← Product Code [PLL](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/PLL) · K200071 # Blue Beacon Submucosal Injectable Solution (K200071) _Micro-Tech (Nanjing) Co., Ltd. · PLL · Nov 3, 2020 · Gastroenterology, Urology · SESE_ **Canonical URL:** https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/PLL/K200071 ## Device Facts - **Applicant:** Micro-Tech (Nanjing) Co., Ltd. - **Product Code:** [PLL](/submissions/GU/subpart-b%E2%80%94diagnostic-devices/PLL.md) - **Decision Date:** Nov 3, 2020 - **Decision:** SESE - **Submission Type:** Traditional - **Regulation:** 21 CFR 876.1500 - **Device Class:** Class 2 - **Review Panel:** Gastroenterology, Urology - **Attributes:** Therapeutic ## Intended Use Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. ## Device Story Blue Beacon is a sterile, nonpyrogenic submucosal injectable solution supplied in pre-filled syringes (5 mL or 10 mL). Used during endoscopic procedures to create a submucosal lift of gastrointestinal lesions (polyps, adenomas, early-stage cancers) to facilitate safe excision with a snare or other endoscopic device. Operated by a physician (gastroenterologist) under endoscopic visualization; injected beneath the lesion using an endoscopic injection needle (≥23G). The solution provides a cushion to elevate the lesion, protecting the underlying muscularis propria during resection. Benefits include improved visualization and reduced risk of perforation during endoscopic mucosal resection (EMR) or endoscopic submucosal dissection (ESD). ## Clinical Evidence No clinical study included. Evidence consists of bench performance testing (appearance, content, pH, viscosity, injection force) and animal testing conducted under GLP (21 CFR 58). Packaging integrity and shelf-life (2 years) validated via accelerated aging (ASTM F1980-16). Sterilization validated per ISO 17665-1. ## Technological Characteristics Composition: Water for Injection, Sodium Hyaluronate, Sodium dihydrogenphosphate, Sodium phosphate dibasic, Sodium chloride, Methylene blue. Form factor: Pre-filled syringe. Sterilization: Moist heat (SAL 10^-6). Standards: ISO 10993-1 (biocompatibility), ISO 17665-1 (sterilization), ASTM F1980-16 (accelerated aging). ## Regulatory 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 - Eleview Submucosal Injection Composition ([K150852](/device/K150852.md)) ## Reference Devices - ORISE Gel ([K180068](/device/K180068.md)) ## Submission Summary (Full Text) > This content was OCRed from public FDA records by [Innolitics](https://innolitics.com). If you use, quote, summarize, crawl, or train on this content, cite Innolitics at https://innolitics.com. > > Innolitics is a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices, including [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/). {0}------------------------------------------------ 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 consists of the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG" in blue, with the word "ADMINISTRATION" underneath. November 3, 2020 Micro-Tech (Nanjing) Co., Ltd. Sally He RA Engineer NO. 10 Gaoke Third Road Nanjing, Jiangsu 210032 CHINA Re: K200071 Trade/Device Name: Blue Beacon Submucosal Injectable Solution Regulation Number: 21 CFR 876.1500 Regulation Name: Endoscope and accessories Regulatory Class: II Product Code: PLL Dated: September 30, 2020 Received: October 2, 2020 Dear Sally He: 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. 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 {1}------------------------------------------------ 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/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); 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 https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems. For comprehensive regulatory information about medical devices and radiation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). 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 (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100). Sincerely, Shanil P. Haugen, Ph.D. Assistant 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 Quality Center for Devices and Radiological Health Enclosure {2}------------------------------------------------ # Indications for Use 510(k) Number (if known) K200071 Device Name Blue Beacon™ Submucosal Injectable Solution Indications for Use (Describe) Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. X Prescription Use (Part 21 CFR 801 Subpart D) | Over-The-Counter Use (21 CFR 801 Subpart C) #### CONTINUE ON A SEPARATE PAGE IF NEEDED. This section applies only to requirements of the Paperwork Reduction Act of 1995. #### *DO NOT SEND YOUR COMPLETED FORM TO THE PRA STAFF EMAIL ADDRESS BELOW.