: K190030
• Device Name: Embrella Endoscopic Distal Attachment
• Applicant: Micro-Tech (Nanjing) Co., Ltd.
• Product Code: FED · Gastroenterology, Urology
• Decision Date: Mar 5, 2019
• Decision: SESE
• Submission Type: Traditional
• Regulation: 21 CFR 876.1500
• Device Class: Class 2

Intended Use

Embrella™ Endoscopic Distal Attachment is intended to the distal end of the endoscope to facilitate endoscopic therapy and maintain an appropriate endoscopic field of view.

Device Story

Embrella™ Endoscopic Distal Attachment is a single-use, umbrella-shaped medical-grade silicone rubber device; attaches to the distal end of an endoscope. Features six flexible wings that fold backwards and forwards to maintain an appropriate endoscopic field of view and facilitate endoscopic therapy. Available in two models (EM-S-01, EM-S-02) compatible with endoscope distal diameters of 11.5-13.0mm and 12.8-14.5mm. Used by clinicians in endoscopic settings. The device provides a mechanical aid to improve visualization during procedures; no electronic, software, or algorithmic components.

Clinical Evidence

No clinical study included. Evidence consists of bench testing (dimension, operating performance, matching performance, tension performance) and animal testing (endoscopy view testing). Device complies with ISO 10993-1 (biocompatibility), ISO 11135 (EO sterilization), and ISO 10993-7 (EO residuals).

Technological Characteristics

Material: Medical grade silicone rubber. Configuration: Short tube with 6 flexible wings. Dimensions: Compatible with endoscope distal diameters 11.5-13.0mm (EM-S-02) and 12.8-14.5mm (EM-S-01). Sterilization: Ethylene Oxide (EO). Single-use. No energy source, software, or connectivity.

Indications for Use

Indicated for attachment to the distal end of an endoscope to facilitate endoscopic therapy and maintain an appropriate endoscopic field of view in patients undergoing endoscopic procedures.

Regulatory Classification

Identification

An endoscope and accessories is a device used to provide access, illumination, and allow observation or manipulation of body cavities, hollow organs, and canals. The device consists of various rigid or flexible instruments that are inserted into body spaces and may include an optical system for conveying an image to the user's eye and their accessories may assist in gaining access or increase the versatility and augment the capabilities of the devices. Examples of devices that are within this generic type of device include cleaning accessories for endoscopes, photographic accessories for endoscopes, nonpowered anoscopes, binolcular attachments for endoscopes, pocket battery boxes, flexible or rigid choledochoscopes, colonoscopes, diagnostic cystoscopes, cystourethroscopes, enteroscopes, esophagogastroduodenoscopes, rigid esophagoscopes, fiberoptic illuminators for endoscopes, incandescent endoscope lamps, biliary pancreatoscopes, proctoscopes, resectoscopes, nephroscopes, sigmoidoscopes, ureteroscopes, urethroscopes, endomagnetic retrievers, cytology brushes for endoscopes, and lubricating jelly for transurethral surgical instruments. This section does not apply to endoscopes that have specialized uses in other medical specialty areas and that are covered by classification regulations in other parts of the device classification regulations.

Special Controls

*Classification* —(1)*Class II (special controls).* The device, when it is an endoscope disinfectant basin, which consists solely of a container that holds disinfectant and endoscopes and accessories; an endoscopic magnetic retriever intended for single use; sterile scissors for cystoscope intended for single use; a disposable, non-powered endoscopic grasping/cutting instrument intended for single use; a diagnostic incandescent light source; a fiberoptic photographic light source; a routine fiberoptic light source; an endoscopic sponge carrier; a xenon arc endoscope light source; an endoscope transformer; an LED light source; or a gastroenterology-urology endoscopic guidewire, is exempt from the premarket notification procedures in subpart E of part 807 of this chapter subject to the limitations in § 876.9.(2) Class I for the photographic accessories for endoscope, miscellaneous bulb adapter for endoscope, binocular attachment for endoscope, eyepiece attachment for prescription lens, teaching attachment, inflation bulb, measuring device for panendoscope, photographic equipment for physiologic function monitor, special lens instrument for endoscope, smoke removal tube, rechargeable battery box, pocket battery box, bite block for endoscope, and cleaning brush for endoscope. The devices subject to this paragraph (b)(2) are exempt from the premarket notification procedures in subpart E of part 807of this chapter, subject to the limitations in § 876.9.

Predicate Devices

• Endoring™ (K133359)

Submission Summary (Full Text)

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Image /page/0/Picture/0 description: The image contains the logo of the U.S. Food and Drug Administration (FDA). On the left is the Department of Health & Human Services logo. To the right of that is the FDA logo, which is a blue square with the letters "FDA" in white. To the right of the blue square is the text "U.S. FOOD & DRUG ADMINISTRATION" in blue.

March 5. 2019

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

Re: K190030

> Trade/Device Name: Embrella™ Endoscopic Distal Attachment Regulation Number: 21 CFR§ 876.1500 Regulation Name: Endoscope and Accessories Regulatory Class: II Product Code: FED Dated: December 27, 2018 Received: January 7, 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 mav, 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 avare 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,

# Mark J. Antonino -S

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)

#### K190030

Device Name

Embrella™ Endoscopic Distal Attachment

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

Indications for Use (Describe)

Embrella™ Endoscopic Distal Attachment is intended to the distal end of the endoscope to facilitate endoscopic therapy and maintain an appropriate endoscopic field of view.

| <span style="font-size: 10pt;"> <span style="text-decoration: underline;"></span> <span style="text-decoration: line-through;"></span> <span style="font-family: Symbol;"> <span style="color: rgb(0, 0, 0);">☑</span> </span> Prescription Use (Part 21 CFR 801 Subpart D) </span> | <span style="font-size: 10pt;"> <span style="text-decoration: underline;"></span> <span style="text-decoration: line-through;"></span> <span style="font-family: Symbol;"> <span>☐</span> </span> Over-The-Counter Use (21 CFR 801 Subpart C) </span> |
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510k summary

Image /page/3/Picture/1 description: The image shows a blue and white logo. The logo is a stylized, three-dimensional representation of the letters 'M' and 'T'. The 'M' is in white and appears to be in front of the blue 'T', creating a layered effect. The logo has a modern and geometric design.

