(295 days)
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.
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.
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."
§ 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.