(28 days)
Pure-Vu System is intended to connect to standard or slim colonoscopes and gastroscopes to facilitate intra-procedural cleansing of the GI tract by irrigating and evacuating the irrigation fluids (water), bodily fluids and other debris, e.g. blood.
It is for use only by trained medical personnel located in hospitals, clinics and doctors' offices.
The Pure-Vu System enables cleansing of the digestive tract during endoscopy using a standard or slim colonoscope with a length of 1630mm - 1710mm and an outer diameter range of 11.7mm - 13.3mm (slim) and 12.8mm - 13.7mm (standard), or gastroscope with length of 950-1030mm and an outer diameter of 10mm - 10.9mm. The Oversleeve, which fits over the endoscope and is connected to an external Workstation, generates fluid and gas to break up debris. The debris & fluids are removed through the suction channels of the Oversleeve into an external waste container.
The Pure-Vu System consists of the following main components:
• Oversleeve (OS) and Umbilical Section (US) - The disposable Oversleeve is mounted on Standard or Slim commercially available colonoscopes or gastroscopes to allow a physician to cleanse the GI tract and is connected to the external Workstation via a disposable US.
• Workstation (WS) – The Workstation [WS] is reusable and supplies an irrigation mixture of water/saline and gas, and evacuates bodily fluid and matter. The Workstation [WS] includes the following components: A monitoring & Control Unit that controls the delivery of irrigation fluids and gas into the colon, and suction of bodily fluid and matter from the GI tract. Inlet Module that includes pumps and regulators enabling fluid & gas flow into the cleansing device. Outlet Module that includes pumps to evacuate fluid and matter from the Gl tract. A foot pedal activates the cleansing, suction and purging function, and switch between cleansing modes used by the physician.
• Loading fixture - The loading fixture is reusable and aids in assembling the Oversleeve onto the endoscope. Unloading aids - A disposable luer lock syringe/ duckbill check valve assembly used in unloading the Oversleeve from the endoscope.
This document is a 510(k) summary for the Motus GI Pure-Vu System, which is a medical device used for intra-procedural cleansing of the GI tract during endoscopy. The document describes the device, its intended use, and the performance data that supports its substantial equivalence to a predicate device.
Here's an analysis of the requested information based on the provided text, keeping in mind that this is a 510(k) submission and not a typical clinical study report for AI-powered devices. The "acceptance criteria" and "study that proves the device meets the acceptance criteria" in this context refer to the engineering and design verification tests conducted for a medical device seeking 510(k) clearance, particularly as it relates to demonstrating substantial equivalence for design modifications. This is not a study for an AI algorithm's performance.
1. A table of acceptance criteria and the reported device performance
| Test | Acceptance Criteria (same as for predicate device) | Reported Device Performance |
|---|---|---|
| Steering Test (Gastro Oversleeve) | Maximum 25% angle difference between a naked gastroscope and a gastroscope with an Oversleeve. | Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance. (Implies criteria met) |
| Head Pull Test (Gastro Oversleeve) | Gastro Oversleeve shall not move linearly in relation to the gastroscope with less than 10N of force applied. | Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance. (Implies criteria met) |
| Loading and maintenance of pressure during Gastro Oversleeve loading procedure | 1. 100% successful loading procedures. |
- No damage to the flexible head identified by 100% visual inspection.
- Maintain pressure of up to 400 mBar.
- No damage to the gastroscope in 100% of the loading procedures verified by examining images using the gastroscope's optics. | Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance. (Implies criteria met) |
Note: The document states that "Design verification and validation testing concluded that the design changes have no impact on the Pure-Vu System performance." This statement implies that the device met all the specified acceptance criteria for these tests. Specific numerical results validating each criterion are not provided in this summary, which is common for 510(k) summaries where the focus is on demonstrating substantial equivalence rather than presenting detailed raw data.
2. Sample sized used for the test set and the data provenance
The document does not explicitly state the sample sizes used for each of the performance tests (Steering Test, Head Pull Test, Loading and Pressure Maintenance Test). These are engineering verification and validation tests, not clinical studies. Therefore, data provenance in terms of country of origin or retrospective/prospective is not applicable in the same way it would be for a clinical trial involving patient data. These tests would have been performed in a lab setting by the manufacturer (Motus GI Medical Technologies Ltd., Israel).
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. The "ground truth" for these performance tests is based on objective, measurable physical properties and engineering specifications, not expert interpretation or clinical judgment. For example, angle differences are measured, force applied is measured, and visual inspections determine damage, not subjective expert opinion.
4. Adjudication method (e.g. 2+1, 3+1, none) for the test set
Not applicable. As noted above, these are objective engineering tests, not involving human interpretation or adjudication processes like those in clinical studies.
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
Not applicable. This device is a mechanical system for cleaning the GI tract, not an AI algorithm for image analysis or diagnosis. Therefore, an MRMC study and AI assistance are irrelevant to this submission.
6. If a standalone (i.e. algorithm only without human-in-the-loop performance) was done
Not applicable. This device is a mechanical system, not an algorithm.
7. The type of ground truth used (expert consensus, pathology, outcomes data, etc)
The "ground truth" in this context is based on engineering specifications and physical measurements. For example:
- Steering test: Measurement of physical angles and direct comparison.
- Head Pull Test: Measurement of force required for linear movement.
- Loading and maintenance of pressure test: Measurement of pressure, visual inspection for damage, and direct observation of loading success.
8. The sample size for the training set
Not applicable. This device is a mechanical system, not an AI-powered device that requires a "training set."
9. How the ground truth for the training set was established
Not applicable. As there is no training set for an AI algorithm, this question is not relevant.
In summary:
This 510(k) submission focuses on demonstrating the substantial equivalence of modifications to an existing mechanical medical device (Pure-Vu System) as defined by its physical performance characteristics. The "acceptance criteria" and "study" described are engineering and design verification tests to ensure the modified device performs as intended and introduces no new safety or effectiveness concerns, thereby maintaining substantial equivalence to the predicate device. It is crucial to understand that this document does not pertain to the validation of an AI/ML algorithm or its clinical performance.
§ 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.