* The burden time for this collection of information is estimated to average 79 hours per response, including the time to review instructions, search existing data sources, gather and maintain the data needed and complete and review the collection of information. Send comments regarding this burden estimate or any other aspect of this information collection, including suggestions for reducing this burden, to: > Department of Health and Human Services Food and Drug Administration Office of Chief Information Officer Paperwork Reduction Act (PRA) Staff PRAStaff@fda.hhs.gov "An agency may not conduct or sponsor, and a person is not required to respond to, a collection of information unless it displays a currently valid OMB number." {3}------------------------------------------------ K200071 Page 1 of 5 Image /page/3/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be stacked on top of each other, creating a sense of depth. A registered trademark symbol is located in the upper right corner of the logo. #### Section 5 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: K200071 ## 1. Date of Preparation: 2020-08-21 - 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: Sally He Position: RA Engineer Tel: +86-25-58646395 Fax: +86-25-58350006 Email: RA.Micro-Tech@outlook.com ## 3. Identification of Proposed Device Trade Name: Blue Beacon™ Submucosal Injectable Solution Common Name: Submucosal Injectable Solution ## Regulatory Information Classification Name: Submucosal Injection Agent Classification: 2 Product Code: PLL Regulation Number: 876.1500 Review Panel: Gastroenterology/Urology {4}------------------------------------------------ K200071 Page 2 of 5 Image /page/4/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly to the right. A small "R" in a circle, indicating a registered trademark, is positioned in the upper right corner of the logo. #### Section 5 510k summary #### 4. Identification of Predicate Device 510(k) Number: K150852 Product Name: SIC 8000 Submucosal Injection Composition Manufacturer: Cosmo Technologies Ltd. Note: The product named in the K150852 clearance is SIC 8000 Submucosal Injection Composition, after the product put into U.S. market, the product name has been changed to Eleview™ Submucosal Injection Composition. Therefore, the product name we purchased is Eleview™™ Submucosal Injection Composition. The product to conduct substantially equivalence with proposed device is Eleview™ Submucosal Injection Composition. Reference Device 510(k) Number: K180068 Product Name: ORISE Gel Manufacturer: Boston Scientific Corporation #### 5. Indications for Use Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. ## 6. Device Description Blue Beacon™ Submucosal Injectable Solution is indicated for submucosal lift of polyps, adenomas, early stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device. Under the surveillance of endoscope, in conjunction with endoscopic injection needles with a diameter equal to or greater than 23G are recommended), inject the product beneath the lesion until enough submucosal lift. {5}------------------------------------------------ Image /page/5/Picture/1 description: The image shows a blue logo with the letters "MT" in a stylized, three-dimensional font. The letters are connected and appear to be angled slightly. A registered trademark symbol is located in the upper right corner of the logo. #### Section 5 510k summary It is supplied in a 5 mL, 10ml syringe. The contents of the syringe are sterile and nonpyrogenic. The proposed devices are moist heat sterilized to achieve the Sterility Assurance Level (SAL) of 10-6 and placed in a sterility maintenance package to ensure a shelf life of 2 years. ## 7. Comparison of Technological Characteristics Blue Beacon™ Submucosal Injectable Solution is substantially equivalent in terms of both intended use, design, composition and fundamental technology to the predicate device Eleview™ Submucosal Injection Composition, which was cleared for marketing under K150852 on Sep. 03, 2015. | Item | Proposed Device
Blue Beacon™ Submucosal
Injectable Solution | Predicate Device
Eleview™ Submucosal
Injection Composition
(K150852) | Comparison
to Predicate
Device | |------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|----------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------| | Product Code | PLL | PLL | Same | | Regulation
No. | 876.1500 | 876.1500 | Same | | Class | 2 | 2 | Same | | Supplied
Sterile | Yes | Yes | Same | | Sterilization | Moist Heat Sterilization | Filtration and Aseptic Filling | Different | | Composition | Water for Injection
Sodium Hyaluronate
Sodium dihydrogenphosphate
anhydrous
Sodium phosphate dibasic,
Sodium chloride
Methylene blue. | Water for Injection
Medium chain triglycerides,
Poloxamer 188,
olyoxyl-15-Hydroxystearate,
Sodium chloride
Methylene blue. | Similar | | Indications for
Use | Blue Beacon™ Submucosal
Injectable Solution is indicated
for submucosal lift of polyps,
adenomas, early state cancers
or other gastrointestinal
mucosal lesions, prior to | Eleview™ Submucosal Injection
