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 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. 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.

AI/ML Overview

The provided document describes the Micro-Tech (Nanjing) Co., Ltd. Blue Beacon™ Submucosal Injectable Solution (K200071) and its substantial equivalence to a predicate device. This document is a 510(k) summary, which focuses on demonstrating equivalence rather than providing detailed acceptance criteria and a comprehensive study report with statistically significant outcomes against specific acceptance thresholds for a diagnostic AI device.

Therefore, the requested information, which is typical for a diagnostic AI device requiring performance against quantitative acceptance criteria, is largely not present in this type of submission. The device described is a medical injectable solution, not an AI or diagnostic device.

However, I can extract the available information which pertains to device performance and testing, and explain why other requested details are not applicable or provided in this context.

Here's a breakdown of the available information:

1. Table of Acceptance Criteria and Reported Device Performance

As this is a 510(k) submission for a non-AI injectable solution, there are no "acceptance criteria" in the sense of accuracy, sensitivity, or specificity metrics typical for AI or diagnostic devices. Instead, the submission relies on demonstrating substantial equivalence to a predicate device (Eleview™ Submucosal Injection Composition, K150852) and meeting general medical device standards.

The "acceptance criteria" are implicitly meeting the performance characteristics of the predicate device and relevant international standards.

Characteristic	Predicate Device (Eleview™ - K150852) Performance	Proposed Device (Blue Beacon™) Performance	Comparison / Acceptance
Product Code	PLL	PLL	Same / Meets
Regulation No.	876.1500	876.1500	Same / Meets
Class	2	2	Same / Meets
Supplied Sterile	Yes	Yes	Same / Meets
Sterilization	Filtration and Aseptic Filling	Moist Heat Sterilization	Different (See note)
Composition	Water for Injection, Medium chain triglycerides, Poloxamer 188, Olyoxyl-15-Hydroxystearate, Sodium chloride, Methylene blue.	Water for Injection, Sodium Hyaluronate, Sodium dihydrogenphosphate anhydrous, Sodium phosphate dibasic, Sodium chloride, Methylene blue.	Similar (See note)
Indications for Use	Submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or other suitable endoscopic device.	Submucosal lift of polyps, adenomas, early state cancers or other gastrointestinal mucosal lesions, prior to excision with a snare or endoscopic device.	Same / Meets
Single Use	Yes	Yes	Same / Meets
Packaging	Ampoule	Syringe	Different (See note)
Shelf Life	Two years	Two years	Same / Meets
Biocompatibility	Assumed to meet ISO 10993 standards	Tested to ISO 10993-1:2009/(R)2013	Meets ISO standards
Sterilization Validation	Assumed to meet relevant standards prior	ISO 17665-1:2006 (Moist Heat)	Meets ISO standards
Bench Tests	N/A (Comparative Testing)	Appearance, Content, pH, Colorant Concentration, Viscosity, Injection Force	Demonstrated "substantially equivalent" to predicate
Pre-filled syringe tests (Specific to packaging)	N/A (Comparative Testing)	Graduation Accuracy, Luer-lock Connection Seal Integrity, Separation Force, Tip Cap Removal Force, Seal Integrity	Demonstrated "qualified"
Accelerated Aging/Shelf-life	N/A (Comparative Testing)	ASTM F1980-16 for accelerated aging; 2-year aging test to support results	Supported 2-year shelf life

Note on Differences: The differences in sterilization method, composition, and packaging are addressed by performance testing (bench tests, syringe tests, biocompatibility, sterilization validation) to demonstrate that these differences do not raise new questions of safety or effectiveness. The conclusion is that despite these differences, the devices are "substantially equivalent."

2. Sample Size Used for the Test Set and the Data Provenance

Sample Size for Test Set: Not explicitly stated numerically for "bench performance tests" (Appearance, Content, pH, etc.) or for the pre-filled syringe tests. The document mentions "a series of bench performance tests" and "a series tests were conducted" which implies multiple samples were tested under each category.
Data Provenance: The studies were conducted by Micro-Tech (Nanjing) Co., Ltd. in China, as indicated by the company's address and the origin of the submission. The studies are retrospective in the sense that they are conducted on manufactured devices and evaluated against established standards and the predicate device's characteristics.

