Disposable Hot Biopsy Forceps

{0}------------------------------------------------ Image /page/0/Picture/1 description: The image shows the logo for the U.S. Department of Health & Human Services. The logo consists of a circular arrangement of text that reads "DEPARTMENT OF HEALTH & HUMAN SERVICES - USA". Inside the circle is an abstract symbol that resembles an eagle or a bird in flight, composed of three stylized human profiles facing to the right. Food and Drug Administration 10903 New Hampshire Avenue Document Control Center - WO66-G609 Silver Spring, MD 20993-0002 June 14, 2016 Micro-Tech (Nanjing) Co., Ltd. Becky Li Quality Director No. 10 Gaoke Third Road National Hi-Tech Industrial Development Zone Nanjing, 210032, Jiangsu Province China Re: K160625 Trade/Device Name: Disposable Hot Biopsy Forceps Regulation Number: 21 CFR 876.4300 Regulation Name: Endoscopic Electrosurgical Unit and Accessories Regulatory Class: Class II Product Code: KGE Dated: May 13, 2016 Received: May 17, 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 mav 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 {1}------------------------------------------------ Part 807); labeling (21 CFR Part 801); medical device reporting (reporting of medical devicerelated 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 (800) 638-2041 or (301) 796-7100 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 (800) 638-2041 or (301) 796-7100 or at its Internet address http://www.fda.gov/MedicalDevices/ResourcesforYou/Industry/default.htm. Sincerely yours. # Benjamin R. Fisher -S 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 {2}------------------------------------------------ DEPARTMENT OF HEALTH AND HUMAN SERVICES Food and Drug Administration ### Indications for Use 510(k) Number (if known) K160625 Device Name Disposable Hot Biopsy Forceps Indications for Use (Describe) This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. | <div> <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> <span style="float: left;">☒</span> <span style="float: left;">Prescription Use (Part 21 CFR 801 Subpart D)</span> </div> | <div> <span style="text-decoration: underline;"></span> <span style="text-decoration: overline;"></span> <span style="float: left;">☐</span> <span style="float: left;">Over-The-Counter Use (21 CFR 801 Subpart C)</span> </div> | |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| |------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|-----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------| CONTINUE ON A SEPARATE PAGE IF NEEDED. 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Type of Use (Select one or both, as applicable) ------------------------------------------------------------------------------------------------------------------------------------------------------------------------------ {3}------------------------------------------------ Image /page/3/Picture/0 description: The image shows the text "510K Summary". The text is in a sans-serif font and is black. The background is white. The text is likely a title or heading for a document or presentation. 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, with the letters colored in blue. 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, also in blue. **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: #### 1. Date of Preparation:01/08/2016 #### 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: +86-25-58646378 Fax: +86-25-58744269 Email: In@micro-tech.com.cn #### 3. Identification of Proposed Device Trade Name: Disposable Hot Biopsy Forceps Common Name: Disposable Hot Biopsy Forceps Classification Name: Forceps, Biopsy, Electric Classification: 2 Product Code: KGE Regulation Number: 876.4300 Review Panel: Gastroenterology/Urology #### 4. Identification of Predicate Device 510(k) Number: K953355 Trade Name: GIP/Medi-Globe Hot Biopsy Forceps Common Name: Forceps, Biopsy, Electric #### 5. Indications for Use This device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. {4}------------------------------------------------ Image /page/4/Picture/1 description: The image shows 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 is some smaller text in a different language, possibly Chinese. A horizontal line underlines the "MICRO-TECH" text. #### Device Description 6. The proposed device Disposable Hot Biopsy Forceps is a sterile, single-use endoscopic device, intended to be used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. It consists of a flexible wire cable and loop which can be extended and retracted from the snare's flexible outer sheath using a handle. When passed through an endoscope the forceps can be activated to deliver a monopolar electrical current to cut polyp with the loop. The main component of the proposed device is jaws, spring sheath and handle. The proposed device is used for endoscopic histological sampling or electrocoagulation of various tissues, within the gastrointestinal and bronchial tracts, via the operating channel of endoscopic instruments. The proposed device has two (2) specifications, HBF55-11023180 and HBF55-11023230. The proposed devices are EO sterilized to achieve the Sterility Assurance Level (SAL) of 10 ° and placed in a sterility maintenance package to ensure a shelf life of 3 years. #### Comparison of Technological Characteristics 7. The Disposable Hot Biopsy Forceps incorporates substantially equivalent device materials, design, catheter configuration, packaging fundamental technology, manufacturing processes, sterilization process and intended use as those featured in the Medi-Globe predicate devices. | Item | Proposed Device | Comparison to<br>Predicate Devices | |-------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|------------------------------------| | | Disposable Hot Biopsy Forceps | Same | | Product Code | KGE | Same | | Regulation No. | 876.4300 | Same | | Class | 2 | Same | | Supplied Sterile | Yes | Same | | Jaws Shape | Oval Jaws | Same | | Outer Tube Diameter | 2.3mm | Similar | | Minimal Working Channel | 2.8mm | Same | | Working Length | 1800mm, 2300mm | Same | | Indications for Use | The device is intended to be used for<br>endoscopic histological sampling or<br>electrocoagulation of various tissues,<br>within the gastrointestinal and bronchial<br>tracts, via the operating channel of<br>endoscopic instruments. | Similar | | Configuration | Jaws, Spring Sheath, High-Frequency, | Same | ### Comparison to predicate Devices: {5}------------------------------------------------ Image /page/5/Picture/0 description: The image shows the logo for MICRO-TECH. The logo consists of the letters "MT" in a stylized, three-dimensional font, with the letters overlapping each other. To the right of the letters is the text "MICRO-TECH" in a simple, sans-serif font. Below the text "MICRO-TECH" are two Chinese characters. | Item | Proposed Device<br>Disposable Hot Biopsy Forceps<br>and Handle | 510K Summary<br>Comparison to<br>Predicate Devices | |------------|----------------------------------------------------------------|----------------------------------------------------| | Single Use | Yes | Same | | Packaging | Single-use EO sterilized pouch with one<br>device per pouch | Similar | | Shelf Life | Four years | Similar | ## 8. Performance Data Bench testing was performed to support a determination of substantial equivalence. The Disposable Hot Biopsy Forceps performs as well as the predicate and is substantially equivalent to the predicate devices. The following in-vitro performance tests were completed on the Disposable Hot Biopsy Forceps: | Dimension Testing Report | Electrode Contact Impedance Testing | |-----------------------------|-------------------------------------| | Cutting Performance Testing | Pushability Testing | | Tensile Strength Testing | Jaws Misalignment Testing | | Package Integrity | Shelf Life Testing | #### Clinical Test Conclusion 9. 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 Disposable Hot Biopsy Forceps has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the GIP/Medi-Globe Hot Biopsy Forceps.