(30 days)
The Blue Eye is indicated for use in gastrointestinal endoscopic procedures for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device.
Blue Eye, submucosal injection agent, is a solution used for submucosal lift of polyps, adenomas, early-stage cancers or other gastrointestinal mucosal lesions prior to excision with a snare or endoscopic device in gastrointestinal endoscopic procedures. The main materials of the solution are sodium hyaluronate and saline, and it is provided in prefilled syringe. It is supplied sterile and disposable.
This is a 510(k) premarket notification for a medical device called "Blue Eye" (model TS-910), a submucosal injection agent used in gastrointestinal endoscopic procedures. The purpose of this submission is to demonstrate substantial equivalence to a predicate device, "Blue Eye" (model TS-905) (K220434), manufactured by the same company.
The provided document describes physical and performance characteristics, but does not include any clinical study data or acceptance criteria relating to device performance for diagnostic accuracy or clinical effectiveness.
The document states that the substantial equivalence determination is based on an assessment of non-clinical performance data. Therefore, the information requested regarding acceptance criteria and a study proving device meets these criteria in a clinical context cannot be fully provided from the given text.
However, I can extract the relevant information from the provided text regarding the non-clinical performance studies conducted:
1. A table of acceptance criteria and the reported device performance
The document does not explicitly state specific numerical acceptance criteria for each non-clinical test, nor does it provide detailed quantitative performance results. It generally states that "The tests were performed on the subject device using the same method as the predicate device, and acceptance criteria," and that based on the results, the device is "as safe and effective and performs as well as the legally marketed predicate device."
| Test Category | Acceptance Criteria (Implied) | Reported Device Performance |
|---|---|---|
| Syringe performance | Meets standards of ISO 11040-6, ISO 80369-7 and ISO 7886-1 | Conforms to standards (implied by conclusion of equivalence) |
| Transportation Validation & Shipping | Meets standards of ASTM D 4169: 2022 | Conforms to standards (implied by conclusion of equivalence) |
| Steam Sterilization Validation | Meets standards of ISO 17655-1, ISO 11737-1, ISO 11737-2 | Conforms to standards (implied by conclusion of equivalence) |
| Packaging Validation | Meets standards of ASTM F 88/ F88M-23 and ASTM F 1929-15 | Conforms to standards (implied by conclusion of equivalence) |
| Shelf-life test | Meets standards of ASTM F 1980-21 | Conforms to standards (implied by conclusion of equivalence) |
2. Sample size used for the test set and the data provenance
The document does not specify the sample sizes used for any of the non-clinical performance tests. There is no information about data provenance because these are non-clinical (laboratory/engineering) tests, not involving human subjects or real-world data collection in a clinical setting.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
This question is not applicable. The studies described are non-clinical engineering and laboratory tests, not clinical studies requiring expert consensus for ground truth establishment.
4. Adjudication method for the test set
This question is not applicable for the same reason as above.
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
A multi-reader multi-case (MRMC) comparative effectiveness study was not conducted. This device is a submucosal injection agent, not an AI-powered diagnostic or assistive tool, so such a study would not be relevant.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
This question is not applicable as the device is not an algorithm or AI system.
7. The type of ground truth used
For the non-clinical tests, the "ground truth" is defined by the specific parameters and requirements outlined in the referenced ISO and ASTM standards (e.g., sterilization effectiveness, packaging integrity, syringe function). The tests simply confirm whether the device meets these established engineering and safety standards.
8. The sample size for the training set
This is not applicable. There is no "training set" as this device is not a machine learning model.
9. How the ground truth for the training set was established
This is not applicable as there is no 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.