3. Number of Experts Used to Establish the Ground Truth for the Test Set and the Qualifications of Those Experts

This information is not applicable and not provided as the device is an injectable solution, not a diagnostic device requiring expert interpretation of results or images. The "ground truth" for the performance tests would be objective measurements against specified physical/chemical properties or validated standards.

4. Adjudication Method for the Test Set

This information is not applicable as the device is not a diagnostic device requiring adjudication of human reader interpretations.

5. If a Multi-Reader Multi-Case (MRMC) Comparative Effectiveness Study was Done, If so, what was the effect size of how much human readers improve with AI vs without AI assistance

This information is not applicable as the device is not an AI diagnostic tool and therefore no MRMC studies involving human readers and AI assistance would be performed.

6. If a Standalone (i.e. algorithm only without human-in-the loop performance) was Done

This information is not applicable as the device is not an AI algorithm.

7. The Type of Ground Truth Used

The "ground truth" for the performance characteristics of this device is based on:

Objective measurements of physical and chemical properties (e.g., pH, viscosity, content, colorant concentration).
Compliance with international standards for medical device safety and performance (e.g., ISO 10993 for biocompatibility, ISO 17665 for sterilization, ASTM F1980 for accelerated aging).
Comparison to the established characteristics of the legally marketed predicate device (K150852) to demonstrate substantial equivalence.
Animal testing for safety and effectiveness, conducted under GLP Regulations (21 CFR §58), is also cited as "ground truth" for in-vivo performance.

8. The Sample Size for the Training Set

This information is not applicable as the device does not involve a "training set" in the context of machine learning or AI.

9. How the Ground Truth for the Training Set Was Established

This information is not applicable as the device does not involve a "training set."

Summary

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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

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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

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Indications for Use

510(k) Number (if known) K200071

Device Name

Blue Beacon™ Submucosal Injectable Solution

Indications for Use (Describe)

X Prescription Use (Part 21 CFR 801 Subpart D)

| Over-The-Counter Use (21 CFR 801 Subpart C)

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K200071 Page 1 of 5

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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

1. 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

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K200071 Page 2 of 5

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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

6. Device Description

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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 DeviceBlue Beacon™ SubmucosalInjectable Solution	Predicate DeviceEleview™ SubmucosalInjection Composition(K150852)	Comparisonto PredicateDevice
Product Code	PLL	PLL	Same
RegulationNo.	876.1500	876.1500	Same
Class	2	2	Same
SuppliedSterile	Yes	Yes	Same
Sterilization	Moist Heat Sterilization	Filtration and Aseptic Filling	Different
Composition	Water for InjectionSodium HyaluronateSodium dihydrogenphosphateanhydrousSodium phosphate dibasic,Sodium chlorideMethylene blue.	Water for InjectionMedium chain triglycerides,Poloxamer 188,olyoxyl-15-Hydroxystearate,Sodium chlorideMethylene blue.	Similar
Indications forUse	Blue Beacon™ SubmucosalInjectable Solution is indicatedfor submucosal lift of polyps,adenomas, early state cancersor other gastrointestinalmucosal lesions, prior to	Eleview™ Submucosal InjectionComposition is intended for usein gastrointestinal endoscopicprocedures for submucosal liftof polyps, adenomas,early-stage cancers or other	Same

Comparison to predicate Devices:

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Section 5 510k summary

Item	Proposed DeviceBlue Beacon ™ SubmucosalInjectable Solution	Predicate DeviceEleview™ SubmucosalInjection Composition(K150852)	Comparisonto PredicateDevice
	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

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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).

Regulation Number and Section

§ 876.1500 Endoscope and accessories.

(a)
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.(b)
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.