# Tab 7

# 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: K190030

# 1. Date of Preparation: 2019-03-01

# 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 and Regulatory Affairs Director

Tel: [phone]

Fax: [phone]

# Email: Beckyli [e-mail]

# 3. Identification of Proposed Device

Trade Name: Embrella™ Endoscopic Distal Attachment

Common Name: Endoscopic Distal Attachment

# Regulatory Information

Classification Name: Endoscope and accessories

Classification: 2

Product Code: FED

Regulation Number: 21 CFR 876.1500

Review Panel: Gastroenterology/Urology

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Image /page/4/Picture/1 description: The image contains the logo for MICRO-TECH (Nanjing) Co., Ltd. The logo consists of the letters MT in a stylized, three-dimensional font on the left. To the right of the letters is the company name in English and Chinese. The English name is MICRO-TECH (Nanjing) Co., Ltd., and the Chinese name is 南京微创医学科技股份有限公司.

### 4. Identification of Predicate Device

510(k) Number: K133359 Product Name: Endoring™ Manufacturer: EndoAid, Ltd.

# 5. Indications for Use

Embrella™ Endoscopic Distal Attachment is intended to be attached to the distal end of the endoscope to facilitate endoscopic therapy and maintain an appropriate endoscopic field of view.

# 6. Device Description

The proposed device Embrella™ Endoscopic Distal Attachment is an additional device, made of medical grade silicone rubber designed to attach to the distal end of the endoscope. Its shape is umbrella shaped, with six flexible wings that easily to fold backwards and forwards. It can be used to facilitate endoscopic therapy and maintain an appropriate endoscopic field of view.

Embrella™ Endoscopic Distal Attachment has two models, one is EM-S-01, which is compatible with endoscopy distal diameter 12.8-14.5mm; the other is EM-S-02, which is compatible with endoscopy distal diameter 11.5-13.0mm.

# 7. Comparison of Technological Characteristics

The Embrella™ Endoscopic Distal Attachment incorporates substantially equivalent device materials, design, configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the predicate device Endoring™.

# Comparison to predicate Devices:

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Image /page/5/Picture/1 description: The image shows a blue logo with the letters "M" and "T" in a stylized, three-dimensional design. The "M" is positioned in front of the "T", creating a sense of depth. The logo has a modern and corporate feel due to its clean lines and simple color scheme.

| | | 510k summary | | |
|-----------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------|--|
| Item | Proposed Device<br>Embrella™ Endoscopic Distal<br>Attachment | Predicate Device<br>Endoring™<br>(K133359) | Substantial<br>Equivalenc<br>e | |
| Product Code | FED | FED | Same | |
| Regulation No. | 21 CFR 876.1500 | 21 CFR 876.1500 | Same | |
| Class | 2 | 2 | Same | |
| Supplied in<br>Sterile | Yes | Yes | Same | |
| Material | Silicone Rubber | Silicone Rubber | Same | |
| Configuration | One short tube with 6 flexible<br>wings | One short tube with 6 flexible<br>wings | Same | |
| Compatible<br>endoscopy<br>working<br>channel | 11.5-13.0mm<br>12.8-14.5mm | 11.5-13.0mm<br>12.8-14.5mm | Same | |
| Indications for<br>Use | Embrella™ Endoscopic Distal<br>Attachment is intended to be<br>attached to the distal end of the<br>endoscope to facilitate endoscopic<br>therapy and maintain an<br>appropriate endoscopic field of<br>view. | The EndoRings is intended to be<br>attached to the distal end of the<br>endoscope to facilitate endoscopic<br>therapy, to be used for the<br>following:<br>*Keeping the suitable depth of<br>endoscope's view field | Same | |
| Single Use | Yes | Yes | Same | |
| Packaging | Single-use EO sterilized pouch<br>with one device per pouch | Single-use EO sterilized pouch<br>with one device per pouch | Same | |
| Shelf Life | One years | Three years | Different | |

# 8. Performance Data

The proposed device the Embrella™ Endoscopic Distal Attachment meets the requirements of ISO 10993-1 "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

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Image /page/6/Picture/1 description: The image shows the logo for MICRO-TECH (Nanjing) Co., Ltd. The logo consists of a blue graphic on the left and the company name in blue text on the right. The company name is written in both English and Chinese. The English name is "MICRO-TECH (Nanjing) Co., Ltd." and the Chinese name is "南京微创医学科技股份有限公司".

510k summary

Development, Validation, and Routine Control of Sterilization processes for

Medical Devices", and ISO 10993-7 "Biological evaluation of medical devices -

Part 7: ethylene oxide sterilization residuals",

The following bench tests were performed on the Embrella™ Endoscopic Distal

## Attachment

- > Dimension;
- > Operating Performance
- > Matching Performance;
- > Tension Performance;

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

# 9. Animal Testing

Endoscopy View Testing were performed on the Embrella™ Endoscopic Distal Attachment.

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

#### 10. Clinical Test Conclusion

No clinical study is included in this submission.

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

Based on the indications for use, technological characteristics, and safety and performance testing, the Embrella™ Endoscopic Distal Attachment has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared predicate device EndoRing™ (K133359).