(88 days)
The 360° Gas Assisted Endoscopic Applicator is intended for the application of two non-homogenous fluids.
The 360° Gas Assisted Endoscopic Applicator is a sterile, single-use, disposable device intended for the application of two non-homogeneous liquids. The 360° Gas Assisted Endoscopic Applicator is designed with two luer connectors at the proximal end, which is used for connection to two syringes containing the non-homogeneous liquids. There is also a connector at the proximal end to be attached to a tubing set which is connected to a compressed air/inert gas power source. The 360° Gas Assisted Endoscopic Applicator is packaged with an air line with filter in a PETG tray/Tyvek lid configuration and sterilized using ethylene oxide. Five individually sterile packaged applicators are contained in a shelf carton along with the instructions for use.
The provided text describes a medical device, the "360° Gas Assisted Endoscopic Applicator," and its non-clinical performance data for 510(k) clearance. However, it does not contain details of a study that proves the device meets specific acceptance criteria in the context of an AI/algorithm-enabled device.
The document describes a traditional medical device submission (a special 510(k)) for a physical applicator, not a software or AI-driven diagnostic device. Therefore, many of the requested categories (like sample size for test set, data provenance, number of experts, MRMC studies, standalone performance, training set size, etc.) are not applicable to the information provided.
Despite this, I will extract the relevant information concerning acceptance criteria and the "study" (non-clinical testing) that demonstrates the device meets these criteria, as described in the provided text.
1. Table of Acceptance Criteria and Reported Device Performance
| Acceptance Criteria Category | Reported Device Performance (as per non-clinical testing) |
|---|---|
| Biocompatibility | Met ISO 10993 Part 1 standards; considered safe for intended biocontact. |
| Mechanical Integrity | Met pre-defined acceptance criteria, demonstrating mechanical integrity and suitability for intended use over labeled shelf life. |
| Leak Testing | Met pre-defined acceptance criteria. |
| Pull (Torque) Testing | Met pre-defined acceptance criteria. |
| Spray Testing | Met pre-defined acceptance criteria. |
| Mixing Test | Met pre-defined acceptance criteria. |
| Sterilization Validation | Met pre-defined acceptance criteria (sterilized using ethylene oxide). |
| Shelf life Evaluation | Met pre-defined acceptance criteria. |
2. Sample size used for the test set and the data provenance
- Sample Size: Not specified. The document refers to "test articles" but does not quantify the number of devices or components tested for each non-clinical test.
- Data Provenance: Not applicable in the context of clinical data. This refers to design verification and biocompatibility testing performed by Micromedics, Inc.
3. Number of experts used to establish the ground truth for the test set and the qualifications of those experts
- Not applicable. This device is hardware for fluid application, not an interpretative AI or diagnostic tool requiring expert ground truth for a test set.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
- Not applicable. This is not a study involving human interpretation or clinical adjudication.
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
- No. This is not an AI-enabled device; therefore, no MRMC study was conducted.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
- Not applicable. This device does not involve an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc.)
- Not applicable. The "ground truth" for this device's performance is based on engineering specifications, standardized test methods (like ISO 10993 for biocompatibility), and internal design verification criteria, not clinical outcomes or expert labels.
8. The sample size for the training set
- Not applicable. This device does not involve a training set as it is not an AI/ML product.
9. How the ground truth for the training set was established
- Not applicable. This 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.