Composition is intended for use
in gastrointestinal endoscopic
procedures for submucosal lift
of polyps, adenomas,
early-stage cancers or other | Same | ### Comparison to predicate Devices: {6}------------------------------------------------ Image /page/6/Picture/1 description: The image shows a blue logo with the letters "M" and "T" stacked on top of each other in a three-dimensional perspective. The letters are bold and have a slightly angled appearance, creating a sense of depth. A registered trademark symbol is visible in the upper right corner of the logo. Section 5 510k summary | Item | Proposed Device
Blue Beacon ™ Submucosal
Injectable Solution | Predicate Device
Eleview™ Submucosal
Injection Composition
(K150852) | Comparison
to Predicate
Device | |------------|--------------------------------------------------------------------|-------------------------------------------------------------------------------------------------------|--------------------------------------| | | excision with a snare or endoscopic device. | gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device. | | | Single Use | Yes | Yes | Same | | Packaging | Syringe | Ampoule | Different | | Shelf Life | Two years | Two years | Same | ### 8. Performance Data The proposed device the Blue Beacon™ Submucosal Injectable Solution meets the requirements of AAMI ANSI ISO 10993-1:2009/(R)2013 "Biological Evaluation of Medical Devices – Part 1: Evaluation and Testing Within A Risk Management Process", ISO 17665-1:2006: Sterilization of health care products — Moist heat —Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. A series of bench performance tests were conducted on the proposed device and predicate device K150852, such as Appearance, Content, pH, Colorant Concentration, Viscosity, Injection Force. The bench tests performed demonstrated that the proposed device and predicate device are substantially equivalent. The packaging of our proposed device is a pre-filled syringe, which is the same as the reference device K180068. For the testing about the pre-filled syringe, a series tests were conducted on the proposed device, such as Graduation Accuracy, Luer-lock Connection Seal Integrity, Separation Force, Tip Cap Removal Force, Seal Integrity. The tests performed demonstrated that the pre-filled syringe proposed device is qualified. Shelf-life testing was conducted based on an accelerated aging test in accordance {7}------------------------------------------------ Image /page/7/Picture/1 description: The image shows a blue logo with the letters "M" and "T" stacked on top of each other. The logo has a three-dimensional appearance, with the letters casting a shadow to the right and below. A small "R" in a circle, indicating a registered trademark, is located in the upper right corner of the logo. #### Section 5 510k summary with ASTM F1980-16 Standard Guide for Accelerated Aging of Sterile Barrier Systems for Medical Devices. Two years aging test is performed to demonstrate longer stability and support the results of the accelerated aging test. Sterilization validation was carried out in accordance with ISO17665-1:2006 Sterilization of health care products - Moist heat - Part 1: Requirements for the development, validation and routine control of a sterilization process for medical devices. Biocompatibility testing was performed in accordance with the FDA Guidance, Use of International Standard ISO-10993, 'Biological Evaluation of Medical Devices Part 1: Evaluation and Testing within a risk management process" issued on June 16, 2016. ### 9. Animal Test Conclusion The proposed device Blue Beacon™ Submucosal Injectable Solution has conducted animal test according to 21 CFR §58 (GLP Regulations) to demonstrate the safety and effectiveness. #### 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 Blue Beacon™ Submucosal Injectable Solution has been shown to be appropriate for its intended use and is considered to be substantially equivalent to the currently cleared the Eleview™™ Submucosal Injection Composition(K150852). --- **Source:** [https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/PLL/K200071](https://fda.innolitics.com/submissions/GU/subpart-b%E2%80%94diagnostic-devices/PLL/K200071) **Published by [Innolitics](https://innolitics.com)** — a medical-device software consultancy. We help companies design, build, and clear FDA-regulated software and AI/ML devices. If you're preparing [a 510(k)](https://innolitics.com/services/510ks/), [a De Novo](https://innolitics.com/services/regulatory/), [a SaMD](https://innolitics.com/services/end-to-end-samd/), [an AI/ML medical device](https://innolitics.com/services/medical-imaging-ai-development/), or [an FDA regulatory strategy](https://innolitics.com/services/regulatory/), [get in touch](https://innolitics.com/contact). **Cite:** Innolitics at https://innolitics.com